2007/0030(COD)

Common framework for the marketing of products (repeal. Decision 93/465/EEC)

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Activities
Documents
History

2007/0030(COD) Common framework for the marketing of products (repeal. Decision 93/465/EEC)

Role	Committee	Rapporteur
Opinion	ENVI	SCHEELE Karin (PSE)
Lead	IMCO	SCHALDEMOSE Christel (PSE)
Opinion	INTA
Opinion	ITRE	PURVIS John (PPE-DE)
Opinion	JURI	KARAS Othmar (PPE-DE)

Lead committee dossier: IMCO/6/46220
Legal Basis EC Treaty (after Amsterdam) EC 095

Subjects

Links

Activites

2008/08/13 Final act published in Official Journal
- Decision 2008/768
- OJ L 218 13.08.2008, p. 0082
2008/07/09 Final act signed
2008/07/09 End of procedure in Parliament
2008/06/23 Act adopted by Council after Parliament's 1st reading
#2881
2008/06/23 Council Meeting
#2852
2008/02/25 Council Meeting
2008/02/21 Text adopted by Parliament, 1st reading/single reading
- T6-0062/2008 summary
  
  The European Parliament adopted a resolution based on the report drafted by Christel SCHALDEMOSE (PES, DK), amending, under the first reading of the codecision procedure, the proposal on a common framework for the marketing of products. The principal amendments were as follows: Objective and scope: a new Article stipulates that products placed on the Community market shall comply with all applicable legislation. When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of the product with all applicable legislation. Economic operators shall be legally responsible that all information they provide with regard to their products is accurate, complete and in compliance with applicable Community rules. Manufacturers' obligations: manufacturers shall keep the technical documentation and the EC declaration of conformity for a period to be specified, proportionate to the lifecycle of the product and the level of risk after the product has been placed on the market. The manufacturer's address must indicate a single point at which the manufacturer can be contacted. Manufacturers shall ensure that the product is accompanied by instructions and safety information supplied in an official language easily understood by consumers and other end-users as decided by the concerned Member State . Importers' obligations: importers shall place only compliant products on the Community market. Parliament has increased the level of responsibility the importers have to bear. Before placing a product on the market, importers shall ensure (rather than "verify" that the appropriate conformity assessment procedure has been carried out by the manufacturer, and shall also ensure that the manufacturer has drawn up the technical documentation. Where an importer considers or has reason to believe that the product is not in conformity with the appropriate legislation, he may not place the product on the market until the product has been brought into conformity. Importers shall, in all cases where appropriate for protection of the health and safety of consumers, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, non-conforming products and product recalls, and keeping distributors informed of such monitoring. CE marking: The CE marking shall be subjected to the general principles set out in the Regulation on market surveillance. (Please see COD/2007/0029). Conformity assessment body: a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, can, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a body. Such bodies shall not engage in any activity that may conflict with their independence of judgement and integrity related to conformity assessment activities for which they are notified. This applies in particular to consultancy services Safeguard measures: with regard to procedures to deal with products presenting a risk, Parliament stipulated that the economic operators concerned shall cooperate in any necessary way with the market surveillance authorities. The market surveillance authorities shall inform the relevant notified body. Member States shall ensure that the appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay. Annex: Parliament made several amendments to the Annex, with particular reference to technical documentation the application for EC-type examination.
- Results of vote in Parliament
2008/02/21 Commission response to text adopted in plenary
- SP(2008)1767
- DG Enterprise and Industry, VERHEUGEN Günter
2008/02/19 Debate in Parliament
2007/12/04 Committee report tabled for plenary, 1st reading/single reading
- A6-0490/2007
- ENVI SCHEELE Karin PSE
- IMCO IMCO/6/46220 SCHALDEMOSE Christel PSE
- INTA
- ITRE PURVIS John PPE-DE
- JURI KARAS Othmar PPE-DE
2007/11/27 Vote in committee, 1st reading/single reading
- ENVI SCHEELE Karin PSE
- IMCO IMCO/6/46220 SCHALDEMOSE Christel PSE
- INTA
- ITRE PURVIS John PPE-DE
- JURI KARAS Othmar PPE-DE
#2832
2007/11/22 Council Meeting
2007/07/02 Committee draft report
- PE391.938
#2801
2007/05/21 Council Meeting
2007/03/13 Committee referral announced in Parliament, 1st reading/single reading
- ENVI SCHEELE Karin PSE
- IMCO IMCO/6/46220 SCHALDEMOSE Christel PSE
- INTA
- ITRE PURVIS John PPE-DE
- JURI KARAS Othmar PPE-DE
2007/02/14 Legislative proposal
- COM(2007)0053 summary
  
