{"change_dates":[],"dossier":{"amendments":[],"changes":{"2014-11-10T01:11:21":[{"data":[{"body":"EC","commission":[{"Commissioner":"VERHEUGEN G\u00fcnter","DG":{"title":"Enterprise and Industry","url":"http://ec.europa.eu/enterprise/"}}],"date":"2007-02-14T00:00:00","docs":[{"celexid":"CELEX:52007PC0037:EN","text":["
PURPOSE: to\n establish requirements for accreditation and market surveillance for the\n marketing of products.
PROPOSED ACT:\n Regulation of the European Parliament and of the Council.
BACKGROUND:\n the free movement of goods forms a central pillar of the single market.\n Community technical legislation ensuring the free circulation of products has\n contributed considerably to the completion and proper functioning of the EU’s\n internal market. A number of secondary legislative initiatives support the\n free circulation of goods across the EU. They include the “new” approach\n Directives; legislation on setting out the basic rules for CE marking and the\n application of harmonised conformity assessment procedures; legislation on\n recognising the role of the European standardisation organisations; and the\n priority of European standards and legislation on product safety.
Experience has\n shown, however, that obstacles to the free movement of goods remain. The\n obstacles identified are:
- \n a distortion of competition due to differing\n practices in the “designation of conformity” by the national assessment\n bodies;
- \n an unequal treatment of “non-complying” or\n dangerous products on the market through the use of very different national\n market surveillance regulations, rules and means;
- \n a certain lack of trust in conformity marking;\n and
- \n a certain lack of coherence in the\n implementation and enforcement of existing EU legislation.
CONTENT: the\n purpose of this proposal, therefore, is:
- \n to lay down rules on the organisation and\n operation of accreditation of conformity assessment bodies that perform\n product assessment;
- \n to provide a framework for market\n surveillance; and
- \n to control products from third countries.
It is being\n presented alongside a proposal for a Decision on a consumer framework for the\n marketing of products. (See COD/2007/0030). The two proposals seek to complete existing\n legislative tools and to reinforce Community policies on market\n surveillance/accreditation. They also seeks to bring coherence to existing\n sectoral instruments by examining how these horizontal instrument can be\n applied to all sectors regardless of whether they are “old” or “new”\n approach.
In summary, the proposed Regulation will:
- \n organise accreditation at\n both a national and a European level – irrespective of the sectors involved. The\n proposal insists on the public authority nature of accreditation;
- \n set out a framework for recognising the\n existing “European co-operation for Accreditation” or EA. This will allow for\n a rigorous peer evaluation;
- \n ensure that national authorities are given\n equivalent means of intervention and the necessary authority to intervene in\n the market should they need to withdraw non-compliant or unsafe products;
- \n ensure co-operation between the internal\n authorities and the customs authorities, who control products entering\n the market from third countries; and
- \n set up a framework for the exchange of\n information between national authorities.
In terms of\n the budgetary impact of the proposal, the Community’s financial contribution\n is expected to be reduced in overall terms. On a final point, the proposal\n provides for the simplification of EU legislation and will lead to the repeal\n of Council Regulation 93/339/EEC.
For further details of the financial impact of the proposal refer\n to the financial statement.
\nThe Committee on the Internal\n Market and Consumer Protection adopted a report drafted by Andre BRIE\n (GUE/NGL, DE), amending, under the first reading of the codecision procedure,\n the proposal for a regulation of the European Parliament and of the Council\n setting out the requirements for accreditation and market surveillance\n relating to the marketing of products.
The main amendments made in committee\n were as follows:
Objective: Members felt\n that the proposal offers an opportunity to establish a broader framework for\n both accreditation and market surveillance. An amended clause on the\n objective stipulates that, to ensure that products benefiting from the free\n movement of goods within the Community respect a high level of protection of\n public interests such as health and safety in general, health and safety at\n the workplace, protection of consumers and of the environment, while ensuring\n that the free movement of products is not restricted beyond what is allowed\n under Community harmonisation legislation, this Regulation provides a\n framework supporting specific rules of sectoral Community harmonisation\n legislation, without making any substantive changes to that legislation, in\n particular, without making changes to rules relating to protection of health\n and the environment and any specific rules on accreditation and market\n surveillance.. For these purposes, this Regulation lays down: a) rules on the\n organisation and operation of accreditation of conformity assessment bodies;\n b) a framework for market surveillance and for the control of products from\n third countries; c) provisions relating to the Community CE mark and CE\n marking.
Scope: favouring a broad\n scope of application the Committee removed all the exclusions proposed by the\n Commission. Instead, the general principle that more specific rules have\n precedence over more general rules is restated. Some definitions, such as\n “products”, “Community harmonisation legislation”, “entering the Community\n market”, “conformity assessment”, “CE marking”, “peer evaluation” and release\n for free circulation” have been introduced.
