REPORT on the proposal for a decision of the European Parliament and of the Council on a common framework for the marketing of products

    4.12.2007 - (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD)) - ***I

    Committee on the Internal Market and Consumer Protection
    Rapporteur: Christel Schaldemose

    Procedure : 2007/0030(COD)
    Document stages in plenary
    Document selected :  
    A6-0490/2007

    DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

    on the proposal for a decision of the European Parliament and of the Council on a common framework for the marketing of products

    (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD))

    (Codecision procedure: first reading)

    The European Parliament,

    –   having regard to the Commission proposal to the European Parliament and the Council (COM(2007)0053),

    –   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6‑0067/2007),

    –   having regard to Rule 51 of its Rules of Procedure,

    –   having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on International Trade, the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs (A6‑0490/2007),

    1.  Approves the Commission proposal as amended;

    2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

    3.  Instructs its President to forward its position to the Council and Commission.

    Text proposed by the CommissionAmendments by Parliament

    Amendment 1

    Recital 4

    (4) Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, and Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency already lay down a common and uniform regime on matters covered by this Decision and should therefore not be subject to this Decision.

    deleted

    Justification

    Amendment 2

    Recital 5 a (new)

     

    (5a) Although the provisions of this Decision cannot be legally enforced on future legislative acts, the co-legislators adopting this Decision have signed up to a clear political commitment which they should respect in any future legislative act falling within the scope of this Decision.

    Justification

    By its legal nature, this Decision can only be seen as a non-binding framework for future legislation: however, it should be emphasised that by agreeing to it, the co-legislator must live up to his commitment and implement future pieces of legislation accordingly

    Amendment 3

    Recital 13 a (new)

    (13a) Products that are placed on the Community market should comply with the relevant applicable Community legislation and economic operators should be responsible for the compliance of products, so as to ensure consumer safety and respect for Community environmental protection goals and to guarantee fair competition on the Community market.

    Amendment 4

    Recital 14 a (new)

    (14a) All economic operators that place products on the market should be under equal obligations and thus should bear the same responsibility for the conformity of their products.

    Justification

    The economic operators that place products on the market are manufacturers, their authorised representatives and importers. The way how they fulfil the responsibility varies, but it should be stressed that they have equal obligations with regard to the conformity of the products placed on the market.

    Amendment 5

    Recital 15

    (15) As certain tasks can only be executed by the manufacturer, it is necessary to clearly distinguish between the manufacturer and the operators further down the distribution chain. It is furthermore necessary to clearly distinguish the importer and the distributor, as the importer introduces products from third countries on the Community market. He has thus to ensure that these products comply with the applicable Community requirements.

    (15) As certain tasks can only be executed by the manufacturer, it is necessary to clearly distinguish between the manufacturer and the operators further down the distribution chain. It is furthermore necessary to clearly distinguish the importer and the distributor, as the importer places products from third countries on the Community market. He has thus to ensure that these products comply with the applicable Community requirements. On the contrary, the distributor makes a product available on the market after it has been placed on the market by the manufacturer, an authorized representative or the importer.

    Justification

    The difference between downstream operators should be clarified. The importer places products on the market for the first time whereas the distributor makes a product available on the market after it has been placed on the market by a manufacturer, an authorized representative or an importer.

    Amendment 6

    Recital 16

    (16) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Importers and distributors perform a trading function and do not have any influence on the production process. The conformity assessment should therefore remain the obligation of the manufacturer alone.

    (16) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. The conformity assessment should therefore remain the obligation of the manufacturer alone.

    Justification

    Importers' and distributors' obligations are included in Recital 17, therefore it is not necessary to address them here. Furthermore, importers and distributors, though indeed perform a trading function, may have influence on the production process (i.e. by declaring to refuse the import or distribution of non-compliant goods).

    Amendment 7

    Recital 17

    (17) Since importers and distributors are downstream operators they cannot in the normal course of events be obliged to ensure themselves that the design and production of the product is in compliance with the applicable requirements. Their obligations in relation to the compliance of the product should be limited to certain control measures to ascertain whether the manufacturer has fulfilled his obligations, such as verifying whether the product bears the required conformity marking and whether the required documents have been supplied. However, it can be expected of both importers and distributors to act with due care in relation to the applicable requirements when placing or making available products on the market.

    (17) Both importers and distributors are expected to act responsibly and in full accordance with the applicable legal requirements when placing or making available products on the market.

    Justification

    Clarifies the text

    Amendment 8

    Recital 17 a (new)

    (17α) Since importers make available on the Community market products from third countries, they must ensure that these products comply with applicable Community requirements. For this purpose they must ensure that the manufacturers have fulfilled any requirements regarding product conformity marking and technical documentation. They must also bear legal responsibility for ensuring that the products they are making available on the market are in accordance with applicable legislation and that product marking and documentation drawn up by manufacturers is available for inspection by the supervisory authorities.

    Justification

    Joint justification for Amendments 7 (recital 17) and 8 (recital 17a).

    In its original version, the wording of recital 17 was inconsistent with that of recital 15, since, while recital 15 specifically states that the importer must ensure that products comply with the applicable Community requirements, recital 17 merely requires importers, in the same way as distributors, to act with due care in relation to the applicable Community requirements.

    Amendment 9

    Recital 18

    (18) Where an importer or a distributor either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected, he should be considered to be the manufacturer.

    (18) Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer.

    Justification

    The definition of ‘manufacturer’ given in Article 6, point 3 of the Decision encompasses any operator that has a product designed or manufactured under his own trademark or name: it is hence the definition also includes authorised representatives. Rather than add ‘authorised representative’ to the list it is suggested to use the defined term ‘economic operators”, since it is self-evident that manufacturer is considered to be a manufacturer.

    Amendment 10

    Recital 18 a (new)

     

    (18a) Importers and distributors should not modify any internal design elements of a product without consulting the manufacturer, since this might affect the risk assessment and would invalidate the manufacturer’s technical documentation and declaration of conformity.

    Justification

    It is possible that distributors decide to save time or money by, instead of shipping back the item to the manufacturer to carry out the necessary modifications, could instead try to make their own changes. Without understanding the design of the product, such changes could interfere with the operation of security devices or safety circuits; thus, a compliant non-dangerous electric appliance or power tool could be turned into a product presenting a serious risk for its user. Therefore, the distributor ought to contact the manufacturer if it intends to do so.

    Amendment 11

    Recital 21 a (new)

    (21a) The CE marking should be the only marking indicating that a product is in conformity with Community law. However, existing national markings may continue to apply as long as such markings provide additional information to the consumer and are not covered by Community law.

    Amendment 12

    Recital 22 a (new)

    (22a) In order to better evaluate the effectiveness of the CE marking and to define strategies aimed at preventing abuse, the Commission should monitor the implementation of the CE marking and report thereon to the European Parliament.

    Justification

    To ensure an efficient CE marking it is necessary to evaluate and monitor the system currently, and it is important that the Parliament will have currently reports on that issue from the Commission.

    Amendment 13

    Recital 23

    (23) The legal protection of the CE marking which is granted by its registration as a community collective mark allows public authorities to ensure proper enforcement and to legally pursue violations.

    (23) The CE marking can only be of value if its affixation respects the conditions laid down in Community law. Therefore Member States should ensure proper enforcement of these rules and pursue violations and abuse of the CE marking by legal means.

    Amendment 14

    Recital 23 a (new)

    (23a) Member States are responsible for ensuring strong, efficient and intelligent market surveillance on their territory and should allocate sufficient powers and resources to their market surveillance authorities.

    Justification

    As written in the Regulation "Setting out the requirements for accreditation and market surveillance relating to the marketing of products" COM(2007)0037 it is strictly necessary to ensure a strong market surveillance system in the Member States. Sufficient resources will have to be allocated to the market surveillance authorities.

    Amendment 15

    Recital 23 b (new)

    (23b) For the purpose of raising awareness regarding the CE marking, the Commission should launch an information campaign targeted primarily at economic operators, consumer and sectoral organisations and sales personnel, since these are the best channels for conveying such information to consumers.

    Amendment 16

    Recital 35 a (new)

    (35a) While recognising that Community legislation must take on board the specific situation of small and medium sized manufacturing enterprises in relation to administrative burdens, it is necessary that, rather than providing for general exceptions and derogations for these enterprises which can only lead to the impression of secondary or sub-quality products or economic operators and to a complex legal situation for the national market surveillance authorities to supervise, Community legislation should provide for the situation of these enterprises to be taken on board in the rules for the selection and implementation of the most appropriate conformity assessment procedures and in the obligations placed on conformity assessment bodies to operate in a proportionate manner in relation to the size of undertakings and to the small serial or non-serial nature of the production concerned.

     

    This Decision provides for the necessary flexibility that the legislator is free to use to take on to treat such situations without having to create unnecessary special inappropriate sub solutions for small and medium sized enterprises.

    Amendment 17

    Recital 35 b (new)

    (35b) Within one year of the publication of this Decision in the Official Journal of the European Union, the Commission should present an in-depth analysis in the field of consumer safety markings, if necessary followed by legislative proposals.

    Amendment 18

    Article -1 (new)

    Article -1

    1. Products placed on the Community market shall comply with all applicable legislation.

    2. When placing products on the Community market, economic operators are responsible for the compliance of the product with all applicable legislation.

    Amendment 19

    Article 1, paragraph 1

    This Decision sets out the common principles determining the content of Community legislation harmonising the conditions for the marketing of products, hereinafter “Community legislation”, with the exception of the following legislation:

    (a) food law as defined in Article 2 of Regulation (EC) No 178/2002;

    (b) feed law as defined in Article 2 of Regulation (EC) No 882/2004;

    (c) Directive 2001/37/EC;

    (d) Directive 2001/82/EC;

    (e) Directive 2001/83/EC;

    (f) Directive 2002/98/EC;

    (g) Directive 2004/23/EC;

    (h) Regulation (EC) No 726/2004.

    This Decision sets out the common principles determining the content of Community legislation harmonising the conditions for the marketing of products, hereinafter “Community legislation”.

    Justification

    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 seems inappropriate to exempt a certain group of existing legislation. The choice of legislative instrument and technique in the future will anyhow take place on a case to case basis.

    Amendment 20

    Article 3, paragraph 1, point (c)

    (c) the need for the manufacturer to have a choice between quality assurance and product certification modules as set out in the Annex;

    (c) where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules as set out in Annex I;

    Justification

    In many cases the third party involvement is not mandatory.

    Amendment 21

    Article 3, paragraph 2

    2. Where a product is subject to several Community acts within the scope of this Decision, coherence in the conformity assessment procedures shall be ensured.

    2. Where a product is subject to several Community acts within the scope of this Decision, coherence in the conformity assessment procedures shall be ensured by the legislator.

    Justification

    It has to be specified more precisely who bears the responsibilities to ensure the coherence in conformity assessment.

    Amendment 22

    Article 3, paragraph 3 a (new)

    3a. For custom-made products and small series production, access to conformity assessment procedures shall be facilitated.

    Amendment 23

    Article 4

    Where Community legislation requires a statement by the manufacturer that fulfilment of requirements relating to a product has been demonstrated, hereinafter “EC declaration of conformity”, the legislation shall provide that the declaration is to contain all relevant information to identify the Community legislation to which it relates, and where a product is subject to requirements set out in several Community acts, it shall provide that a declaration is drawn up in respect of all those acts, mentioning the publication references of the acts concerned.

    Where Community legislation requires a statement by the manufacturer that fulfilment of requirements relating to a product has been demonstrated, hereinafter “EC declaration of conformity”, the legislation shall provide that the declaration is to contain all relevant information to identify the Community legislative acts to which it relates, mentioning the publication references of the acts concerned.

    Justification

    Eliminates redundancy in the text

    Amendment 24

    Article 6, point 3

    (3) “manufacturer” means any natural or legal person who designs or manufactures a product or who has such a product designed or manufactured, under his name or trademark;

    (3) “manufacturer” means any natural or legal person who designs or manufactures a product or who has such a product designed or manufactured, under his name or trademark, and who places it on the market;

    Justification

    Bring the definition in consistency with the definitions of other market players and with the provisions of proposed article 7 paragraphs 1 and 7a (linked with Ams 30 and 36).

    Amendment 25

    Article 6, point 4

    (4) “distributor” means any natural or legal person in the supply chain, who makes a product available on the market;

    (4) “distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

    Justification

    The economic operator "distributor" is used in the Decision without a clear definition.

    Amendment 26

    Article 6, point 11 a (new)

    (11a) "CE marking" means a marking which materializes the declaration of the manufacturer that the product is in conformity with all applicable requirements for its placing on the market;

    Justification

    The addition of this definition is needed to better understand the meaning of the "CE marking".

    Amendment 27

    Article 6, point 11 b (new)

    (11b) "Conformity assessment” means the demonstration that a product, process, system, person or body fulfils the specific requirements set out in the legislative instrument or instruments that apply to them;

    Justification

    The term "conformity assessment" is used in the Decision without a clear definition.

