BETA


2007/0029(COD) Requirements for accreditation and market surveillance relating to the marketing of products (repeal. Regulation (EEC) No 339/93)

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead IMCO
Committee Opinion ENVI LIESE Peter (icon: PPE-DE PPE-DE)
Committee Opinion ITRE PURVIS John (icon: PPE-DE PPE-DE)
Committee Opinion INTA
Committee Opinion JURI
Lead committee dossier:
Legal Basis:
EC Treaty (after Amsterdam) EC 095, EC Treaty (after Amsterdam) EC 133

Events

2022/12/05
   EC - Follow-up document
2017/12/19
   EC - Follow-up document
Details

The report presented by the Commission gives an overview of how the accreditation provisions of Regulation (EC) No 765/2008 and the CE marking were implemented between 2013 and 2017. It was prepared in cooperation with the Member States through the accreditation sub-group of the ‘Internal market for products’ experts group.

The main findings of the report are as follows:

1) Accreditation : the Regulation plays a key part in facilitating the free movement of goods in the internal market and international trade. Under its provisions, the Member States appoint a single National Accreditation Body that provides accreditation of conformity assessment bodies.

The Regulation provides for a uniformly rigorous approach to accreditation in all Member States — so that ultimately one accreditation certificate is enough to demonstrate the technical capacity of a conformity assessment body throughout Europe. Therefore, the benefit of accreditation in the EU is that once a conformity assessment body has been successfully accredited according to the Regulation, Member States' authorities are obliged to recognise the accreditation certificate. This eliminates the unnecessary overhead of being accredited separately in every Member State and having the products checked by different conformity assessment bodies. This creates an environment favourable for developing businesses in the European market.

The proportion of notifications of accredited conformity assessment bodies increased by 34 percentage points between end 2009 and November 2017. By the end of 2016, more than 34 450 accreditations were delivered (in regulated and non-harmonised areas) covering a wide range of activities.

In 2016, the peer evaluation teams reported a total of 135 findings where corrective action was required by national accreditation bodies. The European accreditation is monitoring how the corrective action is being implemented. The Commission recognised the European Cooperation for Accreditation (EA) as the European accreditation infrastructure.

The Regulation established a trustworthy and stable accreditation system in all Member States, as well as EFTA countries and Turkey . With the provisional entry into force of the EU-Canada Comprehensive Economic and Trade Agreement on 21 September 2017, the Protocol on Mutual Acceptance of the Results of the Conformity Assessment of CETA extended the scope of the previous Mutual Acceptance and simplified the procedures for the designation of conformity assessment bodies. The Protocol relies on accreditation, which thus becomes an even more important pillar for international cooperation with third countries.

Legal developments related to accreditation have occurred in specific sectors such as data protection, food and feed and cybersecurity.

However, the challenge is to keep the whole accreditation system in line with the latest state of the art and ensure that it is applied with the same stringency.

It is therefore essential that the Union continues to support the EA to help it carry out its tasks. In addition, it is important to maintain a high level of awareness and understanding of the accreditation system among stakeholders in order to ensure its correct implementation, especially in new policy areas.

2) CE marking : the report confirmed that businesses are also better aware of the important role of CE marking on products in the single market. There is a need for greater consistency and to avoid having different requirements for different pieces of legislation and address the issue of products with multiple parts.

The number of visits to the CE marking web pages demonstrates the importance of this information being made available to stakeholders.

2013/02/13
   EC - Follow-up document
Details

This report gives an overview of the implementation of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products which has applied from 1 January 2010. The main points are as follows:

Accreditation: 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 next few 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;

· greater prominence to accreditation for notification purposes which 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 the European Cooperation for Accreditation (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.

Union market surveillance framework for products : with regard to the national market surveillance programmes , 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. Clarity on how Member States have organised cooperation and coordination among different authorities and with customs could be improved. In addition:

· Products presenting a serious risk : the report discusses the extension of the RAPEX system, which has contributed particularly to the protection of workers and the environment, although the total number of new notifications has been rather limited during the first two years of implementation of the Regulation. Overall, 9 Member States transmitted notifications on professional goods and products which may harm public interests other than health and safety and this figure will increase over time.

· General information support system – ICSMS : in November 2011, the Commission agreed to purchase ICSMS for EUR 1,940,940.

CE Marking and Conformity Assessment : upon request by the European Parliament, the Commission carried out an information campaign on CE marking financed by the Entrepreneurship and Innovation Programme in 2009 and costing EUR 2 million. Feedback and interest shows that the campaign fulfilled its goals.

2013/02/13
   EC - Follow-up document
2013/02/13
   EC - Follow-up document
2008/08/13
   Final act published in Official Journal
Details

PURPOSE: to establish requirements for accreditation and market surveillance for the marketing of products.

LEGISLATIVE ACT: Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

CONTENT: This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. It provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security. The Regulation provides a framework for controls on products from third countries and lays down the general principles of the CE marking.

Accreditation : accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements. The Regulation has developed comprehensive framework for accreditation and lays down at Community level the principles for its operation and organisation. Each Member State shall appoint a single national accreditation body. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect. The accreditation body must be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and ensure that no conflicts of interest with conformity assessment bodies occur.

Market surveillance : this must ensure that products covered by Community harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly. National market surveillance infrastructures and programmes shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. Market surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products.

Products presenting a serious risk : Member States must ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.

CE marking : the Regulation sets out the general principles of CE marking. The CE marking shall be affixed only by the manufacturer or his authorised representative, and it must be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation.

Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned. It will include an evaluation of the extension of the scope of Chapter III to all products. By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation.

APPLICATION: from 1/01/2010.

ENTRY INTO FORCE: 02/09/2008.

2008/07/09
   CSL - Draft final act
Documents
2008/07/09
   CSL - Final act signed
2008/07/09
   EP - End of procedure in Parliament
2008/06/23
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2008/06/23
   CSL - Council Meeting
2008/03/31
   EC - Commission response to text adopted in plenary
Documents
2008/02/25
   CSL - Debate in Council
Documents
2008/02/25
   CSL - Council Meeting
2008/02/21
   EP - Results of vote in Parliament
2008/02/21
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted a resolution based on the report drafted by Andre BRIE (GUE/NGL, DE), amending, under the first reading of the codecision procedure, the proposal for a regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products.