Accreditation and conformity\n assessment: the scope of the accreditation framework should be as wide\n as possible to prevent the creation of several parallel systems, but it\n should be clearly linked to the existing framework. The Committee stated that\n the Commission shall draw up and update the list of the national\n accreditation bodies operating in each Member State. That list shall be made\n publicly available by the Commission. The national accreditation body shall\n act as a public authority and in the public interest. It must not provide\n commercial consultancy services, own shares or otherwise have a financial or\n managerial interest in a conformity assessment body.
Members introduced a new\n Article on the principle of non-competition. National accreditation bodies\n shall not compete with conformity assessment bodies, or with other national\n accreditation bodies within the territory of the European Union with respect\n to accreditation for compulsory conformity assessment activities. National\n accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a\n conformity assessment body in respect of accreditation for a compulsory\n conformity assessment activity in certain circumstances.
National accreditation bodies\n shall establish and maintain appropriate structures to ensure the effective\n and balanced involvement of all interested parties both within their\n organisations and the European accreditation network.
It must be guaranteed that\n conformity assessments are carried out in an appropriate manner, meaning that\n unnecessary burdens are not imposed on undertakings and that due account is\n taken of the size of the undertaking, the sector in which it operates, the\n structure of the undertaking, the degree of complexity of the product\n technology in question and the mass nature of the production process.
Stakeholders shall have the\n right to participate in the system set up for the supervision of peer\n evaluation activities.
European accreditation\n infrastructure: the Committee inserted a clause stating that the\n Commission shall, after consultation with the Member States, recognise a body\n which satisfies the requirements of the Annex to the Regulation. In order for\n a body to be recognised, it shall conclude a framework agreement with the\n Commission. That agreement shall contain, inter alia, the detailed tasks of\n the body, breach of which will entitle the Commission to terminate the\n agreement, funding provisions and provisions for the supervision of the\n recognised body, as well as other provisions customary for an agreement of\n its type. The Commission and the body concerned shall make the framework\n agreement public. Both the Commission and the body concerned shall be able to\n terminate the agreement without cause at the expiry of a reasonable notice\n period to be defined in the agreement. The first body recognised under this\n Regulation shall be the European Co-operation for Accreditation, provided\n that it has concluded a framework agreement as aforesaid.
Market surveillance and\n customs authorities: contrary to the Commission proposal, the Committee\n felt that a framework for market surveillance should by its very nature be\n broad, and accordingly, it stated that Directive 2001/95/EC (the General\n Product Safety Directive) must be included in the market surveillance\n regulation. Similarly, the Committee did not approve of the exclusion of 15\n pieces of other legislation under Article 13(3), as this would contradict the\n establishment of an efficient market surveillance based on EU-wide rules. It\n stated that the objective of market surveillance is to ensure that products\n covered by Community harmonisation legislation which, when used for their\n intended purpose or under conditions which can reasonably be foreseen and\n when properly installed and maintained, are liable to compromise the health\n or safety of users, or which otherwise do not conform to applicable\n requirements set out in Community harmonisation legislation, are\n withdrawn, or restricted and that the public, the Commission and the other\n Member States are informed. Furthermore, Member States shall ensure that\n their market surveillance covers the full range of products which are subject\n to legal requirements, irrespective of whether they are intended for\n consumers or likely to be used by consumers, or intended for professional\n use.
Member States shall ensure that\n market surveillance programmes are established, implemented and periodically\n updated. Each Member State shall draw up a global market surveillance\n programme within one year of the date of entry into force of the Regulation\n and communicate it to the other Member States and the Commission and make it\n available to the public on the internet. Subsequent updates of that programme\n shall be made public in the same manner. Member States may establish\n co-operation agreements with stakeholders, in particular with sectoral\n professional organizations, in order to take advantage of available market\n intelligence.
The decision as to whether or\n not a product represents a serious risk shall be based on an appropriate risk\n assessment based on the character of the risk and the likelihood of it\n occurring. The Committee gives an outline of the nature of the risk\n assessment.
Control of products entering\n the Community market: Members felt that co-ordination and exchange of\n information between customs and market surveillance authorities had to be\n strengthened. Member States must ensure that their relevant authorities\n responsible for control of products entering the Community market have the\n necessary powers and resources in order to properly perform their tasks.\n Member States shall also ensure the effective cooperation between customs and\n market surveillance authorities. Where in a Member State more than one authority\n is responsible for market surveillance and customs controls, those\n authorities shall co-operate with each other.
CE marking: the\n Committee felt that the CE marking needed better protection and inserted a\n new clause entitled “General Principles of the CE Marking”. The provisions\n are (inspired by the proposed Decision. (Please see COD/2007/0030.)
Review clause: not later\n than 5 years after the entry into force of the Regulation, the Commission\n shall submit to the European Parliament and to the Council a report on the\n application of the Regulation and Directive 2001/95/EC on General Product\n Safety and any other relevant Community instrument addressing market\n surveillance. In particular, the report shall analyse the coherence of\n Community rules in the field of market surveillance. If appropriate, the\n report shall be accompanied by proposals to amend and/or consolidate the\n instruments concerned, in the interests of better regulation and\n simplification. The report shall include an evaluation of the extension of\n the scope of Chapter III of the Regulation to all products.