    Amendment 28

    Article 6, point 11 c (new)

     

    (11c) "Putting into service" means the first use, for its intended purpose, of a product in the Community;

    Justification

    The concept of "putting into service" is widely used in existing directives but is not present in the proposal. It is supposed to be replaced by "making available on the market" but this concept is not applicable to complex installations. When is goes about a "combined product" as a part of an industrial plant the global compliance of the final product with all applicable directives only can be assessed when switching on the facility (putting into service). This is the final stage of a succession of placing on the market of different components and sub-components (covered by different directives) by different operators in the supply chain). Great care should be taken in order to avoid the creation of a black hole were nobody will be responsible.

    Amendment 29

    Article 6, point 11 d (new)

     

    (11d) "Community harmonisation legislation" means any Community legislation harmonising the conditions for the marketing of products.

    Justification

    The term "Community harmonisation legislation" is used in the Decision without a clear definition.

    Amendment 30

    Article 7, paragraph 1

    1. Manufacturers shall ensure that their products are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    1. Manufacturers shall ensure, when placing their products on the market, that they are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    Justification

    Bring the provisions of article 7 in consistency with the definitions of other market players in article 6 and with the provisions of proposed article 7 paragraph 7a (linked with ams 24 and 36).

    Amendment 31

    Article 7, paragraph 3

    3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of ….[to be specified] after the product has been placed on the market.

    3. 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.

    Justification

    Although different products may require different storage periods of their technical documentation, a maximum period might be indicated

    Amendment 32

    Article 7, paragraph 4, subparagraph 1

    4. Manufacturers shall ensure that procedures are in place to ensure the continued conformity of series production. Changes in the product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is stated shall be adequately taken into account.

    4. Manufacturers shall ensure that procedures are in place in order for series production to remain in conformity. Changes in the product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is stated shall be adequately taken into account

    Justification

    The expression continued conformity might be misleading. Manufactures have obligation to produce in conformity with requirements in place at the moment of production.

    Amendment 33

    Article 7, paragraph 4, subparagraph 2

    Manufacturers shall, in all cases where appropriate, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, and keeping distributors informed of such monitoring.

    Manufacturers 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.

    Amendment 34

    Article 7, paragraph 6

    6. Manufacturers shall indicate their name and the address at which they can be contacted on the product or, where the size or nature of the product does not allow it, on its packaging or in a document accompanying the product.

    6. Manufacturers shall indicate their registered trade name or registered trade mark and the address at which they can be contacted either on the product, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted.

    Justification

    Other means of identification, namely trade name and trade mark, should be valid means to secure contact.

    Amendment 35

    Article 7, paragraph 7

    7. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    7. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall immediately take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the competent national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    Justification

    It is important to specify to the manufacturer that immediate measures need to be taken to bring products in conformity or withdraw them from the market.

    Amendment 36

    Article 7, paragraph 7 a (new)

    7a. Manufacturers shall guarantee that all information they provide with regard to their products is accurate, complete and in compliance with applicable Community rules.

    Justification

    Clarify the responsibility of manufacturers for the quality of the products they place on the market and for the accuracy of the information relating thereto (linked with ams 24 and 30).

    Amendment 37

    Article 8, paragraph 2, point (a)

    (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of … [to be specified];

    (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a maximum period of 10 years after the product has been placed on the market;

    Amendment 38

    Article 9, paragraph 1

    1. When placing a product on the market, importers shall act with due care in relation to the applicable requirements.

    1. Importers shall place only compliant products on the Community market.

    Amendment 39

    Article 9, paragraph 2, subparagraph 1

    Before placing a product on the market importers shall verify that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall verify that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required documents and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    Before placing a product on the market, importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required documents and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    Justification

    The level of responsibility the importers have to bear is not sufficient and needs to be increased.

    Amendment 40

    Article 9, paragraph 2, subparagraph 2

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the legislation], he may place the product on the market only after it has been brought into conformity with the applicable requirements set out in ... [reference to the relevant part of the legislation]

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the 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 set out in ... [reference to the relevant part of the legislation].

    Amendment 41

    Article 9, paragraph 4 a (new)

    4a. 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.

    Amendment 42

    Article 9, paragraph 3

    3. Importers shall indicate their name and the address at which they can be contacted on the product or, where the size or nature of the product does not allow it, on its packaging or in a document accompanying the product.

    3. Importers shall indicate their registered trade name or registered trade mark and the address at which they can be contacted either on the product, on its packaging or in a document accompanying the product.

    Justification

    Other means of identification, namely trade name and trade mark, should be valid means to secure contact.

    Amendment 43

    Article 9, paragraph 4 a (new)

    4a. Importers shall guarantee that all information they provide with regard to the products they import is accurate, complete and in compliance with applicable Community rules.

    Justification

    Clarify the responsibility of importers for the quality of the products they place on the market and for the accuracy of the information relating thereto.

    Amendment 44

    Article 9, paragraph 5

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall immediately take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the competent national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    Justification

    Ensures equal treatment between the manufacturer and the importer. See amendment 35.

    Amendment 45

    Article 9, paragraph 6

    6. Importers shall, for a period of … [to be specified], keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    6. Importers shall, for a maximum period of 10 years, keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    Justification

    In line with Amendment 31.

    Amendment 46

    Article 9 paragraph 7

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market.

     

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market. 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.

    Justification

    Importers will more cautiously verify the respect of obligations imposed by the law on manufacturers if they know that they will be deemed jointly responsible with them for damages caused by products dangerous or in breach with the Community law prescriptions.

    Amendment 47

    Article 10, paragraph 1

    1. When making a product available on the market distributors shall act with due care in relation to the applicable requirements.

    1. When making a product available on the market, distributors shall act with due care in relation to the applicable requirements, as laid down in paragraphs 2 to 5.

    Amendment 48

    Article 10, paragraph 4

    4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product in conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with applicable Community legislation shall take the necessary corrective measures to have that product brought into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the competent national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    Justification

    The distributor should not be authorized to intervene into the design of a product as they may then turn a compliant product into a non-compliant one. (For instance, they could replace a plastic cover that has problems with breakages with an alternative made of another type of plastic which is physically stronger but which is not fire-retardant when it needs to be. Only when it is known why a particular component or part has been chosen is it possible to select a better alternative, and that requires knowledge of the detailed design which after-sales or downstream operators probably do not have.)

    Amendment 49

    Article 11, paragraph 2

    An importer or a distributor, who modifies a product in such a way that compliance with the applicable requirements may be affected, shall be subject to the obligations of the manufacturer under Article [7] in respect of these modifications.

    An importer or a distributor, who technically modifies a product in such a way that compliance with the applicable requirements may be affected, shall be subject to the obligations of the manufacturer under Article [7] in respect of technical compliance.

    Justification

    If a product is technically changed by the importer or distributor, they should be fully responsible for all aspects, not only for the changes made, as a technical change may influence the compliance of other aspects of the product.

    Amendment 50

    Article 12

    Economic operators shall be able to identify the following:

    Economic operators shall be able, on request, to identify the following to the market surveillance authorities for a maximum period of 10 years:

    (a) any economic operator who has supplied them with a product;

    (a) any economic operator who has supplied them with a product;

    (b) any economic operator to whom they have supplied a product.

    (b) any economic operator to whom they have supplied a product.

    To this end they shall have in place appropriate systems and procedures which allow for this information to be made available to the market surveillance authorities on request, for a period of … [to be specified].

     

    Justification

    The economic operators are required to be able to identify any economic operator who has supplied them with the product or to whom they have supplied a product. However, it should be left to the discretion of the economic operator how to fulfil this obligation.

    Amendment 51

    Article 14, paragraph 1

    1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

    1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall contact the relevant European standardisation organisations (hereinafter "ESOs") for an opinion. The relevant ESO shall deliver its opinion without delay. 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 Committee set up by Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

    Justification

    Under New Approach legislation, harmonised standards are used as a voluntary tool in support to EU legislation. They are drafted by the European standardisation organisations (ESO), CEN, CENELEC and ETSI, usually under the scrutiny of Member States representatives and of a consultant of the European Commission. They reflect the current state of the art. Since harmonised standards are successfully used as a co-regulatory tool for more than 20 years, it appears both logical and consistent with better regulation principles to request an opinion from ESO first, before challenging their standards.

    Amendment 52

    Article 15, paragraph 2

    2. The EC declaration of conformity shall as a minimum contain the elements specified in [the relevant modules set out in Annex I] and in this … [reference to the relevant part of the legislation] and shall continuously be updated. The EC declaration of conformity shall have the model structure set out in [Annex II].

    2. The EC declaration of conformity shall as a minimum contain the elements specified in Annex II and in the relevant modules of Annex I and shall be kept updated. The EC declaration of conformity shall have the model structure set out in Annex II.

    Justification

    The term 'continuously updated' may be misinterpreted. Furthermore, a reference on the language to be used in the declaration should be inserted.

    Amendment 53

    Article 16, paragraph 2

    2. The CE marking shall be the only marking which attests conformity of the product with the applicable requirements. Member States shall refrain from introducing into their national regulations or shall withdraw any reference to a conformity marking other than the CE marking in connection with conformity to the provisions contained in the legislation on CE marking.

    2. The CE marking shall be the only marking which attests conformity of the product with the applicable requirements of the relevant Community legislation providing for its affixation. Member States shall refrain from introducing into their national regulations any reference to a conformity marking other than the CE marking in connection with conformity to the provisions contained in the legislation on CE marking.

    Justification

    This clarification explains the CE mark in line with the definition in Article 6.

    Amendment 54

    Article 16, paragraph 3

    3. The affixing on a product of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, is prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking are not thereby impaired.

    3. The affixing on a product of markings, signs and inscriptions which are likely to mislead the market as to the meaning or form of the CE marking, or both, is prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking are not thereby impaired.

    Justification

    The term 'third parties' is not precise, the term 'the market' (including consumers, surveillance authorities and companies) seems more appropriate

    Amendment 55

    Article 16, paragraph 3 a (new)

     

    3a. 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.

    Justification

    Amendment 56

    Article 17, paragraph 7

    7. Member States shall ensure correct application of the regime governing the CE marking and, if they deem adequate, take legal action in case of improper use. Member States shall also put in place penalties, which may include criminal sanctions, for serious infringements, that must be proportionate to the seriousness of the offence and constitute and effective deterrent against improper use.

    7. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and take legal action in case of improper use. Member States shall put in place penalties for infringements, which may include criminal sanctions for serious infringements. These penalties must be proportionate to the seriousness of the offence and constitute and effective deterrent against improper use.

    Amendment 57

    Article 19, paragraph 2

    2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by their national accreditation bodies within the meaning of and in accordance with regulation (EC) No [...]

    2. Member States shall ensure that the assessment and monitoring referred to in paragraph 1 shall be carried out by an accreditation body within the meaning of and in accordance with Regulation (EC) No [...]

    Justification

    It is important that Notified bodies throughout the European Economic Area are able to assess conformity in a competent, impartial and consistent way and that a common reference and high confidence in the system behind the notification is ensured. Given that accreditation is to be regulated by the proposed regulation COM(2007)0037 it is appropriate to introduce accreditation of Notified bodies as an obligation as defined in Article 3.1 of the proposed regulation.

    Amendment 58

    Article 22, paragraph 3

    3. The conformity assessment body shall be a third-party body independent from the organisation or the product it assesses.

    3. The conformity assessment body shall be independent from the organisation or the product it assesses.

    Justification

    Clarification of the text.

    Amendment 59

    Article 22, paragraph 4, subparagraphs 1 and 2

    4. The conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties.

    4. The conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer or maintainer of the products which they assess, nor the authorised representative of any of those parties.

    Nor shall they become directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, nor represent the parties engaged in those activities.

    Nor shall they become directly involved in the design, manufacture or construction, the marketing, installation or maintenance of those products, nor represent the parties engaged in those activities.

    Justification

    It would be illogical - and impossible to implement - to prohibit the personnel to purchase, own or use a large number of consumer goods.

    Amendment 60

    Article 22, paragraph 4, subparagraph 4 a (new)

    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.

    Amendment 61

    Article 22, paragraph 7, point (d a) (new)

    (da) the obligation to perform their 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.

    Justification

    In order to avoid unnecessary burden for SMEs, the personnel responsible for carrying out the conformity assessment activities should take into consideration the size, the sector, the structure of companies, the relative complexity of the technology used by the products and the serial character of the production.

    Amendment 62

    Article 25, paragraph 1

    1. For the purpose of conformity assessment procedures set out in [Annex 1 – modules A1, A2, C1 or C2], an accredited in-house body, which forms a separate and identifiable part of an undertaking involved in the design, manufacture, supply, installation, use or maintenance of the products that it assesses and which has been established to supply conformity assessment services to the undertaking of which it forms a part, may be used.

     

    1. For the purpose of conformity assessment procedures set out in [Annex 1 – modules A1, A2, C1 or C2], an accredited in-house body which has been established for the purpose of supplying conformity assessment services to the undertaking of which it forms a part and which

     

    (a) constitutes a separate, distinct part of an undertaking which participates in the design, production, supply, installation, use or maintenance of the products to be assessed by it,

     

    (b) belongs to the business organisation and/or professional federations representing undertakings involved in the design, manufacture, provision, assembly, use or maintenance of products which it assesses, on condition that its independence and the absence of any conflict of interest are guaranteed,

    may be used.

