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Document 52013DC0264
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer Agri-Food Chain A modernised legal framework for a more competitive EU
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer Agri-Food Chain A modernised legal framework for a more competitive EU
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer Agri-Food Chain A modernised legal framework for a more competitive EU
/* COM/2013/0264 final */
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer Agri-Food Chain A modernised legal framework for a more competitive EU /* COM/2013/0264 final */
CONTENTS 1........... The current context......................................................................................................... 4 1.1........ Animal Health................................................................................................................. 4 1.2........ Plant health..................................................................................................................... 4 1.3........ Plant reproductive material.............................................................................................. 5 1.4........ Official controls.............................................................................................................. 5 1.5........ Management of
expenditure............................................................................................ 6 2........... The need to modernise the EU
legal framework for animals, plants and the food chain...... 6 2.1........ Animal health.................................................................................................................. 6 2.2........ Plant health..................................................................................................................... 7 2.3........ Plant reproductive material.............................................................................................. 7 2.4........ Official controls.............................................................................................................. 8 2.5........ Management of
expenditure............................................................................................ 8 3........... The ‘Review Package’.................................................................................................... 8 4........... The content of the ‘Review
Package’.............................................................................. 9 4.1........ The Animal Health Law.................................................................................................. 9 4.1.1..... Main changes................................................................................................................. 9 4.2........ The Plant Health Law................................................................................................... 10 4.2.1..... Main changes............................................................................................................... 11 4.3........ The Plant Reproductive Material
Law........................................................................... 12 4.3.1..... Main changes............................................................................................................... 12 4.4........ The Regulation on Official
Controls............................................................................... 14 4.4.1..... Main changes............................................................................................................... 14 4.5........ Management
of expenditure.......................................................................................... 16 5........... Conclusion................................................................................................................... 16 COMMUNICATION FROM THE COMMISSION TO
THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer
Agri-Food Chain
A modernised legal framework for a more competitive EU Introduction Ensuring a high level of health for humans,
animals, and plants is a Treaty objective of the EU. Over time, the EU has
built up a comprehensive body of law designed to prevent and manage risks to animal
and plant health and the safety of the food chain at EU and national level. The
law in these policy areas is enforced by means of a common set of rules on official
controls to be carried out by the competent authorities in the EU Member
States. The legal framework which the EU has
developed so far has proven, overall, to be effective in preventing and
countering risks. However, the modern global market increasingly exposes the EU
to new risks and constantly calls for innovation and competitiveness. This and
the experience gained with EU law in this area, points to the need to simplify
and update available instruments and to further integrate the approach across
the different areas. The Commission therefore conducted a revision
of the current legal framework for animal health, plant health, plant
reproductive material and official controls aimed mainly at increasing
effectiveness, consistency and legal clarity in those areas. In doing so, it was
seeking to foster the productivity, smooth functioning and accessibility of the
internal market and to reinforce the EU’s competitiveness on a global scale.
