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Document 52013SC0167
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)
/* SWD/2013/0167 final */
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation) /* SWD/2013/0167 final */
Table of contents INTRODUCTION || 1 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES || 2 1.1. EX-POST ANALYSES OF THE EU SYSTEM OF OFFICIAL CONTROLS || 2 1.2. DATA COLLECTION BY OR ON BEHALF OF THE COMMISSION || 3 1.3. CONSULTATIONS || 4 1.3.1. MEMBER STATES || 4 1.3.2. STAKEHOLDERS || 4 1.3.3. SUMMARY OF THE CONSULTATION OF THE INTERESTED PARTIES || 4 1.4. INTER-SERVICE STEERING GROUP (ISSG) || 4 1.5. IAB OPINION || 5 2. PROBLEM DEFINITION || 6 2.1. BACKGROUND || 6 2.1.1. THE EU SYSTEM OF OFFICIAL CONTROLS ALONG THE AGRI-FOOD CHAIN || 6 2.1.2. THE INTERNATIONAL DIMENSION || 7 2.2. PROBLEM IDENTIFICATION 2.2.1. DESIGN OF THE OFFICIAL CONTROLS' FRAMEWORK 2.2.2. DIFFICULTIES AND INEQUITIES IN FINANCING OFFICIAL CONTROL ACTIVITIES || 8 8 12 2.3. PARTIES AFFECTED || 15 2.4. HOW WOULD THE PROBLEM EVOLVE, ALL THINGS BEING EQUAL? || 16 2.5. DOES THE EU HAVE THE RIGHT TO ACT (SUBSIDIARITY)? || 17 2.5.1. RIGHT OF THE EU TO ACT (LEGAL BASIS) || 17 2.5.2. NECESSITY FOR THE EU TO ACT (SUBSIDIARITY) || 17 3. OBJECTIVES || 18 3.1. GENERAL OBJECTIVES || 18 3.2. SPECIFIC OBJECTIVES 3.2.1. OBJECTIVES RELATED TO THE DESIGN OF THE OFFICIAL CONTROLS' FRAMEWORK 3.2.2. OBJECTIVES RELATED TO THE FINANCING OF OFFICIAL CONTROLS || 18 19 19 3.3. OPERATIONAL OBJECTIVES || 20 3.4. CONSISTENCY WITH THE OTHER EU POLICIES AND HORIZONTAL OBJECTIVES || 20 4. POLICIY OPTIONS || 21 4.1. POLICY OPTIONS INCLUDED IN THE ANALYSIS || 21 4.2. DISCARDED POLICY OPTIONS || 26 5. ANALYSIS OF IMPACTS || 28 6. COMPARING THE OPTIONS IN LIGHT OF THE OBJECTIVES || 41 6.1. COMPARING THE OPTIONS IN LIGHT OF THE OBJECTIVES || 41 6.2. COST-BENEFIT ANALYSIS 6.3. PREFERRED OPTION || 43 44 7. MONITORING AND EVALUATION || 45 ANNEXES || ANNEX I || GLOSSARY || 47 ANNEX II || OVERVIEW OF THE EXISTING LEGISLATIVE FRAMEWORK || 48 ANNEX III || PROBLEM DEFINITION – DETAILS AND EXAMPLES || 53 ANNEX IV || PROCEDURE – DETAILS OF THE CONSULTATION || 59 ANNEX V || PROCEDURE – SPECIFIC DATA COLLECTION ACTIVITIES || 63 ANNEX VI || PROCEDURE – LIST OF CONSULTED STAKEHOLDERS || 64 ANNEX VII || PROCEDURE – LIST OF FVO AUDITS SINCE 2007 || 66 ANNEX VIII || REVISION OF REGULATION 882/2004 – SUMMARY OF THE MS’ OPINIONS || 75 ANNEX IX || REVISION OF REGULATION 882/2004 – SUMMARY OF THE STAKEHOLDERS’ OPINIONS || 79 ANNEX X || FEES – EXECUTIVE SUMMARY OF FCEC STUDY || 88 ANNEX XI || FEES – STUDY CARRIED OUT BY GHK TO SUPPORT THE IMPACT ASSESSMENT AS REGARDS THE FINANCING OF OFFICIAL CONTROLS || 94 ANNEX XII || FEES – SUMMARY OF STAKEHOLDERS’ OPINIONS || 103 ANNEX XIII || FEES – SUMMARY OF MS’ OPINIONS || 110 ANNEX XIV || FEES – EVIDENCE CONCERNING PROBLEMS OF INTERPRETATION || 117 ANNEX XV || FEES – EXAMPLES OF STATED LIMITED AVAILABILITY OF RESOURCES IN FVO REPORTS || 136 ANNEX XVI || FEES – VALIDATED BASELINE SCENARIO || 151 ANNEX XVII || FEES – SUPPORTING DATA || 179 ANNEX XVIII || LABORATORIES – MS’ CONSULTATIONS ON THE ACCREDITATION OF OFFICIAL LABORATORIES || 189 ANNEX XIX || LABORATORIES – COSTS RELATING TO THE INTRODUCTION OF A MANDATORY ACCREDITATION OF OFFICIAL LABORATORIES CARRYING OUT PLANT HEALTH TESTS AND TO THE CREATION OF EURLs || 200 ANNEX XX || DIRECTIVE 96/23/EC – MS’ CONSULTATIONS ON THE IMPACT OF DIFFERENT OPTIONS || 203 ANNEX XXI || DIRECTIVE 96/23/EC – COSTS REDUCTIONS RELATING TO THE REPEAL OF THE DIRECTIVE 96/23/EC || 228 ANNEX XXII || DIRECTIVE 96/23/EC – ADMINISTRATIVE BURDEN REDUCTION || 231 ANNEX XXIII || MAIN CHANGES TO THE EXISTING LEGISLATIVE FRAMEWORK || 237 ANNEX XXIV || SIMPLIFICATIONS GAINS || 244 ANNEX XXV || EXEMPTIONS AND REDUCTIONS FOR MICRO-ENTERPRISES || 247 ANNEX XXVI || INVASIVE ALIEN SPECIES – ONGOING INITIATIVE || 252 Introduction In order to afford European Union (EU) citizens a high level of human,
animal and plant health, and guarantee the functioning of the internal
market, Union legislation provides for a set of harmonised rules to prevent,
eliminate or reduce the level of health risk to
humans, animals and plants, which may arise along the agri-food chain. The
risks addressed include health risks sensu stricto (risks to the
integrity of humans, animals and plants from pests, diseases, microbial and
chemical contaminants and other hazards) but also the preservation of inherent
qualities required to ensure a safe start of plant production and regulated
production methods (i.e. animal welfare, organic farming, geographical
indications). In
particular, the EU has established rules governing all the activities, from
primary production to retail and catering, which may affect: -
the health of animals and
plants, -
the safety of food and feed
for EU citizens, -
the welfare of animals, -
the quality of plant
reproductive material and other quality aspects such as organic production and
geographical indications. In
addition, rules have also been established to ensure the provision of
information to consumers and to guarantee fair commercial practices in agri-food
chain products' trade. This wide ranging set of rules is referred to in this
Impact Assessment (IA) as
"agri-food chain rules". To
ensure agri-food chain rules are enforced by Member States (MS) across
the EU in a harmonised manner, a legislative framework for the organisation of
official controls has been established. This IA
considers the possible impacts of reviewing such a framework. Figure 1 – application of EU rules across the agri-food chain 1. Procedural issues and consultation of interested parties 1.1. Ex-post analyses of the EU system of official controls In
July 2009 the Commission issued a report for the European Parliament and the
Council[1] to review the
experience gained throughout the first years of application of Regulation (EC)
No 882/2004 (hereafter "the Regulation")[2].
The report showed that the new rules have introduced important changes to the
way competent authorities ("CA") organise and carry out
official controls, establishing a more integrated approach which ensures
confidence in the agri-food chain across the EU. However, given the increasing
integration of business operators along the agri-food chain, it indicated that
improvements could be made to meet the Commission’s Smart Regulation Agenda
objective of simplifying regulation. This would also address issues of
administrative burden reduction and fostering competitiveness. The
report also indicated that in order to rationalise and
simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, consideration should be given to
the possibility of integrating the rules currently applicable to official
controls in specific areas (e.g. residues of veterinary medicines in
live animals and animal products[3]; and plant health[4])
into the framework of the Regulation. Additional
research[5] carried out to evaluate the application of the
Regulation outlined the existence of problems regarding the application of the
rules (Articles 26 to 29) governing the financing of
official controls. The report concluded that the overall objective of
ensuring Member States allocate adequate financial
resources to official controls is not being met throughout the EU. It
recommended reviewing Articles 26 to 29 of the Regulation. The
Regulation also establishes the overall principles for MS’ controls carried out
on third country imports to the EU (import controls). In December 2010,
the Commission adopted a report on the effectiveness and consistency of
sanitary and phytosanitary controls on imports of food, feed, animals and
plants[6]. Whilst concluding that the
comprehensive body of legislation currently in place allows the EU to deal with
emerging risks or emergency situations without causing distortions to trade,
the report also found that import controls could be made more coherent by
reviewing and consolidating existing acts[7]. It concluded
that this improvement would bring benefits for MS and operators handling goods
from third countries (importers). The review of the Regulation was considered a
good opportunity to take account of the findings of the report and consolidate
controls where possible. Besides the above, DG
Health and Consumers (DG SANCO) has conducted further analysis on the alignment
of EU sectoral legislation on official controls[8] with the
overarching principles established in the Regulation. The review of the Regulation is part of a package which also includes
three other major reviews to modernise the animal health, plant health and
plant reproductive material (hereafter 'PRM') acquis[9].
Its aim is therefore to modernise and integrate the system of official controls
in a manner that also consistently accompanies the upgrade of EU policies in
these sectors. The package is scheduled for adoption in 2012. All
the information, data and evidence collected as part of the reviews above, including
evaluations of the existing regimes, has been used throughout this IA to define
problems, assess impacts and appraise options. 1.2. Data collection by or on behalf
of the Commission ·
The Food and Veterinary Office (FVO) The
Commission is responsible for ensuring that Union legislation is properly
implemented and enforced by the competent authorities of the MS. The Food and Veterinary
Office (''FVO'') is a Commission's service which contributes to the fulfilment
of this task, by in particular carrying out audits in the MS to verify the
implementation of agri-food chain legislation and the functioning of national control
systems, and to collect information on implementation practices. The
findings of each audit are set out in an audit report[10].
Information on the realities and difficulties of day-to-day implementation of agri-food
chain legislation comes from such audit reports, in particular the ones assessing
the functioning of national control systems along the agri-food chain. This IA draws on the findings
of these reports and the data contained within them. Within a task force established by DG SANCO, feedback from national authorities and
stakeholders gathered across all sectors (notably through the audit activities
of the FVO) was studied to identify problems and shortcomings of the EU system
of official controls. ·
Studies on the system of financing official controls In
addition to the 2009
study on "Fees or charges collected by Member States to cover the costs
occasioned by official controls" (see foot note 5), DG SANCO commissioned from another
external contractor[11] a study to
support the assessment of the options identified (2011)[12].
Whilst the contractor reported that there was difficulty in obtaining exact
figures from MS to quantify the problem, the report did highlight the diverse
spread of cost recovery within MS and certain problems with the application of
EU rules which corresponded with previous studies and the Commission's own
findings. ·
Other data sources In
addition to the data mentioned above, further information was collected on
specific issues (i.e. official controls in the Plant Health area and official
controls on residues of veterinary medicines) to contribute to the analysis[13].
1.3. Consultations[14] 1.3.1. Member States The
key issues to be addressed by the review of the system of official controls as
well as the changes to be included in the legislative framework have been
extensively discussed within the Working Group on the general application of the
Regulation set up within the Standing Committee on the
Food Chain and Animal Health (SCFCAH)[15].
The main problems
identified and the provisional options were also presented and discussed at
meetings of the Heads of Food Safety Agencies on 29 June-1 July 2011 and on 8
December 2011. Moreover, MS were
consulted in the context of the two studies contracted out by the Commission in
the area of the financing of official controls. Finally, MS have been
consulted within other fora and frameworks on the following specific
issues relating to official controls: accreditation of official laboratories, official
controls on residues of veterinary medicines in live animals and animal
products, veterinary border controls, animal health, plant health and plant
reproductive material. 1.3.2. Stakeholders Stakeholders
(industry association representatives and NGOs) have been consulted during the
evaluation studies and the preparation of the IA. Two ad hoc Working
groups, on the review of the system of official controls and the review of the
rules governing the financing of such controls respectively, were convened
under the Advisory Group on the Food Chain and Animal Health and Plant Health.
Progress was also presented and discussed in the plenaries of the
aforementioned Advisory Group and on invitation at meetings of several industry
representative bodies. In addition to discussions with MS, stakeholder
consultation was a key element of the two studies contracted out to external
consultants in the field of the financing of official controls. 1.3.3. Summary of consultation with
interested parties Annexes VIII, IX, XII and
XIII give an overview of the positions expressed by MS and stakeholders at
different stages of the review; Annex VI lists all the stakeholders that have
been consulted during the process. 1.4. Inter-Service Steering Group (ISSG) A Commission
Inter-Service Steering Group on the IA for the review of the EU system of
official controls along the agri-food chain was established. The group was led
by DG Health and Consumers (SANCO) with the participation of the following
Commission Directorates General and Services: Agriculture and Rural
Development, Budget, Environment, Enterprise and Industry, Research and
Innovation, Taxation and Customs Union, Trade, Development and Cooperation, Maritime
Affairs and Fisheries, Legal Service, Justice and the Secretariat-General. The group met seven times. A final draft was sent
to the group, whose members provided comments at a last meeting on 27 January
2012 which have been incorporated into the IA. 1.5. IAB opinion The IA report was
submitted to the IA board on 29 February 2012 and was formally presented on 28
March 2012. Following this meeting the board issued an opinion on 30 March 2012
emphasising four main points as well as some presentational issues to be addressed
in the final version of the report. Following re-submission on 16 May, a
revised opinion was issued on 8 June clarifying the points to be addressed: 1)
Improve presentation of the problem
definition: -
section 2.2. presents now in a clearer and
balanced manner the two main issues at stake: the deficiencies in the design of
the official controls' framework (2.2.1.), and the uncertainties as regards the
financing of such controls (2.2.2.); evidence as well as examples supporting
both sets of issues are inserted; -
a better distinction has been drawn between
problems, underlying causes and consequences. -
More thorough evidence on the design of the
official controls and their efficiency across MS has been introduced by, where
possible, quantifying the costs of inefficient controls to MS and operators.
Where this is not possible, due to a lack of relevant data caused by
short-comings in the current regime, this has been identified. -
The problem definition is supported by clearer,
referenced examples and is presented in table 1. 2)
Better define objectives and strengthen
the intervention logic: -
the objectives in section 3.2. are now explained
in light of the problem definition and the link between objectives and key
problem issues is made explicit by a new table; -
operational criteria in section 3.3 are
reformulated in order to make them more appropriate and quantifiable; -
the notion of safety has been reinforced in the
intervention logic (problem definition, objectives, options, analysis of
impacts), including by explaining why it is important that SMEs and
micro-enterprises are subject to official controls without exceptions; -
section 4.1. now explains how the policy options
included in the analysis relate to the specific objectives. 3)
Reformulate the options and include options
that address SME/micro enterprise issues -
options to address micro-enterprises issues are
now included in sections 4.1. and 5 (under option 1B, exempting them from fees)
and in section 4.2. (reducing controls on them); -
The text better explains the effect of fees on
micro-enterprises by integrating into section 2.2.2, additional relevant
examples and findings from the referenced studies; -
options 2 to 4 include and assess a mechanism to
alleviate the burden of fees on micro-enterprises while taking into account
competition and sustainability concerns; -
the presentation of the logic flow in the
assessment of impacts has been improved by separating the two steps of the
assessment and explaining their sequence (section 4.1.); -
the earmarking element, presented in the
original report, was eliminated from options 2 to 4 (and is no longer analysed
in detail in the report) as the same objective could be achieved through less
prescriptive tools (transparency, accountability) (section 5, under option 2). 4)
Present a clear overview of costs and
benefits and make comparison of options more transparent -
a new table 4 in section 6.2. provides an
overview of costs and benefits that could be estimated through the assessment
and which are referenced in boxes 6, 7 and 9. It presents figures as both
benefits and costs to MS and industry, and calculations are explained in
footnotes. An explaination of the table now makes it clearer to which sectors
the costs and benefits apply under the different options. -
section 6.2. presents in a more transparent
fashion the comparative advantages of the different options, with regard also
to the views of stakeholders. The figures and results presented in the
analysis of costs and benefits are explained, supported by verifiable evidence,
and clearly referenced. -
With regards to MS which already apply full cost
recovery, Box 6 in section 5, presents examples of practices which are
currently undertaken. 5)
Procedure and presentation: -
references to MS and stakeholders' opinions are
now systematically made throughout the report. All examples and evidence are
clearly referenced; -
Annex XI includes the executive summary of the
GHK study only, and relevent findings are drawn out in a separate annex (XVII)
so that it is clear that the Commission does not endorse the study as a whole; -
Annexes XXVII was removed because it is not
relevant for the report. 2. Problem Definition 2.1. Background 2.1.1. The EU system of official controls along the agri-food
chain The
responsibility to enforce EU agri-food chain legislation lies with the MS,
whose authorities monitor and verify that the relevant requirements are
effectively implemented, complied with and enforced across the Union. In doing that they verify that operators' activities and goods placed on the EU market
(either EU produced or imported from third countries) are in compliance with
the relevant EU agri-food chain standards and requirements. Harmonised EU rules to
govern control activities performed by MS are established in the Regulation
with the aim of creating an integrated and uniform approach to official
controls along the agri-food chain. The Regulation provides for a general
framework for official controls in the sectors of feed and food law, animal
health and animal welfare rules, laying down rules governing both the organisation
and the financing of such controls. Despite the above
integrated approach, for historical reasons controls for animal health purposes
(both on domestic and imported goods) and controls on residues of veterinary
medicines, remained regulated separately. Moreover, certain sectors pertaining
to the agri-food chain were not included in the scope of the Regulation - i.e. plant
health, PRM, animal by-products (hereafter 'ABP') - and specific sectoral
regimes were developed for them.[16] Competent
authorities are required to perform official controls on all business operators
active in the agri-food chain. Given that the emergence of food safety risks
does not necessarily depend on the size of an operator, the current system is
based on the principle that all should be subject to official controls, without
exception, as this is the only way to ensure a risk-based prioritisation of
controls, an efficient use of resources and the safety of the agri-food chain. As
regards the number of business operators concerned, figures suggest that they
amount to approximately 25 million[17]. As highlighted in
section 5 below, in a majority of Member States, micro-enterprises[18]
represent more than half of the total number of business operators (at least in
the four industries which are subject to the most intensive official control
activities)[19]. In this context, the
significance of controlling smaller businesses, including micro-enterprises,
becomes apparent. This need is further reinforced by the fact that,
notwithstanding their size, such enterprises are equally likely to conceal
serious food safety risks/concerns. The recent E.Coli crisis, which
spread across several Member States due to contaminated sprouted seeds, originated
in a micro-enterprise. The crisis not only resulted in dramatic human
losses with a death toll of 55 people and 4000 cases of serious human disease,
but also caused huge economic damage which, in the first two weeks alone,
amounted to approximately €812 million. 2.1.2. The
international dimension The
efficient operation of the EU system of official controls is important for both
EU exports and imports. The
EU is the world's largest exporter and importer of food and drink products. In
2010 EU27 food and beverages imports were worth €78 billion, and exports €73 billion.
The EU27 imported 79.3 million tonnes of food and live animals and 3.4 million
tonnes of beverages in 2010, with a trade deficit of 14 million tonnes for food
and live animals, but a surplus of 6 million tonnes for beverages[20]. The
EU's ability to export towards third countries relies on the reputation of the
high production standards and added value that the EU goods can prove to have
compared to the ones produced outside Europe. This can only be achieved by a
reliable and trusted official controls system which ensures that the EU agri-food
chain safety and quality standards are consistently enforced and corresponding
expectations from trade partners met. As
regards imports, it is essential that all food on the EU market is safe.
Controls perfomed by the MS CAs on goods arriving from third countries ensure
that the latter offer adequate guarantees that they meet equivalent safety
levels. The relevant import control rules must comply with the WTO Sanitary and
Phytosanitary (SPS) Agreement, in particular with the provisions laid down in
Annex C to the SPS Agreement. 2.2. Problem identification MS ensure a good level of
implementation of official controls across the agri-food chain, and progress
can be recorded in the use of the enforcement tools established by Regulation
882/2004 (e.g. control planning and coordination, verification of
effectiveness, auditing[21]). However, evidence gathered over the last five years of
application (feedback from MS' CAs and FVO audits reports) has shown shortcomings stemming, Ø
on the one hand, from the design
of the official controls framework (notably from the incomplete
implementation of certain principles/objectives laid down in Regulation
882/2004, and from the fact that the integrated approach to official controls
across the agri-food chain is consolidated only partly), and Ø
on the other hand, from uncertainties
as to the availability of sufficient resources to adequately finance official
controls. 2.2.1.
Design of the official controls' framework 2.2.1.1. Inconsistencies, gaps in control requirements Despite
the increasingly integrated operation of activities along the agri-food chain,
the integration of the EU system of official controls still suffers inconsistencies
and legal gaps, in particular as regards controls carried out for
plant health, PRM and ABP purposes. Controls in these
areas are in fact not aligned fully with the framework laid down in the
Regulation. On the other hand, overlapping requirements subsist also in
the animal health area, already covered by the scope of the Regulation,
because of the co-existence of sectoral legislation which survived the adoption
of the general framework in 2004. i)
While certain differences in the design of official controls are justified
because of the peculiarities of the concerned sectors (e.g. the certification
procedure in the plant health area differs from that of the veterinary area),
others appear to be arbitrary and result in inconsistencies in those cases
where the same approach would be justified across sectors (e.g. the mechanism
for delegating plant health control tasks differs from that regulated upon by
the Regulation; also, laboratories performing official tasks are required to be
accredited under ISO standards in all areas except plant health and PRM). Control
authorities thus operate on the basis of different approaches and under
different conditions depending on the specific agri-food chain rules they are
called upon to enforce, without differences being justified. ii)
Some of the implementation tools or mechanisms established in Regulation
882/2004 are not available for the performance of official controls in the plant
health, PRM and ABP areas (e.g. transparency requirements in relation to
enforcement activities do not apply to controls on ABP rules; in the same area,
no FVO audits are foreseen; EU rules on PRM do not provide for FVO audits on
the functioning of national control systems, nor do they regulate upon
competent authorities and their duties in this sector). As a result, CAs are
not provided with the complete set of tools meant to ensure accountability, soundness
and effectiveness of their enforcement activities. iii) Certain
requirements or procedures regulated upon by the Regulation in a horizontal
manner are also present in sectoral legislation, in particular in pre-existing
veterinary legislation. For example, the mechanism for administrative
assistance and cooperation is regulated upon by the Regulation and by
Directives 89/662[22] and 89/608[23].
This has resulted in different interpretations of similar procedures by MS who
undertake different activities to verify compliance. Inconsistencies
and legal gaps are due to the fact that EU legislation
on official controls has in the areas of plant health, PRM and ABP developed
separately from the general framework established by the Regulation, and
overlap in control requirements derived from the co-existence, for
animal health related controls, of the Regulation with pre-existing sectoral
legislation. Whilst
it is not always possible to quantify the cost to MS CA and operators of such
inconsistencies and gaps it stands to reason that the inefficiencies so caused
will lead to official control enforcement regimes which are unnecessarily
costly for CAs to operate and are overly burdensome on operators. 2.2.1.2. Inconsistent implementation of risk-based approach Regulation
882/2004 is based on the principle that official controls should be
risk-based in order to maximise the efficiency of control activities directed
at protecting health. Box 1: Risk based approach to official controls The risk
based approach to official controls In a
situation where resources are finite these are to be used selectively and the
selection should be based on a series of criteria which include: the hazard
and risks associated with the specific business activity, or product, the operator's
record of compliance and reliability, indications of possible non-compliance.
Failure to
do so would result in resources being allocated on the basis of non-risk
related criteria and in situations where official controls which are more
relevant for the protection of public health are not receiving appropriate
attention. The
analysis focuses on the areas where the risk-based approach is still not fully
used (controls at the border and controls on residues of veterinary medicines). i)
EU border controls on certain goods from third countries To
ensure harmonised verification of compliance with EU agri-food chain rules, MS
are required to carry out official controls on certain goods coming from third
countries at the external borders of the EU (EU border controls). According to
the risk-based approach, also EU border controls should be limited and
proportionate to what is necessary to contain potential risks for humans,
animals or plants. However,
the continuous and timely adjustment of the control effort at the EU border to
the needs dictated by the actual risk is hampered by the rigidity and
fragmentation of existing rules governing border checks in the different areas.
E.g. current rules require MS to take samples and perform physical checks on 100%
of consignments of animals, products of animal origin and plants intended to be
introduced into the EU. Existing arrangements to reduce the frequency of costly
and time consuming physical checks do not allow for the continuous adjustment
necessary to take account of situations where the potential risk of the
consignment spreading an animal disease or otherwise endangering public health
is reduced. In
addition, the prioritarisation of the controls is carried out in a sectoral
manner (animal health, public health, plant health) and not by comparing the
levels of risk of all commodities of relevance for the agri-food chain across
sectors: in other words, prioritarisation is carried out within sectors and not
across sectors. ii) Official
controls on residues of veterinary medicines MS are
required by the provisions of Directive 96/23/EC to take samples of animals and
foods for the presence of residues of veterinary medicines. Legal requirements
are very strict, dictating the number of samples, which animals/tissues to
analyse and for which substances. The result of such rigidity is that currently
MS are demanded to carry out checks and laboratory analysis for substances for
which over the past years there has been little or no evidence of actual risks. Examples[24] Stilbenes: MS are required to take samples of all animals and animal products to check the presence of 'stilbenes'. The chart below shows that no non-compliance has been detected for several years now but, despite this, between 21000 and 24000 samples are analysed each year across the EU for stilbenes, their derivatives, salts and esters. Year Total number of samples analysed Number of non compliances 2007 23 411 0 2008 21 664 0 2009 21 815 0 2010 23 455 0 Resorcylic acid lactones (including zeranol): Samples taken on pigs to detect resorcylic acid lactones. More than 6000 samples continue to be analysed each year across the EU. Year Total number of samples analysed Number of non compliances 2007 6234 0 2008 5594 0 2009 6237 0 2010 6166 0 The reason for official
controls not being aligned to the risk-based approach in the areas above is
that such controls are currently prescribed by EU rules[25],
pre-existing the Regulation and not repealed by it, which do not establish
appropriate mechanisms to take into account the actual risk a given good,
business activity or third country might present. In addition, as regards the
area of EU border controls, the lack of prioritarisation of controls across all
sectors is due to the fact that existing legislation is highly fragmented, and different
sets of rules apply to different sectors (food and feed of non animal origin,
live animals and their products, plants)[26]. This
results in resources being allocated – in all MS - to controls that are not
justified by the risk and consequently are a significant waste of public
resources (time and money) that could be better used where risks are higher.
The inefficient use of resources also results in unnecessary burdens on
operators (time, staff, equipment and facilities mobilised to allow controls).
Indeed, it is estimated that the result of the current regime for residues of
veterinary medicines may be the lost opportunity to save between €12.4 million
and €98.5 million/year (see Box 4 in Section 5 below). 2.2.1.3. Administrative burden and disproportionate requirements Unnecessary
administrative burdens are placed on MS' CAs. It is the case for the obligation
for annual updates to MS monitoring plans of residues of veterinary medicines that
these be transmitted to and approved by the Commission. In the same area, also
redundant are the specific reporting obligations, as they duplicate the general
reporting requirement in the Regulation. These burdens result from obligations
on MS laid down in Directive 96/23/EC. In
addition, while requiring official laboratories to be accredited in accordance
with EN ISO/IEC 17025[27], the Regulation does not
allow temporary arrangements for emergencies or cases where laboratories have
to use a new method not yet included in the accreditation. Example: no or nearly no official laboratory in the EU was accredited according to ISO 17025 for the detection of mineral oil in sunflower oil or for the detection of melamine in food when respectively the crisis on sunflower oil from Ukraine or the one on melamine in food from China broke out. This lack of ability to allow temporary arrangements for emergencies could have weakened the legitimacy of controls (and analyses) carried out during the emergency, and of any measure taken by MS on that basis. Similarly,
no flexibility is foreseen for small laboratories carrying out extremely basic types
of tests). Example: soon after the adoption of Regulation 882/2004 several MS brought to the attention of the Commission that accreditation is very burdensome and disproportionate in the case of smallest Trichinella laboratories, which are attached to a slaughterhouse or a game handling establishment and only perform a very simple type of test. 2.2.1.4. Uneven enforcement of cooperation and transparency
requirements The
Regulation includes some important principles and mechanisms which are
currently underused by MS' CAs or applied according to divergent practices
among MS. In particular, it calls
for administrative cooperation i) between MS for cross-border enforcement
action, and ii) between sanitary authorities and customs services. However, MS
are not making full use of this tool and/or they encounter difficulties in
understanding the conditions for its application. Examples: - the Commission received a complaint against a MS from a business operator, alleging that the MS's CAs, although aware of a violation of agri-food chain rules perpetrated by the supplier of the complainant (from a second MS), failed to contact the MS of dispatch as requested by Article 38 of Regulation 882/2004 to request their cooperation, and held the complainant solely responsible and liable for the violation. The receiving MS's CAs were acting under the wrong assumption that the notification in the Rapid Alert system for food and feed (RASFF) had satisfied its obligation under Article 38. - Another MS recently sent a complex interpretation query asking whether national customs authorities, in case of food and feed, can trigger the mechanisms foreseen in Articles 27/29 of Regulation 765/2008 (requirements for accreditation and market surveillance relating to the marketing of products) allowing them to suspend release of a product for free circulation on the Union market and inform the sanitary authority any time the product seems to present a serious risk to health, safety. In both cases, uncertain interpretation of the rules has the potential to result in CAs not taking appropriate action (to pursue cross-border violations, to prevent the release of unsafe goods). Another
requirement laid down in the Regulation which is open to divergent practices in
MS is the obligation for the MS' CAs to ensure a 'high level of transparency' of
control activities with regards to operators and the public at large. The uneven enforcement of
the principles and mechanisms above is mainly due to the fact that the
Regulation foresees no comprehensive guidance on how cooperation should take
place (timing, information to be exchanged, etc.) and what information should
be made available to the public. In addition, the Commission is not empowered
to lay down further details and uniform implementation modalities. Whilst it is not possible
to quantify the shortcomings identified in financial terms, it is clear that
the regime established by the legislation is not serving the public to its full
potential. 2.2.2.
Difficulties and inequities in financing official control activities Another
area in which the objective of the Regulation is not fully achieved by MS is
the financing of official controls. MS are
requested to ensure that adequate financial resources are available for
official controls. However,
information from MS and FVO audits indicates widespread difficulties in the MS
to appropriately resource control services. Annex XV lists a number of
significant cases where, during the last 4 years, EU inspectors have reported
that the reason for identified shortcomings in control activities or for
unsatisfactory or insufficient levels of controls is attributed to the lack or
shortage of resources. In some cases the lack of resources leads to under-implementation
of control plans or to a violation of established control requirements. For example
an FVO audit in a MS, to evaluate controls on residues and contaminants in
live animals and animal products and veterinary medicinal products, revealed
that the CA could not afford to have samples, which had been taken from 'suspect'
slaughterhouses, analysed urgently, so as to allow detention of the carcasses
pending the result of the analysis. During a similar audit in another MS it was
revealed that the insufficient provision of staff, equipment and reagents was a
significant obstacle to the proper functioning of the laboratory network
meaning that the MS's CAs were not meeting their legal obligations) . All
cases reported, point to serious difficulties faced by CAs in maintaining an
appropriate level of controls (e.g. of veterinary checks on imported goods at
the border inspection posts, of farm level controls on the use of veterinary
medicines[28]). Further examples are
presented in Annex XV. Such
difficulties are exacerbated by the ongoing economic and financial crisis and
there is a risk that further pressure on public finances and on funds made
available for official controls might increasingly adversely affect MS'
capacity to deliver efficient official controls, and consequently the level of
protection offered by EU law. To
reduce the dependency of the financing of controls on public finances, the
Regulation identifies a number of control activities (mainly on meat, milk,
fishery production, and on controls carried out at EU borders) for which MS
shall collect a fee from operators (mandatory fee) to recover control
costs[29]. For other
control activities, MS can choose whether to charge a fee on operators or not. However,
mandatory fees as currently regulated do not enable CA to recover all their
costs and thus to ensure a stable influx of resources to finance the
performance of controls. On the one hand, fees are only collected for certain
controls, whereas on the other hand, presently collected fees do not
necessarily enable CA to recover their costs fully (MS typically recover between
20% and 80% of costs with respect to controls subject to mandatory fees resulting
in the lost opportunity to mobilise an estimated €0.9bn – €3.4bn per year
across the MS for official control activities[30]). Limited
scope of mandatory fees, lack of consistency/fairness Current
rules only require mandatory fees to be charged for official control activities
on businesses handling meat, fishery products, and milk, for the approval of
feed establishments and for most controls at the borders. With the new
framework for official controls established by the Regulation, and the
requirement that MS carry out such controls at all the stages of the agri-food
chain, the current list of mandatory fees no longer appears justified and fair.
Indeed, the Commission is consistently informed by those sectors currently
subject to mandatory fees that they view the limitation of mandatory fees to
particular sectors as being manifestly unfair. Additionally, by limiting the
collection of mandatory fees to particular sectors, the opportunity is lost to
mobilise a guaranteed flow of resources of official control activities the
amount of which can be estimated to be between €2.3bn and €37bn/year across the
MS (see table 4 below - these figures correspond to the two extreme hypothesis
of all operators being charged at rates currently used for the smallest and
largest scale businesses). Box 2: Control
activities covered/ not covered by mandatory fee under Regulation 882/2004 Control activities covered by a mandatory fee: Ø controls on slaughter, cutting operations and cold storage of meat, production and placing on the market of fishery products, and milk production; Ø controls carried out to grant feed establishments approval; Ø controls carried out at a border on consignments of live animals and their products; certain food and feed of non animal origin. Examples of control activities not covered by a mandatory fee: Ø controls carried out in production of food other than meat, fishery products and milk; that is: eggs and egg products, honey and all foods of non animal origin. Ø controls carried out in distribution (including wholesale, retail and restaurants) of all food; Ø controls carried out in production and distribution (including wholesale and retail) of feed; Ø controls carried out in production and distribution of animal by-products; Ø controls carried out during import of products originating from third countries that need to be checked at the border other than those already covered by a mandatory fee (for example products subject to a safeguard measure). Failure
to achieve sustainable funding in the sectors subject to mandatory fees Current rules are based on
the principle of cost recovery where fees are mandatory. However, in
most cases, full cost recovery is not achieved, due to the fact that, for most
activities for which a fee is due, the current system gives the MS the choice
between a cost based fee and a standard, or minimum fee, whose amount is
fixed in the Regulation[31]: given the wide
variations of control costs across MS, such EU fees may be higher or lower than
the real costs of the activities they are meant to remunerate[32]. Furthermore, resources
obtained through fees are not required to be earmarked for the needs of the
control authorities which collect them. This, coupled with the fact that the
modalities of calculation of the fees, and figures on the amounts collected
through the system and on the use made of such revenues, contributes to the
perceived unfairness of the fees system in the eyes of those currently charged
as was repeatedly noted in consultation with stakeholders. Compliance
/ efficiency drivers are not being used / are not working A
number of mechanism included in Articles 26 to 29, with the aim of promoting efficiency
of the fees system and compliance by operators fail to deliver: ·
despite the obligation laid down in Article
27(12), many MS fail to provide the public and the Commission with the calculation
method they use to "cost" their controls and establish fee levels;
when they do, cost categories, and other details that would ensure full
transparency of the costing exercise are missing. Thus, on the one hand it is
not clear whether fees do cover the actual costs of official controls (and if
so in which areas / MS / regions) and, on the other hand, operators are not
provided with the information and data that would allow them to fully
appreciate the modalities of the calculation of fees and their fair implementation; ·
the results of the external studies demonstrate
that there is a widespread perception (in particular among operators) that the
current system should (but does not) effectively reward compliant businesses by
ensuring that they bear a reduced share of the cost of official controls
compared to non-compliant businesses. Acceptance
of the system by business operators is undermined by the perceived unfairness
of the system, notably by the lack of "penalising" mechanisms for the
less compliant actors. Micro-enterprises As
noted in section 2.1.1, official controls are necessarily performed in
accordance with the same principles regardless of the size of the operator
concerned, and there is no evidence to-date to suggest that this results in a
disproportionate burden being placed upon micro-enterprises in terms of time
and staff being invested because of the controls. On the
other hand, where operators are required to pay mandatory fees for official
controls carried out by competent authorities, stakeholders say that the impact
of such fees may be greater on micro-enterprises by reason of their lower
turnover/throughouput, in particular where standard/minimum fees are applied
instead of cost based fees. Cost based fees are in fact proportional to the
resources deployed during the performance of official controls and when levied
on micro-enterprises, all other things being equal, they should be
comparatively lower than those charged on larger operators. A risk based
approach to the organisation of official controls means that costs on compliant
operators, including micro-enterprises, are kept at a minimum. This
(the fact that cost based fees currently collected are comparatively lower for
microbusinesses) is part of reason why the contractor studies performed on
behalf of the Commission show that there is currently no evidence to suggest
that the mandatory fees charged on the basis of Regulation 882/2004 have, in
actual fact, given rise to adverse or disproportionate effects on
micro-enterprises. This is supported by the fact that, with the exception of
some small businesses' representatives, all stakeholders consulted (be they CAs
or businesses) have not called for an exemption of micro-enterprises (or SME)
from the fees system established by Regulation 882/2004. Notwithstanding
the above, the need to enable control authorities to recover costs so as to
ensure sufficient resources for official controls
should be balanced and weighed against the need to lower the burden on very
small businesses, in line with the new Commission policy on "Minimizing
regulatory burden for SMEs – Adapting EU regulation to the needs of
micro-enterprises"[33]. According to this
policy, micro-enterprises should in principle be excluded from regulatory
burdens, unless the necessity and proportionality of their being covered can be
demonstrated. 2.3.
Parties affected Rules
on official controls are primarly addressed to national control authorities and impact on their activities. Thus, national CAs responsible for
the implementation and enforcement of agri-food chain rules are mainly affected
by the present review[34] (currently, there are
over 100 000 FTE staff involved in the delivery of official controls within the
27 MS). This initiative will indirectly impact on business operators within
the EU (the agri-food chain is a significant sector within the EU, generating €751
008 million of added value – 6% of the EU27’s GDP, and employing over 48
million people) because of the time, staff, equipment and facilities being
mobilised during controls. This burden is inversely proportional to the
efficiency and effectiveness of controls carried out by the MS CAs. Moreover,
the review of the rules applicable to the financing of official controls
(with the possibility to shift a larger share of the cost burden from the
Member State CA to business) will also affect business operators. The
review will look not only at the extent to which operators participate in the
financing of the control system but also at the mechanisms to ensure that
operators (and citizens at large) are provided with information on how
inspection fees are established and used and at the mechanism intended to
reward compliance with agri-food chain rules by business operators. The
efficient operation of the EU system of official controls is of paramount
importance both for EU exports and imports. Businesses (both in the EU and in
third countries exporting to the EU) will also be affected by changes aimed at
improving the efficency of the control system as a whole, and in particular of
the import controls. Consumers
both in the EU and outside the EU, are not directly concerned by the review
although they are the ultimate beneficiaries of measures to ensure the safety
and quality of the agri-food chain. With the increased cost of controls for
operators it is possible that some of the additional costs will be passed on to
them through the price of final products, however by comparison with the
overall cost of food production such an increase is expected to be small (see
Box 6 and Box 8). 2.4.
How would the problem evolve, all things being equal? All
identified shortcomings in the problem definition would remain. Potential under-enforcement of agri-food chain rules due to the suboptimal
design of the legislative framework or to underperformances of the control
system could result in a loss of confidence in the EU market in the long
term. Inefficient use of control resources (including at the EU borders) could
imply the perpetuation of avoidable administrative costs and burdens for
operators. As for
the sectors pertaining to the agri-food chain but currently outside the scope
of this Regulation (plant health, PRM and ABP), separate systems would continue
to operate and develop according to sectoral logics and priorities; here again
the opportunity for efficiency gains would be lost while existing gaps in the
available range of enforcement tools in those areas and differences in national
practices would persist. As
regards the financing of official controls, if the legislation is not revised
the current regime would remain with its recognised limits and shortcomings[35].
None of the problems identified can evolve favourably and most could worsen
without legislative change. In particular, uncertainty would remain as
regards the availability of sufficient resources to finance official control
activities. The
capacity of national control systems to prevent and counter risks which might
arise along the agri-food chain (for humans, animals and plants) would
inevitably be affected by the said shortcomings. This
would represent potential obstacles to the objective of ensuring that national
control systems are well equipped and capable of anticipating/preventing risks
and may therefore adversely impact on the safety of the agri-food chain and its
products. In particular, less efficient controls will increase the probability
of health crises, and reduce the capacity of competent authoritires to remedy
them, which may in turn lead to significant economic and human losses.
Therefore, although cutbacks in relation to the financing of official controls
may seem justified in the short term, given relevant savings and reduced public
expenditure, in the long term they may actually result in higher costs for
citizens and industry where controls are unable to prevent large scale
emergencies[36]. With the
current discriminatory treatment between those operators which must be
charged (mandatory fees) for official controls they receive and those which
can be charged, depending on whether Member States decide to collect
non-mandatory fees, failure to address the perceived unfairness of the
financing system might also increase the reluctance of industry to remunerate
official control activities. 2.5. Does the EU have the right to act (subsidiarity)? 2.5.1. Right of the EU to act (legal
basis) The Regulation was based
on Articles 37, 95 and 152(4)(b) of the EC Treaty, now Article 43, 114 and
168(4)(b) respectively of the TFEU. Article 43 is implementing the Common Agricultural Policy (CAP), policy
qualified by the Lisbon Treaty as shared competence between the EU and its MS.
It is obvious, however, that to a very large extent all fields of agricultural
activity as well as ancillary activities upstream and downstream, have been
regulated at the EU level. This means that legislation is predominantly a role
for the institutions of the European Union. Article 114 provides the legal basis for the establishment and functioning of
the internal market for food products while ensuring a high level of protection
of consumers and the approximation of provisions laid down by the law,
regulation or administrative actions in this respect. Article 168(4)(b) stipulates that in order to meet common safety concerns 'measures
in the veterinary and phytosanitary fields which have as their direct objective
the protection of public health' should be adopted by the EU. 2.5.2. Necessity for the EU to act (subsidiarity) Necessity – The existence of a harmonised EU legislative framework to govern the
organisation and performance of official controls along the agri-food chain is
necessary to ensure the uniform implementation of agri-food chain rules across
the EU and the smooth functioning of the internal market. This rationale, which
is still valid, underpins the existing rules on official controls. As the
problems identified by this review are linked to the current design of the EU
legislative framework, its reform cannot be achieved by
MS acting alone. The intervention of the European legislator is required. European added value
test – The added value of a single, uniform set of
EU rules to govern official controls lies in the fact that it offers national
enforcers (and their operators) a framework within which CAs can rely on
enforcement activities carried out in another MS, and on the reproducibility
and scientific and technical soundness of control results. It also ensures that
EU agri-food chain standards necessary for the functioning of the single market
are applied uniformly and consistently in the different MS and sectors. As to the financing of
controls, common EU rules ensure that CAs can count on a reliable flux of
resources to maintain the control effort at a level justified by the risks and
by enforcement needs (e.g. level of non-compliance). Provisions on fees in
particular ensure that businesses, which benefit directly from efficiently
performed controls, participate to the financing of the latter, so as to minimise
the dependency of control funding on public finances. Common EU rules are
necessary also to prevent discriminatory treatment between operators located in
a MS where the user-pays rule (and thus fees) applies and those located in a MS
where this is not the case. Only common EU rules can ensure a uniform approach
to pursue this objective. EU action should not go
beyond what is necessary to achieve the objectives set. The present exercise
has looked at a broad range of options, including that of harmonising fee
levels across MS, and that of de-regulating the matter. The analysis sought to
design the most proportionate solution to ensure a sufficient and steady flux
of dedicated resources for official controls, whilst leaving MS the time and
flexibility necessary to cater for their internal arrangements and the
specificities of their business population. 3. Objectives 3.1. General
objectives The main purpose of
this exercise is to reinforce the safety of the agri-food chain (in its
broadest meaning) by strengthening the enforcement mechanisms of the relevant
EU rules and enable a more efficient implementation of the harmonised framework
which applies to food, feed, animals, seeds and plants . Thus the general objectives
of this initiative broadly coincide with the Treaty objectives to safeguard the
single market while ensuring delivery of a high level of health protection.
They also reflect the Commission's objective of ensuring proper enforcement of
EU law, as this is the original objective of the Regulation on official
controls. In particular, the following general objectives are envisaged: ·
contribute to promote the smooth functioning of
internal market rules applicable to the agri-food chain; ·
maintain a high level of human, animal and plant
health protection and animal welfare throughout the length of the agri-food
chain and prevent that this is undermined by potential non-implementation of EU
legislation; ·
ensure proper and uniform implementation of EU
legislation. 3.2. Specific
objectives The specific
objectives were set with the aim of eliminating the specific obstacles
identified during the analysis which prevent or hamper the achievement of the
general objectives in this area[37].
The specific objectives address the two sets of obstacles mentioned above, i.e.
those resulting from shortcomings in the design of the official controls'
framework and those resulting from the difficulties and inequities in financing
of official controls. 3.2.1. Objectives
related to the design of the official controls' framework ·
Ensure a comprehensive and consistent
approach to official controls along the agri-food chain, by eliminating
fragmentations and inconsistencies of the current legal framework: -
the system of official controls should be
consistent across all agri-food chain sectors avoiding differences which are
not justified by the peculiarities of a given sector; -
this system should provide for all tools
necessary to ensure accountability, soundness and effectiveness of the enforcement
activities performed in all agri-food chain sectors; -
this system should avoid duplications and
overlaps which result in divergent interpretations and implementation. ·
Allow for a more efficient use of national
control resources, by eliminating residual non risk based mechanisms for the
allocation of control resources: -
the system of official controls should require
MS to allocate, in all agri-food chain sectors, finite control resources on the
basis of the actual risk in order to achieve the most efficient use of such
resources. ·
Reduce administrative burden and remove
unnecessary requirements: -
unnecessary administrative burden, in particular
on MS' CAs, should be eliminated; -
the system should allow for the necessary
flexibility so that important requirements (the accreditation of official
laboratories) can be derogated where appropriate. ·
Foster closer cooperation between MS to
improve official control delivery: -
the system of official controls should enable
swift and effective cooperation, and synergies, among MS' competent authorities
(including customs) which are tasked with controls over the agri-food chain. ·
Improve transparency: -
rules on official controls should provide MS
with clear guidance on how a 'high level of transparency' should be ensured so
that the European citizens can benefit from the same level of transparency
across the EU. 3.2.2. Objectives
related to the financing of official controls ·
Ensure the availability of adequate resources: -
The system of financing of official controls
should ensure the availability of the resources necessary to maintain an
adequate level of controls and, consequently, the level of protection offered
by EU agri-food chain rules. ·
Ensure equity and fairness in the financing
of official controls -
The system of financing of official controls
should ensure that the burden on agri-food chain operators is distribuited in a
fair and equitable manner to avoid distortions. ·
Improve transparency -
The fees system should be transparent and allow
the public and, more specifically, the operators to understand how the fees are
calculed and how revenue therefrom is employed; so that transparency can act as
a driver to accountability and efficiency of the system of financing official
controls. 3.3. Operational
objectives ·
Establish a single, simpler legislative
framework for official controls along the agri-food chain; ·
all controls, including border controls, to be risk
based; ·
increase the number of cases where cross-border
enforcement cases are resolved through administrative assistance and
cooperation; ·
increase the number of formalised instruments
between the CAs and customs (and/or other) authorities for the performance of
official controls; ·
reduce the occurrence of unsatisfactory
enforcement results attributed to resources shortages. Table 1: Link between the objectives and the problems || Problem at stake || Specific objectives Design of official controls' framework || Inconsistencies, gaps and overlaps in control requirements || Ensure a comprehensive and consistent approach to official controls along the agri-food chain Inconsistent implementation of risk based approach || Allow for an efficient use of national control resources Administrative burden and disproportionate requirements || Reduce administrative burden and remove unnecessary requirements Uneven enforcement of cooperation mechanisms || Improve transparency Foster cooperation between MS to improve official control delivery Financing of official controls || Difficulties and inequities in financing official controls activities || - Ensure the availability of adequate resources - Ensure equity and fairness in the financing of official contrls - Improve transparency of the system of financing of official controls 3.4.
Consistency with other EU policies and horizontal objectives The
review requires consistency with the reviews of the animal health law, the
plant health law and the PRM legislation, the four proposals being adopted by
the Commission together as a package (along with a fifth proposal establishing
a multiannual programme for EU financing of actions aimed at ensuring a high
level of health for humans, animals and plants along the agri-food chain). The
review is also intended to ensure that the provisions of Regulation 882/2004
complement in a consistent manner those applicable to official controls in the
field of veterinary medicines, also currently under review. Moreover,
the review preserves synergies between the current system and relevant aspects
of agricultural legislation and creates the possibility for new ones by
enabling environmental legislation on Invasive Alien Species (IAS) to be
supported in its implementation through the control mechanisms established by
the amended Regulation. In order to do so the present review will take into
account the outcome of the ongoing work to develop the EU legislation on IAS. The
review also seeks to align the framework of official controls, in particular
the terminology used, to the modernised customs code. With a
view to the Europe 2020 strategy, the provision of effective controls along the
agri-food chain is to ensure safe food and feed while fostering competitiveness
of business operators, rewarding complaint business operators and ensuring
user-pays principles across all sectors. This
initiative pursues the objectives of the Communication on Smart Regulation in
the European Union. One of the aims of the review is to simplify legislative
burdens in light of comments made by MS and food business operators on the
existing regime. 4. Policy options 4.1.
Policy options included in the analysis[38] The analysis of options
available to address the problems and achieve the objectives above was carried
out in two stages: 1. first, the potential impact of deregulating the matter of the
financing of official controls and of exempting micro-enterprises from the fees
system was considered; 2. the outcome of the analysis under 1 was then used to design options
2 to 4, which combine the following elements: Ø
expand the scope of the Regulation to agri-food
chain sectors currently outside its scope (i.e. plant health, PRM and ABP); Ø
improve and simplify the legislative framework; Ø
ensure full cost recovery through fees; Ø
expand the list of control activities for which the
collection of a fee from operators is obligatory. Table
2: Summary of the options included in the analysis || Scope of the Regulation || Legislative framework || Cost recovery || Scope of mandatory fees Baseline || partial (plant health, PRM, ABP out) || deficiencies and shortcomings || partial || partial (meat, milk, fishery, imports) Option 1A || status quo || status quo || No (deregulation) || / Option 1B || status quo || status quo || status quo || exemption for micro-enterprises Option 2 || status quo || improved || full || status quo Option 3 || expand to plant health and PRM || improved || full || ADD plant health and PRM Option 4 || expand to plant health and PRM || improved || full || ALL registered food and feed operators Base line (status quo) The integration
of the system of official controls along the food agri-chain is partial, some agri-food
chain sectors being outside the scope of the Regulation. Official controls
carried out at EU external borders on certain goods arriving from third
countries, and official controls on residues of veterinary medicines are not
aligned to the risk based approach. This will continue to generate avoidable
costs (for rigidly prescribed, non risk-based controls). Inconsistency and
inefficencies in the deployment of efforts by, and in cooperation between,
national authorities will derive from the lack of uniform guidance on how to
implement administrative cooperation and deliver a high level of transparency.
No derogation is foreseen from the requirement of accrediting official
laboratories. The
collection of fees is mandatory for a limited number of control activities
(control activities on businesses handling meat, fishery products, and milk;
for the approval of feed establishments; at EU borders on certain goods from
third countries). MS can choose to charge a standard EU fee fixed in the
Regulation, which does not correspond to the actual cost of the control. This
results in potential under-resourcing of control authorities and in the risk
that the capacity of the EU control system as whole to prevent and contain
health risks along the agri-food chain is undermined. Box 3: Financing of official controls: baseline[39] Collection of mandatory fees: Twenty-one MS (AT, BE, BG, CY, CZ, DE, DK, EE, IE, EL, FI, FR, HU, IT, LT, NL, PL, PT, RO, SI, SK) collect fees for all official control activities for which mandatory fees apply[40]; however, five (ES, SE, LV, MT, UK) only partly collect such fees (in other words, in these MS, certain mandatory fees are not collected). Fees for milk production controls and fees for residue controls are the two types of control activities for which several of these MS do not collect fees. Data is not available for LU. Twenty-two MS (AT, BE, BG, CY, CZ, DK, EE, EL, ES, FI, HU, IE, IT, LT, LV, NL, MT, PT, RO, SK, SI, UK) collect fees for activities for which fees are not mandatory[41]. On the other hand, two MS (FR, PL) do not collect fees for activities beyond those which are mandatory[42], and two MS (DE, ES i.e. countries with a decentralised management of fees) collect such fees in some regions but not in others. Full cost recovery: Eight MS (NL, IT, AT, PL, LT, LV, PT, SI) currently achieve full or almost full cost recovery of mandatory fees for official control activities whilst eight MS (BG, CZ, EE, ES, FI, SE, EL, IE) achieve a low level of recovery. Eight MS (BE, DK, FR, HU, MT, RO, SK, UK) recover between 34 – 66% of the cost of official controls for which mandatory fees apply. Levels of cost recovery are unknown for three MS. Fee rates: Across the EU fee rates vary considerably, not necessarily in relation with variances in costs. For example, fees paid for controls on the slaughter of adult bovine animals can vary from €2.3/head in some autonomous communities in Spain, to €8.2/head in Denmark and between €10-20/head in Sweden (against a minimum fee of €5/head in Annex IV). Even within MS the scale of the variation can be significant. For example, in Bavaria (Germany) fee rates for the slaughter inspection of adult bovine animals range from €9.4/head to €12.9/head depending on district. Should the status
quo be maintained, the shortcomings identified in Section 2.2 would remain. Options 1A and
1B A preliminary analysis
focuses on two possible changes to the status quo which would specifically aim
to A) repeal Union rules on control fees (thus leaving it to MS to decide how
to ensure the appropriate funding of control activites), and B) maintain
current EU rules on fees, exempting micro-enterprises therefrom. The outcome of such
analysis is then reflected in the design of subsequent options (2 to 4). Although in theory both
Options 1A and 1B could be combined with other elements of Options 2 to 4, they
are presented and assessed individually given the significance of the changes
they purport to introduce. Both would, in fact, substantially alter the current
framework as regards the financing of national control systems and call into
question established principles. Moreover, the combination of Options 1A and 1B
with other elements of Options 2-4 would not result in significant trade-offs
and would therefore not modify the cost/benefit analysis of the former to an
appreciable extent. Option 1A - Repeal
Union rules on control fees (Existing
mandatory inspection fees are repealed; other provisions of the legislative
framework remain unchanged) Under this Option
each MS is given the possibility to determine the approach it follows as
regards the funding of official control activities, provided that it ensures a
level of resources which allows the correct implementation of control
requirements and the efficient enforcement of EU law. It would require repeal
of Articles 27-29 of the Regulation and in particular of the mandatory
collection of fees in certain areas. Option 1B - Mandatory
exemption of micro-enterprises from the application of fees (Existing
mandatory inspection fees are maintained but not applied to micro-enterprises;
other provisions of the legislative framework remain unchanged) Option 1B was
selected in view of the Commission's continued efforts to promote the
competitiveness of micro-enterprises, as highlighted in the Commission policy
on "Minimizing regulatory burden for SMEs – Adapting EU regulation to
the needs of micro-enterprises". This
Option would provide for the mandatory exemption of micro-enterprises from the
application of mandatory fees and would require the breadth of operators upon
which mandatory fees are levied to be appositely restricted. Option 2 –
Streamline (The legislative
framework is improved and streamlined, full cost recovery is ensured where
mandatory fees are already provided, with the possibility for MS to refund fees
paid by micro-enterprises) Option 2 would aim
to improve the legislative framework on official controls by clarifying,
simplifying and streamlining existing provisions on controls in sectors
currently covered by Regulation 882/2004, and by ensuring full cost recovery in
the areas where mandatory fees are already provided. The main changes would be:
a)
repeal redundant and obsolete pre-existing
legislation in the area of veterinary checks in intra-EU trade so that overlaps
in control requirments would be eliminated and the system would become more
consistent because less open to divergent interpretation[43]; b)
repeal existing sectoral provisions[44]
in the area of border controls and establishing, in the Regulation, a
single set of rules applicable to border controls on all goods requiring
special attention at the external borders of the EU because of risks to human,
animal, plant health. This system would be aligned to the risk based approach
underpinnying Regulation 882/2004 so that the allocation of control resources
would be made on this basis. In addition, the elimination of the legislative
fragmentation in this area would allow MS to prioritise the controls across all
sectors covered by the Regulation. c)
repeal Directive 96/23/EC applicable to official
controls on residues of veterinary medicines, with additional rules
established in line with the Regulation; as a consequence, these controls would
be governed by Regulation 882/2004 only on the basis of the risk. In addition,
the repeal of this Directive would eliminate the obligations identified as
administrative burden. d)
clarify the obligation of cooperation
between sanitary authorities and customs services, and include the possibility
of setting control coordination mechanisms with other national authorities (at
borders and elsewhere) so as to take advantage of all potential operational
synergies at borders (including with customs and on controls on IAS). e)
clarify the rules applicable to the methods used
by official laboratories and providing derogations from the
obligation to accredit the laboratories in certain cases in order to avoid this
requirement to be applied in a disproportionate manner; f)
introduce new empowerments to enable the
Commission to i) specify the modalities of the administrative cooperation's
mechanism so as to ensure its uniform application across MS; ii) provide
guidance on how to deliver a 'high level of
transparency'; g)
require MS to calculate existing mandatory fees in
manner which enables them to fully recover the costs of, and
appropriately finance, official controls, and eliminate current obstacles to
full recovery resulting from the provision of minimum fees; h)
improve transparency and introduce incentives
for compliant businesses; i)
provide MS with the possibility to refund
fees to micro-enterprises in accordance with State Aid rules[45]
(current rules include the prohibition to refund, directly or indirectly, fees
collected for the financing of official controls; Option 2 would repeal it
insofar as micro-enterprises could benefit from the refund). As the
establishment and application of a full cost recovery system would require some
adjustments in the Member States' current systems, a transition period of 2
years would be provided. Option 3 – Streamline
+ Integrate (The legislative
framework is improved and streamlined, plant health and PRM, and ABP are
included in its scope, full cost recovery is ensured where mandatory fees are already
provided with the possibility for MS to refund fees paid by micro-enterprises) In addition to the
elements of option 2, option 3 would widen the scope of the Regulation to
cover sectors of the agri-food chain acquis that are currently excluded
(plant health law[46], PRM legislation, ABP
rules) and complete the 'integration' of agri-food chain official controls.