    Amendment 63

    Article 26, paragraph 2

    2. The application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which the body claims to be competent, as well as by an accreditation certificate, where it exists, delivered by a national accreditation body within the meaning of Regulation (EC) No […], attesting that the conformity assessment body meets the requirements laid down in Article ...[22].

    2. The application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which the body claims to be competent, as well as by an accreditation certificate delivered by a national accreditation body within the meaning of Regulation (EC) No […], attesting that the conformity assessment body meets the requirements laid down in Article ...[22].

    Justification

    Notifications should always be based on accreditation. Otherwise the purpose of the provisions concerning accreditation contained in the proposal for a regulation would again be cancelled out by the decision, as the Community-wide accreditation rules should ensure that accreditation by conformity assessment bodies accords with common quality criteria throughout the EU. If, however, accreditation is not a compulsory requirement for conformity assessments, these rules will be rendered inoperative.

    Amendment 64

    Article 27, paragraph 4

    4. Where a notification is not based on an accreditation certificate referred to in Article ... [26(2)], the notifying authority shall provide the Commission and the other Member States with all documentary evidence necessary for the verification of the conformity assessment body's competence.

    deleted

    Justification

    Follows from the amendments to Article 26 paragraph 2.

    Amendment 65

    Article 27, paragraph 5

    5. The body concerned may perform the activities of a notified body only where no objections have been raised by the Commission and the other Member States within two months following that notification.

    Only such a body shall be considered as a notified body for the purpose of this … [act].

    deleted

    Justification

    The suggested procedure appears too cumbersome, as responses from 29 partners - who are not in a position to impartially assess the body concerned, would have to be awaited each time.

    Amendment 66

    Article 29, paragraph 1

    1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements referred to in Article ...[22], or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate. It shall immediately inform the Commission and the other Member States thereof.

    1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements referred to in Article ...[22], or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States thereof.

    Justification

    In order to better define the term 'as appropriate'

    Amendment 67

    Article 31, paragraph 2

    2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burden for economic operators, in particular taking into consideration the size of companies and the relative complexity of the technology used by the products.

    2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators and consumers, in particular 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.

    Amendment 68

    Article 35, paragraph 1, subparagraph 2

    Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down by this … [act], they shall require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements or to withdraw the product from the market or recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.

    Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down by this Decision, they shall require, without delay, the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements or to withdraw the product from the market or recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.

    Justification

    A delayed recall or withdrawn of products or an equally delayed placing into conformity with Community law may have serious impact on the end users. It is therefore recommended that importers who discover that their products are in breach with legislation recall these items in the shortest possible period of time.

    Amendment 69

    Article 35, paragraph 2 a (new)

     

    2a. 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.

    Justification

    Economic operators should be given the opportunity to react on the position of relevant authorities, in particular when other Member States are also involved thus, the procedure may have a significant impact on their business. The proposed period of 28 days provides with a reasonable balance between the needs of the enforcement bodies and the economic operators. The same deadline is already applied in e.g. the UK implementation of the Directive on the restriction of the use of hazardous substances in electrical and electronic equipment and experience has shown that it is appropriate.

    Amendment 70

    Article 35, paragraph 3

    3. The economic operator shall ensure that any corrective actions are taken in respect of all the products concerned which he has made available on the market throughout the Community.

    3. The economic operator shall ensure that all possible corrective actions are taken in respect of all the products concerned which he has made available on the market throughout the Community.

    Justification

    This absolute obligation cannot be fulfilled in practice. There may be many importers of the same product who place the same product on the market (e.g. in different countries). Once a product is on the market in any particular country there could be a wide range of distributors, both large and very small. Experience has shown that even when recalls are notified in the national press, at point of sale in retailers, etc, that the number of returns is less than 70%.

    Amendment 71

    Article 35, paragraph 3 a (new)

     

    3a. Importers and distributors shall not, without first consulting the manufacturer, modify a product in such a way that compliance with applicable legislation may be affected.

    Justification

    Importers and distributors do not generally have the technical competence to make changes to the interior of the product and were they to do so they could seriously degrade the safety or other parameter of the product. Moreover, there are likely to be multiple distributors for a given product and the responsible organisation that placed the product on the market would not want a variety of ad hoc changes made by those multiple distributors.

    Amendment 72

    Article 35, paragraph 4, subparagraph 2 a (new)

     

    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.

    Justification

    It is important that the economic operator be informed if another Member State decides to withdraw one of its products. However, Member State authorities cannot be expected to contact the economic operator before sending information to authorities in another Member State as this would slow the procedure considerably.

    Amendment 73

    Article 35, paragraph 5, introductory part

    5. The information referred to in paragraph 4 shall provide all available details, in particular as regards the necessary data for the identification of the non-complaint product, the origin of the product, the nature of the risk involved, the nature and duration of national measures taken. In particular, the market surveillance authorities shall indicate whether the non compliance is due to either of the following:

    5. The information referred to in paragraph 4 shall provide all available details, in particular as regards the necessary data for the identification of the non-complaint product, the origin of the product, the nature of the non-compliance claimed and the risk involved, the nature and duration of national measures taken, as well as the viewpoints put forward by the economic operator concerned. In particular, the market surveillance authorities shall indicate whether the non compliance is due to either of the following:

    Justification

    The procedure fails to take into account the case where the manufacturer and the market surveillance authorities disagree on the non-compliance or on its nature. The measures taken by the authorities according to Article 35(4) are provisional, awaiting the final results of the evaluation. In such cases, it is essential for the viewpoints of the manufacturer to be brought to the attention of the other MS and the Commission, as the absence of an objection on their part will entail the qualification of the restricting measure as being justified according to Article 35(7)

    Amendment 74

    Article 35, paragraph 5 a (new)

    5a. Member States shall take the measures necessary to ensure that the product concerned is withdrawn from their market.

    Justification

    A provision similar to that outlined in Article 36(2) requiring a withdrawal of products presenting an unacceptable risk from all Member States should be introduced in order to ensure a level playing field and an even level of consumer protection in all Member States.

    Amendment 75

    Article 36, paragraph 3

    3. Where the national measure is considered to be justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards as referred to in Article [35(5) (b)], the Commission or the Member State shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC.

    3. Where the national measure is considered to be justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards as referred to in Article [35(5) (b)], consultation with the relevant ESO shall take place, as outlined in Article 14(1), before the Commission or the Member State brings the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC.

    Justification

    Article 14 should be complemented with an obligation for member States to consult ESO[1] first, when they suspect that a standard has a loophole. This would be in line with current procedures in the EU and would allow the early involvement of ESOs and their technical experts. This is already informally practiced in the context of the Low Voltage Directive.

    Amendment 76

    Annex 1, Module A, point 4.2, paragraph 2

    A copy of the declaration of conformity shall be supplied with each product that is made available on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than to individual products in those cases where a large number of products is delivered to a single user.

    deleted

    (The same amendment applies to Module A1, point 5.2; Module A2, point 5.2; Module C, point 3.2; Module C1, point 4.2; Module C2, point 4.2; Module D, point 5.2; Module D1, point 7.2; Module E, point 5.2; Module E1, point 7.2; Module F, point 6.2; Module F1, point 7.2; Module G, point 5.2; Module H, point 5.2; Module H1, point 6.2.)

    Justification

    To require the declaration of conformity to be supplied with each product as a general rule is not proportionate and would be very burdensome for manufacturers, adding considerable costs. The declaration is meant for the national supervisory authorities, not for the end-user!

    Amendment 77

    Annex I, Module A, point 5 a (new)

     

    5a. Importer

     

    Importers shall keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation is made available to those authorities upon request.

    Horizontal amendment to be applied in all modules listed below:

    - Annex I, Module A, paragraph 5 a (new)

    - Annex I, Module A1, paragraph 6 a (new)

    - Annex I, Module A2, paragraph 6 a (new)

    - Annex I, Module C, paragraph 4 a (new)

    - Annex I, Module C1, paragraph 5 a (new)

    - Annex I, Module C2, paragraph 5 a (new)

    - Annex I, Module D, paragraph 8 a (new)

    - Annex I, Module D1, paragraph 10 a (new)

    - Annex I, Module E, paragraph 8 a (new)

    - Annex I, Module E1, paragraph 10 a (new)

    - Annex I, Module F, paragraph 8 a (new)

    - Annex I, Module F1, paragraph 9 a (new)

    - Annex I, Module G, paragraph 6 a (new)

    - Annex I, Module H, paragraph 8 a (new)

    - Annex I, Module H1, paragraph 8 a (new)

    Justification

    Any economic operator that places products on the Community market should be liable for the conformity of those products. Only the manufacturer can prepare and maintain the technical documentation, as he has information on the product design. However, if the manufacturer is outside the EU without representatives in the EU, there is no way for the authorities to have access to the relevant documentation, which weakens the enforcement. Therefore, in line with Art 7, the importer should be responsible for ensuring that this documentation is at the disposal of the enforcement authorities.

    Amendment 78

    Annex 1, Module A2, point 4, paragraph 2

    The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the product at hand performs within acceptable limits. The appropriate tests, the adequate sampling schemes and the corresponding action to be taken by the body and/or the manufacturer shall be defined by the specific legislative instrument.

    The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the product at hand ensures the conformity of products. The appropriate tests, the adequate sampling schemes and the corresponding action to be taken by the body and/or the manufacturer shall be defined by the specific legislative instrument.

    Justification

    Clarification of the text.

    Amendment 79

    Annex I, Module B, point 8, paragraph 2

    Each notified body shall inform the other notified bodies about the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon reasoned request, about the certificates and/or additions thereto which it has issued.

    Each notified body shall make available to the other notified bodies the EC-type examination certificates and/or any additions thereto which it has refused withdrawn, suspended or otherwise restricted, and, upon reasoned request, about the certificates and/or additions thereto which it has issued.

    Justification

    The notified bodies have no legal link concerning e.g. responsibilities, liabilities or confidentiality to other Member States and the Commission. Therefore information to these institutions is only possible under the responsibility of the national designation authority.

    Amendment 80

    Annex I, Module D, point 7

    7. Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

    7. Each notified body shall inform its notifying authorities of the quality system approvals issued, suspended, withdrawn or otherwise restricted and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals.

    Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or withdrawn, and, upon request, of the quality system approvals which it has issued.

    Each notified body shall make available to the other notified bodies the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of the quality system approvals which it has issued.

    Justification

    The disclosure of information should be basically limited to information about nonconformities with respect to the requirements of the directives. The obligation to inform competitors (or other notified bodies) about certificates issued or providing copies of certificates to them has nothing to do with such requirements and is therefore not necessary.

    • [1]  European Standardisation Organisations (CENELEC, CEN and ETSI)

    OPINION of the Committee on International Trade (14.9.2007)

    for the Committee on Internal Market and Consumer Protection

    on the proposal for a decision of the European Parliament and of the Council on a common framework for the marketing of products
    (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD))

    Draftsman: Helmuth Markov

    SHORT JUSTIFICATION

    The Committee on International Trade welcomes the proposals of the Commission aiming at creating a stricter and more comprehensive Community surveillance on marketing of products. The matter almost completely involves internal market issues for which INTA Committee is not responsible. The draftsperson notes however that the proposed decision may have a significant impact on foreign trade patterns which needs to be separately scrutinized.

    The proposed decision imposes the same obligations which are attributed to the manufacturer on importers which place a product on the market under their name or trademark or modify a product in such a way that compliance may be affected. If instead an importer does not rename or modify a product, he is subject to less stringent obligations. He, in short, will only be requested to verify whether the conformity assessment procedure has been carried out by the manufacturer. This formal verification does not however guarantee that the assessment procedure itself, performed outside the Community, has been carried out in a way consistent with the current stringent Community and Member states laws and procedures.

    Such preferential treatment may have serious implications on the well functioning of the system of accreditation and market surveillance in the Community as well as on the proposed common framework for marketing of products.

    Although it would not be fair to argue that conformity assessments carried out outside the Community are by definition less reliable than those performed in the territory of the European Union, there is the serious risk that products which are either dangerous or in breach of Community provisions are shipped to the Community. The traceability of products manufactured outside the European Union is often difficult if not impossible.

    Despite their remarkable efforts, European customs services are not always in a position to discover all the products which are unsafe or in breach of Community law and to avoid their placing on the market. Previous experience has also shown that abusive practices often involve imported goods which may easily escape from the system of verifications manned by the Community and the competent national authorities, once they have entered the Community.

    It is therefore necessary that the importers assume more obligations than those which have been attributed to them by the draft prepared by the executive Commission. A possible approach would be the one followed by Directive 85/374/EEC which without prejudice to the liability of the manufacturer, inter alia provides that any person who imports into the Community a product for sale, hire, leasing or any form of distribution in the course of his business shall be deemed to be a producer and shall be held responsible as a producer.

    The draftsperson considers therefore appropriate that, within the meaning of this decision, importers are in principle deemed to be jointly responsible for damages caused by unsafe products or by products which are not in conformity with Community's accreditation system. This suggestion aims at improving the efficiency of the system and guaranteeing the Community's public interest as well as the basic right of citizens to be protected from abusive and dangerous practices.

