This document is an excerpt from the EUR-Lex website
Document 52013DC0077
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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
/* COM/2013/077 final */
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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 /* COM/2013/077 final */
REPORT FROM THE COMMISSION TO THE
EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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 (Text with EEA relevance) 1. Introduction This report gives an overview of the
implementation of Regulation (EC) No 765/2008 (also 'the Regulation') setting
out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93. This Regulation
applies from 1 January 2010. Its main objective is to ensure that products on
the Single Market covered by Union legislation fulfil the applicable
requirements, which provide a high level of protection of health and safety and
other public interests. To this purpose the Regulation establishes a framework
for accreditation and market surveillance. The report was prepared in cooperation with the
Member States through the 'SOGS', i.e. the Senior Officials Group for
Standardisation and Conformity Assessment Policy and the ad hoc market
surveillance group called ‘SOGS-MSG’. This report also evaluates the relevance
of the conformity assessment, accreditation and market surveillance activities
that receive Union financing in the light of the requirements of EU policies
and legislation. 2. Accreditation 2.1. National accreditation bodies Regulation (EC) No 765/2008 introduces for the
first time a legal framework for accreditation. It applies in both the
voluntary and regulated sectors. The purpose is to strengthen accreditation as
the last level of control in the conformity assessment system and to enhance
trust in conformity assessment results while responding to the needs of markets
and public authorities alike. The Regulation introduces a number of general
principles and requirements for national accreditation bodies[1]. These requirements are in line
with the globally accepted requirements laid down in the relevant ISO/IEC
international standards, although some of them can be perceived as being more
rigorous, going beyond the requirements set out in the applicable standards. This
is the case of the requirements according to which there is only one
accreditation body per Member State, accreditation is performed as a public
authority activity, accreditation is operated on a non-commercial and non-
profit basis and accreditation bodies do not compete with conformity assessment
bodies or amongst each other. In order to meet the requirements of the
Regulation Member States had to introduce changes to their national
accreditation systems to a varying degree. While for some Member States only some
or minor changes were needed, others had to substantially overhaul their
national accreditation system. In some cases, it was necessary to merge a
number of accreditation bodies. All Member States as well as EFTA countries and
Turkey have set up national accreditation bodies[2]. The process of restructuring and adaptation to
the Regulation is now largely completed, while consolidation is still on-going,
and in some cases national accreditation bodies still need to be strengthened
within their national context. 2.2. Cross-border accreditation The Regulation foresees that conformity
assessment bodies should seek accreditation in the Member State where they are
established. However, there are three scenarios in which a conformity
assessment body may seek accreditation elsewhere: (1)
The first is that the Member State in question has not set up a national accreditation body. (2)
The second scenario is that the national
accreditation body does not perform accreditation for the activity for which
accreditation is sought. (3)
The third scenario is that the relevant national
accreditation body has not successfully undergone peer evaluation. So far the first scenario did not materialise
as all member States have set up a national accreditation body. The second and
third scenarios are more frequent as not all national accreditation bodies
perform the full scope of activities. While these provisions on cross-border
accreditation proved to be relatively straight forward, an issue that has
become increasingly important in recent years is that of multi-site
international conformity assessment bodies and subcontracting. The Commission
has, in consensus with the Member States, adopted a policy document that explains
how accreditation bodies should proceed in such cases with the aim to avoid
multiple accreditations[3].
The European Cooperation for Accreditation, EA (see section on accreditation
infrastructure), has then provided guidelines on how to put into practice these
policy principles. Some fine-tuning of the implementation of these policy
principles may still be required after better experience with these guidelines
has been gathered. 2.3. Peer evaluation Peer evaluation is possibly the most essential
tool in ensuring that the European accreditation system meets expectations of ensuring
the quality of the European conformity assessment system. A successful peer
evaluation is the prerequisite for the mutual recognition of accreditation
certificates. Therefore a rigorous peer evaluation mechanism between
national accreditation bodies is central to the good implementation of the
Regulation. It ensures a continuous control of the quality of the work of the
national accreditation bodies, while also providing a learning process not only
of those who are assessed but also of those who are doing the assessment. It is
the peer evaluation that distinguishes and singles accreditation out in
comparison to other means of assessing the competence and performance of
conformity assessment bodies. The next objective is to further strengthen the
peer evaluation process, to enhance the availability of trained and experienced
peer evaluators and to further harmonise approaches particularly in the
regulated sector. 2.4. European accreditation
infrastructure As set out in the Regulation, the Commission recognised
the European Cooperation for Accreditation (EA) as the European accreditation
infrastructure[4].