This would be done by repealing pre-existing
provisions governing official controls in the sectors being integrated into the
Regulation[47]. Appropriate
transitional periods would be provided for new obligations (such as the
laboratories' accreditation for plant health tests). The inclusion of the
sectors above under Regulation 882/2004 would aim to ensure that, in principle,
competent authorities operate on the basis of the same approach and under the
same conditions no matter the agri-food chain rules they are called to enforce.
Some adjustments would be introduced to account for specificities of those
sectors, in particular as regards the certification procedure and the
accreditation of official laboratories. As
regards the financing of official controls, the control activities covered by a
mandatory fee would remain unchanged with the only
exceptions being in the field of plant health, where mandatory fees will be
introduced for official controls linked to plant passport obligations, and in
the field of PRM, where it is envisaged that the principle of full cost
recovery through fees would be established for certification. Option 4 – Streamline
+ Integrate + broader cost recovery (The legislative
framework is improved and streamlined, plant health and PRM, and ABP are included
in its scope, mandatory fees are extended to cover key areas of the agri-food
chain with the possibility for MS to refund fees paid by micro-enterprises) In addition to the
elements of option 3, option 4 would expand the list of mandatory inspection
fees to all controls carried out on feed and food business for which a
registration requirement is established in accordance with food safety and feed
safety rules, i.e. on all activities for which an obligation for operators to
be registered exists in accordance with Regulation (EC) No 852/2004 (food hygiene)
and/or Regulation (EC) No 183/2005 (feed hygiene). Although responsibility for
the safety of food and feed on the EU market lies primarily with food and feed
business operators, in these areas an increased control effort is also required
from CA to ensure that food and feed business operators comply with safety
requirements, and, ultimately, that food and feed placed on the market is safe.
Compared to the
baseline, fees would also become mandatory for the following activities: -
production of
food other than meat, fishery products and milk (already subject to mandatory
fees): eggs and egg products, honey and all foods of non animal origin; -
distribution (including wholesale, retail and
restaurants) of all food; -
production and distribution (including wholesale
and retail) of feed; -
production and distribution of ABP in so far as the concerned operators have to be registered under
Regulation (EC) No 852/2004 or Regulation (EC) No 183/2005; -
import of goods from third countries that
need to be checked at the border other than those
already covered by a mandatory fee (e.g. goods subject to a safeguard measure). As the
establishment and application of cost based fees in all areas would require
some adjustments in the MS current systems, a transition period of 3 years would
be provided. 4.2. Discarded
policy options · Reducing controls on micro-enterprises or SME's Given the new
Commission policy on "Minimizing regulatory burden for SMEs – Adapting
EU regulation to the needs of micro-enterprises", the possibility of exempting
micro-enterprises or SME's from the performance of official controls was
considered. This option was discarded as it ran counter to the basic
principles underlying Regulation 882/2004 and would also not have addressed the
problems identified in section 2.2. In particular,
micro-enterprises represent a very high proportion of the business population
subject to official control activities[48] and, given
that food safety risks/concerns arise regardless of the size of an operator,
their exemption from official controls would lead to the non-compliance of
numerous goods placed on the EU market with relevant
EU agri-food chain standards and requirements. The safety of the agri-food
chain would be undermined and the number of food crises would increase. Furthermore,
as highlighted with regards to the E. Coli crisis (see section 2.1.1),
the gravity of food crises stemming from micro-enterprises/SME's should not be
underestimated. · Non-legislative option (e.g. development and use of electronic
systems, adoption of informal guidelines at EU level etc.) A general option based
on the development of "soft law instruments" to increase the clarity
of the existing legal text. The option was discarded as the non-binding nature
of soft law instruments was considered insufficient to address the
interpretation and implementation difficulties linked to The Regulation and the
shortcomings of the rules governing inspection fees. Further options relating
exclusively to the availability of adequate resources for official controls
were also excluded: · Imposing mandatory fees on all operators subject to official
controls The option of requiring
MS to apply mandatory fees to all the operators subject to controls in
accordance with the Regulation was discarded. Instead, the option of charging
food and feed operators subject to a specific registration requirement laid
down in Regulation 852/2004 (food hygiene) or in Regulation 183/2005 (feed
hygiene) was retained (see option 4). The discarded all-inclusive option would
have required the application of mandatory fees also on operators not directly
concerned with the production of handling of food or feed (e.g. keepers of non
food producing animals, plant nurseries) and on operators only marginally
involved in the production of food for commercial purposes (e.g. farmers
producing for domestic consumption, or for the direct supply of small
quantities to final consumers or to local retailers supplying final consumers).
These operators do not have to be registered under EU food/feed hygiene rules,
and some of them would be subject to official controls organised in accordance
with the Regulation only after the intended changes to its scope (options 3 and
4). Considering the absence of registration requirements for these operators,
the great numbers and the fragmentation of the business population potentially
concerned, which would further increase with the present review, it would have
been very difficult to accurately assess the impact of this option
(particularly in relation to those areas where Regulation (EC) No 882/2004 would
become applicable only following the review). · Full harmonisation of fees An option based
on full harmonisation of fees across MS (i.e. the establishment of EU
standard fees for each type of control carried out, irrespective of the actual
cost in each MS). This option was discarded since it fails to achieve the
objective of full cost recovery (harmonised fees would in most cases either
'under' or 'over' compensate costs). Furthermore, the development of EU-uniform
cost models for each of the types of controls would be a very burdensome
exercise. Monitoring and maintaining appropriate harmonised fee levels would
also create a disproportionately heavy burden for Member States and the
Commission. The option of adjusting
harmonised fees to the cost of living in each MS was also excluded, as
although adjusted fees could be somewhat closer to the actual costs, they would
not be fully accounted by accurate and actual costing of control activities,
and thus would not guarantee full cost recovery or the absence of
overcompensation. Furthermore, they could only be obtained through a complex mechanism
for the calculation of standard EU costs (and fees) for each type of control,
for the update and application of the chosen adjustment index, and appropriate
monitoring tools to constantly update the EU fees. ·
Harmonised fees for certain import controls During the
consultation phase, some respondents argued in favour of a specific, fully
harmonised fee (i.e. not adjusted to cost-of-living or any other index) to be
applied only for the performance of border controls on goods arriving from
third countries. The argument for harmonised fees for import controls is
that it would create a ‘level playing field’ across the EU-27 for such fees and
remove the potential for trade distortions derived from importers seeking out
border points with lower fees. Although several of those consulted through the
2011 Impact Assessment Study see this as an issue, evidence of such distortions
has not been found in two successive contractor studies. Section 5: Analysis of impacts This
IA analyses the likely social, economic and environmental impacts – be they
direct or indirect – of the different policy options. Each option has been
assessed against the theoretical baseline of 'do nothing' and therefore the
impacts outlined are additional to the current status quo. Economic impacts are
assessed through the following criteria: competitiveness, innovation,
sustainability, simplification, and administrative burden reduction. Equally
important for the analysis are social impacts (safety in particular, but
also accountability). The assessment of each option in terms of
environmental impacts and of impacts on employment rates has not identified
significant impacts (either negative or positive). To help
comparisons between options the impacts have been rated (0: no impact; +, ++, +++:
small, medium or large positive impact; ‑, ‑‑, ‑‑‑: small, medium or large negative impact). Option 1A – Repeal
Union rules on control fees The repeal of the
existing EU framework on inspection fees is likely to result in an increased
variance of national approaches, and possible cuts in resources allocated to
controls. Sustainability
- Although the impact on the level of resources
actually deployed will depend on the policy choices that each MS will make and
so cannot be fully predicted and analysed, the problems identified in relation
to the current fees regime, such as the failure to ensure proper cost recovery,
and thus appropriate and stable resourcing of controls are unlikely to be solved.
On the contrary, stakeholders and MS argue that, given the current economic
crisis, the problems affecting the sustainability of controls could worsen if
MS decisions result in fewer resources being allocated to the operation of
national control systems. Simplification
- The repeal of the EU framework would result in a
more complex legislative landscape as differences in national rules on the
financing of controls are likely to increase. Under the current system MSs
already exhibit significantly wide variance (see tables 1-4 in Annex XVII) in
cost recovery levels, bonus malus arrangements and availability of
information to the public. In the absence of a harmonised framework, national approaches
to the financing of official controls are likely to vary even further over time
as MS make different policy choices. Competitiveness
- Wider disparities amongst MSs might result in
distortions of competition, if operators in one MS are charged for controls
while competitors in another MS are not, with adverse impacts on the operation
of the single market. Accountability
- This option would repeal the obligation for MSs
to publish and communicate to the Commission the method of calculation of the
fees, thus leaving MS free to decide the level of transparency (and of
accountability) of their domestic regimes. Safety
– A decrease in the availability of resources would
inevitably reduce the resources available to CAs to perform official controls
potentially leading to fewer controls being carried out. CA may have
difficulties maintaining an effective oversight of compliance by food business
operators and, ultimately, the safety of the agri-food chain, especially when
faced with large scale crises. Summary of the key impacts under Option 1A Criteria || Impacts Competitiveness || - Innovation || 0 Sustainability || - Simplification || - Administrative Burden || 0 Accountability || - Safety || - Based on the
above analysis, the option to repeal current EU rules on fees as established in
Regulation 882/2004 was not considered further. Option 1B – Mandatory
exemption of micro-enterprises from the application of fees The mandatory
exemption of micro-enterprises from the application of fees would reduce the
financial burden on micro-enterprises However, the exemption would undermine
the objective of ensuring the sustainability of the control system, and through
it the safety of the agri-food chain. Sustainability: Figure 3 gives an overview of the percentage of micro-enterprises on
the total number of operators in the major industries subject to official
controls (and to mandatory fees) under on Regulation 882/2004. In 16 of the 23
Member States for which data is available, micro-enterprises represent more
than half of all businesses, and in 9 such States (AT, BE, CY, FI, IT, NL, PL,
SE, SI) the percentage of micro-enterprises rises to two thirds (or more) of
all business operators[49]. Figure 3 Share
of Micro-enterprises in total number of business operators in the four major
European
industries affected by official control activity (2008)* *Industry
sectors include: processing and preserving of meat and production of meat
products; processing and preserving of fish, crustaceans and molluscs;
manufacture of dairy products; manufacture of prepared animal feeds. Greece and Malta are not included in Eurostat dataset. Data for the Czech Republic and France are not available. In those MS where
micro-enterprises represent an overwhelwing majority of businesses subject to fees,
exempting them from the payment of the latter will have a severe negative
impact on the proportion of costs recovered by CA. The objective of ensuring a
sustainable financing of controls via full cost recovery would, in most (if not
all) Member States, be undermined, as controls will still need to be carried
out on all operators at a frequency dictated by the risk. While the CAs' loss
in revenue represented by the exemption could be compensated by transfers from
the general budget, this would again create a strong dependency of the control
action on public resources and thus create a situation – in particular in times
of crisis and budget restrictions - of financial uncertainty which can not be
reconciled with the objective of ensuring consistent, efficient and risk
commensurate control activities across the agri-food chain. Competitiveness
- The mandatory exemption of micro-enterprises from the
application of fees would reduce the financial burden upon them and help to
encourage the development of small businesses, including artisanal
establishments. However, a mandatory
exemption for micro-enterprises would result in the unfair treatment of larger
operators who might be charged more to fill in the cost recovery 'void' left by
the exemption of micro-enterprises. The impact on larger businesses would be
particularly disproportionate in those Member States and those sectors with a
large percentage of micro-enterprises. Safety – Lower cost recovery by reason of the exemption of
micro-enterprises would result in a lower revenue income for competent
authorities. Over time, unless competent authorities were otherwise subsidised,
this may lead to fewer official controls and result in a higher probability of
food products not complying with EU agri-food chain legislation. The safety of
the agri-food chain could ultimately be jeopardised and the risk of food crises
would increase[50]. The analysis carried out
above is fully in line with the views of competent authorities and industry.
Throughout the consultation process both firmly opposed a mandatory exemption for micro-enterprises
highlighting, amongst other things, that it would have a negative impact on the
sustainable performance of official controls[51] and on
competition. Similarly, stakeholders did not request that data on ways to
support micro-enterprises be obtained. Summary of the key impacts under Option 1B Criteria || Impacts Competitiveness || 0/- Innovation || 0 Sustainability || -- Simplification || 0 Administrative Burden || - Accountability || 0 Safety || -- Based on the above
analysis, it is considered that an automatic exemption of micro-enterprises (or
SME's in general) from the application of fees would, on the one hand,
undermine the policy objective of ensuring the long term sustainability of
national control systems and, on the other hand, create potential distortions
of competition. This conclusion also holds true in cases where other possible
changes to the status quo are considered and, in particular, if mandatory fees
are imposed on all registered food and feed operators (as per Option 4) as the
proportion of micro-enterprises in the different areas of the agri-food chain
is very significant (data published in April 2012 by Fooddrinkeurope shows that
79% of operators in the food and drink industry are micro-enterprises).[52][53] In the
options considered below, the exemption of micro-enterprises from the
application of fees is therfore replaced by a mechanism which aims to respond
to both the abovementioned shortcomings (i.e. sustainability and competition). Option 2 –
Streamline Increased efficiency of
the risk based use of control resources and mobilisation of dedicated financial
resources reducing pressure on national finances allow progress towards the
primary objective of maintaining efficient controls and safety of the agri-food
chain. MS may refund fees paid by micro-enterprises, conforming to State Aid
rules. Competitiveness
- Option 2 would allow for the full implementation
of the risk based approach to official controls in sectors where MS CAs are
currently not allowed to adjust their control efforts to the actual risks (i.e.
official controls carried out at EU border on certain goods from third
counties, and official controls on residues of veterinary medicines). This
would result in a better allocation of control resources and, thus, in a more
efficient control system[54]. Box 4: Reduced
costs for official controls on residues and other substances A risk based approach to controls on residues of veterinary medicines would lead to a decrease of the number of samples ranging from 49 753 to 394 280, thus to a decrease of costs (for CA and ultimately for operators through the corresponding mandatory fee) ranging from € 12.4 million to € 98.5 million when considering the average total cost per sample for laboratory analysis (staff, consumables, overheads, etc.). MS in general expect the sampling capacity that will be freed to be used to increase the sampling of other substances/residues and/or on higher risk matrices. Moreover,
enabling national authorities to focus their control efforts where non
compliances and risks are higher would minimise the burden of official controls
on compliant businesses and have, therefore, a positive impact on their
competitiveness. However,
the benefits in terms of increased efficiency and competitiveness would be only
partial because plant health, PRM and ABP are not included within the scope of the
Regulation according to option 2. In fact, the best allocation of control
resources can only be achieved by ensuring that the risk prioritisation is
carried out by MS CAs across all sectors of the agri-food chain, including those
above. This is prevented by the current fragmentation of official controls
legislation. Fees charged on the
basis of actual costs would be (and be perceived as) fairer across the MS since
at present the use of standard fees and the varying recovery rates applied
across and within MS means that fees recovered by some MS may be either higher
or lower than the cost incurred by the CA performing official controls. Under
the current regime, where a MS is charging a standard fee which is higher than
the actual cost whereas other MS do not, or where a MS recovers a higher
percentage of fees than other MS, the operators in the territory of that MS
will be at a competitive disadvantage in relation to operators in the other MS.
Option 2 will create a level playing field for all operators charged with
mandatory fees. Importantly,
the bonus malus principles which are already inherent in the current
legislation (and which will be retained in the revised legislation), and new
provisions (which will allow businesses currently charged a flat rate fee
regardless of the level of enforcement activity to benefit from recognition of
good performance), will ensure that costs on well-performing, low risk
businesses are comparatively lower than those on non-compliant operators.
Consultation results demonstrate that Industry is very keen to see this taken
forward. The
possibility for MS to alleviate the impact of full cost recovery on micro-entreprises
by refunding them the mandatory fees paid, on condition that this is in
conformity with State aid rules (i.e. does not unduly affect competition),
would ensure that the benefit for the recipients of the refund does not result
in unfair competition for other businesses and does not deprive CA of the
resources which are necessary to perform their control tasks. The 'refund'
mechanism means that the benefit for micro-enterprises is not to be afforded at
the expenses of full cost recovery by CA[55]. Innovation
- By allowing in certain cases the use of methods
not yet included in the scope of the accreditation of an official laboratory,
Option 1 would remove legal obstacles to the introduction and development of
new analytical methods. Simplification
- The repeal of pre-existing sectoral acts or
provisions would streamline all rules dealing with official controls along the agri-food
chain in a single legislative framework, eliminating duplications and overlaps
with the Regulation[56]. Simplification
gains would also come from the streamlining of border official controls on
goods from third countries. CAs, instead of using different sets of rules
depending on the type of goods to be controlled at the border, would refer to a
single framework governing the mechanism of border controls for both live
animals and their products, and food and feed of non animal origin. In
practice, they will find the goods subject to such controls included in one
consolidated list (based as much as possible on CN codes) and will be able to
designate single border control posts where all such goods could be checked; a
single and harmonised entry document will be used for all concerned goods. Economic
operators would benefit from such simplification as they will us the same set
of procedures and requirements, and a harmonised entry document independently
of the goods they introduce into the Union. Box 5: Simplification gains under option 2 Acts or provisions to be repealed under option 2 Ø Directive 89/662/EEC concerning veterinary checks in intra-Community trade Ø Directive 90/425/EEC concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products (except for the provisions concerning zootechnical controls); Ø Directive 89/608/EEC on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (except for the provisions concerning zootechnical controls); Ø Directive 96/93/EC on the certification of animals and animal products; Ø Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products; Ø Directive 97/78/EC laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries; Ø Directive 91/496/EEC laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries. The
legislative framework for the financing of official controls will become
simpler at EU level, as only cost based fees will be permitted as opposed to
the current system which allows the possibility of choosing between actual
costs and standard fees (see Table 5 of Annex XVII, which summarises data in
the baseline scenario to illustrate the variety and combination of calculation
methods employed across the MSs). Moreover by clarifying the list of activities
for which fees are mandatory and the cost elements to factor in to calculations
for each control activity, it is envisaged that implementation of EU provisions
will become more uniform and transparent.[57] Sustainability
- Requiring MS to fully recover the costs of
controls when mandatory fees are used would mobilise a steadier flux of
financial resources collected through such fees, thus reducing the pressure on
national budgets. In the majority of MS,
control costs are only partly recovered through fees, the recovery rate ranging
from 20% to more than 80%, and 8 MS recovering all costs. Thus, introducing full
cost recovery would see in some cases an additional part of the costs of
controls being transferred to, and distributed amongst, agri-food chain
operators. The increase in the level of mandatory fees would vary depending on
the current recovery rate (see Figure 4 below). Figure 4 Potential
impact of requiring MS to achieve full cost recovery on controls
for which fees are currently applied[58] || BG || CZ || EE || ES* || FI** || SE* || GR* || IE || BE || DK || FR || HU || MT || RO || SK || UK || NL || IT || AT || PL || LT || LV || PT || SI || DE || CY || LU High impact || || || || || || || || || || || || || || || || || || || || || || || || || || || Medium impact || || || || || || || || || || || || || || || || || || || || || || || || || || || Low impact || || || || || || || || || || || || || || || || || || || || || || || || || || || No impact || || || || || || || || || || || || || || || || || || || || || || || || || || || Unknown || || || || || || || || || || || || || || || || || || || || || || || || || || || Recovery rate || || 0 – 33% || || 34% - 66% || || 67% - 99% || || 100% || || Unknown *The precise recovery
rate is unknown.**Data about cost recovery rates in Finland is contradictory.
The DG SANCO baseline states that it is 20 per cent, a previous evaluation
(FCEC 2008) found that it was 99 per cent (for large FBOs) and an independent
academic study (Lepostö et al. 2010) found that it is 38 per cent for municipal
control authorities. The 2011 study has concluded that cost recovery rates are
likely to be high for large FBOs (of which there are few) and low for small
FBOs (of which there are many). Such level is
expected not to represent a substantial additional burden for operators, even
in those sectors where the cost of controls impacts most on the operators’
overall production costs, which is meat inspection (see box 6 for some
illustrative simulations).[59] Using the figures in box
6, we can estimate that, depending on the percentage of recovery of costs by
Member States, additional fees corresponding to approximately 0.2% - 0.8% of
the annual production value of a typical operator would be charged. In return, this
would guarantee approximately €0.9bn – 3.4bn of new funds/year for official
controls across the MS.[60] Box 6: Economic impact of full cost recovery (meat
inspection) – examples from the MS The examples below refer to mandatory fees charged for meat inspection in 3 MS which apply cost based fees (as opposed to the standard EU fee). Meat inspection is the area of the agri-food chain where controls are most frequent and intensive (a regular and continuous presence of official inspectors is required in business operator's premises during operations). Thus the impact of fees on production costs is significantly higher in this field than in others. In Belgium, meat inspections are funded via a mandatory fee ("retribution") calculated on the basis of a half hourly rate of €23.13 and applied following specific criteria, such as the throughput of individual establishments[61] (volume and category of animals). According to available data, retributions allow Belgium to recover approximately 37% of the total costs they incur in organising official controls[62]. This allows one to postulate the level of fees in a full cost recovery scenario. Charges[63] on slaughterhouses with a single slaughter line for adult bovines currently vary from approximately €15.8/animal, where hourly throughput does not exceed 4 bovine units, to approximately €5.2/animal, where throughput exceeds 50 units per hour. Assuming that such charges represent 37% of the actual cost of controlling the slaughter line in each case[64], full-cost fees would vary between a maximum of approximately €42.7/animal (slow throughput) to a minimum of approximately €14.05/animal, for operators with a fast throughput. In a representative average case ("vache de reforme") with the price of a bovine carcass at approximately €1,580 (at slaughterhouse, i.e. before any further processing and net of any further profit margin)[65], charging slaughterhouses a full cost fee would represent between 0.89% (fastest lines) and 2.7% (slowest) of the total value of the carcass.[66] The UK presently recovers 43% of mandatory fees[67]. Official controls at approved meat premises are currently charged on a time-basis. The presence of an auxiliary during normal working hours is charged at £29.20 (approximately €35) per hour and the presence of an official veterinarian is charged at £37.60 (approximately €45.50) per hour[68]. Achieving full cost recovery would increase these rates to approximately £68 (€82) and £87 (€105) respectively. Data submitted by the UK Food Standards Agency suggests that the overall cost of delivering official controls is €65.77m per year. Full cost recovery would thus shift a further €37.49m on industry per year. This additional cost represents 0.5% of the total value of the UK meat industry which is thought to be worth €7.65bn per year. Unlike BE and UK, Italy claims to fully recover the costs of meat inspection from fees. An hourly rate of €50/hour has been used to determine minimum fees for certain operators, depending on the throughput of their establishments. Fees vary from €5/animal in slaughterhouses with a yearly throughput of 10,000 units to €3/animal in faster lines (more than 70,000 units/year). Although such fees represent minimum levels and may therefore fluctuate, the fact that Italian authorities claim to fully recover costs would suggest that a move to Option 2 is unlikely to have significant effects on business operators in Italy. Reduction
of administrative burden - Information obligations
in the area of official controls of residues of veterinary medicinal products
(see Annex XXII) and the corresponding administrative burden will be
eliminated. Current rules
require MSs to publish and communicate to the Commission fees' calculation
methods. Strengthening such a requirement by requesting more details on cost
elements and calculation assumptions is not expected to create substantial
additional costs. Analysis has shown that once the move to full cost recovery
has been made, reporting information regarding fees to the Commission and the public
is likely to require little additional administrative cost for most MS,
particularly where such information is already provided through CA websites
(See Figure 5 below). Figure 5: Transparency and reporting to the public on fees for official
controls by EU Member State || BE || IE || UK || ES || FL || NL || SE || DE || EE || FR || IT || LT || PL || SK || MT || AT || BG || CY || CZ || DK || GR || HU || LU || LV || PT || RO || SI All information available online || || || || || || || || || || || || || || || || || || || || || || || || || || || Legislation published in the official journal || || || || || || || || || || || || || || || || || || || || || || || || || || || Information recorded but not available / published || || || || || || || || || || || || || || || || || || || || || || || || || || || No information available / identified || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || High transparency || || Medium transparency || || Low transparency || || No information available / identified With regards to the
requirement within Option 2 to calculate all fees (including those for which a
standard EU fee is established by the Regulation) on the basis of costs it is expected
that no substantial additional administrative burdens will fall upon MS which
already calculate fees in such a manner. Additional efforts will be necessary
in those MS which do not currently establish fees on the basis of costs
incurred as changes to their administrative structures may be required so as to
ensure that costs are reflected in fees and to implement/monitor cost recovery.
Additional costs are expected to be affordable by public budgets (see box 7 below for estimations provided by 2 MS). Option 2 takes account of this adjustment by
giving MS 2 years to ready their administrative systems to the new
costing/charging model. Box 7 – Examples of the costs of establishing a fees regime based on
actual costs for the UK and Finland The UK Food Standards Agency (FSA) has estimated that collating information on total control resources in a centralised manner (i.e. for the country as a whole) would require two days of a middle manager's time and three days of a junior manager's time. Therefore the cost of reporting on the financial resources devoted to official controls would be around €1655 per annum[69]. Given the decentralised nature of the UK, the FSA calculated that a more detailed reporting requirement providing figures for total resources at a sub-national level would require an additional 6 working days by an analyst, at a cost of €1815. A move to a system requiring the collection of precise data on costs, based on actual time spent on each operator, would have a more significant financial impact on MS. The Finnish Food Safety Authority (EVIRA) has estimated that setting up such a system in Finland (where the operation of controls is decentralised) would cost approximately €500,000 for appropriate IT tools. Such an expense would be a "one off" and ongoing costs would result from the need to maintain 4 full time equivalent staff (FTE)[70] to collect and submit information about the resources used by CAs in the execution of official control activities. The possibility
for Member States to refund fees to micro-enterprises is also likely to result
in increased administrative burdens in those MS which would chose to use it. Setting
up a refund system implies the need to determine the eligibility criteria, to collect
fees from micro-enterprises and to re-imburse them on the basis of the
aforementioned criteria. Although there is currently no data available, such a
system would add to the costs resulting from the management of a
costing/charging system applicable to all operators (with no refunds or
exemptions fro certain categories). A refund system
would also be more complex and more costly than the direct exemption of
micro-enterprises from the payment of fees, as it adds the costs of the refund
mechanism to the basic costs of managing the aid scheme. Nonetheless, a refund
system allows for full cost recovery and ensures that competent authorities
have sufficient resources to guarantee the effective organisation of official
controls (as opposed to the exemption mechanisms, which would deprive the CA
from the fees revenue, unless appropriate compensation is granted). Accountability - Option 2 would contribute to increasing the accountability of
control activities in light of the effect of the stronger and certain link
between costs and fees. This would be underpinned by the increased transparency
of the mechanisms through which fees are calculated as operators would be able
to see clearly what they are being charged for and how these charges are
derived in light of costs to CAs. This improved clarity would be a driver for
improved efficiency of official control systems and also allow better
supervision of implementation by the Commission. Furthermore,
increased transparency would contribute to the objective of ensuring that fees
revenues are not unduly distracted from their intended use (compensate control
costs). The option of requiring the establishment of a specific ring-fencing
mechanism to ensure that fee revenues are recycled back in to the CAs' budget would
require legislative changes in a number of MS and could be difficult to
implement. The same result, however, could be obtained by ensuring a clear
definition of eligible costs, transparency of full cost recovery requirements
and thus the accountability of the fees system as a whole, which would enable
the public and operators in particular to appreciate how costs are identified
and charged and how fees are calculated and used. During the consultation, a
number of MS (IT, DE, NL, FR and UK) noted that a fees system that has a clear
definition of eligible costs, transparency of reporting and full cost recovery
requirements, would effectively operate as a ring-fencing mechanism without a
formal requirement to do so. Safety
– Increased efficiency of the risk based use of
resources would ensure a better enforcement of agri-food chain rules covered by
the Regulation (food and feed law, including rules on residues of veterinary
medicines[71], FCM and GMOs, and
animal health and welfare rules) and thus a higher level of protection of the
safety of the agri-food chain. A
stable mobilisation of resources coupled with the other elements mentioned
above (e.g. accountability, bonus malus etc.) allows progress towards
the primary objective of maintaining efficient controls and ensuring the
continued safety of the agri-food chain. Summary of the key impacts under Option 2 Criteria || Impacts Competitiveness || + Innovation || + Sustainability || + + Simplification || + Administrative Burden || + Accountability || + Safety || + Option 3 – Streamline
+ Integrate As
in 2; plus, a fully integrated system of controls along the agri-food chain
would maximise efficiency of enforcement through
simplification and synergy gains, facilitating the fulfilment of the objectives
of agri-food chain legislation. In
addition to the impacts highlighted for Option 2, the following impacts would
be produced by expanding the scope of the Regulation to the plant health, PRM
and ABP sectors. Competitiveness
- As a consequence of including the new areas under
the scope of the Regulation, MS CAs would be able to carry out the risk
prioritisation taking into account all agri-food chain sectors, better allocate
control resources and increase the efficiency of the control system as a whole.
In turn, economic operators would benefit from a more focused, and fully risk
based system of controls. Simplification
- Option 3 would ensure a harmonised approach to
official controls along the entire agri-food chain, while taking into account
the specificities of every sector where necessary. The overall system would
become more consistent and reliable as the same mechanisms and tasks would be
being used by all sectors[72]. Box 8:
Simplification gains under option 3 Acts or provisions to be repealed under option 3 Ø Acts referred to in Box 6. Ø Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (official controls provisions to be replaced by revised Regulation 882/2004; other provisions to be replaced by the new Plant Health Law); Ø 12 Council Directives on the marketing of plant reproductive material (official controls provisions to be replaced by revised Regulation 882/2004; other provisions to be replaced by the new plant reproductive legislation); Ø Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption (only official controls provisions to be repealed by revised Regulation 882/2004). Safety
– A fully integrated system of controls along the agri-food
chain would maximise efficiency of enforcement through simplification and
synergy gains, thus allowing optimal fulfilment of the objectives of the agri-food
chain. As
regards official laboratories, Option 3 would imply a new obligation for
laboratories carrying out plant health tests to be accredited. This would generate
additional costs (for the initial accreditation and for the annual audits): the
costs for the initial accreditation would be borne by the EU, the annual audits
costs would be for the laboratories themselves[73]. A tailor-made
simplified set of requirements and a transitional period of 5 years are
foreseen to facilitate the smooth introduction of such an obligation. Option 3
also foresees the possibility to create a network of reference laboratories to
improve methods and protocols used. This would ensure the soundness and
reliability of laboratory results and would improve safety. Summary of the key impacts under Option 3 Criteria || Impacts Competitiveness || + + Innovation || + Sustainability || + + Simplification || + + Administrative Burden || + Accountability || + + Safety || + + Option 4 –
Streamline + Integrate + Broader cost recovery As
in 3; plus, by broadening the collection of mandatory fees to key activities of
the agri-food chain, this option would improve the sustainability of the
control system as a whole and reduce its overall dependency on budgetary
decisions. It also ensures a more equitable approach to inspection fees, by
eliminating the perceived unfairness of the current system, which only requires
certain categories of operators to be charged. In
addition to each of the changes identified under Option 3, operators who are
registered in accordance with Regulation (EC) No 852/2004 and/or Regulation
(EC) No 183/2005 would be charged fees for official control activities. All of
the benefits applicable to Option 3 also apply to Option 4. Moreover, by
expanding the scope of the list of mandatory fees, this option also
addresses other issues, giving rise to the further effects detailed below. Sustainability
- Option 4, as compared to Option 3, would improve
mobilisation of CA resources for official controls as a stable flux of
resources would be available not only for controls on operators for which
mandatory fees apply under the current regime, but also for other controls carried
out on operators registered in accordance with Regulations (EC) No 852/2004 and
Regulation (EC) No 183/2005. The
economic impact on each MS and on operators would depend on whether (and to
what extent) MS charge sectors which are not subject to mandatory fees but
which would become so under Option 4. For those MS that already collect such
fees, effects are likely to be minimal for CAs and business operators alike. On
the contrary, effects are likely to be more significant in those MS which do
not. Box 9 illustrates the potential impact on business operators of the
extension of mandatory fees.[74]. Data available from MS
currently charging such fees shows that when these are levied upon all
operators subject to controls (irrespective of whether an inspection is
actually carried out during a reference period) the amounts are modulated
according to the size or the throughput of the business and represent a
rather negligible fraction of production costs. For instance, fees applied
annually irrespective of whether an inspection is actually carried out during
the year may range from small (€84.5 for the smallest scale restaurants in
Belgium) to higher, yet still not significant, sums (€1,500 for the largest
scale industrial bakeries in Italy). On the other hand, in MS where the
actual cost of each inspection is charged, amounts vary in relation to the
hourly cost of control activities (see box 9 below for examples). Evidence
suggests that the increase in costs for those individual operators in sectors
which would be covered by the extended scope of mandatory fees is likely to be of
little significance for the overall production costs. It is
impossible to quantify the precise economic impact that the extension of
mandatory fees would have on business operators as this is closely linked to,
and depends upon, national features such as the hourly cost and/or intensity of
controls (i.e. frequency, length, tools employed, training etc.). Nonetheless,
some idea as to the scale of the impact that Option 4 may have can be deduced
by analysing the charges applied by those Member States which already charge
non-mandatory fees. In particular, this can give an indication of the
charges which may result from the expansion of the scope of mandatory fees (assuming
that MS generally devote similar levels of effort to official controls,
guaranteeing equivalent levels of efficiency). It is
also very important to note that in areas currently not covered by mandatory
fees (e.g. inspections in restaurants, in establishments producing non animal
foodstuffs) official controls are not carried out at intensities comparable
with that of meat inspection; thus, costs per year and per operator are a
fraction of little significance of the costs incurred for the latter. The
control frequency in those areas depends on the risk, on the record of
compliance of the operator, on the reliability of its own checks, on
indications of possible non compliance. It varies therefore from one sector and
from one category of business to the other. However, for illustration
purposes a typical example would be the case of a small food retailer,
controlled on a yearly basis, by 1 inspector who spends 1.5 hours to perform
the checks and 1.5 hours of desk work to prepare for and to report from it. Such
a hypothetical control would cost, if charged on the basis of control time
used, around €50/year in Poland and €150/year in a MS using Italy's hourly rate. Inspection visits in a restaurant would have a similar frequency but
would take on average longer (2-3 hours if arrangements facilitate the visit)
and would cost between 30-40% more (from €65/year in Poland up to €210/year in Italy). On a global scale, this could guarantee between €2.3bn - €37bn/year of new funds
for official controls across the Member States.[75] Box 9: Impact on business operators of the extension of
mandatory fees As noted above (see Box 3), in Italy Legislative Decree No. 194 of 19 November 2008[76] calculates fees for official controls across the entire food production chain (such fees include those presently not mandatory under Regulation 882/2004)[77]. Calculations are made on the basis of actual costs in line with the criteria set out in Annex VI of Regulation 882/2004[78]. Moreover full cost recovery is ensured . Amongst the non-mandatory fees currently collected by Italy is a yearly charge imposed on wholesale bakeries and manufacturers producing oven baked products. Such a charge, which is meant to cover official control activities, increases progressively in line with operators' yearly production and ranges from €400/year where production is less than 500 tonnes to a maximum of €1,500/year where production exceeds 1,000 tonnes. In Belgium, non-mandatory fees ("contributions") are charged to all relevant operators at the beginning of the year and are meant to cover routine inspections regardless of whether these actually take place throughout the year. "Contributions" appear to fully recover costs incurred by Belgium in carrying out official controls in the relevant areas[79]. Depending upon the size and sector of establishments, "contributions" may range from approximately €20 - €12,000.[80] Restaurants, for example, are charged as little as €87.68 when they employ 0-4 people and up to €1,719.58 when the employ 100 or more people. In Germany, although charging practices vary across Länder an indicative hourly rate for certain non-animal health controls (i.e. those to which the scope of mandatory fees may be extended) is approximately €44/hour plus transport costs[81] calculated on an actual-cost basis. In Poland, non-mandatory fees for official controls are charged at €13 per control activity with an additional €4 per hour for sampling and testing. Such fees include transport costs, document control and verification procedures and are claimed to represent full cost recovery.[82] Competitiveness
- Option 4 addresses the perceived unfairness of
the current system, which only requires certain categories of operators to
participate in the financing of controls, by ensuring that mandatory fees are
applicable to a wider array of operators within the food production chain. Administrative
burden - As with Option 2, Option 4 would result in
limited additional administrative burdens for CAs to record the cost of
controls and calculating, setting, and collecting fees. The scale of such costs
is likely to be comparable to those to be expected from Option 2, only
marginally increased by the broader scope of the calculations. A transitional
period of 3 years would be provided to MS to organise the new costing/charging
system with the expanded scope. Such costs would in any event decrease over
time and, eventually, only the costs of collecting fees would remain. The
latter would also gradually decrease as fee collecting mechanisms become more
streamlined and effective. Summary of key impacts under Option 4 Criteria || Impacts Competitiveness || + + + Innovation || + Sustainability || + + + Simplification || + + Administrative Burden || + Accountability || + + Safety || + + Section 6: Comparing the options 6.1. Comparing
the options in light of the objectives Table 3: Options compared against the objectives General objectives || Option 1A || Option 1B || Option 2 || Option 3 || Option 4 Contribute to promote the smooth functioning of the internal market || (--) Divergences among MS likely to increase and affect competition || (0) || (+) Distortions due to divergent practices (fees) are eliminated (where mandatory fees apply currently) || (++) As in 2, plus streamlined rules on official controls would apply across all agri-food chain areas || (+++) As in 3, plus distortions linked to fees are eliminated also in the new areas covered by mandatory fees Maintain a high level of human, animal and plant health protection and animal welfare and prevent that this is undermined by potential non-implmentation of EU legislation || (-) Possible reduction of controls and of ability to respond to risks || (0) || (+) More risk-based controls would increase the efficiency and capability to respond to risks || (++) Efficiency of controls is maximised and risks of suboptimal protection reduced || (++) As in 3 Ensure proper and uniform implementation of EU legislation || (-) Possible suboptimal enforcement of law if resources decrease || (0) || (+) Clearer list of activities to be charged and list of costs; only cost based fees || (++) Same requirements and tasks across all agri-food chain sectors || (++) As in 3 Specific objectives || Option 1A || Option 1B || Option 2 || Option 3 || Option 4 Ensure a comprehensive and consistent approach to official controls along the agri-food chain || (0) || (0) || (+) Consistent use of risk based principle || (++) Same tasks & mechanisms used by all sectors || (++) As in 3 Allow for a more efficient use of national control resources || (0) || (0) || (+) Full risk based approach || (++) The inclusion of all agri-food chain areas in would allow cross-sectors risk prioritisation || (++) As in 3 Reduce administrative burden and remove uneccesary requirements || (0) Removes AB linked to EU fee rules, but MS would administer their own regimes || (0) || (+) Redundant plans & reports eliminated || (+) As in 2 || (+) As in 2 Foster closer cooperation between MS to improve official control delivery || (0) || (0) || (+) Rules on admin. cooperation can be adopted, synergies developed (IAS) || (++) Synergies possible also with plant health, PRM sectors || (++) As in 3 Ensure the availability of adequate resources || (-) Sufficient funding would depend on budgetary choices –failure to ensure cost recovery likely to worsen in times of crisis || (- -) insufficient funds, as no fees charged on micro-enterprises || (++) As cost would be recovered through fees, dependency from and pressure on national budgets decreases || (++) As in 2 || (+++) As in 2, on a broader scale Ensure equity and fairness in the financing of official controls || (-) No level playing field guaranteed as approaches to fee likely to vary || (-) No level playing field as micro-enterprises advantaged || (+) All operators charged with mandatory fees would pay the actual cost of controls || (+) As in 2 || (++) As in 2, plus all operators benefiting most from controls would all be charged Improve transparency, including of the system of financing official controls || (0) || || (++) 'High transparency' requirements can be detailed; transparency of fee mechanism would increase || (++) As in 2 || (++) As in 2 6.2.
Costs-benefits analysis Table 4: Policy Options - Significant Costs / Benefits || || Option 1.A deregulate fees || Option 1.B exempt micro-entreprises || Option 2. Streamline || Option 3. Streamline + integrate[83] || Option 4. Streamline + integrate + broader cost recovery || || Action || € || Action || € || Action || € || Action || € Member State CA || Cost || Will depend on choices made by each MS on whether to charge or not for official controls (1A) and on whether to recover costs of controls on micro-enterprises from other businesses and % of the latter (1B) || Estalishing and operating reporting regime for calculation and charging of fees || €0.5m one off + €2000/year (per MS). €13.5m one off + €54,000/year (across EU MS)[84] || Same (as Option 2 + Plant Health and Plant Reproductive Materials) || Same || Same as Options 2&3 || Same Benefit || || Stable funding in areas already charged i.e. meat sector (top up from the % of costs already charged to reach full cost recovery) || Depends on % recovery of costs by MS. Approx. €0.9bn –3.4bn new funds per year across EU MS[85],[86] || Same || Same || Full cost recovery for all OC on registered operators + 'top-up' as per Option 2 || Approx. total of new fees €2.3bn –37bn/year across EU MS[87] + €0.9 – 3.4bn per year || || || || || || || || || Business Oper. || Cost || Will depend on choices made by each MS on whether to charge or not for official controls (1A) and on whether to recover costs of controls on micro-enterprises from other businesses and % of the latter (1B) || Top up to existing fees (meat sector) to reach full cost recovery || Depends on % recovery of costs by MS. Approx. €0.9bn –3.4bn new fees (across EU MS) (approx 0.2 – 0.8% of annual product. value in the meat sector[88]) || Same (as Option 2 + Plant Health and Plant Reproductive Materials) || Same || New costs for operators currently not charged (non meat sector) + 'top-up' as per Option 2 || Approx. total of new charges €2.3bn –37bn/year across EU MS[89] + €0.9 – 3.4bn per year Benefit || || Risk based approach to vet. med. controls || EU-wide saving of €12.4m – 98.5m/year (covered by fee) || Same || Same || Same as Options 2&3 || Same 6.3.
Preferred option In
light of the assessment above, it is considered that Option 4 (i.e. the
legislative framework is improved and streamlined, plant health and PRM are
included in its scope, and mandatory fees are extended to cover key areas of
the agri-food chain) provides the best way to achieve the objectives. It offers
the best approach to simplification, clarity, coherence and reduction of
administrative burden without losing the capacity of the legislative framework
to account for the specificities of every concerned sector. Insofar
as the financing of official controls is concerned, Option 4 preserves
the long term sustainability of national control systems[90].
The conclusion of this IA is that the rationale for the current system is still
valid, i.e. agri-food chain business operators should bear the costs incurred
by competent authorities when performing official controls. While they are
primarily responsibile for preventing that unsafe products enter the agri-food
chain, the system of own controls that they are required to establish could not
deliver fully if it was not complemented by a dedicated, complex and costly
system of official controls maintained by each MS, requiring from CAs an effort
which goes beyond "normal" market surveillance duties. In
this respect, CAs assessment of the changes proposed through option 4 is
overall positive as improvements to the control system as a whole are expected
to result from the extension of the range of mandatory fees and from the full
cost recovery rule. Industry stakeholders worry about costs of such changes,
while recognising the positive impact to be expected from the increased
transparency and comparability of systems across the EU, and stress the need to
eliminate the unfairness of the current system of charging only some sectors
for control costs. As to such costs, while
the move to full cost recovery without expanding the scope of mandatory fees
(Option 2) would impact essentially on the sectors already charged (meat
inspection in particular), generating between €0.9bn and €3.4bn new revenue for
CAs, with an impact on individual operators which remains marginal when
rapported to their turnover, the proposed option of also expanding the scope of
mandatory fees to cover all the sectors which "use" most intensely the
official control capacity of national CAs would impact on all such sectors and
generate yearly an extra revenue estimated to be beteween €2.3bn and several
times this figure (up to €37bn/year in the hypothetical case of all operators
being charged at rates currently applied to the largest food businesses, i.e.
around €1.500). Furthermore, Option 4 ensures the most effective achievement of the objective of
providing an improved legal framework for official controls across all
sectors of the agri-food chain. Options 2 and 3 achieve the set objectives partly, only in the areas specifically
covered by each of them, thus failing to cover the whole agri-food chain in an
integrated approach, and to promote synergies and cost savings. They also fail
to address the unfairness and discriminatory character of the current financing
system and the resulting lack of legitimacy. As to Options 1A and 1B,
they cannot ensure the sustainability of the system of official controls due to
their potential consequences on the availability of sufficient resources for
the performance of such controls. The cost/benefit
comparison of the different options must take into account quantifiable and
non quantifiable elements (an approximation of the former being included in Table
4 above). In terms of costs, options
2 to 4 all imply additional costs for the setting up of a full cost
recovery system in those MS which do not have one (one-off cost for the setting
up of the system and subsequent operating costs). The estimates available
suggest that such costs will be affordable and that they will decrease with
time as the system stabilises and staff and organisations familiarize
themselves with it. These options also alleviate the competent authority from
the burden of some non risk-based controls (and operators from the
corresponding fees). When it comes to the
impact on operators, Option 4 ensures that costs are spread in a more
equitable manner across all operators which are responsible for the safety of
the agri-food chain. This is expected to result in a positive increase of the
legitimacy of the financing system. Also a net benefit of Option
4 is the increased accountability of competent authorities towards the
operators they control and charge, which is the result, on the one hand, of the
direct link between costs and charges and, on the other hand, of the increased
transparency of the financing system, which gives operators direct access to
the details of the costing mechanisms. Operators will thus be able to see and
scrutinise how the cost of controls (and the fees) are established, and thus –
albeit indirectly – the efficient use of fees revenue. Indeed,
the improved transparency of the system is instrumental in ensuring that the
increased financial security of CAs corresponds to an increased accountability
of the control system as such towards business operators and the public in
general. Section 7: Monitoring and evaluation The
review of the EU legislative framework applicable to official controls along
the agri-food chain aims at improving the efficiency and consistency of the
system, and ensuring its long term sustainability. It is considered that
whichever option is taken forward would clarify the existing rules and make
them easier to apply by MS CAs. To
assess the success of the measures introduced, the following core progress
indicators have been identified in line with the operational objectives of the
policy action: Establish a single and simpler legislative framework for official
controls ® Indicator - Number of requests for
legal interpretation received by the Commission ® Indicator - Number of pieces of EU
level legislation applying to official controls per sector/product ® Indicator - The reported change in the
declared average administrative burden on industry and MS All controls, including border controls, risk based ®Indicator –
Surveying MS on whether resources freed by this review are being used to
perform controls in areas of higher risk Increase the
number of cases where cross-border enforcement cases are resolved through
administrative assistance and cooperation ® Indicator - Number
of contacts through administrative cooperation contact points foreseen by
Article 35 of the Regulation ® Indicator - Number of complaints from
economic operators pointing to MS having failed to coordinate investigations in
case of cross border non-compliances Increase the number of formalised instruments between the CAs and
customs authorities for the performance of official controls ® Indicator - Number of service level agreements formalised between CAs and
other authorities including customs Reduce occurrence
of unsatisfactory enforcement results in FVO reports attributed to resources
shortages ® Indicator
– Trends in the number of FVO reports which point to a lack of resources in MS. The monitoring of
the correct implementation of the legislation on official controls along the agri-food
chain is ensured by the audits carried out by the FVO on the functioning of
national systems of controls. This will provide the Commission on a regular
basis with data and information about the indicators listed above and more
generally about the fulfilment by MS of the objectives pursued by the
legislation. Annex I: Glossary EU: European
Union FVO: Food and
Veterinary Office MS: Member
States CA: Competent
authority EURLs: EU
Reference Laboratories NRLs: National
Reference Laboratories MANCP: Multi
Annual National Control Plan CVO: Chief
veterinary offices FCM: Food
Contact Material PH: Plant
Health AH: Animal
Health AW: Animal
Welfare PRM: Plant
Reproductive Material ABP: Animal
by-products FCM: Food
contact material TRACES: TRAde
Control and Expert System BIP: Border
inspection post DPE:
Designated point of entry SCFCAH: Standing
Committee on the Food Chain and Animal Health Annex II: Overview of the legislative framework applicable to official controls along the food chain 1. Official controls
to enforce feed and food law, animal health and welfare rules The EU
system of official controls consists of a general framework established by Regulation 882/2004 of the European Parliament and Council of 29
April 2004 on official controls performed to ensure the verification of
compliance with feed and food law, animal health and welfare rules and
of a complex constellation of sectoral acts laying down official controls
provisions (for the implementation of feed and food law, animal health and
welfare rules). This is due to the fact that when Regulation 882/2004 was
adopted a plethora of pre-existing acts (characterised by a sectoral approach)
were kept in force. Regulation 882/2004 also
provides for a set of rules aimed at ensuring that CAs
tasked with control duties are appropriately resourced, including through the
levying of inspection fees from business subject to official controls. 1.1. Regulation
882/2004 on official controls Regulation
882/2004 was adopted to complement a wider initiative of modernisation, recast
and simplification of EU legislation in the areas of food and feed safety,
animal health, animal welfare and in part, plant health, carried out between
2000 and 2004, with a coherent legal framework for official control activities
in those areas, to ensure the smooth functioning of the Single Market through
the effective implementation of food and feed standards and of public, animal and
(only partially) plant health rules. This new legal framework has been in
application since 1st January 2006. The
Regulation applies to control activities performed to ensure the verification
of compliance with feed and food law, animal health and
welfare rules across the EU. To a limited extent, it also applies to Plant
Health related controls, in particular as far as the provisions on the
multiannual control plans and Union audits are concerned. Regulation
882/2004 provides CAs in the MS with a solid and comprehensive set of rules
which affords them the necessary powers and tools to deliver their enforcement
duties in an efficient and reliable fashion. In particular, the Regulation
includes: §
the obligation for MS to designate the
authorities responsible for the performance of official controls in the areas
covered by the Regulation; §
the all-important principle according to which official
controls must be risk based, so that the deployment of control/enforcement
resources is prioritised on the basis of the risk, §
the obligation to plan official controls through
a multiannual programming instrument (the multiannual control plan – MANCP) and
to report on their implementation and outcomes; §
provisions intended to ensure that o
competent authorities are transparent and
fully accountable with regard to the performance of
their duties and the effectiveness of their work; the outcomes of official
controls are sound and reliable and remain so also in case of
delegation to other control bodies; o
competent authorities possess the powers
necessary to control compliance with the rules and
to enforce them, and the powers necessary to supervise and monitor situations
where risks for the health of humans or animals may arise; o
official laboratories perform to the highest
standards; The Regulation also provides for: §
the general framework and procedures applicable
to official controls on feed and food imported from third countries into the
territory of the Union and specific rules on the establishment of increased
controls at the point of entry into the Union for certain products[91]);
and §
procedures for establishing import conditions
(i.e. the requirements that imports into the Unions must satisfy in order to
ensure that they do not pose a risk to human or animal or health) for such commodities and to the extent that those conditions are not
provided for by other EU law. The Regulation also lays
down the rules governing the audits carried out by Commission experts (the Directorate F, Food and Veterinary Office
[FVO] of DG SANCO) in Member States and third countries
to verify the implementation of EU law and the functioning of the systems of
official controls in MS. Finally, a key section of
the Regulation is Chapter VI, which provides for a set of rules aimed at
ensuring that CAs tasked with control duties are appropriately resourced,
including through the levying of inspection fees from business subject
to official controls. In particular, the Regulation provides for: §
the general principle according to which MS
shall ensure that adequate financial resources are available for official
controls by whatever means considered appropriate, including through general
taxation or by establishing fees or charges; §
an obligation for MS to use fees (mandatory
fees) for financing control activities when it comes to certain sectors: - controls on slaughter, cutting operations and cold storage of meat,
production and placing on the market of fishery products, and milk production; - controls carried out to grand feed establishments approval; -
controls carried out at a border on consignments
of live animals, products of animal origin, animal products, animal by
products; certain food and feed of non animal origin. §
a set of standard fees applicable in some cases
where mandatory fees are required: where standard fees exist, they offer the
CAs a statutory fee in cases where the MS has not calculated the costs of the
activity in question for the purposes of charging a cost based fee; §
a set of common principles applicable to
mandatory and non-mandatory fees among which the all-important one according to
which fees are meant to cover the costs incurred and cannot exceed such costs; §
the obligation for MS to make public the method
of calculation of fees and communicate it to the Commission; §
the obligation for the MS competent authorities
to charge the operators for the expenses arising from additional official
controls carried out when non compliances are detected. 1.2. Official
controls on residues of veterinary medicines in live animals and animal
products (Directive 96/23/EC) Regulation 882/2004 stipulates to keep in place Council Directive 96/23/EC on measures
to monitor certain substances and residues thereof in live animals and animal
products. Directive 96/23/EC
requires MS to implement national residues monitoring plans which are not
included in the MANCP and annually submitted to the Commission together with
the results of the implementation in the previous year and the actions taken as
follow-up of non-complaint results. It also establishes mandatory minimum
number of samples that shall be analysed for each combination sub-group of
substances / animal or animal product according to the national production
without taking into account other elements which may impact on the risk
assessment (e.g. rearing practices, veterinary medicinal products authorised,
etc). The requirements for third countries are essentially the same as for MS.
Apart from residues of veterinary medicines, Annex I to Directive 96/23/EC also
includes several residues of pesticides[92] and several
environmental contaminants[93] among the group of
substances to be controlled within the framework of the national residues
monitoring plans. 1.3.
Official controls on products of animal origin intended for human consumption Regulation
(EC) No 854/2004[94] of the
European Parliament and of the Council lays down specific rules for official
controls on products of animal origin intended for human consumption. The
Regulation addresses specific aspects of official controls associated with such
products, including meat, live bivalve molluscs, fishery products and milk. In
particular, the Regulation lays down specific rules on approval of
establishments, specific official control activities in EU establishments and
specific rules for controls of products imported to the EU. 1.4. Veterinary
border controls As
mentioned above, Regulation 882/2004 sets out the
general framework and the procedures applicable to official controls on feed
and food imported from third countries into the territory of the Union. Moreover, it establishes a legal basis for the introduction of an increased level of
official controls at the point of entry of the Union for certain feed and food
of non-animal origin on the basis of known or emerging risk. Specific rules for
veterinary border controls on animal origin products and on live animals, , are
laid down in Directives 91/496/EEC[95] and 97/78/EC[96].
These specify that veterinary checks have to be carried out in approved border
inspection posts (BIPs) which are listed in Decision 2009/821/EC[97]
on such consignments and how these veterinary checks need to be carried out.
Additional details are laid down in secondary legislation, such as the minimum
requirements for BIP facilities and their technical equipment, the frequency of
physical checks, the list of animals and animal origin products to be checked
in BIPs and details for checks and follow up on specific consignments, e.g.
transit and transhipment. 1.5. Official
controls in the animal health sector The rules of Regulation
882/2004 already apply to official controls carried out to verify compliance
with the requirements of animal health rules. However its wording in certain
cases is more focused on food and feed products and, as a result, not always
consistent when it comes to its applicability to animal health issues. In
parallel, two Directives dealing with official controls carried out to verify
compliance with animal health requirements in intra-Community trade (Directives
89/662/EEC[98] and 90/425[99])
have also remained in force. Those rules are complemented by a Directive
dealing with official certification in the veterinary area[100],
and a Directive on mutual cooperation of competent authorities and
administrative assistance between them[101]. 2. Official controls in sectors not (or
only partially) covered by Regulation 882/2004 There are a number of
provisions governing the food chain whose enforcement is not (or only
partially) governed by Regulation 882/2004. 2.1. Official
controls in the animal by-products sector Regulation
(EC) No 1069/2009 laying down health rules as regards animal by-products and
derived products not intended for human consumption[102]
establishes inter alia its own system of official controls, excluding
thus the applicability of Regulation 882/2004 except
for those provisions explicitly recalled thereof. 2.2 Official
controls in the plant health sector plant propagating material sector Regulation 882/2004 does
not concern, with the exception of some specific Articles (dealing with the
multiannual controls plan and Union audits in MS and
third countries), official controls in the field of plant health.
Official controls in this area are governed by
Council Directive 2000/29/EC[103], which rules and measures concerning certification, import
and intra-EU movements of plants and plant products, with regards to
eradication and containment of outbreaks and in relation to Union co-financing
of measures taken. In
parallel with Regulation 882/2004, it imposes inter alia obligations on
the MS to carry out controls to verify compliance with the requirements thereof
and defines what legal persons may be charged with official tasks in this
respect. It also foresees a system of fees that may (plant passport) or shall
(import) be levied by the MS to finance official controls. 2.3.
Official controls on plant reproductive material The
plant reproductive material legislation is fully outside the scope of
Regulation 882/2004. The limited number of official controls is currently
regulated by a set of 12 Council Directives on the marketing of plant reproductive
material[104]. These
Directives too impose obligations on the MS to carry out controls to verify
compliance with the requirements thereof and define what legal persons may be
charged with official tasks in this respect. They do not foresee a system of
inspection fees. Annex III: Details of the problem identification ·
Inconsistencies, gaps and overlap in
control requirements The EU
legislative framework for official controls on the food chain is an incomplete
patchwork. Inconsistencies and gaps have been identified. In
particular, - differences (e.g. the definitions of CAs and the mechanism for
delegation of official tasks, including laboratory tasks, the logic of risk
based controls, the system of border controls) are apparent between Regulation
882/2004 and the legislation concerning official controls in the plant
health sector; while some of these differences are justified because of the
peculiarities of that sector (i.e. certification procedures), others appear to
be arbitrary insofar as they result in different rules where the activities
regulated upon call for the same set of guarantees to be applied; - current EU rules on plant reproductive material do not
include provisions on official controls; - Regulation 882/2004 only partly applies to controls on animal
by-products and derived products not intended for
human consumption (ABP); as a result, some
important provisions (e.g. on transparency of enforcement activities, on
accreditation of official laboratories, on FVO audits in MS) are currently not
applicable to such controls. - On the other hand, certain requirements and procedures laid down in
Regulation 882/2004 are also present in pre-existing sectoral legislation,
either with an identical formulation or with a slightly different wording which
however does not change the substance of the provisions, calling however for
different interpretations. For example, the mechanism for administrative
assistance and cooperation are regulated upon by Regulation 882/2004,
Directives 89/662[105] and 89/608[106]);
registration and approval requirements for operators are laid down in
Regulation 882/2004, and Regulations 183/2005[107],
852/2004[108], 854/2004[109].