\nThe European\n Parliament adopted a resolution based on the report drafted by Andre BRIE\n (GUE/NGL, DE), amending, under the first reading of the codecision procedure,\n the proposal for a regulation setting out the requirements for accreditation\n and market surveillance relating to the marketing of products.
The main\n amendments were as follows:
Objective:\n Parliament made some amendments to this Article which now states that the Regulation lays down rules on the organisation and operation of\n accreditation of conformity assessment bodies performing conformity\n assessment activities. It also provides a framework for the market\n surveillance of transformed products to ensure that they respect a high level\n of protection of public interests such as health and safety in general, of\n health and safety at the workplace, protection of consumers, of the environment,\n and of security. The Regulation further provides a framework for controls on\n 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\n up a list of the national accreditation bodies, to be made publicly\n available. Where accreditation is not operated directly by the public\n authorities themselves, Member States shall entrust the national\n accreditation body with the operation of accreditation as a public authority\n and grant it formal recognition on behalf of the government. The national\n accreditation body must not provide any services that conformity assessment\n bodies provide, nor shall it provide consultancy services, own shares in or\n otherwise have a financial or managerial interest in a conformity assessment\n body. Each Member State shall ensure that its national accreditation body has\n the appropriate resources for the proper performance of its tasks including\n for the fulfilment of special tasks, such as activities in European and\n international accreditation cooperation and activities that are required to\n support government policy and which are not self-financing. The national\n accreditation body shall be a member of the body recognised by the Commission\n as managing the European accreditation infrastructure. National accreditation\n bodies must maintain appropriate structures to ensure the balanced\n involvement of all interested parties. Member States must monitor their\n national accreditation bodies and take the utmost account of the results of\n peer evaluation. Stakeholders shall have the right to participate in the\n system set up for the supervision of peer evaluation activities, but not in\n individual peer evaluation.
Principle of non-competition: a new Article on the principle of non-competition\n states that national accreditation bodies shall not compete with conformity\n assessment bodies, or with other national accreditation bodies within the\n territory of the European Union with respect to accreditation for compulsory\n conformity assessment activities. National accreditation bodies shall,\n however, be permitted to operate across Member State borders, within the\n territory of another Member State, at the request of a conformity assessment\n body in respect of accreditation for a compulsory conformity assessment\n activity in certain circumstances.
Parliament added that a national accreditation body shall verify that conformity assessments are carried out in an\n appropriate manner, meaning that unnecessary burdens are not imposed on\n undertakings and that due account is taken of the size of the undertaking,\n the sector in which it operates, the structure of the undertaking, the degree\n of complexity of the product technology in question and the mass nature of\n the production process.
European accreditation infrastructure: Parliament inserted a clause stating that\n the Commission shall, after consultation with the Member States, recognise a\n body which satisfies the requirements of the Annex to the Regulation. In\n order for a body to be recognised, it shall conclude an agreement with the\n Commission. That agreement shall contain the detailed tasks of the body, funding provisions and provisions for the supervision of the\n recognised body. The first body recognised under\n the Regulation will be the European Co-operation for Accreditation.
Market surveillance: provisions on market\n surveillance will apply in so far as there are no specific provisions with the\n same objective in rules of Community harmonisation legislation. The\n application of the Regulation will not prevent market surveillance\n authorities from taking more specific measures as provided for in Directive\n 2001/95/EC (GPSD).Market surveillance shall ensure that products covered by\n Community harmonisation legislation which, when used for their intended\n purpose or under conditions which can reasonably be foreseen and when\n properly installed, and maintained, are liable to compromise the health or safety\n of users, or which otherwise do not conform to applicable requirements set\n out in Community harmonisation legislation, are withdrawn, prohibited or\n restricted from being made available on the market and that the public, the\n Commission and the other Member States are appropriately informed. National\n market surveillance infrastructures shall ensure that effective measures can\n be taken in relation to any product category subject to Community\n harmonisation legislation. Such surveillance shall cover products\n assembled or manufactured for the manufacturer's own use where Community\n harmonisation legislation provides that its provisions shall apply to such\n products.
Parliament\n went on to specify that Member States shall draw up either a general market\n surveillance programme or sector specific programmes, covering the sectors in\n which they conduct market surveillance, communicate those programmes to the\n other Member States and the Commission and make them available to the public,\n including by ways of electronic communications. The first such communication\n shall take place by 1 January 2010. Member States shall periodically review\n the functioning of their surveillance activities. Such reviews and\n assessments shall occur at least every fourth year and the results shall be\n communicated to the other Member States and the Commission and made available\n to the public.