It then concluded an agreement that specifies the detailed tasks of EA, funding
provisions and provisions for its supervision. In April 2009, the Commission, EFTA, Member States and EA signed general cooperation guidelines that emphasise their political
commitment to work closely together on a successful implementation of the
accreditation chapter of the Regulation[5].
They express a common understanding of the importance of accreditation for the
European economy as well as its supporting role for several European policies
and corresponding legislation. The guidelines lay down the specific policy
objectives for accreditation so that it may fulfil its goals expressed in the
Regulation. In June 2010, the Commission and EA signed a
framework partnership agreement for the period of 2010-2014. This framework
partnership agreement allows financial support for EA in fulfilling its tasks
as foreseen by the Regulation and meeting the objectives detailed in the
guidelines. The EA activities eligible for EU funding include technical work
linked to the peer evaluation system, information of interested parties and
participation in the international organisations in the field of accreditation,
drawing up and updating of contributions to guidelines related to
accreditation, notification of conformity assessment bodies, conformity
assessment and market surveillance, activities of assistance to third countries[6]. The framework partnership agreement stipulates
the possibility of an annual operational grant for the on-going work of EA and
its secretariat. At the time of writing this report, two annual operational
grants amounting to 375,000€ and approximately 40% of the overall EA budget have
been disbursed. The grant has supported work related to the
operation and management of the peer evaluation system which in 2010 and 2011
included 32 evaluations - including pre-evaluations, initial evaluations,
re-evaluations and extraordinary evaluations of national accreditation bodies -
and 8 trainings of evaluators. The activities in this area also include the
launch of an overall process of enhancing the peer evaluation system that has
produced a number of proposals currently under discussion. Furthermore the EA's horizontal harmonisation
committee as well as the laboratory, certification and inspection committees
have been working on furthering a common understanding on how to perform accreditation
and also on supporting accreditation in the relevant regulated sectors. This
has resulted in a number of guidance documents[7]. EA has also been very active in fulfilling its
tasks of providing technical expertise to different Commission services for the
inclusion of accreditation in legislative projects or in terms of implementing
existing sectoral legislation[8].
In addition, EA has been working with
interested stakeholders through its EA Advisory Board and has fulfilled its
obligations to participate in the international accreditation organisations
ILAC/IAF by participating in their peer evaluation process and in their
different working groups. It has also consolidated relations with third
countries by accepting national accreditation bodies of EFTA and candidate
countries as full members and by signing association agreements with national
accreditation bodies of countries participating in the European neighbourhood
policy. EA currently counts 35 full members and 13 associate members[9]. Besides the annual operational grant, the
framework partnership agreement with EA also stipulates the possibility of
action grants for specific projects. So far, no use has been made of this
possibility. Cooperation with EA has been very fruitful on
the whole. Considerable efforts have been made to meet the changed
circumstances for accreditation with the entry into force of the Regulation and
EA's new role as the European accreditation infrastructure within this context.
The progress made so far should be further consolidated to continue enhancing
accreditation's role as the last level of control in the European conformity
assessment system. As accreditation is increasingly being used for the purposes
of EU legislation, this may also entail a review of the resources and financial
support available to EA. 2.5. Accreditation in support
of notification The Regulation is very clear in its preference
of accreditation as the means for demonstrating the technical competence of a
conformity assessment body for the purposes of 'notification' under specific
legislation, i.e. ultimately to acknowledge the body's ability to assess
product compliance with the requirements of a given regulation or directive. Accreditation has the benefit of being a
transparent, standard-based activity, while the peer evaluation process is in
place to ensure that comparable levels of quality are maintained. This is not
the case for notifications that are not based on accreditation. The Commission
has therefore, in consensus with the Member States, issued a guidance document
on the kind of information that a non-accredited notification should carry[10]. As unaccredited notifications
are not always accompanied by the appropriate documentation and Member States and the Commission have a longer time frame to raise objections, the
notification process can in these cases become rather drawn-out and cumbersome. The use of accreditation for notification