·
Inconsistent implementation of
risk-based approach resulting in insufficient / differing / inefficient
prioritisation of official controls Regulation
882/2004 requires official controls to be risk based, and MS to prioritise
their control efforts and allocate resources giving priority to
situations/areas where the risk is higher. Existing harmonised rules in certain
areas prevent however this principle to fully deploy its benefits in terms of
more efficient use of resources and of reduction of unnecessary burden on
business operators subjected to controls (time, staff, equipment and facilities
being mobilised to allow controls). As
regards import controls, MS are currently required to carry out official
controls on certain commodities arriving from third countries at the outer
borders of the EU (border controls). In
fact, safety of goods from third countries is ensured not only through risk
based controls carried out by national authorities at any stage of the food
chain, but, most importantly, by sanitary checks carried out at the outer
borders of the EU on goods which present an intrinsic risk for human, animal or
plant health. Border Inspection Posts ("BIPs") exist for the
performance of veterinary checks on animals and products of animal origin,
Designated Points of Entry ("DPEs") carry out border checks on
certain foods and feed of non animal origin, and entry points are designated by
each MS for the performance of phytosanitary controls[110]
on imported plants and plant products. The
rationale and the underpinning principles of such controls across the range of
food chain products (from plants to animals and animal products, to food and
feed, animal by-products, food contact materials) are the same and they conform
to the overarching principle according to which border controls shall be
limited and proportionate to what is necessary to contain the potential risks
for humans, animals or plants. The possibility to fully adjust the control
effort to the level of risk is however limited by two different factors: on the
one hand by the rigidity of current rules, which in some areas do not allow the
continuous adjustment of the frequencies of physical checks as established in
legislation to take into account of situations where the risk is reduced. On
the other hand, as the different control systems at the borders are operated in
accordance with different sets of rules (and by different authorities in some
cases) depending on the sectors/products to be controlled, there is no
integrated mechanisms to allow the prioritisation of checks by comparing the
levels of risk of all the commodities of relevance for the food chain; in other
words, risk prioritisation is carried out within sectors and not across
sectors. This
results in burdens (above) and costs (most border controls result in a fee
levied on the business operator responsible for the consignment) not always
justified by the risk posed by the product being introduced into the EU.
Similarly, the lack of integration of the different control structures
operating at the border also prevents efficiency gains and savings in
administrative costs to be reflected in lower fees being charged on operators. Example A number of Member States asked the Commission whether Designated Points of Entry can be located within the same facilities of EU approved Border Inspection Posts. Under Directive 96/23/EC
on official controls of residues of veterinary medicines, MS are required to include in their national residues monitoring
plans a minimum number of samples for each combination of animal (or animal
product) and (sub)group of substances, and to test for certain substances and
substance groups also in cases where there has been little or no evidence of a
risk that would justify that intensity of checks. Examples Stilbenes - All
animals and animal products Although absolutely no
non compliance has been detected for several years now, between 21000 and 24000
samples are analysed each year across the EU for stilbenes, their derivatives,
salts and esters. Year || Total number of samples analysed || Number of non compliances 2007 || 23 411 || 0 2008 || 21 664 || 0 2009 || 21 815 || 0 2010 || 23 455 || 0 Resorcylic acid
lactones (including zeranol) in pigs. Although absolutely no
non compliance has been detected for several years now, more than 6000 samples
continue to be analysed each year across the EU. Year || Total number of samples analysed || Number of non compliances 2007 || 6234 || 0 2008 || 5594 || 0 2009 || 6237 || 0 2010 || 6166 || 0 The
Directive also prescribes in a detailed fashion what enforcement action Member
State’ authorities must take in relation to the different possible violation of
EU rules (illegal treatment, use of unauthorised
substances, presence of residues of veterinary medicines at levels exceeding
the maximum residues limits (MRLs), repeated infringements of MRLs, etc). No
flexibility is left to CAs in view of ensuring that enforcement action is
proportionate to the situation at hand and to their specific enforcement needs.
The rigidities in the system created by the Directive clearly result in an
inefficient allocation of control resources, unnecessary burdens on operators,
and inefficient enforcement action. ·
Administrative burden and
disproportionate control requirements Rules
governing official controls on residues of veterinary medicines result in
avoidable administrative burdens for both the MS CAs and the Commission, in
several respects.
Directive 96/23/EC requires that annual updates to MS’ monitoring plan of
residues of veterinary medicines be transmitted to and approved by Commission.
There is no such requirement for any of the other
control planning instruments or for the MANCP as such and the long and heavy administrative procedure laid down in the Directive
of residues is not justified by any specificity of the controls to be carried
out.
A similar requirement exists in relation to the residues monitoring plans of
third countries exporting animals or animal products to the EU. While of course
appropriate guarantees must be provided by exporting third countries that their
produce offer a level of safety which is equivalent to the one offered by EU
products, less bureaucratic mechanisms can be designed to replace the current
formal approval.
Also redundant with the general reporting requirement set by Regulation
882/2004 for all control activities are the specific reporting obligations laid
down in the Directive. Article 12 of Regulation 882/2004 provides for the
mandatory accreditation of official laboratories in accordance with EN ISO/IEC
17025[111]. No flexibility is allowed for cases where the
official laboratories might have to use a specific method which is not yet
included in the scope of the accreditation because of an emergency or because
the method is new. Example No or nearly no official laboratory in the EU was accredited according to ISO 17025 for the detection of mineral oil in sunflower oil or for the detection of melamine in food when respectively the crisis on sunflower oil from Ukraine or the one on melamine in food from China broke out. Nor there is flexibility for the very specific case of small laboratories attached to operators' establishments, where
extremely basic tests are carried out. Example A concrete example of the latter situation is the small laboratories performing Trichinella tests. Soon after the adoption of Regulation 882/2004 several Member States brought to the attention of the Commission that accreditation is very burdensome for very small Trichinella laboratories, attached to slaughterhouses or game meat handling establishments which only perform that type of test (the test is not complex and easy to carry out) and covering only the needs of the one establishment. Therefore, besides a transitional period for the accreditation of all laboratories granted for 4 years, ending in 2009, the Commission extended such a transitional period until 31 December 2013 for the accreditation of laboratories tasked with Trichinella testing and located in a slaughterhouse or a game handling establishment. ·
Unclear rules and insufficient
implementation details Regulation
882/2004 includes some unclear rules, which may generate divergent
interpretation and application, and thus legal uncertainty. a) The Regulation lays down a general obligation for MS CAs to ensure a
"high level of transparency" when performing their control
activities. The provisions on transparency are unclear as regards both the
types of information to be disclosed and the degree of such disclosure. b) Doubts exist about whether all methods used by a laboratory when
operating as an official laboratory must be included in the accreditation.
Furthermore, divergent interpretation are reported of Article 12(3) of
Regulation 882/2004, according to which the accreditation of testing
laboratories in accordance with EN ISO/IEC 17025 may relate "to
individual tests or groups of tests"(depending on the practice
followed by the different national accreditation bodies, the scope of
accreditation can comprise one method, several methods or even groups of
methods). The scope of accreditation according to EN ISO/IEC 17025 of a laboratory can be fixed or flexible. A flexible scope accreditation is in general more difficult to obtain as it allows the laboratory not only to carry out the methods specified in the scope of accreditation, but also to add methods within the defined limits to the scope on the basis that the competence of the laboratory to develop and validate methods has been positively evaluated. For both types of accreditation scopes, the interpretation of Article 12.3 differs greatly from one MS to another. In some Member States, a fixed scope accreditation can only cover the use of a specific method (to be followed very precisely by the laboratory) on a specific matrix in order to detect a specific substance, virus, bacteria, etc (e.g. HPLC analysis of aflatoxins in pistachios). The consequence is for instance that for each new use of the method (e.g. on another very similar matrix like peanuts or almonds), the laboratory has to undergo a new accreditation procedure. In other Member States, fixed scope accreditations are given for the use of a method on several similar matrices making it for instance possible for the laboratory to use the method on another similar matrix without undergoing a new accreditation procedure. Also, for some accreditation bodies but not for others, a flexible scope accreditation can cover the use of all methods using a same analytical technique (like for instance all methods using the ELISA technique). c) In some cases, identical terms are used to define different
concepts; for instance, while the terms 'surveillance' and 'monitoring'
indicate in Regulation 882/2004 specific forms of official controls to verify
compliance with the law, in the animal health and plant health legislation,
such terms refer to activities carried out by CAs but also by stakeholders,
with the objective of detecting, eradicating or containing diseases or harmful
organisms. d)
While the scope of Regulation 882/2004 covers the
enforcement of feed and food law, and of animal health and animal welfare
rules, the wording of many provisions is specifically focused on feed and food.
This results in uncertainties and divergent interpretations as to whether such
provisions apply to controls on compliance with animal health and animal
welfare rules, or with specific legislation governing the materials and articles intended to come into contact with food (FCM)[112] or the deliberate release into the
environment of genetically modified organisms[113]. Example Recently, Sweden enquired whether the mandate of the FVO as defined in article 45 of Regulation 882/2004 extends to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. In particular, it asked whether controls of field trials, including the authorisation process and the cultivation of the Amflora potato fall within the mandate of the FVO. ·
Insufficient administrative cooperation
amongst public authorities CAs rarely make use of the rules of Regulation 882/2004 on
administrative cooperation, which require them to liaise with their
counterparts in another MS to ensure that serious
non-compliances are also pursued in the MS where the violation originates. The
reason for that is to be found in the fact that no implementing tools exist to
allow the cooperation mechanisms to function (i.e. CAs are not provided with
any rule on how to trigger cooperation requests, on what the request content
could be and what can be expected as a result of it etc., nor on the
technicalities of the cooperation mechanisms). Example The Commission received a complaint against Germany from a food business operator. The complainant indicated that Germany, although aware of the fact that a violation of food chain rules was also to be attributed to the supplier of the complainant located in Poland, failed to contact the MS of dispatch (Poland) as requested by Article 38 of Regulation 882/2004, and held the complainant solely responsible and liable for the violation. Germany maintained instead wrongly that the notification in the Rapid Alert system for food and feed (RASFF) satisfied its obligation under Article 38. For import controls,
Regulation 882/2004 requires customs and sanitary authorities to cooperate
during controls they carry out on imported products. However, feedback from CAs
indicates that some important efficiency gains could be made if the operation
of the two parallel systems of customs and sanitary checks on imported products
could be "synchronised" better so as to eliminate all unnecessary
duplications in the two parallel processes, e.g. in the collection of
pre-arrival information and in the processing of it, or in the processing of
information necessary for the final clearance of products (also from a sanitary
point of view) before they are released for free circulation. Such duplications
are a burden and have a cost for all concerned (customs authorities and
sanitary authorities and, inevitably, importers). This is again the result of
the lack of detailed indications on what modalities the cooperation obligation
laid down in Regulation 882/2004 must take for it to fully deploy its potential
in terms of efficiency gains and reduced burden on operators subject to import
checks. Example France asked the Commission whether the national customs authorities, in case of food and feed, can trigger the mechanisms foreseen in Articles 27 to 29 of Regulation 765/2008 (on setting out the requirements for accreditation and market surveillance relating to the marketing of products) allowing them to suspend release of a product for free circulation on the Union market and inform the sanitary authority any time the product seems to present a serious risk to health, safety. Moreover,
potential synergies of action across different competent authorities are
hampered as no provision of Regulation 882/2004 allows the delegation of
specific controls tasks to the sanitary authority present at border. One
important example is the present inability of the competent authority
responsible for biodiversity rules to delegate border control tasks to the
sanitary authority at the border to verify the presence of Invasive Alien
Species (IAS), which would lead to important efficiency gains.[114] Annex IV: PROCEDURE - Details of the consultation 1) Consultation of
Member States ·
Meetings of the Working Group on the general
Application of Regulation 882/2004 set up within the Standing Committee on the
Food Chain and Animal Health (SCFCAH) were held on: - 7 September 2009, - 3
May, 27 September 2010, - 1 March, 11 April, 23 May, 27 June, 7 October, 10
November and 5 December 2011. In
addition, Member States were consulted on the following specific issues: §
Financing of official controls The
Commission contracted out to an external contractor[115]
a study on the state of the application of the rules on inspection fees imposed
by MS on operators to finance official controls (Inspection Fees). In this
context, a survey of the Member States' competent authorities was carried out
by means of a questionnaire to collect both information on the state of the implementation of the rules on the financing of official
controls and views about a series of possible options for addressing existing
difficulties. The final results of this study were
made available to the Commission in February 2009[116]
and presented at the meeting of the Heads of Food Safety Agencies
organised by the Swedish Presidency in Stockholm on 25-26 September 2009. The
Commission started a second consultation of MS through an ad hoc MS
experts working group which met on 7 September 2009. In preparation of the
impact assessment (IA), a second study was contracted out to an external
contractor[117] to assess the impact of
the options identified to address the weaknesses of the system. The options on inspection fees were discussed with Member
States by the external contractor to gather evidence and data to inform a
decision on the recommended option. The final results were made
available to the Commission on 20th September 2011 and presented to
the Member States at the meeting of the Working Group on the general
application of Regulation (EC) No 882/2004 on
10th November 2011[118]. §
Accreditation of official
laboratories (Article 12 of Regulation (EC) No 882/2004) Accreditation of official
food, feed and animal health laboratories according to Article 12 of Regulation
(EC) No 882/2004 was discussed at two meetings of the Working
Group on the general application of Regulation (EC) No 882/2004 (3 May
and 27 September 2010) with the participation of Directorate General Enterprise
and Industry and European co-operation for Accreditation (EA). As a follow-up
to these meetings, a discussion paper[119] was drafted
with the purpose of summarising the main issues identified during the
discussions as well as the corresponding suggestions for improvement from the
MS. The aim of the paper was to reflect on available options to improve the
enforcement of Article 12 of Regulation (EC) No 882/2004. This paper was sent
in January 2011 to the members of the Working Group on the
general application of Regulation (EC) No 882/2004. In June 2011, the
discussion paper was also sent to the Chief Veterinary Officers (CVOs) in order
to identify any specific issues concerning in particular animal health
laboratories. These results of the discussions as well as the answers to the
consultations received from the Member States have been presented to the Working Group on the general application of Regulation (EC)
No 882/2004 (meeting on 5 December 2011) as well as to the members of EA
(meeting on 8 December 2011) and fed into this Impact Assessment Report. The possible introduction
of a mandatory accreditation for plant health laboratories and the possibility
to establish EU reference laboratories in the plant health sector were discussed
with the chief officers for plant health (COPHs) of the Member States as well
as during the specific task force with MS experts and the Commission on 26 May
2011 (see "Plant Health and Seed and plant propagating material related
controls" hereafter). After these meetings, the COPHs and the task force
members were consulted in writing on the costs of the introduction of a
mandatory accreditation for plant laboratories. Similar consultations were organised during the evaluation and review of
the EU regime for the marketing of seed & plant propagating material (Task
force with MS experts and the Commission – see
"Plant Health and Seed and plant propagating material related
controls" hereafter). §
Official controls on
residues of veterinary medicines in live animals and animal products (Directive
96/23/EC) In 2003 the Commission
launched a broad consultation process to review the whole legislation on
residues of pharmacologically active substances used for the treatment of
animals including Directive 96/23/EC which was finally not modified nor
repealed as its revision was put on hold. At the beginning of 2011,
the extensive material collected at that time was considered, insofar as it was
still relevant, and a new consultation of the MS on the impacts of the different
options available was carried out. The objective of this consultation was to
update and complement the relevant information gathered in 2003 with fresher
input and to collect additional data to be used to assess the impact of the
available options. A questionnaire[120] was
addressed to the Working Group on the general
application of Regulation (EC) No 882/2004, to the Chief Veterinary
Officers (CVOs) of the MS as well as to officials in the MS in particular
responsible for the management of residues of veterinary medicinal products
control plans in the MS (the "residues experts working group" set up
within the SCFCAH). The outcome of the consultation[121]
was then presented to and discussed with the Working Group on the general
application of Regulation (EC) No 882/2004 (meeting on 27 June 2011), the CVOs
(meeting on 29 September 2011) and the "residues experts working
group" (meeting on 5 September 2011). §
Veterinary border
controls In
2007 the Commission launched a questionnaire to all Member States to investigate
in which areas there are difficulties with the implementation of the veterinary
checks in BIPs. All Member States provided detailed replies favouring the
review of the veterinary border control legislation and highlighting the need
for more effective physical checks including a risk based approach. In addition
several problematic areas, such as implementation of pre-notification,
re-enforced physical checks, procedures for specific consignments such as for
transit, for transhipment, channelled and rejected consignments, re-imports and
approval and supervision of specific free and customs warehouses were raised.
These problematic areas were discussed in the Working Group on veterinary check
legislation with Member States' representatives. Two
Steering Group meetings were hold (27.05.2010 and 03.03.2011) to inform the
members (including stakeholders), during which the Commission explained how the
work concerning the Review of the import control legislation started and how it
is planned to continue. Participants in the Steering Groups did raise several
questions for clarification but no major comments in relation to the review
were raised. In
addition two task forces with a limited number of Member States representatives
were held (25.01.2011, 23.06.2011) to discuss the review of Regulation (EC) No
882/2004 to integrate principles of import controls for live animals and
products of animal origin and repealing and replacing Council Directives
91/496/EEC and 97/78/EC. The results of the discussions in the Taskforces were
presented to the Working Group for veterinary checks and the review of
Regulation (EC) No 882/2004 was discussed on 02.12.2010, 11.03.2011 and
06.07.2011. §
Animal Health related controls The Animal Health Law, including related
controls aspects, was discussed at numerous Chief Veterinary Officers' working
group meeting since early 2009. On some elements two public consultations also
took place in 2009 and 2010 respectively and in particular at the meeting on 22
March 2011. In addition, a dedicated meeting of the Working group on the Animal
Health Law, with representatives of the MS was organised on 30 May 2011 to
discuss certain aspects relating to animal health controls. §
Plant Health and plant reproductive material
related controls Repeated consultations were organised for the
review of the EU plant health regime, during the evaluation phase, for the
preparation of options for the future and for assessing the potential impacts
of certain measures. The consultations included the organisation of meetings
and conferences as well as written consultations. The relationship between the plant health
regime and Regulation (EC) No 882/2004 and the possible full inclusion of the
former in the scope of that Regulation was discussed repeatedly with the Chief
Officers for Plant Health of the Member States. On their request, a specific
task force with MS experts and the Commission and reporting to the said Chief
Officers was convened on 26 May 2011 to discuss the feasibility of the
inclusion of plant health related controls in the horizontal framework for
official controls. Repeated consultations were similarly
organised during the evaluation and review of the EU regime for the marketing
of seed & plant propagating material. Also in this area, a task force with
MS experts and the Commission was set up to discuss the feasibility of the
inclusion of seeds and propagating material within the scope of the general
framework for official controls. This task force was convened on 24 May and 19
July 2011. 2) Consultation of
stakeholders ·
Under the Advisory Group on the Food Chain and
Animal Health and Plant Health, two ad hoc Working Groups were
established: - the one on the review
of the inspection fees rules took place on19 October 2009, - the one on the review
of the system of official controls took place on 19 September 2011. ·
The Advisory Group on the Food Chain and Animal
Health and Plant Health took place on: - 14 March 2011, - 14 November 2011. 3) Inter Service
Steering Group
The Commission Inter-Service Steering Group on
the IA for the review of the EU system of official controls along the food
chain met six times on:
-
5
May 2011 (planned approach and problem analysis were discussed), -
24th
June 2011 (collection of data and a first draft of the IA were discussed), -
19
July 2011 (outcome of the results of the consultation on Directive 96/23,
problem definition, objectives and policy options), -
7
September 2011 (problem definition and objectives), -
18
October 2011 (policy options), -
25
November 2011 (policy options and analysis of impacts), -
20
December 2011 (analysis of impacts and preferred options). Annex V: PROCEDURE – Specific data collection activities §
Directive 96/23 on official controls on
residues of veterinary medicines in live animals and animal products Information
collected in the context of the 2003-2009 evaluation in order to review the
whole legislation on residues of pharmacologically active substances used for
the treatment of animals (including Directive 96/23/EC[122])
has been considered for this review insofar as it was still relevant. It has
been updated and complemented by information and data received from the MS
through the consultation carried out at the beginning of 2011. A significant amount of
information was also available in the Commission's "Residues
Application", which records the number of samples of animals or animal
products analysed for residues and the corresponding results. Data on the cost
of the residues controls was collected through a questionnaire sent to the MS
at the beginning 2011[123]. Data from the
"Residues Application" and from the consultations carried out have
been used in particular to assess the potential impacts of the options
available[124]. §
Plant Health The
general evaluation of the EU plant health regime was carried out in 2009-2011[125]
and included elements of the EU regime on official controls in the Plant Health
sector. A data
gathering exercise was also conducted with regard to additional burdens to MS
authorities and operators that could result from 1) a possible link of plant
and plant products imports to the TRACES system, 2) the cost of mandatory
accreditation of laboratories for methods related to plant health and 3) the
cost of setting up EU reference laboratories for plant health. Annex VI[126]: PROCEDURE – List of consulted stakeholders Acronym || Organisation AESGP || European Self-Medication Industry AIPCE-CEP || European Fish Processors Association European Federation of National Organisations of Importers and Exporters of Fish AVEC || Association of Poultry Processors and Poultry Trade in the EU countries CEFIC || European Chemical Industry Council CELCAA || European Liaison Committee for the Agricultural and Agri-Food Trade FOODDRINK EUROPE (former CIAA) || European food and drink industry (recent Confederation of the food and drink industries of the EU) CLITRAVI || Center for the Meat Processing Industry in the European Union COCERAL || Comité du Commerce des céréales, aliments du bétail, oléagineux, huile d'olive, huiles et graisses et agrofournitures COPA-COGECA || Committee of Professional Agricultural Organisations-General Confederation of Agricultural Cooperatives EDA || European Dairy Association EHPM || European Federation of Associations of Health Product Manufacturers ESA || European Seed Association ESA || European Snacks Association EUROCHAMBERS || European Association of Chambers of Commerce and Industry EUROCOMMERCE || The retail, wholesale and international trade representation to the EU EUROGROUP FOR ANIMALS || Eurogroup for animal welfare at European Union level EUROPABIO || European Association for Bioindustries FEFAC || European Feed Manufacturers' Federation FEFANA || EU Association of Specialty Feed Ingredients and their Mixtures FESASS || European Federation for Animal Health and Sanitary Security FRESHFEL EUROPE || European Fresh Produce Association FVE || Federation of Veterinarian of Europe HOTREC || Trade association of hotels, restaurants and cafés in the European IFOAM-EU GROUP || International Federation of Organic Agriculture Movements UEAPME || European Association of craft, small and medium-sized enterprises UECBV || European Livestock And Meat Trading Union FRUCOM || Representation of European Importers of Dried Fruit, Edible Nut, Processed Fruit & Vegetable, Processed Fishery Product, Spices, Honey and Similar Foodstuffs || Breiz Europe UGAL || Union of Groups of Independent Retailers of Europe Annex VII: PROCEDURE – List of FVO audits since 2007 GENERAL AUDITS MEMBER STATE || GENERAL AUDIT YEAR || CLOSING DATE || REFERENCE || DATE OF PUBLICATION FR || 2011 || ongoing || 2011-6092 || Not yet published AT || 2011 || ongoing || 2011-6084 || Not yet published CZ || 2010 || Feb 2011 || 2010-8710 || Not yet published RO || 2010 || Feb 2011 || 2010-8730 || Not yet published FR || 2010 || March 2011 || 2010-8627 || Not yet published IT || 2010 || March 2011 || 2010-8741 || Not yet published SE || 2010 || April 2011 || 2010-8723 || Not yet published BG || 2010 || May 2011 || 2010-8713 || Not yet published UK || 2010 || March 2010 || 2010-8371 || Not yet published CY || 2010 || March 2010 || 2010-8372 || Not yet published EL || 2009 || May 2010 || 2009-8315 || Not yet published PT || 2009 || March 2010 || 2009-8378 || Not yet published CY || 2009 || Nov 2009 || 2009-8783 || 30/03/2011 FI || 2009 || Mar 2010 || 2009-8316 || 01/12/2010 LV || 2009 || Jan 2010 || 2009-8821 || 16/03/2011 LT || 2009 || Jan2009 || 2009-8774 || 31/03/2011 SI || 2010 || Jan2010 || 2010-8779 || 17/08/2011 EE || 2008 || Apr 2009 || 8600-2009 || 11/05/2010 HU || 2008 || Feb 2009 || 2009-8346 || 05/02/2010 IE || 2008 || Nov 2008 || 2008-8724 || 18/08/2010 AT || 2007 || Jan 2008 || 2007-7995 || 10/12/2008 SK || 2008 || Apr 2009 || 2008-8380 || 03/02/2011 GENERAL FOLLOW UP MISSIONS and AUDITS LV || 2010 || Sep 2010 || 2010-8373 || Not yet published SK || 2010 || May 2010 || 2010-8365 || Not yet published NL || 2010 || May 2010 || 2010-8363 || Not yet published IE || 2010 || May 2010 || 2010-8364 || Not yet published FI || 2010 || Nov 2010 || 2010-8375 || Not yet published LT || 2010 || Dec 2010 || 2010-8374 || Not yet published SI || 2011 || March 2011 || 2011-6076 || Not yet published PT || 2011 || April 2011 || 2011-6077 || Not yet published RO || 2011 || Sept 2011 || 2011-6085 || Not yet published DE || 2011 || Nov 2011 || 2011-6075 || Not yet published SE || 2011 || Nov 2011 || 2011-6090 || Not yet published IT || 2011 || Oct 2011 || 2011-6088 || Not yet published ES || 2011 || Jan 2011 || 2011-6074 || Not yet published HU || 2009 || Oct 2009 || 2009-8120 || Not yet published HU || 2011 || Jul 2011 || 2011-6078 || Not yet published CZ || 2011 || May 2011 || 2011-6079 || Not yet published CY || 2010 || ongoing || 2010-8372 || Not yet published BG || 2009 || Oct 2009 || 2009-8100 || Not yet published GR || 2010 || Dec 2010 || 2010-8368 || Not yet published LU || 2011 || Oct 2011 || 2011-6083 || Not yet published SPECIFIC AUDITS MEMBER STATE || SPECIFIC AUDIT YEAR || DATES || TITLE || REFERENCE AT || 2007 || 29/01 – 02/02 || Food, feed and seed consisting of or produced from genetically modified organisms || 2007-7177 AT || 2007 || 05/11 – 09/11 || Import controls on food and feed of non-animal origin || 2007-7224 AT || 2007 || 25/06 – 06/06 || Intra-Community trade in live animals || 2007-7350 AT || 2007 || 04/06 – 11/06 || Intra-Community trade in semen and embryos of domestic animals of the bovine species || 2007-7370 AT || 2007 || 04/09 – 12/09 || Official controls on feed and compliance with requirements for feed hygiene || 2007-7500 AT || 2007 || 22/05 – 30/05 || Health rules on animal by-products || 2007-7518 AT || 2007 || 04/09 – 12/09 || Plant passport system, the current situation of Erwinia amylovora (Burr) and the system of import controls for plant health || 2007-7602 CY || 2009 || 19/01 – 28/01 || Poultry meat and poultry meat products || 2009-8064 CY || 2009 || 02/02 – 10/02 || General Food Hygiene, bottled water, pesticide residues (food of plant origin) || 2009-8143 CY || 2009 || 02/03 – 06/03 || Bovine Spongiform Encephalopathy (BSE) || 2009-8304 CY || 2009 || 17/03 – 24/03 || Residues and contaminants and the use of veterinary medicinal products in food producing animals || 2009-8130 CY || 2009 || 18/05 – 22/05 || Import/transit control system and border inspection posts || 2009-8076 CY || 2009 || 21/09 – 25/09 || Feed hygiene || 2009-8086 CY || 2009 || 19/10 – 23/10 || Animal welfare || 2009-8244 CY || 2009 || 16/11 – 24/11 || Contingency plans for epizootic diseases Eradication programme for Brucella melitensis || 2009-8253 FI || 2009 || 23/02 - 27/02 || Evaluate the implementation of controls for animal welfare on farms, during transport and at the time of slaughter || 2009-8262 FI || 2009 || 23/03 - 01/04 || Evaluate the official controls systems in place for import controls, food additives and food contact materials || 2009-8149 FI || 2009 || 30/03 - 03/04 || Evaluate import/transit control system and border inspection posts || 2009-8081 FI || 2009 || 04/05 - 11/05 || Evaluate the control of residues and contaminants and the use of veterinary medicinal products in food producing animals || 2009-8125 FI || 2009 || 02/06 - 11/06 || Evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products || 2009-8065 FI || 2009 || 30/06 - 09/07 || Evaluate the implementation of measures concerning official controls on feed legislation || 2009-8088 FI || 2009 || 07/09 - 18/09 || Evaluate the follow-up action taken by the Competent Authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products || 2009-8229 FI || 2009 || 05/10 - 09/10 || Evaluate the system of import controls for plant health and the internal market controls of wood products of relevance for Bursaphelenchus xylophilus || 2009-8150 LV || 2009 || 19/01 || Public Health (Hygiene Package) – red meat and milk || 2009-8207 LV || 2009 || 2/02 || Animal welfare || 2009-8271 LV || 2009 || 9/03 || Import / transit controls on live animals and products of animal origin || 2009-8078 LV || 2009 || 16/03 || Public Health (Hygiene Package) poultry meat and poultry meat products || 2009-8068 LV || 2009 || 5/05 || Residues and contaminants in live animals and animal products, veterinary medicinal products || 2009-8126 LV || 2009 || 25/05 || Plant Health – protected zones and import controls || 2009-8166 LV || 2009 || 15/06 || Animal Health – contingency plans and rabies control || 2009-8259 LV || 2009 || 2/11 || Food hygiene, additives and food contact materials || 2009-8174 LV || 2009 || 30/11 || Animal By-Products || 2009-8431 LT || 2009 || 2/03 || Import / transit controls and border inspection posts (BIPs) || 2009-8079 LT || 2009 || 16/03 || Feed and compliance with requirements for feed hygiene || 2009-8089 LT || 2009 || 20/04 || Salmonella risk in the table egg sector || 2009-8069 LT || 2009 || 12/05 || Plant Passport/Protected Zones+ Import controls || 2009-8169 LT || 2009 || 25/05 || General Food Hygiene, Food additives (FA) & Food Contact Materials (FCM) || 2009-8159 LT || 2009 || 9/06 || Residues and contaminants in live animals and animal products, veterinary medicinal products || 2009-8131 LT || 2009 || 20/07 || Contingency plans & Rabies || 2009-8265 LT || 2009 || 19/10 || Traceability and beef products || 2009-8234 LT || 2009 || 23/11 || Animal Welfare || 2009-8252 SI || 2010 || 07/09-11/09 || contingency plans and eradication programmes for epizootic diseases || 2009-8267 SI || 2010 || 26/01-30/01 || measures concerning Bovine Spongiform Encephalopathy (BSE) || 2009-8114 SI || 2010 || 20/04-30/04 || systems in place to control the Salmonella risk in the table egg sector || 2009-8071 SI || 2010 || 04/05-08/05 || Veterinary import/transit control system and border inspection posts || 2009-8203 SI || 2010 || 19/01-23/01 || control of residues and contaminants and the use of veterinary medicinal products in food producing animals || 2009-8132 SI || 2010 || 16/06-24/06 || implementation of controls for animal welfare on farms, during transport and at the time of slaughter || 2009-8241 SI || 2010 || 03/03-13/03 || follow-up action taken with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products || 2009-8223 SI || 2010 || 05/10-13/10 || official control systems in place for food hygiene, traceability, labelling and bottled water and the official control system in place for food additives and food contact materials || 2009-8168 SI || 2010 || 23/03-30/03 || import controls for plant health, the implementation of the protected zone for Erwinia amylovora and the internal market controls of wood products of relevance for Bursaphelenchus xylophilus || 2009-8157 EE || 2008 || 16/06-20/06 || veterinary import/transit control system and border inspection posts || 2008-7756 EE || 2008 || 20/05-29/05 || control systems in place in relation to disease contingency plans for epizootic diseases (in particular foot and mouth disease and classical swine fever) and surveillance activities for bluetongue || 2008-7785 EE || 2008 || 14/04-18/04 || implementation of health rules on animal by-products || 2008-7739 EE || 2008 || 15/09-19/09 || implementation of controls for animal welfare on farms, during transport and at the time of slaughter || 2008-7765 EE || 2008 || 22/04-30/04 || control systems in place governing the production and placing on the market of fishery products || 2008-7640 EE || 2008 || 10/03-14/03 || official control systems in place for food of non-animal origin || 2008-7842 EE || 2008 || 16/09-26/09 || plant health controls for imports, the plant passport system and the protected zone for Erwinia amylovora || 2008-7898 HU || 2008 || 19/5-29/5 || Evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products || 2008-7629 HU || 2008 || 1/9-5/9 || Evaluate the implementation of measures concerning official controls on feed and compliance with requirements for feed hygiene || 2008-7720 HU || 2008 || 13/5-23/5 || Carry out a specific audit to assess import/transit controls and border inspection posts || 2008-7754 HU || 2008 || 20/5-30/5 || Carry out a specific audit to evaluate the implementation of controls for animal welfare on farms, during transport and at the time of slaughter || 2008-7767 HU || 2008 || 8/9-12/9 || Evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products || 2008-7774 HU || 2008 || 2/9-11/9 || Evaluate the Classical Swine Fever eradication control programme || 2008-7798 HU || 2008 || 15/4-25/4 || Carry out a specific audit to evaluate the follow-up action taken by the competent authorities with regard to official controls related to the safety of food (meat, milk and babyfood) || 2008-7817 HU || 2008 || 6/10-10/10 || Evaluate controls of pesticide residues in food of plant origin || 2008-7849 HU || 2008 || 16/6-20/6 || Assess the official control systems in place for food hygiene (within the meaning of Regulation (EC) No 852/2004), traceability and labeling || 2008-7866 HU || 2008 || 14/10-15/10 || Evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products (follow up to mission 2008/7629) || 2008-8009 IE || 2008 || 04/02 – 15/02 || To evaluate the system of import controls for plant health || 2008-7891 IE || 2008 || 04/02 – 15/02 || To evaluate the implementation of the plant passport system, the situation of Erwinia amylovora (Burr) and its protected zone and the control of Ralstonia solanacearum || 2008-7893 IE || 2008 || 27/02 – 07/03 || To evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products || 2008-7631 IE || 2008 || 31/03 – 04/04 || To assess controls on food of non-animal origin || 2008-7843 IE || 2008 || 07/04 – 11/04 || To carry out a specific audit to evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products || 2008-7780 IE || 2008 || 21/04 – 25/04 || To evaluate import/transit controls and border inspection posts || 2008-7750 IE || 2008 || 19/05 – 23/05 || To carry out a specific audit to evaluate the implementation of measures concerning official controls on feed and compliance with requirements for feed hygiene || 2008-7721 IE || 2008 || 03/09 – 12/09 || To evaluate the control systems in place governing the production and placing on the market of fishery products || 2008-7641 IE || 2008 || 07/09 – 12/09 || To carry out a specific audit to evaluate the implementation of controls for animal welfare on farms, during transport and at the time of slaughter. || 2008-7768 IE || 2008 || 03/11 – 10/11 || To evaluate the implementation of EU animal health requirements for intra-community trade in semen and embryos of domestic animals of the bovine species, as part of the general audit in Ireland || 2008-7802 SK || 2008 || 22/10 || Public Health (Hygiene Package) - Meat/Milk || 2008-7815 SK || 2008 || 12/05 || Salmonella risk in the table egg sector || 2008-7634 SK || 2008 || 22/09 || Poultry meat and poultry meat products || 2008-7635 SK || 2008 || 9/06 || Food additives (FA) and food contact materials (FCM) || 2008-7850 SK || 2008 || 3/11 || Food hygiene and other issues related to food production and distribution3 || 2008-7861 SK || 2008 || 14/04 || Residues and contaminants in live animals and animal products, veterinary medicinal products || 2008-7776 SK || 2008 || 16/06 || Feed and compliance with requirements for feed hygiene || 2008-7722 SK || 2008 || 1/04 || Import / transit controls and border inspections posts (BIPs) || 2008-7751 SK || 2008 || 13/10 || Animal Welfare || 2008-7769 Annex VIII: Member States' Opinions This Annex presents an
overview of the positions taken by the Member States in reply to the
consultations about the review of Regulation (EC) No 882/2004 held within: 1) the Working Group on the general application of Regulation (EC) No
882/2004; 2) the Working Group of Chief Officers for Plant Health and its Task
Force on the inclusion of plant health in regulation (EC) No 882/2004; 3) the Task Force on " Plant reproductive material" under Regulation
(EC) No 882/2004 The Commission has
attempted to correctly summarise and refer to those positions, which however
had to be re-arranged and interpreted for the purposes of this Annex. Scope
Issue:
clarifying the scope of Regulation (EC) No 882/2004
Member States: general support. MS would welcome some clarifications on
the extent to which the Regulation applies to AW and AH sectors. Some MS stated
it must be clear that the Regulation does not apply to food itself, but also to
packaging and food contact materials.
Specific measures: clarify the definitions of the terms
"monitoring", "survey" and "surveillance" in
order to align them to those included in the sectoral legislation and
clarify to which extent Regulation (EC) No 882/2004 applies to these
activities.
Member States: general support. Many MS suggest aligning these definitions
to those of the OIE or other international organizations. One MS claim it
should be clarified if the "surveys" carried out in the PH sector (in
its opinion a crucial part of the control activities carried in this sector)
are to be considered as an official control and, thus, included within the
scope of Regulation (EC) No 882/2004.
Issue:
extending the scope of Regulation (EC) No 882/2004 to ABP, PH and Plant
Reproductive material legislation.
Member States: diverging views. Some MS (4) are in favour of this measure,
as it would permit to build a more coherent and exhaustive framework of
official controls. Other MS (4) opposed the proposal to
extend the scope to PH and Plant reproductive material legislation: since the
aims and the functioning of control activities in these sectors differ
profoundly, such an extension would be a complex and possibly costly exercise. Language and
terminology
Issue:
Adjust the language and the terminology used throughout Regulation (EC) No
882/2004 in order to avoid divergent interpretations and take fully
account of all sectors already covered by the Regulation as well as, in
case of an extension to PH, Plant reproductive material and ABP sectors,
will fall under its scope.
Member States: general support. All MS recognise the need to reformulate
the language and terminology, in particular if the scope of Regulation (EC) No
882/2004 is to be expanded.
Issue:
clarify the definitions of "official controls", "competent
authority", "control body", "official
certification", "import" provided for by article 2, in
particular when inconsistencies exist with the respective definitions
provided for by AH and PH legislation.
Member States: general support. Many MS proposed to align these
definitions to those of the OIE, IPPC, EPPO, ISTA or other international
relevant organizations. Regarding the definition of "official
control" one MS suggested including, under the definition of
"official controls", the follow-up activities carried out in case of
non compliance under article 54. Some MS also stated that the definition of
"official certification" should be amended in order to take into
account the specificities of the Plant reproductive material sector. Transparency
Issue:
amendment to the provision on transparency (article 7), in order to set
the minimum level of information to be disclosed by the Competent
Authorities as well as the degree of such disclosure. The possibility of
establishing a common format for providing this information was also
considered.
Member States: general support except for one MS, according to which the
extension of this provision to the Plant Health and to the Plant reproductive
material sectors (if included in the scope of the Regulation) would de
disproportionately onerous for MS control services. Another MS considers that
information should only be disclosed in summary format, and that, in any case,
CA should be left free to decide the format to adopt for the report.
Issue:
introduction of an obligation for MS to make the MANCPs and the ARs
available to the public.
Member States: one MS opposed this measure, affirming that the decision on
the disclosure should pertain to MS. Border controls
Issue:
establishing a common set of rules governing border controls in relation
to all commodities requiring controls prior to their entry into the EU. A
list of the abovementioned commodities would be adopted. The type and
frequency of the border controls, as well as their frequency, would be
harmonised and risk-based.
Member States: general support. MS believe this measure would enhance the
transparency and efficiency of border controls. However, two MS affirm that EU
action should be limited to establish the general principles and requirements
governing border controls, while the more specific issues would be regulated
under sectoral legislation. As concerns the Plant Health sector, some MS
opposed the adoption of a risk-based approach, insisting that the rule should
be 100% frequency checks. Information
management and handling system for official controls (TRACES+)
Issue:
establishment of a computerised information system for the management and
exchange of data and information concerning official controls. TRACES+
should be interoperable and integrated with other European and national
systems.
Member States: general support except for one MS according to which the
establishment of TRACES+ would result in additional administrative burdens and
costs. Interface problems between national IT systems and the current TRACES
were reported by MS, which affirmed that attention is required on this point in
the development of IT tools in the implementation phase. Official
certification
Issue:
clarify and harmonise the principles governing official certification and
the conditions under which it is issued. Amendment of the definition of
"official certification in order to include the official
certification issued by operators under the supervision of the Competent
authority.
Member States: general support. MS suggest aligning the provisions
concerning official certification to the existing internationally recognised
rules. Some MS affirm the peculiarities of the Plant Health and of the Plant
reproductive material sectors should be taken into account when establishing
the rules governing official certification. As regards the Plant reproductive
material sector, MS welcome the possibility of amending the definition of
"official certification", as this would allow to take into account the
peculiarities of this sector. Planning and
reporting
Issue:
extension of planning and reporting requirements to the sectors newly
introduced within the scope of Regulation (EC) No 882/2004.
Member States: MS are against this measure, in particular as regards the
extension of planning and reporting requirements to the Plant reproductive
material sector (note that the obligation already covers the plant health
sector). In their opinion, this obligation would represent an unnecessary and
excessive burden.
Issue: empowerment
to the EC to provide MS with standard templates for the drafting of the
MANCPs and of the ARs.
Member States: general support except for one MS, according to which there
is no need for such a template.
Issue: empowerment
to introduce a minimum level of controls for certain illegal substances in
the MANCPs
Member States: Ms were sceptical about this measure, as it is incoherent
with the risk-based approach of official controls and might lead to an
ineffective use of financial resources by MS. In any case, MS stated further
discussions on this point were needed. In addition, overviews of
the positions expressed by MS in relation to specific issues can be found in
the following Annexes: Ø
Annex XVIII – Laboratories - MS' consultations
on the accreditation of official laboratories (discussion paper and results). Ø
Annex XX – Directive 96/23 - MS' consultations
on the available options (questionnaire and results). Ø
Annex XXI – Directive 96/23 - costs reductions relating to the repeal of the Directive. Annex IX: REVISION OF REGULATION 882/2004 – Summary of stakeholders' opinions in 2011 This Annex presents an
overview of the positions taken by the stakeholders in reply to the
consultations, either at conferences and consultation meetings or in writing
about general issues relating to the review of Regulation 882/2004. The
Commission has attempted to accurately summarise and refer to those positions,
which however had to be re-arranged for the purposes of this Annex[127]. I. Issues specifically addressed during
the Working Group held on the 19/09/2011 1. Transparency 1.1 High level of
transparency The issue of transparency
was addressed by the majority of the stakeholders as one of the priority of the
review. Eurogroup provided the Commission with a detailed proposition on how to
improve the level of transparency throughout the Regulation. Firstly they
underlined that in Article 7 the meaning “a high level of transparency”,
“relevant information” or “information on the control activities and their
effectiveness” is unclear. Consequently they suggest that the text specifies
which information the member states must make publicly available and what they
need to do to inform the public that this information is available. Secondly
they suggest that the following documents are made available on the Commission
website: -
Above mentioned documents, with links to each of the national reports, plans
and other documents of each member state, - Reports including following controls on-farm
and in slaughterhouses, - Multi Annual Control Plans (MANCP), of the Annual reports
and of reports of controls conducted by third countries administrations on food
and feed products and live animals to be imported, - Measures taken by the member States take in case of infringements
to the European Commission (eg. the amount in case of a fine) The
European Snack Association and Fooddrink
strongly believe that the primary objective of the
revision of Regulation (EC) No 882/2004 is to ensure a greater level of
transparency and clarity at all levels among stakeholders. Furthermore
practices and interpretation by authorities should be more transparent to food
operators throughout the supply chain. Another key concern for them is
transparency in the listing and delisting process. They suggest creating a more
transparent process regarding how decisions on testing frequencies are reached.
In addition ESA affirms that greater cooperation and information exchange would
enable food operators and their suppliers to more quickly and directly respond
to food safety concerns, resolving them expeditiously and thus would benefit
the entire food supply chain. Finally they warn that the existent lack of
transparency adds to the fear among food operators and suppliers that it will
continue to be easier to add things to the list than take them off, leading to
a gradual lengthening of the Annex I list (and associated increase in costs to
importers). UECBV is in favour of full transparency between Food Business Operators
and Competent Authorities in both directions. It is important for FBOs to know
what criteria are applied when inspections are carried out and the reasons
behind the decisions taken. Similarly, it must also be clear to CAs what is
done at company level, in particular with regard to the framework of their
HACCP-based systems or certification schemes. With regards transparency
towards the public, they believe the most important and relevant
information is whether a plant is EU approved. Such approval ensures that the
FBO is producing safe food. They are concerned that providing more complex and
detailed information would lead to misunderstandings by consumers and possible
distortions of competition. CELCAA emphasises that the authorities need to provide
a complete picture of the risk involved to the public.
Transparency
of official controls on feed and food on non-animal origin
The European Snack
Association claims that there is a lack of transparency about how
foodstuffs that are subject to increased levels of control have been defined,
the criteria used to make such decisions and also regarding the basis used for
adding or deleting foodstuffs from the high risk list. They would welcome an
explanatory note with the background for each of the commodities/origins
included in the Annex as well as for any deletions to the list, as this would
enable origins/suppliers to better understand where any deficiencies exist, and
how they can be addressed. Since there appears to be no formal notification of
3rd countries or of the commodities regarding the imposition of mandatory
import controls (where commodities are added to the list), they request
stakeholders/interested parties to be informed as early as possible and that
appropriate transitional arrangements are put in place to allow industry to
ensure compliance. In addition they would consider the publication of a
consolidation of the quarterly reports provided by the Member States to the
Commission to be of great value to stakeholders since it would not only help
them to understand better how the Annex review process works but also add
credibility to the actions taken. Finally they emphasise that not all Member
States adhere to the established timeframe of 15 days for control and that
given improvements in analytical methods and costs associated with demurrage, a
shorter period should be established when dealing with food products
(especially perishable items). 1.2. Publication of MANCP and Annual reports While five stakeholders claim that these documents should
be made available to the public, one is opposed to this
measure. The European Snack
Association, Fooddrink and UECBV believe that these two documents should be
made publicly available in order to increase transparency and confidence among
stakeholders. In their view Member States should also be obliged to report
their focus for the coming year, where they are going to be doing surveillance,
etc. In the same line of thought, they believe that Member States should be
obliged to include how they deal with retesting, ability to move goods to
bonded warehouse pending testing/release/reshipment, fees, etc. FEFAC is
of the opinion that the MANCP and the Annual reports should be made available
to the public, as this would help operators and national authorities from other
Member States to review and adapt their own risk analyses. UECBV claims
that these documents should be made available on the Commission web-site. CELCAA notices that the publication of these documents should be well
reflected and submitted to clear criteria in view of the damage some
information may cause to FBOs. Nevertheless CELCAA would welcome to have access
to information (on at least the parts relevant to them) via the CIRCA system. 1.3. Performance rating
('system of smileys') While
one stakeholder fully supports of the introduction of a 'smileys system', and
another one is clearly opposed to it, three believe this issue deserves more
investigation. According to Eurogroup
system of rating (smileys) could be a good way to
inform the public of the level of compliance found for specific food business
operators. However more information is needed on how it is applied, what level
of information it represents and what is the perception of the public. UECBV is not in favour of performance ratings such as smileys, since
where such ratings exist, they differ very much from one Member State to another, can be misleading and may not be comparable at an EU level. HORTEC also
considers that Member States should remain free to implement or not such
systems. They argue that the experience has shown that the divergences between
the countries where the system is already in place and other ones, have no
impact on the single market. Fooddrink'view is that the suggested system based on
‘smileys’ or similar initiatives would need further investigation. CELCAA notes that such a system has
little relevance for B2B communication. In addition caution and diligence
should be used in developing such a performance rating and in defining the
criteria to be used. FEFAC is not opposed in principle to a system of
performance rating. As a matter of fact, they believe performance of individual
companies is an element to be taken into account by control authorities when
establishing their control plan. However, they are not in favour of a
publication of this performance rating by individual companies. They suggest
instead encouraging Member States to develop tools allowing to measure an
overall performance level for the whole feed and food chain in order to provide
a picture of the evolution of the overall safety status of feed and food over
time. 2.
Right of second opinion (extent of the right provided in Article 12) The
three stakeholders who expressed their views on this question claimed that the
right to get a second opinion should be systematic. It is
considered by CELCAA as one of the FBOs' basic right. It would be useful
to get a second opinion of a neutral arbitrator when tolerance levels approach
the detection level. FEFAC is of the opinion that the possibility for an
operator to call for a second expert opinion should be systematic. However,
they underline that the legislation should specify the conditions under which
this second expert opinion may be requested and what should happen in case of
contradictory opinions. They insist in particular, on the fact that the method
of analysis to be used is an essential element to be clarified. Regulation (EC)
No 882/2004 indeed favours official EU analytical methods over standardized
(ISO/CEN) methods over in-house methods (cascade approach). However, official
or CEN methods are tested and validated for certain matrixes or sample types.
In case the composition of a sample to be tested deviates from these
"standard samples", the official / standardised method may not be as
accurate and should be in principle validated for each type of sample, which is
never the case in practice. As a result, the analytical data obtained by a
standard routine may not be more correct than results obtained by an in-house
method which is well adapted to the specific properties of a sample. We
therefore hold the view that second expert opinion based on analytical results
should allow using a second sample preparation / analytical method. UECBV is strongly in favour of such a right as the
urgent need for such a system has been emphasized in different food crises,
including the latest incident regarding ”ecoli in cucumbers”. However, UECBV is
not in favour of a system such as that in DK and in FR, where only one party is
heard i.e. the Competent Authorities. On the contrary they are in favour of a
referee system, consisting of members of different disciplines and composed of
representatives both from FBOs and from CAs. It must be fair and balanced,
involving independent experts. The European Snack
Association argues that the lack of a clear specified timeframe for the
second opinion test (and reference test) can discourage food operators from
exercising their rights if told it will take 30 days for a retest. They suggest
establishing an obligation on inspection authority to adhere to timelines –
either fees are not charged or, at least, goods undergoing retest should be
allowed to be moved (under supervision) to avoid incurring further charges. 3.
Import controls 3.1.
Use of improved IT tools CELCAA claims that TRACES should be expanded to
products of non-animal origin, in order to provide reliable information on
serious risks detected in relation to food and feed. They further suggest the
Commission to look closely at the community customs code and the e-customs
initiative. 3.2. Documentary checks v Analytical checks (Article 16) FEFAC
highlights that EU legislation gives priority to analytical controls, in
particular for the control of the presence of contaminants or constituents.
They underline that it may happen that even if a method of analysis exists, it
may not always be relevant for control purposes. They give two examples to
illustrate this: - control of the added amount of copper as declared on the
compound feed label: copper can be analysed by an analytical method but this
method will not be able to differentiate between added and native copper;
therefore, the result of the analysis is likely to exceed the amount of added
copper declared under the feed additive heading on the compound feed label. - control of added amounts of antioxidants: the level of
antioxidants in compound feed is decreasing overtime as they are eliminated
when performing their function; therefore, the amount of antioxidants to be
determined by analytical means is likely to be below the declared amount on the
label. In both cases, they claim that the only adequate way to
control that the declaration on the label of the added amount of copper or
antioxidant is correct is documentary checks. They therefore suggest to introducing a provision in the
Regulation (EC) No 882/2004 whereby specific rules for the performance of
official controls could be developed by comitology, in particular as regards
the relevance of documentary vs. analytical checks. 3.3. Points of entry
and prior notification (Article 17) The European Snack
Association stresses that not all points of entry have facility to inspect
consignments – e.g. to unload containers, warehousing, etc… 3.4. Special treatment
(Article 20) The European Snack
Association argues that in the absence of any effective recourse on damage
resulting from delays the net result is that all these costs end up with the
consumer and add to food inflation. Moreover they underline that the
administration costs for this regulation are hidden but are huge in terms of
communications, claims, etc. They also emphasise the absurd situation whereby
small sample consignments, (e.g. 200g), which some DPE’s insist are covered by
the requirement for a CED (at a cost of £75). 3.5. Approval of
pre-export checks by third countries (Article 23) The European Snack
Association claims that no real account appears to be taken of companies
who have invested in GAP, GMP, certification and which undertake origin testing
before shipment. They state that it is possible that investments towards safeguarding
imports into the EU would be adversely affected if Article 23 was not changed,
since implementing such costly pre-export controls does not provide any
additional consideration or confidence among EU authorities. According to them
it is crucial that the Commission specifies that controls should be <1%,
otherwise it is left to Member States interpretation. It is also important to
ensure that documentation is clearly different from commodities coming in under
emergency measures – again, import authorities do not easily distinguish
between the two schemes, since the documentation is very similar (basically the
same CED). 3.6.
Border Control Points BREIZ
highlights that the EU lacks a
coherent policy concerning food imports controls and particularly the BIPs.
They underline that they are more than 300 BIPs (with comparison to ten in the US for veterinary and phytosanitary controls). Consequently they argue that a reduction of
the number of BIPs would enhance their administrative, financial and staff
resources. 4. Administrative assistance and
cooperation 4.1 Assistance in the
event of non-compliance (Article 38) The European Seed
Association is in favour of the introduction of a harmonized approach to
address non-compliance on the national as well as on EU level in respect of
S&PM and PH legislation. UGAL welcomes the initiative to overhaul
the provisions on administrative assistance so that competent authorities more
systematically and effectively work together to enforce food law against the
Union operators actually responsible for food risks and non-compliances. 4.2 Relations with
third countries (Article 39) The European Snack
Association requests that where emergency measures are to be introduced,
there should be more formal consultation with third country governments;
otherwise it is unclear how they are to respond or work with their industries
to improve a perceived deficiency in their production practices. 4.3. Coordinated
assistance and follow-up by the Commission (Article 40) The European Snack
Association's opinion is that where issues are raised to the Commission,
there should be a transparent way of having these issues added to the agenda of
a Working Group meeting. II. Other issues 5. General comments Fooddrink underlines the following shortcomings of the system: fees are not
posted, it is unclear when reprocessing is/is not allowed, process for
selecting consignments is not clear, FBOs do not receive any summary
information regarding the number of consignments received, inspected, and percentage
rejected. 6.
Scope of the Regulation While the three stakeholders who addressed this issue
supported the extension of the scope of the regulation to include PH and
S&PM, two of them underlined that the sectoral specificities should be
carefully taken into account. Eurogroup
has welcomed the inclusion of animal welfare legislation in the scope of the
official control regulation. They believe that guaranteeing the welfare of
animals is essential to provide for a high degree of food safety. FEFANA
supports the idea of including the review of Regulation No 882/2004 within the
context of an integrated package. Nevertheless they stress that sufficient
attention has to be paid to the different provisions of the sectorial
legislations and their combination. The European Seed Association is, in general, in favor of harmonization and therefore
supports the idea of making use of the already existing harmonized EU framework
also in respect of controls for the purposes of S&PM and PH legislation as
long as it is consistent with the specificities of these sectoral legislations.
In particular they support the introduction of harmonized EU controls over the
controls carried out on national level also in the field of S&PM and PH
legislation. Nevertheless they underline that they are in favour of leaving the
sector specific elements in place whenever it appears appropriate (e.g. seed
certification and delegation of official tasks under official supervision to
third parties, including private operators). 7. Risk-based controls (Article 3) All three stakeholders who addressed this issue supported
the risk-based approach. According to Fooddrink it is
essential that the future EU framework for a control system clearly defines
that official controls should be carried out on a risk basis. CELCAA
believes official controls should be carried out based on the risk involved as
well. They precise that the risk should be determined by clearly defined,
objectively verifiable and harmonised criteria. The risk-based analysis should
determine the nature and intensity of the controls to which the diverse
agricultural commodities should undergo. The English National Federation of Meat & Food Traders (member of IBC)
believes that meat inspection should be greatly reduced in scale. Operator
responsibility should be enhanced and legislation should be based on a risk
based approach. 8.
Competent authorities (Title II, Chapter 2) Eurogroup has highlighted the following problems relating to the
infrastructure of national authorities: -
Failure to carry out or include the necessary proportion of animal welfare
checks in the annual inspection programmes - Lack
of staff or appropriately trained staff -
Failure to put in place effective and dissuasive sanction systems to react to
infringements They
underline that standards are especially poorly enforced in the area of: - the
protection of live animals during transport: insufficient controls at the start
of journeys including on journey plans; -
production systems for laying hens: lack of progress in the conversion of
barren battery cages into enriched cages or alternative systems - the protection of pigs:
tail docking is performed routinely and no foraging material is generally
provided. CELCAA makes two observations: - The quality and efficiency of controls has an impact on the costs -
Decisions taken by the competent authorities may have great consequences for
the business operators. They
conclude that the time efficiency in performing official controls, in terms of
staff, procedures and equipment as well as in delivering results by control
authorities is essential. They stress that inefficiencies by control
authorities should be avoided as far as possible as they create additional
burden to FBOs in terms of costs and delays in discharging/delivering the
goods. 8.1. Delegation of tasks (Article 5) The European Seed Association is of the opinion that
the specificities of the Seed sector are key to a flexible and well-functioning
seed legislation and that there is a risk that these key elements may be harmed
with a full integration of the S&PM and PH legislations into the scope of
the Regulation (EC) No 882/2004. In particular, bringing the seed-related
controls under this regulation should not have any consequences for existing
and new possibilities for delegation of official tasks under official
supervision to third parties, including private operators. Bundesinnung der Fleischer
(member of IBC) claims that meat inspections in slaughterhouses
slaughtering 1,000 livestock units or less per year should be authorized to be
carried out by an official meat inspector instead of an official veterinarian
(only in case of doubt an official veterinarian should have to be consulted).
The English National Federation of Meat & Food
Traders (member of IBC) also stresses that there is no need for extensive
veterinary attendance in the case of meat inspection. They argue that meat
inspectors (auxiliaries) can carry out post mortem inspections after
slaughtering has finished if it can be proved that it is necessary and
efficient. 8.2.
Verification procedures (Article 8) Eurogroup believes that the verification procedures are essential provisions
and therefore guidelines should be established for their preparation. They
suggest adding to Paragraph 4(d) a requirement for the documented procedures to
be submitted to the European Commission for advice. 8.3. Reports (Article
9) The European Snack
Association and Fooddrink recommend that inspection reports should
always be provided as one of the specific documentation accompanying a
consignment the Authorities require. They stress that their members have
reported situations where laboratory analyses were not provided, even when
requested. In the light of two concrete examples they
underline the need for maximum transparency and best practice shared between Member States and more commitment on the part of the authorities to avoid unnecessary
recalls. They suggest that a basic level of information on reports (e.g. date
codes etc.) should be harmonised across the EU to prevent uncertainty for FBO’s
who operate across different Member States. Eurogroup states that reports should be made
available to the public. 9. Methods of sampling and analysis
(Article 11) The European Snack
Association stresses the importance of protecting both product quality and
food safety during this part of the inspection procedure. They have been
informed that some inspection points do not have the ability to move goods to a
warehouse to unload the container before inspection or while awaiting testing
results, leading to excessive costs/demurrage and exposure to weather.
Furthermore where containers are unloaded, there is frequently a problem with
re-loading the entire product back into the container, leaving individual
pallet(s) with no where to go. Food operators have reported containers being
unloaded, and authorities not properly reloading, resulting in losses/damage
during onward transit. In the light of these information they claim that
not having specific areas for unloading can also result in the product being
exposed to cross contamination/microbial contamination from standing water,
birds, etc. Moreover they underline that importers have no realistic recourse
to the Port companies or PHA's for any damage caused and that labs are often not
all located at the port, resulting in delays for analysis. 10.