Thus, the review is ultimately contributing to delivering smart, sustainable
and inclusive growth in line with the EU 2020 goals. This Communication presents the resulting four
legislative proposals in the four areas of animal health, plant health, plant
reproductive material and official controls (the ‘review package’) and
explains, for each of them, the current context, the rationale behind the
package and the main improvements introduced. The review package also includes 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 and in related areas while allowing businesses to operate in an
environment that favours competitiveness and job creation. Food production and consumption is central to any society, and has
economic, social and, in many cases, environmental consequences. The agri-food
industry is the second largest segment of EU industry. The total output of the
food chain is worth some € 750 billion a year. The sector employs over 48
million people, from primary production through to retail and catering. There
are around 14 million primary agricultural producers and 25 million food
businesses operating along the EU agri-food chain. 1. The
current context In order to afford citizens a high level of
human, animal and plant health while encouraging the efficient functioning of
the internal market, EU legislation provides a set of harmonised rules to
prevent, eliminate or reduce health risks to humans which may arise along the agri-food
chain and in the two areas most closely related to it, i.e. plant and animal
health. Overall, EU rules aim at addressing health risks proper — i.e. risks to
the integrity of humans, animals and plants from microbial and chemical
contamination, diseases and pests — but they may also include measures ensuring
productivity and diversity in plant production (for food security purposes) and
regulating specific production methods (e.g. animal welfare and geographical indications). 1.1. Animal
health Animal health is a concern for all. Currently, EU
intervention is focused on preventing and controlling transmissible diseases
that may have significant health and economic impacts. The impact of an animal
disease outbreak can vary widely, but it usually poses a direct risk to animal
and often public health, partly through food of animal origin. However, there
can also be indirect negative effects (possibly economic or social), including the
cost to livestock farmers and related industries of dealing with disease and of
business disruption, the cost to the public sector of eradicating and
monitoring the disease, and changes in consumption patterns. Often, disease
outbreaks also have significant effects on international trade in animals and
animal products. Across the EU, the farming sector is the largest
user of animals, with at least 2 billion birds (chickens, laying hens,
turkeys, etc.) and 334 million mammals (pigs, sheep, goats, cattle, fur
animals, etc.). There are 13.7 million animal holdings in the EU. The value of
livestock farming output in the EU is € 156 billion a year. 1.2. Plant
health Plant health is a key factor in sustainable and
competitive agriculture, horticulture and forestry. A large proportion of the
food we consume, and of the feed fed to food-producing animals, comes from
plants. The first objective of plant health rules is to protect the living
products (i.e. trees, shrubs and plants) of EU agriculture, horticulture and
forestry, public and private green (for example street trees, plants within
public / private gardens) and the environment by preventing the entry and
spread of non-native pests. Plant health rules secure safe trade by imposing EU
import requirements and conditions for the movement of plants and plant
products within the EU. Outbreaks of listed pests have to be eradicated or, if
that is impossible, contained to protect the rest of EU territory. A second
objective is to ensure that healthy plant material is used at the beginning of
the chain of plant production, by preventing the spread of pests in seeds and
planting material. The value of crops grown in the EU is € 205
billion annually. Without the protection afforded by plant health rules, EU
agriculture, horticulture and forestry would suffer severe economic damage. A
range of internationally regulated pests threatens the cultivation of crops such
as wheat (value of EU exports: € 9 billion), potatoes (EU production value:
€ 9 billion) and tomatoes (production value: € 9-12 billion). 1.3. Plant
reproductive material Plant reproductive material is the cornerstone of
agricultural, horticultural and forest production. It is the first link in the agri-food
chain, affecting the diversity, health and quality of plants and food. Plant
reproductive material is controlled to ensure the identity, health and quality
of the material for the benefit of its users, e.g. farmers, gardeners or
foresters. The objectives of EU legislation on plant reproductive material are
to improve agricultural, horticultural and forest productivity, ensure the
smooth operation of the EU market for those products and the competitiveness of
the sector on a global scale. Today, the EU commercial seed market is worth
approximately € 6.8 billion, which represents more than 20 % of total
worldwide sales of commercial seed. The EU is a net exporter of seeds. The EU sector is also highly competitive in world
trade: it is the world’s largest exporter of seeds, with an estimated export
value of € 4.4 billion, representing roughly 60% of the total worldwide seed
export value of €7.7 billion. 1.4. Official
controls A high level of health along the agri-food
chain depends on consistent, effective and timely enforcement of EU standards
by the Member States. The correct application of agri-food chain rules and of
the rules on animal health and animal welfare, on plant health, on plant
reproductive material and on plant protection products must be ensured across
the EU for humans, plants and animals to be healthier and for the internal
market to thrive and work smoothly. For this to be possible, the relevant authorities
in the Member States must be given a clear, reliable and consistent legal
environment in which to make effective and efficient use of enforcement tools,
and of official controls in particular. They also need appropriate resources to
ensure continuity and consistency in their work, on the basis of needs linked
to enforcement objectives. More than 100 000 full-time staff are assigned
to performing official controls in the EU, which involve inspections and other