  PURPOSE: to establish a common framework for the marketing of products. PROPOSED ACT: Decision 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: - set the general framework for future sectoral legislation; - give guidance on how to use common elements; and - ensure as much coherence, in future sectoral legislation, as is politically and technically feasible. It is being presented alongside a proposal for a Regulation on accreditation and market surveillance. (See COD/2007/0029). The two proposals seek to complete the existing legislative framework. 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 set out: - harmonised definitions; - common obligations for economic operators; - common criteria for the selection of conformity assessment bodies; - common criteria for the national notifying authorities; - rules for the notification process; - common accreditation provisions; - a single definition for CE marking; - common rules of responsibility for those who affix the CE mark to their products; - a proper information and market surveillance procedure as a prolongation of the GPSD system; and - harmonised provisions for the future safeguard mechanisms; to complement those for market surveillance. 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.
- DG Enterprise and Industry, VERHEUGEN Günter

Documents

Legislative proposal published: COM(2007)0053
Committee draft report: PE391.938
Committee report tabled for plenary, 1st reading/single reading: A6-0490/2007
Decision by Parliament, 1st reading/single reading: T6-0062/2008
Results of vote in Parliament: Results of vote in Parliament
Commission response to text adopted in plenary: SP(2008)1767
: Decision 2008/768
: OJ L 218 13.08.2008, p. 0082