purposes differs across Member States and across sectors. While some Member
States have made accreditation for notification purposes compulsory, this is
not the case in others that apply a rather mixed approach. It is a fact that at
the end of 2009, before the entry into force of the Regulation, out of 2249
notifications 1089 were not accredited and 1118 accredited, while until June
2012 there were 3106 notifications of which 861 were not accredited and 2196 were
accredited. Accreditation is thus successfully taking on its role in support of
notification. A closer communication between national authorities and the
accreditation body is therefore warranted. 2.6. Guidance documents The Commission has, in consensus with the
Member States, issued guidance documents which are set out in the accompanying
Commission staff working document. 2.7. Challenges While the Regulation has set a solid legal
framework for accreditation, the major challenges in the implementation of the
accreditation chapter of the Regulation for the coming years will be to
consolidate and strengthen the system as well as raising awareness and a better
understanding of accreditation's benefits. Apart from a number of legal
questions surrounding accreditation, this will require a further strengthening
of the peer evaluation system as the main tool for ensuring a continued quality
of certificates throughout the EU. Furthermore accreditation for notification
purposes will need to be given greater prominence and it will have to be used
more systematically in EU legislation where the latter provides for conformity
assessment and the designation of conformity assessment bodies. This may also
require that the Commission and EA develop sectoral accreditation schemes to
ensure that conformity assessment bodies meet the level of competence required
by Union harmonisation legislation in fields with specific requirements[11]. 3. Union market surveillance framework for
products This section summarises the state of play of
the implementation of the main provisions of Regulation (EC) No 765/2008
concerning the establishment of a market surveillance framework for all
harmonised products in the single market. This chapter complements the
information contained in the impact assessment accompanying the Commission's
proposals for a Consumer Products Safety Regulation and for a Market
Surveillance Regulation. 3.1. Requirements for the
organisation of market surveillance by Member States The Regulation establishes specific
requirements for the organisation of market surveillance by Member States since
2010. Most of them have then fine-tuned their administrative structures and put
in place specific solutions to ensure the fulfilment of those requirements. The
replies of the Member States to a questionnaire on the implementation of the
Regulation can be summarized[12]
as follows: ·
Responsibility and identity of authorities: in most Member States, the Regulation only required some small
adjustments to pre-existing market surveillance activities (e.g. establishing a
programme for the enhancement of market surveillance) as Member States have had
already set up market surveillance procedures by relevant national legislation. ·
The communication and coordination mechanism
between market surveillance authorities varies
amongst Member States: communication channels are sometimes based on an
informal agreement, or communication takes place via a coordination body for
market surveillance, through a Working Group responsible for implementation of
New Legislative Framework or through a Market Surveillance Committee. ·
Procedure to follow up complaints: before the Regulation, most Member States had already set up
systems for complaints. Although these systems are updated on a regular basis, the
majority of Member States indicate that they can be improved further. ·
Procedure to monitor accidents and harm to
health: some Member States believe that an improved
system for accident data is needed and could be based on the current EU
Injuries Database. ·
Strengthen market surveillance authorities'
powers: there were some minor adjustments in Member
States as the enforcement powers have been mostly compatible to those required
by the Regulation. Some Member States had to amend existing national legislation
to comply with the Regulation (EC). ·
Strengthen market surveillance authorities'
financial and human resources: the financial and
human resources for market surveillance were reduced due to budgetary
constraints in the majority of Member States, while in a minority of Member States
no major adjustments were considered necessary until now. ·
Penalties for economic operators: penalties for non-compliant economic operators existed already
before the Regulation came into force, but were slightly amended in certain
Member States as a consequence of the new competences for market surveillance
authorities. At the beginning of 2010 all Member States, Iceland and Turkey, informed the Commission of their market surveillance authorities and their areas
of competence as specifically requested by the Regulation[13]. These communications provide
a good overview of the distribution of tasks and responsibilities in the area
of market surveillance for harmonised goods, including relevant contact
details. They were published on the website of the Commission[14] and certainly contribute to