On the\n question of risk, Parliament stated that the decision as to whether or not a\n product represents a serious risk shall be based on an appropriate risk\n assessment based on the character of the hazard and the likelihood of it\n occurring. The feasibility of obtaining higher levels of safety or the\n availability of other products presenting a lesser degree of risk shall not\n constitute grounds for considering a product to present a serious risk.
Control of products entering the Community market: Member States must ensure that their\n relevant authorities responsible for control of products entering the\n Community market have the necessary powers and resources in order to properly\n perform their tasks. Where in a Member State more than one authority is\n responsible for market surveillance and customs controls, those authorities\n shall co-operate with each other.
CE marking:\n Parliament inserted a new clause entitled “General Principles of the CE\n Marking”. The provisions are inspired by the proposed Decision. (Please see COD/2007/0030).\n The CE marking shall only be affixed by the\n manufacturer or his authorised representative.
Review clause: not later than 5 years after the entry into force of\n the Regulation, the Commission shall submit a report on the application of\n the Regulation and Directive 2001/95/EC on General Product Safety and any\n other relevant Community instrument addressing market surveillance. In\n particular, the report shall analyse the coherence of Community rules in the\n field of market surveillance. If appropriate, the report shall be accompanied\n by proposals to amend and/or consolidate the instruments concerned. It will\n include an evaluation of the extension of the scope of Chapter III to all\n products.
\nPURPOSE: to\n establish requirements for accreditation and market surveillance for the\n marketing of products.
LEGISLATIVE\n ACT: Regulation (EC) No 765/2008 of the European Parliament and of the\n Council setting out the requirements for accreditation and market\n surveillance relating to the marketing of products and repealing Regulation\n (EEC) No 339/93.
CONTENT: This\n Regulation lays down rules on the organisation and operation of accreditation\n of conformity assessment bodies performing conformity assessment activities.\n It provides a framework for the market surveillance of products to ensure\n that those products fulfil requirements providing a high level of protection\n of public interests, such as health and safety in general, health and safety\n at the workplace, the protection of consumers, protection of the environment\n and security. The Regulation provides a framework for controls on products\n from third countries and lays down the general principles of the CE marking.
Accreditation: accreditation is part of an overall system, including conformity\n assessment and market surveillance, designed to assess and ensure conformity\n with the applicable requirements. The Regulation has developed comprehensive\n framework for accreditation and lays down at Community level the principles\n for its operation and organisation. Each Member State shall appoint a single\n national accreditation body. A national accreditation body shall, when\n requested by a conformity assessment body, evaluate whether that conformity\n assessment body is competent to carry out a specific conformity assessment\n activity. Where it is found to be competent, the national accreditation body\n shall issue an accreditation certificate to that effect. The accreditation\n body must be organised in such a manner as to make it independent of the\n conformity assessment bodies it assesses and of commercial pressures, and\n ensure that no conflicts of interest with conformity assessment bodies occur.\n
Market\n surveillance: this must ensure that products\n covered by Community harmonisation legislation which, when used in accordance\n with their intended purpose or under conditions which can be reasonably\n foreseen and when properly installed and maintained, are liable to compromise\n the health or safety of users, or which otherwise do not conform to\n applicable requirements set out in Community harmonisation legislation are\n withdrawn or their being made available on the market is prohibited or\n restricted and that the public, the Commission and the other Member States\n are informed accordingly. National market surveillance infrastructures and\n programmes shall ensure that effective measures can be taken in relation to\n any product category subject to Community harmonisation legislation. Market\n surveillance shall cover products assembled or manufactured for the\n manufacturer's own use where Community harmonisation legislation provides\n that its provisions shall apply to such products.
Products\n presenting a serious risk: Member States must\n ensure that products which present a serious risk requiring rapid\n intervention, including a serious risk the effects of which are not\n immediate, are recalled, withdrawn or that their being made available on\n their market is prohibited, and that the Commission is informed without\n delay. The decision whether or not a product represents a serious risk shall\n be based on an appropriate risk assessment which takes account of the nature\n of the hazard and the likelihood of its occurrence. The feasibility of obtaining\n higher levels of safety or the availability of other products presenting a\n lesser degree of risk shall not constitute grounds for considering that a\n product presents a serious risk.
CE marking: the Regulation sets out the general principles of CE marking.\n The CE marking shall be affixed only by the manufacturer or his authorised\n representative, and it must be affixed only to products to which its affixing\n is provided for by specific Community harmonisation legislation.
Review\n clause: not later than 5 years after the entry\n into force of the Regulation, the Commission shall submit a report on the\n application of the Regulation and Directive 2001/95/EC on General Product\n Safety and any other relevant Community instrument addressing market\n surveillance. In particular, the report shall analyse the coherence of\n Community rules in the field of market surveillance. If appropriate, the\n report shall be accompanied by proposals to amend and/or consolidate the\n instruments concerned. It will include an evaluation of the extension of the\n scope of Chapter III to all products. By 1 January 2013, and every five years\n thereafter, the Commission, in cooperation with the Member States, shall\n produce and submit to the European Parliament and to the Council a report on\n the implementation of this Regulation.
