18/03/13

European Commission Adopts New Legislative Package To Increase Protection From Hazardous Products

On 13 February 2013, in pursuit of its aim to clarify the current regulatory framework, the European Commission (the “Commission”) proposed a new legislative package on product safety and market surveillance (the “Package”).

The Package consists of (i) a proposal for a Regulation on consumer product safety (which would replace Directive 2001/95/EC of 3 December 2001 on general product safety (“Directive 2001/95/EC”) and Directive 87/357/EEC of 25 June 1987 on food-imitating products); (ii) a proposal for a single Regulation on market surveillance for products covering the period 2013-2015; and (iii) a multiannual action plan in which the Commission sets out 20 concrete actions to be undertaken over the next three years. Accompanying the above, and completing the Package, is a Report (the “Report”) on the implementation of Regulation No 765/2008 of 9 July 2008 “setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93” (“Regulation 765/2008”). The Report presents the Commission’s findings, which are reflected in the proposed set of new rules.

The Commission’s objective of clarifying the regulatory framework on product safety results from the fact that, at present, several pieces of legislation can be applied to non-food products. In addition to the application of Directive 2001/95/EC and Regulation 765/2008, sectoral legislation for “harmonised products” such as toys, chemicals and cosmetics also applies to non-food products. Thus, the overlap in legislation in this field is a source of complexity. Indeed, Regulation 765/2008 and the sectoral legislation apply to all harmonised products, whereas Directive 2001/95/EC concerns all types of consumer goods, regardless of whether they are harmonised. The result is that differing methods of evaluation and varying requirements are applied in accordance with the category of the product, i.e., whether it is harmonised or not, which creates overlaps and gaps within the legal framework.

Accordingly, the Commission seeks to clarify and strengthen the rules regulating the identification and traceability of consumer products and enable better coordination of the way in which authorities check products and enhance product safety rules across the EU.

In furtherance of this aim, the proposed market surveillance Regulation will bring all of the rules together into a single legal instrument. The new draft market surveillance Regulation will abolish the distinction between harmonised and non-harmonised products (except where this is unavoidable in applying specific provisions), in addition to abolishing the distinction between consumer and professional products, which also exists under the current regulatory framework.

The Package contains several changes. The following salient points should be noted:

  • The Package will improve the traceability of consumer products throughout the supply chain. In so doing, it will require that manufacturers and importers ensure that products bear an indication of the country of origin of the product or, where the size/nature of the product does not allow it, the indication is to be provided on the packaging or in an accompanying document. For products manufactured within the EU, the indication will have to refer to the Union or to a particular EU Member State. This requirement will supplement the basic traceability requirements concerning the name and address of the manufacturer.
  • Manufacturers will have to provide information on the safety of their products to the public authorities, in particular, on how they have ensured, throughout the manufacturing process, that their products are safe.
  • The existing procedures for the Rapid Alert Information System (“RAPEX”) and the Information and Communication System for Market Surveillance (“ICSMS”) will be streamlined. The two procedures will become a single procedural flow, with certain events triggering a single notification to the other EU Member States and the Commission (therefore meaning that only one notification need be made).
  • The Package will create a more collaborative system of market surveillance across the EU, which will be established in a single set of coherent rules.
  • The Package will provide more effective tools to enforce safety and other product-related requirements and to take action against dangerous and non-compliant products. The Package will make it easier to remove products considered dangerous from the EU market, and, based on the seriousness of the situation, the Commission will be entitled to prohibit the sale of products, and in some cases withdraw them from the market entirely.
  • Importantly, the Package will set out clearer responsibilities for manufacturers, importers and distributors when they sell consumer products.
  • The Package also proposes the creation of a European Market Surveillance Forum to help develop best practices for a harmonised implementation across the EU. The aim of the Forum is to facilitate the exchange of information on products presenting risk, risk assessments, testing methods etc., and will provide the opportunity for businesses and consumers’ associations to make their voice heard, in addition to the Commission and the EU Member States.

On the one hand, the Package will seek to benefit consumers by ensuring that products throughout the EU are safe and compliant. On the other hand, it will aid manufacturers by producing more coherent rules which apply across all product sectors and which will in turn lower compliance costs.

The Package is now being discussed by the European Parliament and the Council, and is expected to come into effect in 2015.

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