Official certification (Article 30) Eurogroup states that the kind of certification covered and its purpose needs
to be clarified in Article 30. The European Snack
Association emphasises the fact that lab reports/inspection reports should
always be provided. The European Seed
Association believes it has to be noted that both the S&PM and the PH
legislation contain some very specific provisions as regards controls that have
to be carried out for the purposes of seed certification. Since decades seed
certification under the EU S&PM legislation is carried out according to the
rules as defined by ISTA, the International Seed Testing Agency. Similarly,
seed certified in third countries in accordance with OECD seed schemes is
eligible for equivalence recognition in the EU. As these international
standards exist and have long been used by the seed industry the EU should
continue to make use of them instead of creating new ones. 10.1
Veterinary certificate BREIZ underlines that the veterinary certificate that
FBOs receive in exchange of the fees they pay (which hinders their
competitivity) is not recognize by administrations whose control tasks are
relating to other legislations than those of sanitary rules. This is
particularly problematic when the customs services do not recognize the
certificate and refuse to allow a product to be exported to third countries.
Breiz's opinion is that it discredits the entire OC system in the eyes of the
European and international firms. 10.2
Third party certification FEFANA
They believe that the revision of this Regulation
should be an excellent opportunity to explore with Member States and Commission
the role of third party certification as a support to the official
control and to bring the feed legislation closer to the Commission
communication on third party certification. 11.
Registration/approval of feed and food business establishments (Article 31) The European Seed
Association is in favour of the introduction of an obligation for S&PM
suppliers of being registered at national and/or EU level. They are of the
opinion that from the perspective of controls such a registration obligation
could be very helpful in spotting or avoiding non-compliance with the legislation
as well as other possible illegal activities. 12. National
enforcement measures 12.1.
Action in case of non-compliance (Article 54) The European Snack Association notices that not all
Member States allow the practices provided by technological improvement in
terms of resorting, reprocessing, etc... It is important in their view to have
a better understanding of individual Member State’s interpretation of this
Article. 12.2. Sanctions
(Article 55) Eurogroup argues that since sanctions play an important role in improving
enforcement of EU rules, they should be harmonised. They underline that in the
field of animal welfare sanctions are not always dissuasive and thus not
effective. They would welcome guidelines from the European Commission on what they
consider to be appropriate sanctions in specific infringement cases. Annex X: FEES – Executive summary of the study on fees or charges collected by the MS to cover the costs occasioned by official controls prepared by food chain evaluation consortium (FCEC) Regulation 882/2004[128]
(hereafter referred to as ‘The Regulation’) sets out requirements for the
authorities in EU Member States that have responsibility for monitoring and
verifying compliance with, and enforcement of, feed and food law, animal health
and animal welfare rules, i.e. the 'Competent Authorities' (CAs) responsible
for organising and undertaking 'official controls' (OCs). According to Article 65 of
the Regulation, three years after its entry into force, the Commission should
review the experience gained from its application, in particular in terms of
scope and the fee-setting mechanism, and whether/how the current fees regime
can be improved. The data collected and results of this study, which focused on
the implementation of the financing provisions of the Regulation (Articles
26-29), will feed into a Commission Report to the European Parliament and
Council for a possible modification of the current legislation. The
objectives of the study are two-fold: a) to establish a detailed picture and evaluate the present situation
as regards the application of the current fees regime, in particular the way in
which the system operates in practice; and, b) to assess the advantages and disadvantages of a range of policy
options (regarding the scope of current rules and the fee-setting mechanism). As
such, the final aim is to provide input to the Commission’s development of
proposals to improve the fees system in future. The
assessment of the current system and future policy options take into account
the wider objectives and principles of EU policy in this sector. As such, the
study considers the overall objective of the Regulation to ensure a harmonised
approach with regard to official controls, the objectives of EU food and feed
law[129] to ensure a high level
of protection of human life and health and achieve the free movement in the
Community of compliant feed and food, and the objectives of the Lisbon Strategy
to promote better regulation and support industry competitiveness. Furthermore,
the principles of proportionality, subsidiarity (Article 5 of the Treaty) and
FBO responsibility (in accordance with current food and feed law) frame the
approach of this study. The
study was carried out in the period April-November 2008 through a survey of
EU27 CAs, in depth analysis (case studies) in six MS representing a variety of
fee regimes (Germany, the UK, Italy, Poland, France and Slovakia), interviews
with key experts and stakeholders at EU level[130],
and extensive literature and data review (including relevant FVO reports and
national legislation). The study has found that
significant progress has been made in the application of the Regulation by MS,
and in particular the financing provisions of Articles 26-29, since their entry
into force on 1 January 2007. However, the enforcement of these provisions has
been slow and gradual, with significant delays in most MS. In some cases, full
implementation is still pending subject to the approval of draft national
legislation enacting Article 27, despite the fact that the deadline for its
definitive entry into force was 1 January 2008. In these cases the fee system
in place is largely based on that laid down in previous, repealed legislation
(Directive 85/73). Despite
progress a number of important shortcomings have been identified in the current
state of implementation of Articles 26-29, as follows: Competent
Authorities (CAs): There are significant
differences in the organisation, structure and staffing (number and profiles of
staff) between MS, which have financial implications for the cost of official
controls (OCs). Contrary to the Commission’s expectations, more than one CA is
involved in most cases, which may create lack of transparency and of
central/overall responsibility. In MS with decentralised management, the central
CA is not always in control and efficient/effective coordination is not always
ensured. The study findings confirm issues which are already highlighted in
relevant FVO reports. In several MS initiatives are under way to rationalize
veterinary services, such as the use of appropriately trained contractual staff
for the OCs rather than civil servants. Activities for which
fees are collected: A distinction is made
throughout the study between OC activities for which fee collection is ‘compulsory’
(Article 27.2, activities of Annexes IV and V), and those for which fee
collection is optional or ‘non-compulsory’ (Article 27.1). The study has
found that, in the case of ‘compulsory’ fees: 9 MS collect such
fees only partly; fees for milk production and for residue controls were found
to be ‘controversial’ and often not collected at all; on the other hand, in
some MS fees are collected for the same OCs more than once along the production
chain (e.g. at slaughter and cutting plant even within the same establishment,
contrary to Article 27.7). In the case of ‘non-compulsory’ fees: 19 MS
collect fees for activities beyond those of Article 27.2, while 6 do not
collect any such fees; fees are collected in some MS for OCs on products of
non-animal origin. Fee rates used: Regulation 882/2004 leaves it up to MS to define fee system: either
minimum fees as defined in Annex IV (domestic controls) and V (import controls)
or fee rates calculated on the basis of the actual costs of OCs (‘flat
rates’). In practice, a multitude of fee rates apply
for the various activities: 18 MS use a mix of the two systems (flat rates and
minimum rates); the current situation is quite complex, not transparent and
confusing for FBOs; the CAs appear to have interpreted relevant provisions of
Article 27 rather ‘openly’. Furthermore, 12 MS apply fees below minimum rates,
however it is not clear or sufficiently justified whether the conditions of
Article 27.6 (controls of reduced frequency and criteria of para 5) are
respected in these cases. Fee calculation: Article 27.4 stipulates that where flat rates are used, fee levels
need to be set within the limits of the minimum fees set out in Annexes IV and
V, and a maximum set by the actual controls costs; the fee calculation in this
case must respect the criteria of Annex VI. In practice: the calculation method
used is not always available, or has not always been communicated to the
Commission (contrary to requirements of Article 27.12); even when the method is
available, it is not always transparent what type of costs are included under
the various cost categories and what reference time period is used; in most
cases it is not clear whether the actual costs included in the calculation
respect the criteria of Annex VI (staff salaries; staff costs including
overheads; lab analysis and sampling). Fee collection &
use of revenue: The rationale of the system is to
ensure adequate financial resources to provide the necessary staff and other
resources (Article 26). In practice: in the majority of MS the collected
revenue is incorporated into the General State Budget, either entirely (11 MS)
on in part (7 MS); only 9 MS claim to be ‘ring fencing’ revenues specifically
for the CAs performing the controls; 14 MS indicated they do not cover the OC
costs through the fees, while a further 6 MS claim this is occurring in some
cases (regions, activities). This partial cost coverage may be due to
inappropriate fee setting (insufficient fee levels) as well as inappropriate
fee collection / use of revenue. The position appears to be better in the case
of imports controls, partly because Article 27.8 stipulates that such fees
should be paid to the CA in charge. Enforcement of Article
27: Although the Regulation should be directly
enforceable, Article 27 allows some discretion to MS on the actual fee system
to use and the activities for which OCs should be charged beyond those of
Article 27.2. The study has found that, in practice, there is significant
variation between MS in the enforcement of Articles 26-29. Underlying this, there
is a strong perception - in some cases documented by FVO reports - of
significant variation in the organisation and effectiveness of OCs, and that –
as documented by the study findings - CAs have rather liberally interpreted
provisions of Articles 26-29 (this is particularly a problem in some MS with
decentralised management and lack of sufficient central control by the CCA). The study has therefore
concluded that, as it currently stands, the system of fees for OCs does not
fully fulfil its key objective: to provide sufficient resources for the
effective and efficient operation of the OCs. Furthermore, the actual
implementation of the system raises issues with regard to its contribution to
the functioning of the internal market and the cost-efficiency of the system of
OCs. Contribution to the
functioning of the internal market: MS broadly
agree with the rationale of Articles 26-29. However, could the heterogeneity in
their application in practice cause distortions in competition? The study has
investigated various potential distortions that may arise in this context. It
has found that in practice: · Distortions at EU level: There is a
general concern amongst stakeholders in the various MS that implementation of
rules by national authorities put them at disadvantage vis-a-vis other MS.
However, it is difficult to substantiate these claims due to lack of clarity
and uniformity in MS approaches which makes the comparison of actual fees
difficult. Although evidence of unjustified variations in fee levels were found
between MS, there is no evidence of significant distortion in competitiveness
between MS caused by differing fee levels. Other key factors affecting
competitiveness appear to be more significant. · Regional distortions are a concern
particularly in some MS with decentralised management e.g. amongst the case
study countries (Germany, also Italy and Spain); · Discrimination against the meat sector, which is seen as
unfairly bearing the cost of the OCs, from which other sectors along the chain
also benefit; · Discrimination against smaller or disadvantaged FBOs, which
compound the difficulties they face in the general economic climate; this is
particularly evident for those MS that have not adopted special provisions for
these businesses in line with Article 27.5. Cost efficiency issues have been raised with regard to: · Staff costs: Stakeholders argue that
Regulation 882/2004 could go further than the general requirement to have “a
sufficient number of suitably qualified and experienced staff”. In practice,
there are wide variations in the number and profile of staff involved in
controls, and this has repercussions on salary costs; · Administrative costs: There is lack of
transparency on what type of costs are taken into account, the formulation of
Annex VI is considered too broad (in particular criterion 2: ‘associated
costs’), resulting in wide variation between MS and unjustifiably high costs in
some cases; · Proportionate and risk based controls: important
cost savings could be made in the costs of OCs if the guiding principles of OCs
(risk basis, FBO responsibility and ‘self-control’ systems) were sufficiently
taken into account by MS in implementing the provisions of Articles 26-29. To address the various
shortcomings in the current application of the Regulation[131],
the study has examined the following key options: moving from the current
system towards more harmonisation; moving towards more subsidiarity; and, the
continuation of the status quo. A complementary option, which transcends
the above three alternative options, is the extension of the financing
obligation to sectors beyond those currently covered by the Regulation. The key components of the financing system
(basis of fee charging; level of fee rates; fee calculation method; fee
reductions and penalties; and, list of activities covered by fees), as
identified on the basis of the intervention logic of the current legislation
(Articles 26-29), were combined to develop a range of scenarios within the
above options (Error!
Reference source not found.). The basis of fee charging is compulsory for all MS under the
harmonisation option, optional under the subsidiarity option, and a mixed
approach under the continuation of current rules. The scenarios were
assessed in terms of advantages and disadvantages, feasibility (whether and
under which conditions they would work in practice), and the acceptance that
they might have from the various groups of stakeholders. Key criteria for the
assessment were the main goals and principles of the Regulation, as well as the
wider objectives of Community food and feed law and the Lisbon strategy, in
particular: improving the effectiveness and efficiency of the official
controls; simplification of the current system; and providing the right incentives
for FBOs to encourage compliance and discourage non-compliance. As these
criteria may not necessarily point in the same direction, the initial
assessment of the scenarios provided here aims to provide a balance between the
various objectives and needs of stakeholders. The assessment has shown
that neither harmonisation nor subsidiarity would work in their most extreme
expression. Although both scenarios would simplify the current system at the
level of central management (particularly if full subsidiarity is pursued),
they ultimately carry the risk that they may not lead to sufficient
cost-recovery in some MS, and that the level of cost-recovery may vary
significantly between MS. This could undermine the overall effectiveness of the
official control system at EU level, and/or act as a disincentive to improving
its efficiency. An intermediate solution
would clearly provide the most pragmatic way forward. Intermediate scenarios
provide different degrees of balance between the flexibility that the majority
of MS require, as an incentive inter alia to rationalise the system,
with the simplification needed at the level of central management (Commission,
MS CCAs). The study has found that the rationale for a flexible approach, which
underlies the current Regulation, continues to apply today. The majority of MS
CAs and stakeholders have indicated that a system that allows MS flexibility to
set the fee rates, within a commonly agreed set of rules, continues to be the
most favoured option. This approach is considered the most appropriate for the
system to be able to adapt to national conditions. On balance, amongst the
various scenarios that can be envisaged at an intermediate level, those leading
to more subsidiarity appear to be more attractive than those that lead to more
harmonisation. This is because the degree of flexibility given to MS
diminishes, while the degree of complexity of the legislation increases. Moving towards more
subsidiarity, if the primary aim of the legislation is to ensure that MS have
the funds necessary to cover the costs of official controls whatever the means,
scenario 4 (maintain only the general obligation for MS to provide adequate
funding, in the line of a modified Article 26) could present an attractive
alternative to pursue for the purposes of simplification. The disadvantage of this
scenario would be that it could result in wider variations between MS than
those created by the current system. To reduce these variations, conditions
could be attached in the form of common principles at EU level for a more
harmonised calculation of the fees and/or fee reductions/penalties across the
EU (scenario 3). Although the
continuation of the status quo would be an alternative intermediate
solution, the analysis of current shortcomings under section Error! Reference source not found. has
shown that to do nothing is clearly not an acceptable or a pragmatic
option. However, if the current mixed approach of the Regulation (which
represents the political reality of the evolution of the system since Directive
85/73) was to be maintained, certain improvements could be introduced as
follows: at a general level improve the understanding of the Regulation;
provide a rationale for setting minimum fee levels and review Annexes IV and V
in the light of this rationale; reinforce transparency and accountability
criteria; refine and define certain provisions more precisely at technical
level; update Articles 26-29 with the progress made since the adoption of the
General Food Law and the Hygiene Package. Whatever the scenario to
be pursued at an intermediate level, the study has identified the need for the
definition of common principles that can apply for a more harmonised
calculation of the fees and/or fee reductions/penalties across the EU. These
could be general principles only or they could be more detailed criteria
defined at a technical level. General principles would include: transparency in
the calculation method of fee setting and for calculating fee
reductions/penalties, on the basis of actual costs; and, the obligation for MS
to communicate these to the Commission and the public. Detailed technical
criteria would include for instance the calculation method to be followed for
fee setting and for fee reductions/penalties, cost-recovery targets that should
be sought, precise cost categories that should be taken into account, and even
maxima/ceilings for each cost element. The level at which
common principles should be set needs to be further explored, as it is crucial
in controlling MS flexibility and mitigating the potential disadvantages of
subsidiarity. The greater the degree to which EU legislation moves from
defining common principles and general guidelines (as is currently the case
with Articles 27-29) to more technical criteria, the more difficult it will be
for MS to deviate from a common denominator. On the other hand, this increases
the complexity of the provisions and the extent of follow up needed at central
level (Commission, MS CCAs). In terms of
the calculation of fee reductions and penalties, in particular, the principles
could build on the advantages and benefits of self-control systems, as
introduced at EU level by the Hygiene Package. Both MS and stakeholders are in
principle in favour of providing incentives to FBOs to assume greater
responsibility. The study has examined the possibility to follow an integrated
approach more consistently linking compliance and non-compliance, and therefore
fee reductions and penalties, to the uptake of self-control systems by industry
(through a bonus-malus system). Such systems have already been
developed in few MS (e.g. Belgium), highlighting the advantages of an
integrated approach. The study has concluded that, although the development of
such systems needs to be encouraged at EU level, their actual design can at
present only be pursued at MS level. Furthermore, the
cross-cutting theme of the extension in scope of the Regulation was favourably
assessed, in relation in particular to the inclusion of all stages along the
food chain. The case of the extension of the system to stages upstream and
downstream of the slaughtering and meat cutting operations along the meat
production chain was a case in point. The study has concluded that an extension
in this form would spread the costs of controls currently pursued only at a
particular point in the chain but for the benefit of stages upstream/downstream
more equitably along the food chain. Again, this approach is currently being
adopted/explored in several MS. This
forward looking element of the project aimed to provide an initial assessment
of certain key scenarios. The purpose was not to provide a full feasibility
analysis (whether at political or technical level). Nonetheless, specific
recommendations were made to develop these scenarios, or indeed other potential
combinations of their components, including through future impact assessments. Annex XI: FEES – Executive summary of the study carried out by GHK to support the impact assessment as regards the financing of official controls Preparatory work to support the impact assessment on reviewing the rules on the financing of official controls A final report to DG SANCO Date: 20 September 2011 Executive
Summary E.1 This
report examines the impacts of proposed changes to Regulation (EC) 882/2004 regarding
the rules on financing official controls This is the final report
of a study to assess the impacts of potential revisions to Regulation (EC)
882/2004 regarding the rules on financing official controls. The report
presents results of the research conducted and impact analysis on options
proposed by the Directorate-General for Health and Consumers (DG SANCO) to
change the current system in order to improve shortcomings identified in an
evaluation of the Regulation conducted in 2008. The study was led by GHK
Consulting Ltd working with ADAS UK Ltd. This study contributes to
the preparation of an impact assessment of proposed revisions to Regulation
882/2004/EC regarding the rules on financing official controls. The objective
of the study was to provide the Commission with: ▪
Data
that substantiate the problems in the current operation of the legislation with
respect to financing official controls; and ▪
An
assessment of the impacts of policy options identified by the Commission to
address these problems. The analysis demonstrates
that there are options available that, when suitably packaged and with careful
implementation, could mobilise the resources needed to finance efficient
controls at the same time as fostering the development of a system that is fairer,
more transparent, and does more to encourage efficient management of risk by
both food business operators and competent authorities. E.2 The objectives
of the existing legislation are not being met The objective of Articles
26-29 of the Regulation is to ensure that the approach to financing official
controls is consistent across Member States (MS). The Regulation describes the
general approach that should be taken by MS, and the principles that should be
adopted by the relevant authorities. Articles 26-29 of the Regulation outline the provisions related to the financing
of official controls. They specify that: ▪
Member States must ensure that adequate financial resources are
made available for official controls (Article 26); ▪
Where inspection fees are imposed on feed and food business
operators, common principles must be observed for fee-setting and the methods
and data used for calculating the fees must be published or otherwise made
available to the public (Article 27); and ▪
When official controls reveal non-compliance with feed and food
law, the extra costs that result from more intensive controls must be borne by
the feed and food business operator concerned (Article 28). Previous
analysis of the implementation of Articles 26-29 has identified four main problems with the legislation and its implementation: a lack
of clarity and uniformity, a lack of transparency in the calculation of costs
by competent authorities, the fact that in most instances fees do not cover
inspection costs, and a lack of flexibility in the current legal framework.
The reforms are intended to address those issues. E.2.1 There
is a lack of clarity and uniformity in the Regulation, which results in
diverging interpretations in EU Member States Text of the Regulation is
imprecise in places. This has resulted in differences of interpretation by
Member States and led, in turn, to significantly different fee charging systems
in which Member States calculate fees on different bases. Fees that, according
to EU law, are compulsory are not always collected. The level of cost recovery
achieved varies widely. Article 3 specifies criteria
that Member States should follow in the design of their official control fees
systems. These are particularly relevant where Member States adapt their controls
systems in light of risk factors, the degree of businesses’ past compliance and
own checks, the presence of small businesses and issues related to the location
of remote businesses. The way in which these criteria are described in the
legislation makes them difficult to implement. E.2.2 There is a lack
of transparency in the calculation of costs at Member State level Many Member States
calculate fees in breach of the terms set out in Article 27 of the Regulation.
Many also fail to provide the Commission with the calculation method they use
as required by Article 27.12. Where the calculation method has been made
available it has often not been transparent: the cost categories included and
the Competent Authority that has incurred them are unclear, as are the time
periods to which the costs relate. Furthermore, under Annex VI of the
Regulation fees can be used to recover ‘staff salaries’, ‘staff costs’ and
‘laboratory analysis and sampling’. But the wording of the Annex is
insufficiently precise and has proven to be open to various interpretations –
resulting in a lack of consistency of approach across and even within Member
States. E.2.3 Fees do not
cover inspection costs The general principle of
financing official controls is that funding should be made available to
Competent Authorities for control activities and that for some controls a fee
must be levied. Where fees must be levied, these should cover the costs of
carrying out the specified control activities. In the majority of Member
States, however, the fees collected do not cover the inspection costs. Fees
collected are often incorporated into a Member State’s general revenues (either
in entirety or in part), with no restrictions or conditions regarding how they
should be used subsequently. E.3 The
Commission has developed proposals for revision of the legislation that are
intended to address these problems The legislative revision
is intended to develop a clearer, simpler and more transparent system, while
taking into account the principles of proportionality and subsidiarity and the
need to avoid disturbing the internal market. Embedded in the general
objectives are principles of proportionality, subsidiarity and food business
operator responsibility that to be taken into account by Member States when
considering the scope and specification of fees. The specific objectives for
the reforms are to ensure: ▪
Mobilisation
of resources for efficiently delivered controls: ensuring that Member State official bodies have adequate financial means to efficiently perform official
controls to ensure food safety; ▪
Simplification: providing a
clearer and simpler legal framework; ▪
Comparability: avoiding
disturbance of the internal market while accounting for different cost
structures across Member States; ▪
Streamlining: reducing
the administrative burden on Member States and stakeholders as far as possible;
and ▪
Accountability: ensuring
that stakeholders have access to information on how resources are collected and
used. DG SANCO has identified
three policy options, drawing on an conducted in evaluation in 2008 and further
evidence collected from stakeholders and the Food and Veterinary Office. These
options are: ▪
Option
A:
Improve the current system; ▪
Option
B:
Harmonise inspection fees; and ▪
Option
C:
Implement full subsidiarity of inspection fees. Option A includes a number
of distinct sub-options. In this analysis interactions between sub-options have
been considered with a view to the development of a coherent ‘package’ of
complementary and mutually reinforcing measures. Options have been assessed
against a reference ‘do nothing’ scenario represented by the Member States’
current arrangements for financing official controls. E.4 The
analysis suggests that the problems with the Regulation would best be remedied
by improving the current system, rather than moving to a model based on full
harmonisation or on full subsidiarity Option
A – improvement of the current system – is the most promising reform option.
The various potential components of the option have each been assessed on their
own merits, and the way in which they might best be ‘packaged’ also
considered. The paragraphs below summarise that analysis. E.4.1 Extend the
scope of mandatory fees This sub-option specifies
an extension in the scope of the mandatory fees (i.e. increasing the number of
official controls for which Member States are obliged to collect fees). In
simple terms, it shifts the financing of controls from tax revenue to the
businesses that are subject to controls but do not currently pay fees. Managed
appropriately and in combination with other sub-options, this sub-option could
encourage processes that improve Competent Authority efficiency and improve
comparability, creating a level playing field across the EU and the food chain.
The measure would result in new costs for those sectors that are not currently
charged. It could also increase administrative costs to Competent Authorities
in the additional assessment and collection of fees (though such costs could
themselves be covered by fees if the legislation was appropriately worded). The
controls for which fees are mandatory should be clearly stated. Clearer
definitions of cost should be considered in conjunction with potentially
extending the scope of fees. Some of the industry which pays fees today
believes that extension of mandatory fees across the food chain would reduce
the cost of controls to those businesses. E.4.2 Require full
cost recovery This sub-option would
impose a legal requirement on Member States to achieve full cost recovery of
the (eligible) costs of official controls where mandatory fees apply. This is
likely to have a positive impact on mobilisation of resources to finance
controls, and therefore meets the primary objective that this sub-option is
designed to achieve. Most Member States do not achieve full cost recovery at
present, and a requirement would enable Member States to put systems in place
to do so. It would shift the financing burden from general taxation to the
food chain, increasing costs to FBOs. A year-by-year staged increase in cost
recovery rates (where these are currently less than 100%) would provide time
for adjustment both by FBOs and by Competent Authorities. If businesses are
being asked to pay more it is important that the system is seen to be fair, transparent
and efficient therefore this option would best be combined with complementary
measures on transparency, governance and clear definition of eligible costs.
The sub-option that gives Member States the option to provide fee exemptions to
micro-enterprises would also enable Member States to mitigate impacts of full
cost recovery on very small businesses where necessary. E.4.3 Clearly define
eligible costs This sub-option would
change Annex VI of the Regulation in order to define more clearly the costs
that can be recovered via fees linked to performing official controls. A
precise definition of eligible costs is required. Definitions that leave scope
for differences of interpretation (e.g. on the recovery of overheads and
administrative costs) are unlikely to solve the present problems. An
alternative list of eligible costs proposed by the Commission provides a solid
basis for discussion. It would be helpful to have clear rules on recovery of
competent authorities’ overheads and administrative costs, such as by setting a
ceiling on such recovery that is set at a given percentage of eligible staff
costs. E.4.4 Introduce
time-based fees This sub-option would
require that time-based fees (rather than flat fees) are used for official
controls that require continuous or systematic presence of officials, and
potentially for other controls too. Time-based fees can be aligned to
efficient, risk-based inspection strategies. A shift from flat fees to
time-based fees where continuous/systematic presence of officials is needed can
affect the distribution of payments within a sector. Larger operations with
high throughput may pay less under a time-based fee regime while small
operations with low throughputs may find that charges increase. The potential
risks to FBOs of time-based fees – that is, of excess payments for
inefficiently delivered inspections – can be mitigated by other sub-options on
governance, transparency, clear definition of eligible costs and the option for
micro-enterprise exemptions. The extension of time-based fees to controls where
continuous presence is not required warrants careful consideration on a
case-by-case basis. E.4.5 Require
ring-fencing of resources Under this sub-option the
Regulation would introduce a requirement that fee revenue be used exclusively
to cover the costs of the official controls for which they are being charged.
This sub-option could have significant positive impacts on mobilisation of
resources for official controls and result in improved accountability and comparability
of official controls systems. E.4.6 Incorporate
bonus-malus principles This sub-option would
introduce new wording into the Regulation that supports the incorporation of
bonus-malus principles in the fee system for official controls such that best
performers are rewarded while the worst performers are penalised. Bonus-malus
principles are likely to have a positive impact on the efficiency of official
controls systems by encouraging risk-minimising behaviour. They can reinforce
risk-based controls strategies in which resources are used to target
establishments that pose greater risks to the food chain. It may be difficult
to provide specific measures within the Regulation’s text on the financing of
official controls but Articles 26-29 should be screened to ensure that they do
not inadvertently inhibit use of such strategies and application of bonus-malus
principles. The specification of minimum fees in EU legislation, for instance,
can inhibit the application of fee schedules that reward good performance with
lower fees. E.4.7 Introduce
transparency and reporting requirements In this sub-option the
Regulation would require Member States to provide information to the Commission
regarding the financial resources devoted to official controls each year, and
to the public regarding fees, modes of payment and other administrative
procedures. Providing information to the public regarding fees for official
controls will have positive impacts on accountability and the additional
administrative costs are expected to be modest. A requirement to report to the
Commission on resources devoted to official controls will have similarly
positive impacts on accountability, but comes with greater administrative cost
burdens to Competent Authorities, particularly in Member States with
decentralised systems. The scale of that burden will vary depending on exactly
what data or indicators are required and on whether existing reporting
requirements are rationalised and clarified. Increased transparency will
contribute to the creation of a fairer, more efficient system and thus has
significant indirect positive impacts for FBOs. E.4.8 Provide for
industry participation In this sub-option the
Regulation would provide FBOs with the right to participate in the process
of setting the structure of fee rates (though not in determining the fee
levels). More participatory governance arrangements should have positive
impacts on accountability, giving industry a voice in the fee setting process.
Industry participation could provide opportunities for FBOs and Competent
Authorities to work together to pursue common objectives. Fee acceptance is
also likely to be higher where industry can participate in the process.
Enhancing provisions for consultation, together with improved transparency, ought
to promote efficiency in the application of official controls and the emergence
of a fairer system. E.4.9 Introduce
exemptions and reductions for micro-enterprises Under this sub-option the
Regulation would provide reduced fees or fee exemptions for micro-enterprises
(or provide an option for Member States to apply such exemptions). Where this
sub-option is made a requirement, it may reduce cost recovery in Member States,
particularly for those with a large number of such businesses. Respondents indicated
a clear preference for having an option to provide such an exemption or no
provision of such an exemption, rather than a requirement to provide universal
exemptions or reductions. Providing Member States with the option to determine
whether or not to provide an exemption or reduction would allow this decision
to be made on a case-by-case basis in each Member State. This would also
enable Member States to make judgements about how to mitigate impacts of other
sub-options (e.g. full cost recovery) on their smallest food businesses. E.5 A
policy ‘package’ built from the proposed sub- options under Option A has the
potential to significantly reduce administrative burdens, improve cost recovery
and create greater efficiencies in the system, if the potential for positive
interactions between the sub-options is exploited It is clear from the
consultations and analysis that the sub-components of Option A need to be
considered as a ‘package’. The individual components deal with different
elements of the ‘system’ and have a cumulative and collective impact on the
problems that the reforms are intended to address. The interactions between
sub-options are mostly positive but sometimes negative. The core purpose of the
reforms is to ensure that the official controls are properly resourced but also
efficiently delivered and that charges that are fair, transparent and based on
principles common to all within the EU. Several of the core sub-options would
increase payments made by food business operators for the financing of official
controls, shifting the financial burden from pressurised public finances to the
food chain. In some cases this represents a shift in approach, moving away from
controls being a free public service. If the scope and level of fees for
business is to increase then there needs to be counter-veiling pressures on
competent authorities to discharge their responsibilities efficiently, not
least to reduce the financial impact to FBOs. This can be done through, for
instance, enhanced transparency, industry participation, a clearer definition
of what costs can be included. Risk-based control strategies that result in
efficient use of authorities’ resources and focus effort on FBOs which pose
greater risk will also help relieve burdens on well-run businesses. A coherent
reform package can thus encourage a restructuring of the cost base (where
needed) at the same time as addressing fees and revenues. E.6 Full
harmonisation of inspection fees for official controls is unlikely to be
feasible There are valid questions
about the feasibility of full harmonisation of inspection fees for official
controls throughout the EU, as proposed in Option B. Developing a cost model
or set of pricing principles for each official control that was seen by
stakeholders to be fair and appropriate (given control costs) would be an
extremely challenging exercise. Due to the significant differences in the
organisation of official controls systems, variation in cost factors, etc.
amongst Member States it would be impossible to identify a fee level that would
be appropriate for every country. Harmonised fees would also be politically
difficult to implement in Member States with highly decentralised decision
making and governance structures. In Member States with decentralised control systems,
it may not be possible to specify the fee rates under existing national
legislative arrangements. There are cases where new national legislation would
be needed. E6.1 Introduce
unified fees for the EU-27 In this sub-option fees
for the provision of controls are determined on a unified basis for the EU as a
whole (i.e. the same fee rates apply in each Member State). This is likely to
have a negative impact on official controls systems across the EU-27. Full
harmonisation, applying a unified rate across the EU-27, is likely to reduce
the efficiency of the official control system. The distribution of impacts is
affected by the level at which harmonised fees are set. If fees were harmonised
at the level of the highest prevailing fee in Europe then aggregate payment by
industry would rise substantially. If the fees were harmonised at the level of
the lowest prevailing fee then industry would, on balance, gain but there would
be a corresponding deficit in government income and in the overall cost-recovery
rate. If fees were set in the middle of the current range then there would be
‘winners’ and ‘losers’ on a state-by-state basis. E.6.2 Adjust unified
fees using a cost of living index This sub-option is a
modified version of the above, in which harmonised fees are adjusted for each Member State using a cost of living index. Indexation of rates according to the cost of
living would mitigate some of the impacts of harmonisation on a unified basis
but the process of setting an appropriate harmonised fee would remain
burdensome and is very unlikely to result in a schedule of fees that reflects
the actual costs of inspecting individual FBOs or even whole sectors at a
Member State level. Although the sub-option could result in positive impacts on
comparability and streamlining, these are likely to be outweighed by the
significant negative impacts on efficiency and also of fairness and adherence
to principles of cost recovery. E.6.3 Introduce EU
harmonised fees only for certain import controls Under this sub-option the
Regulation would require that certain import controls are subject to harmonised
fees, particularly those controls where there is a higher degree of
harmonisation (e.g. BIPS and DPEs). A single, uniform price would apply to any
EU border point. As with the other sub-options for harmonised fees,
harmonisation of fees for import controls is likely to have a negative impact
on the official controls systems across the EU-27. Development of a cost model
or set of pricing principles for import controls would be an extremely
challenging exercise, and due to variance in the current controls systems it
would be impossible to identify a fee level that would be appropriate for every
country. E.7 Repealing
Articles 26-29 of the Regulation and moving to full subsidiarity is expected to
increase problems associated with lack of coherence and consistency in the
application of fees for official controls Option C considers the
possibility that Member States are obliged to allocate ‘sufficient resources’
to official controls but that each Member State will be free to determine the
approach they follow. Option C requires repeal of Articles 26-29 in Regulation
882/2004/EC. This option is likely to have a negative impact on the coherence
and consistency of the financing of official controls system in the EU. It is
likely to widen disparities between Member States. Some Competent Authorities
may be pressured to lower fees in order to maintain industry’s competitive
advantage which would constrain the resources available for proper delivery of
official controls. Other CAs may increase fees and/or expand fee collection
for control activities in order to achieve full cost recovery. E.8 Monitoring
indicators should be collected in order to assess the effectiveness and impact
of the legislative revision In order to assess whether
the legislative revision is achieving its objectives, and whether there are any
unexpected impacts, the European Commission will need to collect, review and
publish monitoring indicators. It will also be necessary to undertake a more
detailed evaluation exercise once sufficient time has elapsed, in order to
thoroughly review the performance of the revised legislation. Two sets of indicators can
be considered. Macro indicators linked to strategic objectives can be used to
track progress of the system as a whole, using aggregate data reported by
Member States. Alongside that a set of micro indicators can be used to
identify impacts on specific groups of actors within the system, particularly
food business operators and competent authorities. These impacts could be
identified and tracked through following a cohort over time and/or through
periodic sampling of the population of FBOs and authorities. Work by the Commission,
previous evaluations, and this study have all demonstrated the challenges of
mapping the situation in Member States in a context where arrangements for the
financing of controls vary widely, interpretation of the legislation varies and
there has not always been timely compliance with European legislation. In
Member States, the central Competent Authorities themselves often have limited
visibility of the situation in different parts of their own countries due to
the devolution of powers of control to local and regional authorities and
limited pass-through of information back up to the centre. Changes
in the financing of official controls could be tracked more easily if two
changes are made. First, the annual reports produced by Member States under
Regulation 882/2004/EC need to be improved in terms of their consistency,
coverage and clarity. There is a case for reviewing the existing system of
reporting under the Regulation so that the performance of the overall system
can be monitored more effectively and efficiently against a set of key indicators
without imposing undue burden on Member States. Second, adoption of
sub-option A7 on publication of cost data (and/or the second component of
sub-option A7 on reporting to the Commission) would ensure that information is
made available to track changes over time. Annex XII: FEES - Summary of the opinions of stakeholders This Annex presents an
overview of the positions taken by the stakeholders in reply to the
consultations, either at conferences and consultation meetings or in writing
about specific issues relation to the financing of official controls. Positions
were summarised and compiled for the purposes of this Annex[132]. 1. Cost recovery
principle Stakeholders are in
general (predictably) opposed to charges being collected for official controls,
and thus to the cost recovery principle. Many would claim that official
controls are a public service, whose costs should be borne by society at large.
Positions become
more nuanced when questions refer to what changes to the current system would
be needed in order to ensure the sustainability of the system and its increased
efficiency. The answers suggest that the position of full cost recovery is
dependent of the range of costs which are being considered. Opposition to full
cost recovery is linked particularly to certain costs (e.g. transport) and on
costs which would impact disproportionately on mall scale or remote
businesses. CLITRAVI, CELCAA, UEAPME Food Forum and the National
Federation of Meat and Food Traders (member of the IBC) claim that here should be no charges at all
of official controls. FEFAC believes
that the principle of fees is an obstacle to improve control cost efficiency.
An incentive to control authorities to reduce costs can only be achieved if the
costs are born by authorities. Fees also raise issues of independency of
control bodies. HOTREC
considers that, as far as food hygiene inspections in restaurants are
concerned, the possibility for national authorities to charge fees for
inspections should remain optional. UEAPME
also argues that any full cost recovery would
prejudice small remote food businesses (because of transport costs), thus full
costs recovery is not acceptable for SME. Bundesinnung der Fleischer
(member of IBC) states that the cost recovery principle always leads to
higher fees, as there is no link between the work involved and the result. The
English National Federation of Meat & Food Traders argues that
full cost recovery should be abandoned as it is unfair for operators to pay
travel costs and overtime etc. (which impact most on smaller operators). UECBV
is not in favour of including transport costs in the fees as the geographical
location and travelling distances of officials are decided by the Competent
Authorities. If the principle of full cost recovery is retained, UECBV can
accept this only in respect of direct costs. All indirect costs, including
transport, must be borne by the CA. In favour of a system
of shared costs Danish Agriculture Food
Council argues there is a strong need for official
control to be fully or partly publicly financed by the EU and MS. EDA
also claims that part of the costs of inspections should be publicly funded
(with FRUCOM and UGAL). AVEC claims that cost sharing will be an incentive for both sides to do
the job as efficiently and effectively as possible. CIAA claims that each Member State should prove that it is charging the
entire food chain for at least 50% of the total cost of controls (the remaining
50% can be paid by the MS). AVEC claims that up to 75% of the official
inspection costs should be funded through taxation in case of well performing
operators. 2. Extension of the
scope of mandatory fees As to the question
of whether the list of mandatory fees should be extended to cover sectors
currently not charged for controls, answers depend largely on whether the
respondents are currently charges a mandatory fee (meat, milk, imports) or not
(other animal origin products, non-animal origin products). In favour Some stakeholders would
welcome an extension of the scope of mandatory fees. In particular, according
to AVEC mandatory fees are essential. CLITRAVI would like to see
the principle of mandatory fees extended to food sectors other than the one of
fresh meat. The Danish Agriculture Food Council argues that a fees
system covering the whole food chain (where e.g. retailers would also
contribute to the general principle of ensuring the adequate financial
resources for official control is needed. Against UGAL claims that the extension of mandatory fees along feed/food chain is
not justified and would result in illegitimate costs and burdens for operators.
According to them it is repugnant to the principle of
primary responsibility of food business operators to charge producers whose
operations do not involve major veterinary risks. Moreover, there is a risk
that by extending mandatory fees to other operators in the supply chain,
competent authorities will increase inspections of large low risk operators as
a way to generate revenue. Outside the veterinary area, it is the responsibility
of MS to ensure that adequate resources are provided via national budgetary
allocations. 3.
Harmonised/Non-harmonised fee rates While no one argues
in favour of fully harmonised fee rates, opinions are divided on what criteria
should be used to limit variances of fee rates (minimum levels, maximum levels,
indexation). Against harmonised fee
rates AVEC
argues that a system of harmonized fees would be too rigid and suggests that
fees should reflect the different cost structures between MS, with a maximum
fee payable by any individual slaughterhouse. Verband Schweizer Metzgermeister
(member of ICB) remarks that a harmonized fee rates system will probably
lead to an increase of the fees and therefore oppose this proposition. In favour of harmonised
fees Koninklijke Nederlandse
Slagersorganisatie (member of IBC) claims that it would be a good idea
to harmonized fee rates if this leads to a reduction of the costs for small
slaughterhouses. Another member of IBC (and FEFANA)
state that harmonized fee rates would put an end to competitive distortion and
ensure a level-playing-field. According to them harmonisation does not
necessarily mean that a single identical fee is applied in all MS, but rather
that the system is consistent and does not create unfair competition. In favour of
minimum/maximum fees UECBV argues that to avoid the disregard of the veterinary fees system by
any MS, it is necessary to fix a minimum amount for the fees. They are also in
favour of a maximum fee. AVEC warns that although a minimum fee per
animal might be considered it should not discourage an efficient and effective
inspection. Verband Schweizer
Metzgermeister (member of IBC) suggest to introduce an explicit rule
stating that the authorities can go below the minimum fees (eg. by one third),
'to counterbalance unfair competition for decentralized small businesses'. 4.
Harmonised/Non-harmonised fee calculation Most stakeholders
would agree that harmonised common criteria for the calculation of fees are
necessary. In favour of a
harmonized framework for fee calculation Most respondents are in favour of harmonised calculation
criteria. CIAA would favour further harmonisation regarding the
calculation of fees since it believes that the current rules cause distortion
in competition between Member States and sometimes even between companies in
different regions of a Member State. ESA believes that the inspection costs charged to importers should be
calculated following a harmonized method and list of criteria, which should be
fully transparent and available for consideration by industry prior to
shipment. AVEC argues that the actual costs components to be included in
the calculation of the fee should be harmonised and that the calculation should
be kept simple and be based upon the time spent by the inspector and using the
average salary per hour of all inspectors involved. CLITRAVI supports
the harmonization since in their view it would ensure the right mix of
flexibility and fair competition. FRUCOM suggests that inspection costs
charged to importers should be calculated following a harmonised method and
list of criteria, based only on the direct costs. UGAL is also in favour
of a harmonized framework. In the
opinion of CELCAA criteria for calculating the fees have to be transparent
and should be harmonized. FEFAC understands that, for sectors already
subject to fees, further harmonization in the method for the calculation of
fees might be needed. Breiz Europe supports the idea of a harmonized framework for fee rates. They
argue that the current situation is extremely complicated and constraining for
the FBOs. Furthermore they claim that the national difference concerning the
fee rates impedes the smooth functioning of the single market. Criticisms
of existent system / suggestions for improvements Others
expressed criticism with regard to the current system. CLITRAVI's
opinion is that fixing the fee per head of animal slaughtered is not the right
approach when considering that the real cost comes from the staff inspectors in
slaughterhouses. According to them, this method of calculation is seriously
penalizing the largest and more efficient slaughterhouses which are bearing
exorbitant costs. UECBV remarks that the existing payment per tonnage
(in slaughterhouses and cutting plants) is not related to the actual costs
incurred by CAs. VION suggests to clarify in Art. 27(4) that the costs borne encompass
the actual costs but not the theoretical costs. The term "single fee"
in Art. 27 (7) should be clarified as well. Finally in Annex IV the definition
of the costs for staff involved in the official controls has to be clarified,
in particular that only the direct costs should be calculated. For example it
should be clearer that the costs of the training of assistants should not be included. AVEC believes that an average of full EU rate should be calculated and that only 50% of
this rate will be the reference for charging the inspections fees. They suggest
that this 50% rate may be adjusted per MS by an index which is based on the
difference between the costs of living or average salary per hour in that MSs
compared to the same indicators in the EU. They stress that in this fee no
differentiation should be made between the time spent by a veterinarian or an
auxiliary. 5. Bonus-malus system Stakeholders generally support the
introduction of bonus-malus mechanisms. In favour of an
integrated bonus-malus system CIAA argues that fee reductions/ penalties should be linked to the uptake
of self-control systems by industry through an integrated bonus-malus system. CLITRAVI
underlines that a bonus-malus system should be risk-based and foresee clear
implementing measures in order to guarantee that establishments with reliable
and strong self-controls and precautionary systems would have their premises
visited by a gradually reduced number of inspectors and thus paying a low
inspection cost. UECBV thinks that the basic principle of a future
veterinary fee system should be a bonus-malus system open to all
operators i.e. each plant has to be regarded individually and has to be charged
with fees proportionally to its individual cost. UGAL is also in favour
of this measure. FEFANA suggests increasing the scope of the bonus-malus system, already
present in the current regulation, particularly taking into account the use of
certification bodies and Code of Good Practice established by a number of
regulations affecting the products. CELCAA supports the idea of
criteria of a bonus-malus system. However they underline that the criteria for
the establishment of such a system have to be well reflected and clearly
defined in the Regulation. FEFAC emphasizes that bonus-malus systems should be established at national level in order
to encourage companies in further investing in effective certified feed safety
systems. Against a harmonised
bonus-malus system Two stakeholders do not
hold this measure for necessary. Danish Agriculture & Food Council's
view is that it should not be a matter for the EU to set up a penalty system
towards individual citizens in MS. It may nevertheless be considered to launch
community guidelines supporting a common approach. AVEC claims that if
fees are directly related to the time spent on inspections (as they suggest)
the reward or penalty is already incorporated for operators who contribute to a
higher efficiency of the inspection services, will be charged less. A
bonus-malus system is therefore not needed. FEFANA
claims that the costs of controls should be based
on a specific control strategy and plan, and thus on a risk assessment (example
of increased control at the border for certain products). Furthermore they
emphasize that there should be a strong connection between the established
control plans and the determination of the fee. This would be a good incentive
for operators to source from safer manufacturing site and processes, in order
to avoid that their products are subject to increased control. 6. Costs to be covered
by the fees Stakeholders
criticise the wording of the list of cost elements in Annex VI, as it allows CA
to "overprice" controls. Some stakeholders have views on which costs
should be covered by the MS and which ones by FBOs, most take issue with
administrative/overhead costs. Critics of the current
system / suggestions to improve UEAPME
stresses that there is under the current system no
common interpretation of what might be considered as the costs of inspections
and what might be seen as extras. FRUCOM underlines the fact that the
lack of infrastructure should not create extra-costs for importers as it is
currently done. For example in ports where there is a shortage of space to
store containers, the related costs are charged to importers as part of the
inspection fees although it is not in line with Art. 16(3) of Regulation
882/2004. UGAL argues that a list of the activities to be covered by
fess should be established in order to create a harmonized framework. Costs to be covered by
the MSs FRUCOM claims that the extra costs as well as the random/routine controls
have to be covered by the budget of the MS. They assert as well that indirect
costs should be bornby CAs. UEAPME argues that visits to enforce general
food hygiene regulations, to approve premises to be used for the processing of
products of animal origin should not carry any charge on the FBOs. UECBV
states that overhead costs (indirect costs) have to be borne by CAs. VION
specifies with regards to Annex VI that the salaries of the staff involved
should not include the working breaks and the times for changing clothes. Costs to be covered by
the FBOs FRUCOM suggests that the costs of reinforced controls at the specific
levels set in the EU legislation be covered by importers. Danish Agriculture
& Food Council stresses that a fees system must cover the actual costs
but not the additional ones. It is important to them that fees collected for
the purpose of official controls shall not be higher than the costs born by the
responsible competent authorities. EDA claims that the fees that FBOs
pay should cover the real costs only, as it would consequently encourage CAs to
operate in an efficient manner and to demonstrate that their overheads are
reasonable. 7. Transparency to the
Commission and the FBOs Stakeholders are
largely in favour of increased transparency of the methods and assumptions used
by CA when costing the controls and establishing fees. Criticisms of the
current system Danish Agriculture
& Food Council complains about the fact that
although according to Regulation 882/2004 MSs must provide information to the
Commission on the application of the Regulation, e.g. the method of calculation
of fees, this is not done. In favour of a more
transparent system Some stakeholders made
suggestions on how to improve the transparency. FRUCOM argues that MSs
should be required to report to the Commission and explain in detail the method
applied for calculating and charging inspection fees on operators. UEBCV
claims that the detailed calculation of the fees, showing how each parameter is
taken into account for the calculation of the fee of each FBO, must be available
for the FBO concerned. VION shares the view that MSs shall make the
detailed method of calculation regularly public to the FBOs. They specify that
the report shall include the actual times worked by the veterinarians and the
assistants, a description of the kind of work, and the details of the
additional costs. ESA claims that Member States should
be required to post the costs they charge. 8. The Principle of
Thriftiness Many stakeholders
worry that revenues collected through fees would not be used efficiently by
CAs. Suggestion of new
dispositions to be introduced in Regulation 882/2204 Two stakeholders
underlined the importance of the principle of thriftiness and suggested
referring to it in the new Regulation. UEBV underlined that a clear stipulation
should be established in Regulation 882/2004 which specifies that the
administration must strictly follow the economic principles of thriftiness
while fulfilling inspection tasks pursuant to Regulation 854/2004. VION
suggests that a new paragraph should be added to Art. 27(13) in order to oblige
the authorities to follow the principle of thriftiness, especially concerning
the costs of the staff involved to employ not more persons than needed and not
more expensive staff than needed as defined in the regulation 854/2004. UECBV underlines that since the main cost of the ante and post mortem
inspection consists of salaries it has to be ruled how many persons-hours are
needed for the corresponding tasks. They add that the approach must be
risk-based proportionately to the individual plant-risk for food safety. 9. Ringfencing FRUCOM states that inspection fees collected by the Competent Authorities
from operators should be allocated to a specific budget and not to the general
budget. 10. Time-based calculation
of fees Views are divided
and vary depending on the area considered. Consequences of time based fees are
difficult to anticipate. Views on the merits and
consequences of time-based fees AVEC argues that the fees should be calculated on a time basis to
encourage and reward the establishments that adopt best practice and reduce the
hygiene risks and therefore the official time that needs to be spent in the
establishment. UECBV remarks that combined with minimum inspection times
and maximum inspection figures it leads to disproportionate incomes of the
veterinarian personal to the prejudice of the industry. They believe the risk
of such a system, is that more time is spent in the establishments than needed.
In favour of time-based
calculation of fees AVEC thinks the EU should establish a rate per
hour that might be charged and in this way harmonize the system. UECBV is in favour of a time-based fee
in cutting plants, where the presence of CA officials is not permanent and a
fee of 2€ per tonne is most commonly applied amongst the Member States,
independently of the presence of the official authorities. It is important to
link the fee with the effective work of the official authorities. Other position CELCAA underlines that time based fee may be difficult to apply for
certain kinds of businesses. They believe that their feasibility and impact on
businesses has to be carefully evaluated sector-by-sector. They clarify that if
this becomes the favored approach it would be essential to ensure that in the
counterpart competent authorities commit to perform as efficient and timely
controls as possible. 11. Small
establishments Views are divided.
No respondents supports the automatic exemption of small businesses from the
payment of fees. Larger scale operators are of the view that smaller ones
already benefit from the current system, by paying less than actual costs would
require, at the expenses of larger competitors. In favour of a system
that favours small establishments Two stakeholders argued
that the new Regulation should include a system protecting small establishments
from paying to high fees. AVEC claims that there is a need for having at
least a maximum fee per animal or tonnage to avoid small establishments will
have no chance at all to survive due to disproportionate share of inspections
fees in the total costs. CLITRAVI states that as a consequence of the
different fees according to the size of slaughterhouses, big establishments
usually pay lower fees per animal. If an equal amount were to be imposed
regardless of the throughput, this would imply that big slaughterhouses would
subsidize the official controls for small establishments. Koninklijke Nederlandse
Slagersorganisatie (member of the IBC) argues that special rules
regarding fees should apply to small slaughterhouses. In favour of a system
that does not taken into account the size of the establishment Two stakeholders
underlined that the current system already favoured small establishments. FRUCOM
suggested that large importers should be controlled in the same proportion as
smaller companies so as to better spread the potentiality of finding a problem
and to better share the total costs of inspection fees. VION argued that
MS tend to calculate fees on the total costs of the authorities and not with
the total costs at the individual plant. As a result, while small FBOs do not
have to pay for all the costs they caused, bigger FBOs have to. In addition
they claim that Art. 27 (5) (b) might be confusing and should be clarified. VION suggested clarifying Art 27 (5) (b), in particular, that the
subsidizing of businesses with a low throughput has to be done by the national
authorities and not with the fees of the businesses with a high throughput. Annex XIII: FEES – Summary of MS' opinions Introduction MS were consulted in the
context of a first study contracted out by the Commission to an external
contractor[133]
on the state of the application of the rules of
Regulation 882/2004 governing the financing of official controls (2009)[134];
and during a second study carried out in the same field by another external
contractor[135] to support the
assessment of the options identified (2011)[136][137]. In addition to the two
contractor studies referred to above, however, the
key issues were discussed within the Working Group on the general application
of Regulation 882/2004[138] set up
within the Standing Committee on the Food Chain and Animal Health
(SCFCAH)[139]. These discussions are
summarised below (Sections 1 and 2). Moreover the main problems identified and
provisional options were also presented and discussed at meetings of the Heads
of Food Safety Agencies on 29 June-1 July 2011 and on 8 December 2011.
Discussions are summarised here at Sections 3 and 4. It should be stressed that
views expressed at these fora do not necessarily represent the agreed
positions of the MSs but are in fact an opportunity to discuss the issues at
hand with national experts from the different MS. Nonetheless, the points
raised in discussion at these meetings were given careful consideration when
developing the Impact Assessment. NB: The numbering of options which the MS were consulted on does not
correspond to the ones used in this Impact Assessment. Option 1 (Full
subsidiarity) is in Option 1 of the IA; Option 2 (Improvement of the financing
of official controls through fees) is in Options 2 and 3. Option 3 (Extend the
scope of mandatory fees) is in Option 4 of the IA; Option 4 (Fully harmonise
inspection fees for official controls) was discarded and is not included in the
analysis carried out in the IA. 1. Summary of the comments made on inspection fees during the MS
Working Group meeting, Brussels, 10 November 2011. The Commission presented
the Contractor Study (Annex XI of this Impact Assessment). Option 1 - Full
subsidiarity (deregulation) DE, IE, FR, LV against full subsidiarity but all stressed the need for room for MS
flexibility. Option 2 – Improvement
of the financing of official controls through fees 2. i) - Eliminate
minimum / standard fees UK, FI supported option noting the minimum fees hinder recovery of actual
costs if lower than min. fee. SE, NL, IE, DE, LV, against this option. Preferred maintaining minimum fees whilst
making it more effective. For example: - indexing the minimum
fees to the costs of living - calculating on a time-basis - calculating them as a
percentage of the costs charged for carrying out official controls, 2. ii) - clarify the
list of activities for which fees are mandatory SE and FI supported. FI suggested that two approaches.
(i) fees charged "product by product", (ii) horizontal
(activity-based) approach (e.g. residues control for all sectors except the
meat sector). In this case, the amount of fees should be defined according to
the kind of control activity. 2.iii) - Clarify
list of eligible costs - NL, FR, PT,
supported but wished for broad interpretation., 2. (iv) - Ring fence
fees revenue No comments in support of
or against this issue. 2. (v) -
Micro-enterprises NL, CY, PT, LXsupported. However, they pointed out the necessity to agree on a
definition of micro-enterprises in order to avoid distortions of competition
within the single market. FI argued that this measure could lead to enterprises splitting their
activities into micro enterprises in order to benefit from the exemption. As a
consequence they preferred a risk-based approach to a size-based one. 2. (vi) - Introduce
transparency and reporting requirements SE, LT, FR, DE against this option, (supported transparency per se, but
believed it would increase the administrative burden. 2.(vii) – Incorporate
bonus-malus principles NL, BE, UK, FI, SE supported in principle and NL referred back to discussions
on standard fees, agreeing that they hindered bonus malus. MS also noted that
in most cases it would be sufficient to apply a risk-based system, taking into
account the past record of compliance (or non-compliance) of the operator. FR cautioned against increased administrative burdens. NL noted that this system was used by there CAs and expanded further,
saying that fees were calculated not company by company bur rather by sector.
If the sector performed well, fees went down, whereas if the sector performed
badly, fees went up. In this way, "good" operators from the sector
would automatically pressure "bad" ones. They felt, therefore, that
in this way bonus-malus principles were used. They noted too that Article 28
still applied to individual underperforming operators. Option 3 – Extend the
scope of mandatory fees Those against (SE, IE,
DK), argued that: - it is too extreme an
option, since it would include the primary producers and the retail area (risk
of distortion of competition in these sectors is the main concern of the
stakeholders), - based on previous
experience, one DK noted that it would create administrative problems
and high administrative costs, - will make food more
expensive for the consumers (to be avoided in the context of the financial
crisis) Those in favour (FI,
FR, LV) pointed out that: - in some cases they
already collected fees across the whole food production chain, - supermarkets and
canteens, with high food safety risks, they should also be subject to mandatory
fees, - one FR proposed
expanding mandatory fees further than the proposed option, to finance control
activities on the primary producers in the animal health sector. Option 4 – Fully
harmonise inspection fees for official controls NL against any extreme option (1 or 4). Favour intermediate solution
(option 2 or 3). LV supported harmonised fees for border controls. 2. Summary of the comments made on inspection fees during the MS
Working Group meeting, Brussels, 5 December 2011. Option || Supported by: || Opposed by: 1 || LV, but with harmonisation in the areas of A defined maximum fee Clarification of eligible costs Expenses arising from additional official controls Recognition of operator own-checks with regard to bonus malus || IT 2 || DE, FR, SE, IE || 3 || UK, NL, IT, PT, DK || LV, FR, IE 4A || || 4B || DE, LV || Additional Comments Expanding scope Direct support from
IT, UK, NL. Opposition from FR. Concerns regarding high admin burden from FR, DK, IE. However,
UK suggested that it can be cost effective. Eligible Costs NL, FI, DK, UK, FR, SE wish for wide interpretation. NL prefers subsidiarity with regard to indirect costs. Ring Fencing No direct support. IE, DE, FI and SE opposed, but IT, DE, NL, FR, UK in support of 'ring fencing principles'. Bonus Malus Supported by UK, IT, FR, SE, NL, LV, IE, DK. LV, FR - strong role for 3rd party accreditation. SE - should apply at the company level on a case by case basis. Concern regarding
wider review LV – PH / AH needs to be addressed specifically. PL – Bringing in 12 pieces of legislation will cause problems. Harmonisation of
Import Fees NL - current minimum fees sufficient. Minimum Fees No support for EU-wide
minimum fees, but flexible mechanisms suggested by NL (all direct
costs to be collected) and IE (a minimum % of total cost). 3. Summary of the comments made on inspection fees during the Heads
of Agencies meeting (Rotterdam, June 30th – July 1st 2011) The Heads of Agencies
considered it necessary to have a flexible framework in the 882 to enable the
introduction of fees in the entire food supply chain. Flexibility is needed
because of the differences in traditions regarding fees in the different member
states. The HoA suggested to
explicitly mention the option of bonus malus in the 882. Experience in member
states which have such a system shows that it contributes to a safer food
chain. A clarification in the 882 would enable the introduction of this in the
member states. When considering the
introduction of bonus malus systems it is advised to have a good discussion
with the sectors involved, beforehand. The objective has to be to make the food
chain safer and to stimulate the FBO’s to act in conformity with the law. In
this respect is it of importance that the system is transparent in terms of the
fee calculation and the way the system is applied. The agencies should be able
to report to the sector that it contributes to a safer food system with less
costs for the “good” FBO’s and higher costs for the “bad” operators. It helps also when the
fees collected are used for improving food safety, not just as a contribution
(tax) to the state budget or a municipality budget. The HoA suggested the
bonus part could be a reduced frequency of inspections or a lower fee. The
malus part could be just to let them pay for the additional and a full fee
until there is compliance. At a certain stage other instruments as penalties
and other enforcement measures are necessary. 4.