APPLICATION: from\n 1/01/2010.
ENTRY INTO FORCE: 02/09/2008.
\nPURPOSE: to\n establish requirements for accreditation and market surveillance for the\n marketing of products.
PROPOSED ACT:\n Regulation of the European Parliament and of the Council.
BACKGROUND:\n the free movement of goods forms a central pillar of the single market.\n Community technical legislation ensuring the free circulation of products has\n contributed considerably to the completion and proper functioning of the EU’s\n internal market. A number of secondary legislative initiatives support the\n free circulation of goods across the EU. They include the “new” approach\n Directives; legislation on setting out the basic rules for CE marking and the\n application of harmonised conformity assessment procedures; legislation on\n recognising the role of the European standardisation organisations; and the\n priority of European standards and legislation on product safety.
Experience has\n shown, however, that obstacles to the free movement of goods remain. The\n obstacles identified are:
- \n a distortion of competition due to differing\n practices in the “designation of conformity” by the national assessment\n bodies;
- \n an unequal treatment of “non-complying” or\n dangerous products on the market through the use of very different national\n market surveillance regulations, rules and means;
- \n a certain lack of trust in conformity marking;\n and
- \n a certain lack of coherence in the\n implementation and enforcement of existing EU legislation.
CONTENT: the\n purpose of this proposal, therefore, is:
- \n to lay down rules on the organisation and\n operation of accreditation of conformity assessment bodies that perform\n product assessment;
- \n to provide a framework for market\n surveillance; and
- \n to control products from third countries.
It is being\n presented alongside a proposal for a Decision on a consumer framework for the\n marketing of products. (See COD/2007/0030). The two proposals seek to complete existing\n legislative tools and to reinforce Community policies on market\n surveillance/accreditation. They also seeks to bring coherence to existing\n sectoral instruments by examining how these horizontal instrument can be\n applied to all sectors regardless of whether they are “old” or “new”\n approach.
In summary, the proposed Regulation will:
- \n organise accreditation at\n both a national and a European level – irrespective of the sectors involved. The\n proposal insists on the public authority nature of accreditation;
- \n set out a framework for recognising the\n existing “European co-operation for Accreditation” or EA. This will allow for\n a rigorous peer evaluation;
- \n ensure that national authorities are given\n equivalent means of intervention and the necessary authority to intervene in\n the market should they need to withdraw non-compliant or unsafe products;
- \n ensure co-operation between the internal\n authorities and the customs authorities, who control products entering\n the market from third countries; and
- \n set up a framework for the exchange of\n information between national authorities.
In terms of\n the budgetary impact of the proposal, the Community’s financial contribution\n is expected to be reduced in overall terms. On a final point, the proposal\n provides for the simplification of EU legislation and will lead to the repeal\n of Council Regulation 93/339/EEC.
For further details of the financial impact of the proposal refer\n to the financial statement.
\nThe Committee on the Internal\n Market and Consumer Protection adopted a report drafted by Andre BRIE\n (GUE/NGL, DE), amending, under the first reading of the codecision procedure,\n the proposal for a regulation of the European Parliament and of the Council\n setting out the requirements for accreditation and market surveillance\n relating to the marketing of products.
The main amendments made in committee\n were as follows:
Objective: Members felt\n that the proposal offers an opportunity to establish a broader framework for\n both accreditation and market surveillance. An amended clause on the\n objective stipulates that, to ensure that products benefiting from the free\n movement of goods within the Community respect a high level of protection of\n public interests such as health and safety in general, health and safety at\n the workplace, protection of consumers and of the environment, while ensuring\n that the free movement of products is not restricted beyond what is allowed\n under Community harmonisation legislation, this Regulation provides a\n framework supporting specific rules of sectoral Community harmonisation\n legislation, without making any substantive changes to that legislation, in\n particular, without making changes to rules relating to protection of health\n and the environment and any specific rules on accreditation and market\n surveillance.. For these purposes, this Regulation lays down: a) rules on the\n organisation and operation of accreditation of conformity assessment bodies;\n b) a framework for market surveillance and for the control of products from\n third countries; c) provisions relating to the Community CE mark and CE\n marking.
Scope: favouring a broad\n scope of application the Committee removed all the exclusions proposed by the\n Commission. Instead, the general principle that more specific rules have\n precedence over more general rules is restated. Some definitions, such as\n “products”, “Community harmonisation legislation”, “entering the Community\n market”, “conformity assessment”, “CE marking”, “peer evaluation” and release\n for free circulation” have been introduced.
Accreditation and conformity\n assessment: the scope of the accreditation framework should be as wide\n as possible to prevent the creation of several parallel systems, but it\n should be clearly linked to the existing framework. The Committee stated that\n the Commission shall draw up and update the list of the national\n accreditation bodies operating in each Member State. That list shall be made\n publicly available by the Commission. The national accreditation body shall\n act as a public authority and in the public interest. It must not provide\n commercial consultancy services, own shares or otherwise have a financial or\n managerial interest in a conformity assessment body.
