Considerations on COM(2013)78 - Consumer product safety - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)78 - Consumer product safety. |
|---|---|
| document | COM(2013)78  |
| date | February 13, 2013 |
(2) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States. A Regulation ensures that legal requirements are applicable at the same time throughout the Union.
(3) This Regulation must contribute to the attainment of the objectives referred to in Article 169 of the TFEU. In particular it should aim at ensuring the functioning of the internal market as regards products intended for consumers by laying down uniform rules regarding a general safety requirement, assessment criteria and obligations of economic operators. Given that rules on market surveillance, including rules on RAPEX, are laid down in Regulation (EU) No […/…] [on market surveillance of products][14] which applies also to products covered by this Regulation, no further provisions on market surveillance or RAPEX are needed in this Regulation.
(4) Union legislation on food, feed and related areas sets up a specific regime ensuring the safety of the products covered by it. This Regulation should therefore not apply to those products with the exception of materials and articles intended to come into contact with food insofar as risks are concerned that are not covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles to come into contact with food[15] or by other food specific legislation which only covers chemical and biological food related risks.
(5) Medicinal products are subject to a pre-market assessment that includes a specific risk-benefit analysis. They should therefore be excluded from the scope of this Regulation.
(6) This Regulation should not cover services. However, in order to secure the attainment of the protection of health and safety of consumers, it should apply to products that are supplied or made available to consumers in the context of the provision of services, including products to which consumers are directly exposed during a service provision. Equipment on which consumers ride or travel which is operated by a service provider should be excluded from the scope of this Regulation since it has to be dealt with in conjunction with the safety of the service provided.
(7) Despite the development of sector-specific Union harmonisation legislation that addresses safety aspects of specific products or categories of products, it is practically impossible to adopt Union legislation for all consumer products that exist or may be developed. There is therefore still a need for a legislative framework of a horizontal nature to fill gaps and ensure consumer protection not otherwise ensured, in particular with a view to achieving a high level of protection of safety and health of consumers, as required by Article 114 and Article 169 of the TFEU.
(8) In respect of the consumer products subject to this Regulation the scope of application of the different parts of it should be clearly delimited from sector-specific Union harmonisation legislation. Whilst the general product safety requirement and related provisions should be applicable to all consumer products, the obligations of economic operators should not apply where Union harmonisation legislation includes equivalent obligations, such as Union legislation on cosmetics, toys, electrical appliances or construction products.
(9) In order to ensure consistency between this Regulation and sector-specific Union harmonisation legislation with regard to specific obligations of economic operators, the provisions concerning manufacturers, authorised representatives, importers and distributors should be based on the reference provisions included in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products[16].
(10) The scope of this Regulation should not be limited to any selling technique of consumer products, and thus also cover distance selling.
(11) This Regulation should apply to second hand products that re-enter the supply chain in the course of a commercial activity, except for those second-hand products for which the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, such as antiques.
(12) This Regulation should also apply to consumer products which, although not foodstuff, resemble foodstuff and are likely to be confused with foodstuff in a way that consumers, especially children, may place them in their mouths, suck or ingest them, which might cause, for example, suffocation, poisoning, the perforation or obstruction of the digestive tract. Those food-imitating products have so far been regulated by Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers[17] which should be repealed.
(13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
(14) To avoid overlapping safety requirements and conflicts with other Union legislation, a product which conforms to sector-specific Union harmonisation legislation that aims at the protection of health and safety of persons should be presumed to be safe under this Regulation.
(15) Economic operators should be responsible for the compliance of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the health and safety of consumers.
(16) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are safe and in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process.
(17) Importers bear the responsibility that products from third countries that they place on the Union market comply with the requirements of this Regulation. The specific obligations of importers should therefore be included in this Regulation.
(18) Distributors make products available on the market after they have been placed on the market by the manufacturer or the importer and should act with due care to ensure that their handling of the product does not adversely affect the compliance of the product with this Regulation.
(19) 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 the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer and, if applicable, of the importer. Manufacturers should also establish technical documentations regarding their products for which they may choose the most appropriate and cost-efficient way such as by electronic means. Moreover, economic operators should be required to identify the operators who supplied them and to whom they supplied a product. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data[18] is applicable to the processing of personal data for the purposes of this Regulation.
(21) The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions.
(22) In order to facilitate the effective and consistent application of the general safety requirement set out in this Regulation, it is important to make use of European standards covering certain products and risks in such a way that a product which conforms to such a European standard, the reference of which is published in the Official Journal of the European Union, is to be presumed to be in compliance with that requirement.
(23) Where the Commission identifies a need for a European standard ensuring compliance of certain products with the general safety requirement under this Regulation, it should apply the relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation[19] to request one or several European standardisation organisations to either draft or identify a standard which is suitable to ensure that products which conform to it are presumed to be safe. The references of such European standards should be published in the Official Journal of the European Union.
(24) The procedures to request European standards in support of this Regulation, and on formal objections against them, should be laid down in this Regulation and be aligned with Regulation (EU) No 1025/2012. To ensure overall consistency in European standardisation issues, requests for European standards, or objections to a European standard, should therefore be brought before the committee set up by that Regulation, after appropriate consultation of experts of the Member States in the field of consumer product safety.
(25) European standards, the references of which have been published in accordance with Directive 2001/95/EC, should continue providing presumption of conformity with the general safety requirement. Standardisation mandates issued by the Commission in accordance with Directive 2001/95/EC should be deemed standardisation requests issued in accordance with this Regulation.
(26) Where no relevant European standards or other recognised means to assess the safety of products exist, the assessment of product safety should take into account Commission recommendations adopted for this purpose pursuant to Article 292 TFEU.
(27) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the exemption to the obligation to inform market surveillance authorities about products presenting a risk, as regards the type of data carrier and its placement on the product for the purposes of the traceability system, as regards standardisation requests to European standardisation organisations and as regards decisions on formal objections to European standards. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers[20].
(28) The advisory procedure should be used for the adoption of implementing acts with respect to the objections to European standards and where the references to the European standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the general safety requirement laid down in this Regulation.
(29) In order to maintain a high level of health and safety of consumers, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of products for which the name and address of the manufacturer and of the importer does not need to be indicated on the product itself due to the low level of risk related to such products, and in respect of the identification and traceability of products bearing a potential serious risk to health and safety. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(30) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.
(31) To allow economic operators, Member States and the Commission to adapt to the changes introduced by this Regulation, it is appropriate to provide for a sufficient transitional period until the requirements of this Regulation are applicable.
(32) Since the objective of this Regulation, namely to ensure the functioning of the internal market as regards products intended for consumers while guaranteeing a high level of health and safety protection of consumers, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(33) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular this Regulation seeks to ensure full respect for the obligation to ensure a high level of human health protection and consumer protection as well as the freedom to conduct business.