control-related activities. To give but a few examples: some 70 000
samples a year on average are analysed by over 270 accredited laboratories checking
for pesticide residues. In 2010 alone, 736 806 samples were taken to check
veterinary residues. Some 320 000 samples from domestic poultry and wild
birds were analysed in 2011 purely in relation to avian influenza. The efficient operation of an EU-wide system of
official controls is of paramount importance both for exports and imports. The EU’s
capacity to export to non-EU countries relies on the added value that its products
can be shown to have compared to those of competitors from outside the EU. This
can be only be achieved by having an efficient official controls system which
ensures that high standards of safety and quality are consistently enforced and
the corresponding expectations of trade partners are met. In the other
direction, the EU is the world’s largest importer of live animals, food and
feed. Checks carried out by the Member States’ competent authorities on
products arriving from non-EU countries ensure that the latter comply with EU standards
or with standards which offer an equivalent level of protection. In 2010 EU food and beverage imports were worth € 78
billion, and exports € 73 billion. The EU 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, and
a surplus of 6 million tonnes for beverages. 1.5. Management
of expenditure The current legal basis for
EU funding is: Council Decision 2009/470/EC for veterinary eradication
programmes and veterinary emergency measures; Council Directive 2000/29/EC for
plant health measures; and Regulation (EC) No 882/2004 of the European
Parliament and of the Council for funding measures regarding EU reference laboratories,
Better Training for Safer Food (BTSF) and other measures deployed to implement official
control rules. In 2011 € 314.6 m was
mainly allocated to animal disease eradication programmes. Expenditure on laboratories,
BTSF and other measures represented 9 % of the total. 7 % was allocated
to plant health operational measures, while 3 % was allocated to the
emergency fund for veterinary and other diseases. 2. The
need to modernise the EU legal framework for animals, plants and the agri-food
chain 2.1. Animal
health The current EU animal health legislative
framework consists of around 50 basic directives and regulations, some of which
were adopted in the early 1960s. Since then a body of over 400 veterinary acts —
most of them drawn up between 1988 and 1995 for a Community of only 12 Member
States — has been built up. Meanwhile, new challenges have emerged: diseases
have sprung up which were unknown a decade ago, while others (e.g. foot and
mouth disease, bluetongue and avian flu) have recently reappeared, reminding us
of the serious risks they pose. Trading conditions have also changed radically,
with the volume of trade in animal products increasing significantly both
within the EU and worldwide. In 2004 the Commission launched an independent
evaluation to assess the performance of the Community Animal Health Policy (CAHP)
over the previous decade. Although both this evaluation and the later
consultations concluded that, overall, the current system was functioning
properly, it also revealed the need for a revision of the current rules to
address the following issues: –
the complexity of the policy framework; –
the lack of an overall animal health strategy; –
insufficient focus on disease prevention; –
the possibility of improving intra-EU trade in
live animals. 2.2. Plant
health Since their introduction in 1977, plant health
rules have protected the EU against the introduction and spread of many pests.
Currently, Council Directive 2000/29/EC is the main instrument in this area.
However, with trade globalisation and climate change the EU is facing a higher
risk of entry of new pests, increased opportunities for their establishment and
spread as well as increased vulnerability of agricultural and natural
ecosystems. An evaluation of plant health rules carried out
in 2010 showed that the current regime must adapt in order to address new risks
effectively. Indeed, in the last ten years major outbreaks of dangerous
import-related pests affecting forestry (e.g. pine wood nematode, citrus
longhorn beetle, and red palm weevil) have raised awareness among policy makers
and the public of the cost and impact of inadequate protection. The main
problems identified by the 2010 evaluation related to: –
insufficient focus on prevention in relation to imports
presenting high risks; –
the need to focus on pests which spread across
Member States and so are a priority for the EU; –
the need for more effective instruments for
controlling the presence and natural spread of pests; –
the need to modernise existing instruments for intra-EU
movement (i.e. plant passports and protected zones). 2.3. Plant
reproductive material The EU legal framework for plant reproductive
material has developed since the 1960s. It consists of 12 basic Council directives
and nearly 90 secondary acts covering variety listing for the purpose of authorisation
for marketing and specific marketing requirements for different species. While EU legislation has achieved the initial
objectives of guaranteeing free marketing and ensuring the safety and quality
of plant reproductive material, the following issues require further attention: –
the complexity and the fragmentation of the current
legislation; –
the considerable administrative burden for
authorities, as most of the tasks on registration and certification need to be carried
out by official authorities; –
the lack of consistency with other EU policies
(e.g. sustainable agriculture and forestry, biodiversity protection, climate
change, the bio-economy); –
the lack of a consistent approach to recovering
the costs of registering varieties and certifying plant reproductive material. 2.4. Official
controls Official controls are governed by Regulation
(EC) No 882/2004. Evidence of its implementation has been collected primarily
through on-the-spot auditing by experts of the European Commission, but also
through feedback from Member States and stakeholders regarding the actual
day-to-day implementation. This evidence confirms that the main changes
introduced by the 2004 Regulation to the way competent authorities organise and
carry out official controls along the agri-food chain has laid the basis for a
more integrated and horizontal, and thus more efficient, approach to enforcement.