Members introduced a new\n Article on the principle of non-competition. National accreditation bodies\n shall not compete with conformity assessment bodies, or with other national\n accreditation bodies within the territory of the European Union with respect\n to accreditation for compulsory conformity assessment activities. National\n accreditation bodies shall, however, be permitted to operate across Member State borders, within the territory of another Member State, at the request of a\n conformity assessment body in respect of accreditation for a compulsory\n conformity assessment activity in certain circumstances.
National accreditation bodies\n shall establish and maintain appropriate structures to ensure the effective\n and balanced involvement of all interested parties both within their\n organisations and the European accreditation network.
It must be guaranteed that\n conformity assessments are carried out in an appropriate manner, meaning that\n unnecessary burdens are not imposed on undertakings and that due account is\n taken of the size of the undertaking, the sector in which it operates, the\n structure of the undertaking, the degree of complexity of the product\n technology in question and the mass nature of the production process.
Stakeholders shall have the\n right to participate in the system set up for the supervision of peer\n evaluation activities.
European accreditation\n infrastructure: the Committee inserted a clause stating that the\n Commission shall, after consultation with the Member States, recognise a body\n which satisfies the requirements of the Annex to the Regulation. In order for\n a body to be recognised, it shall conclude a framework agreement with the\n Commission. That agreement shall contain, inter alia, the detailed tasks of\n the body, breach of which will entitle the Commission to terminate the\n agreement, funding provisions and provisions for the supervision of the\n recognised body, as well as other provisions customary for an agreement of\n its type. The Commission and the body concerned shall make the framework\n agreement public. Both the Commission and the body concerned shall be able to\n terminate the agreement without cause at the expiry of a reasonable notice\n period to be defined in the agreement. The first body recognised under this\n Regulation shall be the European Co-operation for Accreditation, provided\n that it has concluded a framework agreement as aforesaid.
Market surveillance and\n customs authorities: contrary to the Commission proposal, the Committee\n felt that a framework for market surveillance should by its very nature be\n broad, and accordingly, it stated that Directive 2001/95/EC (the General\n Product Safety Directive) must be included in the market surveillance\n regulation. Similarly, the Committee did not approve of the exclusion of 15\n pieces of other legislation under Article 13(3), as this would contradict the\n establishment of an efficient market surveillance based on EU-wide rules. It\n stated that the objective of market surveillance is to ensure that products\n covered by Community harmonisation legislation which, when used for their\n intended purpose or under conditions which can reasonably be foreseen and\n when properly installed and maintained, are liable to compromise the health\n or safety of users, or which otherwise do not conform to applicable\n requirements set out in Community harmonisation legislation, are\n withdrawn, or restricted and that the public, the Commission and the other\n Member States are informed. Furthermore, Member States shall ensure that\n their market surveillance covers the full range of products which are subject\n to legal requirements, irrespective of whether they are intended for\n consumers or likely to be used by consumers, or intended for professional\n use.
Member States shall ensure that\n market surveillance programmes are established, implemented and periodically\n updated. Each Member State shall draw up a global market surveillance\n programme within one year of the date of entry into force of the Regulation\n and communicate it to the other Member States and the Commission and make it\n available to the public on the internet. Subsequent updates of that programme\n shall be made public in the same manner. Member States may establish\n co-operation agreements with stakeholders, in particular with sectoral\n professional organizations, in order to take advantage of available market\n intelligence.
The decision as to whether or\n not a product represents a serious risk shall be based on an appropriate risk\n assessment based on the character of the risk and the likelihood of it\n occurring. The Committee gives an outline of the nature of the risk\n assessment.
Control of products entering\n the Community market: Members felt that co-ordination and exchange of\n information between customs and market surveillance authorities had to be\n strengthened. Member States must ensure that their relevant authorities\n responsible for control of products entering the Community market have the\n necessary powers and resources in order to properly perform their tasks.\n Member States shall also ensure the effective cooperation between customs and\n market surveillance authorities. Where in a Member State more than one authority\n is responsible for market surveillance and customs controls, those\n authorities shall co-operate with each other.
CE marking: the\n Committee felt that the CE marking needed better protection and inserted a\n new clause entitled “General Principles of the CE Marking”. The provisions\n are (inspired by the proposed Decision. (Please see COD/2007/0030.)
Review clause: not later\n than 5 years after the entry into force of the Regulation, the Commission\n shall submit to the European Parliament and to the Council a report on the\n application of the Regulation and Directive 2001/95/EC on General Product\n Safety and any other relevant Community instrument addressing market\n surveillance. In particular, the report shall analyse the coherence of\n Community rules in the field of market surveillance. If appropriate, the\n report shall be accompanied by proposals to amend and/or consolidate the\n instruments concerned, in the interests of better regulation and\n simplification. The report shall include an evaluation of the extension of\n the scope of Chapter III of the Regulation to all products.