The main amendments were as follows:

Objective: Parliament made some amendments to this Article which now states that t he Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. It also provides a framework for the market surveillance of transformed products to ensure that they respect a high level of protection of public interests such as health and safety in general, of health and safety at the workplace, protection of consumers, of the environment, and of security. The Regulation further provides a framework for controls on products from third countries. It also contains provisions on CE marking .

Accreditation and conformity assessment : each Member State must appoint a single national accreditation body. The Commission shall draw up a list of the national accreditation bodies, to be made publicly available. Where accreditation is not operated directly by the public authorities themselves, Member States shall entrust the national accreditation body with the operation of accreditation as a public authority and grant it formal recognition on behalf of the government. The national accreditation body must not provide any services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body. Each Member State shall ensure that its national accreditation body has the appropriate resources for the proper performance of its tasks including for the fulfilment of special tasks, such as activities in European and international accreditation cooperation and activities that are required to support government policy and which are not self-financing. The national accreditation body shall be a member of the body recognised by the Commission as managing the European accreditation infrastructure. National accreditation bodies must maintain appropriate structures to ensure the balanced involvement of all interested parties. Member States must monitor their national accreditation bodies and take the utmost account of the results of peer evaluation. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation.

Principle of non-competition : a new Article on the principle of non-competition states that national accreditation bodies shall not compete with conformity assessment bodies, or with other national accreditation bodies within the territory of the European Union with respect to accreditation for compulsory conformity assessment activities. National accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a conformity assessment body in respect of accreditation for a compulsory conformity assessment activity in certain circumstances.

Parliament added that a national accreditation body shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of the undertaking, the sector in which it operates, the structure of the undertaking, the degree of complexity of the product technology in question and the mass nature of the production process.

European accreditation infrastructure : Parliament inserted a clause stating that the Commission shall, after consultation with the Member States, recognise a body which satisfies the requirements of the Annex to the Regulation. In order for a body to be recognised, it shall conclude an agreement with the Commission. That agreement shall contain the detailed tasks of the body, funding provisions and provisions for the supervision of the recognised body. The first body recognised under the Regulation will be the European Co-operation for Accreditation.

Market surveillance : provisions on market surveillance will apply in so far as there are no specific provisions with the same objective in rules of Community harmonisation legislation. The application of the Regulation will not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC (GPSD). Market surveillance shall ensure that products covered by Community harmonisation legislation which, when used for their intended purpose or under conditions which can reasonably be foreseen and when properly installed, and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation, are withdrawn, prohibited or restricted from being made available on the market and that the public, the Commission and the other Member States are appropriately informed. National market surveillance infrastructures shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. Such surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products.

Parliament went on to specify that Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, including by ways of electronic communications. The first such communication shall take place by 1 January 2010. Member States shall periodically review the functioning of their surveillance activities. Such reviews and assessments shall occur at least every fourth year and the results shall be communicated to the other Member States and the Commission and made available to the public.

On the question of risk, Parliament stated that the decision as to whether or not a product represents a serious risk shall be based on an appropriate risk assessment based on the character of the hazard and the likelihood of it occurring. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to present a serious risk.

Control of products entering the Community market : Member States must ensure that their relevant authorities responsible for control of products entering the Community market have the necessary powers and resources in order to properly perform their tasks. Where in a Member State more than one authority is responsible for market surveillance and customs controls, those authorities shall co-operate with each other.

CE marking : Parliament inserted a new clause entitled “General Principles of the CE Marking”. The provisions are inspired by the proposed Decision. (Please see COD/2007/0030 ). The CE marking shall only be affixed by the manufacturer or his authorised representative.

Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned. It will include an evaluation of the extension of the scope of Chapter III to all products.

Documents
2008/02/19
   EP - Debate in Parliament
2007/12/13
   ESC - Economic and Social Committee: opinion, report
Documents
2007/12/04
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2007/12/04
   EP - Committee report tabled for plenary, 1st reading
Documents
2007/11/27
   EP - Vote in committee, 1st reading
Details

The Committee on the Internal Market and Consumer Protection adopted a report drafted by Andre BRIE (GUE/NGL, DE), amending, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products.

The main amendments made in committee were as follows:

Objective: Members felt that the proposal offers an opportunity to establish a broader framework for both accreditation and market surveillance. An amended clause on the objective stipulates that, to ensure that products benefiting from the free movement of goods within the Community respect a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers and of the environment, while ensuring that the free movement of products is not restricted beyond what is allowed under Community harmonisation legislation, this Regulation provides a framework supporting specific rules of sectoral Community harmonisation legislation, without making any substantive changes to that legislation, in particular, without making changes to rules relating to protection of health and the environment and any specific rules on accreditation and market surveillance.. For these purposes, this Regulation lays down: a) rules on the organisation and operation of accreditation of conformity assessment bodies; b) a framework for market surveillance and for the control of products from third countries; c) provisions relating to the Community CE mark and CE marking.

Scope : favouring a broad scope of application the Committee removed all the exclusions proposed by the Commission. Instead, the general principle that more specific rules have precedence over more general rules is restated. Some definitions, such as “products”, “Community harmonisation legislation”, “entering the Community market”, “conformity assessment”, “CE marking”, “peer evaluation” and release for free circulation” have been introduced.

Accreditation and conformity assessment : the scope of the accreditation framework should be as wide as possible to prevent the creation of several parallel systems, but it should be clearly linked to the existing framework. The Committee stated that the Commission shall draw up and update the list of the national accreditation bodies operating in each Member State. That list shall be made publicly available by the Commission. The national accreditation body shall act as a public authority and in the public interest. It must not provide commercial consultancy services, own shares or otherwise have a financial or managerial interest in a conformity assessment body.

Members introduced a new Article on the principle of non-competition. National accreditation bodies shall not compete with conformity assessment bodies, or with other national accreditation bodies within the territory of the European Union with respect to accreditation for compulsory conformity assessment activities. National accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a conformity assessment body in respect of accreditation for a compulsory conformity assessment activity in certain circumstances.