Summary of the comments made during the Heads of Agencies meeting (Lodtz, 8
December 2011) COM gave a presentation of the state of play
of the Review of Regulation (EC) No 882/2004, in particular as regards the fees
chapter. Tour de table: HoA || Comment || Preferred option CZ || Asked how standard fees would be replaced under the new system || Option 2 HU || Support for extending scope of mandatory fees -FBO should share costs, risk map has changed, resources for contingencies / emergency should be made available || Option 3 IE || Fees = taxes, FBO look at overall cost (including fees/taxes) and see no difference || Option 1(?) UK || OK to expanding the scope of mandatory fees, insist on bonus malus, on flexibility and subsidiarity in implementation, no to exemption for small businesses, ok to deletion of minimum fees, support for cost recovery principles but MS should be free to determine how to recover money. || Option 3 FI || Asks whether there is a clear link between suggested changes and food safety || PL || Apart from border checks, other fees should not be harmonised; yes to reduced fees for microbusiness, yes to bonus malus, doubts that any option will reach consensus || (?) + Option 4 B NL || Fees review should consider that FBO are responsible for safety and therefore pay for checks – suggestion: link fees with custom duties? || Option 3 IT || Agrees with L. Miko (fees necessary to maintain food safety) Important to ring fence resources || Option 3 + Cost of living (?) DK || Agrees with NL and UK || Option 3 BE || Minimum levels of controls should not be dependent on fees, ok to transparency || Option 2 or 3 SW || Ok to bonus malus || Option 2 or 3 Annex XIV - Evidence concerning problems of interpretation/implementation of the rules governing the financing of official controls[140] Provision concerned/ Sources || Requests for interpretation addressed to the COM by MS || ECJ Judgements || Infringement cases Regulation (EC) No 882/2204 || || || Annex VI (list of eligible costs) || 1) Author: International Butchers' Confederation Question: Are the UK's competent authorities allowed to include a pension deficit in their calculation of inspection fees? 2) Author: Farmers' Union of Wales Question: Is the UK's Food Standard Agency's inclusion of their pension deficit in the calculation of transferable costs legal under EC 882/2004? || || Article 27 || || || 2008/4966, 4967, 4968 and 4969 Complainant: law firm Keul & Farber Complaint: The Länder Northrhine-Westphalia (Case 2008/4966), Schleswig-Holstein – Kreis Steinfurt (Case 2008/4967) and Baden-Württemberg – Landratsamt Waldshut-Tiengen(2008/4968) are said to have violated Article 27 (2) to Regulation (EC) No 882/2004, by not having charged some of the fees for activities covered by Article 27 (2) in conjunction with Annex IV Part A and Annex V Part A , e.g. milk, imported fishery products, poultry, rabbit meat, import and transit of live animals. In Case 2008/4967, Article 27 (10) is said to be violated because separate control fees are charged for the meat-cutting division of the complainant. In Case 2008/4968, Article 27 (12) is said to be violated because the authorities claim that they were under no obligation to make a detailed calculation method available to the complainant. In Case 2008/4969 (Rhineland-Palatinate – Eifelkreis Bitburg-Prüm) there are travel supplements and percentage-wise increases of the basic rate, which are particularly disadvantageous for small establishments. Annex IV, Section A (list of activities for which a fee shall be collected) || Author: French Ministry of Agriculture and Fisheries Question: Are pet food establishments included among feed establishments for which point 2, Section A, Annex IV of Regulation (EC) No 882/2004 requires the collection of a fee for their approval? || || Article 27(3) in relation with 27(4) || Author: UK, Imports Border Controls Question: Could the Commission exlpain the apparent contradiction between Article 27.3 of Regulation (EC) No 882/2004 (where it is stated that inspection fees shall not be lower than the minimum set out in the Regulation) and Article 27.4 of the same Regulation (where it is stated that inspection fees should not be higher than the costs borne by the Competent Authorities)? || || Article 27 (4) || Author: RA'e Dr Fuchs und Renger Questions: a) According to the legal interpretation by Germany's highest administrative court (the Federal Administrative Court), under the previous Directive 85/73/EEC as amended by Directive 96/43/EC, collection of fees other than the flat-rate fees fixed in Annex A, Chapter I, Nos 1 and 2a was possible, according to either No 4a or No 4b. However, the competent authority had to opt for one of the two alternatives. Can this interpretation also be applied to the wording of Article 27.4.b? If so, is a combination of both alternatives within an authority's area of competence possible? b) If the Competent Authority opts to collect a flat-rate fee, can it then calculate fees on the basis of the costs borne over a given period of time as a result of all the controls carried out pursuant to paragraphs 1or 2, taking into account only the types of costs referred to in Annex VI? || || || c) If the Competent Authority opts for minimum fees in accordance with Annexes IV and V of Regulation (EC) No 882/2004, is the fixing of fees by the Competent Authority in compliance with the provisions of Article 27 of Regulation (EC) No 882/2004? d) Is the Competent Authority obliged to fix at least the minimum fees referred to there for all the activities listed in Annexes IV and V (official controls)?" || || Article 27(4) (a) || || C-523/09 7 July 2011 Maag Piimattööstus AS v Veterinaar- ja Toiduamet (reference for preliminary ruling) Question: Must Article 27(4)(a) of Regulation [No 882/2004] be interpreted as not prohibiting the demanding of a fee from an operator at the minimum rate laid down in Part B of Annex IV to that regulation for the activities listed in Part A of Annex IV to the regulation, even if the costs borne by the responsible competent authorities in connection with the items listed in Annex VI to that regulation are lower than the abovementioned minimum rates? || Article 27(4)(b) || Author: Counsellor for Agricultural Affairs, Permanent Representation of Estonia to the EU Question: When a Member State implements Regulation (EC) No 882/2004 in such a way that the fees collected for the official controls are fixed at the minimum rates provided in Annex IV Section B [Article 27 part 4(b)], is that Member State required to take into consideration the actual costs borne by the competent authorities in order to make sure that the fees are not higher than the costs?" || || Article 27(7) || Author: Association of Independant Meat Suppliers Question: What is your view on the way Article 27.7 of Regulation (EC) No 882/2004 has been implemented in the UK (who charges two fees for establishments carrying out both slaughter and cutting)? || || Article 27(12) || 1) Author: Studio Giffoni sprl/bvba Customs Consultancy Question: Article 27 paragraph 12) says that "Member States shall make public the method of calculation of fees and communicate it to the Commission".Is it possible to receive the complete list of fees or charges related to official controls in the Communityapplied by each Member States? 2) Author: International Butchers' Confederation Question: What charges are levied in the different Member States, for meat inspection? || || || 3) Author: Belgian federal Agency for the Safety of the Food Chain Question: How is the method of calculation of fees to be made public? is it sufficient for the person in question to be informed in a meeting, and for the information to be set out in the minutes? || || Annex IV , Section A || || C-523/09 7 July 2011 Maag Piimattööstus AS v Veterinaar- ja Toiduamet (reference for preliminary ruling) Question: Is a Member State entitled, on the conditions mentioned in the previous question [see Article 27(4)(a)], to establish fees for the activities listed in Part A of Annex IV to [Regulation No 882/2004] that are lower than the minimum amounts laid down in Part B of Annex IV to that regulation, if the costs borne by the responsible competent authorities in connection with the items listed in Annex VI to that regulation are lower than the above mentioned minimum rates, without the conditions laid down in Article 27(6) of that regulation being satisfied?’ || Annex IV, Section B || Author: Belgian Federal Agency for the Safety of the Food Chain Question: Why are no minimum tariffs laid down for all official controls, e.g.: controls on imported feed and food of non-animal origin; registration/recognition of feed and food companies, export of feed and food? || || 2007/4703 Complainant: Keul & Farber Complaint: The veterinary fees charged by the District of Bergstraße, Hessen are higher than the minimum fees set out in Annex IV, Part B, to Regulation (EC) No 882/2004 on official controls. 2007/4755 Complainant: Keul & Farber Complain: The veterinary fees charged by the District of Steinburg, Schleswig-Holstein, are higher than the minimum fees set out in Annex IV, Part B, to Regulation (EC) No 882/2004 without there being a proper implementing act. Annex IV, Section B, Chapter I || Author: Belgian Federal Agency for the Safety of the Food Chain Question: Do the fees for inspections during slaughter include the fees for sampling, residue analysis and BSE analysis (in cattle)? || || Annex IV, Section B, Chapter II || Author: Law firm Tuengerthal & Liebenau Question: What is the opinion of the Commission on their own interpretation of the legislation: the collection of fees for controls in cutting plants pursuant to Annex IV, Chapter II leads to fees that are not reflecting the actual costs that the authority has to bear? || || Annex IV , Section B, Chapter IV || Author: Ministry of Foreign Affairs of Latvia Question: Regulation 882, Annex IV, Section B, Chapter IV milk production – what exactly is meant – raw milk production in the holdings or milk processing in dairies? || || Annex IV, Section B, Chapter V || 1) Author: Belgian Federal Agency for Safety of the Food Chain Question: What is the difference between 'first placing on the market of fishery and aquaculture products' and 'first sale in fish market' ? 2) Author: Veterinary Directorate General Questions: a) What is the difference between "first placing on the market of fishery" and "first sale in fish market"? b) The correct implementation of Regulation 882/2204 implies the rupture with the repealed Directive procedures and determines the charge of first placing on the market to the primary producer? c) If so to whom should be charged the first sale in fish market: to the auction all operator or to the first purchaser? || || Annex VI, point 2 || Author: Belgian Federal Agency for Safety of the Food Chain Questions: a) What exactly does "associated costs" mean? b) To what extend can overheads be charged? For example can electricity and heating costs be partly through-charged by the Personnel Department? || || Directive 85/73/CEE as amended by Directive 96/43/CEE || || || C-270/07 19 March 2009 Commission of the European Communities v Federal Republic of Germany (failure to fulfil obligation) Request: The applicant requested the Court to declare that, by failing to adapt to the Community provisions Paragraph 4 of the law implementing the legislation on the health inspection of meat and poultrymeat in the Land Schleswig‑Holstein, the Federal Republic of Germany has failed or continues to fail to fulfil its obligations under Articles 1 and 5(3) and (4) of Council Directive 85/73/EEC and under Article 27(2), (4) and (10) of Regulation (EC) No 882/2004 || || C284/00 and C-288/00 30 May 2002 C-284/00 Stratmann GmbH und CO.KG and Landrätin des Kreises Wesel C-288/00 Fleischversorgung Neuss GmbH und Co. KG and Landrat des Kreioses Neuss (references for a preliminary ruling) Questions: a) Does the standard fee applicable under Council Directive 85/73/EEC for the inspection of fresh meat intended for the domestic market, in accordance with Council Directive 64/433/EEC, also cover the costs of carrying out examinations of fresh pigmeat for trichinae? b) Does the standard fee applicable under Council Directive 85/73/EEC, in conjunction with Council Decision 88/408/EEC, for the inspection of fresh meat intended for the domestic market, also cover the costs of carrying out a bacteriological examination required in an individual case? || 2006/4749 Complainant: Keul & Farber Complaint: The Land Schleswig-Holstein did not transpose Directive 85/73, Decision 88/408 and Directive 93/118. The relevant law of 12.1.1998, which provides for veterinary fees which cover the costs, including for bacteriological and trichinae examinations had retroactive effect. 2006/4750 and 4773 Complainant: Keul & Farber Complaint: The Land Niedersachsen did not transpose Decision 88/408 and Directive 93/118. Directive 85/73 as amended by Directive 96/43 has not been transposed completely and accurately. An amendment of 23.01.2003 still maintains specific fees for bacteriological and trichinae examinations by way of an increase of the general examination fee. || || || 2006/4751 Complainant: Keul & Farber Complaint:The Land Brandenburg did not transpose Directive 85/73 as amended by Directive 93/118 and transposed Directive 85/73 as amended by Directive 96/43 incompletely and incorrectly. It charges fees in excess of the Community flat rate and adds specific fees for bacteriological and trichinae examinations, which is in contradiction with the Directive as interpreted by the Court in Cases C-284/00 and C-288/00 - Stratmann. 2006/4761 Complainant: Keul & Farber Complaint: The Land Nordrhein-Westfalen transposed Directive 85/73 as amended by Directive 96/43 belatedly, incompletely and with retroactive effect and increased the Community flat rate. In a regulation of 18.9.2000 it provides for specific fees in addition to the general examination fee in contradiction with the Directive as interpreted by the Court in Cases C-284/00 and C-288/00. || || || 2006/4762 Complainant: Keul & Farber Complaint: A local authority in Sachsen-Anhalt has requested fees which the complainant considers to be in contradiction with the ECJ judgements in C-284/00 and C-288/00 - Stratmann since the inclusion of specific fees is considered to be contrary to the principles of a uniform fee and transparency. 2006/4763 Complainant: Keul & Farber Complaint: The Land Niedersachsen did not transpose Decision 88/408 and Directive 93/118. Directive 85/73 as amended by Directive 96/43 has not been transposed completely and acurately. An amendment of 23.01.2003 still maintains specific fees for bacteriological and trichinae examinations by way of an increase of the general examination fee. 2006/4764 and 4766 Complainant: Keul & Farber Complaint: In Hessen a regulation adds fees for trichinae examinations to the general veterinary examination fee, which is said to be incompatible with Directive 85/73 and the Stratmann case law (Cases C-284/00 and C-288/00). || || || 2006/4767 Complainant: Keul & farber Complain: A local authority in Sachsen-Anhalt has requested fees which the complainant considers to be in contradiction with the ECJ judgements in C-284/00 and C-288/00 - Stratmann since the inclusion of specific fees is considered to be contrary to the principles of a uniform fee and transparency. In addition the complainant criticises the retroactive application of derogations in Directive 85/73/EEC in Sachsen-Anhalt. 2006/4778 Complainant: Keul & Farber Complaint: The competent local authority in Rheinland-Pfalz charges veterinary fees which include fees for bacteriological and trichinae examinations. These fees are higher than the flat rate provided for in Directive 85/73 and the complainant considers them to be incompatible the Directive as interpreted by the Court in Cases C-284/00 and C-288/00 - Stratmann. 2006/4843 and 4915 Complainant: Keul & Farber Complaint: In Bavaria the Directive was transposed and applied at local level (Landkreise). Additional fees were charged, e.g. for examinations for trichinae. Article 2(3) || || C-374/97 9 September 1999 Anton Feyer and Landkreis Rottal-Inn, Intervener: Landesanwaltschaft Bayern (reference for prelimanry ruling) Question: Is the authorisation given to Member States under Article 2(3) of Council Directive 85/73/EEC as amended by Directive 93/118/EC to collect an amount exceeding the Community fees dependent on the total fee collected in the Member State as a whole and the actual figure for inspection costs incurred in the Member State as a whole or is it sufficient, when the Member State has delegated authorisation to collect the fees to the local authorities, that the total fee collected by the local authority is not greater than the actual figure for inspection costs incurred by that authority? || Annex relating to Article 2(1) || || C-374/97 9 September 1999 Anton Feyer and Landkreis Rottal-Inn, Intervener: Landesanwaltschaft Bayern (reference for prelimanry ruling) Questions: a) Can an individual oppose the collection of fees higher than the standard amounts listed in point 1 of the annex relating to Article 2(1) of Council Directive 85/73/EEC as amended by Council Directive 93/118/EC where the Member State has not transposed Directive 93/118/EC into national law within the prescribed period? b) Can a Member State collect fees higher than the standard amounts in reliance on point 4(b) of the annex relating to Article 2(1) of Council Directive 85/73/EEC as amended by Directive 93/118/EC provided that the fees levied do not exceed the actual costs, no further conditions being imposed? || Article 5(3) and Chapter I of Annex A || || C-309/07 19 March 2009 Baumann GmbH v Land Hessen (reference for a preliminary ruling) Questions: a) Is a national legislature, when availing itself of the power laid down in Article 5(3) of [Directive 85/73] and in point 4(a) of Chapter I of Annex A thereto to increase the standard amounts of fees for individual establishment and in point 4(b) to collect a fee which covers actual costs, strictly bound by the fee structure laid down in points 1 and 2(a) of Chapter I of Annex A or may it make a distinction, when setting the amounts of scales of fees, between inspections of slaughtering units in large establishments and other inspections and, in addition, also within those two groups adjust the rate of fees on a diminishing scale according to the number of animals slaughtered within the animal types, provided only that that reflects the actual costs? || || || b) On the basis of the abovementioned provisions, may a national legislature collect, in respect of slaughtering carried out outside normal slaughtering hours at the request of the owner, an additional fee on a percentage basis on top of the fee collected for slaughtering inspections in normal slaughtering hours when that increase reflects the additional actual costs, or must those costs be contained in the standard (increased) fee for all persons subject to a fee? || Article 5(4), second subparagraph || || C-430/07 25 June 2009 Exportslachterij J. Gosschlak & Zoon B v Minister van Landbouw, Natuur en Voedselkwaliteit (reference for a preliminary ruling) Question: Must the second subparagraph of Article 5(4) of Directive 85/73/EEC be interpreted as meaning that this Directive does not preclude the Member State from charging a fee on account of the costs of the BSE tests which were carried out? If so, what requirements must be met by a fee for the BSE tests which were carried out?’ || Annex A, Chaper 1,No 4(b) || || || 2006/4747 and 4830 Complainant: Keul & Farber Complaint: Incorrect transposition/application in Baden-Württemberg of Directive 85/73 as amended by Directive 93/118 and 96/43. Although the relevant provision provided for an increase of the EC flat rate based on the particularities of the establishment, additional fees for bacteriological and trichinae examination were charged. The Directive was re-transposed retroactively. Directive 96/23/EC || Author: Fuchs und Renger Question: According to which criteria must the competent authority take account of the costs of testing for residues (Directive 96/23/EC): - when fixing flat-rate fees? - when fixing minimum fees? || || 2006/4746, 4774, 4781, 4809, 4963 and 5034 Complainant: Keul & Farber Complaint: The Land Nordrhein-Westfalen transposed Directive 85/73 as amended by Directive 96/43 belatedly, incompletely and with retroactive effect and increased the Community flat rate. In a regulation of 18.9.2000 it provides for specific fees in addition to the general examination fee in contradiction with the Directive as interpreted by the Court in Cases C-284/00 and C-288/00 - Stratmann. Annex A, Chaper 1,No 2(a) || || || 2006/4703 Complainant: law firm Keul & Farber Complaint: Germany (and in particular the city of Koblenz) is violating Directive 85/73/EEC, as amended by Directive 96/43/EC, which provides, in Annex A Chapter 1 No 2(a), that the hygiene controls and inspections connected with meat cutting establishments must be covered a standard fee of € 3/tonne of meat. Derogation from the standard fee is only allowed under certain conditions. The City of Koblenz (Rhineland-Palatinate) has disregarded these conditions by adopting a blanket scale of fees on the basis of which an increased flat-rate fee of € 30.91 is being charged. Annex XV: FEES - Examples of stated limited availability of resources as reported in FVO reports MS || FVO Audit Reference || Instances where MS have stated that they could not carry out controls because of a lack of resources || Problem raised by the MS ES || 2008-7781 SA (residues and contaminants in live animals and animal products, including veterinary medicinal products) || "In the autonomous community visited there had been no controls on private veterinary practitioners. The competent authority explained that this was due to the need to prioritise resources. Controls on retailers were deemed to be of greater importance." || Lack of financial resources HU || 2008-7774 SA (residues and contaminants in live animals and animal products, including veterinary medicinal products) || "The discrepancy between planned arrangements and the factual number of controls is due to budgetary reductions" || Lack of financial resources DK || 2010-8440 SA (residues and contaminants and the use of veterinary medicinal products in food producing animals) || "At one of the RVFA offices delays in follow-up investigations were ascribed to a lack of staff, particularly during holiday periods, and due to subsequent priority setting." || Lack of staff SE || 2010-8438 SA (residues and contaminants and the use of veterinary medicinal products in food producing animals) || "According to the two County Administrative Boards visited, limited staff resources had led to strict prioritisation of official controls. [...] A lack of staff and a re-organisation of the District Veterinary Organisation by the Board of Agriculture had led to under-sampling for the NRCP (on-farm samples) in 2009. [...] Participation in training was sometimes restricted due to lack of staff and resources." || Lack of financial resources, staff and training BU || 2010-8436 SA (residues and contaminants and the use of veterinary medicinal products in food producing animals) || "At regional level, appropriate and properly maintained facilities and equipment were available to staff in charge of controls. However, this was not the case in the laboratory where (laboratory management) claims of inadequate funding have resulted in a situation whereby the competent authority is not complying with Articles 4 (2) c of Regulation (EC) No 882/2004 and can not meet its obligations under Article 15 of Council Directive 96/23/EC." || Lack of resources results in lack of appropriate facilities and equipment RO || 2010-8441 SA (residues and contaminants and the use of veterinary medicinal products in food producing animals) || "As a result of substantial budgetary constraints, there is currently insufficient laboratory capacity or capability to enable the analyses of the number of samples and substances included in the NRCP"; "So far in 2010, the IHVPH has received 15% of its annual budget and has announced that as a result, analyses of a range of substances can no longer be performed";"although the laboratories visited had sufficient analytical equipment, the Director of one laboratory stated that substantial refurbishment was necessary [...]"; "Officials met in the counties visited had been provided with relevant training during 2008 but little or none in 2009 owing to budgetary issues". "Little relevant training has been provided and the resulting lack of awareness of certain requirements, combined with the effects of on-going budgetary problems and limited ability to oblige farmers and FBOs to undergo sampling, prevents the effective implementation of the official control system for residues and the NRCP in particular." || Lack of financial resources resulting in insufficient laboratory capability; inappropriate equipment, no/little training. RO || 2010-8479 SA (controls on feed legislation) || "Training concerning feedingstuffs for 2009 and 2010 has been cancelled due to financial reasons" || Lack of financial resources resulting in a lack of training BU || 2010-8478 SA (controls on feed legislation) || "In the regions visited, the audit team noted that neither NVS feed inspectors nor municipality inspectors met were supplied with the equipment necessary to take samples of feed"; "Representatives of NVS at central and regional level acknowledged that NVS feed inspectors in the 28 regions and municipality veterinarians had not received training prior to their appointment [...] NVS representatives met informed the audit that, at present, there is no training programme related to feed issues neither for regional NVS inspectors nor for municipality veterinarians". || Lack of equipment and training SK || 2010-8807 SA (health rules on animal by-products (ABP)) || "the officials from the RVFAs and the DVFAs visited as well as the inspectors responsible for official controls met in the processing plants visited, stated that they had not received training on HACCP based procedures nor on their assessment. According to the SVFASR representatives met, training in this respect was planned for end of 2010 but due to financial limitations has been postponed to 2011." || Lack of financial resources results in a lack of training. SK || 2008-7776 SA (residues and contaminants in live animals and animal products, veterinary medicinal products) || "The SVFA stated that due to budgetary limitations, 'suspect' samples are taken and submitted to the laboratory as ordinary 'targeted' NRCP samples which means that the carcasses are not detained in the slaughterhouse as required by Article 24 of Council Directive 96/23/EC." || Lack of financial resources GR || 2008-7793 MR (animal health - bovine brucellosis and tuberculosis, ovine & caprine brucellosis) || "In the Prefectures visited the number of veterinarians employed was very low compared with the posts in the organisation chart (e.g. in one Prefecture 21 out of 76, in another one 3 out of 11). Due to the lack of veterinary staff, in one Prefecture visited one LVS (Local veterinary station) was not in operation and in another one, only 6 LVSs out of 9 were actually in operation. In another Prefecture visited, the activities of the local level were performed by the official of the Prefectural level. [...] No specific technical training has been organized at Central level for new or existing staff since 2003 and no training has been planned at central or Prefectural level for 2008 on issues related to the programmes." || Lack of staff and training LT || 2009-8131 SA (residues and contaminants and the use of veterinary medicinal products in food producing animals) || "In 2008, the ratio between samples taken for Group A analyses in bovines on farms and in the slaughterhouses was 40:60 and not 50:50 as planned and required under Council Directive 96/23/EC. The NRCP coordinator explained that this discrepancy was spotted after the second quarter of the sampling year. However, due to the number of samples already taken, it was impossible to rectify the situation without additional financial resources - which were not available." || Lack of financial resources MT || 2009-8278 MR (Public Health - Food Hygiene) || "The CA stated that certain laboratory analyses were not carried out due to a shortage of staff in the laboratory." || Lack of staff MT || 2010-8590 SA (Food hygiene, food contact materials and food additives) || "Staffing levels in the PHL are insufficient [...]. Inspectors have not been adequately trained in FCM and FA [...]." || Lack of staff and appropriate training MT || 2010-8558 SA (import/transit control system and border inspection posts) || "BIP infrastructure is generally in accordance with requirements except in Luqa airport BIP where significant shortcomings in maintenance and operational hygiene were noted[...]. The attribution of staff resources especially official veterinarians for BIPs is not satisfactory. This leads to certain veterinary controls being carried out by improperly qualified staff, as a result veterinary checks are not carried out appropriately. [...] Training is provided for BIP matters, and a plan is in place for 2010. However, some of the shortcomings noted regarding veterinary checks and veterinary decision indicate that the training provided is not satisfactory." || No properly mantained facilities and equipment; lack of staff and appropriate training NL || 2009-8095 MR (controls on feed legislation) || "Training arrangements were mainly satisfactory except in the areas of import controls and inspections at primary production of feed, for which the official met had not received the appropriate training required by Art. 6 of Regulation (EC) No 882/2004. The resources dedicated by AID and VWA to the implementation of official controls on feed were insufficient to meet the objectives of their respective control programmes. Resources were also inadequate in order to provide a timely follow-up on corrective actions imposed and to undertake all necessary legal proceedings." || Lack of human and financial resources; lack of appropriate training GR || 2009-8077 SA (import/transit control system and border inspection posts) || "The CA indicated that due to a long-term staff shortage at the Animal Health Directorate (AHD) it has not been possible to set up a centrally approved sampling programme for BIPs. [...] The lack of staff at central level is central to problems in the provision of training, updating and development of necessary manuals and the implementation of a verification system. This has also contributed to the lack of a system to ensure ongoing training needs are identified and met.[...] For Customs training is insufficient, in those entry points where they are responsible for checks on accompanied pet animals, to ensure correct execution of controls. (as evidenced by a lack ofawareness of the requirements by officials encountered)." || Lack of staff and training FI || 2009-8316 GA || "Various competent authorities stated that they had not access to a sufficient number of suitably qualified and experienced staff as required by Article 4 of Regulation (EC) No 882/2004. Subsequently auditing and control tasks were not consistently completed [.. ] No specific training on FA was provided to the official inspectors in the last two years at any level.[..] Some theoretical training related to post mortem inspection has been provided to slaughterhouse staff also by official veterinarian in charge of slaughterhouse. However overall training duration was less than 30 hours for the course led by the official veterinarian. There was no evidence of training provided to the newcomers." || Lack of staff and training MT || 2010-8458 SA (poultry meat and the systems in place to control the Salmonella risk in poultry) || "There is insufficient number of staff to complete the assigned tasks in poultry meat producing establishments.[...] Scheduled frequency of inspections in poultry establishments is based on risk assessment however due to the lack of human resources the planned schedule set in 2009 is currently not being met." || Lack of staff GR || 2009-8333 MR (health rules on animal by-products (ABP)) || "Significant staff shortages remain in the CA with responsibilities for the ABP chain which might affect the implementation of the official controls required by Art. 26 of Regulation (EC) No 1774/2002. As such, the relevant recommendation made following report 2007-7611 has not been addressed and the requirements of Art. 4(2) of Regulation (EC) No 882/2004 ave not been fulfilled." || Lack of staff and training FR || 2007-7185 MR (import controls - food of non-animal origin) || "In the DDCCRF of Marseille, the human resources available for the control of imported foodstuffs were not sufficient, which could compromise the frequency of sampling established in Commission Decision 2006/504/EC." || Lack of staff IT || 2009-8233 MR (public health - baby food) || "The LSV and the SIAN are using the same risk classification but the frequency of the visits is not the same. In one establishment visited (under the joint supervision of the LVS and the SIAN) which was classified as high risk, the LVS carry out monthly inspections whereas the SIAN officers visit once a year. In one other establishment visited, also classified as high risk, the LVS performs 8 inspections per year and the SIAN only 3. The CA stated that this is because of limited human resources in the SIAN." || Lack of staff UK || 2009-8299 SA (Plant Health - import controls; Bursaphelenchus xylophilus; and Anoplophora chinensis) || "Mainly because of lack of human resources, the frequency of documentary checks, physical identity checks and plant health checks falls far short of meeting EU requirements for import controls, and the mission team considers that these shortcomings result in a significant risk of introduction and spread of harmful organisms into the Community. Furthermore having no or reduced frequency checks outside the framework of the EC legislation could result in redirection of trade in favour of UK points of entry." || Lack of staff DE || 2010-8567 MR (import/transit control system applied in the border inspection post of Bremerhaven) || "According to the head of BIP the failure to enter all relevant data in TRACES was due to lack of staff" || Lack of staff RO || 2010-8528 SA (Fishery products) || "According to the information provided to the AT during the mission 910 jobs were lost this year for budgetary reasons. [...] At central level, it appeared during the mission that due the numerous responsibilities applied to a limited number of staff, some planned activities cannot be always ensured. [...] at central level where staff is accommodated in premises with limited working area per person and where many people have to share the same room. In another county once the official samples are taken and sealed by the OVs, it is the responsibility of the FBOs to deliver them to the laboratory due to limited availability of means of transport for the official sampletaker.[...] Since 2009, the training frequency has decreased (one training session every two months took place in 2008 while in 2009 only one training session took place). [...] The efficiency of the implementation of the official control system is diminished by insufficient staffing at central level, insufficient training of inspecting staff at county level and insufficient availability of means of transport identified in some counties. || Lack of financial resources resulting in staff shortages, lack of appropriate training and equipment RO || 2010-8512 SA (public health - food hygiene) || "The CCA stated that there has not been considerable progress in the re-evaluation of approved establishments due to a limited number of staff available for this task and due to financial problems concerning travel expenses. In addition the CCA informed the FVO team that they had a salary cut of 25% in 2010. [...] According to the CCA a shortage of financial resources has had an impact on training organised in 2010. Recommendation 2 has not been satisfactorily addressed and inadequate training for OVs in certain areas was noted by the FVO team." || Lack of financial resources resulting in lack of staff and training BU || 2010-8513 SA (public health - food hygiene) || "The NVS informed the FVO team that the GDCVA prepare an audit plan each year. In 2010 ten audits were planned to ten different RVS, however the CA stated that only six of these audits had been carried out due to budgetary constraints." || Lack of financial resources RO || 2008-8003 MR (Control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products) || "Significant delays in allocation of the budget allied with the fact that the national residue control plan is not yet financed by fees pursuant to Article 27 and Annex IV Section B to Regulation (EC) No 882/2004, have contributed to the marked delay in the implementation of the 2008 plan which is not in line with point 2.1. of Annex to 16 Commission Decision 98/179/EC. Budgetary constraints and late implementation of the plan collectively undermine the effectiveness of the residues control system." || Lack of financial resources GR || 2011-8840 MR (Poultry meat and poultry meat products) || "The number of controls performed varied between regions. In one region visited the set target was achieved. In a second region, due to budgetary constraints, only approximately 20% of foreseen checks were performed. As a result some establishments were never controlled in 2010. The audit team was informed that for 2011 this specific region will be in the same situation." || Lack of financial resources GR || 2011-8810 MR (Health rules on animal by-products (ABP)) || "At two prefectures out of the 11 visited by the audit team, evidence was shown that a risk based plan was set up, however; the inspectors met by the audit team declared that they were not able to execute this plan due to lack of resources." || Lack of financial resources GR || 2010-8609 MR (Protected zones, harmful organisms and controls for Rhynchophorus ferrugineus) || "Greece has organised an official action programme aiming to seek confirmation that the relevant harmful organisms are not endemic or established in the protected zones in 2009. The action programme is generally based on appropriate planning and methodology. However, a number of Prefectures were omitted from the survey plan because of a lack of resources." || Lack of financial resources RO || 2010-8560 SA (Import/transit control system and border inspection posts) || "All BIPs in Romania are approved for HC and NHC and they are also listed as Designated Points of Entry under Regulation (EC) No. 669/2009. The BIP facilities are shared for controls of POAO and products of non-animal origin. At the BIPs visited no formal system for minimising the risk of cross-contamination was in place. The effectiveness of the existing measures,however, cannot be ensured due to the lack of resources for cleaning and disinfection of the shared facilities." || Lack of financial resources UK || 2009-8092 SA (Official controls on feed legislation) || One of the LAs responsible for official controls on imported feed at one seaport visited (England) had no documented procedure in place for the implementation of such controls. According to a representative from this LA, documentary checks were not performed and physical checks (sampling) were very limited due to a lack of resources [..]. As a result, few samples were taken and they were tested for melamine and genetically modified organisms only." || Lack of resources RO || 2010-8460 SA (Salmonella National Control Programme in particular poultry populations) || "A shortage of financial resources has had an impact on sampling levels in 2009 and training organised in 2009/2010. As of today, the CA has the necessary legal powers needed for the SNCP implementation. While some training has been organised relevant to SNCP, in some cases this has been insufficient/ineffective." || Lack of financial resources affecting controls and training FI || 2009-8065 SA (poultry meat and poultry meat products) || "Sampling plans were not always fully mplemented; in one MFCA visited the plan for first half of 2008 was not implemented at all and no official samples were taken.As a reason the MFCA indicated lack of financial resources." || lack of financial resources PL || 2010-8602 SA (Plant Health - potatos and the general system of surveillance for harmful organisms) || "The mission team noted that in one of the local offices visited, the chief inspector reported that there was too few staff to carry out the minimum level of planned checks, in particular, that in 2009, it had not been possible to carry out the mandatory annual documentary check at premises registered in accordance with Directive 92/90/EC." || Lack of staff PT || 2010-8611 MR (Pinewood Nematode) || Trucks sealed with private seals are not controlled and due to a lack of resources there is no system in place to control that trucks intercepted with non-compliant material follow the instructions of GNR. || Lack of financial resources BU || 2010-8552 SA (Import/transit control system and border inspection posts) || "No internal or external audits subject to independent scrutiny and transparency have been done in the framework of Regulation (EC) No 882/2004. According to the CA this was due to lack of resources. No concrete plans were in place for implementation of such audits for BIPs. [...] The lack of supervision for the biggest BIP in Bulgaria cannot ensure that official controls are carried out correctly." || Lack of financial resources SE || 2010-8501 SA (Public Health - Food Hygiene) || "The NFA stated that there is not yet a uniform training system in place across the different CAs in Sweden to ensure the competence of officials carrying out official controls. […] the basis for future training has been established through the completion of the "skills in food control" project but so far no funding for the implementation of the project has been secured." || Lack of financial resources resulting in lack of training SE || 2007-7433 MR (Import controls for plant health) || "Most of the shortcomings are related to limited human resources. Not all regulated articles are checked, and some checks are carried out after customs clearance.[...] The competent authorities in Sweden are recommended to ensure that: (1) There are adequate staff available to enable plant health checks to be carried out [..]" || Lack of staff SE || 2010-8606 SA (plant health import controls) || "Understaffing is the major limiting factor for carrying out plant health controls. This affects for example import controls, where not all checks are carried out, where it is required by EU legislation. […] despite the increase in the number of ID inspectors, there still appears to be a shortage of staff and inspectors are charged with a wide range of tasks in other food and feed safety areas. Thus, recommendation 1 of the 2007 mission report has not been fully addressed." || Lack of staff IE || 2010-8408 MR (Animal health - bovine tuberculosis) || "The CCA indicated that the reduction in staff did not significantly affect the performance in the field. However: ◦ One DVO visited lacked supervisory staff: it had no district superintending veterinary officer (SVI) (not replaced), and had been for the last two years without Higher Executive Officer (HEO, in charge of administrative and staff matters). Poor supervision and enforcement was observed in this DVO. ◦ Significant delays in notifying IUT movements were explained by the staff in charge (at the DVO level) as due to the limitation of human resources. [...] Impact of the reduction of staff, and consequently the field presence of the CA in charge of the TB eradication programme, is mitigated by the automation of tasks and the reorganisation of official controls on a risk basis. However, the level of implementation of official controls is insufficiently verified to ensure their effectiveness throughout the country. This verification is all the more necessary in the execution of the TB eradication plan [...]." || Lack of staff GR || 2011-8901 MR (Monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products) || "[...] the insufficient provision of staff, equipment and reagents commensurate with designated tasks remains a significant obstacle to the proper functioning of the laboratory network and the Greek competent authorities have therefore not met their obligations under Article 4(2)(a), 4(2)(c) and 4(4) of Regulation (EC) No 882/2004." || Lack of staff and equipment Annex XVI FEES - Validated baseline scenario[141] Issue to be considered || Belgium || Italy || UK Fees as a tool of financing official controls || Belgium's system is based on the the idea that costs for official controls need to be shared between FBOs and MS. So FBOs only contribute to part of the costs and the rest is financed with the general budget (at the moment around 40%FBOs-60%MS). There are 2 types of fees: - retributions: these are the areas covered by mandatory fees and an hourly rate between 40 and 60 eur is applicable (depending on the qualifications of the inspectors) unless the application of throughput charges is higher than that (these charges are similar to the mandatory fees in 882/2004). - contributions: paid by all FBOs at the beginning of the year depending on size and sectors. They cover routine inspections throughout the year regardless if inspections take place for a specific FBO. Out of office hours activities have, in certain cases, a surcharge. || With the new legislation of 2008 (Legislative Decree 194/2008) Italy intends to use the fees to cover 100% of the costs related to official controls along the food chain but with the exclusion of retail, ABP, primary production, feed. There are 2 types of fees: - mandatory fees under Reg. 882/2004 are calculated on a throughput/quantity basis (similar to Annex IV and V) - fees are provided also for import of food of non-animal origin - fees for all the other FBOs are calculated as a flat rate contribution paid at the beginning of the year depending on size/category (from 400 to 1500 eur /year) || UK mainly collect the mandatory fees. From 9/2009 a time-based fee has been introduced in the meat slaughterhouses and cutting plants The fee to the establishments varies depending on their size, as the percentage of cost recovery was originally based on previous charges that hinged on livestock and throughput units. The aim is to reach 100% coverage of costs in a few years. Fees are not applied in the dairy sector. According to UK the fact that they did not apply those fees prior to Reg. 882/2004 exempts them from this obligation. There are differing levels of fees being applied on the fish sector as it is acknowledged that the actual administrative burden of running the fee system in some establishments is greater than the fees collected An exercise to improve efficiency of the inspection services in the meat sector is on going and has led to a decrease of costs. However fees are growing at the moment because: - UK aim at increasing cost coverage towards 100% - the weak pound. Costs covered with fees || 2005: 42% of total costs 2006: 46% of total costs 2007: 39% of total costs 2008: 38% of total costs 2009: 37% of total costs || 2005: 50% estimate 2006: 50% estimate 2007: 50% estimate From 2009 fees are to be applied with an automatic 20% increase, then after the end of the year the actual cost is calculated and the automatic increase/decrease is re-calculated to reach 100% cost coverage. A 0.5% increase is meant to cover costs related to the implementation of MANCP and ring fenced for this purpose to the Ministry of Health. || Annex VI is the reference including social security costs and overheads. In the slaughterhouse and cutting plant sector the following level of cost recovery was achieved 2007:41% 2008:43% 2009:44% Non-mandatory fees || Covered by the contributions paid by all participants to the food chain at the beginning of the year. || Covered by the flat rates contributions paid by FBOs at the beginning of the year + fees on import of food of non animal origin. || Only specific areas: approval of irradiation facilities, pesticide residues programme (fee on chemical industry), sampling and testing of raw cow milk in England and Wales Activities covered || The whole food chain (also primary production). Also activities carried out on FBOs request are subject to fees (e.g. export certificates) - a combination of cost per certificate and hourly rates. In general authorisation/registration requests are not covered by fees even if they require an inspection on the spot. However the authorisation of some establishments (agrement) is subject to a fee. || The food chain with exclusion of retail, ABP, feed and primary production. Authorisation of establishments (also feed) is subject to a flat rate fee. Export certification is subject to hourly rate of 50 eur. Out of office hours activities have a surcharge (30%). Italy is considering the possibility to extend fees also to the transhipment part of import. || Only mandatory areas under Reg. 882/2004 (with the exclusion of dairy sector and the few exceptions mentioned above) Calculation method || For retributions, the hourly rates/throughput fees are determined by legislation. For contributions a declaration is made every year (also electronically) and yearly fees depend on size and sector (from 50eur up to 11,000). || All fees are calculated on the basis of Annex VI of Reg. 882/2004 (including social contributions) and reviewed at least every 2 years to ensure coverage of 100% of costs. For administrative costs a reference is made to them being "linked to the controls carried out". || Fees are calculated on the basis of annex VI of Reg. 882/2004 including social contributions and overheads. In the meat slaughterhouses and cutting plant establishments fees are calculated as a percentage of actual costs, the percentage being paid will differ depending on the size of the business, therefore it takes into account livestock and throughput units. In the case of the percentage that is being charged being lower than the EU minima, charges will then be increased to meet EU minima. In the fish sector guidance provided to Local Authorities explains a calculation method that is based on relevant 882/2004 annex. Small/disadvantaged FBOs || Some small establishments and businesses are exempted from payment or payment reduced. || Some flexibility is mentioned in the basic law with a reference to paragraphs 5 and 6 of Art. 27 Reg. 882/2004 but that cannot derogate 100% cost recovery. Unclear if specific rules are needed. || A discount is calculated on the time-based fee as the percentage to be paid decreases as throughtput and livestock units decrease. Guidance on "Cold inspection" have been developed to maximize CA efficiency Transparency || All information is available on line and regularly updated. www.afsca.be || Basic law is published on the official journal. Then information are prepared and published by local competent authorities. No centralized information. The basic law prescribe regular information to the Commission on: - calculation method - figures on use of income from fees. || All information is available on line and regularly updated. www.food.gov.uk Mechanisms to increase efficiency || A bonus-malus system is in place. If haccp system of the FBO is certified by accredited bodies recognized by AFSCA, then the yearly contributions is reduced by 50%. If not, a malus of 20%(2009), 60% (2010) and 100% (from 2011) is applied. For poultry slaughterhouses where FBOs are involved in controls the fees are reduced. || Application of mandatory fees can take into consideration previous record of conformity, risk category and efficient own checks but cannot derogate to 100% cost recovery. With an agreement State/Regions it is possible to detemine time-based fees for slaughterhouses on the basis of minimum inspection times to be respected by the CA (e.g. 4 minutes per cattle). || CA and FBOs sign Business Agreements where the presence of the CA is agreed. In case of disagreements a mechanism is in place to solve them. If the CA loses the case and they believe an increased presence of the CA is all the same needed, they pay for it. FBOs can propose changes to the way of production in order to decrease the need for CA presence. This system has ensured that the pressure to ensure efficient and effective delivery of OCs has been shared with FBOs. Reward/penalize systems || See above. For the mandatory fees a specific system is not in place apart from an increase in the fees in case animals with unclear identification (slaughterhouse) || See above || The UK was to further develop a fee system that clearly takes into account FBO compliance levels when setting the fee system. Unclearness within the UK as to the legal meaning and scope of articles 27 and 28 has previously hampered developments on that front. Fees for several controls at the same place || / || The principle included in Art. 27.7 of Reg. 882/2004 is repeated in the basic legislation clarifying that the single fee to be applied is based on the recovery of actual costs. || No specific rules. In general fees take into consideration the proximity of slaughterhouses and cutting plants which is to be considered in line with Art. 27.7 of Reg. 882/2004. Operators charged || The FBOs || The FBOs || the FBOs Ring-fence || Ring-fenced for AFSCA activities || 95% of the income from fees on domestic activities is ring fenced for the local CA and laboratories. 5% is for regional and central authorities to cover costs related to implementation of MANCP. 20% of the income from fees on imported products is ring fenced for the CA. 80% goes to the general budget. || In part. Controls carried out by Food standards agency operations in slaughterhouses and meat cutting plants are ring fenced (collected and used within the agency). The rest of the sectors when monies are collected this is done through Local Authorities and kept within the authority. Art. 28 - non-routine checks || Inspections which reveal non-compliances are not charged per se. However the costs related to sampling and analysis and further enforcement actions (destruction, treatment, etc. ) are paid by the FBOs. || Controls under Article 28 (and on the basis of EU emergency measures) are charged to the operators with an hourly rate of 50eur + costs of analysis (rate calculated on the basis of Annex VI Reg. 882/2004). || UK has a very restrictive understanding of Art. 28 which leads to its application only in extreme cases of non compliances which lead to a risk for consumers. So, in general, additional controls are not charged to FBOs even if they reveal non-compliances as it was felt at a UK level that art. 28 was not drafted to that effect, and that it was unclear whether art. 27 applied instead. Information sources || AFSCA website Questionnaire submitted in 2008 (fees study) || Legislative Decree 194/2008 Case study in the 2008 fees study Web sites of a few local authorities || FSA web site Case study in 2008 fees study Questionnaire submitted in 2008 (fees study) Information received from UK CA after working group with MSs Issue to be considered || France || Poland || Germany Fees as a tool of financing official controls || France only collect mandatory fees. Fees are based on cost recovery. For import on the basis of the costs calculated the year before (BIP by BIP) and then adjusted for the next year to cover 100% costs. For domestic production following rules similar to the national rules on VAT. Rates are slightly below minimum fees in Reg. 882/2004. From June 2010 a fee has been introduced for the authorisation of animal feed producers. From 1 January 2010, fees for controls on slaughtering and aquaculture production now include also costs related to the control of residues of veterinary medicines (before they were separately charged). In the fish and aquaculture sectors a process of alligning the mandatory fees to the requirements of Regulation 882/2004 is on-going. || Poland collects all the mandatory fees under Reg. 882/2004 at the minimum levels indicated (some differences are due to the exchange rate). In the veterinary area some non-mandatory fees are set (feed, certification, ABP, etc.). In 2009 Regulation of the Minister of Health 656/2009 introduced fees for all official controls performed on FBOs dealing with food (and not included in the veterinary sector). In this way fees cover the whole food chain (apart from primary production) || Fees are under the responsibility of each Lander and therefore systems vary greatly. In general they only cover mandatory fees but a significant number of Landers cover also non mandatory fees in the areas of food safety and animal health. Also approval of plants is mentioned among non mandatory fees. Costs covered with fees || 2005: For import: 3.8 million costs - 3.7 million recovered 2006: For import: 4.1 million costs - 4.4 million recovered 2008: For import : 4,16 million costs - 4,21 million recovered For domestic production: 70% estimate (80 million euro costs, 56 million recovered) => 45 % estimate (125 million euro costs, 55 millions recovered) For import: around 100% (but in general rental costs are not included here and paid by operators directly. This accounts for about 20% of total costs) || 2008: CA claims 100% cost coverage (no data) || No data Non-mandatory fees || No. Fees for export certification and authorisation of plants are being considered inside and outside of the EU A fee for animal by-products during slaughter is collected on national basis (part fee part subsidy). || In the veterinary area. They refer mainly to certification (export, health), feed (domestic), ABP, emergency slaughter outside plant, genetic materials, markets, animal quarantine. Outside the veterinary area, Regulation 656/2009 introduces a fee for official controls on food other than veterinary area. || Charged in some Landers. Activities covered || Only mandatory areas under Reg. 882/2004 (with some exceptions) || The whole food chain (apart from primary production) but with specific systems for veterinary and non veterinary areas. || Mainly veterinary area but in some Landers also food safety in general (whole food chain). Calculation method || For import the following elements are considered:rental costs for BIPs if not already paid by operators, equipment, training, cleaning, travelling expenses, salaries of staff directly involved in controls, sampling. For domestic production salaries of staff directly involved, training, property charges, operational costs including sampling. || In the veterinary area: fees include the costs for salaries of personnel involved in controls, administrative costs related to controls, training of inspectors, sampling and testing. Minimum fees are used for areas covered as mandatory by Reg. 882/2004. Specific fees for veterinary non mandatory fees Outside the veterinary area: fees include transport costs, document control, sampling and testing, verification procedures. Flat rate of 45 PLN (13 EUR) is charged per control + 15 PLN (4 EUR) per hour + sampling + testing (specific rates). Specific rates are also set for import. || In general a mix between minimum fees and cost based fees is used. Costs are calculated but then the minimum fee acts as a lower limit (apart from Bavaria). In some Landers fees are calculated for each establishment. In some Landers also maximum ceilings are included. The costs recorded the previous year are the basis for the fees in the following one. For some fees (e.g. authorisation of plants) a hourly fee is set (with min and max) at 44 eur/hour + travel Small/disadvantaged FBOs || No specific rules but the way fees are applied seems not to create particular problems to them. || No specific rules. || No specific rules Transparency || Legislation is published in the OJ. Notes de service are sent to the CA. Relevant ministries publish information (Agriculture, Customs) || Legislation is published in the OJ. || Legislation published in the OJ Mechanisms to increase efficiency || No specific rules. || No specific rules. || No specific system in place. A system of categorization of meat establishments according to risk is being tried in some Landers in order to modulate frequency of inspections to the related risk category. Industry is asking for consultation on the setting of fees in order to increase efficiency and risk based approach. Salaries are one of the biggest cost but industry is not involved in their setting (only CA and trade unions) Reward/penalize systems || A bonus malus system is being considered. Slaughterhouses are classified in 4 categories depending on level of compliance. The first 2 categories would have a bonus, the others a malus. || No specific rules. || No specific rules Fees for several controls at the same place || No specific rules || No specific rules. || No specific rules Operators charged || The FBOs || The FBOs || The FBOs Ring-fence || Fees for import are ring fenced but not for domestic production. All fees are reversed to the general budget. A direct budget line is against national tax legislation. || Fees go to the general budget. Fees for veterinary controls are ring-fenced for the CA when contractors are used. || In general fees are collected to be directly used to finance the official controls (they are in fact mainly based on full cost recovery). In those Landers where fees go to the general budget in any case they are earmarked for the CA. Art. 28 - non-routine checks || No specific rules || No specific rules. || No specific rules Information sources || Case study in 2008 fees study Questionnaire submitted in 2008 (fees study) Information received from France after an FVO inspection Notification from France under Art. 27.12 || Case study in 2008 fees study Questionnaire submitted in 2008 (fees study) Notification from Poland under Art. 27.12 || Case study in 2008 fees study Questionnaire submitted in 2008 (fees study) Notification from Germany under Art. 27.12 Issue to be considered || Slovakia || Estonia || Latvia Fees as a tool of financing official controls || Fees included in Annexes IV and V are collected at the minimum rates. Non mandatory fees are also collected for import of food of non-animal origin, veterinary controls of animals, hatching eggs, germinal products and animal by products (also with reference to export). These fees are collected as time-based fees. || Fees included in Annexes IV and V are collected at the minimum rates. Outside these sectors: - food sector: FBOs are charged using a time based fee - feed sector: rates are calculated quarterly on the basis of quantities produced/exported - veterinary sector other than Annexes IV and V: a time based fee is used. || Fees cover all mandatory fees (but not milk) and some minor activities outside these sectors. Specific rules and calculation method apply fo fees in the residues area (Dir. 96/23). The other sectors are either covered with the minimum fee or a flat rate based on actual costs (depending on the activity) Costs covered with fees || 2005: 52% 2006: 55% 2007: 51% || 2005: 31% 2006: 28% 2007: 20% || 100% (according to the CA) Non-mandatory fees || Non mandatory fees are also collected for import of food of non-animal origin, veterinary controls of animals, hatching eggs, germinal products and animal by products (also with reference to export). These fees are collected as time-based fees. || The whole food and feed chain is covered but fees are calculated in different ways according to sector. || Fees cover issuing of health certificates and permits. Fees cover also import of food contact materials and feed of non-animal origin Activities covered || mandatory fees, import of food of non-animal origin, veterinary controls of animals, hatching eggs, germinal products and animal by products (also with reference to export). || The whole food and feed chain. || Only mandatory fees and minor activities outside them. Calculation method || Minimum fees for the mandatory ones. For import controls on food of non animal origin, veterinary controls of animals, hatching eggs, germinal products and animal by products (also with reference to export) a time based fee (hourly) is calculated on the basis of the items included in Annex VI of the Regulation. || Fees under Annex IV and V are collected at the minimum rates. Feed sector: fees depend on quantity and quality of feed. Other veterinary fees and food sector: hourly fee calculated on the basis of average remuneration of a supervisory official + average administrative and economic costs relating to carrying out the inspection. The remuneration refers to an official working for the local CA or at BIPs - the average refers to remuneration in the previous year. The administrative and economic costs are the average cost per official with reference to the items listed in point 2 of Annex VI to the Regulation and related to the inspection activities. Every year the hourly fee is updated taking into consideration the costs of the year before. || Covering the costs mentioned in Annex VI (administrative costs are included adding 10% to the direct costs) Small/disadvantaged FBOs || No specific rules (CA feel that different rules would put some business categories at disadvantage compared to others - there is also the need to maintain a minimum level of income for official controls). || Fully considered in the food sector and partly considered in the veterinary area with the use of a time based fee outside Annexes IV and V. || No information Transparency || Relevant legislation is published in the official journal. || Legislation published in the OJ. || No information Mechanisms to increase efficiency || No specific rules. || No specific rules. || No information Reward/penalize systems || No specific rules. || No specific rules. || No information Fees for several controls at the same place || CA apply only one fee in slaughterhouses with annexed cutting plants. || No specific rules. || No information Operators charged || FBOs In the milk sector only dairy farms (not processors) are charged. || FBOs || FBOs Ring-fence || Fees go to the general budget and only in part it goes back to the competent authorities || Fees (except for feed control) are used directly to finance official controls. Fees for feed control go to the general budget. || Yes, fully. Art. 28 - non-routine checks || Specific legislation for additional official controls needed after detection of non compliance. FBOs are charged using a time based fee (hourly) identical to the one foreseen for import of food of non-animal origin and veterinary controls of animals, hatching eggs, germinal products and animal by products (also with reference to export). Costs related to sampling needed in relation to the detected non compliance are also included. || FBOs are charged using a time based fee, in case of laboratory investigations the costs of these are added. || In the residues area, if non compliance is detected the costs of the controls carried out are charged to the operators. Information sources || Case study in 2008 fees study Questionnaire submitted in 2008 (fees study) Notification from Slovakia under Art. 27.12 || Estonia notification under Art. 27.12 || Questionnaire submitted in 2008 (fees study) Issue to be considered || Lithuania || Bulgaria || Cyprus Fees as a tool of financing official controls || Fees cover all mandatory fees and some minor activities outside these sectors. Flat rate fees are calculated on the basis of actual costs. || Fees cover all mandatory fees and some minor activities outside these sectors. Flat rate fees are calculated on the basis of actual costs. || Fees cover all mandatory fees and some minor activities outside these sectors. Minimum fees are followed apart from cutting plants where an hourly rate is used. Costs covered with fees || 100% (according to the CA) || 2005: no data 2006: 25% 2007: 29% || No data (CA state that fees do not cover costs but no data are available) Non-mandatory fees || Fees cover issuing of specific certificates || Fees cover animal welfare controls and import of feed of non animal origin, || Fees cover export certificates and import of products of animal origin outside Regulation 882/2004. Activities covered || Only mandatory fees and minor activities outside them. || Only mandatory fees and minor activities outside them. || Only mandatory fees and minor activities outside them. Calculation method || Covering the costs included in Annex VI (including social security of inspectors). Fees are calculated on the basis of actual costs and can go below minimum fees if costs are lower. || Covering the costs included in Annex VI (including social security of inspectors). Fees are calculated on the basis of actual costs using average costs and a specific hourly fee per inspector (10 BGN) || Minimum fees for all mandatory sectors apart from cutting plants where an hourly fee is used (calculated on the basis of the salaries of inspectors) Small/disadvantaged FBOs || No information || No information. || No information Transparency || Basic law (Resolution) and annual updates are published in the official journal || No information. || No information Mechanisms to increase efficiency || No information || No information. || No information Reward/penalize systems || No information || No information. || No information Fees for several controls at the same place || No information || No information. || No information Operators charged || FBOs || FBOs || FBOs Ring-fence || Fees go to the general budget and only in part it goes back to the competent authorities || Fees go to the general budget and only in part it goes back to the competent authorities || Fees go to the general budget and only in part it goes back to the competent authorities Art. 28 - non-routine checks || No information || No information. || No information Information sources || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) Issue to be considered || Czech Republic || Denmark || Finland Fees as a tool of financing official controls || Fees cover all mandatory fees and some minor activities outside these sectors. Minimum fees are followed for activities within the EU and flat rates, on the basis of actual costs, for import. || Fees cover all mandatory fees and some other activities outside these sectors. Flat rates are used and calculated on the basis of actual costs. Minimum fees are used for small abattoirs || Fees cover all mandatory fees and some other activities outside these sectors. Flat rates are used and calculated on the basis of actual costs. Minimum fees can be used for smaller establishments under the responsibility of municipalities. Costs covered with fees || 2005: 36% 2006: 33% 2007: 28% || CA state full cost coverage with the exception of small abattoirs where only 35% of costs is recovered (this subsidy is calculated in around 10 million DKK a year) || 2005: around 100% (20% for small plants) 2006: around 100% (20% for small plants) 2007: around 100% (20% for small plants) Non-mandatory fees || Fees cover issuing certificates and approval and registration of establishments and laboratories || Fees cover food and feed of non animal origin, food additives, ABP, food contact materials, animal welfare during transport, approval and registration of establishments || Fees cover all feed controls and approval of establishments Activities covered || Only mandatory fees and minor activities outside them. || Mandatory fees and some activities outside them. || Mandatory fees and some activities outside them. Calculation method || Minimum fees for domestic activities. For import, flat rates are calculated on the basis of actual costs according to the items of Annex VI || Flat rates are calculated on the basis of actual costs. Small abattoirs are charged minimum fees. A time based fee is calculated plus a starting fee for each control which covers associated costs). Feed establishments pay also an annual fee. Analysis are charged at cost. For residues a quantity based fee is calculated. || Flat rates are calculated with a time based fee. Smaller establishments are under the responsibility of municipalities and they can be charged on the basis of costs or at minimum fees depending on the municipality. Small/disadvantaged FBOs || No information || Small abattoirs are charged only minimum fees and the extra costs are paid with the state budget. || Smaller establishments in municipalities can be charged minimum fees instead of at cost. Transparency || No information || No information || Relevant legislation is published in the official journal and on the EVIRA wesite Mechanisms to increase efficiency || No information || No information || No information Reward/penalize systems || No information || No information || No information Fees for several controls at the same place || No