At the same time, it points to a set of shortcomings which call for further
improvements, in particular: –
simplification of the overall legal framework,
which currently suffers from the remaining fragmentation, overlaps and gaps,
and therefore differences in interpretation and implementation at national
level; –
more consistent use of the ‘risk-based controls’
principle; –
more systematic and consistent use of
administrative cooperation tools and of computerised information systems; –
the repeal of unnecessary administrative
requirements. As regards the financing of official controls
and the need to ensure steady and consistent funding of the work of the
competent authorities, the evidence also points to current uncertainties about the
long-term sustainability of official controls. An external study carried out in
2011 found that the Regulation’s provisions on financing official controls from
fees are not fully delivering on the objective of ensuring an adequate level of
resources to conduct official controls. There is also evidence that the current rules are
failing to ensure a fair and consistent approach across sectors: only some sectors
are charged, and fees are not calculated in a uniform and transparent manner
across Member States, or in a manner that rewards operators’ compliance. 2.5. Management
of expenditure The current legal framework
has to be adjusted in line with the proposed changes in the different policy
areas to ensure their objectives are met. Furthermore, management of expenditure
is currently complex and needs aligning with the Multiannual Financial Framework
(MFF). A new legal basis is therefore needed. 3. The
‘Review Package’ To pursue the objective of strengthening,
modernising and streamlining the current legal environment in order to ensure a
high level of protection of human, animal and plant health, the Commission is
putting forward a package of five proposals to
revise EU rules: –
laying down animal health requirements (the Animal
Health Law); –
laying down protective measures against pests of
plants (the Plant Health Law); –
governing the production and placing on the
market of plant reproductive material (the Plant Reproductive Material Law); –
governing official controls and other official
activities performed to ensure compliance with the entire set of agri-food
chain rules (including the above) (the Regulation on Official Controls); and –
governing the management of
EU expenditure in the main areas of the agri-food chain. All five legislative proposals covered by the package
are to be submitted to the European Parliament and Council for adoption under
the ordinary legislative procedure (under Articles 289(1) and 294 of the Treaty
on the Functioning of the European Union). The European Economic and Social
Committee and the Committee of the Regions will be asked for an opinion. 4. The
content of the ‘Review Package’ 4.1. The
Animal Health Law The EU Animal Health Strategy 2007-2013 was
adopted in 2007[1].