transparency on national market surveillance authorities in the EU. 3.2. The national market
surveillance programmes According to the Regulation[15] Member States must establish,
implement and update their market surveillance programmes. They must also
communicate the programmes to other Member States and to the Commission and
make them accessible to the public via internet. The purpose of these
programmes is to allow the other countries' authorities, as well as citizens in
general, to understand how, when, where and in which areas market surveillance
is carried out. National programmes then contain information on the general
organisation of market surveillance at national level (e.g. mechanisms of
coordination between different authorities, resources attributed to them,
working methods, etc.) and on specific areas of intervention (e.g. product
categories, risk categories, types of users, etc.). The majority of Member States communicated
their national (general or sectoral) programmes and any necessary revision to
the Commission in 2010, 2011 and 2012 (see Table 1). In 2012, the Commission
published on its website a non-confidential original and translated version of
the latest national programmes received from Member States, Iceland and Turkey[16]. The assessment of the efforts made by Member
States is overall very positive, despite the fact that some countries have put
more emphasis on information concerning the general organisation of market
surveillance, while others have chosen to privilege information on sector
activities, so the information is not always fully comparable. The clarity on
how Member States have organised cooperation and coordination among different
authorities and with customs could be improved. The Commission helped Member States'
implementation of these provisions of the Regulation in particular by proposing
a common template to lay out their sector programmes. This now greatly
facilitates the comparability of national information in specific product or
legislation areas and makes it possible for market surveillance authorities to
plan cross-border cooperation in areas of common interest. Table 1: National Market Surveillance Programmes (NMSP) –
state of play 2010-2012 Country || Type of programme[17] || 2010 || 2011 || 2012 Austria || General and Sectoral || x || x || x Belgium || General * || x || x || x Bulgaria || General * || x || x || x Cyprus || General and Sectoral || x || x || x Czech Republic || Sectoral || x || x || x Denmark || General and Sectoral || x || x || x Estonia || General and Sectoral || x || x || x Finland || Sectoral || x || x || x France || General and Sectoral || x || x || x Germany || General * || x || x || x Greece || General || x || x || x Hungary || Sectoral || x || x || x Ireland || General * || x || x || x Italy || General || x || x || x Latvia || General and sectoral || x || x || x Lithuania || Sectoral || x || x || x Luxembourg || General and Sectoral || x || x || x Malta || Sectoral || x || x || x Netherlands || Sectoral || x || x || x Poland || General and Sectoral || x || x || x Portugal || General and Sectoral || x || x || x Romania || General and Sectoral || x || x || x Slovakia || General and Sectoral || x || x || x Slovenia || General and Sectoral || x || x || x Spain || Sectoral || -- || x[18] || x Sweden || General and Sectoral || x || x || x United Kingdom || General and Sectoral || x || x || x Iceland || General || x || x || x Turkey || General || x || x || x * The programme covers
also some information on specific sectors, although this is not detailed 3.3. Products presenting a
serious risk The Regulation establishes a general obligation
for Member States to ensure that the goods liable to compromise the health or
safety of users (consumers and workers) or in any case non-compliant with
product requirements set out in the EU harmonisation legislation are withdrawn,
prohibited or their supply restricted[19].
Moreover, it sets out that when products – on the basis of an appropriate risk
assessment – are considered to present a serious risk, Member States must also
inform the Commission without delay of the measures taken by using the rapid
information system "RAPEX"[20]. The inclusion in the Regulation of a reference
to the RAPEX system has acknowledged the importance of this exchange
information mechanism for market surveillance in the Single Market and the link
of this mechanism to product-specific regulations. The reference to the RAPEX
system has also had the effect of extending the obligation to send RAPEX
notifications to all goods falling within the scope of EU harmonisation
legislation, including products for use in a professional context (e.g.
industrial machinery) and products which may harm public interests other than
health and safety (e.g. environment, security, fairness of commercial
transactions, etc.). This extension has contributed particularly to
the protection of workers[21]
and the protection of the environment[22],
although the total number of new notifications has been rather limited during
the first two years of implementation of the Regulation. Besides the RAPEX
notifications pursuant to the General Products Safety Directive, the Commission
received, in 2010, 20 notifications under Regulation (EC) No 765/2008 (7 of
them presenting a serious risk); in 2011 it received 25 such notifications (17
of them presenting a serious risk)[23].