    Finally, in order to increase the speed and the reliability of verifications made by market surveillance authorities, it has also been proposed that importers keep at their premises copy of the relevant technical documentation related to any imported good and not only a copy of the declaration of conformity.

    AMENDMENTS

    The Committee on International Trade calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:

    Text proposed by the Commission[1]Amendments by Parliament

    Amendment 1

    Article 6, paragraph 1, point (3)

    (3) “manufacturer” means any natural or legal person who designs or manufactures a product or who has such a product designed or manufactured, under his name or trademark;

    (3) “manufacturer” means any natural or legal person who designs or manufactures a product or who has such a product designed or manufactured, under his name or trademark, and who places it on the market;

    Justification

    This addition aims at bringing consistency with the rest of the provisions. Provisions contained in articles 9.1 and 10.1 clearly indicate for what importers and distributors are responsible. Indeed: The definition of distributor (indent 4) clearly indicates that “distributor” is the one who “makes the products available on the market”. The definition of importer (indent 5) clearly indicates that “importer” is the one who “places the product on the Community market”. On the contrary, there is no indication which operator is responsible for the placing on the market when importers are not concerned. However, in article 7 indent 7 it appears that the manufacturer is the one “who places the product on the market”. For the sake of legal certainty, it is necessary to give clear indications about the operator responsible for the placing of the market, if this operator is different from the importer.

    Amendment 2

    Article 7, paragraph 1

    1. Manufacturers shall ensure that their products are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    1. Manufacturers shall ensure, when placing their products on the market, that they are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    Justification

    In line with the modification proposed for article 6, and consistently with what is provided for in article 7.7, the above modification should be introduced in article 7.1. It should be indeed specified that manufacturers are responsible for the placing of their products on the market as indicated later.

    Amendment 3

    Article 7, paragraph 7 a (new)

     

    7a. Manufacturers shall guarantee that all information they provide with regard to their products is accurate, complete and in compliance with applicable Community rules.

    Justification

    This amendment is justified because the manufacturer is the operator who best knows the products and their characteristics. It is also the manufacturer who keeps the technical documentation of the products, as foreseen in article 7.3. Being the only one having such information available, this makes him responsible for the presence of the required information and for its accuracy. Moreover, the information supplied must also be in conformity with the Community legislation, such as, for example, the Unfair Commercial Practices Directive or the Directive concerning misleading advertising.

    Amendment 4

    Article 9, paragraph 2, subparagraph 1

    Before placing a product on the market importers shall verify that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall verify that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required documents and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required documents and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    Justification

    The level of responsibility the importers have to bear is not sufficient and needs to be increased.

    Amendment 5

    Article 9, paragraph 2, subparagraph 2

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the legislation], he may place the product on the market only after it has been brought into conformity with the applicable requirements set out in ... [reference to the relevant part of the legislation]

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the 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 set out in ... [reference to the relevant part of the legislation].

    Justification

    In order to ensure a level playing field between EU manufacturers and importers of products coming from third countries, it is crucial to provide for equal obligations among the economic operators placing products on the Community market. An equal level of obligations will ensure the same level of responsibility in case of non-compliant products. This can be achieved by requiring them to declare to take responsibility for the products they place on the market.

    Amendment 6

    Article 9, paragraph 3 a (new)

     

    3a. 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, and keeping distributors informed of such monitoring.

    Justification

    It is important that the importers, in same cases, will carry out sample testing of marketed products.

    Amendment 7

    Article 9, paragraph 4 a (new)

     

    4a. Importers shall guarantee that all information they provide with regard to the products they import is accurate and complete as required by Community rules.

    Justification

    As for manufacturers, this amendment is justified because the importer is the operator who is in a position to better know the products and their characteristics. Moreover, and as provided for in article 9.7, importers bear the responsibility to keep the technical documentation of the products. Being the only one having such information available, this makes him responsible for the presence of the required information and for its accuracy. Moreover, the information supplied must also be in conformity with the Community legislation, such as, for example, the Unfair Commercial Practices Directive or the Directive concerning misleading advertising.

    Amendment 8

    Article 9, paragraph 5

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users without delay, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    Justification

    A delayed recall or withdrawn of products or an equally delayed placing into conformity with Community law may have serious impact on the end users. It is therefore recommended that importers who discover that their products are in breach with the legislation recall these items in the shortest possible period of time.

    Amendment 9

    Article 9, paragraph 6

    6. Importers shall, for a period of … [to be specified], keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    6. Importers shall, for a period of ten years after the last product unit has been manufactured, keep a copy of the EC declaration of conformity prepared by the manufacturer and of the relevant technical documentation at the disposal of the national surveillance authorities.

     

    Importers shall declare in a separate document accompanying the EC declaration of conformity to have verified that the appropriate conformity assessment procedure has been carried out, and to take legal responsibility for the products they place on the Community market. Importers shall keep this statement at the disposal of national surveillance authorities for a period of ten years after the last product unit has been manufactured.

    Justification

    The amendment to paragraph 6 consists in adding the requirement that importers declare in an accompanying document to the Declaration of Conformity to have verified that the conformity assessment procedure has been carried out and to take legal responsibility for the products they place on the Community market. This is the only way to ensure a level playing field between manufacturers and importers.

    Amendment 10

    Article 9, paragraph 6 a (new)

     

    6a. Importers shall, for a period of ten years after the last product unit has been manufactured, keep the technical documentation at the disposal of national surveillance authorities. They shall ensure that the technical documentation remains current. Importers may choose either to keep themselves a copy of the technical documentation within the Community or to ensure that the manufacturer keeps such a copy.

    Justification

    This paragraph is aimed at amending paragraph 6 of the original text of the Commission, which requires importers to ensure that technical documentation can be available to authorities upon request. The amendment suggests requiring importers to keep the technical documentation. If the manufacturer is outside the EU and he does not have an authorised representative within the EU, it is difficult for the authorities to have access to the technical file. We also suggest fixing the period to ten years.

    Amendment 11

    Article 9 paragraph 7

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market.

     

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market. Importers shall be deemed jointly liable, together with the foreign manufacturer, for the damage caused by dangerous or non-compliant products they have placed on the market.

    Justification

    Importers will more cautiously verify the respect of obligations imposed by the law on manufacturers if they know that they will be deemed jointly responsible with them for damages caused by products dangerous or in breach with the Community law prescriptions.

    Amendment 12

    Article 10, paragraph 1

    1. When making a product available on the market distributors shall act with due care in relation to the applicable requirements.

    1. When making a product available on the market distributors shall act with due care in relation to the applicable requirements, as defined in paragraph 2.

    Justification

    This clarification is intended to ascertain that distributors are not subject to any kind of requirements but those provided for by EU legislation as indicated in paragraph 2.

    Amendment 13

    Article 35, paragraph 1, subparagraph 2

    Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down by this … [act], they shall require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements or to withdraw the product from the market or recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.

    Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down by this … [act], they shall require, without delay, the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements or to withdraw the product from the market or recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.

    Justification

    A delayed recall or withdrawn of products or an equally delayed placing into conformity with Community law may have serious impact on the end users. It is therefore recommended that importers who discover that their products are in breach with legislation recall these items in the shortest possible period of time.

    Amendment 14

    Annex I, Module A, paragraph 4.2., subparagraph 2

    A copy of the declaration of conformity shall be supplied with each product that is made available on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than to individual products in those cases where a large number of products is delivered to a single user.

    A copy of the declaration of conformity shall be supplied to the relevant authorities upon request.

    Justification

    The obligation of providing a copy of the Declaration of Conformity with each unit sold is burdensome beyond proportions for economic operators. Its qualification of interpretation applies only to bulk sales. Such requirement is unfeasible for mass products sold individually and such provision in article 4.2 must be deleted.

    Amendment 15

    Annex I, Module A, paragraph 5 a (new)

     

    5a. Importer

     

    Importers shall, for a period of ten years after the last product unit has been manufactured, keep a copy of the EC declaration of conformity prepared by the manufacturer at the disposal of national surveillance authorities.

     

    Importers shall declare in a separate document accompanying the EC declaration of conformity to have verified that the appropriate conformity assessment procedure has been carried out, and to take legal responsibility for the products they place on the Community market. Importers shall keep this statement at the disposal of national surveillance authorities for a period of ten years after the last product unit has been manufactured.

     

    Importers shall, for a period of ten years after the last product unit has been manufactured, keep the technical documentation at the disposal of national surveillance authorities. They shall ensure that the technical documentation remains current. Importers may choose either to keep themselves a copy of the technical documentation within the Community or to ensure that the manufacturer keeps such a copy.

    (This amendment applies also to the following modules: Module A1, Module A2, Module C, Module C1, Module C2, Module D, Module D1, Module E, Module E1 Module F, Module F1, Module G, Module H, Module H1. Adopting it will necessitate corresponding changes throughout.)

    Justification

    Importers are required: to keep a copy of the Declaration of Conformity; to declare in an accompanying document to the DoC to have verified that the conformity assessment procedure has been carried out and to take legal responsibility for the products they place on the market; and to keep the technical documentation.

    Amendment 16

    Annex I, Module A1, paragraph 5.2.

    5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it with the technical documentation at the disposal of the national authorities for a period of 10 years1 after the last product has been manufactured. The declaration of conformity shall identify the product for which it has been drawn up.

    A copy of the declaration of conformity shall be supplied with each product that is made available on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than to individual products in those cases where a large number of products is delivered to a single user.

    deleted

    (This amendment applies also to Module A1 - point 5.2; Module A2 – point 5.2; Module C – point 3.2; Module C1 – point 4.2; Module C2 – point 4.2; Module D – point 5.2; Module D1 – point 7.2; Module E – point 5.2; Module E1 – point 7.2; Module F – point 6.2; Module F1 – point 7.2; Module G – point 5.2; Module H – point 5.2; Module H1 - point 6.2. Adopting it will necessitate corresponding changes throughout.)

     

    1 The specific legislative instruments may alter this period.

     

    Justification

    Regarding quality insurance and management system, we should verify it contains also product CA requirement, like in Module H1 point 4 – Design examination this is apparently not the case in Module H. Indeed, if management certification is less prescriptive than product assessment, unscrupulous manufacturing exporters might have their system certified by a local Third Party and might manufacture anything within it for exporting cheap bad products having presumption of conformity.

    PROCEDURE

    Title

    Common framework for the marketing of products

    References

    COM(2007)0053 - C6-0067/2007 - 2007/0030(COD)

    Committee responsible

    IMCO

    Opinion by

           Date announced in plenary

    INTA

    13.3.2007

     

     

     

    Drafts(wo)man

           Date appointed

    Helmuth Markov

    21.3.2007

     

     

    Discussed in committee

    7.5.2007

    28.6.2007

     

     

    Date adopted

    12.9.2007

     

     

     

    Result of final vote

    +:

    –:

    0:

    29

    1

    0

    Members present for the final vote

    Kader Arif, Graham Booth, Daniel Caspary, Françoise Castex, Glyn Ford, Eduard Raul Hellvig, Jacky Henin, Syed Kamall, Sajjad Karim, Alain Lipietz, Marusya Ivanova Lyubcheva, Helmuth Markov, Cristiana Muscardini, Vural Öger, Georgios Papastamkos, Godelieve Quisthoudt-Rowohl, Tokia Saïfi, Peter Šťastný, Robert Sturdy, Gianluca Susta, Daniel Varela Suanzes-Carpegna, Corien Wortmann-Kool, Zbigniew Zaleski

    Substitute(s) present for the final vote

    Harlem Désir, Vasco Graça Moura, Małgorzata Handzlik, Pia Elda Locatelli, Eugenijus Maldeikis, Javier Moreno Sánchez, Jan Marinus Wiersma

    • [1]  Not yet published in OJ.

    OPINION OF THE COMMITTEE ON THE ENVIRONMENT, PUBLIC HEALTH AND FOOD SAFETY (22.11.2007)

    for the Committee on the Internal Market and Consumer Protection

    on the proposal for a European Parliament and Council decision on a common framework for the marketing of products
    (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD))

    Draftswoman: Karin Scheele

    SHORT JUSTIFICATION

    The proposal for a decision on a common framework should be rejected. It is not suitable for harmonising the requirements on the marketing of products in the internal market. The proposal aims to commit the Community institutions themselves, with a view to future legislation in the area of the ‘old and new approach’. Yet in legal terms such a binding effect is not possible. The EU institutions may always issue provisions that deviate from this decision when revising existing internal market rules, or introducing new ones. For reasons of legal certainty, if the decision cannot have any binding effect on the Community legislator, it should avoid giving the impression that it does so. Otherwise, considerable implementation problems could occur.

    In light of this, it is considered that the proposal for a decision does not offer any added value to the current legal situation. In terms of content, it cannot in fact go any further than making recommendations to the legislator to regulate internal market requirements in a certain way in the future. Such recommendations have, until now, been recorded in the ‘Guide to the implementation of directives based on the new approach and the global approach’ (European Commission, Brussels 2000).