National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties both within their organisations and the European accreditation network.

It must be guaranteed that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of the undertaking, the sector in which it operates, the structure of the undertaking, the degree of complexity of the product technology in question and the mass nature of the production process.

Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities.

European accreditation infrastructure : the Committee inserted a clause stating that the Commission shall, after consultation with the Member States, recognise a body which satisfies the requirements of the Annex to the Regulation. In order for a body to be recognised, it shall conclude a framework agreement with the Commission. That agreement shall contain, inter alia, the detailed tasks of the body, breach of which will entitle the Commission to terminate the agreement, funding provisions and provisions for the supervision of the recognised body, as well as other provisions customary for an agreement of its type. The Commission and the body concerned shall make the framework agreement public. Both the Commission and the body concerned shall be able to terminate the agreement without cause at the expiry of a reasonable notice period to be defined in the agreement. The first body recognised under this Regulation shall be the European Co-operation for Accreditation, provided that it has concluded a framework agreement as aforesaid.

Market surveillance and customs authorities : contrary to the Commission proposal, the Committee felt that a framework for market surveillance should by its very nature be broad, and accordingly, it stated that Directive 2001/95/EC (the General Product Safety Directive) must be included in the market surveillance regulation. Similarly, the Committee did not approve of the exclusion of 15 pieces of other legislation under Article 13(3), as this would contradict the establishment of an efficient market surveillance based on EU-wide rules. It stated that the objective of market surveillance is to ensure that products covered by Community harmonisation legislation which, when used for their intended purpose or under conditions which can reasonably be foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation, are withdrawn, or restricted and that the public, the Commission and the other Member States are informed. Furthermore, Member States shall ensure that their market surveillance covers the full range of products which are subject to legal requirements, irrespective of whether they are intended for consumers or likely to be used by consumers, or intended for professional use.

Member States shall ensure that market surveillance programmes are established, implemented and periodically updated. Each Member State shall draw up a global market surveillance programme within one year of the date of entry into force of the Regulation and communicate it to the other Member States and the Commission and make it available to the public on the internet. Subsequent updates of that programme shall be made public in the same manner. Member States may establish co-operation agreements with stakeholders, in particular with sectoral professional organizations, in order to take advantage of available market intelligence.

The decision as to whether or not a product represents a serious risk shall be based on an appropriate risk assessment based on the character of the risk and the likelihood of it occurring. The Committee gives an outline of the nature of the risk assessment.

Control of products entering the Community market : Members felt that co-ordination and exchange of information between customs and market surveillance authorities had to be strengthened. Member States must ensure that their relevant authorities responsible for control of products entering the Community market have the necessary powers and resources in order to properly perform their tasks. Member States shall also ensure the effective cooperation between customs and market surveillance authorities. Where in a Member State more than one authority is responsible for market surveillance and customs controls, those authorities shall co-operate with each other.

CE marking : the Committee felt that the CE marking needed better protection and inserted a new clause entitled “General Principles of the CE Marking”. The provisions are (inspired by the proposed Decision. (Please see COD/2007/0030.)

Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit to the European Parliament and to the Council a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. The report shall include an evaluation of the extension of the scope of Chapter III of the Regulation to all products.

2007/11/23
   EP - Committee opinion
Documents
2007/11/22
   CSL - Debate in Council
Documents
2007/11/22
   CSL - Council Meeting
2007/10/16
   EP - Amendments tabled in committee
Documents
2007/10/05
   EP - Committee opinion
Documents
2007/09/14
   EP - Committee opinion
Documents
2007/06/29
   EP - Committee draft report
Documents
2007/05/21
   CSL - Debate in Council
Documents
2007/05/21
   CSL - Council Meeting
2007/05/10
   EP - LIESE Peter (PPE-DE) appointed as rapporteur in ENVI
2007/04/12
   EP - PURVIS John (PPE-DE) appointed as rapporteur in ITRE
2007/03/13
   EP - Committee referral announced in Parliament, 1st reading
2007/02/14
   EC - Legislative proposal
Details

PURPOSE: to establish requirements for accreditation and market surveillance for the marketing of products.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: the free movement of goods forms a central pillar of the single market. Community technical legislation ensuring the free circulation of products has contributed considerably to the completion and proper functioning of the EU’s internal market. A number of secondary legislative initiatives support the free circulation of goods across the EU. They include the “new” approach Directives; legislation on setting out the basic rules for CE marking and the application of harmonised conformity assessment procedures; legislation on recognising the role of the European standardisation organisations; and the priority of European standards and legislation on product safety.

Experience has shown, however, that obstacles to the free movement of goods remain. The obstacles identified are:

- a distortion of competition due to differing practices in the “designation of conformity” by the national assessment bodies;

- an unequal treatment of “non-complying” or dangerous products on the market through the use of very different national market surveillance regulations, rules and means;

- a certain lack of trust in conformity marking; and

- a certain lack of coherence in the implementation and enforcement of existing EU legislation.

CONTENT: the purpose of this proposal, therefore, is:

- to lay down rules on the organisation and operation of accreditation of conformity assessment bodies that perform product assessment;

- to provide a framework for market surveillance; and

- to control products from third countries.

It is being presented alongside a proposal for a Decision on a consumer framework for the marketing of products. (See COD/2007/0030 ). The two proposals seek to complete existing legislative tools and to reinforce Community policies on market surveillance/accreditation. They also seeks to bring coherence to existing sectoral instruments by examining how these horizontal instrument can be applied to all sectors regardless of whether they are “old” or “new” approach.

In summary, the proposed Regulation will:

- organise accreditation at both a national and a European level – irrespective of the sectors involved. The proposal insists on the public authority nature of accreditation;

- set out a framework for recognising the existing “European co-operation for Accreditation” or EA. This will allow for a rigorous peer evaluation;

- ensure that national authorities are given equivalent means of intervention and the necessary authority to intervene in the market should they need to withdraw non-compliant or unsafe products;

- ensure co-operation between the internal authorities and the customs authorities, who control products entering the market from third countries; and

- set up a framework for the exchange of information between national authorities.