Overall, 9 Member States transmitted notifications on professional goods and products
which may harm public interests other than health and safety. More recent patterns show an increase in the
number of communications received as in 2012 the Commission validated
altogether 37 new notifications, 31 of which presented a serious risk. In the
same period an additional Member State started to notify. These figures are
expected to definitely go up overtime as Member States become more proactive in
the area of professional products and fully adjust their practice to the
broader scope of RAPEX. On the side of the Commission the
implementation of the Regulation has required some efforts to coordinate the
expertise necessary to assess the new notifications and to adjust the
operational procedures to the system's wider scope. The completion of the new
IT platform for RAPEX notifications, called GRAS-RAPEX[24], was a major step forward for
the handling of new notifications. 3.4. An appropriate risk
assessment methodology As part of implementation of the Regulation
carried out through the 'SOGS' groups, the Commission set up in 2011 a Risk
Assessment Task Force composed of Member States' experts. The mission of the
task force was to advice on appropriate means of carrying out risk assessment
for all non-food products and all risks falling within the harmonisation
legislation. The existing RAPEX Guidelines[25]
already provide for the risk assessment methodology for consumer goods, which
certainly constitute an important reference for Member States. The task force
was then asked to assess: (i) whether the existing methodology, whose main
focus is on non-harmonised products, could suitably take into account the legal
requirements of harmonised goods; (ii) how to address the need to assess risks
to public interests other than health and safety, which are not taken on board
by this methodology. At the end of the project the Risk Assessment
Task Force concluded that the methodology referred to by the RAPEX Guidelines
represents a good basis, however its suitability to the harmonised area should
be improved by including explicit references to the product essential
requirements and to the relevant harmonised standards. Furthermore, the
language of the methodology should be adjusted to a broader set of public
interests by focusing on the concept of 'harm' instead of that of 'injury'[26]. 3.5. General information
support system - ICSMS According to the Regulation, the Commission must
develop and maintain a general archiving and exchange of information system, on
issues relating to market surveillance activities[27]. Commission experts examined possible
alternatives (acquire an existing tool, develop a new tool etc.) and came to
the conclusion that the most appropriate solution was to acquire the “ICSMS”
tool (Information and Communication System for Market Surveillance), which is
the only information system of its nature currently already operating. At that
moment, ICSMS was used by 12 EU/EFTA Member States (Austria, Belgium, Cyprus, Estonia, Germany, Luxemburg, Malta The Netherlands, Slovenia, Sweden, Switzerland and UK) as communication means for market surveillance authorities to exchange
information on investigations of specific products and related activities. In November 2011, the Commission agreed with ICSMS-AISBL
(the body regrouping market surveillance authorities in the EU/EFTA Member
States that are ICSMS users) and LUBW (Agency for environmental measurements
depending on the Ministry of Environment and Transport of Baden-Wuerttemberg
that hosts physically ICSMS) to purchase ICSMS for €1,940,940. Under the
contract, ICSMS-AISBL and LUBW undertook to: –
transfer the IPRs of the ICSMS tool to the
Commission; –
integrate Member States not yet ICSMS members
and provide training to users of the new ICSMS member countries. The first
trainings have taken place in May-June 2012; –
provide technical support and assistance to all
ICSMS users (including help desk); –
manage ICSMS on a daily basis and ensure quality
of service; –
transfer the know-how of ICSMS to the
Commission. Supported by the internet, ICSMS enables a
comprehensive exchange of information between all the market surveillance
bodies. The system allows to quickly and efficiently share between its users
test results, product identification data, photographs, economic operator
information, risk assessments including hazard data, accident information, and
measures taken by surveillance authorities. ICSMS consists of an internal and a public
area. The internal area is for the use of market surveillance authorities. It
can also be used by customs authorities and EU officials. It contains all
information available (product description, test results, measures taken etc.).
The public area is for the use of consumers and economic operators. The
information which is visible to the public provides only the data, which
references the product and its non-compliance and not any internal documents
(i.e. between authority and manufacturer/importer etc.). ICSMS already gathers test results on more than
47,500 products and lists more than 650 authorities in all EEA countries for
more than 45 directives. The number of user accounts is 3,600. ICSMS enables
all internal and public users to carry out a specific search. A search can be
made, for example, according to individual products, and according to test
results for entire product groups. Test results can be obtained for products
from specific countries. Information can be obtained for products coming under
certain directives, safeguard clause notifications, information about RAPEX
notifications, for manufacturers, importers and dealers. Confidentiality
aspects are protected by a system of access authorisations. Each market surveillance authority can input
data about investigated products, which are not yet in the database and add
comments to an already existing product information file, i.e. feedback about