    It seems disproportionate to involve the legislators in a time-consuming codecision procedure for this draft decision. If the intention of the internal market package submitted on 14 February 2007 is to obtain horizontal harmonisation of all internal market relevant sectors that is as wide-ranging as possible, then a corresponding harmonisation of all relevant sectors should be immediately and directly implemented. Accordingly, in its internal draft of 6 September 2006 ‘A horizontal legislative approach to the harmonisation of legislation on industrial products’ (N 560 - 1 EN), the Commission had planned only a legislative proposal directly affecting current law.

    This proposal for a decision contradicts the efforts of all Community bodies to improve and simplify legislation. The initiative presented gives the impression that the legislators should deal with a proposal for a decision that is, in this form, unnecessary and also unclear. For example, the scope is unclear and the definitions of exceptions seem to have been prepared at random (Article 1).

    For these reasons the draft decision should be rejected. Elements of the proposal for a decision should be incorporated into the ‘Proposal for a regulation on setting out the requirements for accreditation and market surveillance relating to the marketing of products’ (COM(2007)0037).

    ******

    The Committee on the Environment, Public Health and Food Safety calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to propose rejection of the Commission proposal.

    PROCEDURE

    Title

    Proposal for a European Parliament and Council decision on a common framework for the marketing of products

    References

    COM(2007)0053 – C6-0067/2007 – 2007/0030(COD)

    Committee responsible

    IMCO

    Opinion by
      Date announced in plenary

    ENVI
    13.3.2007

    Draftswoman
      Date appointed

    Karin Scheele
    10.5.2007

    Discussed in committee

    26.6.2007

    8.10.2007

     

     

     

    Date adopted

    22.11.2007

    Result of final vote

    +:

    –:

    0:

    21

    15

    0

    Members present for the final vote

    Pilar Ayuso, Johannes Blokland, Frieda Brepoels, Dorette Corbey, Chris Davies, Avril Doyle, Mojca Drčar Murko, Edite Estrela, Jill Evans, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Marie Anne Isler Béguin, Caroline Jackson, Dan Jørgensen, Marie-Noëlle Lienemann, Peter Liese, Alexandru-Ioan Morţun, Roberto Musacchio, Riitta Myller, Miroslav Ouzký, Frédérique Ries, Guido Sacconi, Karin Scheele, Carl Schlyter, Richard Seeber, Bogusław Sonik, Antonios Trakatellis, Thomas Ulmer, Anja Weisgerber, Glenis Willmott

    Substitutes present for the final vote

    Alfonso Andria, Kathalijne Maria Buitenweg, Duarte Freitas, Alojz Peterle

    OPINION of the Committee on Industry, Research and Energy (5.10.2007)

    for the Committee on the Internal Market and Consumer Protection

    on the proposal for a decision of the European Parliament and of the Council on a common framework for the marketing of products
    (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD))

    Draftsman: John Purvis

    SHORT JUSTIFICATION

    The draftsman welcomes the proposal for a regulation on the accreditation and market surveillance of products, and the accompanying proposal for a decision on a common framework for the marketing of products. These are designed to facilitate the operation of the internal market of goods whilst ensuring that the products entered and circulated in the internal market are safe.

    The Decision will work as a common toolbox for future sectoral legislation. It sets out a common legal framework to create coherent and simple definitions and procedures for the marketing of industrial products, and clarifies the role and meaning of the CE marking.

    Though the draftsman, as stated above, welcomes the proposals, he is of the opinion that there is a room for further improvement and therefore proposes amendments along the following lines:

    § New definitions on "ITT", "shared ITT results", "cascading ITT" have to be introduced; coherence of definitions in the Regulation and the Decision must be ensured. Therefore, Article 6 of the Decision (on definitions) now refers to Article 2 of the Regulation, with only these additional definitions;

    § As far as procedures are concerned: in order to avoid unnecessary red tape burdens, other factors such as the size of the company, the relative complexity of the technology used, and whether or not a product is a result of unit or series production should be taken into account when carrying out conformity procedures. Articles 3, 9, 22 and 31 of the Decision are amended in this way. Economic operators should have the right to respond to decisions by authorities on their products before these inform other Member States, but they should be obliged to ensure that all possible measures are taken to withdraw non-compliant products. These points are covered by amendments to Article 35;

    § Legislation relating to possible loopholes in harmonised standards (Article 14) has been amended to incorporate references to the European Standard Organisation (ESO), which should be consulted in the first instance. This would reduce unnecessary bureaucracy, and is current practice in the context of the Low Voltage Directive;

    § Article 16, paragraph 1 and Article 34 of the Regulation, as well as Article 14 of the Decision are amended to ensure more involvement of stakeholders and professional organizations. An amendment to Article 25 makes it possible for industry-run conformity assessment bodies to be accredited;

    § In order to avoid having "double standards" (i.e. a set of requirements introduced by Directive 2001/95/EC on general product safety (GPSD), and another set introduced by the present proposal) and to ensure the higher level of protection introduced by this proposal, the exemption stipulated in Article 13 (2) of the Regulation should be deleted. Also, exceptions listed in Article 1 of the Decision should be deleted as this is a sui generis decision directed towards the legislator and therefore not directly applicable;

    § The CE marking needs better protection. Its meaning of conformity with EU regulatory standards is not always clearly understood. As a result, an increasing number of products bearing the CE marking do not in fact comply with the relevant legislation. It is a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future national legislation, Articles 16-17 of the Decision should be placed in the Regulation;

    § Balance must be found concerning the obligations and responsibilities of economic operators (manufacturers, importers, distributors) in order to achieve a level playing field while at the same time ensuring that all products on the market are in conformity with relevant Community legislation. Therefore Articles 9-10 of the Decision and the corresponding recitals (Recitals 15, 16, 17 and 18a) are amended accordingly;

    § An amendment to Article 7 clarifies that this Decision and these standards are to apply to products intended for the Community market, and not to those either produced in the EU, or transported via the EU, which are intended for a third country market;

    § Various references have been made to the importance of manufacturers retaining the technical documentation related to a product for at least 10 years, and to be available to the authorities upon request, as many products have a lifetime of 15 years or more. These are in amendments to Articles 7, 8 and 9 of this Decision;

    § Amendments have been tabled to Article 10 which require that the user documentation accompanying a product be in the official language of the Member State where it is sold.

    AMENDMENTS

    The Committee on Industry, Research and Energy calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to incorporate the following amendments in its report:

    Text proposed by the Commission[1]Amendments by Parliament

    Amendment 1

    Recital 10

    (10) The modules for the conformity assessment procedures to be used in the technical harmonisation legislation were initially set out in Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives. This Decision replaces that Decision.

    (10) The modules for the conformity assessment procedures to be used in the technical harmonisation legislation were initially set out in Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives. This Decision and Regulation (EC) No ... of the European Parliament and of the Council of ... [setting out the requirements for accreditation and market surveillance relating to the marketing of products] 1 replace that Decision.

    ________________

    1 OJ L...

    Justification

    The CE marking needs better protection. As the meaning of the CE marking is not clearly understood, an increasing number of products bearing the CE marking do not comply with the legislation. It is therefore a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future legislation, Articles 16 & 17 and the corresponding recitals of this Decision should be moved to the Regulation and this recital has to be amended accordingly.

    Amendment 2

    Recital 15

    (15) As certain tasks can only be executed by the manufacturer, it is necessary to clearly distinguish between the manufacturer and the operators further down the distribution chain. It is furthermore necessary to clearly distinguish the importer and the distributor, as the importer introduces products from third countries on the Community market. He has thus to ensure that these products comply with the applicable Community requirements.

    (15) As certain tasks can only be executed by the manufacturer, it is necessary to clearly distinguish between the manufacturer and the operators further down the distribution chain. It is furthermore necessary to clearly distinguish the importer and the distributor, as the importer places products from third countries on the Community market. He has thus to verify that these products are in conformity with the applicable legislation.

    Justification

    To be in line with text in Recital 14, as well as with the definition of "importer" in Article 2 of the Regulation (COM(2007)0037).

    Amendment 3

    Recital 16

    (16) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Importers and distributors perform a trading function and do not have any influence on the production process. The conformity assessment should therefore remain the obligation of the manufacturer alone.

    (16) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. The conformity assessment should therefore remain the obligation of the manufacturer alone.

    Justification

    Importers' and distributors' obligations are included in Recital 17, therefore it is not necessary to address them here. Furthermore, importers and distributors, though indeed perform a trading function, may have influence on the production process (i.e. by declaring to refuse the import or distribution of non-compliant goods).

    Amendment 4

    Recital 17

    (17) Since importers and distributors are downstream operators they cannot in the normal course of events be obliged to ensure themselves that the design and production of the product is in compliance with the applicable requirements. Their obligations in relation to the compliance of the product should be limited to certain control measures to ascertain whether the manufacturer has fulfilled his obligations, such as verifying whether the product bears the required conformity marking and whether the required documents have been supplied. However, it can be expected of both importers and distributors to act with due care in relation to the applicable requirements when placing or making available products on the market.

    (17) Since importers and distributors are downstream operators they cannot in the normal course of events be obliged to ensure themselves that the design and production of the product is in compliance with the applicable requirements. Their obligations in relation to the compliance of the product should be limited to certain control measures to ascertain whether the manufacturer has fulfilled his obligations, such as verifying whether the product bears the required conformity marking and whether the required user documentation has been supplied in the official language of the Member State where the product is placed or made available on the market. However, importers and distributors should ensure that products which they place or make available on the Community market are in conformity with the applicable legislation.

    Justification

    To be in line with text in Recital 14. Furthermore, it is important that the user documentation needs to be understandable by those who must follow it and therefore it needs to be written in the official language or languages of the country of use.

    Amendment 5

    Recital 18

    (18) Where an importer or a distributor either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected, he should be considered to be the manufacturer.

    (18) Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer.

    Justification

    The definition of ‘manufacturer’ given in Article 2, paragraph 3 of the Regulation encompasses any operator that has a product designed or manufactured under his own trademark or name: it is hence the definition also includes authorised representatives. Rather than add ‘authorised representative’ to the list it is suggested to use the defined term ‘economic operators”, since it is self-evident that manufacturer is considered to be a manufacturer.

    Amendment 6

    Recital 18 a (new)

     

    (18a) Importers and distributors should not modify any internal design elements of a product without consulting the manufacturer, since this might affect the risk assessment and would invalidate the manufacturer’s technical documentation and declaration of conformity.

    Justification

    It is possible that distributors decide to save time or money by, instead of shipping back the item to the manufacturer to carry out the necessary modifications, could instead try to make their own changes. Without understanding the design of the product, such changes could interfere with the operation of security devices or safety circuits; thus, a compliant non-dangerous electric appliance or power tool could be turned into a product presenting a serious risk for its user. Therefore, the distributor ought to contact the manufacturer if it intends to do so.

    Amendment 7

    Recital 21

    (21) The CE marking, materialising conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the use of the CE marking, and rules as to its affixing, to be applied in Community harmonisation legislation providing for the use of that marking should therefore be set out in this Decision.

    (21) The CE marking, materialising conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense and attests that the manufacturer has submitted the product to the necessary assessment procedures. It is crucial to make clear to both manufacturers and users that by affixing the CE marking to the product the manufacturer declares that the product is in conformity with all applicable legislation and that he takes full responsibility for it. This Decision and Regulation EC (No) ... of the European Parliament and of the Council of ... [setting out the requirements for accreditation and market surveillance relating to the marketing of products]1 set out the main significance of the CE marking and the general principles governing its use, as well as the detailed rules as to its affixing, to be applied in Community harmonisation legislation.

     

    The legal protection of the CE marking which is granted by its registration as a Community collective mark allows public authorities to ensure proper enforcement and to legally pursue infringements.

    ---------------------------------------------

    1OJ L...

    Justification

    The CE marking needs better protection. As the meaning of the CE marking is not clearly understood, an increasing number of products bearing the CE marking do not comply with the relevant legislation. It is therefore a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future legislation, Articles 16 and 17 of the Decision (COM(2007)0053) should be included in the Regulation, as well as the corresponding recitals.

    Amendment 8

    Recital 22

    (22) It is crucial to make clear to both manufacturers and users that by affixing the CE marking to the product the manufacturer declares that the product is in conformity with all applicable requirements and that he takes full responsibility thereof.

    deleted

    Justification

    The CE marking needs better protection. As the meaning of the CE marking is not clearly understood, an increasing number of products bearing the CE marking do not comply with the legislation. It is therefore a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future legislation, Articles 16 & 17 and the corresponding recitals of this Decision should be moved to the Regulation and this recital has to be amended accordingly.

    Amendment 9

    Recital 23

    (23) The legal protection of the CE marking which is granted by its registration as a Community collective mark allows public authorities to ensure proper enforcement and to legally pursue violations.

    deleted

    Justification

    The CE marking needs better protection. As the meaning of the CE marking is not clearly understood, an increasing number of products bearing the CE marking do not comply with the legislation. It is therefore a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future legislation, Articles 16 & 17 and the corresponding recitals of this Decision should be moved to the Regulation and this recital has to be amended accordingly.