In terms of the budgetary impact of the proposal, the Community’s financial contribution is expected to be reduced in overall terms. On a final point, the proposal provides for the simplification of EU legislation and will lead to the repeal of Council Regulation 93/339/EEC.

For further details of the financial impact of the proposal refer to the financial statement.

2007/02/14
   EC - Document attached to the procedure
2007/02/14
   EC - Document attached to the procedure
2007/02/13
   EC - Legislative proposal published
Details

PURPOSE: to establish requirements for accreditation and market surveillance for the marketing of products.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: the free movement of goods forms a central pillar of the single market. Community technical legislation ensuring the free circulation of products has contributed considerably to the completion and proper functioning of the EU’s internal market. A number of secondary legislative initiatives support the free circulation of goods across the EU. They include the “new” approach Directives; legislation on setting out the basic rules for CE marking and the application of harmonised conformity assessment procedures; legislation on recognising the role of the European standardisation organisations; and the priority of European standards and legislation on product safety.

Experience has shown, however, that obstacles to the free movement of goods remain. The obstacles identified are:

- a distortion of competition due to differing practices in the “designation of conformity” by the national assessment bodies;

- an unequal treatment of “non-complying” or dangerous products on the market through the use of very different national market surveillance regulations, rules and means;

- a certain lack of trust in conformity marking; and

- a certain lack of coherence in the implementation and enforcement of existing EU legislation.

CONTENT: the purpose of this proposal, therefore, is:

- to lay down rules on the organisation and operation of accreditation of conformity assessment bodies that perform product assessment;

- to provide a framework for market surveillance; and

- to control products from third countries.

It is being presented alongside a proposal for a Decision on a consumer framework for the marketing of products. (See COD/2007/0030 ). The two proposals seek to complete existing legislative tools and to reinforce Community policies on market surveillance/accreditation. They also seeks to bring coherence to existing sectoral instruments by examining how these horizontal instrument can be applied to all sectors regardless of whether they are “old” or “new” approach.

In summary, the proposed Regulation will:

- organise accreditation at both a national and a European level – irrespective of the sectors involved. The proposal insists on the public authority nature of accreditation;

- set out a framework for recognising the existing “European co-operation for Accreditation” or EA. This will allow for a rigorous peer evaluation;

- ensure that national authorities are given equivalent means of intervention and the necessary authority to intervene in the market should they need to withdraw non-compliant or unsafe products;

- ensure co-operation between the internal authorities and the customs authorities, who control products entering the market from third countries; and

- set up a framework for the exchange of information between national authorities.

In terms of the budgetary impact of the proposal, the Community’s financial contribution is expected to be reduced in overall terms. On a final point, the proposal provides for the simplification of EU legislation and will lead to the repeal of Council Regulation 93/339/EEC.

For further details of the financial impact of the proposal refer to the financial statement.

Documents

History

(these mark the time of scraping, not the official date of the change)