\nThe European\n Parliament adopted a resolution based on the report drafted by Andre BRIE\n (GUE/NGL, DE), amending, under the first reading of the codecision procedure,\n the proposal for a regulation setting out the requirements for accreditation\n and market surveillance relating to the marketing of products.
The main\n amendments were as follows:
Objective:\n Parliament made some amendments to this Article which now states that the Regulation lays down rules on the organisation and operation of\n accreditation of conformity assessment bodies performing conformity\n assessment activities. It also provides a framework for the market\n surveillance of transformed products to ensure that they respect a high level\n of protection of public interests such as health and safety in general, of\n health and safety at the workplace, protection of consumers, of the environment,\n and of security. The Regulation further provides a framework for controls on\n 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\n up a list of the national accreditation bodies, to be made publicly\n available. Where accreditation is not operated directly by the public\n authorities themselves, Member States shall entrust the national\n accreditation body with the operation of accreditation as a public authority\n and grant it formal recognition on behalf of the government. The national\n accreditation body must not provide any services that conformity assessment\n bodies provide, nor shall it provide consultancy services, own shares in or\n otherwise have a financial or managerial interest in a conformity assessment\n body. Each Member State shall ensure that its national accreditation body has\n the appropriate resources for the proper performance of its tasks including\n for the fulfilment of special tasks, such as activities in European and\n international accreditation cooperation and activities that are required to\n support government policy and which are not self-financing. The national\n accreditation body shall be a member of the body recognised by the Commission\n as managing the European accreditation infrastructure. National accreditation\n bodies must maintain appropriate structures to ensure the balanced\n involvement of all interested parties. Member States must monitor their\n national accreditation bodies and take the utmost account of the results of\n peer evaluation. Stakeholders shall have the right to participate in the\n system set up for the supervision of peer evaluation activities, but not in\n individual peer evaluation.
Principle of non-competition: a new Article on the principle of non-competition\n states that national accreditation bodies shall not compete with conformity\n assessment bodies, or with other national accreditation bodies within the\n territory of the European Union with respect to accreditation for compulsory\n conformity assessment activities. National accreditation bodies shall,\n however, be permitted to operate across Member State borders, within the\n territory of another Member State, at the request of a conformity assessment\n body in respect of accreditation for a compulsory conformity assessment\n activity in certain circumstances.
Parliament added that a national accreditation body shall verify that conformity assessments are carried out in an\n appropriate manner, meaning that unnecessary burdens are not imposed on\n undertakings and that due account is taken of the size of the undertaking,\n the sector in which it operates, the structure of the undertaking, the degree\n of complexity of the product technology in question and the mass nature of\n the production process.
European accreditation infrastructure: Parliament inserted a clause stating that\n the Commission shall, after consultation with the Member States, recognise a\n body which satisfies the requirements of the Annex to the Regulation. In\n order for a body to be recognised, it shall conclude an agreement with the\n Commission. That agreement shall contain the detailed tasks of the body, funding provisions and provisions for the supervision of the\n recognised body. The first body recognised under\n the Regulation will be the European Co-operation for Accreditation.
Market surveillance: provisions on market\n surveillance will apply in so far as there are no specific provisions with the\n same objective in rules of Community harmonisation legislation. The\n application of the Regulation will not prevent market surveillance\n authorities from taking more specific measures as provided for in Directive\n 2001/95/EC (GPSD).Market surveillance shall ensure that products covered by\n Community harmonisation legislation which, when used for their intended\n purpose or under conditions which can reasonably be foreseen and when\n properly installed, and maintained, are liable to compromise the health or safety\n of users, or which otherwise do not conform to applicable requirements set\n out in Community harmonisation legislation, are withdrawn, prohibited or\n restricted from being made available on the market and that the public, the\n Commission and the other Member States are appropriately informed. National\n market surveillance infrastructures shall ensure that effective measures can\n be taken in relation to any product category subject to Community\n harmonisation legislation. Such surveillance shall cover products\n assembled or manufactured for the manufacturer's own use where Community\n harmonisation legislation provides that its provisions shall apply to such\n products.
Parliament\n went on to specify that Member States shall draw up either a general market\n surveillance programme or sector specific programmes, covering the sectors in\n which they conduct market surveillance, communicate those programmes to the\n other Member States and the Commission and make them available to the public,\n including by ways of electronic communications. The first such communication\n shall take place by 1 January 2010. Member States shall periodically review\n the functioning of their surveillance activities. Such reviews and\n assessments shall occur at least every fourth year and the results shall be\n communicated to the other Member States and the Commission and made available\n to the public.
On the\n question of risk, Parliament stated that the decision as to whether or not a\n product represents a serious risk shall be based on an appropriate risk\n assessment based on the character of the hazard and the likelihood of it\n occurring. The feasibility of obtaining higher levels of safety or the\n availability of other products presenting a lesser degree of risk shall not\n constitute grounds for considering a product to present a serious risk.