    Amendment 10

    Recital 28 a (new)

     

    (28a) While Community legislation should acknowledge the particular situation of small and medium-sized manufacturing enterprises as regards administrative burdens, rather than provide for general exceptions and derogations to address this situation, which can only lead to the impression of substandard products or economic operators and to a complex legal situation for the national market surveillance authorities to supervise, Community legislation should provide for this situation to be acknowledged in the rules for the selection and implementation of the most appropriate conformity assessment bodies to operate in a proportionate manner in relation to the size of companies and to the serial or unit-production nature of the product concerned.

     

    The present decision allows the Member States the necessary flexibility of action in such situations, without laying down special and possibly inappropriate solutions for SMEs.

    Justification

    In the interests of reduction of red tape burdens, future legislation should take into account the specific needs of SMEs.

    Amendment 11

    Article 1, paragraph 1

    This Decision sets out the common principles determining the content of Community legislation harmonising the conditions for the marketing of products, hereinafter “Community legislation”, with the exception of the following legislation:

    This Decision sets out the common principles determining the content of Community legislation harmonising the conditions for the marketing of products, hereinafter “Community legislation”.

    (a) food law as defined in Article 2 of Regulation (EC) No 178/2002;

     

    (b) feed law as defined in Article 2 of Regulation (EC) No 882/2004;

     

    (c) Directive 2001/37/EC;

     

    (d) Directive 2001/82/EC;

     

    (e) Directive 2001/83/EC;

     

    (f) Directive 2002/98/EC;

     

    (g) Directive 2004/23/EC;

     

    (h) Regulation (EC) No 726/2004.

     

    Justification

    Exceptions have no sense as this is a sui generis decision directed towards the legislator and therefore is not immediately applicable.

    Amendment 12

    Article 1, paragraph 3

    Community legislation shall have recourse to the general principles of Title I and to the relevant reference provisions of Title II and of Annexes I and II, while, where necessary, taking into account the specificities of the legislation concerned.

    Community legislation shall have recourse to the general principles of Title I and to the relevant reference provisions of Title II and of Annexes I and II, while, where necessary, taking into account the specificities of the legislation concerned and the specificities of the domain concerned.

    Justification

    In the interests of reduction of red tape burdens, future legislation should take into account the specific needs of SMEs.

    Amendment 13

    Article 3, paragraph 3 a (new)

     

    3a. Unit-production and small-series production products, in particular made-to-measure products, shall not be subject to conformity assessment procedures unless they have significant consequences for health and safety, in which case the producer shall issue an EC declaration of conformity.

    Justification

    As the cost of conformity assessment is very high and can only be affordable when large series are manufactured, non- and small series production should be exempted when the product does not have a significant impact on health and safety. When non- and small series productions are submitted to CE marking, a declaration of conformity should be sufficient.

    Amendment 14

    Article 6

    For the purposes of this … [type of instrument] the following definitions shall apply:

    For the purposes of this Decision the definitions contained in Regulation (EC) No … [setting out the requirements for accreditation and market surveillance relating to the marketing of products] shall apply together with the following definitions:

    (1) “making available on the market” means any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

     

    (2) “placing on the market” means the first making available of a product on the Community market;

     

    (3) “manufacturer” means any natural or legal person who designs or manufactures a product or who has such a product designed or manufactured, under his name or trademark;

     

    (4) “distributor” means any natural or legal person in the supply chain, who makes a product available on the market;

     

    (5) “importer” means any natural or legal person established within the Community, who places a product from a third country on the Community market;

     

    (6) “economic operators” means the manufacturer, the importer, the distributor and the authorised representative;

     

    (7) “technical specification”, “national standard”, “international standard” and “European standard” shall have the meanings assigned to them by Directive 98/34/EC;

     

    (8) “harmonised standard” means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC in accordance with Article 6 of Directive 98/34/EC;

     

    (9) “accreditation” has the meaning assigned to it by Regulation (EC) No […];

     

    (10) “withdrawal” means any measure aimed at preventing the making available on the market of a product in the supply chain;

     

    (11) “recall” means any measure aimed at achieving the return of a product that has already been made available to the end user.

     

    Justification

    These definitions are included in Regulation (COM(2007)037). Future legislation based on this Decision should simply refer to the Regulation for these common definitions. However, new concepts, such as ITT, shared ITT results and cascading ITT, which are too technical and not used in the Regulation, have to be introduced here.

    Amendment 15

    Article 6, point 11 a (new)

     

    (11a) "initial type testing (ITT)" means the complete set of tests or other procedures (e.g. calculation) described in a technical specification to determine the performance of samples of products representative of a product type, for the mandated characteristics;

    Justification

    As a large part of conformity assessment cost is generated by tests, shared ITT and cascading ITT should be accepted by third party certification bodies and thus the above definitions should be incorporated.

    Amendment 16

    Article 6, point 11 b (new)

     

    (11b) "shared ITT results" mean already existing transferable test results that are shared among manufacturers producing functionally identical products;

    Justification

    As a large part of conformity assessment cost is generated by tests, shared ITT and cascading ITT should be accepted by third party certification bodies and thus the above definitions should be incorporated.

    Amendment 17

    Article 6, point 11 c (new)

     

    (11c) "cascading ITT" means the transfer of ITT results from an assembly designer (who may be either a component manufacturer, a designer, a “system house” or a body providing a common service to manufacturers) to the manufacturer of the product placed or made available on the market.

    Justification

    As a large part of conformity assessment cost is generated by tests, shared ITT and cascading ITT should be accepted by third party certification bodies and thus the above definitions should be incorporated.

    Amendment 18

    Article 7, introductory part before paragraph 1 (new)

     

    The following provisions shall apply only to products which are intended to be placed and made available on the Community market:

    Justification

    Manufacturers, both within and without the EU, make a variety of products for a variety of geographic markets. Provisions contained with Directives made according to this Decision must only apply to products intended to be placed on the Community market.

    Amendment 19

    Article 7, paragraph 1

    1. Manufacturers shall ensure that their products are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    1. Manufacturers shall ensure, when placing their products on the market, that they are designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation].

    Justification

    Bring the provisions of Article 7 in consistency with the definitions of other market players in Article 6 and with the provisions of proposed Article 7(7) (linked with Amendments 1 and 3).

    Amendment 20

    Article 7, paragraph 3

    3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of ….[to be specified] after the product has been placed on the market.

    3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of ten years after the last unit of the product has been manufactured.

    Justification

    The period of ten years is contained with the Low Voltage Directive (Directive 2006/95/EC). Some products have a lifetime of 15 years or more. It is therefore important for the manufacturer to hold and maintain the technical documentation for a reasonable period.

    Amendment 21

    Article 7, paragraph 7 a (new)

     

    7a. Manufacturers shall guarantee that all information they provide with regard to their products is accurate, complete and in compliance with Community legislation.

    Justification

    Clarify the responsibility of manufacturers for the quality of the products they place on the market and for the accuracy of the information relating thereto (linked with Amendments 1 and 2).

    Amendment 22

    Article 8, paragraph 2, point (a)

    (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of … [to be specified];

    (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of … [to be specified]after the last unit of the product has been manufactured;

    Amendment 23

    Article 9, paragraph 1

    1. When placing a product on the market importers shall act with due care in relation to the applicable requirements.

    1. Importers shall ensure that the products they place on the Community market are in conformity with applicable legislation.

    Justification

    To be in line with text of Recitals 14-17. The obligation for importers to place only compliant products on EU market should be further emphasised; the wording ‘due care’ is too vague for conveying the importer's obligation to verify that the manufacturer outside the EU has carried out the proper risk assessment.

    Amendment 24

    Article 9, paragraph 2, subparagraph 2

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the legislation], he may place the product on the market only after it has been brought into conformity with the applicable requirements set out in ... [reference to the relevant part of the legislation]

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the 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 set out in ... [reference to the relevant part of the legislation].

    Amendment 25

    Article 9, paragraph 3

    3. Importers shall indicate their name and the address at which they can be contacted on the product or, where the size or nature of the product does not allow it, on its packaging or in a document accompanying the product.

    3. Importers shall indicate their name and the address at which they can be contacted on the product or in a document accompanying the product.

    Justification

    In order to put only reasonably necessary obligations on the importers, the contact details should be indicated only on the product or on the accompanying documents and not on the packaging.

    Amendment 26

    Article 9, paragraph 3 a (new)

     

    3a. Importers shall, wherever appropriate for the protection of the health and safety of consumers, carry out sample testing of marketed products, investigating, and, if necessary, keeping a register of complaints, and keeping distributors informed of such monitoring.

    Justification

    In paragraph 3 we ask for the second paragraph of Article 7(4) of the European Commission's original text to be added. In addition, we would like to insert 'for protection of the health and safety of consumers' after 'in all cases where appropriate'.

    Amendment 27

    Article 9, paragraph 4 a (new)

     

    4a. Importers shall guarantee that all information they provide with regard to the products they import is accurate, complete and in compliance with Community legislation.

    Justification

    Clarify the responsibility of importers for the quality of the products they place on the market and for the accuracy of the information relating thereto.

    Amendment 28

    Article 9, paragraph 6

    6. Importers shall, for a period of … [to be specified], keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    6. Importers shall, for a period of ten years, keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    Justification

    In order to make importers' obligation clear, the period for which importers are obliged to keep the documentation has to be defined in the decision.

    Amendment 29

    Article 10, paragraph 1

    1. When making a product available on the market distributors shall act with due care in relation to the applicable requirements.

    1. When making a product available on the market distributors shall act with due care in relation to the applicable requirements, in particular as set out in paragraph 2.

    Justification

    Clarify that the requirements referred to in this paragraph are those provided for by the EU legislation.

    Amendment 30

    Article 10, paragraph 2, subparagraph 1

    1. Before making a product available on the market distributors shall verify that the product bears the required conformity marking(s) and is accompanied by the required documents and that the manufacturer and the importer have respected the requirements set out in Article [7 (5) and (6)] and [Article 9 (3)].

    1. Before making a product available on the market distributors shall verify that the product bears the required conformity marking(s) and is accompanied by the user documentation in the official language of the Member State where the product is to be made available on the market and that the manufacturer and the importer have respected the requirements set out in Article [7 (5) and (6)] and [Article 9 (3)].

    Justification

    For distribution to the end user, only the user documentation is necessary. It is important that the user documentation needs to be understandable by those who must follow it and therefore it needs to be written in the official language or languages of the country of use.

    Amendment 31

    Article 10, paragraph 4

    4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product in conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to have that product brought into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    Justification

    The distributor should not be authorized to intervene into the design of a product as they may then turn a compliant product into a non-compliant one. (For instance, they could replace a plastic cover that has problems with breakages with an alternative made of another type of plastic which is physically stronger but which is not fire-retardant when it needs to be. Only when it is known why a particular component or part has been chosen is it possible to select a better alternative, and that requires knowledge of the detailed design which after-sales or downstream operators probably do not have.)

    Amendment 32

    Article 14, paragraph 1

    1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

    1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall ask the relevant European standardisation body or national standardisation committee within that body for an explanation and justification. The European standardisation body shall deliver its opinion without delay.

    Justification

    Article 14 should be complemented with an obligation for member States to consult ESO[2] first, when they suspect that a standard has a loophole. This would be in line with current procedures in the EU and would allow the early involvement of ESOs and their technical experts. This is already informally practiced in the context of the Low Voltage Directive.

    Amendment 33

    Article 14, paragraph 1 a (new)

     

    1a. Where the requesting Member State or the Commission considers that the explanation given by the European standardisation body or national standardisation committee is not entirely satisfactory, the Member State or the Commission shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

    Justification

    As consequence of the amendment to Article 14, paragraph 1, this amendment gives consistency to the procedure and brings in the reference to the Commission's committee which was deleted from Article 14, paragraph 1.

    Amendment 34

    Article 14, paragraph 3

    3. The Commission shall inform the European standardisation body concerned and, if necessary, request the revision of the harmonised standards concerned.

    3. The Commission shall inform the European standardisation body concerned and, if necessary, request the revision of the harmonised standards concerned. Where such revision is requested, the European standardisation body shall submit to the Commission a description of the deficiency together with an action plan.

    Justification

    This clarifies the procedure to be followed by the ESO.

    Amendment 35

    Article 17

    Article 17

    deleted

    Rules and conditions for the affixing of the CE marking

     

    1. The CE marking shall consist of the initials “CE” taking the following form:

     

     

    2. If the CE marking is reduced or enlarged the proportions given in the graduated drawing in paragraph 1 must be respected.

     

    3. Where specific legislation does not impose specific dimensions, the CE marking shall have a height of at least 5 mm.

     

    4. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where this is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents, where the legislation concerned provides for such documents.

     

    5. The CE marking shall be affixed before the product is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.

     

    6. The CE marking shall be followed by the identification number of the notified body where such body is involved in the production control phase.

     

    The identification number of the notified body shall be affixed by the body itself or under its instructions, by the manufacturer or his authorised representative established within the Community.