At its heart is the notion that ‘prevention is better than cure’ and its goals
are to ensure a high level of public health and food safety; to support farming
and the rural economy; to improve economic growth, cohesion and competitiveness;
and to promote farming practices and animal welfare which minimise
environmental impacts. Later on, the Action Plan for the implementation of the
strategy[2]
referred to the development of an EU Regulation on animal health, referred to
here as the Animal Health Law (AHL), as one of the main deliverables of the
strategy for a modern and innovative legal framework supporting the
achievements of the above goals. The Commission’s proposal for the AHL is the
result of extensive consultations of interested parties. 4.1.1. Main
changes Simplification, modernisation and increased consistency across EU animal health legislation
have been major driving principles of the revision process in this area. In line with this approach, the AHL lays down
the foundations for a wide and comprehensive legislative framework for
EU animal health policy. It clearly sets out the overarching principles and
objectives necessary to reduce animal disease further while maintaining the EU’s
economic competitiveness. Detailed provisions — such as specific disease
control measures, identification and registration rules for certain species, and
specific measures on intra-EU movement for particular species — are to be dealt
with by means of delegated or implementing acts. Using these acts to introduce
more specific rules or requirements allows the flexibility and speed needed to
react to rapidly changing scenarios and veterinary emergencies. Enhancement of disease surveillance, disease
notification and reporting networks will
better support early detection and control of diseases, including emerging
diseases such as those linked to climate change, and ensure greater convergence
with international standards. Simplification and clarification A simpler legislative framework will help
authorities and operators to understand and use it, ensure their actions are
more consistent and objective-focused, and set out general principles to be
followed to promote disease prevention and control. This has the potential to reduce
the administrative burden on them by cutting down the time taken to
familiarise themselves with the legislation and by introducing scope for simplifying
certain administrative requirements and making them more coherent including a
more coherent and consistent legal framework for vaccination. The new AHL will clarify the animal health responsibilities
of operators, veterinarians and others, partly by requiring a basic level of
knowledge for the first time. Introducing new technologies The AHL will allow more scope for using new
technologies for animal health activities such as monitoring pathogens,
electronic identification and registration of animals and electronic
certificates. Use of new technologies and systems will tend to reduce the
administrative burden on both veterinary authorities and operators in their day-to-day
work. Increased flexibility through the use of a risk-based
approach Criteria for listing animal diseases,
categorised systematically and on a scientific and evidential basis will be
introduced. This will allow the EU to better prioritise the use of its resources,
giving less priority to diseases which pose less risk. Wider use of ‘compartmentalisation’ will
be permitted (i.e. where some farms are considered safe even during disease
outbreaks), allowing a more risk-based approach to animal disease control and
potentially fewer trade restrictions. 4.2. The
Plant Health Law The Commission’s proposal for
a Regulation on protective measures against pests of plants, referred to here
as the Plant Health Law, meets the request of the Council of 21 November 2008 for an evaluation of
the EU plant health rules, considering the need to amend the existing
legal framework and the impact of such amendments. Stakeholders and Member
States authorities were extensively consulted throughout the revision process. Against this background,
the proposed Regulation aims to overcome the flaws identified following the
evaluation of the plant health rules in 2010 and to put in place a robust,
transparent and sustainable regulatory framework that is ‘fit for purpose’.
Overall, synergies with the plant reproductive material regime are reinforced,
while avoidable duplications and unnecessary burdens are removed. Official
controls by Member States’ competent authorities on operators’ compliance with
EU plant health requirements are covered in the proposal for a Regulation on
Official Controls. 4.2.1. Main
changes Scope The geographical scope of the proposed
Regulation is limited to the territories of the Member States in Europe,
excluding overseas countries and territories and outermost regions, where the
pests against which the EU needs to be protected are indigenous. The proposed Regulation covers all organisms directly
harmful to plants, i.e. insects, mites, nematodes, pathogenic micro-organisms and
parasitic plants (now called pests). It covers both quarantine pests and
quality pests, as currently regulated under the ‘Marketing Directives’
for seed and plant propagating material. Criteria for deciding on the
appropriate assignment of pests (quarantine or quality) are provided in the
Annexes to the Regulation. The Annexes also set out principles and measures for
the management of phytosanitary risks. Exports of
plants, plant products and other objects to third countries are also covered
by the proposed Regulation. Exports are governed either in accordance with
the relevant EU requirements, or, if the non-EU country’s rules so allow or
that country so agrees, in accordance with the requirements of that country.