the activities of market surveillance authorities with regard to investigated
products. Furthermore the possibility to transfer the responsibility for a
product from one authority to another (so called “baton passing”) exists and is
extensively used. An evaluation of the ICSMS contract is
premature as it was signed in November 2011 and as the roll-out of the system
to EU countries which were not already members has just started. However, in
view of the potential of ICSMS, the contract offers good “value for money” for
the Commission and all concerned stakeholders (national authorities,
manufacturers, citizens). The general information support system established
under the Regulation is meant to be a policy tool that facilitates market
surveillance across the European Union, in particular by increasing the
effectiveness and coherence of investigations carried out at national level. According to the experts who use ICSMS, the
exchange of information on test results and investigations offers advantages
for market surveillance authorities such as: –
Prompt intervention: information on unsafe
products can be announced immediately and immediate measures may be taken; –
Deterrence: “black sheep” among manufacturers
will be detected earlier and punished more effectively; –
Avoiding duplication of work: Test results by
one surveillance authority will be immediately made available to all other
Member States; –
Possibility to generate statistics by sector,
product, etc.; –
Coverage of all issues concerning non-compliance
of products. In addition, ICSMS provides a valuable platform
for the implementation of the European market surveillance policy by creating
the basis for: –
the coordination of wide-scale market
interventions against suspicious products; –
the elaboration of best practices, the exchange
of general knowledge and experience; –
the adoption of a common approach to market
surveillance in different countries (thus avoiding distortion to competition); –
the availability of an encyclopaedia of EU
market surveillance intelligence; –
the information of citizens about non-compliant products
and the contact details of the competent authorities[28]. 3.6. Support to administrative
cooperation Regulation (EC) No 765/2008 gives the
Commission the legal basis to assist with financial aid and support to the
Member States in relation to ADCO (Administrative Co-operation on Market
Surveillance) groups' activities[29]. The main objective of the Administrative
Co-operation groups on Market Surveillance is to guarantee proper, uniform
application of the technical provisions of the directives (certification
procedures) and thus limit the use by the Member States of restrictions on the
placing on the market of products certified to be in conformity. There are currently twenty ADCO groups. They
hold, in general, about 40 meetings a year covering areas such as construction,
safety of toys, noise emissions, pyrotechnics, radio and telecommunication terminal
equipment, electromagnetic compatibility, low voltage equipment, medical
devices, equipment and protective systems intended for use in explosive
atmospheres, pressure and transportable pressure equipment, machinery, lifts,
cableways, personal protective equipment, eco-design, energy labelling,
measuring and non-automatic weighing instruments or recreational crafts. The
participants are officials of national market surveillance authorities who also
ensure the chairmanship of the meetings. The Commission is also represented in
the groups. However, different levels of attendance to ADCO
groups meetings, from one sector to another, have been noticed. The main reason
of the weak attendance of several groups seems to be the lack of financial
resources for travel and accommodation of the representatives. On the other
hand, some market surveillance authorities do not apply for the chairmanship of
the group because of the same financial problem in organising meetings. 4. Controls of products entering the EU
market In addition, Regulation (EC) No 765/2008 sets
out a regulatory framework for external border controls[30]. The overall objective of
these provisions is to ensure that Member States have appropriate control
mechanisms in place in order to verify that products originating from third
countries and entering the EU market comply with the requirements set out in
Union legislation. To this end the Regulation establishes basic principles on
the operation of external border controls, on the authorisation or not of the
release of the goods for free circulation and on the cooperation of all
authorities involved in relation to both tasks. These provisions build on Council Regulation (EEC) No 339/93[31], which was repealed by the
Regulation. 4.1. Implementation by Member
States Therefore the Member States implemented
specific provisions on border controls by: ·
establishing a single point of contact in order
to develop effective and efficient border controls; ·
making available funding for border controls; ·
developing policy on how border controls should
be carried out; ·
broadening border controls in order to cover
more points of entry; ·
ensuring that border controls are properly
targeted and that trade facilitation is not adversely affected; ·
establishing written agreements between customs
and market surveillance authorities to strengthen cooperation in the area of
border controls; ·
improving cooperation between customs and market
surveillance authorities (e.g. improving information sharing, intensifying
cooperation with market surveillance authorities of third countries); ·
providing assistance to custom officers who
perform custom controls; ·
carrying or assisting in risk analyses; ·
harmonizing customs actions; ·
training customs officers. 4.2. Guidance by the Commission In order to facilitate the implementation of
Regulation (EC) No 765/2008 the Commission, together with the Member States,
has drafted the Guidelines for imports controls in the area of product safety
and compliance[32].