information || No information || No information Operators charged || FBOs || FBOs || FBOs Ring-fence || Fees go to the general budget and only in part it goes back to the competent authorities || Fees are used direclty to finance official controls. || Fees are used directly to finance official controls in case of controls under the responsibility of municipalities. Otherwise it goes to the general budget and only in part it goes back to the competent authorities. Art. 28 - non-routine checks || Outside the veterinary sector, when inspections detect a non compliance, the cost of the analysis that detected the non compliance is charged to the FBOs || No information || No information Information sources || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) Issue to be considered || Ireland || Greece || Spain Fees as a tool of financing official controls || Ireland collect mandatory and some non-mandatory fees. Minimum fees are followed for imports of animal origin. For meat, a system of standard unit charges (which may or may not recover the full cost of the service). In the dairy sector a flat-rate system applies, based on the quantity of milk purchased on a monthly basis. The level of Inspection fee currently applying for imports of products of animal origin exceeds the minimum level requirements under Regulation (EC) No. 882/2004. The National Standards Authority of Ireland (NSAI) provide official food control services in premises requiring recognition for the extraction of natural mineral water. A fees is charged by the NSAI to cover the costs of audit and on site activites. || Fees cover all mandatory fees and some minor activities outside these sectors, with the exception of the costs for the approval of feedingstuffs' establishments that is covered by annual fees. Flat rates are used and calculated on the basis of actual costs. || Fees are under the responsibility of each Autonomous Community, not all control activities are covered by rules or specific provisions on fees collection under Reg. 882/2004. For imports of differents products the fees are under responsability of the Central Competente Authority and they are different of the indicated in the Reg.882/2004.In this moment,it is preparing a new rule on reinforced controls in the products of non animal origin (Reg 669/2009) and a new fee should be created. Costs covered with fees || 2005: Meat: 48% Milk: 90% Animal Feed: 82% 2006: Meat: 38% Milk: 90% Animal Feed: 80% 2007: Meat: 42% Milk: 90% Animal Feed: 76% Imports of animal origin: 27% 2009 Meat: 40% Milk: 90% (approx) Imports of animal origin no change, Mineral Water Establishments 50-70% || Fees do not cover costs. No data available (for the years before 2008 fees were not collected). || In general the fees do not cover the costs. Non-mandatory fees || Yes for meat cold stores supervised by DAFF. The NSAI fees for premises requiring recognition for the extraction of natural mineral water. || Fees cover all type of inspections in feedingstuffs. || Charged in some Autonomous Communities.Also la Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) has some fees on several dietetic foods in relation with the evaluation and registration. Activities covered || Mandatory areas under Reg. 882/2004 and non mandatory fees charged for official controls in coldstores (See Appendix from Ireland for further information on rates) || Mandatory fees and other minor activities outside them. || Not all control activities are covered by rules or specific provisions on fees collection under Reg. 882/2004.In imports they cover the imports of food of animal origin. Calculation method || On what concerns meat these fees are either a fee per animal slaughtered, a fee per tonne of product going through cutting plants and independent cold stores or an hourly charge for time spent supervising product in processing plants, integrated cold stores and for overtime on meat inspection work. In the dairy sector a flat rate system is followed, fees are collected according to quantity of milk produced and cost of services on a monthly basis. || Flat rates are calculated on the basis of actual costs, according to the criteria of Annex VI of Regulation 882/2004. || In principle, minimum fees are applied. In the dairy sector, flat-rates and minimum rates are both used.In imports the calculation of fees is based on the type of product and the weight and it is calculateted by telematique way. Small/disadvantaged FBOs || Some small establishments are exempted from payment or payment reduced || The budget for the cost of controls has been planned and it was allocated according to the amounts that each establishment produced and disposed. || There are no exemptions for the small establisments. Transparency || Relevant legislation is accessible on the website www.fsai.ie and www.irishstatutebook.ie || No information || Basic laws and annual updates are published on the official journals of the State (imports and fees of AESAN) and the Autonomous Communities.For the imports is also in the web page of Ministerio de Sanidad y Politica Social.Also some Autonomous Communities and AESAN have developped informatic applications in their web pages. Mechanisms to increase efficiency || A working group has been established to review and evaluate the fees charged by the Department of Agriculture, Fisheries and Food for the provision of official controls and inspection services in the meat and dairy hygiene sector as required under EU legislation || No information || Industry is asking for consultation on the setting of fees when a basic law or an update is preparing. Reward/penalize systems || Not applied || No information || Application of mandatory fees can take into consideration previous record of conformity, risk category , efficient own checks and other items (not working at night ,administrative support) but cannot derogate to 100% cost recovery. Fees for several controls at the same place || Not applied || No information || There is not a general rule.In some case is charged a single fee (the highest).In other cases there is an acumulation of the fees. Operators charged || FBOs of approved meat and milk etsbalishments and importers of food of animal origin (for imports of non animal origin see details in Annex) || FBOs || FBOs included importers or responsibles for the consignements. Ring-fence || Fees go to the general budget and only a percentage is used to cover the costs of the controls carried out. || Fees go to the general budget of the Ministry of Rural Develpoment and Food and only a percentage is used to cover the costs of the contros carried out. || Fees go to the general budget and only in part it goes back to the competent authorities. Art. 28 - non-routine checks || Not applied || No information || In the most part of the cases when there are detections of non compliance the additional official controls are charged FBOs (operators responsible for the non compliance or importers or FBO responsible for the consignements). Information sources || Questionnaire submitted in 2008 (fees study); notification from Ireland under art. 27.12. || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study).Consult to competent authorities(june 2010). Issue to be considered || Luxembourg || Hungary || Malta Fees as a tool of financing official controls || || Fees cover all mandatory activites and some other activites outside them. Flat rates are used and calculated on the basis of actual costs, in the case of import control a fee below the minimum rate is applied. || Fees are collected according to the Fees for Abattoir and Veterinary Service Regulations (LN 68/1986) (SL 35.10). Implementing legislation covers only red meat inspection fees. However, fees charged by Border Inspection Posts are collected according to Annex V of Regulation 882/2004, under a minimum rate system. SL 35.10 is currently under review to render collection of fees for red meat inspection in line with minimum rates of Annex IV of Council Regulation (EC) 882/2004 and introduce new fees for other areas that are not covered by Council Regulation (EC) 882/2004 or SL 35.10 Costs covered with fees || || 2005: around 60% 2006: around 60% 2007: around 60% || 2005: 36.5 % 2006: 36.9 % 2007: 39.4 % Non-mandatory fees || || Fees cover inspection of herds; certification and control of animals and animal products transport; control of animal exhibition, competition; tuberculine testing and sampling. || No, implementing legislation is required. Activities covered || || Mandatory fees and some activities outside them. || The present implementing legislation directly covers only red meat inspection fees. However, fees charged by Border Inspection Posts are in line with Annex V since July 2007. Calculation method || || Flat rates are calculated on the basis of the actual costs. In the case of import control, a fee below the minimum rate is being applied. || Fees under Annex V of Regulation 882/2004 are collected at minimum rates. Cost of salaries of staff involved in official controls are included. Small/disadvantaged FBOs || || No information || Malta's largest FBOs are to be considerd small enterprises as per definition of SMEs. The greater majority of Maltese FBOs are microenterprises with highly reduced activity and personnel. Transparency || || No information || Collection of funds by the Agriculture and Fisheries Regulation Department for official controls and meat inspection are all recorded in a general direct accounting system (DAS) under the revenue vote. An electronic receipt is issued for each payment. The system falls under the Public Service Auditing system and is audited as part of the normal audits that take place from time to time. Mechanisms to increase efficiency || || No information || We have combined various controls to be carried out during inspections. This saves sending numerous teams of veterinarians and officers to the same establishments or farms to carry out inspections for different issues/purposes. Reward/penalize systems || || No information || No mechanism exists for reward systems but an administrative fine procedure exists in the parent Act (CAP 437) for breaches of regulations falling under this Act. Fees for several controls at the same place || || No information || The system of compunding fees is not adopted at present. Operators charged || || FBOs || FBOs are charged. Red meat slaughtering establishments are run by the state and therefore only internal paper transactions are considered. Ring-fence || || Fees are used directly to finance official controls. || Fees go to the general budget and only in part return back to the competent authorities Art. 28 - non-routine checks || || No information || At present there is no extra collection of fees for enforcement work arising out of additional official controls for non-compliance. Information sources || || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) (Updated 30.06.10) Issue to be considered || Netherlands || Austria || Portugal Fees as a tool of financing official controls || Fees cover mandatory areas and some activites outside them. For imports minimum fees are followed, for other activites under Annex IV of Reg.882/2004, meat and official controls on residues a flat-rate system is used. In fee calculation the principles of direct benefit and cost/effectiveness are considered. For milk the fee is below the minimum rate because the actual costs of these official controls are below the minimum fee. || Fees cover all mandatory fees and some minor activites outside them. Flat rates are used and calculated on the basis of actual costs. The fees for border checks are calculated on a minimum rate basis. For small establishments, fee setting is under responsibility of the different Landers. || Fees cover all mandatory fees and some other activities. Minimum fees are applied, with the exception of plant approval and inspection on HACCP, where a flat-rate is adopted. The plant health fees, are the minimal fees according the EU regulation. Costs covered with fees || 2005: 75 % 2006: 86 % 2007: 81 % 2008/2009: 90% (est.) || CA state that fees entirely cover costs, with the exception of border checks (no data available). At the Swiss border, lower fees are charged in accordance with an agreement between the Ec and Switzerland. || No data (CA state that fees do not cover costs but no data are available) Non-mandatory fees || Fees cover all official controls and analyses in FBO's (meat and feed). There are also fees for registration of other foodoperators, approval an maintenance of approvals for dairy and milk products and eggs and egg products. || Fees cover hygiene checks in establishments that are subject to approval in accordance with Regulation (EC) No 853/2004 (processing; milk; eggs; fish). || Fees cover certification, slaughter, rabies vaccination, medicines and veterinary products approval and licensing. other fees cover oficial checks in establishments that are subject to approval in accordance with Regulation (EC) No 853/2004 (processing; milk; eggs; fish), and subject to control under Regulation (EC) no 1774/2002 and import from third countries (BIP, minimum annex V).; considering vaccines it is in place a fee, due to lab control, before release to market/users. On the import control of foodstuffs of non-animal origin and within the scope of audits to verify the traceability and HACCP requirements, operators support the cost of the analysis. Activities covered || Mandatory fees and some activities outside them. In general fees are applied for all all official veterinary controls and analyses in approved FBO's and border inspection posts. || Mandatory fees and some minor activities outside them. || Mandatory fees and some activities outside them. Calculation method || Minimum fees apply for import activities. In the areas under Annex IV of Reg.882/2004, for meat products and official controls on residues a flat-rate system is followed. In fee calculation the following principles are taken into consideration: direct benefit, a direct link is needed between the benefit of the control activites for the FBOs and the fee to be paid for such activity; the cost/effectiveness, fees have to cover integral costs, but never being higher than the costs to be covered in a (group of) sector(s) or activities. Most fees have an hourly rate. || Fees are charged on a flat rate basis taking into account the duration, the position of the person performing the activity, the type of activity and resources used, and the type of establishment, distinctions being made on the basis of throughput. The fees for border checks are calculated, under a minimum rate system, on the basis of Annex V to Regulation (EC) 882/2004. || Minimum fees are applied as defined in Regulation 882/2004. Minimum fees apply even if they can clash with other criteria set by the Regulation (e.g. fees cannot be higher than costs). For plant approval, plant inspection and HACCP (under the Regulation (EC) No 853/2004) a flat-rate system on the basis of the actual costs is adopted. On the import control of foodstuffs of non-animal origin a standard value for issuing certificates are applied to all operators. In addition, if the commodity is randomly selected for analytical control the full costs of laboratory analyses are billed directly to the operator Within the scope of audits to verify the traceability and HACCP requirements, operators support only the cost of the analysis if sampling is done. Small/disadvantaged FBOs || There are reduced fees for AM and PM inspections in very small slaughteries taking into consideration their low throughput. || In the case small establishments, Landers are responsible for fee seeting. || Some small establishments (local micro-economies) outside from Annex IV of Reg (CE) n.º 882/2004 have reduced fees. Transparency || Legislation and fees are published in OJ. This information an further information on calculation method is available on line (www.vwa.nl) || No information || No information Mechanisms to increase efficiency || > call fee and time based fee (fee by quarter of an hour): the better the FBO functions, shorter and fewer official controls are needed which reduce the costs for FBO's. > set of rules for requests for official controls by FBO's > surcharges for i) requests for controls outside regular working hours i) overtime (on top of original requested time) || No information || No information Reward/penalize systems || If possible official controls are risk-based which in combination to the time based fees leads to less or more charges to FBOs || No information || No information Fees for several controls at the same place || Just one call fee for the same official; the total time for each offical is charged according to the applicable fee for the specific control || No information || No information Operators charged || FBOs, BIPs, cattle dealers, citizens who need a veterinary certificate || FBOs || FBOs Ring-fence || Fees are directly and only used to finance control activities. || Fees are used directly to finance official controls. In the case of Border Checks they are incorporated into the State's General Budget. || Fees are used directly to finance official controls. Art. 28 - non-routine checks || All FBOs, BIPs and cattle traders - including retail - are charged for additional official controls according to art. 28 of Reg. 882/2004. || No information || No information Information sources || Questionnaire submitted in 2008 (fees study); questionnaire submitted in 2010 || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) Decreto-Lei nº 154/2005 (plant health inspection);Decreto-Lei n.º 178/2008 e Portaria n.º 1450/2009 (controls according Reg.(CE) n.º 853/2004; n.º 183/2005 e n.º1774/2002) Issue to be considered || Romania || Slovenia || Sweden Fees as a tool of financing official controls || Fees cover all mandatory fees and some other activites outside them. Minimum fees are used on a time-basis that takes into account the salaries and the training cvosts for the personnel. For official controls on residues, FBOs dealing with products of non animal origin and some general activites a flat-rate is applied. || Fees cover all mandatory fees and some control activites outside them. Minimum fees are followed, except for official controls on residues and all non-mandatory activities, where a flat-rate system based on the actual costs is used. || Food: Full cost recovery (Meat in 2010 approx 95% cost recovery). General national system where FBO's pay an annual fee for official controls. Annual fees are based on annual control time, which in its turn is calculated by using av model for risk classification of FBO's, taking into account type and size of the FBO's activities, the risks involved and the FBO's past record. For slaughterhouses and GHE (and, to a certain extent, cutting plants) a different system applies, with annual fees calculated by estimating control hours per year multiplied by hourly rates based on actual costs for control performed by official veterinarians and official auxiliaries. Costs covered with fees || Fees entirely cover costs for FBOs processing products of animal origin, but not for FBOs that process, stores and trades products of non animal orgin. 2006: 60% 2007: 50% || 100% (According to the CA) || Food: Generally speaking, the aim of the fees system is full cost recovery for all official controls. The fees charged must be sufficient to finance the official control deemed necessary, and fees may not be used to finance other activities. Administrative costs, training, overheads, development of OC are included in the hourly rate. Slaughter upp to 200 tonnes per year is partly subsidised (approx. total of 9 million SEK in subsidies 2010). Non-mandatory fees || Fees cover businnesses of products of non animal origin || Fees cover animal feed (control of approved establishments) and official control not covered by Annex IV of Regulation 882/2004 || Fees cover all official controls on food (including imports), pesticides and residues, and the import of feed of non animal origin and animal by-products.Animal welfare in slaughterhouses is included. Activities covered || Mandatory fees and some other activities outside them. || Mandatory areas and some activities outside them (animal feed for control of approved establishments, official controls not covered by Annex IV of Regulation 882/2004 - to be further described). || Food: The whole food chain, except primary producers. Calculation method || Minimum fees are applied on a time-basis system that considers the total cost/hour for the control activites making the sum between the salaries of the involved personnel/hour and the costs for personnel training/hour. For what concerns official controls on residues, processing, storage and trading businnesses of products of non animal origin and some other general activites (cold stores, repackaging units, en-gross market) flat-rates are applied. || Minimum fees for the mandatory sectors, including total costs under Annex VI to regulation 882/2004 and, in case of live animals in I/C trade, also the costs covered by Regulation 1857/2006. For what concerns official controls on residues (Directive 96/23) and all activites covered by non-mandatory fees a flat-rate system is adopted. || Food: Fees are calculated on the basis of Annex VI of Reg. 882/2004. Flat rates are used, they are based on an hourly rate including travel costs and out-of-office hours costs. Overheads, training, administrative costs are included. Minimum levels in EU-legislation are obeyed. Small/disadvantaged FBOs || In the amount of time calculation, the production volume and the sector of activity are also taken into account. || No information || Food: Annual fees for control take into account the size of the FBO's activities. Reduced fees apply for small slaughterhouses, based on applicable minimum fees according to Regulation 882/2004 Transparency || No information || No information || Laws and regulations on fees are published officially. Guidelines on risk classification have been published by the NFA. Detailed information on the calculating of fees is published on the NFA's homepage. Detailed info on calculation of control hours regarding slaughter houses and GHE is published on the NFA´s homepage.FBO's and other organisations receive proposals for new fee rules or fee levels and are given opportunity to comment the proposals. Mechanisms to increase efficiency || No information || No information || Food: Risk-based approach to fees means that the risks in the FBO's activities are reflected in annual control time. System also takes into account the FBO's past record, where compliance or non-compliance can lead to a reduction or an increase in the annual control time and annual fees. Reward/penalize systems || No information || No information || See above. FBO's past record affects the annual fee paid. Fees for several controls at the same place || No information || No information || Food: Separate fees may apply for export authorisation, control of imported foodstuffs and of residues. Authorization covering several activities, i.e. Slaughterhouse with annexed cutting plant and/or production plant, will be charged one fee calculated on volumes placed on market from each separate activity, provided each activity can be considered separate from the other activities. Operators charged || FBOs || FBOs || Food: FBOs Ring-fence || Fees are used directly to finance official controls. || Fees go to the general budget and only in part it goes back to the competent authorities. || Local and central authorities use fees directly to finance their official controls. Fees may not be used to finance other activities. Art. 28 - non-routine checks || No information || No information || Food: Article 28 is applied in all cases where non-compliance leads to extra control. An hourly rate applies. Costs for all types of control are covered. Information sources || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) || Questionnaire submitted in 2008 (fees study) Annex XVII: FEES – Supporting data (*)This
Annex only refers to the inspection fees collected for the purpose of control
activities currently covered by Regulation 882/2004 (feed and food law, animal
health and animal welfare rules). Table
1 Full cost recovery across EU Member States Member state || Percentage of costs recovered || Percentage of costs not recovered || Impact of reaching 100% recovery AT || 100% || 0% || No impact BE || 37% (2009) || 63% || Medium BG || 27% (2007) || 73% || High CY || No information || Unknown || Unknown impact CZ || 28% (2007) || 72% || High DE || No information || Unknown || Unknown impact DK || 35% (small abattoirs) || 65% || Medium EE || 20% (2007) || 80% || High ES || Costs not covered || Unknown || High FI || 20% (small FBOs) || 80% || High FR || 45% - 70% (domestic) || 30% - 55% || Medium GR || Costs not covered || Unknown || High HU || 60% (2007) || 40% || Medium IE || 40% meat 90% milk 76% imports (2009) || 67% (average) || High IT || 100% (2009) || 0% || No impact LT || 100% || 0% || No impact LU || No information || Unknown || Unknown impact LV || 100% || 0% || No impact MT || 39% (2007) || 61% || Medium NL || 81% (2007) || 19% || Low PT || 100% || 0% || No impact PL[142] || 100% || 100% || No impact RO || 50% non-animal origin (2007) || 50% || Medium SE || Costs not covered || Unknown || High SI || 100% || 0% || No impact SK || 51% (2007) || 49% || Medium UK || 43% (2008) || 57% || Medium DG SANCO baseline Notes
on the baseline data presented in Table 1 United
Kingdom: ▪
Annex
VI is the reference including social security costs and
overheads.
In the slaughterhouse and cutting plant sector the following level of cost
recovery was achieved Poland: ▪
The
baseline data provided by DG SANCO indicate that Poland achieves full cost
recovery; interviews with the Polish CA for this study, however, suggest that
there is little data on cost recovery and that the available data indicate that
cost recovery is insufficient. Portugal: ▪
CA
claims 100% but has no data to support claim Lithuania ▪
CA
claims 100% Greece ▪
Fees
do not cover costs. No data available (for the years before 2008 fees were not
collected). Austria ▪
At
the Swiss border, lower fees are charged in accordance with an agreement
between the EU and Switzerland. Sweden ▪
Generally
speaking, the aim of the fees system is full cost recovery for all official
controls. The fees charged must be sufficient to finance the official control
deemed necessary, and fees may not be used to finance other activities.
Administrative costs, training, overheads, development of OC are included in
the hourly rate. Slaughter upp to 200 tonnes per year is partly subsidised
(approx. total of 9 million SEK in subsidies 2010). Table 2 Ring-fencing of resources for
official control activity in EU Member States MS || All resources ring-fenced || Percentage 0f resources ring-fenced (if less than 100%) || Resources ring-fenced, with some exceptions || Resources to general budget || No information AT || || || || Border inspection fees || BE || || 95% local CA and laboratories 5% regional and central CAs 20% import fees || For AFSCA activities || || BG || || || || || CY || || || || || CZ || || || || || DE || || || || || DK || || || || || EE || || || || Feed control || ES || || || || || FI || || || Controls by municipal authorities || Other controls || FR || || || Imports || Domestic production || GR || || || || || HU || || || || || IE || || || || || IT || || 95% domestic fee income for local CA and laboratories 5% regional and central CAs 20% import fees || || || LT || || || || || LU || || || || || LV || || || || || MT || || || || || NL || || || || || PT || || || || || PL || || || Veterinary controls when contractors used || || RO || || || || || SE || || || || || SI || || || || || SK || || || || || UK || || 100% FSA controls for slaughterhouses and cutting plant controls. Other controls are performed by local authorities and revenue remains at this level. || || || DG SANCO baseline Notes on baseline data for ring-fencing in EU
MS: United
Kingom: ▪
Controls
carried out by Food standards agency operations in slaughterhouses and meat
cutting plants are ring fenced (collected and used within the
agency). ▪
The
rest of the sectors when monies are collected this is done through Local
Authorities and kept within the authority. Germany: ▪
In
general fees are collected to be directly used to finance the official controls
(they are in fact mainly based on full cost recovery). In those Landers where
fees go to the general budget in any case they are earmarked for the CA. Sweden: ·
Local and central authorities use fees directly
to finance their official controls. Fees may not be used to finance other
activities. Table 3 Member State bonus-malus
arrangements for official controls fees Member State || Description BE || Annual contributions are reduced by 50% if the Hazard Analysis Critical Control Point system of the FBO is certified by accredited bodies (recognised by AFSCA). If such an accredited system is not in place then FBOs must pay an additional 20% (2009), 60% (2010) and 100% (2011). Poultry slaughterhouses where FBOs are involved in controls have reduced fees. Animals in slaughterhouses that are not clearly identified are subject to a higher fee. FR || Slaughterhouses are classified in 4 categories depending on their level of compliance. FBOs in the two categories with good compliance receive a reward, while FBOs in the two categories with poor compliance receive a punishment. The reward / punishment system is specified in the case study analysis Error! Reference source not found.. DE || Some Landers have trialled a system of categorising meat establishments according to risk. The frequency of inspections is changed to reflect the risk posed by the FBO. IT || The application of mandatory fees may take into consideration the FBO’s previous record of conformity, risk category and the efficiency of their own checks. MT || No mechanism exists to reward FBOs. However there is a procedure to levy fines for breaches of some elements of the Regulation. NL || There is a fee per inspection visit and a time-based fee charged per quarter of an hour. FBOs that have better organised operations and require less CA time have lower cost. Where possible official controls are risk-based. There are surcharges for requests for controls outside regular working hours, and CA overtime that is incurred over the time originally requested by the FBO. SP || The application of mandatory fees may take account of an FBO’s previous record of conformity, its risk category, the efficiency of its own checks, and other items such as the level of administrative support required, or if inspections occur at unsocial hours. SE || FBO’s deemed to have a higher risk incur longer and / or more frequent inspections, and thus have higher inspection costs. The level of risk posed by an FBO is determined by the FBO’s past record; compliance or non-compliance can lead to a reduction or an increase in the annual control time and annual fees. UK || FBOs and CAs agree to the amount of time a CA will spend during inspections. FBOs can propose changes to the production process to decrease the need for CA presence. Source: DG SANCO baseline Table 4 Transparency and reporting to the
public on fees for official controls by EU Member State || BE || IE || UK || ES || FL || NL || SE || DE || EE || FR || IT || LT || PL || SK || MT || AT || BG || CY || CZ || DK || GR || HU || LU || LV || PT || RO || SI All information available online || || || || || || || || || || || || || || || || || || || || || || || || || || || Legislation published in the official journal || || || || || || || || || || || || || || || || || || || || || || || || || || || Information recorded but not available / published || || || || || || || || || || || || || || || || || || || || || || || || || || || No information available / identified || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || High transparency || || Medium transparency || || Low transparency || || No information available / identified DG SANCO baseline Table
5 Fee rates used for official controls across the EU-27 Member State || Flat rates only || Minimum rates only || Flat + min rates || Reduction below minimum rates || Flat rates on throughput or time basis AT || || || P || || BE || || || || || P BG || P || || || || P CY || || || P || || P CZ || || || P || || DE || || || P || P || P DK || || || P || || P EE || || || P || || P ES || || || P || || P FI || || || P || || P FR || P || || || P || GR || P || || || || HU || || || P || P || P IE || || || P || || P IT || P || || || || P LT || P || || || P || P LU* || || || || || LV || || || P || || MT || || P || || || NL || || || P || P || P PT || || || P || || PL || || || P || || RO || || || P || || P SE || P || || || || P SI || || || P || || SK || || || P || || P UK || P || || || || P TOTAL || 7 || 1 || 17 || 5 || 17 Source: DG SANCO Baseline data (2010) *Luxembourg – no data available Table
6 Data for the Standard Cost Model obtained through the survey indicate high
variation in FTE rates across MS (between €3.31/hour and €64.74/hour) MS || CA || Response || || Q1 || Q2 || Q3 BE || Federal Agency for the Safety of the Food Chain (FASFC) || €64.74 / hr || Staff time: 836 hours External costs: 0 || Staff time: 836 hours External costs: 0 BG || Bulgarian Food Safety Agency || €1.86 / employee / hr || n/a || n/a ES || SG Sanidad Exterior (MSPSI); SG Acuerdos Sanitarios y Control en Frontera (MARM) || €20.42 / hr || n/a || n/a FI || Finnish Food Safety Authority (Evira) || €42 / hr || Staff time: 4 FTE External costs: €500,000 || n/a FR || Direction générale de l’alimentation (DGAI) – Ministère chargé de l’agriculture || €29.50 / hr || n/a || n/a LT || State Food and Veterinary Service of Republic of Lithuania || €3.31 / hr || n/a || n/a UK || Food Standards Agency (FSA) || Grade 7: €55.44 / hr Senior Executive Officer: €42.07 / hr || Staff time: 5-6 FTE || n/a Source: Survey of CAs conducted as part
of GHK Impact Assessment study. Table
7 Potential impact of extending the scope of mandatory fees to include
enterprises related to Regulations 852 /2004 and
183/2005, excluding primary holdings* || UK || ES || CY || SE || PT || BE || AT || IE || BG || LU || IT || De || NL || DK || HU || SL || RO || PL || FI || LV || SK || EE || LT || CZ || FR || GR || MT High impact || ü || ü || || || || || || || || || || || || || || || || || || || || || || || || || Medium impact || || || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || || || || || || || || || || || || Low impact || || || || || || || || || || || || || || || || ü || ü || ü || ü || ü || ü || ü || ü || || || || No data available || || || || || || || || || || || || || || || || || || || || || || || || ü || ü || ü || ü || || || || || High impact (>20% enterprises) || || Medium impact (10% - 19% enterprises) || || Low impact (0% - 9% enterprises) || || Eurostat 2008 *Total number of enterprises in the following
sectors: Processing and preserving of fruit and vegetables; Manufacture of
vegetable and animal oils and fats; Manufacture of grain mill products,
starches and starch products; Manufacture of prepared animal feeds; Manufacture
of beverages; Wholesale of agricultural raw materials and live animals;
Wholesale of food, beverages and tobacco; Retail sale of food, beverages and
tobacco in specialised stores; Restaurants and mobile food service activities;
Event catering and other food service activities; and, Beverage serving
activities. Table
8 Potential impact of extending the scope of mandatory fees to include primary
holdings (excluding other potentially relevant enterprises) related to
Regulations 852 /2004 and 183/2005* || RO || LT || BG || LV || PL || SK || SL || HU || CY || IE || PT || AT || EE || IT || ES || SE || SE || UK || FI || FR || DK || NL || BE || LU || CZ || GR || MT High impact || ü || ü || ü || ü || ü || ü || || || || || || || || || || || || || || || || || || || || || Medium impact || || || || || || || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || || || || || || || || Low impact || || || || || || || || || || || || || || || || || || || || ü || ü || ü || ü || ü || ü || || No data available || || || || || || || || || || || || || || || || || || || || || || || || || || ü || ü || || || || || High impact (>67% enterprises) || || Medium impact (33% - 66% enterprises) || || Low impact (0% - 33% enterprises) || || Eurostat 2008 *Primary holdings include: All holdings
with arable land; All holdings growing permanent crops; All holdings rearing
livestock; and, All holdings rearing other livestock. Table
9 Potential impact of extending the scope of mandatory fees to include
enterprises and primary holdings related to Regulations 852/2004 and 183/2005* || RO || LT || BG || PL || LV || SK || SL || HU || CY || IE || UK || PT || AT || ES || SE || IT || EE || FI || DK || DE || BE || FR || NL || LU || CZ || GR || MT High impact || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || || || || || || || || || || || || || || || || || Medium impact || || || || || || || || || || || ü || ü || ü || ü || ü || ü || ü || ü || ü || ü || || || || || || || Low impact || || || || || || || || || || || || || || || || || || || || || ü || ü || ü || ü || ü || || No data available || || || || || || || || || || || || || || || || || || || || || || || || || || ü || ü || || || || || High impact (>67% enterprises) || || Medium impact (33% - 66% enterprises) || || Low impact (0% - 33% enterprises) || || Eurostat 2008 *Total number of enterprises in the following sectors:
Processing and preserving of fruit and vegetables; Manufacture of vegetable and
animal oils and fats; Manufacture of grain mill products, starches and starch
products; Manufacture of prepared animal feeds; Manufacture of beverages;
Wholesale of agricultural raw materials and live animals; Wholesale of food,
beverages and tobacco; Retail sale of food, beverages and tobacco in
specialised stores; Restaurants and mobile food service activities; Event
catering and other food service activities; and, Beverage serving activities.
Primary holdings include: All holdings with arable land; All holdings growing
permanent crops; All holdings rearing livestock; and, All holdings rearing
other livestock. Annex XVIII: LABORATORIES – Consultations on current issues related to the accreditation of official laboratories and possible options for improvement – Discussion paper and results of the consultations A.
Discussion paper sent to the Chief Veterinary Officers (CVOs) and to the
Regulation (EC) No 882/2004 competent authorities on current issues related to
the accreditation of official laboratories and possible options for improvement Background Article 12 of Regulation
(EC) No 882/2004 establishes that competent authorities may only designate
laboratories that are accredited in accordance with certain European standards
listed in the Regulation (EN ISO/IEC 17025 applicable to laboratories and EN
ISO/IEC 17011 applicable to Accreditation Bodies). The transitional period
(Commission Regulation (EC) No 2076/2005) is over (1 January 2010) and no
derogation is applicable with the only exception of Trichinella laboratories
attached to slaughterhouses or game handling establishments (transitional
period extended until end of 2013, Article 6 of Commission Regulation (EC) No
1162/2009). Results of laboratory
analysis are a key element in the framework of official controls carried out in
order to verify compliance with EU legislation and to ensure that food is safe.
Many decisions are based on the results of those analyses, including remedial
action in case of non compliance. The results of laboratory tests must
therefore be as sound and as reliable as possible. It is thus necessary that
the analyses are carried out according to agreed validated methods and
standards which can be endorsed by all stakeholders across the food chain
within the EU and by our trade partners. The lack of accreditation
of some laboratories is a recurrent finding of the Food and Veterinary Office
(FVO) missions, in particular for certain sectors and with differences between
MS (some being more advanced than others). Accreditation was
discussed at the first working group on Regulation 882/2004 in May 2010, where
DG ENTR presented the EU common framework for accreditation[143],
in particular the role of national accreditation bodies and the co-ordinating
role of the European co-operation for Accreditation (EA). A representative from
EA was invited at the 2nd meeting of the working group on 27th
September 2010, and her presentation was followed by discussions with the
Member States (MS). The purpose of this paper
is to summarise the main points identified during the discussions and the
suggestions from the MS with the aim to reflect on available options to
improve/facilitate the enforcement of this important requirement. 1. Existing legislation Accreditation Bodies (ABs)
use legislation, reference methods laid down in legislation and official
documents as benchmark for the accreditation. 1.1. Introduction of new legal requirements including new analytical
techniques
Accreditation standard EN ISO/IEC 17025 requires
the laboratory to use validated methods: the laboratory "shall validate
non-standardised methods, laboratory designed/developed methods, standardised
methods used outside their intended range and amplifications of standardised
methods to confirm that the methods are fit for the intended use" (cf.
requirement 5.4.5.2). Validation is the confirmation that the particular
requirements for a specific intended use of the method are fulfilled (cf. EN
ISO/IEC 17025 requirement 5.4.5.1).In fact, without proper validation, it
cannot be proved that the method is fit for the intended use, produces
comparable results and can be used when making decisions. This accreditation
requirement is not always easy in particular with new analytical techniques. Þ
Are general rules on how to legislate about
the introduction of new analytical methods necessary? Should it be considered
when drafting new legislation or when introducing new methodological
requirements that the laboratories might need some time for the validation of
the methods? 1.2. Not "up-to-date" legislation. Reference methods
laid down in the legislation might be out of date or no standards are available
but nevertheless they are still in the legislation. Þ
This point was raised at the meeting. Any
concrete example(s)? 2. Flexible scope/fixed scope Historically,
accreditation has generally been based on so called fixed scopes of
accreditation. The fixed scope provides for a certain degree of flexibility as
limited extensions to the scope can be done at any time throughout the
assessment cycle. In 2008 EA has also
published its requirements for the accreditation of flexible scopes. They allow
not only to carry out the methods in use, but also to add methods within the
defined limits to the scope of accreditation on the basis that the competence
of the laboratory to develop and validate methods has been positively
evaluated. EA has carried out some
surveys and has confirmed that most ABs offer accreditation on flexible scopes.
Those ABs who don't yet are in the process of developing the service. However, the choice of
a flexible scope would not necessarily result in a reduced cost. In fact, this
accreditation is more demanding both initially and on-going. The flexible scope
should be considered depending on the case. It is in general more suitable for
activities where changes are frequent. Þ
Could guidance from EA on differences, pros
and cons, etc. of flexible scope accreditation and fixed scope accreditation
help each laboratory in order for it to take the best decision as regards to
its specific situation? 3. Emergency situations Under emergency situations,
for example during a food crisis (melamine, Sudan red, etc.), there is a need
for having reliable results under time pressure by an accredited laboratory
using a validated method because results given by: - a non validated
method cannot be used when making decisions, - a non-accredited
laboratory can be legally challenged. Þ
Does the flexible scope offer a solution?
Should this be mentioned in the EA guidance mentioned in 2.? Þ
If not, what other options are available? 4. Scope of the accreditation
ABs have diverging interpretations of Article 12.3
of Regulation (EC) No 882/2004 according to which "the accreditation and
assessment of testing laboratories (in accordance with EN ISO/IEC 17025) may
relate to individual tests or groups of tests". Þ
Should a clearer definition of what is
covered by accreditations related to "groups of tests" be discussed
in the framework of EA on the basis of examples of differences provided to
better understand the issue? (e.g. HPLC analysis of aflatoxins in pistachios:
in some MS the scope of accreditation covers "foodstuffs" and in
other MS laboratories need to be accredited for every different matrix). Should
this be mentioned in the EA guidance mentioned in 2.? 5. New laboratories or new staff For new official laboratories, accreditation
is as well a requirement to start operating. However they might not have proven
the necessary experience to the AB. This problem can also be applicable to new
staff who need proper training and time to be considered sufficiently
competent. Þ
Concerning new personnel, EN ISO/IEC 17025
allows new personnel under condition of their appropriate supervision and
training (5.2.1 "The laboratory management shall ensure the competency of
all who operate specific equipment, who perform tests and/or calibrations,
evaluate results and sign test reports and calibration certificates. When using
staff which is undergoing training, appropriate supervision shall be
provided"). Þ
Concerning new laboratories, is there a need
to regulate the pre-accreditation phase so as to allow new laboratories to
operate (as official laboratories) prior to their formal accreditation? Which
legal consequences would a pre-accreditation phase have? 6. Proficiency tests Participation at
proficiency tests (PTs) is used as external quality control to prove that the
laboratory is indeed capable of producing valid results. ISO 17025 recommends
the participation at PTs ("5.9 The laboratory shall ensure the quality of
results by monitoring test and/or calibration results. This monitoring shall be
planned and reviewed and may include, but not limited to the …
participation in inter-laboratory comparison or proficiency testing
programmes") and the results of the participation are considered by
the ABs as an important source of information. However, in some areas,
like residues of veterinary medicines[144] and
pesticides[145], legislation provides
compulsory participation at PTs for official control laboratories. This
apparently results in a heavier burden for laboratories with a large scope of
accreditation. Also, there can be areas
for which there are no PTs schemes yet. Þ
Are there divergent interpretations of EN
ISO/IEC 17025 requirement 5.9 made by ABs ? The problems raised
seem more to be linked with the legal requirement of mandatory participation at
PTs than with the EN ISO/IEC 17025 accreditation. Þ
Concerning residues of pesticides, could a
common (e.g. together with EU Reference Laboratories) and precise understanding
of the implementation of Article 28.3 of Regulation (CE) No 396/2008 ("All
laboratories analysing samples for the official controls on pesticides residues
shall participate in the Community proficiency tests for pesticides residues
organised by the Commission") be of any help? Þ
Concerning residues of veterinary medicines: 1. Should any legal modification be envisaged during the review of
Directive 96/23/EC and its implementing Decision (EC) No 396/2008 (Annex :
"laboratories must prove their competence by regularly and successfully
participating in adequate proficiency testing schemes recognised or organised
by the national or community reference laboratories"); 2. Could a common (e.g. together with EU Reference Laboratories) and
precise understanding of the implementation of this requirement of the Annex be
of any help? 7. Rapid tests Rapid tests are by
definition easy to use and don't require high expertise or sophisticated
equipment. They provide results within a very short time, allowing testing of a
high number of samples in a speedy manner; therefore they are very useful for
controls purposes. Rapid tests aim at having low percentage of false negatives.
However, these interesting characteristics make their performance difficult to
accredit as they are not as accurate as other more sophisticated methods. In some cases if the
result obtained after a rapid test is positive, it needs confirmation by
confirmatory methods and usually the scope of the accreditation covers the
performance of both tests. If they are not used as screening i.e. if they have
a meaning by themselves (e.g. microbiological tests for E. coli in water or
Salmonella in meat), their performance can also be accredited independently. Þ
A discussion within EA on what are the
difficulties for the ABs to accredit the performance of rapid tests could be
organised. Are these difficulties linked to a lack of clear validation
requirements for rapid tests? Would therefore guidance on the validation of
rapid tests by the EURLs help? B. Results of the consultations carried out Following
input from the Member States and discussions have been taken into account in
this part: - meetings
of the Working Group on the general application of
Regulation (EC) No 882/2004 held in
May and September 2010, - answers from Regulation (EC) No 882/2004 competent
authorities to the discussion paper presented in part A of this annex, - meeting of the Working Group
on the general application of Regulation (EC) No 882/2004 held in May 2011, - answers from the Chief Veterinary Officers (CVOs) to
the discussion paper presented in part A of this annex, - meetings in 2011 of the
Working Group of Chief Officers for Plant Health (COPHs) and of its Task Force
on the inclusion of plant health in Regulation (EC) No 882/2004, - meetings in 2011 of the Task
Force on " Plant reproductive material" under Regulation (EC) No 882/2004. Twelve
issues have been identified during these consultations and discussions. Each
issue as well as the main comments from the Member States on it and the
corresponding favourite option(s) are described hereafter. 1.
Article 12.3 of Regulation (EC) No 882/2004 Issue
1: Article
12.3 of Regulation (EC) No
882/2004 according to which the accreditation of laboratories in accordance
with ISO 17025 “may relate to individual tests or groups of tests” is
unclear. Main
comments from the MS and corresponding options: The
sentence needs to be clarified. « Groups
of tests » refers in particular to flexible scope accreditation. EA Guide
– 2/15 on accreditation of flexible scopes needs to be clarified. Ä
Option: clarification
of Article 12 of Regulation (EC) No 882/2004: unless otherwise specified, the scope of accreditation
shall include all methods used by the laboratory as official laboratory. Ä
Option: clarification
of EA Guide – 2/15 on
accreditation of flexible scopes. 2.
Use of a method recently required in legislation Issue
2: The use
of a method is a recent/new requirement in Union legislation and requires
the validation of the new method and (in general) a new accreditation or an
extension of accreditation of the laboratory. General
comments from MS and corresponding option: Time
is needed for the validation of the method and the accreditation of the
laboratory. The use of a validated but « not (yet) accredited »
method by an already ISO 17025 accredited official laboratory should be
possible. Ä
Option: in this case,
possibility for the CA to temporarily designate the laboratory under specific conditions (alternative
guarantees): the laboratory is already accredited according to ISO 17025 (i.e.
a solid quality assurance system is already in place) to ensure sound and
reliable results; analysis/diagnosis are carried out under the supervision of
the CA or the national reference laboratory (NRL); the temporary designation
shall not exceed one year renewable once – Modification of Article 12 of
Regulation (EC) N° 882/2004. 3.
Changes of a method already in use Issue
3: Changes
of a method already in use
require a new accreditation or an extension of the accreditation already
obtained by the laboratory. General
comments from MS and corresponding option: Time is
needed for the validation of the method and the (extension of) accreditation of
the laboratory. The use of a validated but « not (yet) accredited »
method by an already ISO 17025 accredited laboratory should be possible. Ä
Option: in this case,
possibility for the CA to temporarily designate the laboratory under specific conditions (alternative
guarantees): the laboratory is already accredited according to ISO 17025 (i.e.
a solid quality assurance system is already in place) to ensure sound and
reliable results; analysis/diagnosis are carried out under the supervision of
the CA or the national reference laboratory (NRL); the temporary designation
shall not exceed one year renewable once – Modification of Article 12 of
Regulation (EC) N° 882/2004. 4.
Emergency situations and emerging risks Issue
4: Emergency
situations or cases of emerging risks where a sudden increase of analytical needs
requires the use by official laboratories of a non standardised or non
validated method or a standardised method which is not included in their scope
of accreditation General
comment from MS and corresponding option: The
swift and efficient management of the situation/risk is the priority. The use
of a validated but « not (yet) accredited » method by an already ISO
17025 accredited laboratory should be possible. Ä
Option: in this case,
possibility for the CA to temporarily designate the laboratory under specific conditions (alternative
guarantees): the laboratory is already accredited according to ISO 17025 (i.e.
a solid quality assurance system is already in place) to ensure sound and
reliable results; analysis/diagnosis are carried out under the supervision of
the CA or the national reference laboratory (NRL); the temporary designation
shall not exceed one year renewable once – Modification of Article 12 of
Regulation (EC) N° 882/2004. 5.
Small sized Trichinella laboratories Issue
5: Small
sized Trichinella laboratories attached to slaughterhouses or game handling
establishments have important difficulties to be accredited according to ISO
17025. General
comment from MS and corresponding option: The
requirement for these laboratories carrying out extremely basic tests, to be
accredited according to ISO 17025 is disproportionate and not adapted. Ä
Option: modification
of Article 12 of Regulation (EC) No 882/2004: possibility for the competent
authority to permanently derogate small sized laboratories attached to food
business operators’ (FBOs) premises ·
exclusively carrying out
specific basic tests prescribed in Union legislation on a limited number of
samples pertaining to the FBOs’ process, ·
using
standardised/validated methods, ·
having a quality
assurance system in place, ·
and operating under the
supervision of an official laboratory accredited according to ISO 17025 or of
the competent authority.
6. Accreditation of plant health and plant reproductive material laboratories Issue
6: Currently
official laboratories operating
under the Plant Health and/or the Plant Reproductive Material regimes are not
obliged to be accredited according to ISO 17025. There is a need to improve
reliability, soundness and uniformity of their results. Weaknesses and
problems as regards the performance of official Plant Health or Plant
Reproductive Material laboratories have often been identified during FVO
audits. General
comments from MS: Worldwide,
there is a strong trend towards accreditation of laboratories. The move
towards accreditation has to be supported under certain conditions.
Many official Plant Health or Plant Reproductive Material laboratories are
already accredited. Ä
Option: modification
of Article 12 of Regulation (EC) No 882/2004: extension of the mandatory accreditation:
·
to laboratories under the
Plant Health and the Plant Reproductive Material regimes carrying out plant
(or seeds) health tests, ·
after a transitional
period, ·
with the possibility to: Ä
determine exemptions to
Article 12.3 taking into account the characteristics of the different
sectors (e.g. accreditation at least for a single diagnostic protocol or a
single protocol per taxonomic discipline), Ä
permanently derogate universities and research centres, Ä
temporarily designate
laboratories (like foreseen for
food/feed and animal health laboratories – see issues 2, 3 and 4) 7.
Accreditation of animal health laboratories Main
comments from MS and corresponding option: Accreditation
is globally not a problem. Accreditation may however be difficult: - for methods used in diagnosis of viral diseases
because of the important resources needed for documentation and validation of the
methods (solution: accreditation for types of methods or techniques?), - for methods used in the diagnosis of parasitic
diseases because of the multitude of parasitic diseases and the broad spectrum
of diagnostic tests. Ä
Option: modification
of Article 12 of Regulation (EC) No 882/2004: possibility
to determine exemptions to Article 12.3 taking into account the
characteristics of the different sectors. 8.
Participation in proficiency tests (PTs) or comparative tests (CTs) Issue
8: ISO
17025 recommends the participation in PTs/CTs: “5.9 The laboratory shall ensure the quality of results
by monitoring test and/or calibration results. This monitoring shall be planned
and reviewed and may include, but not limited to the … participation in
inter-laboratory comparison or proficiency testing programmes”. In
some areas, like residues of veterinary medicines and residues of pesticides,
EU legislation provides for the mandatory participation in PTS/CTs. Interpretations of ISO 17025 on this point differ
from one Member State to another. Different mandatory minimum frequencies of
participation in PTs/CTs furthermore exist accross the EU. Finally, a lack
of participation of laboratories in PTs/CTs and a lack of PTs/CTs
organised are sometimes reported. Main
comments from the MS and corresponding option: The
frequent/regular participation in PTs/CTs relevant to the scope of accreditation of the laboratory
and the satisfactory performance at these PTs/CTs are absolutely necessary/
mandatory. The participation in PTs/CTs has to be verified
during the assessment of the laboratory by the accreditation body. The lack of
participation in PTs/CTs is sometimes/rarely due to high costs, more often to
the unavailability of PTs/CTs. To
ensure a higher level of participation at PTs/CTs, the participation at PTs
organised by the EU reference laboratories (EURLs) should be made possible for
routine laboratories, as well as the possibility to participate at PTs/CTs
organised by national reference laboratories (NRLs) from other MS. Less
limited/narrow scopes of accreditation according to ISO 17025 and "a more
horizontal" organisation of PTs/CTs should also be considered. Ä
Option: modification
of Article 12 of Regulation (EC) No 882/2004: mandatory participation of laboratories in PTs/CTs
organised in their scope of accreditation by the EURL or the NRL on request by
either of them. 9.
Validation of methods Issue
9: According
to ISO 17025, the laboratory
has to use standardised methods or validated methods: - Requirement 5.4.5.1: « Validation is the
confirmation by examination and the provision of effective evidence that the
particular requirements for a specific intended use are fulfilled ». - Requirement 5.4.5.2: « The laboratory shall
validate non-standardised methods, laboratory designed/ developed methods,
standardised methods used outside their intended range and amplifications of
standardised methods to confirm that the methods are fit for the intended use“. Which methods can be given equivalent status to
« standardised methods »? Main
comments from MS and corresponding option: Methods
validated by EURLs/NRLs should be given equivalent status to
« standardised methods »: - validated
methods by EURLs: all EU accreditation bodies should deliver the accreditation
for their use within the intended scope without requesting a supplementary
internal validation by the laboratory (only a verification by the laboratory
would be necessary); - validated
methods by the NRL in a MS: the national accreditation body of this MS should
deliver the accreditation for their use within the intended scope without
requesting a supplementary internal validation by the laboratory in the MS
(only a verification by the laboratory would be necessary). Ä
Option: modification
of Article 11 of Regulation (EC) No 882/2004: methods validated by EURLs/NRLs are given equivalent
status to « standardised methods » and are incorporated accordingly
in the cascade of methods of Article 11.1 of Regulation (EC) No 882/2004. 10.
Specific mandatory methods in legislation Issue
10: There
is a global lack of flexibility of the system (e.g. in case of changes of the
method, emergency situations) due to too specific mandatory methods in
EU legislation. Proposal
from several MS: Mandatory
method performance criteria should
be preferred when establishing legislation (instead of mandatory specific
methods) to ease/fasten the introduction and the use of the latest and most
appropriate method. 11.
Flexible scope / fixed scope accreditation Issue
11: There
are very different/diverging requirements in particular for flexible scope
accreditation (but also for fixed scope accreditation) from one national
accreditation body to another. Main
comments from MS and corresponding option: The EA
Guide – 2/15 on accreditation of flexible scopes is too general. A harmonised
interpretation of the accreditation of flexible scopes is absolutely needed
across the EU. If not, huge differences in levels of difficulty, time needed
and costs for laboratories will continue to exist. The
accreditation of flexible scopes is useful in particular when no specific
assessment by accreditation body prior to the addition of the
matrix/analyte/method to the scope is requested (e.g. in case of emergency
situations and emerging risks). Some examples of diverging interpretations between
accreditation bodies are: - In some Member States, a fixed scope accreditation
can only cover the use of a specific method (to be followed very precisely by
the laboratory) on a specific matrix in order to detect a specific substance,
virus, bacteria, etc. The consequence is for instance that for each new use of
the method (e.g. on another very similar matrix), the laboratory has to have a
new accreditation. In other Member States, fixed scope accreditations are given
for broader combinations method/analyte/matrix making it for instance possible
for the laboratory to use the method on another similar matrix without
undergoing a new accreditation procedure. - In some Member States, the use of a slightly newer
version of a method (on the same matrix in order to detect the same substance,
virus, bacteria, etc) by an official laboratory being already accredited
according to ISO 17025 for the use of the slightly older version is only
possible when the laboratory has a flexible scope accreditation for the use the
older version of the method. In other Member States, the use of the slightly
newer version is possible for laboratories having only a fixed scope
accreditation for the use of the older version of the method. - When a new method is already covered by the flexible
scope accreditation of the laboratory, then in some MS the accreditation body
includes it automatically in the scope of accreditation without carrying out a
specific assessment of the laboratory. In other Member States, the accreditation
body first carries out a specific accreditation assessment. - For some accreditation bodies but not for others, a
flexible scope accreditation can cover the use of all methods using a same
analytical technique (e.g. ELISA, LC-MS/MS). Ä
Option: additional EA
guidance on pros and cons of flexible and fixed scopes, with examples, on what
a flexible scope could cover and corresponding precise requirements, on degrees
of flexibility of flexible scopes, on flexible scope accreditation assessments
by Abs 12.
New laboratories/new personal Issue
12: New laboratories have
first to be accredited according to ISO 17025 before being able to be
designated by the competent authority. The possibility to use new
staff in already accredited laboratories is very difficult. Main
comments from MS and corresponding option: The
designation, by the competent authority, of the laboratory before its formal
accreditation is risky (because the laboratory is not yet accredited for the
use of any method), difficult and not necessary. It shouldn't be allowed. ISO
17025 allows already touse new personal under the condition of their
appropriate supervision and training. Ä
Option: no action. Annex XIX: LABORATORIES – Costs relating to the introduction of a mandatory accreditation of official laboratories carrying out plant health tests and to the creation of EU reference laboratories 1. Cost relating to
the introduction of a mandatory accreditation of laboratories carrying out
plant health tests The inclusion of plant
health and plant reproductive material regimes in the scope of Regulation (EC)
N° 882/2004 would legally create the obligation for laboratories carrying out
plant health tests to be accredited according to EN ISO/IEC 17025. Some
flexibility would be foreseen as regards the scope of accreditation
(laboratories would at least be accredited for a single diagnostic protocol or
a single diagnostic protocol per taxonomic discipline) and the transitional
period (five years). The costs for the initial accreditation (valid for four
years) would be borne by the EU, the following accreditation costs (following
accreditations are each time valid for five years) would be for the
laboratories themselves and should be included in the cost-recovery based fees
to the extent that a laboratory carries out official diagnoses. Financial impact: accreditation according to EN ISO/IEC 17025 requires laboratories
to set up a quality assurance system, including the appointment of a quality
assurance officer (this may be an additional task for a staff member who is not
actively involved in the diagnoses). Quality assurance should be good practice
for any modern laboratory and the associated costs should therefore not be
taken into account as additional. The transitional period of five years should normally
be sufficient. The additional costs
relate to the formal accreditation itself, which depends on the size of the
laboratory and the price level in the MS. Based on a survey of MS laboratories[146]
and information available from different accreditation bodies, the average
costs of the accreditation according to EN ISO/IEC 17025 are assumed to be €3,000
per laboratory per year. 1.1. Official
laboratories performing plant health tests under the EU plant health regime In some MS, the
laboratories have already been accredited or largely so. In others, this is not
yet the case. The number of laboratories per MS presumably ranges between one
(for centralised MS)[147] and 26 (for MS with
regional laboratories). In this study, it is assumed that 20 MS still have
laboratories which need to apply for accreditation that this would concern on
average six laboratories[148] per MS. Based on these
assumptions, the accreditation costs would be: - for the Commission: 20 x
6 x € 3,000 x 4 years = € 1,44 million (total costs) - for the MS: 20 x 6 x
€3,000 = €360,000 per year 1.2. Official
laboratories performing plant health tests under the EU plant reproductive
material regime Official laboratories
under the EU plant reproductive materials regime would only be required to be
accredited according to EN ISO/IEC 17025 when they carry out plant health (i.e.
seed health) tests. Specialised seed testing
laboratories as well as laboratories charged with the testing of: - seed potatoes, - wine and fruit plant
propagating material, vegetable young plants, forest reproductive material and
propagating material of ornamental plants would be concerned. 1.2.1.
Official seed testing laboratories According
to the information available (in particular data from the International Seed
Testing Association (ISTA) and information available on the websites of the
laboratories), it is assumed that approximately 35 official seed testing
laboratories in the EU carrying out plant health (i.e. seed health) tests are
not yet accredited according to EN ISO/IEC 17025[149]. Based on these
assumptions, the accreditation costs would be: - for the Commission: 35 x
€ 3,000 x 4 years = € 420,000 (total costs), - for the MS: 35 x €3,000
= €105,000 per year. 1.2.2.
Official laboratories testing seed potatoes Laboratories charged under
the plant reproductive material regime with testing of seed potatoes (i.e.,
small potato tubers for planting) would in general not incur additional costs
as, in principle, they also carry out the plant health tests under the EU plant
health regime and any supplementary accreditation costs are covered above under
that regime. 1.2.3. Official
laboratories testing wine and fruit plant propagating material, vegetable young
plants, forest reproductive material and propagating material of ornamental
plants The number of laboratories
concerned not yet accredited according to EN ISO/IEC 17025 is estimated to be
70. Based on these
assumptions, the accreditation costs would be: - for the Commission: 70 x
€ 3,000 x 4 years = € 840,000 (total costs), - for the MS: 70 x €3,000
= €210,000 per year. In total: - the total costs
for the Commission (financing of the initial accreditations valid for four
years) would be: 1,440,000+ 420,000 +
840,000= €2,700,000 - the yearly costs
for the MS for the accreditation according to EN ISO/IEC 17025 of official
laboratories carrying out plant health tests would amount to 360,000 + 105,000
+ 210,000 = €675,000 2. Cost relating to
the creation of EU Reference Laboratories (EURLs) for plant health diagnosis The inclusion of plant
health and plant reproductive material regimes in the scope of Regulation (EC)
N° 882/2004 would legally create the possibility to set up EURLs in the these
areas and support these financially from the EU budget. Financial
impact: it is estimated that in due course EURLs
would be set up for circa ten to twelve priority pests. At present, the EU
supports 44 EU Reference Laboratories in the food, feed and animal health areas
covered by Regulation (EC) N° 882/2004 for a total annual sum of €14.2 millions
(figure for 2010/2011); the average EU support thus amounts to €323,000. This
implies that the annual costs for EURLs in the plant health and plant
reproductive material areas would be €3.2 millions to €3.9 millions (based on
this our assumption is €4 millions). Annex XX: Directive 96/23/EC - Consultation of the competent authorities in the MS on the impacts of the different options regarding the revision of Directive 96/23/EC – Questionnaire and results of the consultations The questionnaire addressed to the Member
States is made of parts 1, 2, 3 and 4 hereafter. Part 5 presents the results of
the consultations carried out.
1. About the consultation
1.1. Background of the
consultation
Pharmacologically active
substances administered to animals both intentionally and non-intentionally,
may result in the presence of residues in the food obtained from such animals.
Whereas animals need to be treated for animal health and welfare reasons, the
intake of residues in the food can be harmful to the consumers. The adoption of Directive
96/23/EC aimed at increasing consumer protection by establishing harmonised
rules for the controls to be carried out by Member States on residues of
veterinary medicines in live animals and foodstuffs of animal origin produced
in the EU and imported. The first objective of this Directive was the fight
against the illegal use of growth promoters in livestock. The second was to
ensure that consumers are exposed neither to harmful residues of veterinary
medicinal products and pesticides, nor to contaminants, at levels above those
established by the legislation. In 2003, the Commission
launched a broad consultation process to review the legislation on residues of
pharmacologically active substances used for the treatment of animals (Reflection
Paper on residues in foodstuffs of animal origin)[150].
The main purpose of the exercise was to eliminate inconsistencies between
different legal instruments and to replace them with a single act. Indeed, at that time, the following
legislative acts were in force: 1.
Regulation (EC) No 2377/90[151]
laying down Community procedures for the establishment of maximum residues
limits (MRLs) of pharmacologically active substances in foodstuffs of animal
origin ("MRLs regulation"), 2.
Council Directive 96/22/EC[152]
concerning the prohibition on the use in stockfarming of certain substances
having a hormonal or thyrostatic action and of beta-agonists (ban on the use of
hormones for growth promotion - "Hormone Directive"), 3.