History

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

2012-02-09

activities	added	date 2007-02-14 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2007&nu_doc=0053 text PURPOSE: to establish a common framework for the marketing of products. PROPOSED ACT: Decision 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: - set the general framework for future sectoral legislation; - give guidance on how to use common elements; and - ensure as much coherence, in future sectoral legislation, as is politically and technically feasible. It is being presented alongside a proposal for a Regulation on accreditation and market surveillance. (See COD/2007/0029). The two proposals seek to complete the existing legislative framework. 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 set out: - harmonised definitions; - common obligations for economic operators; - common criteria for the selection of conformity assessment bodies; - common criteria for the national notifying authorities; - rules for the notification process; - common accreditation provisions; - a single definition for CE marking; - common rules of responsibility for those who affix the CE mark to their products; - a proper information and market surveillance procedure as a prolongation of the GPSD system; and - harmonised provisions for the future safeguard mechanisms; to complement those for market surveillance. 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. celexid CELEX:52007PC0053:EN type Legislative proposal published title COM(2007)0053 body EC commission DG Enterprise and Industry Commissioner VERHEUGEN Günter type Legislative proposal date 2007-03-13 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP responsible False committee ENVI date 2007-05-10 committee_full Environment, Public Health and Food Safety rapporteur group PSE name SCHEELE Karin body EP responsible True committee IMCO date 2007-03-20 committee_full Internal Market and Consumer Protection rapporteur group PSE name SCHALDEMOSE Christel body EP responsible False committee_full International Trade committee INTA body EP responsible False committee ITRE date 2007-04-12 committee_full Industry, Research and Energy rapporteur group PPE-DE name PURVIS John body EP responsible False committee JURI date 2007-06-18 committee_full Legal Affairs rapporteur group PPE-DE name KARAS Othmar date 2007-05-21 body CSL type Council Meeting council Competitiveness (Internal Market, Industry, Research and Space) meeting_id 2801 date 2007-07-02 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE391.938 type Committee draft report title PE391.938 body EP type Committee draft report date 2007-11-22 body CSL type Council Meeting council Competitiveness (Internal Market, Industry, Research and Space) meeting_id 2832 date 2007-11-27 text The Committee on the Internal Market and Consumer Protection adopted a report drafted by Christel SCHALDEMOSE (PES, DK), amending, under the first reading of the codecision procedure, the proposal on a common framework for the marketing of products. The principal amendments were as follows: Objective and scope: a new Article stipulates that products placed on the Community market shall comply with all applicable legislation. When placing products on the Community market, economic operators are responsible for the compliance of the product with all applicable legislation. The Committee stated that the decision sets the general structure for future legislation and gives guidance on how to use the common elements to ensure as much coherence in future legislation as can be politically an technically possible. Given the legislative nature of the decision it was inappropriate to exempt a certain group of existing legislation as the Commission had proposed; Manufacturers' obligations: manufacturers shall keep the technical documentation and the EC declaration of conformity for a maximum period of 10 years after the product has been placed on the market. They shall, in all cases where appropriate for protection of the health and safety of consumers, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, non-conforming products and product recalls. Manufacturers shall guarantee that all information they provide with regard to their products is accurate, complete and in compliance with applicable Community rules. Importers' obligations: importers shall place only compliant products on the Community market. The Committee felt that the e level of responsibility the importers have to bear under the Commission proposal was not sufficient and needed to be increased. Accordingly, it stipulated that, before placing a product on the market, importers shall ensure (rather than "verify" that the appropriate conformity assessment procedure has been carried out by the manufacturer, and shall also ensure that the manufacturer has drawn up the technical documentation. Where an importer discovers that the product is not in conformity with the appropriate legislation, he may not place the product on the market until the appropriate risk assessment has been carried out and the product has been brought into conformity with the applicable requirements. Importers shall, in all cases where appropriate for protection of the health and safety of consumers, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, non-conforming products and product recalls, and keeping distributors informed of such monitoring. They must guarantee that all information they provide with regard to the products they import is accurate, complete and in compliance with applicable Community rules. They must, for a maximum period of 10 years, keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities. Importers shall be deemed jointly liable, together with the foreign manufacturer, for damage caused by dangerous or non-compliant products which they placed on the market. Harmonised standard: when a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers, the Commission or the Member State concerned shall contact the relevant European standardisation organisations ("ESOs") for an opinion. When a Member State or the Commission considers that the opinion of the ESO does not entirely satisfy the request, the Commission or the Member State concerned shall bring the matter before the relevant Commission Committee. CE marking: Member States shall ensure the correct implementation of the regime governing the CE marking and take legal action in the case of improper use thereof. Member States shall also provide for penalties, which may include criminal sanctions for serious infringements. Such penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use. A new recital states that within one year of the publication of this Decision in the Official Journal of the EU, the Commission should present an in-depth analysis in the field of consumer safety markings, if necessary followed by legislative proposals. Conformity assessment body: the conformity assessment body shall perform its activities taking into consideration the size, the sector, the structure of the undertakings involved, the relative complexity of the technology used by the products and the serial character of production. Safeguard measures: where the market surveillance authorities of one Member State provide information to the market surveillance authorities of another Member State , they shall first contact the economic operator concerned at the address stated on the product in question, on its packaging or in the document accompanying the product. The economic operator shall be permitted a reasonable period in which to respond, which shall be 28 days where there is no immediate risk to the health and safety of the public. Where the market surveillance authorities of one Member State wish to withdraw a product manufactured in another Member State, they shall advise the economic operator concerned thereof at the address stated on the product in question, on its packaging or in the document accompanying the product. body EP committees body EP responsible False committee ENVI date 2007-05-10 committee_full Environment, Public Health and Food Safety rapporteur group PSE name SCHEELE Karin body EP responsible True committee IMCO date 2007-03-20 committee_full Internal Market and Consumer Protection rapporteur group PSE name SCHALDEMOSE Christel body EP responsible False committee_full International Trade committee INTA body EP responsible False committee ITRE date 2007-04-12 committee_full Industry, Research and Energy rapporteur group PPE-DE name PURVIS John body EP responsible False committee JURI date 2007-06-18 committee_full Legal Affairs rapporteur group PPE-DE name KARAS Othmar type Vote in committee, 1st reading/single reading date 2007-12-04 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-0490&language=EN type Committee report tabled for plenary, 1st reading/single reading title A6-0490/2007 body EP committees body EP responsible False committee ENVI date 2007-05-10 committee_full Environment, Public Health and Food Safety rapporteur