The Guidelines are intended as an instrument to assist customs and market
surveillance authorities in improving cooperation methods and good
administrative practice. At the same time, the Guidelines focus on the
practical questions customs are faced with when performing controls related to
product safety and compliance. The Guidelines consist of a Generic and a
Specific Part. The generic part is essential to
understand the overall relevant applicable EU legislation and in particular the
obligations on safety and compliance controls and the cooperation between the
relevant national authorities. The specific part of the Guidelines consists of
practical tools for customs officers, i.e. information sheets and check lists
for individual product groups intended to facilitate controls. The Commission is coordinating Member States'
efforts to disseminate and use the Guidelines at national level. It is also
engaged in an extensive programme of country visits to provide as wide as
possible guidance to national officials and to address specific questions they
may have. All these initiatives have been financed
through the Customs 2013 programme[33]. 5. CE marking and Conformity Assessment The Commission has in the past detected a lack
of understanding of what CE marking means amongst economic operators, in
particular SMEs. For this reasons, Regulation (EC) No 765/2008 lays down the
general principles underlying the CE marking. In this respect, upon request by
the European Parliament and as part of the Regulation implementation, the
Commission committed itself to carry out an information campaign on CE marking
addressed in particular to economic operators (with focus on SMEs) but also to
public authorities and consumers. 5.1. The CE Marking information
campaign The CE Marking
information campaign was intended to raise the stakeholders' knowledge
regarding CE marking. It was financed by the Entrepreneurship and Innovation
Programme in 2009 and cost in total 2 million EUR. The campaign started in the
1st quarter of 2010 and lasted until March 2012. The outputs of the campaign include: –
the creation of a dedicated website in all
EU/EFTA languages that serves as a one-stop-shop for information on CE marking
(http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/)
–
the development of a stand for presence at
commercial fairs[34];
educational seminars in all EU/EFTA Member States (for Switzerland and Lichtenstein there was one joint seminar); –
the production of leaflets and brochures in all
EU/EFTA languages for professionals and consumers; the production of two videos
and promotional material; the production of factsheets describing the situation
regarding CE Marking in various sectors in all EU/EFTA languages and various articles
in the specialised press. The campaign appears to have fulfilled its
goals. The feed-back from the seminars and the fairs (the high number of
participants[35]
and their positive written evaluations), the high demand for informational
material[36]
and the strong interest of print and on-line media[37] show the success of the
campaign. Furthermore the majority of the questions being
asked by stakeholders on the CE Marking demonstrate that the stakeholders are now
more familiar with the meaning of the CE Marking and are more aware of their
rights and obligations. The number of the written questions from the
stakeholders to the Commission has increased over the period of the campaign.
The questions themselves became more complex and refined, demonstrating a much
better knowledge of the CE Marking than before. In addition the guidance
provided by the website reduces the risk of possible mistakes and
misunderstandings. 5.2. Guidance to sectoral
legislator and other stakeholders The correct use of the CE marking presupposes a
good understanding of conformity assessment procedures applicable to different
products. In order to help legislators, national
authorities, Accreditation Bodies, Conformity Assessment Bodies, operators and
other stakeholders to select the correct assessment procedures, the Commission provided specific guidance through policy documents: ·
SOGS-N593 EN or CERTIF 2009-03
"Orientations for selecting and implementing the modules of Decision
768/2008 and SMEs specificities in the area of conformity assessment"
provides guidance to the sectoral legislator how to select conformity assessment
modules from the “menu” of the Decision No 768/2008/EC. Furthermore it provides
guidance to Notified Bodies performing conformity assessment. In line with the
better regulation objectives, the legislator must take into account the
complexity of the product, the size of the undertakings operating in the sector
addressed (e.g. SMEs) the technology in question, the risk for the public
interest, the mass or serial nature of the production process. Notified bodies
must, in a similar way, avoid unnecessary burden for the economic operators,
maintaining however the required high level of protection of the public interest. ·
SOGS-N594 EN or CERTIF
2009-04 "Introduction to conformity assessment of
the New Legislative Framework as laid down in Decision 768/2008" is addressed to newcomers (legislator, Notified Bodies,
manufacturers) into conformity assessment. It explains what conformity
assessment is and describes its mechanisms and its role in the supply chain of
a product. Furthermore it explains the role of the stakeholders involved and provides
a detailed analysis of the conformity assessment procedures as defined in
Decision 768/2008. ·
SOGS N612 EN or CERTIF 2009–08 "Using Harmonised Standards to assess the competence of