Council Directive 96/23/EC[153] on measures to
monitor certain substances and residues thereof in live animals and animal
products ("Residue Control Directive"). Member States (MS), Third Countries (TC) and
stakeholders provided substantive encouraging feedback during the
abovementioned process[154] and Regulation (EC) No
2377/90 as well as Directive 96/22/EC were amended. Indeed some of the issues
identified by the consultation process were addressed through the adoption of
the following acts: 1. Regulation (EC) No 470/2009[155] laying down
Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin The aim of this new Regulation is to limit
the exposure of consumers to pharmacologically active substances and at the
same time to enhance the availability of veterinary medicinal products in the
European Union (EU). 2. Directive 2008/97/EC[156] amending Council
Directive 96/22/EC concerning the prohibition on the use in stockfarming of
certain substances having a hormonal or thyrostatic action and of beta-agonists
This act introduced two main modifications
of Directive 96/22/EC: the limitation of the scope of Directive to
food-producing animals only and the total prohibition of the use of 17
beta-oestradiol in food producing animals. Directive 96/23/EC was not revised. In 2004, with the adoption
of Regulation (EC) No 882/2004[157] on official controls performed to ensure the verification of the
compliance with feed and food law, animal health and animal welfare rules, a
general framework for the performance of official controls along the food chain
was established. The "Official Controls Regulation" created an integrated approach to official controls in all areas related to
the food chain. Considering that during the abovementioned exercise of review
of the rules on veterinary medicines was ongoing, controls on residues covered
by Directive 96/23/EC were excluded from the scope of Regulation (EC) No
882/2004. In July 2009, the
Commission transmitted a Report to the European Parliament and the Council on
the implementation of Regulation (EC) No 882/2004 since 1st January
2006, reporting on the first years' experience of enforcement and pointing at
some necessary reviews to be considered. The Report indicated the need to consider
the possibility of integrating the rules currently applicable to official
controls on pesticides, contaminants and residues of pharmacologically active
substances in food into the framework of Regulation (EC) No 882/2004, so as to
rationalise and simplify the overall legislative framework whilst allowing the
Member States to integrate controls on residues in food in their multi-annual
control plans (MANCPs). This would also allow a more consistent approach on
controls of residues of veterinary medicines in food produced or imported to
the EU.
1.2. Purpose of the consultation
This consultation is part
of the exercise aiming to review Directive 96/23/EC. A roadmap for the exercise
is published at: http://ec.europa.eu/governance/impact/planned_ia/docs/418_sanco_rev_dir_substances_animals_en.pdf. In order to align the
legislative framework applicable to official controls on residues of veterinary
medicinal products with the more modern principles established in Regulation
(EC) No 178/2002[158] as well as with the
provisions of Regulation (EC) No 882/2004 and, notably, with the need to plan
and carry out control activities on the basis of risks, the extensive material
collected in the framework of the evaluation started in 2003 will be
considered, insofar as it is still relevant after the adoption of Regulation
(EC) No 470/2009, and complemented with fresher input and additional feedback
from MS and stakeholders to specifically address the issues related to the
alignment of the veterinary medicines' residues controls with the requirements
of Regulation (EC) No 882/2004. Therefore the purpose of
this consultation is twofold: 1. to update (relevant) information gathered during the consultations carried out in the past, 2. to collect additional data to be used to assess the impact of the options available: MS are requested to provide as detailed
information as possible to allow the evaluation of the impacts of the different
options proposed. The information collected
through this questionnaire will be used to assess the potential impacts of the
main options possible to reach the objective stated, consideration being given
also to possible synergies and trade-offs.
1.3. Who is consulted and how to
submit contributions
This questionnaire is
addressed to the Competent Authorities (CA) of the Member States (MS)
responsible for the management of official controls in the food, feed and
animal health sectors (members of the "Working group on the general
application of Regulation (EC) No 882/2004"), to the Chief Veterinary
Officers (CVOs) of the Member States as well as to officials in the MS in
particular responsible for the management of residues of veterinary medicinal
products control plans in the Member States (members of the "Residue
expert working group"). The questionnaire can be shared with other
departments concerned. For the purpose of
consolidating the responses, only one contribution per Member State should be
sent to the Commission per email to Alexander Rogge at alexander.rogge@ec.europa.eu
. An acknowledgement of
receipt will be issued for each contribution received within five working days.
1.4. Timetable
All contributions should be submitted to the
Commission by the 1st April 2011 latest (the ones received before
this deadline being of course warmly welcomed).
1.5. Next steps
All contributions will be
carefully analysed. A summary of the outcome of the consultation will be
published on the website of the European Commission and also sent directly to
all contributors. The results of the consultation will be used for the impact
assessment report on the revision of the Directive 96/23/EC.
2. Problem definition and objective
Directive 96/23/EC brought
about a significant degree of harmonisation of controls on residues of
veterinary medicinal products and contaminants in the MS. The act provides for
a minimum number of samples to be taken for each type of live animal or product
per group or sub-group of substances according to the animal production as
listed in the Annexes. While harmonisation
clearly has the advantage of ensuring a uniform approach to enforcement actions
performed to fight against the use of illegal substances and to control
compliance with levels of residues of authorised veterinary medicinal products,
the lack of flexibility, which is the consequence of the detailed and over
prescriptive nature of the Directive, may result in a reduced efficiency of the
controls carried out. In fact, this rigidity: ·
limits the possibility to establish control
priorities and to allocate controls resources on the basis of risks (other than
the size of the animal production), ·
does only permit very limited risk based changes
to frequencies and methods of controls. The general objective of
the current exercise is therefore to assess the possibility of aligning the
rules applicable to official controls on residues of veterinary medicines to
the principles and rules on which the system of official controls is based
following the adoption of Regulation (EC) No 882/2004, so as to rationalise and
simplify the overall legislative framework and to allow MS more flexibility
necessary to ensure the integration of residues controls into their MANCPs. More specifically the
objective announced above would require the following to be achieved: ·
simplify existing rules and eliminate overlaps
which may result from the implementation of Directive No 96/23/EC and other
legislation, in particular, on contaminants (Council Regulation (EEC) No 315/93
of 8 February 1993 laying down Community procedures for contaminants in food
and Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum
levels for certain contaminants in foodstuffs) and plant protection products
(Regulation (EC) No 396/2005 of the European Parliament and of the Council of
23 February 2005 on maximum residue levels of pesticides in or on food and feed
of plant and animal origin and amending Council Directive 91/414/EEC); ·
ensure that official controls on residues of veterinary medicinal products are carried
out with a frequency established on the basis of risk and taking into account
past records of compliance, any indication of non-compliance and reliability of
own checks; ·
if necessary, ensure a minimum level of control
of certain substances whose illegal or non-compliant use would represent a
particularly serious health risk (e.g. growth promoters or antibiotics); ·
reduce the burden resulting from redundant or
unnecessary procedures, in particular those laid down in Directive 96/23/EC for
the approval of the control plans, and eliminate overlapping requirements on
the MS; ·
in line with EU's international obligations
under WTO SPS Agreement, increase transparency vis-à-vis Third Countries by
simplifying import requirements and making them clearer (increased transparency
facilitating also EU's exports due to a better understanding of Third Countries
of EU's control system(s)).
3. Data needs
A significant amount of
information is already available in the Residues Application in particular in
terms of number of samples analysed and results of analysis. However, the
Commission is lacking important data on the cost of the residues controls which
is indispensable to evaluate the impacts of the different options proposed. Therefore, the following
data would be necessary: ·
total annual
cost of implementing the national residue control plan (NRCP) referred to in
Chapter II of Directive 96/23/EC including all expenses: staff, laboratories,
consumables, overheads, etc., ·
average total cost per sample,
including all expenses, ·
average cost per sample for laboratory
analysis only, Data on number of samples
and on results of analysis will be taken from submissions to the Residues
Application. Please provide the following data only if figures differ from
those recorded in the Residues Application, stating the reasons for this
difference (e.g. additional control system in place): ·
number of samples taken for residue controls per
year under Directive 96/23/EC (please provide the average figure per year for
the last two years), ·
number of non-compliant samples.
4. Key issues
4.1. Key issue 1- List of
substances in Annex I
Annex I of Directive
96/23/EC provides for two groups of substances to be investigated: Ø
Group A "substances having anabolic effect
and unauthorised substances" whose use is partly or entirely explicitly
prohibited in food producing animals, Ø
Group B "veterinary drugs and
contaminants": ·
B1 and B2 substances that may be authorised for
use in veterinary medicinal products for food producing animals, ·
B3 "other substances and environmental
contaminants" (organochlorine compounds, organophosphorus compounds,
chemical elements, mycotoxins, dyes and "others"). Minimum sampling levels
depending on type of animals (bovine, porcine, ovine, caprine and equine
animals, poultry) or animal products (aquaculture products, milk, eggs, honey,
rabbit meat, meat of wild and farmed game) are required for the groups and
sub-groups of substances. Specific enforcement
measures to be taken in case of non-compliance depend on the classification of
the substance: non-compliance with Group A substances is reckoned as more
severe than exceeding MRLs for an authorised substance of Sub-Group B1 or B2. Finally, unlike substances
of Groups A, B1 and B2, the presence of the substances and contaminants
referred to in Sub-Group B3 (e.g. cadmium, lead, mercury, PCBs and dioxins,
aflatoxin B1, ochratoxin A) is in general not due to intentional use.
4.1.1. Contaminants
Issue According
to Article 2 of Regulation (EC) No 315/93 laying down Community procedures for
contaminants in food, foodstuffs shall not be placed on the market when they
contain a contaminant exceeding a maximum level set in the relevant
legislation. Commission Regulation (EC) No 1881/2006 sets the maximum levels
for certain contaminants listed in its Annex: nitrate, mycotoxins, metals
(lead, cadmium, mercury, inorganic tin), 3-monochloropropane-1,2-diol (3-MCPD),
dioxins and PCBs, and Polycyclic Aromatic Hydrocarbons (PAHs), in food of
animal origin (e.g. milk, eggs, fish, meat of bovine animals, sheep, pig and
poultry). Unlike Directive 96/23/EC, the Regulation does not provide for the
mandatory establishment and approval of a control plan, nor for a minimum
number of samples to be planned and analysed each year: Member States carry out
control activities on the basis of their own risk assessment. Article 9 of Commission
Regulation (EC) No 1881/2006 furthermore requires Member States to report to
the Commission findings from official controls on most of the mycotoxins, as
well as on dioxins, PCBs, acrylamide and furan, whereas according to Article 8
of Directive 96/23/EC, MS have to forward annually to the Commission the
results of their monitoring plans comprising all substances listed in its
Annex. Finally, methods for
sampling and analysis for contaminants are laid down in different specific
legislation and the approaches for the validation of analytical methods and the
establishment of measurement uncertainty differ between both (on one hand,
Commission Regulations (EC) No 333/2007 (lead, cadmium, mercury, inorganic tin,
3-MCPD, benzo(a)pyrene), No 1882/2006 (nitrates), No 401/2006 (mycotoxins), No
1883/2006 (dioxins and dioxins-like PCBs) and, on the other hand, Commission
Decision 2002/657/EC implementing Directive 96/23/EC). Against this background,
several Member States suggested in their answers to the Reflection Paper,
contaminants to be taken out of the scope of this Directive 96/23/EC and the
intensity of official controls to be based on each Member State's risk
assessment. Number of samples and
results: In 2009, 45 014
samples were analysed in the EU under Directive 96/23/EC for substances in
group B3 of which 487 samples were found to be non-compliant (1.08 %). The highest percentage of
non-compliant samples in almost all species was found for chemical elements
(B3c) (2.25 %). Cadmium, lead and mercury were the most frequently
reported elements. Instances of non-compliance for organochlorine compounds
(B3a) and organophosphorus compounds (B3b) were much lower: 0.19 % and
0.04 %, respectively. For mycotoxins (B3d), nine non-compliant samples for
ochratoxin A in pigs, one for aflatoxin B1 in sheep and goats, and five for aflatoxin
M1 in milk were reported. Dyes (B3e) were reported in aquaculture (1.6 %).
Substances found were malachite green and leuco-malachite-green[159]. There is no overview of
the number of samples analysed for control of contaminants in food of animal
origin in the EU under the contaminants legislation. Questions (1) Evaluation of potential impacts of repealing the requirements on
official controls on contaminants currently laid down in Directive 96/23/EC (so
that Regulation (EC) No 882/2004 and the existing specific EU contaminants
legislation would only apply) 1. Do you agree with the description of the issue? Yes No Comments 2. Socio economic impacts 2.1.
How many samples are taken for Subgroup B3 per
year in your Member State? (please provide data if different from the
information submitted to the Residues Application and exclude pesticide
residues as they are treated in 4.1.2 hereafter) 2.2.
Do you consider that the number of samples taken
to test for the presence of contaminants would have been globally lower in your
country, had you been allowed to establish the frequency of sampling only
on the basis of risk assessments? If
yes, §
would you be able to give an indication of the
impact of the reduction (in %, both in relation to the number of samples and to
the overall costs)? §
would you expect the sampling capacity that
would be freed to be used to increase sampling on other substances? If
not, §
would you expect an increase of the number of
samples taken for contaminants? or §
would you expect the level to remain more or
less the same? 3. Public Health impacts Would an exclusively
risk based system of controls for contaminants (and thus the repeal of
the requirements on official controls on contaminants currently laid down in
Directive 96/23/EC) improve consumer protection? Yes. Please
substantiate your answer. No. Please substantiate
your answer. Other comments: 4. Administrative burden impacts What would be the effect
on administrative burden on national Competent Authorities if the requirements
on official controls on contaminants currently laid down in Directive 96/23/EC
were repealed so that Regulation (EC) No 882/2004 and the existing specific EU
contaminants legislation would only apply? Administrative
burden would increase. Please substantiate your answer. Administrative
burden would decrease. Please substantiate your answer. Administrative
burden would not change. Please substantiate your answer. Other
comments: 5. Other impacts Please indicate any other
impact that you consider relevant.
4.1.2. Pesticide residues
Issue Directive 96/23/EC
determines minimum sampling levels to be respected in the national monitoring
plans depending on type of animals or products for the following subgroups of
pesticides: –
carbamates and pyrethroids (B2c), –
organochlorine compounds (B3a), –
organophosphorus compounds (B3b), –
others (B3f). Following the entry into
application of Regulation (EC) No 396/2005 on maximum residue levels (MRLs) of
pesticides in or on food and feed of plant and animal origin, Member States are
required to carry out official controls on pesticide residues in accordance
with the relevant provisions of Regulations (EC) N° 178/2002 and 882/2004.
Annex I of Regulation (EC) No 396/2005 establishes a list of 315 products
(animal products included) to which MRLs apply. Article 29 requires the
Commission to prepare a coordinated multi-annual Community control programme
with a view to assessing consumer exposure and the application of current
legislation and Article 30 requires Members States to establish risk based
multi-annual national control programmes. Thus, in each MS several
plans or programmes for testing pesticide residues in food and feed are
currently in place: 1. the
EU coordinated programme under Regulation (EC) No 396/2005: the lots sampled
are chosen without any particular suspicion towards a specific operator and/or
consignment and the results obtained are considered as an indicator of MRL
compliance in food placed on the market and of consumer exposure (statistical
approach); 2. the
risk based national controls programmes under Regulation (EC) No 396/2005 based
on past records and focused on food and feed with higher probability for non
compliance; 3. the control
plan under Directive 96/23/EC with its targeted approach. Each year, the two
programmes and the plan as well as the results thereof are communicated to the
Commission. The evident overlap of the
two sets of rules also implies that methods of analysis and corresponding
validation requirements can differ for the same substance and matrix depending
on which rules are applied: whereas laboratories carrying out analysis under
Directive 96/23/EC follow Commission Decision 2002/657, laboratories carrying
out analysis under Regulation (EC) No 396/2005 apply the "Method
Validation and Quality Control Procedures for Pesticide Residues
(Doc. SANCO/2007/3131), 31 October 2007". One important difference
results from the different rationale of the two sets of rules: whereas each
year, carbamates, pyrethroids, organochlorine compounds and organophosphorus
compounds are analysed in the live animals and the products mentioned in the
Annex of Directive 96/23/EC, the product-pesticide combinations selected in the
EU coordinated and national control programmes under Regulation (EC) No
396/2005 may vary from one year to another, depending on risk prioritisation. Number of samples and results: According to the European Food Safety Authority (EFSA)
report for 2009 on the results from the monitoring of veterinary medicinal
product residues and other substances in live animals and animal products, 32
796 targeted samples were taken for groups B3a, B3b and B2c under Directive
96/23/EC in animals and products of animal origin. Instances of non-compliance
for organochlorine compounds (B3a) and organophosphorus compounds (B3b) were
0.19 % and 0.04 %, respectively. EFSA publishes also annual
reports on the EU coordinated programme and the national control programmes of
pesticides residues according to Article 32 of Regulation (CE) No 396/2005. The
last report presented the results of the analyses in food commodities sampled
during 2008 in the 27 EU Member States as well as in Norway and Iceland (two
EFTA (European Free Trade Association) states). More than 70 000 samples of
nearly 200 different types of food were analysed. 96.5% of the samples complied
with the MRLs of pesticides. 11 610 samples of nine
different commodities (of plant origin only) were taken in the 2008 EU
coordinated programme where the overall MRL exceedance rate was 2.3%. The 70
143 samples analysed in the context of the national control programmes in 2008
included 67 887 surveillance samples and 2 256 enforcement samples (N.B.: these
figures do also comprise the number of samples taken for the EU coordinated
programme). The majority of samples taken originated from the European
reporting countries (77%), while 20% of the samples were taken from imported
consignments or lots. For 3 % of the samples the origin was not reported. Data on controls in food
of animal origin will only be available in the 2009 report. Questions (2) Evaluation of potential impacts of repealing the requirements on
official controls on pesticides B3a, B3b, B3f and B2c currently laid down in
Directive 96/23/EC (other than authorised veterinary medicines) (so that
Regulation (EC) No 882/2004 and the existing specific EU pesticides legislation
would only apply) 1. Do you agree with the description of the issue? Yes No Comments 2. Socio economic impacts. 2.1.
How many samples are taken for the analysis of
pesticides residues under Directive 96/23/EC per year? (please provide data if
different from the information submitted to the Residues Application) 2.2.
Do you consider that the number of samples taken
to test pesticides residues would have been globally lower in your country, had
you been allowed to establish the frequency of sampling only on the basis of
risk assessments? If yes,
§
would you be able to give an indication of the
impact of the reduction (in % points, both in relation to the number of samples
and to the overall costs)? §
would you expect the sampling capacity that
would be freed to be used to increase sampling on other substances? If
not, §
would you expect an increase of the number of
samples taken for pesticides residues? or §
would you expect the level to remain more or
less the same? 3. Public Health impacts Would an exclusively
risk based system of national controls for pesticides residues (and thus
the repeal of the requirements on official controls on pesticides
currently laid down in Directive 96/23/EC) improve consumer protection? (Please
do not consider the EU coordinated programme in your answer) Yes. Please substantiate
your answer. No. Please substantiate
your answer. Other comments: 4. Administrative burden impacts What would be the effect
on administrative burden on national Competent Authorities if the requirements
on official controls on pesticides currently laid down in Directive 96/23/EC
were repealed so that Regulation (EC) No 882/2004 and the existing specific EU
pesticides legislation would only apply? Administrative
burden would increase. Please substantiate your answer. Administrative
burden would decrease. Please substantiate your answer. Administrative
burden would not change. Please substantiate your answer. Other
comments: 5. Other impacts Please indicate any other
impact that you consider relevant.
4.2. Key issue 2 - National
residues monitoring plans
Issue Council Directive 96/23/EC
requires Member States to submit annual national residues monitoring plans to
the Commission respecting the minimum number of samples per type of animal or
product and (sub)group of substances combinations laid down in Annex IV of the
Directive as well as in the Decision 97/747/EC. As the number of samples
is linked to the individual Member States’ animal production in the preceding
years, this can result in very small numbers of samples being taken in those MS
where there is limited production of certain species and the relevance of
taking one or two samples is questionable. On the other hand, in countries with
larger animal productions, the numbers of samples specified by the Directive
are much greater than if a statistically based sampling approach (e.g. the one
advocated by the Codex Alimentarius[160]) is followed. Furthermore the current
rigid framework of Directive 96/23/EC militates against the application of a
risk-based approach as laid down in Article 3 of Regulation (EC) No 882/2004
which states that official controls shall be carried out regularly, on a risk
basis, with appropriate frequency and taking into account identified risks,
past records, reliability of own checks and any indication of non-compliance
(risk approach). Whilst some degree of risk-based approach is possible under
the current Directive (for example MS are free to prioritise certain substances
within specific substance groups and the minimum sample numbers specified in
the Directive can be exceeded), the fact remains that MS are forced to test for
certain substances and substance groups where there has been little evidence of
a residues problem for many years (e.g. Group A1 – stilbenes). Moreover,
the approval of the national monitoring plans involves a long and heavy
administrative procedure including notification, formal examination and
approval by the Commission to be carried out every year and no clear indication
is given of the possible consequences of not approving a national plan. Against
this background, MS expressed during the consultations their view that the
requirements for the national monitoring plans under Directive 96/23/EC were
not providing satisfactory results in relation to the resources invested. They
suggested that (part of) the samples should be selected in accordance to the
principles in Regulation (EC) No 882/2004 (i.e. on a risk basis) while
considering the opportunity to give some priority to the detection of the use
of prohibited substances presenting a serious health risk for consumers. Number
of samples and results: A total
of 445 968 targeted samples and 38 119 suspect samples were
reported under the Directive 96/23/EC in 2009. There
were 1 342 non-compliant samples (0.30 %) out of the total targeted
samples. From the total of
collected targeted samples, 40.9 % were analysed for substances having
anabolic effect and prohibited substances (group A) and 63.1 % for
veterinary drugs and contaminants (group B). Questions (3) Evaluation of potential impacts of: Option 1: repealing the current
prescriptive harmonisation of the modalities for control planning laid down in
Directive 96/23/EC and allowing Member States to
plan controls according to their own risk assessments and to integrate these
controls in their MANCP; Option 2: option 1 combined with EU
harmonised uniform control modalities for certain substances or groups of
substances and/or certain combinations animal(s) or product(s) and substance(s)
established in case of specific "intrinsic"
risks (e.g. growth promoters) or other risks that would justify the introduction of minimum control frequencies at EU level under
certain conditions and for certain combinations animal(s) or product(s) and
substance(s). Please do not consider
contaminants (treated in 4.1.1.) and pesticides residues (treated in 4.1.2.)
when answering to the following questions. 1. Do you agree with the description of the issue? Yes No Comments 2. Socio economic impacts 2.1.
Do you consider that the number of samples taken
would have been lower in your country, had you been allowed to plan controls
only on the basis of your risk assessments (as in option 1)? (a) If yes: (i) would you be able to give an indication of the impact of the
reduction (in % points, both in relation to the number of samples and to the
overall costs)? (ii) would you expect the sampling capacity that will be freed to be used
to increase sampling on other substances or for a monitoring programme to
assess consumer exposure? (b) If not: (i) would you expect an increase of the number of samples taken? or (ii) would you expect the level to remain more or less the same? 2.2.
Would you be able to estimate any impact of EU
harmonised uniform control modalities for certain (groups) substances and/or
certain combinations animal(s) or product(s) and substance(s) (as in option 2)
on the number of samples taken in your country? Yes. Please
substantiate your answer. No, I'm not able to
estimate any difference between options 1 and 2. Please substantiate your
answer Other
comments: 3. Public Health impacts 3.1.
Would a system of controls exclusively based on
your own risk assessments (as in option 1) improve consumer protection? Yes. Please
substantiate your answer. No. Please substantiate
your answer. Other comments 3.2.
Would you be able to estimate any impact of EU
harmonised uniform control modalities for certain (groups) substances and/or
certain combinations animal(s) or product(s) and substance(s) (as in option 2)
in regard to consumer protection? Yes. Please
substantiate your answer. No. Please substantiate
your answer. Other comments 4. Administrative burden impacts Option 1 and option 2 would
require the MS to draft the national residues control programmes according to
its own risk assessments but they would no longer require each MS to submit its
national control plan and its results for specific approval (each MS would
include its plan in the MANCP). 4.1. What
would be the effect of option 1 on the administrative burden for the national
Competent Authority? Administrative
burden would be increased. Please substantiate your answer. Administrative
burden would be decreased. Please substantiate your answer. Administrative
burden would not change. Please substantiate your answer. Other
comments: 4.2. Would
you be able to estimate any impact of EU harmonised uniform control modalities
for certain (groups) substances and/or certain combinations animal(s) or
product(s) / substance(s) (as in option 2) on the administrative burden of the
Competent Authority? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments 5. Other impacts Please indicate any
other impact that you consider relevant.
4.3. Key issue
3 - Requirements for Third Countries on residues controls/imports
Issue Article 29 of Directive
96/23/EC requires that Third Countries (TCs) provide "guarantees"
that have an "effect at least equivalent" to the measures that are to
be implemented by Member States (MS) according to the Directive. In particular,
TCs have to submit on an annual basis a residues monitoring plan, the
requirements being very prescriptive and essentially the same as for the Member
States' plans (minimum sampling frequencies, etc.), and to provide details on
their control system. According to this article, TCs with an approved residues
monitoring plan appear on a list from which MS are authorised to import
(Commission Decision 2004/432/EC). During the consultation, a
simpler and more transparent framework as well as the definition of criteria to
assess the effective equivalence of monitoring plans and control systems were
requested and to a certain extent, this has been delivered already with the
publication of the Commission's Third Country residues web page in which the
provision of guarantees equivalent to those provided for by Directive 96/23/EC
are described[161]. In 2004, the entry into
force of Regulation (EC) No. 882/2004 has created a more horizontal approach to
the establishment of import requirements. In particular: 1. Article
47 of the Regulation requires TCs to provide accurate and up-to-date
information on the general organisation and the management of their sanitary
control systems, sanitary regulations, control and inspection procedures, risk
assessment procedures and the factors taken into consideration, results of
their controls, their follow up to the recommendations made pursuant to FVO
missions, changes of the structure and functioning of the relevant control
systems, etc.; 2. Article
48 gives the possibility to lay down if necessary specific import conditions
and detailed procedures which may include the establishment of a list of Third
Countries from which specific products may be imported and the definition of
specific import conditions depending on the type of animal or product and the
possible risks associated therewith. 3. Article 46 requires FVO controls to be carried out in TCs
in order to verify, on the basis of the information referred to in Article 47,
the compliance or equivalence of TCs legislation and systems with EU feed and
food law and animal health legislation. These
controls shall have particular regard to the legislation of the TC, the
organisation of the its competent authorities, their supervision, powers and
independence, the training of their staff, their resources including diagnostic
facilities, the existence and operation of documented and adequate control procedures
and systems as well as the assurances which the Third Country can give
regarding compliance with, or equivalence to, EU requirements. Approximately
80 countries are listed in Commission Decision 2004/432/EC for animals and food
from animal origin for which a residues monitoring plan has been submitted and
positively assessed by the Commission. FVO missions are furthermore carried out
to check the effective implementation of the plans. Questions (4) Evaluation of potential impacts of: Option 1: repealing the current
prescriptive modalities for TCs' residues monitoring plans in Directive
96/23/EC and replacing them by a set of minimum specific guarantees as regards
equivalence or compliance of the control system and programme of veterinary
medicines' residues of the TC (legislation, authorisation, control of
production and use of veterinary medicines, identification of prohibited
substances, control programme for testing residues in animals and food from
animal origin) which shall be provided by the Third Country in order for it to
be inscribed in the list established under Article 48 of Regulation (EC) No 882/2004 and which shall be controlled during
FVO missions at frequencies determined in accordance with prescriptions of
Article 46 of Regulation (EC) No 882/2004; Option 2: option 1 combined with
mandatory minimum control frequencies in the
TC's control programme for certain substances or groups
of substances whose illegal use would represent
a particularly serious violation and/or health risk for the consumers (e.g.
growth promoters or certain antibiotics) and which require a specific approach (special import conditions). Impacts: 1. Do you agree with the description of the issue? Yes No Comments 2. Socio economic impacts 2.1. Would
you be able to estimate any socio-economic impact of option 1 on your national
Competent Authority (human resources, controls, etc.)? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments 2.2. Comparing
option 1 with option 2, would you be able to estimate any difference in the
socio-economic impact on your national Competent Authority (human resources,
controls, etc.)? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other
comments: 3. Public health impacts 3.1. Would
option 1 improve consumer protection? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments 3.2. Comparing
option 1 with option 2, would you be able to estimate any impact of mandatory
minimum control frequencies in the TCs' control programmes (for certain
substances or groups of substances whose illegal use would represent a
particularly serious violation and/or health risk for the consumers) on
consumer protection? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments 4. Administrative burden 4.1. What
would be the effect of option 1 on the administrative burden for your national
Competent Authority? Administrative
burden would be increased. Please substantiate your answer. Administrative
burden would be decreased. Please substantiate your answer. Administrative
burden would not change. Please substantiate your answer. Other
comments: 4.2. Comparing
option 1 with option 2, would you be able to estimate any impact of mandatory
minimum control frequencies in the TCs' control programmes (for certain
substances or groups of substances whose illegal use would represent a
particularly serious violation and/or health risk for the consumers) on the
administrative burden of your Competent Authority? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments. 5. Other impacts Please indicate any
other impact that you consider relevant.
4.4. Key issue 4 - Enforcement
measures
Articles
13, 16, 17 and 18 as well as Articles 22, 23, 24 and 25 of Directive 96/23/EC
provide very precise and specific enforcement measures to be taken by Member
States in case of illegal treatment, use of unauthorised substances or presence
of their residues, levels exceeding the maximum limit for residues, repeated
infringements of MRLs, etc. (e.g. immediate slaughter of all animals in case of
confirmation of illegal treatment). The very detailed
and over prescriptive nature of the Directive may result in some confusion for
the Competent Authorities and their enforcement officers as well as in a
reduced flexibility as regards of the possible enforcement actions in a given
situation. Regulation
(EC) No 882/2004 has a more flexible and rationalised approach: Article 54 of the Regulation requires that actions taken by the
Competent Authority shall ensure that the operator remedies the situation and
that they take account of the nature of the non-compliance as well as the
operator's past record with regard to the non compliance. It furthermore lists
the possible measures without linking them rigidly to specific non-compliances:
imposition of sanitation
procedures or any other action deemed necessary to ensure the safety of
feed or food or compliance with law;
restriction or prohibition
of the placing on the market, import or export of feed, food or animals;
monitoring and, if
necessary, ordering the recall, withdrawal and/or destruction of feed or
food;
authorisation to use feed or
food for purposes other than those for which they were originally intended;
suspension of operation or
closure of all or part of the business concerned for an appropriate period
of time;
suspension or withdrawal of
the establishment's approval;
any other measure the
competent authority deems appropriate (for instance slaughter of animals).
Article
54 finally requires that all expenditure incurred shall be borne by the
responsible feed and food business operator. The
alignment of the rules applicable for residues of veterinary medicines controls
with the ones of Regulation (EC) No 882/2004 would thus allow specific case by
case adapted measures remedying the situation without preventing Competent
Authorities to take, if needed, the same enforcement measure than the one they
would have taken under Directive 96/23/EC. Questions (5) Evaluation of potential impacts of repealing the requirements on
enforcement measures currently laid down in Directive 96/23/EC (Articles 13, 16, 17, 18, 22, 23, 24 and 25) so
that Article 54 of Regulation (EC) No 882/2004 would only apply 1. Do you agree with the description of the issue? Yes No Comments 2. Socio economic impacts 2.1. Do you
consider that, in general, you would have taken the same enforcement measures,
had current provisions in Article 54 of Regulation (EC) No 882/2004 been
applicable? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments. 2.2. Do you
consider that your enforcement actions would have been better targeted and/or
adapted, had current provisions in Article 54 of Regulation (EC) No 882/2004
been applicable? Yes.
Please substantiate your answer. No.
Please substantiate your answer. Other comments. 3. Public Health impacts Would the repeal
of the rigid requirements on enforcement measures currently laid down in
Directive 96/23/EC and the application of current provisions in Article 54 of
Regulation (EC) No 882/2004 improve consumer protection? Yes. Please
substantiate your answer. No. Please substantiate
your answer. Other answer: 4. Administrative burden impacts What would be the
effect on administrative burden on national Competent Authorities in case of
repeal of the rigid requirements on enforcement measures currently laid down in
Directive 96/23/EC and the application of current provisions in Article 54 of
Regulation (EC) No 882/2004? Administrative
burden would increase. Please substantiate your answer. Administrative
burden would decrease. Please substantiate your answer. Administrative
burden would not change. Please substantiate your answer. Other
comments: 5. Other impacts Please indicate any other
impact that you consider relevant.
5. Results of the consultation
All 27 Member States (MS) and Norway answered to the questionnaire.
5.1. Overlaps resulting
from the implementation of Directive 96/23/EC and the specific EU contaminants
legislation (Regulations (EC) N° 315/93 and N° 1881/2006)
The option considered
was to repeal the requirements on official controls on contaminants currently
laid down in Directive 96/23/EC so that Regulation (EC) No 882/2004 and the
existing specific EU contaminants legislation would only apply. 26 MS agreed with the
description of the issue (1 disagreed). No MS was opposed to the option. General comments from
the MS Some MS underlined the
specific case of dyes (malachite green and leucomalachite green used for the illegal
treatment of farmed fish) which should be considered separately. Others called for the
inclusion in EU legislation of an EU coordinated programme for at least some
priority environmental contaminants which should be reviewed regularly or
annually. Several MS stressed the
need to ensure future the financing of official controls on contaminants
through fees paid by industry and some were of the opinion that private
controls carried out by food business operators (FBOs) should be more taken
into account. Some MS focussed on the
possible consequences of this option on EU exports: export possibilities would
have to be re-negotiated with each third country (TC) and new specific requests
from TCs (e.g. analyses of consignments) could be possible. Member States'
perception of the potential impacts of the option 1. Socio-economic
impacts The majority of the MS
(18) considered that the number of samples taken to test for the
presence of contaminants would have been globally lower in their
country, if the frequency of sampling was only on the basis of risk
assessments. 7 MS mentioned reductions of the number of samples (globally or
for one or several group(s) of substances) between – 10 % and – 60 %. The majority of these MS
(11/18) expected the sampling capacity that would be freed to be used to
increase the sampling of other substances and/or on other matrices (in general
if justified by risk assessments). Several MS noticed however that any increase
of the number of samples is difficult in the current situation of public
deficits and scarce public budgets. 6 MS felt that the number
of samples would remain unchanged (they would be distributed differently) and 3
MS didn't or couldn't answer. 2. Public health
impacts For the majority of MS
(17), an exclusively risk based system of controls for contaminants would
improve consumer protection (sampling better focussed and more
efficient, better allocation of resources, local specificities better taken
into account). Some MS proposed a rolling program based on risk assessments
with more or less intensive samplings from one year to another. 2 MS felt that the level
of consumer protection would remain the same (because of very few samples
concerned). All other MS having answered explained that an exclusively risk based
system would not or not necessarily improve consumer protection unless it
comprises also a monitoring programme of low risk or low occurrence substances
in order to observe medium and long term trends, to keep track of consumer
exposure and to identify incidents. 3. Administrative
burden impacts on national competent authorities The majority of Member
States (15) answered that the burden would decrease (10) after
perhaps an initial increase (due to the reduced number of samples and an
optimum allocation of resources, the repeal of the annual submission and
approval by the Commission, as well as of the double reporting) or that
it would not change globally (5). 9 MS estimated that the burden
would increase at least initially (because of risk assessments to be carried
out, plans to be reviewed on a regular basis/every year). 3 MS didn't or
couldn't answer.
5.2. Overlaps resulting
from the implementation of Directive 96/23/EC and the specific EU pesticides
residues legislation (Regulation (EC) N°396/2005)
The option considered
was to repeal the requirements on official controls on pesticides B3a, B3b, B3f
and B2c currently laid down in Directive 96/23/EC (other than authorised
veterinary medicines) so that Regulation (EC) No 882/2004 and the existing specific
EU pesticides legislation would only apply. 26 MS agreed with the
description of the issue (1 disagreed). No MS was opposed to the option. General comments from
the MS 6 MS underlined that some
group B2c pesticides were pharmacologically active substances for which a MRL
was set up in accordance with Regulation (EC) No 470/2009 and which were used
as VMPs (ecto-parasitics). These pesticides should be treated as VMPs. Several MS were of the
opinion that a broader monitoring of pesticides residues in animals and their
products was needed in order to observe medium and long term trends, to keep
track of consumer exposure and to identify incidents and requested that animals
and food of animal origin should be better represented in the current EU
coordinated (monitoring) programme on pesticides residues. Some MS proposed that
requirements concerning methods of analysis should also be aligned. Several MS stressed the
need to ensure the future financing of official controls on pesticides residues
through fees paid by industry. Member States'
perception of the potential impacts of the option 1. Socio-economic
impacts The majority of the MS
(17) considered that the number of samples taken to test for the
presence of pesticides residues would have been globally lower in
their country, if the frequency of sampling was only determined on the basis of
risk assessments. More than half of them (9/17) expected the sampling capacity
that would be freed to be used to increase the sampling of other substances
and/or on other matrices (in general if justified by risk assessments) or to
use more efficient and expensive methods. 7 MS mentioned reductions of the
number of samples between – 2 % and – 100 % depending on the type of animals or
animal products and the substance or group of substances. Only 6 MS estimated
that the number of samples would remain more or less unchanged (different
distribution of samples or very few samples concerned) and 4 didn't or couldn't
answer. 2. Public health
impacts For the majority of MS
(16), an exclusively risk based system of national controls for pesticides
residues would improve consumer protection (sampling better focussed and
more efficient, better allocation of resources, local specificities better
taken into account). Some MS proposed a rolling program based on risk
assessments with more or less intensive samplings from one year to another. 3 MS felt that the level
of consumer protection would remain the same (inter alia because of very
few samples concerned). All other MS having expressed an opinion (4) answered
that an exclusively risk based system would not or not necessarily improve
consumer protection unless it comprises also a monitoring programme of low
risk/low occurrence substances in order to observe medium/long term trends, to
keep track of consumer exposure and to identify incidents. 3. Administrative
burden impacts on national competent authorities The majority of Member
States (15) answered that the burden would decrease (9) after
perhaps an initial increase (because of less samples, no annual submission and
approval by the Commission, no double reporting, etc.) or that it would
not change (6). 7 MS estimated that the burden would increase at least
initially (because of risk assessments to be carried out, plans to be reviewed
on a regular basis/every year). 5 MS didn't or couldn't answer.
5.3. Enforcement measures
The option considered
was to repeal the requirements on enforcement measures currently laid down in
Directive 96/23/EC (Articles 13, 16, 17, 18, 22,
23, 24 and 25) so that Article 54 of Regulation (EC) No
882/2004 would only apply. 25 MS agreed with the
description of the issue (2 disagreed). General comments from
the MS Some MS were of the
opinion that Article 54 would be sufficient while others were opposed to the
option and requested the current measures to be kept. Several MS differentiated
between minor and major infringements: in their opinion, Article 54 seemed
sufficient for group B substances and simple cases of exceeded MRLs, where more
flexibility was necessary, whereas for group A substances (non authorised
substances, growth promoters), stronger and more uniform enforcement measures
more adapted to animals (than those in Article 54) were needed because of the
use of illegal substances being related to (organised) criminal activities.
Others thought that, if enforcement measures in Directive 96/23/EC were to be
deleted then measures not explicitly covered by Article 54 of Regulation
882/2004 should be "transferred" to the Regulation (this concerned in
particular movement restrictions on livestock and destruction of livestock) Finally, some MS
underlined that enforcement measures would probably be more
questioned/contested by concerned FBOs. Member States'
perception of the potential impacts of the option 1. Socio-economic
impacts 1.1 The majority of the MS (14) considered that, in general,
they wouldn't have taken the same enforcement measures, had current
provisions in Article 54 of Regulation (EC) No 882/2004 been applicable. The
reasons were following: - a more
flexible individual case by case approach as well as better targeted and easier
measures were needed, - in some
cases concerning non authorised substances or growth promoters, measures would
have been less drastic and in others more and/or profounder investigations
would have been necessary, - in cases
of first non conformity concerning an authorised substance, measures would have
been essentially administrative and the focus would be more on repeated
offenders, - if several
different measures were possible, the national approach would be to start with
less harmful measure. 10 MS estimated that they
would have taken more or less the same enforcement measures. 3 MS didn't or
couldn't answer. 1.2. The majority of the MS (16) considered that their
enforcement actions would have been better targeted and/or adapted, had
current provisions in Article 54 of Regulation (EC) No 882/2004 been
applicable. The reasons were globally the same as those described under point
1.1. For 1 MS, they would have been the same. 7 MS only answered that their
enforcement actions would not have been better targeted and/or adapted. 3
didn't or couldn't answer. 2. Public health
impacts For a majority of MS
(17), the repeal of the rigid requirements on enforcement measures
currently laid down in Directive 96/23/EC and the application of current
provisions in Article 54 of Regulation (EC) No 882/2004 would per se
not improve consumer protection (the reason often specified being that the
repeal would have no significant impact on consumer protection).
9 MS were of the opinion that it would improve consumer protection. 1 MS didn't
answer. 3. Administrative
burden impacts on national competent authorities The majority of the MS
(17) estimated that the burden would not change (14) (because of the few
cases concerned, the fact that enforcement measures would remain similar, the
better allocation of time and resources) or that it would decrease (2). 6 MS were however of the
opinion that the burden would increase (mainly because of a more complicated
decision process and an increased number of measures contested by the concerned
FBOs). 4 MS didn't or couldn't answer. 5.4.
National residues monitoring plans The options considered
were: Option 1: repeal the
current prescriptive harmonisation of the modalities for control planning laid
down in Directive 96/23/EC and allow MS to plan
controls according to their own risk assessments and to integrate these
controls in their multi-annual control plan (MANCP) Option 2: option 1
combined with EU harmonised uniform control modalities for certain substances
or groups of substances and/or certain combinations animal(s) or product(s) and
substance(s) established in case of specific "intrinsic"
risks (e.g. growth promoters) or other risks that would justify the introduction of minimum control frequencies at EU level under
certain conditions and for certain combinations animal(s) or product(s) and
substance(s) 24 MS agreed with the
description of the issue (2 disagreed). Option 2 was supported by most of the
MS. General comments from
the MS Option 1 was in general
not supported by the MS (the main reason mentioned was the risk of a non
harmonised approach between the MS with potential impacts on the internal
market and on bilateral agreements with TCs). Option 2 was supported
by most of the MS (18). A lot of MS indeed
underlined the need for a mandatory (if possible EU coordinated) monitoring
plan of at least group A substances (non authorised substances and growth
promoters) and antibiotics (justified by the growing antimicrobial resistance)
as well as dyes, in order to assess consumer exposure to their residues, to
generate sufficient data for the risk assessments, to establish common
guarantees for EU exports towards TCs and to maintain the preventive effect of
such a monitoring. Most MS mentioned that this plan should be revised regularly
and some that it could comprise minimum numbers of samples in accordance with Codex
alimentarius rules (significantly less samples than currently). A lot of MS
underlined that this EU coordinated monitoring plan should be complemented by
national plans based on MS' own risk assessments. Some MS mentioned the
proposal made during the previous consultation on this issue: 60 % of samples
for the EU coordinated plan and 40 % for the national plan. Some MS requested common
principles or guidelines or procedures for the elaboration of the plans based
on risk assessments, others proposed a common set of criteria or the use of
internationally recognised criteria for the risk assessments to ensure a
harmonised approach. Finally,
several MS underlined also: - the
need to ensure the financing of at least a part of the controls trough fees
paid by FBOs, - the
importance of the data on the distribution and use of VMPs (seen as essential
for the risk assessments by some MS), - the
possibility to extend the range of substances analysed through the use of
multi-residue methods, - the
possibility to carry out rolling programmes based on risk assessments with more
or less intensive samplings from one year to another. Member States'
perception of the potential impacts of the options 1. Socio-economic
impacts 1.1. The majority of MS (15) considered that the number of
samples taken would have been lower in their country, had they been
allowed to plan controls only on the basis of their risk assessments (as in
option 1). For several MS, the current number of mandatory samples was indeed
excessive and very few non compliant samples for group A substances were
detected. 13 MS expected the sampling capacity that would be freed to be used
to increase the sampling of other substances and/or on other matrices (in
general if this was justified by corresponding risk assessments) or to use more
efficient and expensive methods. 7 MS mentioned reductions of the number of
samples between – 10 % and – 75 % depending on the type of animals or animal
products and the substance or group of substances. 4 MS estimated the number of
samples would be more or less unchanged (the distribution only of the samples
would be different), 1 MS that the number would not decrease and 7 MS didn't or
couldn't answer. 1.2. 12 MS were able to estimate an impact of EU harmonised uniform
control modalities for certain (groups) substances and/or certain combinations
animal(s) or product(s) and substance(s) (as in option 2) on the number of
samples taken in their country. They mostly mentioned a decrease of the
number of samples compared to the current system which wouldn't be as
significant as for option 1. 2. Public health
impacts 2.1. For a majority of MS (15), a system of controls exclusively
based on their own risk assessments (as in option 1) would improve
consumer protection (as the sampling would be better targeted/focussed,
local specificities taken into account and resources better allocated). 1 MS
estimated that the level of consumer protection would remain unchanged. 7 MS however were of the
opinion that it would not or not necessarily improve consumer protection (inter
alia because a real monitoring of group A substances and antibiotics would
not be guaranteed). 4 MS didn't or couldn't answer. 2.2. Most of the MS (21) were able to estimate an impact of EU
harmonised uniform control modalities for certain (groups) substances and/or
certain combinations animal(s) or product(s) and substance(s) (as in option 2)
in regard to consumer protection. Nearly all of them thought that option 2
would have the most favourable impact on consumer protection. 3. Administrative
burden impacts on national competent authorities 3.1. 10 MS estimated that option 1 would increase the burden at least at
the beginning (because of the establishment of new plans based on own risk
assessments and the regular review of them) and 6 MS answered that the burden
would not change (after an initial increase for some of them). 5 MS were of the
opinion that the burden would decrease (because of less samples to be taken,
the better allocation of resources, the absence of the annual submission and
approval of plans, etc.) and 6 MS didn't or couldn't answer. 3.2. Only 12 MS were able to estimate the impact of option 2 on the
administrative burden of their CA. Views were rather varied however most of the
MS thought the burden would increase at the beginning and then decrease.
5.5. Requirements for third countries (TCs) from which products may be
imported
The options considered
were: Option 1: to repeal the
current prescriptive modalities for TCs' residues monitoring plans in Directive
96/23/EC and replace them by a set of minimum specific guarantees as regards
equivalence or compliance of the control system and programme of veterinary
medicines' residues of the TC (legislation, authorisation, control of
production and use of veterinary medicines, identification of prohibited
substances, control programme for testing residues in animals and food from
animal origin) which shall be provided by the third country in order for it to
be inscribed in the list established under Article 48 of Regulation (EC) No 882/2004 and which shall be controlled during
missions of the Food and Veterinary Office (FVO) at frequencies determined in
accordance with prescriptions of Article 46 of Regulation (EC) No 882/2004 Option 2: option 1
combined with mandatory minimum control
frequencies in TCs' control programmes for certain substances
or groups of substances whose illegal use would
represent a particularly serious violation and/or health risk for the consumers
(e.g. growth promoters or certain antibiotics) and which require a specific
approach (special import conditions). 22 MS agreed with the
description of the issue (3 disagreed). General comments from
the MS MS often insisted on the necessary
equivalence of the system for MS with the system for TCs. Several MS expressed their
clear preference for option 2 which should include mandatory minimum control
frequencies at least for unauthorised substances (even more if these are
authorised in the TC) and growth promoters as well as antibiotics. Other MS
underlined that the submission of plans by TCs and their approval by the Commission
should globally be kept (some adjustments were proposed). Some
MS were also of the opinion that: - residue
control plans of TCs should be based on risk assessments, - common
principles or guidelines or procedures for the elaboration of the plans based
on risk assessments should be established to ensure a harmonised approach by MS
and TCs, - a
harmonised approach for the controls and analyses of imports in the EU was also
needed. Member States'
perception of the potential impacts of the options 1. Socio-economic
impacts 1.1 17 MS were able to estimate a socio-economic impact of option 1 on
their national CA (human resources, controls, etc.). For 7 MS of them, it
shouldn't have a significant impact. The 10 other MS however estimated that
option 1 may result in an increase of the controls at EU boarders (as well as
in an increase of re-exports and alerts for some MS). 1.2 Comparing option 1 with option 2, 18 MS were able to estimate a
difference in the socio-economic impact on their national CA. For 6 of them,
there was no significant difference between option 1 and 2. 7 MS answered that
the increase of controls on imports would be higher in option 1 than in option
2. 3 MS finally estimated that controls on imports would increase only if
certain conditions are not fulfilled by the TC. 2. Public health
impacts 2.1. 13 MS considered that option 1 would not improve consumer protection
whereas 6 MS were of the opinion that it would. 8 MS didn't or couldn’t answer. 2.2. Comparing option 1 with option 2, 20 MS were able to estimate an
impact of mandatory minimum control frequencies in the TCs' control programmes
on consumer protection. For the majority of these MS (18), option 2
would result in a higher consumer protection. For 1 MS, both options would
increase consumer protection and for 1 MS both options were not sufficiently
strong as regards consumer protection. 3. Administrative
burden impacts on national competent authorities 3.1. 13 MS estimated that option 1 would increase the administrative
burden for their national competent authority (mainly because of increased
controls of imports at boarders/in MS). On the contrary 10 MS were of the
opinion that the burden would not change. 4 MS didn't or couldn't answer. 3.2. Comparing option 1 with option 2, 18 MS were able to estimate an
impact of mandatory minimum control frequencies in the TCs' control programmes
on the administrative burden of their competent authority. For 8 of them, there
would be no significant difference between options 1 and 2. 7 other MS
estimated that the burden would be lower in case of option 2 (because of less
controls and less non conformities detected). Annex XXI: DIRECTIVE 96/23/EC - Costs reductions relating to the repeal of Directive 96/23/EC on controls of certain substances (veterinary medicinal products (VMPs), contaminants, residues of pesticides) and residues thereof in live animals and animal products In the MS' replies to the
consultation[162], the average cost per
sample for laboratory analysis only ranged: - from €41 to
€265 when considering all 17 MS having transmitted exploitable data, - from €120 to
€210 when considering 12 out of the 17 MS having transmitted exploitable data. In this study, it is thus
assumed that the EU average cost per sample for laboratory analysis only
is €165. Furthermore, in their
answers, the average total cost per sample including all expenses
(staff, laboratories, consumables, overheads, etc.) ranged: - from €62 to
€436 when considering all 18 MS having transmitted exploitable data, - from €150 to
€350 when considering 16 out of the 18 MS having transmitted exploitable data. In this study, it is thus
assumed that the EU average total cost per sample for laboratory
analysis is €250. Changes under
consideration: (a)
Deletion of the overlaps resulting from the
implementation of Directive 96/23/EC and the specific EU contaminants
legislation (Regulations (EC) N°315/93 and N° 1881/2006) i.e. repeal of the
requirements on official controls on contaminants currently laid down in
Directive 96/23/EC so that Regulation (EC) No 882/2004 and the existing
specific EU contaminants legislation would only apply (sampling only based on
risk assessments) Financial impact: Based on the results of
the consultation of the Member States (MS), the decrease of the number of
samples taken to test for the presence of contaminants is assumed to range
between – 10 % and – 60 %. As in 2009 45 014 samples were analysed under
Directive 96/23/EC for contaminants (i.e. for sub-groups B3a
organochlorine compounds including PcBs, B3b organohosphorus compounds, B3c
chemical elements, B3d mycotoxins, B3e dyes and B3f "others" of Annex
I of the Directive), the decrease would range from 4 501 to 27 008 samples.