docs/4/docs/0/url
https://www.europarl.europa.eu/doceo/document/INTA-AD-388413_EN.html
docs/5/docs/0/url
https://www.europarl.europa.eu/doceo/document/ITRE-AD-390374_EN.html
docs/7/docs/0/url
https://www.europarl.europa.eu/doceo/document/ENVI-AD-390476_EN.html
docs/10/docs/0/url
/oeil/spdoc.do?i=14415&j=0&l=en
docs/16
date
2022-12-05T00:00:00
docs
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Follow-up document
body
EC
events/0
date
2007-02-13T00:00:00
type
Legislative proposal published
body
EC
docs
summary
events/12
date
2008-08-13T00:00:00
type
Final act published in Official Journal
summary
docs
events/13
date
2008-08-13T00:00:00
type
Final act published in Official Journal
summary
docs
events/13/docs/1/url
Old
https://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:218:SOM:EN:HTML
New
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:218:TOC
links/National parliaments/url
Old
http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2007&number=0029&appLng=EN
New
https://ipexl.europarl.europa.eu/IPEXL-WEB/dossier/code=COD&year=2007&number=0029&appLng=EN
procedure/instrument/1
See also 2011/0349(COD) See also 2011/0350(COD) See also 2011/0351(COD) See also 2011/0352(COD) See also 2011/0353(COD) See also 2011/0354(COD) See also 2011/0356(COD) See also 2011/0357(COD) See also 2011/0358(COD) Amended by 2013/0048(COD)
procedure/instrument/1
See also 2011/0349(COD) See also 2011/0350(COD) See also 2011/0351(COD) See also 2011/0352(COD) See also 2011/0353(COD) See also 2011/0354(COD) See also 2011/0356(COD) See also 2011/0357(COD) See also 2011/0358(COD)
committees/0/rapporteur
  • name: BRIE André date: 2007-03-20T00:00:00 group: European United Left/Nordic Green Left abbr: GUE/NGL
committees/1/rapporteur
  • name: MARKOV Helmuth date: 2007-03-21T00:00:00 group: European United Left/Nordic Green Left abbr: GUE/NGL
docs/0
date
2007-02-14T00:00:00
docs
summary
type
Legislative proposal
body
EC
docs/1
date
2007-02-14T00:00:00
docs
type
Document attached to the procedure
body
EC
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docs
  • date: 2007-02-14T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2007/0173/COM_SEC(2007)0173_EN.pdf title: SEC(2007)0173 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=SECfinal&an_doc=2007&nu_doc=173 title: EUR-Lex type: Document attached to the procedure body: EC
  • date: 2007-02-14T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2007/0174/COM_SEC(2007)0174_EN.pdf title: SEC(2007)0174 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=SECfinal&an_doc=2007&nu_doc=174 title: EUR-Lex type: Document attached to the procedure body: EC
  • date: 2007-06-29T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.753 title: PE390.753 type: Committee draft report body: EP
  • date: 2007-09-14T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE388.413&secondRef=02 title: PE388.413 committee: INTA type: Committee opinion body: EP
  • date: 2007-10-05T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.374&secondRef=02 title: PE390.374 committee: ITRE type: Committee opinion body: EP
  • date: 2007-10-16T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE396.408 title: PE396.408 type: Amendments tabled in committee body: EP
  • date: 2007-11-23T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.476&secondRef=02 title: PE390.476 committee: ENVI type: Committee opinion body: EP
  • date: 2007-12-04T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-491&language=EN title: A6-0491/2007 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2007-12-13T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:1693)(documentyear:2007)(documentlanguage:EN) title: CES1693/2007 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2008-03-31T00:00:00 docs: url: /oeil/spdoc.do?i=14415&j=0&l=en title: SP(2008)1767 type: Commission response to text adopted in plenary
  • date: 2008-07-09T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F08&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 03614/2008/LEX type: Draft final act body: CSL
  • date: 2013-02-13T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2013/0077/COM_COM(2013)0077_EN.pdf title: COM(2013)0077 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=77 title: EUR-Lex summary: This report gives an overview of the implementation of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products which has applied from 1 January 2010. The main points are as follows: Accreditation: 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 next few 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; · greater prominence to accreditation for notification purposes which 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 the European Cooperation for Accreditation (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. Union market surveillance framework for products : with regard to the national market surveillance programmes , 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. Clarity on how Member States have organised cooperation and coordination among different authorities and with customs could be improved. In addition: · Products presenting a serious risk : the report discusses the extension of the RAPEX system, which has contributed particularly to the protection of workers and the environment, although the total number of new notifications has been rather limited during the first two years of implementation of the Regulation. Overall, 9 Member States transmitted notifications on professional goods and products which may harm public interests other than health and safety and this figure will increase over time. · General information support system – ICSMS : in November 2011, the Commission agreed to purchase ICSMS for EUR 1,940,940. CE Marking and Conformity Assessment : upon request by the European Parliament, the Commission carried out an information campaign on CE marking financed by the Entrepreneurship and Innovation Programme in 2009 and costing EUR 2 million. Feedback and interest shows that the campaign fulfilled its goals. type: Follow-up document body: EC
  • date: 2013-02-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0035:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0035 type: Follow-up document body: EC
  • date: 2013-02-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0036:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0036 type: Follow-up document body: EC
  • date: 2017-12-19T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2017/0789/COM_COM(2017)0789_EN.pdf title: COM(2017)0789 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2017&nu_doc=0789 title: EUR-Lex summary: The report presented by the Commission gives an overview of how the accreditation provisions of Regulation (EC) No 765/2008 and the CE marking were implemented between 2013 and 2017. It was prepared in cooperation with the Member States through the accreditation sub-group of the ‘Internal market for products’ experts group. The main findings of the report are as follows: 1) Accreditation : the Regulation plays a key part in facilitating the free movement of goods in the internal market and international trade. Under its provisions, the Member States appoint a single National Accreditation Body that provides accreditation of conformity assessment bodies. The Regulation provides for a uniformly rigorous approach to accreditation in all Member States — so that ultimately one accreditation certificate is enough to demonstrate the technical capacity of a conformity assessment body throughout Europe. Therefore, the benefit of accreditation in the EU is that once a conformity assessment body has been successfully accredited according to the Regulation, Member States' authorities are obliged to recognise the accreditation certificate. This eliminates the unnecessary overhead of being accredited separately in every Member State and having the products checked by different conformity assessment bodies. This creates an environment favourable for developing businesses in the European market. The proportion of notifications of accredited conformity assessment bodies increased by 34 percentage points between end 2009 and November 2017. By the end of 2016, more than 34 450 accreditations were delivered (in regulated and non-harmonised areas) covering a wide range of activities. In 2016, the peer evaluation teams reported a total of 135 findings where corrective action was required by national accreditation bodies. The European accreditation is monitoring how the corrective action is being implemented. The Commission recognised the European Cooperation for Accreditation (EA) as the European accreditation infrastructure. The Regulation established a trustworthy and stable accreditation system in all Member States, as well as EFTA countries and Turkey . With the provisional entry into force of the EU-Canada Comprehensive Economic and Trade Agreement on 21 September 2017, the Protocol on Mutual Acceptance of the Results of the Conformity Assessment of CETA extended the scope of the previous Mutual Acceptance and simplified the procedures for the designation of conformity assessment bodies. The Protocol relies on accreditation, which thus becomes an even more important pillar for international cooperation with third countries. Legal developments related to accreditation have occurred in specific sectors such as data protection, food and feed and cybersecurity. However, the challenge is to keep the whole accreditation system in line with the latest state of the art and ensure that it is applied with the same stringency. It is therefore essential that the Union continues to support the EA to help it carry out its tasks. In addition, it is important to maintain a high level of awareness and understanding of the accreditation system among stakeholders in order to ensure its correct implementation, especially in new policy areas. 2) CE marking : the report confirmed that businesses are also better aware of the important role of CE marking on products in the single market. There is a need for greater consistency and to avoid having different requirements for different pieces of legislation and address the issue of products with multiple parts. The number of visits to the CE marking web pages demonstrates the importance of this information being made available to stakeholders. type: Follow-up document body: EC