Conformity Assessment Bodies in the context of the New Legislative Framework"
is addressed mainly to Accreditation Bodies and describes
for every conformity assessment module which of the Harmonised Standards
published in the Official Journal of the EU reflect the criteria Conformity
Assessment Bodies must fulfil in order to be notified for the module in
question. The documents are available
on the Commission's website[38]. [1] See Articles 4, 6 and 8 of the Regulation. [2] Their contact details are available on the Commission
website at the following address: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=ab.main
[3] CERTIF 2009-06 Rev. 6.0 Cross Border Accreditation
Activities (See accompanying Commission staff working document). [4] See Article 14 of the Regulation. [5] General guidelines for the cooperation between the
European Cooperation for Accreditation and the European Commission, the
European Free Trade Association and the competent national authorities. OJ 2009/C 116/04: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:116:0006:0011:EN:PDF [6] See Article 32 of the Regulation. [7] http://www.european-accreditation.org/content/publications/pub.htm. [8] Activities have not been limited to the services of
the Directorate-General "Enterprise and Industry" but have spanned to
other Directorates-General (amongst others DG SANCO, DG AGRI, DG ENV, DG MOVE, DG
CLIMA). A prime example would be cooperation on the new European Emission
Trading (ETS) Accreditation and Verification Regulation, where EA cooperated
closely with DG ENTR and DG CLIMA in order to come up with a solution that
meets the needs of this legislation. (Commission Regulation (EU) No 600/2012 of
21 June 2012 on the verification of greenhouse gas emission reports and
tonne-kilometre reports and the accreditation of verifiers pursuant to
Directive 2003/87/EC of the European Parliament and of the Council Text with
EEA relevance). [9] http://www.european-accreditation.org/content/ea/members.htm [10] CERTIF 2010-08 Rev.1 Notification without Accreditation
(Art. 5(2) of Regulation (EC) No 765/2008). [11] See Article 13(3) of the Regulation. [12] A full overview of the replies can be found in the
accompanying Commission staff working document. [13] See Article 17. [14] http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/market-surveillance-authorities/index_en.htm. [15] See Article 18(5). [16] http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/national-market-surveillance-programmes/index_en.htm. [17] The situation reflects in particular the approach
followed for year 2012. [18] Only for a limited number of products. [19] See Article 16. [20] See Articles 20 and 22. RAPEX is an alert system
already established under Article 12 of the GPSD. [21] Examples are the notification of a feed mixer used in
agriculture that was found not to comply with the Machinery Directive
2006/42/EC after having caused a fatal accident in the notifying country and of
various dangerous professional tools found not to comply with the Low Voltage
Directive 2006/95/EC. [22] Examples are the notifications on various consumer
protective equipment and packages of toys containing a quantity of cadmium
exceeding the limit allowed in the REACH Regulation (EC) 1907/2006 and the
notifications of fireworks containing persistent organic pollutants. [23] More details on these notifications (notifying Member
States, product categories, etc.) can be found in chapter 2.3 of the RAPEX
Annual Reports for 2010 and 2011 available at: http://ec.europa.eu/consumers/safety/rapex/key_docs_en.htm.
[24] GRAS-RAPEX has replaced the RAPEX-REIS application on
29 May 2012. The new IT platform contains more advanced functionalities among
which drop down menus allowing RAPEX Contact Points to upload information on
professional products and other risks than health and safety. [25] Adopted by Commission Decision 2010/15/EU of 16
December 2009, OJ L 22, 26.1.2010, p. 1, http://ec.europa.eu/consumers/safety/rapex/docs/rapex_guid_26012010_en.pdf [26] Document SOGS-MSG N031Rev1 or
CERTIF 2012-01 Rev1. [27] See Article 23 of the Regulation. [28] See Article 19(2). [29] See Article 32(1)(e). [30] See Articles 27, 28 and 29. [31] Council Regulation (EEC) No 339/93 of 8 February 1993
on checks for conformity with the rules on product safety in the case of
products imported from third countries (OJ L 40, 17.2.1993, p.1). [32] http://ec.europa.eu/taxation_customs/resources/documents/common/publications/info_docs/
customs/product_safety/guidelines_en.pdf. [33] Decision No 624/2007/EC of the
European Parliament and of the Council of 23 May 2007 establishing an
action programme for customs in the Community. [34] Presence at the following fairs: Hannover Messe 2010
(April 2010), Paris Hopital Expo (May 2010), London CEDIA EXPO (June 2010),
Berlin IFA (September 2010), Madrid Orto Pro Care (September-October 2010),
Krakow Eurotool (October 2010), Nuernberg International Toy fair (February
2011), Milano fair (January 2011), Hannover Cebit (March 2011), Brno (Czech
Republic) Amper fair (March-April 2011), Hannover Messe (April 2011). [35] Almost two thousand stakeholders have followed the
seminars. At some fairs, more than two thousand people visited the campaign
stand, while more than two hundred visitors participated in deeper discussions
with the stand personnel. [36] Sixty thousand copies of leaflets and brochures already
distributed. [37] Over one hundred and forty press clippings/publications
in magazines, newsletters and on specialised websites. [38] http://ec.europa.eu/enterprise/policies/single-market-goods/documents/certif_doc_en.htm.