     

    7. Member States shall ensure correct implementation of the regime governing the CE marking and, if they deem adequate, take legal action in case of improper use. Member States shall also put in place penalties, which may include criminal sanctions, for serious infringements, that must be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

     

    Justification

    The CE marking needs better protection. As the meaning of the CE marking is not clearly understood, an increasing number of products bearing the CE marking do not comply with the legislation. It is therefore a shared interest of manufacturers, traders and consumers to have clear rules on the CE marking. In order to have these rules applied straight away and not to make them subject to future legislation, Articles 16 & 17 and the corresponding recitals of this Decision should be moved to the Regulation and this recital has to be amended accordingly.

    Amendment 36

    Article 22, paragraph 4, subparagraph 4 a (new)

     

    The conformity assessment body shall, in carrying out its activities, take into account the size, sector and structure of companies and the relative complexity of the technology applied to products and, lastly, the unit or serial nature of production.

    Justification

    The concerns expressed by the Commission with regard to size and the relative complexity of the technology applied to products in connection with conformity procedures, so as to avoid unnecessary burdens, are appreciated. Additional parameters such as the sector, the structure of firms and the serial nature of production, should also be taken into account.

    Amendment 37

    Article 22, paragraph 7, point (d a) (new)

     

    (da) the ability, carrying out their activities, to take into account the size and structure of any company and the relative complexity of the technology applied to any product and the unit or serial nature of production.

    Justification

    The concerns expressed by the Commission with regard to size and the relative complexity of the technology applied to products in connection with conformity procedures, so as to avoid unnecessary burdens, are appreciated. Additional parameters such as the sector, the structure of firms and the serial nature of production, should also be taken into account.

    Amendment 38

    Article 25, paragraph 1, subparagraph 1 a (new)

     

    For the same purpose, an accredited body, which forms a separate and identificable part of a undertaking or sectoral organisation representing undertakings involved in the design, manufacture, supply, installation, use or maintenance of the products that it assesses and which has been established to supply conformity assessment services to the undertaking or organisation of which it forms a part, may be used.

    Justification

    In order to better answer SME needs regarding certification and to ensure that conformity assessment procedures are carried out according to the size, the structure, the involved technology, the sector and the serial character of the production, laboratories and conformity assessment structures belonging to business intermediary organisations and/or sectoral organisations should be entitled to be accredited.

    Amendment 39

    Article 31, paragraph 2

    2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burden for economic operators, in particular taking into consideration the size of companies and the relative complexity of the technology used by the products.

    2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators, in particular taking into consideration the size, sector and structure of companies, the relative complexity of the technology used by the products and whether the product is a result of unit or series production.

    Justification

    In order to avoid unnecessary burden, other factors, such as size, the relative complexity of the technology used by the products, and the serial character of the production should be taken into account when carrying out conformity procedures. This is also an added cost for consumers.

    Amendment 40

    Article 35, paragraph 2 a (new)

     

    2a. 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 or in the document accompanying the product. The economic operator shall be permitted a reasonable period in which to respond, which shall be twenty-eight days where there is no immediate risk to the health and safety of the public.

    Justification

    Economic operators should be given the opportunity to react on the position of relevant authorities, in particular when other Member States are also involved thus, the procedure may have a significant impact on their business. The proposed period of 28 days provides with a reasonable balance between the needs of the enforcement bodies and the economic operators. The same deadline is already applied in e.g. the UK implementation of the Directive on the restriction of the use of hazardous substances in electrical and electronic equipment and experience has shown that it is appropriate.

    Amendment 41

    Article 35, paragraph 3

    3. The economic operator shall ensure that any corrective actions are taken in respect of all the products concerned which he has made available on the market throughout the Community.

    3. The economic operator shall ensure that all possible corrective actions are taken in respect of all the products concerned which he has made available on the market throughout the Community.

    Justification

    This absolute obligation cannot be fulfilled in practice. There may be many importers of the same product who place the same product on the market (e.g. in different countries). Once a product is on the market in any particular country there could be a wide range of distributors, both large and very small. Experience has shown that even when recalls are notified in the national press, at point of sale in retailers, etc, that the number of returns is less than 70%.

    Amendment 42

    Article 35, paragraph 3 a (new)

     

    3a. Importers and distributors shall not without consulting the manufacturer modify a product in such a way that compliance with applicable legislation may be affected.

    Justification

    Importers and distributors do not generally have the technical competence to make changes to the interior of the product and were they to do so they could seriously degrade the safety or other parameter of the product. Moreover, there are likely to be multiple distributors for a given product and the responsible organisation that placed the product on the market would not want a variety of ad hoc changes made by those multiple distributors.

    Amendment 43

    Article 35, paragraph 4, subparagraph 2 a (new)

     

    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 at the address stated on the product in question or in the document accompanying the product.

    Justification

    It is important that the economic operator be informed if another Member State decides to withdraw one of its products. However, Member State authorities cannot be expected to contact the economic operator before sending information to authorities in another Member State as this would slow the procedure considerably.

    Amendment 44

    Article 36, paragraph 3

    3. Where the national measure is considered to be justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards as referred to in Article [35(5) (b)], the Commission or the Member State shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC.

    3. Where the national measure is considered to be justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards as referred to in Article [35(5) (b)], consultation with the relevant European standardisation body shall take place, as outlined in Article 14(1), before the Commission or the Member State bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC.

    Justification

    Article 14 should be complemented with an obligation for member States to consult ESO[3] first, when they suspect that a standard has a loophole. This would be in line with current procedures in the EU and would allow the early involvement of ESOs and their technical experts. This is already informally practiced in the context of the Low Voltage Directive.

    Amendment 45

    Annex I, Module A, paragraph 4, point 4.2, subparagraph 2

    A copy of the declaration of conformity shall be supplied with each product that is made available on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than to individual products in those cases where a large number of products is delivered to a single user.

    A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

    Horizontal amendment to be applied in all modules listed below:

    - Annex I, Module A, paragraph 4, point 4.2, subparagraph 2

    - Annex I, Module A1, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module A2, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module C, paragraph 3, point 3.2, subparagraph 2

    - Annex I, Module C1, paragraph 4, point 4.2, subparagraph 2

    - Annex I, Module C2, paragraph 4, point 4.2, subparagraph 2

    - Annex I, Module D, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module D1, paragraph 7, point 7.2, subparagraph 2

    - Annex I, Module E, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module E1, paragraph 7, point 7.2, subparagraph 2

    - Annex I, Module F, paragraph 6, point 6.2, subparagraph 2

    - Annex I, Module F1, paragraph 7, point 7.2, subparagraph 2

    -Annex I, Module G, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module H, paragraph 5, point 5.2, subparagraph 2

    - Annex I, Module H1, paragraph 6, point 6.2, subparagraph 2

    Justification

    The obligation of providing a copy of the Declaration of Conformity with each unit sold is burdensome beyond proportions for economic operators.

    Amendment 46

    Annex I, Module A, paragraph 5 a (new)

     

    5a. Importer

     

    Importers shall keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request.

    Horizontal amendment to be applied in all modules listed below:

    - Annex I, Module A, paragraph 5 a (new)

    - Annex I, Module A1, paragraph 6 a (new)

    - Annex I, Module A2, paragraph 6 a (new)

    - Annex I, Module C, paragraph 4 a (new)

    - Annex I, Module C1, paragraph 5 a (new)

    - Annex I, Module C2, paragraph 5 a (new)

    - Annex I, Module D, paragraph 8 a (new)

    - Annex I, Module D1, paragraph 10 a (new)

    - Annex I, Module E, paragraph 8 a (new)

    - Annex I, Module E1, paragraph 10 a (new)

    - Annex I, Module F, paragraph 8 a (new)

    - Annex I, Module F1, paragraph 9 a (new)

    - Annex I, Module G, paragraph 6 a (new)

    - Annex I, Module H, paragraph 8 a (new)

    - Annex I, Module H1, paragraph 8 a (new)

    Justification

    Any economic operator that places products on the Community market should be liable for the conformity of those products. Only the manufacturer can prepare and maintain the technical documentation, as he has information on the product design. However, if the manufacturer is outside the EU without representatives in the EU, there is no way for the authorities to have access to the relevant documentation, which weakens the enforcement. Therefore, in line with Art 7, the importer should be responsible for ensuring that this documentation is at the disposal of the enforcement authorities.

    Amendment 47

    Annex I, Module A2, paragraph 4, subparagraph 3 a (new)

     

    The notified body shall accept the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT).

    Justification

    Given that most of the cost of conformity assessment is generated by tests, it is considered that the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT) must be accepted by external certification bodies.

    Amendment 48

    Annex I, Module C1, paragraph 3, subparagraph 2 a (new)

     

    The notified body shall accept the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT).

    Justification

    Given that most of the cost of conformity assessment is generated by tests, it is considered that the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT) must be accepted by external certification bodies.

    Amendment 49

    Annex I, Module C2, paragraph 3, subparagraph 3 a (new)

     

    The notified body shall accept the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT).

    Justification

    Given that most of the cost of conformity assessment is generated by tests, it is considered that the sharing of test results (shared ITT) and the downstream transfer of test results (cascading ITT) must be accepted by external certification bodies.

    PROCEDURE

    Title

    Common framework for the marketing of products

    References

    COM(2007)0053 - C6-0067/2007 - 2007/0030(COD)

    Committee responsible

    IMCO

    Opinion by

           Date announced in plenary

    ITRE

    13.3.2007

     

     

     

    Drafts(wo)man

           Date appointed

    John Purvis

    12.4.2007

     

     

    Discussed in committee

    26.6.2007

     

     

     

    Date adopted

    2.10.2007

     

     

     

    Result of final vote

    +:

    –:

    0:

    45

    0

    1

    Members present for the final vote

    Jan Březina, Philippe Busquin, Jerzy Buzek, Jorgo Chatzimarkakis, Silvia Ciornei, Pilar del Castillo Vera, Lena Ek, Nicole Fontaine, Adam Gierek, Umberto Guidoni, András Gyürk, Fiona Hall, David Hammerstein, Rebecca Harms, Mary Honeyball, Ján Hudacký, Romana Jordan Cizelj, Anne Laperrouze, Pia Elda Locatelli, Eluned Morgan, Angelika Niebler, Reino Paasilinna, Miloslav Ransdorf, Vladimír Remek, Mechtild Rothe, Paul Rübig, Andres Tarand, Radu Ţîrle, Patrizia Toia, Claude Turmes, Nikolaos Vakalis, Alejo Vidal-Quadras, Dominique Vlasto

    Substitute(s) present for the final vote

    Alexander Alvaro, Pilar Ayuso, Ivo Belet, Manuel António dos Santos, Avril Doyle, Robert Goebbels, Françoise Grossetête, Erika Mann, John Purvis, Bernhard Rapkay, Silvia-Adriana Ţicău, Vladimir Urutchev, Lambert van Nistelrooij

    • [1]  Not yet published in OJ.
    • [2]  European Standardisation Organisations (CENELEC, CEN and ETSI)
    • [3]  European Standardisation Organisations (CENELEC, CEN and ETSI)

    OPINION of the Committee on Legal Affairs (12.9.2007)

    for the Committee on the Internal Market and Consumer Protection

    on the proposal for a decision of the European Parliament and of the Council on a common framework for the marketing of products
    (COM(2007)0053 – C6‑0067/2007 – 2007/0030(COD))

    Draftsman: Othmar Karas

    SHORT JUSTIFICATION

    Obstacles to the free movement of goods remain. The Commission identifies those obstacles as: distortion of competition due to differing practices in the “designation of conformity” by the national assessment bodies; unequal treatment of “non-complying” or dangerous products on the market through the use of very different national market surveillance regulations, rules and means; lack of trust in conformity marking; and lack of coherence in the implementation and enforcement of existing EU legislation.

    The purpose of the proposal 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.

    In this opinion, your rapporteur has identified one issue which he considers warrants particular attention in view of the committee's particular concern about legal certainty and the quality of drafting.

    As the proposal stands, it would appear to preclude affixing voluntary third-party marks of conformity alongside the CE marking, which constitutes merely a claim by the manufacturer that the product is in conformity with the requirements of European legislation. This would result in business and jobs moving to countries outside the EU, where certain international test houses already have a de facto monopoly in North America and the USA, and would be detrimental to consumers.

    To effect such a radical change incidentally and inconspicuously by wording which does not promote legal certainty in a legislative package which is otherwise beneficial is contrary to the principles of better legislation.

    AMENDMENTS

    The Committee on Legal Affairs calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to incorporate the following amendments in its report:

    Text proposed by the Commission[1]Amendments by Parliament

    Amendment 1

    Recital 17

    (17) Since importers and distributors are downstream operators they cannot in the normal course of events be obliged to ensure themselves that the design and production of the product is in compliance with the applicable requirements. Their obligations in relation to the compliance of the product should be limited to certain control measures to ascertain whether the manufacturer has fulfilled his obligations, such as verifying whether the product bears the required conformity marking and whether the required documents have been supplied. However, it can be expected of both importers and distributors to act with due care in relation to the applicable requirements when placing or making available products on the market.

    (17) Since distributors are downstream operators they cannot in the normal course of events be obliged to ensure themselves that the design and production of the product is in compliance with the applicable requirements. In order to do this, they have to rely on economic operators who place products on the Community market. Distributors’ obligations should be limited to certain control measures, such as verifying whether the product bears the required conformity marking and whether the required user documentation has been supplied. It can be expected that distributors act with due care in relation to the applicable requirements when making products available on the market.