The proposal also provides for the introduction of a pre-export certificate,
for cases where plant material is exported from a Member State which is not the
Member State of origin. The pre-export certificate is meant to replace the
informal guidance document currently in use. Enhanced prevention on import and reinforced
early action against outbreaks Prevention is enhanced by empowering the
Commission to adopt precautionary measures concerning new, high-risk
planting material imported from non-EU countries, based on a preliminary
risk assessment, for a time limit of four years. This time span is considered
necessary to perform a full risk assessment and rule on the appropriateness of
permanent measures. The proposed Regulation provides that when passengers
bring regulated plants into the EU territory in their luggage they must now
comply fully with the relevant requirements and prohibitions. Furthermore, the proposed Regulation obliges Member
States to carry out surveillance in their territory for the presence of
pests in areas where they were not previously known to occur. If pests are
detected, Member States will be expected to carry out eradication measures,
including the demarcation of a restricted area consisting of an infested zone
surrounded by a buffer zone. In addition, enhanced levels of preparedness and
surveillance are required for quarantine pests identified as priority pests.
Surveillance and eradication obligations will not apply to quality pests. The proposed Regulation empowers the Commission
to adopt implementing acts to contain (control) quarantine pests that cannot be
eradicated from the EU territory. Reinforcement and modernisation of the
internal market provisions Where plant material is to be moved within the
EU, the proposed Regulation provides for the mandatory use of a plant passport,
attesting compliance with the legislation on quarantine and quality pests. The passport,
simplified and standardised under the Commission’s proposal, is to be issued
by operators, under the supervision of the competent authorities. Operators
will have to store the information necessary to trace infested consignments, but
the passport can contain data carriers (barcodes, etc.) instead of the current
lot number. Where planting material requires both, a plant passport and a
certification label under EU law on plant reproductive material, the two labels
can now be combined in a single document, thus reducing the administrative
burden on operators. Plant passports will be required for all nursery
stock, but not for sales to final non-professional users. 4.3. The
Plant Reproductive Material Law In 2007, Member States in the Council asked
that the existing legislation on marketing plant reproductive material be made
simpler. Following an external evaluation[3]
in 2007-2008, an Action Plan[4]
was adopted in 2009. The Commission’s proposal for a Regulation on the
marketing of plant reproductive material (referred to here as the Plant
Reproductive Material Law, builds on extensive consultations of Member States,
stakeholders and the Community Plant Variety Office (CPVO). 4.3.1. Main
changes The major principles behind the revision were simplification,
modernisation, cost reduction, greater efficiency and increased flexibility
for operators, ensuring an appropriate level of harmonisation across the EU and
horizontal coordination with other, mostly environmental EU policy objectives. Simplification and modernisation These objectives have been achieved by replacing
the 12 directives currently dealing with specific types of plant
reproductive material, such as agricultural crops, fruit plants, ornamental
plants, vegetables and forest reproductive material, with one regulation.
It introduces harmonised basic rules to all types of plant reproductive
material (such as freedom from harmful organisms and defects) while maintaining
stricter rules for important plants marketed throughout the EU, e.g. listed
plant species, the varieties of which have to undergo tests for distinctness,
uniformity and stability and certification and inspections for marketing. In
addition, the scope of the law is extended to exports and to supply for
industrial processes. Flexibility,
cost reduction and efficiency gains The aim of significantly reducing the overall administrative burden
and cost has been achieved by giving operators and competent authorities considerable
freedom in completing registration and certification tasks and by
introducing the principle of cost recovery for variety registration (and
for certification via the Regulation on Official Controls). However,
micro-enterprises will be exempted and fees could be reduced for varieties with
an officially recognised description and for registration of heterogenous
material, in the interest of conserving genetic resources and biodiversity. The new legislation fosters flexibility in variety
registration by allowing most registration tasks for new varieties to be
performed by operators under official supervision if the operator requests this. The current obligation to notify the Commission
of a variety and include it in the Common Catalogues before marketing
throughout the EU will be abolished to speed up innovation, i.e. market
access for new plant varieties. Registering a plant variety in one Member
State will be sufficient. The CPVO will have a greater role in variety
registration. The CPVO will manage the EU Plant Variety Database instead of
the Commission and the option of registering a variety directly with the CPVO
will be introduced. To ensure the quality of the registration process, national
variety examination centres will be audited by the CPVO. The CPVO will also continue
to harmonise testing protocols for new varieties. In addition, a ‘one-key,
several doors’ approach will enable a new variety to be registered for
marketing purposes and granted plant variety rights under a single procedure. The process of certifying plant reproductive
material lots before marketing will also be made more flexible. The option
of certification by the operator under the official supervision of a Member
State competent authority will be extended to all listed species and to all
marketing categories of plant reproductive material. Horizontal coordination with other EU policy
objectives In order to improve biodiversity and
conservation of plant genetic resources on farm, the requirements for traditional
and conservation varieties and other material, e.g. heterogenous and niche
market material, have been considerably reduced. No variety testing and
certification are required. This will considerably improve market access for such
material. Traditional and conservation varieties can be registered at low cost on
the basis of historical data by using a variety description recognised by the
competent authority. In addition, the rules have been amended to cater for the
possibility to authorise for marketing of heterogenous material (e.g.