Control of products entering the Community market: Member States must ensure that their\n relevant authorities responsible for control of products entering the\n Community market have the necessary powers and resources in order to properly\n perform their tasks. Where in a Member State more than one authority is\n responsible for market surveillance and customs controls, those authorities\n shall co-operate with each other.
CE marking:\n Parliament inserted a new clause entitled “General Principles of the CE\n Marking”. The provisions are inspired by the proposed Decision. (Please see COD/2007/0030).\n The CE marking shall only be affixed by the\n manufacturer or his authorised representative.
Review clause: not later than 5 years after the entry into force of\n the Regulation, the Commission shall submit a report on the application of\n the Regulation and Directive 2001/95/EC on General Product Safety and any\n other relevant Community instrument addressing market surveillance. In\n particular, the report shall analyse the coherence of Community rules in the\n field of market surveillance. If appropriate, the report shall be accompanied\n by proposals to amend and/or consolidate the instruments concerned. It will\n include an evaluation of the extension of the scope of Chapter III to all\n products.
\nPURPOSE: to\n establish requirements for accreditation and market surveillance for the\n marketing of products.
LEGISLATIVE\n ACT: Regulation (EC) No 765/2008 of the European Parliament and of the\n Council setting out the requirements for accreditation and market\n surveillance relating to the marketing of products and repealing Regulation\n (EEC) No 339/93.
CONTENT: This\n Regulation lays down rules on the organisation and operation of accreditation\n of conformity assessment bodies performing conformity assessment activities.\n It provides a framework for the market surveillance of products to ensure\n that those products fulfil requirements providing a high level of protection\n of public interests, such as health and safety in general, health and safety\n at the workplace, the protection of consumers, protection of the environment\n and security. The Regulation provides a framework for controls on products\n from third countries and lays down the general principles of the CE marking.
Accreditation: accreditation is part of an overall system, including conformity\n assessment and market surveillance, designed to assess and ensure conformity\n with the applicable requirements. The Regulation has developed comprehensive\n framework for accreditation and lays down at Community level the principles\n for its operation and organisation. Each Member State shall appoint a single\n national accreditation body. A national accreditation body shall, when\n requested by a conformity assessment body, evaluate whether that conformity\n assessment body is competent to carry out a specific conformity assessment\n activity. Where it is found to be competent, the national accreditation body\n shall issue an accreditation certificate to that effect. The accreditation\n body must be organised in such a manner as to make it independent of the\n conformity assessment bodies it assesses and of commercial pressures, and\n ensure that no conflicts of interest with conformity assessment bodies occur.\n
Market\n surveillance: this must ensure that products\n covered by Community harmonisation legislation which, when used in accordance\n with their intended purpose or under conditions which can be reasonably\n foreseen and when properly installed and maintained, are liable to compromise\n the health or safety of users, or which otherwise do not conform to\n applicable requirements set out in Community harmonisation legislation are\n withdrawn or their being made available on the market is prohibited or\n restricted and that the public, the Commission and the other Member States\n are informed accordingly. National market surveillance infrastructures and\n programmes shall ensure that effective measures can be taken in relation to\n any product category subject to Community harmonisation legislation. Market\n surveillance shall cover products assembled or manufactured for the\n manufacturer's own use where Community harmonisation legislation provides\n that its provisions shall apply to such products.
Products\n presenting a serious risk: Member States must\n ensure that products which present a serious risk requiring rapid\n intervention, including a serious risk the effects of which are not\n immediate, are recalled, withdrawn or that their being made available on\n their market is prohibited, and that the Commission is informed without\n delay. The decision whether or not a product represents a serious risk shall\n be based on an appropriate risk assessment which takes account of the nature\n of the hazard and the likelihood of its occurrence. The feasibility of obtaining\n higher levels of safety or the availability of other products presenting a\n lesser degree of risk shall not constitute grounds for considering that a\n product presents a serious risk.
CE marking: the Regulation sets out the general principles of CE marking.\n The CE marking shall be affixed only by the manufacturer or his authorised\n representative, and it must be affixed only to products to which its affixing\n is provided for by specific Community harmonisation legislation.
Review\n clause: not later than 5 years after the entry\n into force of the Regulation, the Commission shall submit a report on the\n application of the Regulation and Directive 2001/95/EC on General Product\n Safety and any other relevant Community instrument addressing market\n surveillance. In particular, the report shall analyse the coherence of\n Community rules in the field of market surveillance. If appropriate, the\n report shall be accompanied by proposals to amend and/or consolidate the\n instruments concerned. It will include an evaluation of the extension of the\n scope of Chapter III to all products. By 1 January 2013, and every five years\n thereafter, the Commission, in cooperation with the Member States, shall\n produce and submit to the European Parliament and to the Council a report on\n the implementation of this Regulation.
APPLICATION: from\n 1/01/2010.
ENTRY INTO FORCE: 02/09/2008.
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