Based on these assumptions, the decrease in costs would range: - from
€743 000 to €4 456 000 when considering the average cost per sample for
laboratory analysis only, - from
€1 125 000 to €6 752 000 when considering the average total cost per
sample for laboratory analysis (b)
Deletion of the overlaps resulting from the
implementation of Directive 96/23/EC and the specific EU pesticide residues
legislation (Regulation (EC) N°396/2005) i.e. repeal of the requirements
on official controls on residues of pesticides currently laid down in Directive
96/23/EC so that Regulation (EC) No 882/2004 and the existing specific EU
pesticides legislation would only apply (national sampling only based on risk
assessments). Financial impact: Based on the results of
the consultation of the MS, the decrease of the number of samples taken to test
for the presence of residues of pesticides is assumed to range between – 2 %
and – 100 %. As in 2009 32 796 samples were analysed under Directive 96/23/EC
for residues of pesticides (i.e. for sub-groups B2c carbamates and
pyrethroids, B3a organochlorine compounds, B3b organophosphorus compounds and
B3f "others" of Annex I of the Directive), the decrease
would range from 655 to 32 796 samples. Based on these assumptions, the
decrease in costs would range: - from
€108 000 to €5 411 000 when considering the average cost per sample for
laboratory analysis only, - from
€164 000 to €8 199 000 when considering the average total cost per
sample for laboratory analysis (c)
Repeal the current prescriptive harmonisation
of the modalities for control planning laid down in Directive 96/23/EC
(mandatory minimum numbers of samples) and MS'
controls (and sampling) according to their own risk assessments Financial impact: Based on the results of
the consultation of the MS, the decrease of the number of samples taken is
assumed to range between – 10 % and – 75 %. As in 2009 a total of 445 968
samples were analysed under Directive 96/23/EC, the decrease would range from
44 597 to 334 476 samples. Based on these assumptions, the decrease in costs
would range: - from
€7 358 000 to €55 188 000 when considering the average cost per sample for
laboratory analysis only, - from
€11 149 000 to €83 619 000 when considering the average total cost per
sample for laboratory analysis. (d)
Repeal the current prescriptive harmonisation
of the modalities for control planning laid down in Directive 96/23/EC
(mandatory minimum number of samples), MS'
controls (and samplings) according to their own risk assessments and definition
of EU harmonised uniform control modalities for certain substances or groups of
substances and/or certain combinations animal(s) or product(s) and substance(s)
established in case of specific "intrinsic"
risks (e.g. growth promoters) or other risks that would justify the introduction of minimum control frequencies (or minimum number
of samples) at EU level under certain conditions and for certain combinations
animal(s) or product(s) and substance(s) According
the answers of the MS to the consultation, the decrease of the number of
samples taken compared to the current regime would be lower than the ones
estimated under (c), as a consequence that the decrease in costs would be lower
too. Annex XXII: Directive 96/23/EC – Administrative burden reduction in relation to the repeal of the Directive || Art. no. || Description of the Information Obligation (mainly juridical) || Target group(s) / segments || Total nbr of entities concerned || Frequency per year || Additional information on administrative cost imposed on public authorities by these information obligations Directive 96/23/EC || || || || || || || 5 (1) || By 31 March at the latest of the year of the update, Member States shall submit to the Commission any update of plans setting out the national measures to be implemented previously approved on the basis of the experience of the previous years. || Member States || 27 || Once a year || ACTIVITIES: Coordination and drafting of the changes to the previous plan, changes of the data in the application (addition of substances, methods, limits, levels, number of analyses, etc), uploading the data. STAFF REQUIERED: 3 legislators, senior officials, managers TIME SPENT: 20,000 minutes per MS; 540,000 minutes for the 27 MS COST: € 10,430 per MS; € 281,610 for the 27 MS || 8 (2) || Annual amendments to the initial plans communicated by the Member States shall be forwarded by the Commission to the other Member States once the Commission has established their conformity with this Directive. || Commission || 1 || Once a year || ACTIVITIES: a) Evaluation of the plan, b) Submission to the MS STAFF REQUIERED: several legislators, senior officials, managers TIME SPENT: 28 500 minutes COST: € 14,863 || 8 (2) || If their are no comments from Member States (in 10 working days), the amendments to the plans should be deemed to be approved. The Commission shall inform the Member States of such approval immediately. || Commission and MS || 28 || Once a year || MS ACTIVITY: Drafting of comments STAFF REQUIERED: 1 legislator, senior official, manager TIME SPENT: 700 minutes per MS; 18 900 for the 27 MS COST: € 365 per MS; € 9,860 for the 27 MS COMMISSION ACTIVITY: Information of the MS STAFF REQUIERED: 1 legislator, senior official, manager TIME SPENT: 60 minutes COST: € 31 || 8 (2) || Where there are comments from Member States or where the Commission deems the update not to be in conformity or to be insufficient, the Commission shall submit the updated plans to the Standing Veterinary Committee, which must act under the regulatory procedure referred to in Article 33 (3). || Commission || 1 || Once a year || ACTIVITY: Submission of the updated plans to the Standing Veterinary Committee STAFF REQUIERED: 1 legislator, senior official, manager TIME SPENT: 900 minutes COST: € 469 || 8 (3) || Every six month, Member States shall inform the Commission and the other Member States of the implementation of plans approved or of the development of the situation. || Member States || 27 || Every six month || ACTIVITY: Creation of data, report STAFF REQUIERED: 1 academic legislator, senior official, manager TIME SPENT: 10,000 minutes per MS; 270,000 minutes for the 27 MS COST: € 5,215 per MS; € 140,800 for the 27 MS ACTIVITY: Transmission to the Commission STAFF REQUIERED: 1 technician, associate professional TIME SPENT: 120 minutes per MS; 3,240 minutes for the 27 MS COST: € 37 per MS; € 997 for the 27 MS || 8 (3) || By not later than 31 March each year, Member States shall forward to the Commission the results of their residue and substances detection plans and of their control measures. || Member States || 27 || Once a year || ACTIVITY: Creation of data, report STAFF REQUIERED: 2 legislators, senior officials, managers TIME SPENT: 10,000 minutes per MS; 270,000 minutes for the 27 MS COST: € 5,215 per MS; € 140,800 for the 27 MS ACTIVITY: Transmission to the Commission STAFF REQUIERED: 1 technician, associate professional TIME SPENT: 120 minutes per MS; 3,240 minutes for the 27 MS COST: € 37 per MS; € 997 for the 27 MS || 8 (3) || Member States shall make public the outcome of the implementation of the plans. || Member States || 27 || Once a year || ACTIVITY: Creation of data, report STAFF REQUIERED: 1 legislator, senior official, manager TIME SPENT: 3 300 minutes per MS; 89,100 minutes for the 27 MS COST: € 1,720 per MS; € 46,466 for the 27 MS ACTIVITY: Transmission to the Commission STAFF REQUIERED: 1 technician, associate professional TIME SPENT: 120 minutes per MS; 3240 minutes for the 27 MS COST: € 37 per MS; € 997 for the 27 MS || 8 (3) || The Commission shall inform Member States, within the Standing Veterinary Committee, of developments in the situation in the various regions of the Community. || Commission || 1 || Once a year || ACTIVITY: Information of the MS STAFF REQUIERED: legislators, senior officials, managers TIME SPENT:1 300 minutes COST: € 678 || 8 (4) || Each year, or whenever it deems it necessary on public health grounds, the Commission shall report to Member States within the Standing Veterinary Committee on the outcome of the checks and surveys. || Commission || 1 || Once a year || ACTIVITY: Report to the MS STAFF REQUIERED: 2 legislators, senior officials, manager TIME SPENT: 1 300 minutes COST: € 678 || 8 (5) || The Commission shall send the European Parliament and the Council a communication each year on the results of the action taken at regional, national or Community level, bearing in mind the report and Member States' comments on it. || Commission and MS || 28 || Once a year || MS ACTIVITY: Drafting of comments STAFF REQUIERED: 1 legislator, senior officials, manager TIME SPENT: 900 minutes per MS; 24 300 for the 27 MS COST: € 469 per MS; € 12,673 for the 27 MS EC ACTIVITY: Preparation and sending of the report STAFF REQUIERED: 1 legislator, senior officials, manager TIME SPENT: 13 500 minutes COST: € 7,040 TOTAL COST (per year) || || COMMISSION: € 23,759 27 MS: € 635,175 per MS: € 23,525 || || || || Remarks 1) Source of the "Additional information" column: - MS: informal consultation of the Austrian and UK competent authorities. - EC: phone calls to the different EC officials involved in the process. 2) Method of calculation of the "COST": based on the Calculator of Administrative Costs (AC) & Administrative Burdens (AB) on Public Authorities - types of obligation and main actions taken into account - cost calculation based on the employee type and the corresponding employee tariff 3) The employee tariff are based on standardised ESTAT data. They cover both wages and non-wage labour costs for 9 different types of activities and for all 27 Member States. They reflect 2006 prices and include a standard proportion of so-called overheads costs (i.e. 25%) linked with individual employees and borne by businesses but not included in their salaries (fixed administration costs such as premises, telephone, heating, electricity and IT equipment). Annex XXIII: Main changes to the existing legislative framework under the options included in the analysis This Annex gives an
overview of the main changes to the existing legislative framework implied by
each of the options included in the analysis of this IA. As regards the legislative
technique, while the changes under Option 1 will be introduced by a
Regulation amending Regulation 882/2004, under Options 2 to 4, the changes
would be introduced either through a legislative act amending Regulation
882/2004 and repealing relevant sectoral legislation or by an act which repeals
and replaces Regulation 882/2004 and repeal relevant sectoral legislation. Option 1A – Repeal Union rules on control fees (Existing
mandatory inspection fees are repealed (other provisions of the legislative
framework remain unchanged) The provisions of
Articles 27-29 of Regulation 882/2004, which prescribe the scope and level of
mandatory fees for official controls, will be repealed leaving only the
requirement on MS that they ensure a level of resources necessary to allow the
correct implementation of control requirements and efficient enforcement of EU
law, currently laid down in Article 26 of the Regulation. Option 1B -
Mandatory exemption of micro-enterprises from the application of fees (Existing
mandatory inspection fees are maintained but not applied to micro-enterprises;
other provisions of the legislative framework remain unchanged) This Option would
provide for the mandatory exemption of micro-enterprises from the application
of mandatory fees and would require the breadth of operators upon which
mandatory fees are levied to be appositely restricted. For the rest, Option 1B would maintain the current framework as it stands now. Option 2 –
Streamline (The legislative
framework is improved and streamlined, full cost recovery is ensured where
mandatory fees are already provided) Scope (a) a new provision
will be introduced to explicitly cover official activities performed by the
competent authority not directly linked to ensuring compliance by operators
(e.g. surveillance and monitoring of sanitary status, surveying in view of
planning control activities); (b) the definitions
of 'surveillance', 'monitoring' and 'survey' currently laid down in Regulation
882/2004 will be aligned with those included in the sectoral legislation; Language and
terminology The language and
terminology used throughout the Regulation will be amended to fully account for
all sectors included under its scope, including animal health and animal
welfare legislation, and specific food legislation such as the rules governing
food contact material, and the ones governing the release in the environment of
genetically modified organisms. Methods of
sampling and analysis The cascade of
methods currently in Article 11 of Regulation 882/2004 will be structured more
clearly. It will also be clarified that business operators have the right to
apply for a supplementary expert opinion which can take several forms, inter
alia, where technically possible and relevant, the one of a second
sampling (adjustments for sectoral specificities in the animal health areas
will be provided). Official laboratories (a) The provisions
currently laid down in Article 12 of Regulation 882/2004 will be clarified to
clearly state that all the methods used for analysis or diagnosis by a
laboratory when operating as an official laboratory shall be included in the
scope of accreditation of this laboratory; and that the scope of accreditation
can comprise one or several methods. (b) The possibility of temporary designations
by the competent authority of laboratories not yet having the required method
in their scope of accreditation will be introduced for following cases: -
the
use of the method is a recent requirement in Union legislation, -
changes
of the method in use require a new accreditation or an extension of the scope
of the accreditation of the laboratory, -
an
emergency situation occurs and the sudden increase of analytical or diagnostic
needs requires the urgent use of a validated or standardised method by official
laboratories, -
an
emerging risk requires the performance of analysis or diagnosis by official
laboratories for which no standardised nor validated method exists (e.g.
emerging risks). (c) An empowerment for the Commission to grant permanent
derogations to the mandatory accreditation according to EN ISO 17025 for small
sized laboratories attached to business operator's premises will be introduced. (d) In order to take into account specific characteristics
of the animal health sector, an empowerment for the definition of exemptions to
the general rule that all the methods or protocols used for analysis or
diagnosis by an official laboratory shall be included in the scope of
accreditation, will be created. Official controls for animal
health purposes (a)
Repeal of Directives 89/662, 90/425, 96/93, 89/609. (b)
Account in the Regulation for certain specificities of this sector that is: -
the delegation of official
control tasks to individuals (i.e. approved veterinarians); -
the obligation for the MS
competent authorities to ensure that animals and animal
products and products of animal origin intended for dispatch to another Member
State, and for which official certification is required by Animal Health Law,
are controlled at the place of origin prior to dispatch to another Member
State. Border controls on
goods from third countries (a)
Repeal Directives 97/78/EC and 91/496/EEC and Article
15(5) of Regulation (EC) No 882/2004. (b)
Establish a new set of rules to govern a single system of border controls
capable of handling live animals and their products, food and feed of non
animal origin and other goods of relevance for the food chain (e.g. food
contact materials). Such rules will be the result of streamlining existing
legislation. The single and streamlined system of border controls will consist
of the following elements (for which detailed uniform implementation modalities
will be provided by the Commission through the use of implementing/delegated
powers): -
the categories of goods that
require controls prior to their entry into the EU are explicitly listed, with
an empowerment to determine the specific goods which need to undergo border
import controls (CN codes will be indicated as far as possible); -
the type and frequency of
border controls are harmonised and based on risk criteria. The mechanism for
the continuous adjustment of control rates are, on the basis of risk
assessments, rates applied to specific commodities is established by delegated
acts. -
the current Border
Inspection Posts and Designated Points of Entry are replaced by border posts
potentially capable of carrying out controls on all commodities. Such entities
are subject to a single set of rules and requirements to ensure consistency of
practices; -
similarly, the various health
entry documents currently enshrined in legislation (e.g. Common Veterinary
Entry Document, Common Entry Document) are replaced by a single harmonised
model for all commodities (with necessary adjustments). (c) Introduction of
provisions to strengthen and specify the modalities of cooperation between
competent sanitary authorities designated under Regulation 882, customs
services and other relevant authorities. The objectives and minimum
requirements of such cooperation will be established: e.g. type of information
to be shared between sanitary and customs authorities, timing and modalities of
it, possibility to delegate certain tasks etc, in view of optimising the
synchronisation of parallel processes on the same goods and maximising
efficiency gains. Similarly, the possibility of delegating certain tasks to non
sanitary authorities will be introduced (e.g. controls on passengers' luggage[163]),
and vice versa the possibility that controls on non food chain issues be
delegated to staff of the sanitary authorities present at the borders (e.g.
border controls for the presence of invasive alien species). (d)
Introduction of a provision for the competent
authorities designated under Regulation 882 to be tasked by national
authorities responsible for Invasive Alien Species (IAS) with carrying out
border controls to verify the presence of IAS in the interest of efficiency,
coherence and transparency with the border control system. (e) Empowerments to adopt delegated /
implementing acts to address technicalities of specific sectors are foreseen Information
management and handling system for official controls
(TRACES+) An
empowerment to upgrade the IT tools at the disposal of the Commission and
Member States would also appear necessary under this option in order to
guarantee full efficiency gains. In particular, TRACES would need to be geared
to deal with all commodities, including plants and plant products, and would be
modified to deal with all import controls and documents, including the said
harmonised entry document. Moreover, the interoperability and integration of
TRACES with other Commission and Member State IT tools would need to be
developed so as to ensure a proper and rapid exchange of information at defined
levels with other competent authorities. Finally, in relation to TRACES itself,
a legal basis would need to be foreseen for full electronic certification
including the use of e-signatures so as to guarantee more efficient and safe
import procedures. Official certification Streamline
the requirements currently laid down in Article 30 of Regulation 882/2004 with
those of Directive 96/93 and repeal the latter. Empowerments In
addition to the empowerments mentioned in other sections, the review will seek
to introduce appropriate delegated or implementing powers for the Commission in
those cases where the absence of uniform modalities for the application of the
Regulation's provision is a potential source of under enforcement. Examples
are: (a) Empowerments for the adoption of delegated/implementing acts establishing
minimum requirements and mechanisms for cooperation amongst liaison bodies for
the purpose of improving the administrative assistance and cooperation amongst
MS. (b) Empowerment to
introduce template for annual reports (c) Empowerments to adopt delegated/implementing acts to provide for
uniform minimum requirements of the transparency provisions. Official controls on
residues of veterinary medicines Repeal Directive 96/23/EC so that: -
for
environmental contaminants, only Regulation (EC) N° 882/2004 and the existing
specific EU contaminants legislation would apply (sampling and testing of
environmental contaminants only based on risk assessments), -
for
residues of pesticides, only Regulation (EC) N° 882/2004 and the existing
specific EU residues of pesticides legislation would apply (only the risk
based national control programmes as well as the EU coordinated control
programme under Regulation (EC) N° 396/2005 would exist), -
for
residues of veterinary medicines, only Regulation (EC) N° 882/2004 as well
as eventual implementing/delegated acts imposing minimum levels of mandatory
controls in the MANCPs in cases where the nature of the risks involved requires
a uniform minimum frequencies of controls across the EU would apply, -
only
specific import conditions determined under the common regime of
Regulation (EC) No 882/2004 would apply (third countries would have to
provide information and data on legislation, control plans for testing residues
of veterinary medicines providing guarantees at least equivalent to the ones
provided by the minimum uniform frequencies of controls in the EU, etc.), -
only
Article 54 of Regulation (EC) N° 882/2004 on enforcement measures would apply. Financing of official controls The
list of mandatory fees currently laid down in Regulation 882/2004 will remain
unchanged. Some changes will be introduced to improve the legislative
framework. (a) - Cost recovery The
following requirements will be introduced
where fees are mandatory
Member States shall establish fees on the basis of costs incurred for the
control activities;
fees shall be established at
a level such that they enable CA to fully recover their costs;
where fees are levied on all
operators irrespective of whether the operator receives an inspection
during the reference period, Member States shall set up a system that,
taking into account the record of compliance of each operator, establishes
higher fee rates for less compliant businesses;
the Annexes IV and V to
Regulation 882/2004, which currently set standard/minimum fees will be
repealed.
(b) -
Clearer costing
Control activities which an
operator should be charged for will be specifically listed as follows:
- controls on slaughter, cutting operations and cold storage of meat,
production and placing on the market of fishery products, and milk production; - controls carried out to grant feed establishments approval; - controls carried out at a border on consignments of live animals and
their products,; certain food and feed of non animal origin
The list of elements to be
included in the calculation of overall costs will be better defined.
(c) Transparency The
requirements on MS to inform operators and the public of how control costs are
established and fees calculated will be re-enforced by specifying the elements
of information to be made publicly available. Such element shall include in
particular: ·
Overall cost of
official control activity ·
Breakdown per
cost element (direct and indirect) ·
Level of fee
applied on operator ·
Reference period used for calculation of
costs (e.g. in case of flat rate) (d) Micro-enterprises MS will be provided with the possibility to (partly
or totally) exempt micro-enterprises[164]
from the payment of fees, provided that the exemption does not result in an
equivalent cut in the resources necessary to CA for the performance of official
controls. In other words, the exemption shall be compensated by the allocation
to CA of additional resources equivalent to the difference between the cost of
controls and the fees collected[165]. (e) A transition period of 2 years will be provided for the
smooth introduction of the all provisions governing the financing of official
controls. Option 3 –
Streamline + Integrate (The legislative
framework is improved and streamlined, plant health and plant reproductive
material, and animal by-products are included in its scope, full cost recovery
is ensured where mandatory fees are already provided) In addition to changes described under option 2, option 3
would imply the following changes. Scope (a) the provision designing the scope of the Regulation will
fully include plant health law, plant reproductive material and legislation
governing animal by-products; as a consequence all provisions of the
Regulation, streamlined and amended following option 2, will apply to official
controls (including border controls and communication with customs) and other
official activities not directly linked to ensuring compliance as regards these
sectors unless otherwise provided. (b) following the repeal of Directive 2000/29 and the 12 PRM
marketing Directives, the new Regulations on plant health and plant
reproductive material will no longer include horizontal issues covered under
Regulation 882/2004 (c) repeal of official controls provisions laid down in
Regulation 1069/2009 (animal by-products Regulation) Language and
terminology The language and terminology used throughout the Regulation
will be amended to fully account for the new sectors included under its scope. Official laboratories carrying out plant health
tests (a) determine tailor-made obligations for the accreditation
of official laboratories carrying out plant health tests (accreditation only
for limited numbers of pests representative for pest groups); (b) provide for a five years transitional period to allow
smooth introduction of the obligation to accredit official laboratories in
charge plant health tests; (c) provide for a permanent derogation for universities and
research centres in the plant health and plant reproductive material sectors; (d) introduce the possibility to establish a system of EU
and national reference laboratories. Official certification (a) amend the definition of 'official certification' to
include the official certification issued by operators under the supervision of
the competent authority; (b) amend Article 30 of Regulation (EC) No 882/2004 to
foresee the possibility for the operators to issue the certification under the
supervision of the competent authority, without prejudice of more specific
legislation; (c) specificities of certification will be provided in the
sectoral Regulations on plant health and plant reproductive material. Financing of official controls The
list of mandatory fees will remain as under Option 2 with the only exceptions
being in the field of plant health, where mandatory fees will be introduced for
official controls linked to plant passport obligations[166],
and in the field of plant propagating material, where the principle of full
cost recovery through fees will be established for certification and
registration of varieties.[167] Option
4 – Streamline + Integrate + Broader cost recovery (The
legislative framework is improved and streamlined, plant health and plant
reproductive material, and animal by-products are included in its scope, and
mandatory fees are extended to cover key areas of the food chain) In
addition to the elements of option 3, option 4 would imply the following
changes. (a) the list of mandatory fees will be expanded so as to also cover
official controls carried out on activities for which an obligation for
operators to be registered exists in accordance with Regulation (EC) No
852/2004 on the hygiene of foodstuffs and/or Regulation (EC) No 183/2005 laying
down requirements for feed hygiene. In addition, a fee will be required for all
border controls on goods from third countries carried out to ascertain
compliance with EU food chain requirements. This
option would imply that, in addition to the list of mandatory fees under Option
3, Member States should ensure that a fee is collected to cover the costs
generated by official controls in the following cases: ·
production of
food other than meat, fishery products and milk - these being already included;
that is: eggs and egg products, honey and all foods of non animal origin. ·
distribution (including wholesale, retail and
restaurants) of all food; ·
production and distribution (including
wholesale and retail) of feed; ·
production and distribution of ABP in so far as the concerned operators have to be registered under
Regulation (EC) No 852/2004 or Regulation (EC) No 183/2005; ·
import of products originating from third
countries that need to be checked at the border
other than those already covered by a mandatory fee (for example products
subject to a safeguard measure). (b) A
transition period of 3 years will be provided for the smooth introduction of
all provisions governing the financing of official controls. Annex XXIV- Simplification gains || Title || Description || Expected impact Option 1 1. || Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market || This Directive deals with official controls carried out to verify compliance with animal health requirements in intra- EU trade, with a view to the completion of the internal market. || Repealed because it overlaps with Regulation 882/2004 2. || Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market || This Directive lays down rules relating to veterinary and zootechnical checks to be applied to live animals and products of animal origin for intra-Community trade. This legislation abolishes veterinary and zootechnical checks at the Union's internal borders and reinforces those carried out at the point of origin, during transit and at the place of destination. || Provisions for the application of the veterinary legislation will be repealed because they overlap with Regulation 882/2004. Provisions regarding the zootechnical aspects will remain untouched. 3. || Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products || This Directive defines the prescriptions to be respected when drafting, submitting and executing national residue monitoring plans for live animals and products of animal origin as well as specific enforcement measures in case of non compliances by food businness operators, the requirements for third countries being essentially the same as for Member States. A principal objective of Council Directive 96/23/EC is to detect illegal use of substances in animal production as well as detecting the misuse of authorised veterinary medicinal products. Apart from residues of veterinary medicines, the Directive covers also several residues of pesticides and several environmental contaminants among the group of substances to be controlled within the framework of the national residues monitoring plans. || Repealed and streamlined with the pertinent provisions of Regulation 882/2004 4. || Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters || This Directive establishes the modalities according to which Member States provide each other with mutual assistance to ensure that veterinary and zootechnical laws are properly applied. || Provisions for the application of the veterinary legislation will be repealed because they overlap with Regulation 882/2004. Provisions concerning the zootechnical aspects will remain untouched. 5. || Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC || This Directive defines the prescriptions to be respected when drafting and executing national residue monitoring plans for live animals and products of animal origin. A principal objective of Council Directive 96/23/EC is to detect illegal use of substances in animal production as well as detecting the misuse of authorised veterinary medicinal products. || Repealed. Certain provisions will be streamlined into Regulation 882/2004. 6. || Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries || This Directive sets out the legal framework governing the checks to be carried out on products of animal origin from third countries at border inspection posts. || Repealed and replaced by the new chapter on import controls of Regulation 882/2004. 7. || Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC. || The Directive defines the arrangements for the external border checks and for the internal movement of live animals from third countries. || Repealed and replaced by the chapter on import conditions in Regulation (EC) No 882/2004. Delegated / Implementing acts Option 2 8. || Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community || This Directive lays down measures designed to protect Member States against the introduction of organisms harmful to plants and plant products from other Member States or third countries. This Directive also lays down measures designed to protect Member States against the spread of harmful organisms within the European Union || Repealed. Regulation 882/2004 will apply for the aspects related to official controls. For the rest the new Plant Health Law will apply 9. || 12 Directives on the marketing of plant reproductive material || || 10. || Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) || The purpose of the legislation is to safeguard public and human health by providing enforceable controls for the safe disposal of animal by-products. || Repealed because redundant General principles in Regulation 882/2004 Annex XXV: Exemptions and reductions for micro-enterprises Regulation 882/2004
requires MS to account for the interests of low-throughput businesses when
setting fees, as it can be expected that these establishments may be
disproportionately affected by the charging of fees, by comparison with larger
establishments. During the consultation process for the 2011 external study of
inspection fees, the issue of whether sufficient consideration is
currently given to the needs of SMEs was raised, and in particular, to the
needs of micro-enterprises[168]. Summary of
stakeholder opinions Through the 2011 study,
stakeholders (CAs and industry) were asked to consider the advantages and
disadvantages of including fee exemptions or reductions in the revised
legislation, impacts on the different stakeholder groups, and whether the
Regulation should provide a universal exemption for micro-enterprises under EU
law or provide the option for MS to implement reductions or exemptions as
they choose. For the purpose of the 2011 external study supporting the impact assessment[169], the definition of "micro-enterprise" applied is that set out in Commission Recommendation 2003/361/EC[170]. This states that a micro-enterprise is a business which has fewer than 10 employees and has: · An annual turnover of not more than €2 million; and / or · A balance sheet of not more than €2 million. CA and industry
respondents were clearly in favour of the option to have an exemption or
reduction, or to have no special terms for micro-enterprises, rather than to
introduce a universal exemption or reduction. CAs and industry
recognised that such an amendment would reduce the financial burden on
micro-enterprises and help to encourage development of small businesses.
Indeed exemptions are currently provided to micro-enterprises in 11 Member States
(five Member States do not offer such reductions or exemptions and information
is not available for the remaining 11 Member States[171]). Industry noted that
provisions to reduce the burden on micro-enterprises would be important if
Regulation 882/2004 was to be amended to achieve full cost recovery (for
example by better defining the activities subject to mandatory fees and the
removal of minimum fees), and particularly in light of the possibility to
expand the scope of mandatory fees to sectors not currently covered, whereby
micro-enterprises in a number of sectors would be required to pay fees for the
first time. On the other hand,
several industry respondents expressed concern that fee exemptions or
reductions for micro-enterprises were unfair on those enterprises not subject
to exemptions. It was suggested that an effective risk-based system might
automatically reduce the costs for the best-performing micro-enterprises. Both CAs and
industry commented that a universal exemption / reduction for micro-enterprises
would have a negative impact or, at best, no impact at all on the sustainable
performance of official controls. In particular, CAs voiced their concerns
that a universal exemption / reduction would be likely to have a negative
impact on resource mobilisation in situations where less fee revenue is
collected but the number of controls remains the same, for example in MS with a
large quota of micro-enterprises. CAs felt that the fees charged to
micro-enterprises, if at a reduced rate, may not cover the cost of collection. These views,
expressed by stakeholders, are consistent with, and confirm the overall
conclusion drawn in the Impact Assessment that it would not be appropriate to
introduce a universal requirement for MS to exempt all micro-businesses from
payment of mandatory fees as: (i) stakeholders (businesses and MSs) have
opposed a rigidly established mandatory exemption (ii) such an exemption would
have a disproportionate impact on competition and on cost recovery in MS with a
large quota of micro-businesses. Measure of the
impact of a universal exemption / reduction for micro-enterprises As highlighted by
CAs during consultation (see above) a universal exemption / reduction for
micro-enterprises would have a disproportionate impact on cost recovery in MS
with a large quota of micro-businesses. Figure 1
demonstrates the number of SMEs as a percentage of the total number of
enterprises in the major industries affected by official control activities and
it can be seen from Figure 2 (and broken down by industry in Table 2) that the
large majority of these are micro-enterprises. Indeed, for 16 of the 23 Member
States for which data are available, micro-enterprises represent more than half
of all FBOs in the four major industries affected by official controls (for 9
of the 23[172], this figure rises to
two thirds or more of all enterprises). Table 2 demonstrates that the
strongest disruption to effective cost recovery would occur for official
control in the dairy products industry where 72% of all operators are
micro-enterprises. In Slovakia, only 13% of relevant enterprises are
micro-enterprises and potential impact might be expected to be smaller, whereas
in Sweden, the figure rises to 80% and potential impact would be expected to be
much larger. Figure 1. Share of SMEs in total number of
enterprises in the four major European industries affected by official control
activity (2008)* Figure 2 Share
of Micro-enterprises in total number of enterprises in the four major European
industries affected by official control activity (2008)* *Industry sectors include: processing and preserving of meat and
production of meat products; processing and preserving of fish, crustaceans and
molluscs; manufacture of dairy products; manufacture of prepared animal feeds.
Greece and Malta are not included in Eurostat dataset. Data for the Czech
Republic and France are not available. Table 2 - Share of micro-enterprises in
total number of enterprises in EU MS by sub-sectors (2008) || Processing and preserving of meat and production of meat products || Processing and preserving of fish, crustaceans and molluscs || Manufacture of dairy products || Manufacture of prepared animal feeds || Total || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share AT || 1,092 || 763 || 70% || 6 || 2 || 33% || 158 || 117 || 74% || 56 || 25 || 45% || 1,312 || 907 || 69% BE || 823 || 571 || 69% || 56 || : || : || 442 || 373 || 84% || 149 || 76 || 51% || 1,470 || 1,020 || 69% BG || 475 || 201 || 42% || 31 || 8 || 26% || 273 || 125 || 46% || 106 || 47 || 44% || 885 || 381 || 43% CY || 71 || 46 || 65% || : || : || : || 147 || 127 || 86% || 38 || 28 || 74% || 256 || 201 || 79% CZ || 1,467* || : || : || : || : || : || 146 || : || : || : || : || : || 1,613 || : || : DK || 147 || 89 || 61% || 119 || 55 || 46% || 75 || 49 || 65% || 67 || 39 || 58% || 408 || 232 || 57% EE || 53 || 20 || 38% || 59 || 23 || 39% || 31 || 11 || 35% || 13 || 9 || 69% || 156 || 63 || 40% FI || 204 || 142 || 70% || 147 || 129 || 88% || 52 || 29 || 56% || 77 || 55 || 71% || 480 || 355 || 74% FR || 10,410* || : || : || 496* || : || : || 1,457 || : || : || : || : || : || 12,363 || : || : DE || 11,044 || 6,558 || 59% || 233 || : || : || 401 || 207 || 52% || 420 || 263 || 63% || 12,098 || 7,028 || 58% HU || 592 || 334 || 56% || 13 || 11 || 85% || 100 || 53 || 53% || 196 || 119 || 61% || 901 || 517 || 57% IE || 133 || 26 || 20% || 68 || 15 || 22% || 59 || 20 || 34% || 58 || 22 || 38% || 318 || 83 || 26% IT || 3,559 || 2,495 || 70% || 442 || 277 || 63% || 3,295 || 2,469 || 75% || 579 || 365 || 63% || 7,875 || 5,606 || 71% LV || 128 || 62 || 48% || 108 || 36 || 33% || 42 || 15 || 36% || 16 || 8 || 50% || 294 || 121 || 41% LT || 176 || 69 || 39% || 66 || 37 || 56% || 69 || 46 || 67% || 25 || 10 || 40% || 336 || 162 || 48% LU || 27 || 14 || 52% || 0 || 0 || 0% || 5 || 1 || 20% || 0 || 0 || 0% || 32 || 15 || 47% NL || 491 || 325 || 66% || 115 || 64 || 56% || 258 || 206 || 80% || 182 || 96 || 53% || 1,046 || 691 || 66% PL || 3,283 || 2,134 || 65% || 410 || 280 || 68% || 718 || 467 || 65% || 461 || 343 || 74% || 4,872 || 3,224 || 66% PT || 633 || 382 || 60% || 211 || 112 || 53% || 439 || 345 || 79% || 128 || 52 || 41% || 1,411 || 891 || 63% RO || 909 || 532 || 59% || 41 || 25 || 61% || 633 || 413 || 65% || 128 || 88 || 69% || 1,711 || 1,058 || 62% SK || 72 || 17 || 24% || 8 || 3 || 38% || 38 || 3 || 8% || 60 || : || : || 178 || 23 || 13% SI || 163 || 110 || 67% || 5 || 2 || 40% || 87 || 77 || 89% || 16 || 9 || 56% || 271 || 198 || 73% ES || 4,153 || 2,771 || 67% || 689 || 356 || 52% || 1,462 || 1,168 || 80% || 837 || : || : || 7,141 || 4,295 || 60% SE || 494 || 367 || 74% || 214 || 180 || 84% || 127 || 108 || 85% || 100 || 91 || 91% || 935 || 746 || 80% UK || 1,035 || 545 || 53% || 343 || 189 || 55% || 543 || 357 || 66% || 426 || 263 || 62% || 2,347 || 1,354 || 58% Total || 29,757** || 18,573 || 62% || 3,095*** || 1,804 || 58% || 9,454** || 6,786 || 72% || 3,241 || 2,008 || 62% || 60,709 || 29.171 || 48% Source: Eurostat. *2007 figure ** Sum does
not include CZ and FR. *** Sum does not include BE, FR, DE GR and MT are not included in Eurostat
dataset Figures in Total column includes all available
data Despite the large
share of total enterprises attributed to micro-enterprises within the sectors
most affected by official control activities, their share of the total
turn-over within their respective MS is, by comparison, low. Table 3 illustrates
that in all but one MS (Cyprus) share of total turn-over attributed to
micro-enterprises is less than 10% (and for 17 MS it is 5% or less). This
re-enforces the fact that a very low turn-over of individual micro-enterprises
by comparison with larger operators in these sectors, makes the relative impact
of fees for official controls disproportionately greater. Table 3 Share of micro-enterprises'
sectoral turnover in total sectoral turnover in EU MS (2008) (absolute figures
in millions of euros) || Processing and preserving of meat and production of meat products || Processing and preserving of fish, crustaceans and molluscs || Manufacture of dairy products || Manufacture of prepared animal feeds || Total* || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share AT || 3,276 || 244 || 7% || 32 || : || : || 2,394 || 61 || 3% || 900 || : || : || 6,602 || 305 || 5% BE || 5,267 || 454 || 9% || 482 || 0 || : || 4,241 || 153 || 4% || 3,259 || 297 || 9% || 13,248 || 904 || 7% BG || 897 || 33 || 4% || 30 || 1 || 2% || 372 || : || : || 147 || 6 || 4% || 1,445 || 40 || 3% CY || 325 || 26 || 8% || : || : || : || 234 || 27 || 11% || 136 || 68 || 50% || 695 || 121 || 17% CZ || : || : || : || : || : || : || : || : || : || : || : || : || : || : || : DK || 5,374 || 76 || 1% || 1,761 || 51 || 3% || 0 || : || : || 2,973 || 59 || 2% || 10,109 || 185 || 2% EE || 246 || 10 || 4% || 124 || 15 || 12% || 383 || : || : || 67 || 4 || 7% || 820 || 30 || 4% FI || 2,499 || 49 || 2% || 160 || 33 || 20% || 0 || : || : || 439 || 36 || 8% || 3,098 || 117 || 4% FR || 35,750 || 3,597 || 10% || 3,140 || : || : || 26,780 || 2,907 || 11% || 11,978 || 812 || 7% || 77,648 || 7,316 || 9% DE || 39,522 || 1,720 || 4% || 2,533 || : || : || 27,593 || 69 || 0% || 8,882 || 158 || 2% || 78,529 || 1,946 || 2% HU || 2,645 || 109 || 4% || 3 || 1 || 32% || 1,106 || 11 || 1% || 926 || 47 || 5% || 4,680 || 168 || 4% IE || 4,275 || 31 || 1% || 373 || 14 || 4% || 3,556 || 32 || 1% || 1,082 || 53 || 5% || 9,287 || 129 || 1% IT || 19,153 || 1,251 || 7% || 2,114 || 309 || 15% || 17,423 || 1,589 || 9% || 6,000 || 579 || 10% || 44,691 || 3,728 || 8% LV || 375 || 9 || 2% || 218 || 3 || 1% || 349 || 2 || 1% || 51 || : || : || 993 || 13 || 1% LT || 615 || 9 || 1% || 232 || 5 || 2% || 856 || 1 || 0% || 339 || : || : || 2,042 || 14 || 1% LU || 116 || 4 || 3% || 0 || 0 || : || 0 || : || : || 0 || 0 || : || 116 || 4 || 3% NL || 8,248 || 267 || 3% || : || : || : || 9,642 || 95 || 1% || 7,219 || 222 || 3% || 25,109 || 584 || 2% PL || 11,800 || 487 || 4% || 1,442 || 52 || 4% || 6,064 || 96 || 2% || 2,947 || 117 || 4% || 22,253 || 752 || 3% PT || 2,199 || 94 || 4% || 1,093 || : || : || 1,703 || 58 || 3% || : || 98 || : || 4,995 || 249 || 5% RO || 2,481 || 63 || 3% || 68 || 2 || 3% || 1,053 || 33 || 3% || 233 || 2 || 1% || 3,834 || 101 || 3% SK || 703 || 16 || 2% || 56 || 1 || 2% || 585 || : || : || 233 || : || : || 1,576 || 17 || 1% SI || 670 || 30 || 5% || 15 || : || : || 316 || 6 || 2% || 98 || : || : || 1,099 || 36 || 3% ES || 19,637 || 1,414 || 7% || 4,160 || 178 || 4% || 10,659 || 817 || 8% || 9,852 || : || : || 44,308 || 2,408 || 5% SE || 3,502 || 218 || 6% || : || 89 || : || 2,752 || 53 || 2% || 698 || 77 || 11% || 6,951 || 438 || 6% UK || 16,624 || 276 || 2% || 2,981 || 64 || 2% || 9,609 || 144 || 1% || 5,880 || 247 || 4% || 35,092 || 731 || 2% Total || 186,197 || 10,484 || 6% || 13,722 || 729 || 5% || 126,913 || 6,151 || 5% || 52,865 || 2,784 || 5% || 399,220 || 20,335 || 5% *Figures in Total column includes all available data Annex XXVI: The development of an EU dedicated legislative instrument to tackle Invasive Alien Species – potential synergies with the revision of the rules on border control Invasive
alien species (IAS) are animals and plants that are introduced accidentally or
deliberately outside of their natural past or present distribution. They
represent a serious threat to biodiversity in Europe, as well as to plant
health (e.g. agricultural weeds), to animal and human health (e.g. disease
transmitting insects, allergenic weeds, poisonous species) and to the economy
(e.g. blocking drainage systems), causing millions of euro worth of damage
every year. The
Commission published a Communication[173]
"Towards an EU Strategy on Invasive Species" in December 2008 and
noted that there is currently no comprehensive instrument at EU level to tackle
IAS, except for some aspects of the problem which are addressed by the plant
and animal health regimes. As
announced in its EU 2020 biodiversity strategy[174],
the European Commission is currently developing a dedicated legislative
instrument to tackle outstanding challenges relating to IAS prevention, early
detection and rapid response and containment and management, beside seeking to
streamline biodiversity concerns into the existing legal instruments of the
animal and plant health regimes. The dedicated instrument on IAS is expected to
close the policy gaps, not yet addressed by the EU animal and plant health
regimes, including a mechanism to control the import of listed IAS. Possible
synergies between Regulation 882 and the forthcoming IAS legal instrument In the interest of efficiency and clarity,
border controls on the import of listed IAS could be performed at the same
entry points designated for other EU official border controls as established by
Regulation 882, carried out to apply the plant and animal health legislation.
This would avoid creating a parallel system of border controls but would take
advantage of a well functioning system with limited extra investment, mainly
limited to extra staff resources and training, as well as increased
collaboration with the designated competent authorities. A provision in Regulation 882 could allow
that the competent authorities designated by Regulation 882 can be tasked by
the IAS relevant competent authorities to carry out the necessary border
controls to verify the presence of IAS. This is expected to create efficiency
gains as well as avoiding the creation of a confusing legal framework for
importers, through the establishment of a parallel system of border controls.
The impacts and benefits of such possibility will be fully described and
analysed in the Impact Assessment accompanying the legislative proposal on IAS. Consultations
and finding Within the framework of
the work on the forthcoming proposal for a dedicated legislative instrument on
IAS, an intensive consultation exercise was held between 2010 and 2011. A
crucial element of discussion was how to prevent the entry of new IAS into the
territory of the EU: it was generally recognised that prevention is a much more
cost-effective way of dealing with IAS, rather than reacting to established
species or after the onset of an invasion. Border
controls done according to harmonised EU rules were strongly supported as an
appropriate means to avoid new invasions. There were calls to streamline as
much as possible the border control with existing EU instruments in order to on
the one hand ensure an efficient and cost effective use of resources and on the
other hand to avoid creating an overly complex system by creating a parallel
system of controls. The need to create synergies with existing and
well-functioning systems was often stressed. This lends support to the
mechanism whereby border controls on IAS could be delegated to the competent
authorities established by Regulation 882, with a view to increasing efficiency
and maintaining the system of border control as simple and streamlined as
possible. [1] COM/2009/334/Final. [2] Regulation
(EC) No 882/2004 of the European Parliament and Council of 29 April 2004
on official controls performed to ensure the verification of compliance with
feed and food law, animal health and welfare rules. [3] Council Directive
96/23/EC of 29 April 1996 on measures to monitor certain substances and
residues thereof in live animals and animal products and repealing Directives
85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC. [4] Council Directive 2000/29/EC
of 8 May 2000 on protective measures against the introduction into the
Community of organisms harmful to plants or plant products and against their
spread within the Community. [5] These conclusions were based
on a 2009 study on "Fees or charges collected by Member States to cover
the costs occasioned by official controls". The executive summary is
available at Annex X. [6] (COM (2010) 785 final); the
report is published on: http://ec.europa.eu/food/animal/bips/guidelines_en.htm
[7] Article 15(5) of Regulation
(EC) No 882/2004 establishing the framework for the
performance of import controls on feed and food of non-animal origin;
Directives 97/78 of 18 December 1997 laying down the principles governing the
organisation of veterinary checks on products entering the Community from third
countries, and 91/496 of 15 July 1991 laying down the principles governing the
organization of veterinary checks on animals entering the Community from third
countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC;
Directive 2000/29 on protective measures against the introduction into the
Community of organisms harmful to plants or plant products; the latter
governing, inter alia, border controls on plants and plant products. [8] For an overview of the
legislation on official controls co-existing with Regulation 882/2004 see
figure 1 and Annex II. [9] The IAs accompanying those
initiatives are available at: http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm#sanco.
[10] The FVO audits reports since
2007 are listed in Annex VII. [11] GHK Consulting Ltd working
with ADAS UK Ltd. [12] Annex XI provides for the
executive summary of the study carried out by GHK to support the impact
assessment on reviewing the rules on the financing of official controls. [13] See Annex V. [14] Details on the consultation
process are available at Annex IV. [15] http://ec.europa.eu/food/committees/regulatory/index_en.htm.
[16] For a complete overview of
the existing legislative framework applicable to official controls along the agri-food
chain see Annex II. [17] See Eurostat Pocketbooks,
Food: From Farm to Fork Statistics 2008 Edition European Commission [18] Enterprises with less than 10
employees and or a turnover or balance sheet equal to or less than €2 million. [19] Micro-enterprises are also
likely to be represented in large numbers in other industries subject to
official controls. [20] Source: Comext various years. [21] For the most recent overview
of the operation of controls activities in the Member States (years 2008-2009)
and of the Commission's own control activities (2008-2010), see Commission
Report on the overall operation of official controls on food safety, animal
health and animal welfare and plant health COM(2012) 122. [22] Directive 89/662/EEC of 11
December 1989 concerning veterinary checks in intra-Community trade with a view
to the completion of the internal market. [23] Council Directive 89/608/EEC of 21 November 1989 on mutual assistance
between the administrative authorities of the Member States and cooperation
between the latter and the Commission to ensure the correct application of
legislation on veterinary and zootechnical matters. [24] The data presented in these
examples have been collected from Member States under Directive 96/23/EC and
stored in DG SANCO application 'Residues: Monitoring Plants and Results version
4.1.1. [25] EU border controls:
Directives 97/78/EC of 18 December 1997 laying down the principles governing
the organisation of veterinary checks on products entering the Community from
third countries, and 91/496/EEC of 15 July 1991 laying down the principles
governing the organization of veterinary checks on animals entering the
Community from third countries and amending Directives 89/662/EEC, 90/425/EEC
and 90/675/EEC; Directive 2000/29 on protective measures against the
introduction into the Community of organisms harmful to plants or plant
products; the latter governing, inter alia, border controls on plants and plant
products. Official controls on residues of veterinary medicines: Council Directive 96/23/EC of 29
April 1996 on measures to monitor certain substances and residues thereof in
live animals and animal products and repealing Directives 85/358/EEC and
86/469/EEC and Decisions 89/187/EEC and 91/664/EEC. [26] Ibid. [27] A
laboratory can only be accredited for the use of standardised and/or validated
method. [28] See also Impact Assessment
report on "the proposal to revise the EU Plant Health Legislation",
which highlights the same difficulties in that area and indicates that full
cost recovery of control costs is essential for the good functioning of the
relevant control systems. [29] Separate fee provisions are
also laid down in Directive 2000/29, covering certain aspects of official plant
health control activities. [30] Annex XI and Table 4 of this
Impact Assessment Report [31] Where standard / minimum fees
are higher than the actual cost of the official control activities they are
meant to remunerate, MS can apply lower fees. [32] The EP recently received a
petition from a MS veterinary department, concerned that the fees collected by
that MS could not fully compensate costs incurred and thus finance controls. [33] COM (2011)803 [34] A detailed description of the
organisation of control authorities in each MS, prepared and constantly updated
by the Commission in close cooperation with each MS can be found at: http://ec.europa.eu/food/fvo/country_profiles_en.cfm
[35] DG SANCO has developed an
extensive baseline scenario (see Annex XVI) against which each of the options
has been assessed. [36] See Impact Assessment report
on "the proposal to revise the EU Plant Health Legislation" for an
overview of the economic and environmental impacts which may result from an
increase in the influx of harmful organisms into the EU. [37] As the Treaty of Lisbon has
made the Charter of Fundamental Rights of the EU legally binding, the results
of this review shall be in full compliance with the Charter of Fundamental
Rights of the EU, in particular the right to protection of personal data and the
right to an effective remedy. [38] For a description of the
elements of each option and main changes implied see Annex XXIII. [39] The baseline only describes
the situation in MS as regards the collection of fees for the purposes of
control activities currently falling within Regulation 882/2004. [40] Article 27(2) of the
Regulation. [41] Article 27(1) of the
Regulation. [42] Article 27(2) of the
Regulation. [43] Council Directive 89/662/EEC
of 11 December 1989 concerning veterinary checks in intra-Community trade with
a view to the completion of the internal market; Council Directive 90/425/EEC
of 26 June 1990 concerning veterinary and zootechnical checks applicable in
intra- Community trade in certain live animals and products with a view to the
completion of the internal market;; Council Directive 96/93/EC of 17 December
1996 on the certification of animals and animal products; Council Directive
89/608/EEC of 21 November 1989 on mutual assistance between the administrative
authorities of the Member States and cooperation between the latter and the
Commission to ensure the correct application of legislation on veterinary and
zootechnical matters. [44] Article 15(5) of Regulation
(EC) No 882/2004 establishing the framework for the
performance of import controls on feed and food of non-animal origin;
Directives 97/78 of 18 December 1997 laying down the principles governing the
organisation of veterinary checks on products entering the Community from third
countries, and 91/496 of 15 July 1991 laying down the principles governing the
organization of veterinary checks on animals entering the Community from third
countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC;
Directive 2000/29 on protective measures against the introduction into the
Community of organisms harmful to plants or plant products; the latter
governing, inter alia, border controls on plants and plant products. [45] The option of requiring MS to
exempt all micro-businesses from payment of mandatory fees is presented in
Option 1B and analysed in section5 (Analysis of impacts). With regard to Plant
Health, exemptions for micro-enterprises will not apply given that most
operators under these health regimes could qualify as micro-businesses (see
Impact assessment report on "the proposal to revise the EU Plant Health
Legislation"). The IA accompanying the proposal to review PRM acquis
follows the approach presented here. [46] At present only Articles
41-46 of Regulation 882/2004 apply to Plant health. [47] Official controls provisions
laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures
against the introduction into the Community of organisms harmful to plants or
plant products and against their spread within the Community; 12 Council
Directives on the marketing of plant reproductive material; Regulation (EC) No
1069/2009 of the European Parliament and of the Council of 21 October 2009
laying down health rules as regards animal by-products and derived products not
intended for human consumption and repealing Regulation (EC) No 1774/2002. [48] See section 2.1.1 and the
analysis of Option 1B in section 5. The proportion mentioned is even higher if
SME's are considered alongside micro-enterprises. [49] Also see Annex XXV. [50] Given the huge economic losses and human suffering that may result
from food crises (see e.g. the dioxins/E. Coli crises) any policy option should
aim to avoid them, even when this implies imposing burdens on operators. [51] See Annex XXV for a summary
of stakeholder opinions. [52] http://www.fooddrinkeurope.eu/uploads/publications_documents/Final_Data__Trends_30.4.2012.pdf
[53] For plant health, see impact
assessment report on "the proposal to revise the EU Plant Health
Legislation" [54] For a quantification of the
costs reductios relating to the repeal of Directive 96/23/EC see Annex XXI;
those data are also included in the table 4 (section 6.2.) providing an
overview of the costs and benefits associated to each option. [55] Therefore, the refund could
be replaced by an exemption from the payment of the fees only if an amount
equivalent to the loss of cost recovery is transferred from the general budget
to the CA. [56] Simplification gains
described in Annex XXIV. [57] Obviously in those areas in
which no mandatory fees are required, variations, which are not accounted for
by cost differences, will remain. [58] The data used to construct
this table is highly uncertain. It is intended to provide an indicative
assessment of the distributional impact of requiring full cost recovery based
on current rates of recovery. Actual impacts will be influenced by a range of
factors in addition to current cost recovery rates. [59] In certain MS the level of
cost recovery for mandatory fees is unknown and may amount to 0%. Such MS are
not compliant with existing EU legislation which requires recovery on the basis
of actual costs or minimum/standard fees. While these MS will inevitably face
a greater burden if Option 2 is adopted and the principle of full cost recovery
is reinforced, part of that additional cost is the result of bringing the
national practice into line with existing rules, and not the
consequence of the option being considered here. [60] Sector production value
€400bn/year. No of enterprises 60,000 (Eurostat 2008). Average annual
inspection charge per operator at full cost recover approximately €80,000/year
(Industry data). [61] See Article 3(1) Arrête Royal du 10
Novembre 2005 relatif aux rétributions visées à l'article 5 de la loi du 9
Décembre 2004 portant financement de l'Agence fédérale pour la Sécurité de la
Chaine alimentaire. [62] See SANCO validated baseline,
Annex XVI. [63] See Arrête Royal du 10 Novembre 2005
relatif aux rétributions, cited above. [64] It should be noted that
Option 2 does not prescribe how Member States should achieve full cost
recovery. The latter are therefore free to choose the type and manner of cost
recovery, which does not necessarily imply it will be spread evenly across all
fees. [65] In other words, this figure
does not include further processing costs (e.g. cutting, de-boning, packaging,
etc.), nor profit margins down the processing and distribution line. Taking
such elements into account would result in a significant increase of the total
value of meat per kilogram (at least 25% on average). [66] Such percentages would be
even lower if compared to the final value of the carcass noted in the footnote
above. [67] See SANCO validated baseline,
Annex XVI. [68]
http://www.food.gov.uk/foodindustry/meat/mhservice/chargesguide. [69] This calculation is carried
out on the basis of hourly rates applicable to middle and junior managers in
the UK. See http://www.statistics.gov.uk/statbase/product.asp?vlnk=13101. [70] Costs of an FTE within a
particular MS will depend on the applicable salary levels. See Table 6, Annex
XVII for a breakdown of hourly salary rates for the food safety agencies of
several MS. [71] See Section 5 of Annex XX. [72] Simplification gains
described in Annex XXIV. [73] For a quantification of these
costs see Annex XIX; these data are also included in table 4 (section 6.2.)
providing an overview of the costs and benefits associated to each option. [74] Annex XVII, Tables 7-8 present an analysis
of the number of enterprises in each Member State that could be affected by an
extension of the scope of mandatory fees to cover operators registered in
accordance with Regulations (EC) No 852/2004 and No 183/2005. In summary, the
assessment of expanding the scope of mandatory fees indicates that high impact
will be felt in a relatively small number of countries, but where a large
number of businesses may be affected. In the majority of MS, operators would
see moderate impact from this extension. See also Annex XI. [75] Combined new fees for sectors
currently subject to mandatory fees (i.e. top up fees in meat sector under
Option 2) and those to be charged for the first time under Option 4. No. of
enterprises 25m (Eurostat 2008). Typical range of fees charged under Option 4 -
€85-€1500 (see Box 6). [76] See Italian Official Journal
No. 289 of 11 December 2008. [77] Ibid, Annex A. [78] The hourly charge for
official control activities in Italy has been calculated as being €50/hour and
this forms the basis for all subsequent determination of fees. See Italian
Official Journal No. 289 of 11 December 2008, Annex C. [79] See DG SANCO's validated
baseline, Annex XVI. [80] Feed producers are charged
€11,984.70 where production is more than 200,000 tonnes per year. See Avis relative a l'indexation des
montants fixes a l'arrête royal du 10 Novembre 2005 fixant les contributions
visees a l'article 4 de la loi du 9 decembre 2004 relative au financement de
l'Agence Federale pour la securite de la chaine alimentaire. [81] See Annex XVI. [82] Ibid. [83] For Option 3, costs/benefits
would relate to inclusion of plant health, PRM and ABP into the scope, impacts
of which have been assessed within the relevant Impact Assessments for these
sectors and which are not included here. [84] Based on FI / UK data. See
Box 6. [85] Sector production value
€400bn/year (DG Enterprise). No. of enterprises 60,000 (Eurostat 2008). Average
annual inspection charge per operator at full cost recovery approximately
€80,000/year (Annex XI). [86] , The majority of operators,
in individual MS, are currently being charged between 30% and 80% of inspection
charges, with some paying 100% (see figure 4) [87] New fees for those sectors to
be charged for the first time under option 4. Average cost to operators not
currently subject to fees - €85 – 1500/yr (See Box 6). No. of operators who are
not currently subject to fees – 25m (Eurosat 2008). [88] Based on UK industry
estimates (see Box 6) [89] See footnotes 85-87 above [90] This is in line with the conclusions of the
abovementioned impact assessment reports on plant health and plant reproductive
material where full cost recovery is also foreseen. [91] Commission
Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No
882/2004 of the European Parliament and of the Council as regards the increased
level of official controls on imports of certain feed and food of non-animal
origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 1). [92] Regulation (EC)
N°396/2005 on maximum residue levels of pesticides in or on food and feed of
plant and animal origin and amending Council Directive 91/414/EEC requires MS
to carry out official controls on pesticides residues in accordance with
relevant provisions of Regulation (EC) N° 882/2004 and to establish risk based
multi-annual national control programmes. It requires also the Commission to
prepare a coordinated multi-annual Union control programme with a view to
assessing consumer exposure and the application of current legislation. [93] Council
Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures
for contaminants in food defines contaminant as any substance not intentionally
added to food which is present in such food as a result of the production
(including operations carried out in crop husbandry, animal husbandry and
veterinary medicine), manufacture, processing, preparation, treatment, packing,
packaging, transport or holding of such food, or as a result of environmental
contamination. Regulation (EEC) 315/93 and Regulation (EC) N° 1881/2006 require
MS to carry out official controls on contaminants on the basis of their own
risk assessment. [94] Regulation (EC)
No 854/2004 of the European Parliament and of the Council of 29 April 2004
laying down specific rules for the organisation of official controls on products
of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206). [95] Council Directive 91/496/EEC of 15 July
1991 laying down the principles governing the organization of veterinary checks
on animals entering the Community from third countries and amending Directives
89/662/EEC, 90/425/EEC and 90/675/EEC. [96] Council Directive 97/78/EC of 18 December
1997 laying down the principles governing the organisation of veterinary checks
on products entering the Community from third countries. [97] Commission
Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border
inspection posts, laying down certain rules on the inspections carried out by
Commission veterinary experts and laying down the veterinary units in Traces. [98] Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks in intra- Community trade with a
view to the completion of the internal market. [99] Council Directive 90/425/EEC of 26 June
1990 concerning veterinary and zootechnical checks applicable in intra-
Community trade in certain live animals and products with a view to the
completion of the internal market. [100] Council Directive 96/93/EC of 17 December
1996 on the certification of animals and animal products. [101] Council Directive 89/608/EEC of 21 November 1989 on
mutual assistance between the administrative authorities of the Member States
and cooperation between the latter and the Commission to ensure the correct
application of legislation on veterinary and zootechnical matters [102] Regulation (EC) No
1069/2009 of the European Parliament and of the Council of 21 October 2009
laying down health rules as regards animal by-products and derived products not
intended for human consumption and repealing Regulation (EC) No 1774/2002
(OJ L 300, 14.11.2009, p. 1). [103] Council Directive
2000/29/EC of 8 May 2000 on protective measures against the introduction into
the Community of organisms harmful to plants or plant products and against
their spread within the Community (OJ L 169, 10.7.2000). [104] Council Directive
66/401/EEC of 14 June 1966 on the marketing of fodder plant seed; Council
Directive 66/402/EEC on the marketing of cereal seed; Council Directive
68/193/EEC of 9 April 1968 on the marketing of material for the vegetative
propagation of the vine; Council Directive 98/56/EC of 20 July 1998 on the
marketing of propagating material of ornamental plants; Council Directive
1999/105/EC of 22 December 1999 on the marketing of forest reproductive
material; Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of
varieties of agricultural plant species; Council Directive 2002/54/EC of 13
June 2002 on the marketing of beet seed; Council Directive 2002/55/EC of 13
June 2002 on the marketing of vegetable seed; Council Directive 2002/56/EC of
13 June 2002 on the marketing of seed potatoes; Council Directive 2002/57/EC of
13 June 2002 on the marketing of seed of oil and fibre plants; Council
Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating
and planting material, other than seed; Council Directive 2008/90/EC of 29
September 2008 on the marketing of fruit propagating material and fruit plants
intended for fruit production. [105] Directive
89/662/EEC of 11 December 1989 concerning veterinary checks in intra- Community
trade with a view to the completion of the internal market [106] Council Directive 89/608/EEC
of 21 November 1989 on mutual assistance between the administrative authorities
of the Member States and cooperation between the latter and the Commission to
ensure the correct application of legislation on veterinary and zootechnical
matters [107] Regulation (EC)
No 183/2005 of the European Parliament and of the Council of 12 January 2005
laying down requirements for feed hygiene [108] Regulation (EC)
No 852/2004 of the European Parliament and of the Council of 29 April 2004
on the hygiene of foodstuffs [109] Regulation (EC)
No 854/2004 of the European Parliament and of the Council of 29 April 2004
laying down specific rules for the organisation of official controls on
products of animal origin intended for human consumption [110] Official controls
carried out in the area of plant health. [111] A laboratory can
only be accredited for the use of standardised and/or validated method [112] Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004 on materials and
articles intended to come into contact with food and repealing Directives
80/590/EEC and 89/109/EEC. [113] Directive
2001/18/EC of the European Parliament and of the Council of 12 March 2001 on
the deliberate release into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC. [114] On the ongoing
initiative on Invasive Alie Species, see Annex XXVI. [115] Food Chain
Evaluation Consortium (FCEC), consisting of Civic Consulting, Agra CEAS
Consulting (project leader), Van Dijk Management Consultants and Arcadia
International. [116] http://ec.europa.eu/food/food/controls/inspection_fees/docs/external_study_en.pdf;
Annex X to this document provides for the executive summary of this study. [117] GHK [118] Annex XI to this
document provides for the study carried out by GHK to support
the impact assessment on reviewing the rules on the financing of official
controls. [119] See Annex XVIII. [120] See Annex XX. [121] See annex XX of
this document [122] Council Directive 96/23/EC of 29 April
1996 on measures to monitor certain substances and residues thereof in live
animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC
and Decisions 89/187/EEC and 91/664/EEC. [123] The questionnaire
and the results of this consultation are presented in Annex XX. [124] See Annex XXI. [125] http://ec.europa.eu/food/plant/strategy/index_en.htm
[126] Stakeholders active in the
fields of Plant Health and Plant reproductive material were also consulted in
the context of the related reviews. [127] Stakeholders active in the
fields of Plant Health and Plant reproductive material were also consulted in
the context of the related reviews, inter alia as regards the inclusion
of those sectors under Regulation 882 and consequent implications. [128] Regulation (EC) No 882/2004 of
the European Parliament and of the Council of 29 April 2004 on official
controls performed to ensure the verification of compliance with feed and food
law, animal health and animal welfare rules. [129] Regulation (EC)
178/2002 (General Food law) and the Hygiene Package (Regulations (EC) 852/2004,
853/2004 and 854/2004). [130] Including consultations
with the following EU professional organisations: AVEC, CIBC/IMV/IBC, CLITRAVI,
EDA, FEFAC, FVE, and the UECBV. [131] It is noted that addressing
some of the current shortcomings identified by this study requires action that
extends beyond the financing provisions of Regulation 882/2004, to the wider
legislation in the area of food and feed safety. The discussion of solutions to
such shortcomings was therefore limited to its relevance to the costs and the
financing of the official controls. [132] This Annex only refers to the
inspection fees collected for the purpose of control activities currently
covered by Regulation 882/2004 (feed and food law, animal health and animal
welfare rules). [133] Food Chain
Evaluation Consortium (FCEC), consisting of Civic Consulting, Agra CEAS
Consulting (project leader), Van Dijk Management Consultants and Arcadia
International. [134] http://ec.europa.eu/food/food/controls/inspection_fees/docs/external_study_en.pdf;
Annex II provides for the executive summary of this study. [135] GHK [136] Annex III
provides for the study carried out by GHK to support the impact assessment on
reviewing the rules on the financing of official controls. [137] This Annex only
refers to the inspection fees collected for the purpose of control activities
currently covered by Regulation 882/2004 (feed and food law, animal health and
animal welfare rules). [138] At it's meetings
of 10 November and 5 December 2011. [139] http://ec.europa.eu/food/committees/regulatory/index_en.htm
[140] This Annex only
refers to the inspection fees collected for the purpose of control activities
currently covered by Regulation 882/2004 (feed and food law, animal health and
animal welfare rules). [141] This Annex only
refers to the inspection fees collected for the purpose of control activities
currently covered by Regulation 882/2004 (feed and food law, animal health and
animal welfare rules). [142] The baseline data
provided by DG SANCO indicate that Poland achieves full cost recovery;
interviews with the Polish CA for this study, however, suggest that there is
little data on cost recovery and that cost recovery is thought to be insufficient. [143] Regulation (EC) No
765/2008 of the European Parliament and of the Council of 9 July 2008 setting
out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218,
13.8.2008, p. 30–47) [144] Commission Decision
98/179/EC. [145] Regulation (EC) No 396/2008 [146] Replies were received from
AT, BE, CZ, DE, DK, ES, FR, IE, LV, NL, MT, PL, SE, SI, SK. [147] One MS does not have any such
laboratory at all but has contracted out all analyses to other MS. [148] This is the average number of
relevant laboratories in the 15 MS that replied to the consultation. [149] Most of these laboratories
are accredited according to and by ISTA which does not comply with the
requirements for national accreditation bodies and the operation of
accreditation of Regulation (EC) N° 765/2008 of the European Parliament and of
the Council of 9 July 2008 setting out requirements for accreditation and
market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93. [150] Reflection Paper on residues in foodstuffs
of animal origin [151] OJ L 224, 18.8.1990, p. 1. [152] OJ L 125, 23.5.1996, p. 3 [153] OJ L 125, 23.05.1996, p. 10 [154] Comments to the Reflection
paper-29.6.2004 [155] OJ L 152, 16.6.2009, p. 11 [156] OJ L 318, 28.11.2008, p. 9 [157] OJ L 165, 30.04.2004, p. 1 [158] Regulation (EC) No 178/2002
of the European Parliament and of the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in matters of food safety – OJ
L 31, 01.02.2002, p. 1 [159] EFSA Report for 2009 on
the results from the monitoring of veterinary medicinal product residues and
other substances in live animals and animal products [160]
http://www.codexalimentarius.net/download/standards/11252/CXG_071e.pdf [161] http://ec.europa.eu/comm/food/food/chemicalsafety/residues/third_countries_en.htm [162] Revision of
Directive 96/23/EC on measures to monitor certain substances and residues
thereof in live animals and animal products: consultation of the competent authorities
in the Member States on the impacts of the different options 08/02/2011 [163] Currently, the possibility
for sanitary authorities to delegate controls on passengers' luggage to customs
services exists only in the animal health area. [164] Enterprises with less than 10
employees and a turnover or balance sheet total equal or less than €2 million. [165] The option of requiring MS to
exempt all micro-businesses from payment of mandatory fees was discarded. See
section 4.2. (Discarded policy options). With regard to Plant Health,
exemptions for micro-enterprises will not apply given that most operators under
these health regimes could qualify as micro-businesses; the new plant health
legislation will foresee specific exemptions from plant passporting obligations
for small companies operating exclusively on the local market (see Impact
assessment report on "the proposal to revise the EU Plant Health
Legislation"). With regards to plant reproductive material, whether or not
exempting micro-business is still under consideration in the context of the
ongoing IA. [166] See Impact Assessment report
on the proposal to revise the EU Plant Health Legislation. [167] See Impact Assessment report
on the placing on the market and production, with a view to placing on the
market, of plant reproductive material [168] Annex X [169] Annex XI [170]
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:en:PDF [171] DG SANCO baseline and Eurostat
2008 [172] AT, BE, CY, FI, IT, NL, PL,
SE, SI [173] http://ec.europa.eu/environment/nature/invasivealien/docs/1_EN_ACT_part1_v6.pdf
[174]http://ec.europa.eu/environment/nature/biodiversity/comm2006/pdf/2020/1_EN_ACT_part1_v7%5b1%5d.pdf