events
  • date: 2007-02-14T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2007/0037/COM_COM(2007)0037_EN.pdf title: COM(2007)0037 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2007&nu_doc=37 title: EUR-Lex summary: PURPOSE: to establish requirements for accreditation and market surveillance for the marketing of products. PROPOSED ACT: Regulation of the European Parliament and of the Council. BACKGROUND: the free movement of goods forms a central pillar of the single market. Community technical legislation ensuring the free circulation of products has contributed considerably to the completion and proper functioning of the EU’s internal market. A number of secondary legislative initiatives support the free circulation of goods across the EU. They include the “new” approach Directives; legislation on setting out the basic rules for CE marking and the application of harmonised conformity assessment procedures; legislation on recognising the role of the European standardisation organisations; and the priority of European standards and legislation on product safety. Experience has shown, however, that obstacles to the free movement of goods remain. The obstacles identified are: - a distortion of competition due to differing practices in the “designation of conformity” by the national assessment bodies; - an unequal treatment of “non-complying” or dangerous products on the market through the use of very different national market surveillance regulations, rules and means; - a certain lack of trust in conformity marking; and - a certain lack of coherence in the implementation and enforcement of existing EU legislation. CONTENT: the purpose of this proposal, therefore, is: - to lay down rules on the organisation and operation of accreditation of conformity assessment bodies that perform product assessment; - to provide a framework for market surveillance; and - to control products from third countries. It is being presented alongside a proposal for a Decision on a consumer framework for the marketing of products. (See COD/2007/0030 ). The two proposals seek to complete existing legislative tools and to reinforce Community policies on market surveillance/accreditation. They also seeks to bring coherence to existing sectoral instruments by examining how these horizontal instrument can be applied to all sectors regardless of whether they are “old” or “new” approach. In summary, the proposed Regulation will: - organise accreditation at both a national and a European level – irrespective of the sectors involved. The proposal insists on the public authority nature of accreditation; - set out a framework for recognising the existing “European co-operation for Accreditation” or EA. This will allow for a rigorous peer evaluation; - ensure that national authorities are given equivalent means of intervention and the necessary authority to intervene in the market should they need to withdraw non-compliant or unsafe products; - ensure co-operation between the internal authorities and the customs authorities, who control products entering the market from third countries; and - set up a framework for the exchange of information between national authorities. In terms of the budgetary impact of the proposal, the Community’s financial contribution is expected to be reduced in overall terms. On a final point, the proposal provides for the simplification of EU legislation and will lead to the repeal of Council Regulation 93/339/EEC. For further details of the financial impact of the proposal refer to the financial statement.
  • date: 2007-03-13T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2007-05-21T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2801*&MEET_DATE=21/05/2007 title: 2801
  • date: 2007-11-22T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2832*&MEET_DATE=22/11/2007 title: 2832
  • date: 2007-11-27T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The Committee on the Internal Market and Consumer Protection adopted a report drafted by Andre BRIE (GUE/NGL, DE), amending, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products. The main amendments made in committee were as follows: Objective: Members felt that the proposal offers an opportunity to establish a broader framework for both accreditation and market surveillance. An amended clause on the objective stipulates that, to ensure that products benefiting from the free movement of goods within the Community respect a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers and of the environment, while ensuring that the free movement of products is not restricted beyond what is allowed under Community harmonisation legislation, this Regulation provides a framework supporting specific rules of sectoral Community harmonisation legislation, without making any substantive changes to that legislation, in particular, without making changes to rules relating to protection of health and the environment and any specific rules on accreditation and market surveillance.. For these purposes, this Regulation lays down: a) rules on the organisation and operation of accreditation of conformity assessment bodies; b) a framework for market surveillance and for the control of products from third countries; c) provisions relating to the Community CE mark and CE marking. Scope : favouring a broad scope of application the Committee removed all the exclusions proposed by the Commission. Instead, the general principle that more specific rules have precedence over more general rules is restated. Some definitions, such as “products”, “Community harmonisation legislation”, “entering the Community market”, “conformity assessment”, “CE marking”, “peer evaluation” and release for free circulation” have been introduced. Accreditation and conformity assessment : the scope of the accreditation framework should be as wide as possible to prevent the creation of several parallel systems, but it should be clearly linked to the existing framework. The Committee stated that the Commission shall draw up and update the list of the national accreditation bodies operating in each Member State. That list shall be made publicly available by the Commission. The national accreditation body shall act as a public authority and in the public interest. It must not provide commercial consultancy services, own shares or otherwise have a financial or managerial interest in a conformity assessment body. Members introduced a new Article on the principle of non-competition. National accreditation bodies shall not compete with conformity assessment bodies, or with other national accreditation bodies within the territory of the European Union with respect to accreditation for compulsory conformity assessment activities. National accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a conformity assessment body in respect of accreditation for a compulsory conformity assessment activity in certain circumstances. National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties both within their organisations and the European accreditation network. It must be guaranteed that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of the undertaking, the sector in which it operates, the structure of the undertaking, the degree of complexity of the product technology in question and the mass nature of the production process. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities. European accreditation infrastructure : the Committee inserted a clause stating that the Commission shall, after consultation with the Member States, recognise a body which satisfies the requirements of the Annex to the Regulation. In order for a body to be recognised, it shall conclude a framework agreement with the Commission. That agreement shall contain, inter alia, the detailed tasks of the body, breach of which will entitle the Commission to terminate the agreement, funding provisions and provisions for the supervision of the recognised body, as well as other provisions customary for an agreement of its type. The Commission and the body concerned shall make the framework agreement public. Both the Commission and the body concerned shall be able to terminate the agreement without cause at the expiry of a reasonable notice period to be defined in the agreement. The first body recognised under this Regulation shall be the European Co-operation for Accreditation, provided that it has concluded a framework agreement as aforesaid. Market surveillance and customs authorities : contrary to the Commission proposal, the Committee felt that a framework for market surveillance should by its very nature be broad, and accordingly, it stated that Directive 2001/95/EC (the General Product Safety Directive) must be included in the market surveillance regulation. Similarly, the Committee did not approve of the exclusion of 15 pieces of other legislation under Article 13(3), as this