    Justification

    As it stands, Recital (17) is in contradiction with Recital (15). Recital (15) states that the importer has to ensure that the products he places on the market comply with the applicable Community requirements, while Recital (17) requires the importer to act with due care.

    Since the requirements placed on importers differ from those placed on distributors, mixing them for both importers and distributors in one recital is likely to cause confusion. Therefore, Recital (17) should be split into two parts to distinguish distributors from importers and their respective obligations.

    Distributors take a product that has already been placed on the Community market and make it generally available. Their obligation should consequently be limited to checking that the product carries the CE Marking and that any documentation delivered to the user and required to use the product safely, securely and with respect for the environment. They should not be required to check or keep copies of the declaration of conformity or the technical documentation. For this reason we believe that the reference to “documents” in the original proposal should read “user documentation”.

    Amendment 2

    Recital 17 a (new)

    (17a) Importers may not control the design and manufacturing characteristics of products but, because they place them on the Community market, they have an obligation to ensure that products comply with all applicable legislation. In order to meet this obligation, importers need to ensure in the first place that the manufacturers are aware of what the applicable legislation is and that the manufacturers have prepared the corresponding declarations of conformity and technical documentation. As the entity resident in the Community, importers should have the legal responsibility for ensuring that the products which they place on the market comply with the applicable legislation and that the above-mentioned declarations of conformity and technical documentation are available to enforcement authorities.

    Justification

    As it stands, Recital (17) is in contradiction with Recital (15). Recital (15) states that the importer has to ensure that the products he places on the market comply with the applicable Community requirements, while Recital (17) requires the importer to act with due care.

    Since the requirements placed on importers differ from those placed on distributors, mixing them for both importers and distributors in one recital is likely to cause confusion. Therefore, Recital (17) should be split into two parts to distinguish distributors from importers and their respective obligations.

    As distinct from distributors, importers do place products on the Community market and therefore they should understand in detail what Community laws apply. Importers are resident in the Community; they alone place products on the Community market; and so they must have the legal obligation to ensure compliance – including the making available of Declarations of Conformity and the technical documentation.

    Amendment 3

    Recital 22 a (new)

    (22a) It is important to make it clear, however, that the CE marking is a visual indication affixed by the manufacturer that the product is in conformity with the requirements of all specific European legislation. As such, it is not an indication of quality or that the product has been certified, approved or inspected by a third party, public or private (except where a specific directive requires the CE marking to be accompanied by the number of the Notified Body involved in the production control phase). Because the New Approach is based on directives containing ‘essential requirements’, products bearing the CE marking may not have been tested to ascertain their compliance with official harmonised standards, where these exist. Nor does the CE marking indicate approval on the part of the Commission or any other European or national authority. Lastly, it is not an indication of origin.

    Justification

    It is necessary to make it clear that the CE marking is not a quality mark and does not imply that the product has been certified, approved or inspected by a third party or that it complies with official harmonised standards. It is merely an aid to enforcement and enforcement authorities. In order not to cause confusion, we do not propose to make the CE marking voluntary. It must in this regard remain as it is in present New Approach Directives, mandatory for all manufacturers and authorised representatives irrespective of their size or other factors: to make any change in this regard would introduce unnecessary confusion for both enforcement authorities and purchasers of products.

    Amendment 4

    Article 6, point 11 a (new)

    (11a) “CE marking” means a readily discernable means by which the manufacturer or his authorised representative signifies to enforcement authorities that the product is in conformity with all applicable Community legislation which requires the CE marking.

    Amendment 5

    Article 9

    1. When placing a product on the market importers shall act with due care in relation to the applicable requirements.

    1. Importers shall be obliged to place only compliant products on the market.

    2. Before placing a product on the market importers shall verify that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall verify that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required documents and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    2. Before placing a product on the market importers shall verify that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall verify that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking(s), is accompanied by the required user documentation and that the manufacturer has respected the requirements set out in Article [7(5) and (6)].

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the legislation], he may place the product on the market only after it has been brought into conformity with the applicable requirements set out in ... [reference to the relevant part of the legislation]

    Where an importer discovers that the product is not in conformity with … [reference to the relevant part of the legislation], he may place the product on the market only after it has been brought into conformity with the applicable requirements set out in ... [reference to the relevant part of the legislation].

    3. Importers shall indicate their name and the address at which they can be contacted on the product or, where the size or nature of the product does not allow it, on its packaging or in a document accompanying the product.

    3. Importers shall indicate their name and the address at which they can be contacted on the product or, where the size or nature of the product does not allow it, on its packaging or in a document accompanying the product.

     

    3a. Importers shall, in all cases where appropriate for protection of the health and safety of consumers and where commensurate with the characteristics of the products which they supply, carry out sample testing of marketed products, investigating and, if necessary, keeping a register of complaints, and shall keep distributors informed of such monitoring.

    4. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in … [reference to the relevant part of the legislation].

    4. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in … [reference to the relevant part of the legislation].

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    5. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community legislation shall take the necessary corrective measures to bring that product into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the product available to this effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

    6. Importers shall, for a period of … [to be specified], keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    6. Importers shall:

     

    (a) issue a statement declaring that they have verified that the appropriate conformity assessment procedures have been carried out by the manufacturer or his authorised representative and that they accept legal responsibility for the products which they import;

     

    (b) keep and maintain the EC declaration of conformity prepared by the manufacturer or his authorised representative;

     

    (c) keep and maintain a copy of the technical documentation prepared by the manufacturer or his authorised representative, either at their own premises or at the premises of a third party;

     

    (d) keep the information described in points (a), (b) and (c) for a period of ten years after the last product unit has been manufactured … [or such other period as may be specified] at the disposal of the market surveillance authorities.

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market.

    7. Importers shall, on request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the product. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by products which they have placed on the market.

    Justification

    In order to ensure a level playing field between EU manufacturers and importers of products coming from third countries, it is crucial to provide for equal obligations among the economic operators placing products on the Community market. An equal level of obligations will ensure the same level of responsibility in case of non-compliant products.

    The text of the proposed Article 9(1) is based on Article 3(1) of the General Product Safety Directive (GPSD), which states that “Producers shall be obliged to place only safe products on the market”.

    We propose to add a new sub-section 3 to the European Commission’s original text in order to align it with Article 5 of the General Product Safety Directive.

    In Article 9(6) importers are required to sign an accompanying document to the Declaration of Conformity so as to take responsibility for the products they place on the market, and to keep the technical documentation. If the manufacturer is outside the EU and he does not have an authorised representative within the EU, it is difficult for the authorities to have access to the technical file.

    Amendment 6

    Article 16, paragraph 2

    2. The CE marking shall be the only marking which attests conformity of the product with the applicable requirements. Member States shall refrain from introducing into their national regulations or shall withdraw any reference to a conformity marking other than the CE marking in connection with conformity to the provisions contained in the legislation on CE marking.

    2. The CE marking shall be the only marking which signifies that the manufacturer or his authorised representative has determined that the product is in conformity with the requirements of the applicable Community legislation. Member States shall refrain from introducing into their national regulations or shall withdraw any reference to a conformity marking, within the meaning of the CE marking as defined in Article 6(11a), in connection with conformity with the provisions contained in the legislation on CE marking.

     

    Economic operators shall not be prevented from affixing other marks voluntarily and in addition to the CE marking, providing that there is no possibility of confusion.

    Amendment 7

    Article 16, paragraph 3

    3. The affixing on a product of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, is prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking are not thereby impaired.

    3. The affixing on a product of markings, signs and inscriptions which are likely to mislead the market as to the meaning and form of the CE marking is prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking are not thereby impaired.

    Justification

    The CE marking is only a visual indication by the manufacturer or his representative that his product is in conformity. It can only be such since the EU does not itself, at present, have the resources to carry out the required level of market surveillance to ensure that each and every product complies. As a result, the CE marking has to be distinguished from voluntary private marks, whose use is monitored and enforced by those independent testing and certifying bodies who own them.

    As this provision is worded in the Commission's proposal, it would mean that the conformity markings of well-known European testing and certification bodies (BSI, CEBEC, SEMKO, KEMA, TÜV, VDE etc.) could no longer be affixed to products, which would be to the detriment of consumers.

    It would also result in a transfer of business and jobs to non-member countries, since the markings of international test houses (e.g. UL in the USA or CCC in China) could not be prohibited in Europe. They already have a de facto monopoly in North America.

    No safety risk would be associated with allowing private markings to be affixed in addition to the CE marking.

    Amendment 8

    Annex I, Module A, paragraph 5 a (new)

    Importer

     

    The importer shall:

     

    (a) issue a statement declaring that he has verified that the appropriate conformity assessment procedures have been carried out by the manufacturer or his authorised representatives and that he accepts legal responsibility for the products which he imports;

     

    (b) keep and maintain the EC declaration of conformity prepared by the manufacturer or his authorised representative;

     

    (c) keep and maintain a copy of the technical documentation prepared by the manufacturer or his authorised representative, either at his own premises or at the premises of a third party;

     

    (d) keep the information described in points (a), (b) and (c) for a period of ten years after the last product unit has been manufactured … [or such other period as may be specified] at the disposal of the market surveillance authorities.

     

    This amendment should apply also to the following modules:

     

    Module A1 – paragraph 6a new

     

    Module A2 – paragraph 6a new

     

    Module C – paragraph 4a new

     

    Module C1 – paragraph 5a new

     

    Module C2 – paragraph 5a new

     

    Module D – paragraph 8a new

     

    Module D1 – paragraph 10a new

     

    Module E – paragraph 8a new

     

    Module E1 – paragraph 10a new

     

    Module F – paragraph 8a new

     

    Module F1 – paragraph 9a new

     

    Module G – paragraph 6a new

     

    Module H – paragraph 8a new

     

    Module H1 – paragraph 8a new

    Justification

    This suggested amendment is in line with the one proposed to Article 9 on importers’ obligations.

    PROCEDURE

    Title

    Common framework for the marketing of products

    References

    COM(2007)0053 - C6-0067/2007 - 2007/0030(COD)

    Committee responsible

    IMCO

    Opinion by

           Date announced in plenary

    JURI

    13.3.2007

     

     

     

    Drafts(wo)man

           Date appointed

    Othmar Karas

    18.6.2007

     

     

    Date adopted

    11.9.2007

     

     

     

    Result of final vote

    +:

    –:

    0:

    24

    0

    0

    Members present for the final vote

    Marek Aleksander Czarnecki, Bert Doorn, Cristian Dumitrescu, Monica Frassoni, Giuseppe Gargani, Lidia Joanna Geringer de Oedenberg, Othmar Karas, Piia-Noora Kauppi, Klaus-Heiner Lehne, Katalin Lévai, Hans-Peter Mayer, Manuel Medina Ortega, Hartmut Nassauer, Aloyzas Sakalas, Francesco Enrico Speroni, Daniel Strož, Rainer Wieland

    Substitute(s) present for the final vote

    Janelly Fourtou, Jean-Paul Gauzès, Barbara Kudrycka, Michel Rocard, Jacques Toubon

    Substitute(s) under Rule 178(2) present for the final vote

    Albert Deß, María Sornosa Martínez

    • [1]  Not yet published in OJ.

    PROCEDURE

    Title

    Common framework for the marketing of products

    References

    COM(2007)0053 - C6-0067/2007 - 2007/0030(COD)

    Date submitted to Parliament

    14.2.2007

    Committee responsible

           Date announced in plenary

    IMCO

    13.3.2007

    Committee(s) asked for opinion(s)

           Date announced in plenary

    INTA

    13.3.2007

    ENVI

    13.3.2007

    ITRE

    13.3.2007

    JURI

    13.3.2007

    Rapporteur(s)

           Date appointed

    Christel Schaldemose

    20.3.2007

     

     

    Discussed in committee

    7.5.2007

    27.6.2007

    16.7.2007

    12.9.2007

     

    2.10.2007

    5.11.2007

    26.11.2007

     

    Date adopted

    27.11.2007

     

     

     

    Result of final vote

    +:

    –:

    0:

    39

    0

    0

    Members present for the final vote

    Charlotte Cederschiöld, Gabriela Creţu, Mia De Vits, Janelly Fourtou, Vicente Miguel Garcés Ramón, Evelyne Gebhardt, Malcolm Harbour, Anna Hedh, Iliana Malinova Iotova, Pierre Jonckheer, Kurt Lechner, Lasse Lehtinen, Toine Manders, Arlene McCarthy, Nickolay Mladenov, Catherine Neris, Bill Newton Dunn, Zita Pleštinská, Giovanni Rivera, Zuzana Roithová, Heide Rühle, Leopold Józef Rutowicz, Christel Schaldemose, Andreas Schwab, Alexander Stubb, Eva-Britt Svensson, Marianne Thyssen, Horia-Victor Toma, Jacques Toubon

    Substitute(s) present for the final vote

    Emmanouil Angelakas, André Brie, Wolfgang Bulfon, Colm Burke, Giovanna Corda, Filip Kaczmarek, Manuel Medina Ortega, Joseph Muscat, Ieke van den Burg, Anja Weisgerber