populations) and niche market material in small quantities by micro-enterprises. Testing protocols for the agricultural
sustainability criteria (e.g. for disease and drought resistance) for
variety registration will be harmonised for the first time to steer plant
breeding in a more sustainable direction. However, the Member States
may continue to manage testing of new varieties for value for cultivation and
use, based on their agro-ecological conditions. 4.4. The
Regulation on Official Controls The proposal to amend the general framework for
official controls laid down in Regulation (EC) No 882/2004 incorporates the
outcome of a number of evaluations which have dealt with the different aspects
of that framework. Options for revision were extensively discussed
with Member States within the Working Group on the General Application of
Regulation 882/2004 and at the preparatory stages of two studies (in 2009 and
2011) carried out on the state of application of the rules governing the
financing of official controls. Stakeholders were consulted in the Advisory
Group on Food Chain and Animal Health and Plant Health. 4.4.1. Main
changes Consolidation of the integrated approach,
with sector-specific flexibility One major novelty is the broadening of the
scope of the rules on official controls, and in particular, their extension to
relevant controls on plant health, plant reproductive materials and animal
by-products, which until now have been governed by sectorial provisions not
fully consistent with the approach laid down in Regulation (EC) No 882/2004. The
current detailed set of rules applicable to official controls on residues of
veterinary medicines will be repealed to allow this area to be regulated in a
more risk-based, but still health-protective way, under the same legislative
framework. This revision will have a significant impact on
the legal framework governing official controls on products from non-EU countries.
It provides a set of common rules for all control activities to be performed at
EU borders on animals and goods from non-EU countries which require increased
attention for health reasons. In this context, it introduces Border Control
Posts (BCPs) designed to replace the current Border Inspection Posts (BIPs —
for animals and derived products), Designated Points of Entry (DPEs — for feed
and food products of plant origin) and Points of Entry (plants and plant
products). A uniform set of rules will apply to controls carried out at the
BCPs and a Common Health Entry Document (CHED) will be used for prior
notification of the arrival of consignments and to record official controls and
decisions (replacing the standard documents currently in use in each sector)[5]. While documentary controls
will remain systematic for all regulated goods and for animals, common criteria
will ensure that identity and physical controls do not exceed what is required
having regard to the risk posed by different categories of products. Provision is made for adopting further rules for
specific sectors by means of delegated and implementing acts. More effective enforcement mechanisms A number of changes will ensure that the toolkit offered by
Regulation (EC) No 882/2004 to national enforcers is made simpler to use and
more effective: –
for each of the sectors covered by the package, each
Member State will be asked to designate a single authority responsible for
coordinating preparation and ensuring the coherence of a multi-annual control plan
and to act as a contact point for the Commission and other Member States in relation
to official controls; –
electronic handling and processing of the CHED for
all animals and goods subject to controls at the border will be introduced; –
while the requirement for all official
laboratories to be accredited against ISO standard 17025 is reaffirmed,
transitional measures and temporary or permanent derogations are provided for
as appropriate. The proposal also aims at improving the
usability of the rules on ‘administrative assistance’, i.e. the mechanisms
which allow cooperation between national control authorities on cross-border
enforcement issues, where violations of EU rules need to be pursued not only in
the Member State in which the violation was detected but also in the Member
State where it originates. A new EU wide mechanism for the rapid exchange of
information related to serious and widespread violations will enable Member
States to address fraudulent practices more effectively. Financing of
official controls Allocating appropriate resources to official
controls is essential to prevent major disruptions to the EU’s system of
official controls in the agri-food chain and to guarantee its capacity to