group PSE name SCHEELE Karin body EP responsible True committee IMCO date 2007-03-20 committee_full Internal Market and Consumer Protection rapporteur group PSE name SCHALDEMOSE Christel body EP responsible False committee_full International Trade committee INTA body EP responsible False committee ITRE date 2007-04-12 committee_full Industry, Research and Energy rapporteur group PPE-DE name PURVIS John body EP responsible False committee JURI date 2007-06-18 committee_full Legal Affairs rapporteur group PPE-DE name KARAS Othmar type Committee report tabled for plenary, 1st reading/single reading date 2008-02-19 body EP type Debate in Parliament date 2008-02-21 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2008-0062 text The European Parliament adopted a resolution based on the report drafted by Christel SCHALDEMOSE (PES, DK), amending, under the first reading of the codecision procedure, the proposal on a common framework for the marketing of products. The principal amendments were as follows: Objective and scope: a new Article stipulates that products placed on the Community market shall comply with all applicable legislation. When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of the product with all applicable legislation. Economic operators shall be legally responsible that all information they provide with regard to their products is accurate, complete and in compliance with applicable Community rules. Manufacturers' obligations: manufacturers shall keep the technical documentation and the EC declaration of conformity for a period to be specified, proportionate to the lifecycle of the product and the level of risk after the product has been placed on the market. The manufacturer's address must indicate a single point at which the manufacturer can be contacted. Manufacturers shall ensure that the product is accompanied by instructions and safety information supplied in an official language easily understood by consumers and other end-users as decided by the concerned Member State . Importers' obligations: importers shall place only compliant products on the Community market. Parliament has increased the level of responsibility the importers have to bear. Before placing a product on the market, importers shall ensure (rather than "verify" that the appropriate conformity assessment procedure has been carried out by the manufacturer, and shall also ensure that the manufacturer has drawn up the technical documentation. Where an importer considers or has reason to believe that the product is not in conformity with the appropriate legislation, he may not place the product on the market until the product has been brought into conformity. Importers shall, in all cases where appropriate for protection of the health and safety of consumers, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, non-conforming products and product recalls, and keeping distributors informed of such monitoring. CE marking: The CE marking shall be subjected to the general principles set out in the Regulation on market surveillance. (Please see COD/2007/0029). Conformity assessment body: a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, can, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a body. Such bodies shall not engage in any activity that may conflict with their independence of judgement and integrity related to conformity assessment activities for which they are notified. This applies in particular to consultancy services Safeguard measures: with regard to procedures to deal with products presenting a risk, Parliament stipulated that the economic operators concerned shall cooperate in any necessary way with the market surveillance authorities. The market surveillance authorities shall inform the relevant notified body. Member States shall ensure that the appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay. Annex: Parliament made several amendments to the Annex, with particular reference to technical documentation the application for EC-type examination. type Decision by Parliament, 1st reading/single reading title T6-0062/2008 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=14414&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, 1st reading/single reading date 2008-02-21 docs url http://www.europarl.europa.eu/oeil/spdoc.do?i=14414&j=0&l=en type Commission response to text adopted in plenary title SP(2008)1767 body EC commission DG Enterprise and Industry Commissioner VERHEUGEN Günter type Commission response to text adopted in plenary date 2008-02-25 body CSL type Council Meeting council Competitiveness (Internal Market, Industry, Research and Space) meeting_id 2852 date 2008-06-23 body type Act adopted by Council after Parliament's 1st reading date 2008-06-23 body CSL type Council Meeting council Agriculture and Fisheries meeting_id 2881 date 2008-07-09 body type Final act signed date 2008-07-09 body EP type End of procedure in Parliament date 2008-08-13 text PURPOSE: to establish a common framework for the marketing of products. LEGISLATIVE ACT: Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC. CONTENT: this Decision lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Subject matter and scope: the Decision sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products (Community harmonisation legislation). Community harmonisation legislation will have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place, as for example in the fields of feed and food, cosmetic and tobacco products, common market organisations for agricultural products, plant health and plant protection, human blood and tissues, medicinal products for human and veterinary use and chemicals. Specificities also occur where sectoral needs require specific adaptation of the common principles and reference provisions, as for example in the fields of medical devices, construction products and marine equipment. General principles: products placed on the Community market must comply with all applicable legislation. When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation. Economic operators are responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable. The Regulation sets out: harmonised definitions; common obligations for economic operators; common criteria for the selection of conformity assessment bodies; common criteria for the national notifying authorities; rules for the notification process; common accreditation provisions; a single definition for CE marking; common rules of responsibility for those who affix the CE mark to their products; a proper information and market surveillance procedure as a prolongation of the GPSD system; and harmonised provisions for the future safeguard mechanisms, to complement those for market surveillance. Report: within one year of the publication of the Decision, the Commission should present an in-depth analysis in the field of consumer safety markings, followed by legislative proposals if necessary. It should be noted that this legislation is closely linked to that for market surveillance. See COD/2007/0029). 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=32008D0768 title Decision 2008/768 url http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:218:SOM:EN:HTML title OJ L 218 13.08.2008, p. 0082
committees	added	body EP responsible False committee ENVI date 2007-05-10 committee_full Environment, Public Health and Food Safety rapporteur group PSE name SCHEELE Karin body EP responsible True committee IMCO date 2007-03-20 committee_full Internal Market and Consumer Protection rapporteur group PSE name SCHALDEMOSE Christel body EP responsible False committee_full International Trade committee INTA body EP responsible False committee ITRE date 2007-04-12 committee_full Industry, Research and Energy rapporteur group PPE-DE name PURVIS John body EP responsible False committee JURI date 2007-06-18 committee_full Legal Affairs rapporteur group PPE-DE name KARAS Othmar
links	added	National parliaments url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2007&number=0030&appLng=EN title IPEX European Commission url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2007&DocNum=0030 title PreLex
other	added	body EC dg Enterprise and Industry commissioner VERHEUGEN Günter
procedure	added	dossier_of_the_committee IMCO/6/46220 reference 2007/0030(COD) subtype Legislation legal_basis EC Treaty (after Amsterdam) EC 095 stage_reached Procedure completed summary See also See also See also See also See also See also See also See also See also instrument Decision title Common framework for the marketing of products (repeal. Decision 93/465/EEC) type COD - Ordinary legislative procedure (ex-codecision) final url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008D0768 title Decision 2008/768 subject 2.10 Free movement of goods 2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 4.60.08 Safety of products and services, product liability

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2007/0030(COD)

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