would contradict the establishment of an efficient market surveillance based on EU-wide rules. It stated that the objective of market surveillance is to ensure that products covered by Community harmonisation legislation which, when used for their intended purpose or under conditions which can reasonably be foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation, are withdrawn, or restricted and that the public, the Commission and the other Member States are informed. Furthermore, Member States shall ensure that their market surveillance covers the full range of products which are subject to legal requirements, irrespective of whether they are intended for consumers or likely to be used by consumers, or intended for professional use. Member States shall ensure that market surveillance programmes are established, implemented and periodically updated. Each Member State shall draw up a global market surveillance programme within one year of the date of entry into force of the Regulation and communicate it to the other Member States and the Commission and make it available to the public on the internet. Subsequent updates of that programme shall be made public in the same manner. Member States may establish co-operation agreements with stakeholders, in particular with sectoral professional organizations, in order to take advantage of available market intelligence. The decision as to whether or not a product represents a serious risk shall be based on an appropriate risk assessment based on the character of the risk and the likelihood of it occurring. The Committee gives an outline of the nature of the risk assessment. Control of products entering the Community market : Members felt that co-ordination and exchange of information between customs and market surveillance authorities had to be strengthened. Member States must ensure that their relevant authorities responsible for control of products entering the Community market have the necessary powers and resources in order to properly perform their tasks. Member States shall also ensure the effective cooperation between customs and market surveillance authorities. Where in a Member State more than one authority is responsible for market surveillance and customs controls, those authorities shall co-operate with each other. CE marking : the Committee felt that the CE marking needed better protection and inserted a new clause entitled “General Principles of the CE Marking”. The provisions are (inspired by the proposed Decision. (Please see COD/2007/0030.) Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit to the European Parliament and to the Council a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. The report shall include an evaluation of the extension of the scope of Chapter III of the Regulation to all products.
  • date: 2007-12-04T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-491&language=EN title: A6-0491/2007
  • date: 2008-02-19T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20080219&type=CRE title: Debate in Parliament
  • date: 2008-02-21T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=14415&l=en title: Results of vote in Parliament
  • date: 2008-02-21T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2008-61 title: T6-0061/2008 summary: The European Parliament adopted a resolution based on the report drafted by Andre BRIE (GUE/NGL, DE), amending, under the first reading of the codecision procedure, the proposal for a regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products. The main amendments were as follows: Objective: Parliament made some amendments to this Article which now states that t he Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. It also provides a framework for the market surveillance of transformed products to ensure that they respect a high level of protection of public interests such as health and safety in general, of health and safety at the workplace, protection of consumers, of the environment, and of security. The Regulation further provides a framework for controls on products from third countries. It also contains provisions on CE marking . Accreditation and conformity assessment : each Member State must appoint a single national accreditation body. The Commission shall draw up a list of the national accreditation bodies, to be made publicly available. Where accreditation is not operated directly by the public authorities themselves, Member States shall entrust the national accreditation body with the operation of accreditation as a public authority and grant it formal recognition on behalf of the government. The national accreditation body must not provide any services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body. Each Member State shall ensure that its national accreditation body has the appropriate resources for the proper performance of its tasks including for the fulfilment of special tasks, such as activities in European and international accreditation cooperation and activities that are required to support government policy and which are not self-financing. The national accreditation body shall be a member of the body recognised by the Commission as managing the European accreditation infrastructure. National accreditation bodies must maintain appropriate structures to ensure the balanced involvement of all interested parties. Member States must monitor their national accreditation bodies and take the utmost account of the results of peer evaluation. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation. Principle of non-competition : a new Article on the principle of non-competition states that national accreditation bodies shall not compete with conformity assessment bodies, or with other national accreditation bodies within the territory of the European Union with respect to accreditation for compulsory conformity assessment activities. National accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a conformity assessment body in respect of accreditation for a compulsory conformity assessment activity in certain circumstances. Parliament added that a national accreditation body shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of the undertaking, the sector in which it operates, the structure of the undertaking, the degree of complexity of the product technology in question and the mass nature of the production process. European accreditation infrastructure : Parliament inserted a clause stating that the Commission shall, after consultation with the Member States, recognise a body which satisfies the requirements of the Annex to the Regulation. In order for a body to be recognised, it shall conclude an agreement with the Commission. That agreement shall contain the detailed tasks of the body, funding provisions and provisions for the supervision of the recognised body. The first body recognised under the Regulation will be the European Co-operation for Accreditation. Market surveillance : provisions on market surveillance will apply in so far as there are no specific provisions with the same objective in rules of Community harmonisation legislation. The application of the Regulation will not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC (GPSD). Market surveillance shall ensure that products covered by Community harmonisation legislation which, when used for their intended purpose or under conditions which can reasonably be foreseen and when properly installed, and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation, are withdrawn, prohibited or restricted from being made available on the market and that the public, the Commission and the other Member States are appropriately informed. National market surveillance infrastructures shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. Such surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products. Parliament went on to specify that Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, including by ways of electronic communications. The first such communication shall take place by 1 January 2010. Member States shall periodically review the functioning of their surveillance activities. Such reviews and assessments shall occur at least every fourth year and the results shall be communicated to the other Member States and the Commission and made available to the public. On the question of risk, Parliament stated that the decision as to whether or not a product represents a serious risk shall be based on an appropriate risk assessment based on the character of the hazard and the likelihood of it occurring. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to present a serious risk. Control of products entering the Community market : Member States must ensure that their relevant authorities responsible for control of products entering the Community market have the necessary powers and resources in order to properly perform their tasks. Where in a Member State more than one authority is responsible for market surveillance and customs controls, those authorities shall co-operate with each other. CE marking : Parliament inserted a new clause entitled “General Principles of the CE Marking”. The provisions are inspired by the proposed Decision. (Please see COD/2007/0030 ). The CE marking shall only be affixed by the manufacturer or his authorised representative. Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned. It will include an evaluation of the extension of the scope of Chapter III to all products.
  • date: 2008-02-25T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2852*&MEET_DATE=25/02/2008 title: 2852