anticipate and respond to health emergencies as effectively as possible. The proposal builds on the current system of
mandatory fees (at present only charged to certain operators and/or for certain
controls). It strengthens the principle according to which competent
authorities should be able to charge businesses in order to recover the costs
they incur in carrying out their official control duties along the agri-food
chain and in certain related areas (e.g. veterinary and phytosanitary controls,
controls on plant reproductive material). A number of improvements to the current set of
rules are proposed with a view to ensuring a consistent and steady stream of
resources to the competent authorities and to eliminating the known shortcomings
of the existing system: –
mandatory fees will be charged to all registered
food and feed businesses and to operators in the plant and plant reproductive
material sectors so as to spread the cost of controls across the entire chain; –
fees will enable the competent authorities to
fully recover the costs incurred, so as to make their revenues less dependent on
national budgetary policies and reduce the risk of under-resourcing as a result
of funds being reallocated to competing priorities; –
more equity and fairness will be achieved by
ensuring that the methods used to calculate the fees and the list of costs
covered are fully transparent, and by requiring Member States to reward
consistent compliance by operators (e.g. with reduced fee rates); –
as a rule, micro-enterprises will be exempted
from the payment of the fees. 4.5. Management
of expenditure The main objective of the
Commission’s proposal on management of expenditure is to accompany proposed
changes in the relevant policy areas and to seek alignment with the EU’s
Multiannual Financial Framework, while allowing the use of reserves in the
agricultural sector under certain circumstances, for example in response to
crises. Regarding plant health, in
order to protect the EU against the introduction and spread of pests, survey
programmes for the presence of pests will be funded as well as phytosanitary
support measures for the outermost regions of Member States. The new framework
will also allow funding of initiatives designed to update legislation in order
to keep up with technological and scientific development and to ensure
efficient and effective enforcement. In case of
emergency measures, Union co-financing will be possible as of the entry into
force of the Plant Health Law for compensation to growers for the lost value of
plant material subject to destruction. 5. Conclusion The proposed legislative package is the result
of a major revision of the most relevant components of EU legislation governing
the production and placing on the market of food, the safety of the food and
feed chain, and the health of plants and animals. The revision in question has involved experts
from the Member States, and all concerned stakeholders, since 2004 in the case
of the animal health legislation and for more than three years in the other areas. It was carried out to
assess the fitness for purpose of the vast range of rules which the EU has
produced over time to deliver the Treaty objectives of ensuring a high level of
health for humans, animals and plants during the various processes along the
path from farm to fork (from primary production to the consumption and disposal
of food). Production methods and techniques have changed, globalisation and
increased exchanges are having an impact on the spread of hazards and risks,
new hazards and risks have arisen, and consumers’ expectations and education
have evolved with all that. This comprehensive revision has resulted in the
proposed changes to the animal health legislation, to the legislation governing
plant health and plant reproductive material and to the rules on official
controls and other official activities along the agri-food chain. These changes
aim to deliver a more effective and modern legal framework for those issues, to
increase the flexibility and proportionality of rules established in some cases
more than 40 years ago and, overall, to better meet the needs of citizens and
businesses. [1] http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm. [2] COM(2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm. [3] FCEC (2008), Evaluation of the Community acquis on
the marketing of seed and plant propagating material (S&PM). Final Report. [4] SEC(2009) 1272 final. [5] I.e. the Common Veterinary Entry Document (CVED) in
the area of veterinary controls, the Common Entry Document (CED) for
non-veterinary controls, and the phytosanitary certificate currently in use in
the plant health sector.