On 13 February 2013 the European Commission (“the Commission”) proposed new rules to improve the safety of products circulating in the European Union (“the Union”) and to improve market surveillance.
The 2008 adoption of a New Legislative Framework1 on the marketing of products and other measures has meant that the product safety regime has been in need of an overhaul, in order to ensure better integration of the legislative tools in the area of consumer product safety.
The February 2013 proposal comprises a “package” of the following measures:
- A proposal for a new Regulation on Consumer Product Safety.
- A proposal for single Regulation on Market Surveillance for products.
- A communication for safer and compliant products for Europe, setting out a multi-annual plan for market surveillance.
- A report on the implementation of Regulation (EC) No. 765/20082 , including a financial valuation.
The focus of this briefing note is on the two new proposed Regulations, which, once implemented, will be directly binding on Member States. The two proposed Regulations will operate in the same way as the Revised General Product Safety Directive i.e. the measures contained in the draft Regulations will apply where there is no sector-specific regime.
1. Proposed New Regulation on Consumer Product Safety
This proposed new Regulation concerns all non-food consumer products, with certain clearly defined exceptions, such as medicinal products for human or veterinary use, food and feed3. It is intended to replace Directive 2001/95/EC, the Revised General Product Safety Directive, which is currently the “cornerstone” of product safety legislation in the Union and which is implemented at a national level by the various Member States.
The Commission’s explanatory memorandum accompanying the draft Regulation states “the proposed regulation requires that consumer products must be “safe”, sets out certain obligations on economic operators and contains provisions for the development of standards and support of the general safety requirement. The operation of the proposed regulation and its interface with other union legislation will be significantly streamlined and simplified whilst maintaining a high level of protection of the health safety of consumers”.
Of note is the fact that the proposed Regulation does not refer to “producer” unlike the current legislation, but instead to “economic operator” and identifies obligations in relation to specific roles in the supply chain, such as “manufacturer”, “authorised representative” and “distributor”.
Key elements of the proposed Regulation on Consumer Product Safety
- Article 2 confirms that the new regulation expands upon the previous rules in that it applies to products to which consumers are exposed in the context of a service provided to them.
- Article 4 states that economic operators shall make available on the Union market, only safe products (known as the “general safety requirement”).
- Article 5 states that a product will be presumed to be in compliance with the general safety requirement if it conforms with Union harmonisation legislation, as regards the risks covered by the requirements designed to protect human health and safety (within sector specific regimes).
- Article 7 requires that products (or packaging / accompanying documentation) must bear country of origin indications.
- Article 8 places an obligation on manufacturers to draw up technical documentation (including an analysis of risks) and retain this for a period of 10 years after the product has been placed on the market and also to make this available to Market Surveillance Authorities on request. This Article also provides that products should provide a type / batch / serial number and full contact details of the manufacturer.
- Articles 9, 10 & 11 set out detailed responsibilities of manufacturers, authorised representatives, importers and distributors, including an obligation to notify Market Surveillance Authorities of risks. There are certain exemptions from the obligation to inform Market Surveillance Authorities set out in Article 13, for example, “only a limited number of well identified products are not safe”, or “the manufacturer, importer or distributor can demonstrate that the risk has been fully controlled and cannot any more endanger the health and safety of persons”.
- Article 15 sets out specific requirements for traceability (including electronic traceability) for certain products which, due to their specific characteristics, or specific conditions of distribution or usage are susceptible to bear a serious risk to the health and safety of consumers.
- Article 18 deals with penalties and allows for Member States to lay down the rules on infringement which are to be notified to the Commission 3 months prior to the date of application of the Regulation. Of note is the provision that the penalty should have regard to the size of the business and whether the economic operator has committed a previous similar infringement. Criminal sanctions may apply for serious infringement.
2. Proposed New Regulation on Market Surveillance
The Commission’s explanatory memorandum accompanying this draft Regulation highlights that market surveillance has not kept pace with developments in the Union’s general regulatory framework and ought to be coordinated and capable of reacting rapidly over a large geographical area. It recognises that there is a large overlap between the various pieces of existing legislation in terms of the market surveillance rules and obligations on economic operators. The Commission finds that this has led to confusion on the part of both economic operators and national authorities.
The new Regulation will apply consumer and non-consumer products with certain exceptions, such as, for example, food, for which there is a separate market surveillance regime in place4.
Key elements of the proposed Regulation on Market Surveillance
- Article 5 provides that each Member State is to designate Market Surveillance Authorities and define their duties, powers and organisations.
- Article 6 states that Market Surveillance Authorities shall perform appropriate checks on an “adequate scale” and with “adequate frequency” by means of documentary checks and physical and laboratory checks where necessary.
- Article 9 provides for Market Surveillance Authorities to carry out risk assessment and sets out obligations on economic operators to rectify formal non-compliance with legislation in relation to e.g. CE marking or labelling.
Where Market Surveillance Authorities find that a product does present a risk they shall, without delay, specify the necessary corrective action to be taken by the economic operator to address the risk within a specified period. This corrective action can be recommended or agreed with the economic operator. Types of corrective action to be taken by economic operators in circumstances where a product presents a risk include affixing warnings, temporary prevention from placing on the marking pending a risk assessment, withdrawing or recalling the product and alerting the public to the risk presented.
- Article 10 gives Market Surveillance Authorities the power to take “all necessary measures” to deal with the risk presented by the product in circumstances where the economic operator cannot be identified or, has not taken the necessary corrective action within the time frame specified. This Article also provides that in cases where Market Surveillance Authorities consider a product presents a serious risk, they shall take “all necessary measures” without first requiring the economic operator the opportunity to take corrective action.
- Articles 14-18 set out detailed measures for control of products entering the Union.
- Articles 19 & 20 deal with workings of the RAPEX system (Rapid Information Exchange System). This is currently a provision of the Revised General Product Safety Directive and the fact that it is proposed that this now be housed within the proposed Market Surveillance Regulation, demonstrates that both this and the proposed Consumer Product Safety Regulation, are intended to operate in close conjunction with one another.
- Article 25 establishes a European Market Surveillance Forum to meet at regular intervals. Tasks of this body will include the exchange of expertise and best practises and organising joint market surveillance and joint testing programmes.
These proposed new pieces of legislation represent a significant revision of the current status quo. Both economic operators and Market Surveillance Authorities will have to adapt to the new regime within a relatively short lead in time, once both draft Regulations have been finalised. The proposals will now be discussed by the European
Parliament and the Council. The proposed new legislation is expected to come into effect in 2015. We will report further with any changes to the proposals as matters develop