  • date: 2008-06-23T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2008-07-09T00:00:00 type: Final act signed body: CSL
  • date: 2008-07-09T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2008-08-13T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to establish requirements for accreditation and market surveillance for the marketing of products. LEGISLATIVE ACT: Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. CONTENT: This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. It provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security. The Regulation provides a framework for controls on products from third countries and lays down the general principles of the CE marking. Accreditation : accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements. The Regulation has developed comprehensive framework for accreditation and lays down at Community level the principles for its operation and organisation. Each Member State shall appoint a single national accreditation body. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect. The accreditation body must be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and ensure that no conflicts of interest with conformity assessment bodies occur. Market surveillance : this must ensure that products covered by Community harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly. National market surveillance infrastructures and programmes shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. Market surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products. Products presenting a serious risk : Member States must ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. CE marking : the Regulation sets out the general principles of CE marking. The CE marking shall be affixed only by the manufacturer or his authorised representative, and it must be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation. Review clause : not later than 5 years after the entry into force of the Regulation, the Commission shall submit a report on the application of the Regulation and Directive 2001/95/EC on General Product Safety and any other relevant Community instrument addressing market surveillance. In particular, the report shall analyse the coherence of Community rules in the field of market surveillance. If appropriate, the report shall be accompanied by proposals to amend and/or consolidate the instruments concerned. It will include an evaluation of the extension of the scope of Chapter III to all products. By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation. APPLICATION: from 1/01/2010. ENTRY INTO FORCE: 02/09/2008. docs: title: Regulation 2008/765 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008R0765 title: OJ L 218 13.08.2008, p. 0030 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:218:TOC
other
  • body: CSL type: Council Meeting council: Former Council configuration
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: VERHEUGEN Günter
procedure/dossier_of_the_committee
Old
IMCO/6/46225
New
  • IMCO/6/46225
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008R0765
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008R0765
procedure/instrument
Old
Regulation
New
  • Regulation
  • See also 2011/0349(COD) See also 2011/0350(COD) See also 2011/0351(COD) See also 2011/0352(COD) See also 2011/0353(COD) See also 2011/0354(COD) See also 2011/0356(COD) See also 2011/0357(COD) See also 2011/0358(COD) Amended by 2013/0048(COD)
procedure/subject
Old
  • 2.10 Free movement of goods
  • 2.10.03 Standardisation, EC standards and trademark, certification, compliance
  • 4.60.08 Safety of products and services, product liability
New
2.10
Free movement of goods
2.10.03
Standardisation, EC/EU standards and trade mark, certification, compliance
4.60.08
Safety of products and services, product liability
procedure/summary
  • Amended by
  • See also
  • See also
  • See also
  • See also
  • See also
  • See also
  • See also
  • See also
  • See also
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities/13/docs/1/url
Old
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:218:TOC
New
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:218:SOM:EN:HTML
activities
  • date: 2007-02-14T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2007/0037/COM_COM(2007)0037_EN.pdf title: COM(2007)0037 type: Legislative proposal published celexid: CELEX:52007PC0037:EN body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: VERHEUGEN Günter
  • date: 2007-03-13T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee: ENVI date: 2007-05-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: LIESE Peter body: EP responsible: True committee: IMCO date: 2007-03-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: GUE/NGL name: BRIE André body: EP responsible: False committee: INTA date: 2007-03-21T00:00:00 committee_full: International Trade rapporteur: group: GUE/NGL name: MARKOV Helmuth body: EP responsible: False committee: ITRE date: 2007-04-12T00:00:00 committee_full: Industry, Research and Energy rapporteur: group: PPE-DE name: PURVIS John body: EP responsible: False committee_full: Legal Affairs committee: JURI
  • body: CSL meeting_id: 2801 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2801*&MEET_DATE=21/05/2007 type: Debate in Council title: 2801 council: Competitiveness (Internal Market, Industry, Research and Space) date: 2007-05-21T00:00:00 type: Council Meeting
  • body: CSL meeting_id: 2832 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2832*&MEET_DATE=22/11/2007 type: Debate in Council title: 2832 council: Competitiveness (Internal Market, Industry, Research and Space) date: 2007-11-22T00:00:00 type: Council Meeting
  • date: 2007-11-27T00:00:00 body: EP committees: body: EP responsible: False committee: ENVI date: 2007-05-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: LIESE Peter body: EP responsible: True committee: IMCO date: 2007-03-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: GUE/NGL name: BRIE André body: EP responsible: False committee: INTA date: 2007-03-21T00:00:00 committee_full: International Trade rapporteur: group: GUE/NGL name: MARKOV Helmuth body: EP responsible: False committee: ITRE date: 2007-04-12T00:00:00 committee_full: Industry, Research and Energy rapporteur: group: PPE-DE name: PURVIS John body: EP responsible: False committee_full: Legal Affairs committee: JURI type: Vote in committee, 1st reading/single reading
  • date: 2007-12-04T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-491&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0491/2007 body: EP committees: body: EP responsible: False committee: ENVI date: 2007-05-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: LIESE Peter body: EP responsible: True committee: IMCO date: 2007-03-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: GUE/NGL name: BRIE André body: EP responsible: False committee: INTA date: 2007-03-21T00:00:00 committee_full: International Trade rapporteur: group: GUE/NGL name: MARKOV Helmuth body: EP responsible: False committee: ITRE date: 2007-04-12T00:00:00 committee_full: Industry, Research and Energy rapporteur: group: PPE-DE name: PURVIS John body: EP responsible: False committee_full: Legal Affairs committee: JURI type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2008-02-19T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20080219&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2008-02-21T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=14415&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2008-61 type: Decision by Parliament, 1st reading/single reading title: T6-0061/2008 body: EP type: Results of vote in Parliament
  • body: CSL meeting_id: 2852 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2852*&MEET_DATE=25/02/2008 type: Debate in Council title: 2852 council: Competitiveness (Internal Market, Industry, Research and Space) date: 2008-02-25T00:00:00 type: Council Meeting
  • date: 2008-06-23T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2881
  • date: 2008-06-23T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2008-07-09T00:00:00 body: CSL type: Final act signed
  • date: 2008-07-09T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2008-08-13T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008R0765 title: Regulation 2008/765 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:218:TOC title: OJ L 218 13.08.2008, p. 0030
committees
  • body: EP responsible: False committee: ENVI date: 2007-05-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: LIESE Peter
  • body: EP responsible: True committee: IMCO date: 2007-03-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: GUE/NGL name: BRIE André
  • body: EP responsible: False committee: INTA date: 2007-03-21T00:00:00 committee_full: International Trade rapporteur: group: GUE/NGL name: MARKOV Helmuth
  • body: EP responsible: False committee: ITRE date: 2007-04-12T00:00:00 committee_full: Industry, Research and Energy rapporteur: group: PPE-DE name: PURVIS John
  • body: EP responsible: False committee_full: Legal Affairs committee: JURI
links
National parliaments
European Commission
other
  • body: CSL type: Council Meeting council: Former Council configuration
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: VERHEUGEN Günter
procedure
dossier_of_the_committee
IMCO/6/46225
reference
2007/0029(COD)
subtype
Legislation
legal_basis
stage_reached
Procedure completed
summary
instrument
Regulation
title
Requirements for accreditation and market surveillance relating to the marketing of products (repeal. Regulation (EEC) No 339/93)
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject