The New Legislative Framework for the marketing of products (NLF)
The NLF was adopted by the EU on 9 July 2008 and was incorporated into the EEA Agreement on 14 July 2012.
The NLF consists of the following two legal acts:
- Regulation 765/2008/EC setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93
The Regulation has three main aims. Firstly, to strengthen accreditation at national level, as a tool for assessing the competence of notified bodies. Secondly, it aims to strengthen market surveillance in Member States, while enhancing cooperation with customs authorities, in partnership with the European Commission. Thirdly, it aims at strengthening the protection of the CE marking.
- Decision No 768/2008/EC on a common framework for the marketing of products and repealing Council Decision 93/465/EEC
This Decision lays down common principles and reference provisions intended to apply across sector legislation in order to provide a coherent basis for revision or recasts of existing legislation. The Decision also constitutes a general framework of a horizontal nature for new legislation harmonising the conditions for the marketing of products.
Harmonisation of technical regulation
The free movement of goods is one of the cornerstones of the European Single Market. One way to secure that products can move freely is to remove national technical product regulations that are different causing a need for products to be adopted or amended in order to be placed on a national market. One way to remove such technical barriers to trade is by harmonising technical regulations/conditions in the Single Market. This is why the EU and the EEA EFTA States in several product sectors have harmonised technical product regulations. It secures free movement of goods, and protects health, safety and the environment.
Two regulatory methods have been applied; the Old Approach and the New Approach. CE marking is an important element in most of the New Approach legislation.
The principle of mutual recognition
While the new legislative framework for goods forms a template for future product harmonisation legislation, another regulation aims at strengthening the internal market for a wide range of products that are not subject to harmonisation - Regulation 764/2008/EC laying down the procedures relating to the application of certain technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC.
Regulation 764/2008 defines the rights and obligations of national authorities, on the one hand, and, on the other, enterprises wishing to sell products lawfully marketed in one Member State in another Member State where the competent authorities intend to put restrictive measures on the product in accordance with national technical rules. In particular, the Regulation concentrates on the burden of proof by setting out the procedural requirements for denying mutual recognition.
Regulation 764/2008 clarifies how to apply the principle of mutual recognition. This is a general principle of the free movement of goods which is established in Articles 11-13 of the EEA Agreement / Articles 34-36 of the Treaty on the Functioning of the European Union. According to the principle of mutual recognition, an EEA State cannot forbid the sale on its territory of products which are lawfully marketed in another EEA State, even when the product does not fully comply with the technical rules of the importing State. Exceptions to this principle are restrictions which are justified on the grounds described in Article 13 of the EEA Agreement, or on the basis of overriding reasons of public interest and are proportionate to the aim pursued. Mutual recognition applies to products which are not subject to harmonisation measures at EEA level, or to aspects of products falling outside the scope of EEA harmonisation measures and is the means of ensuring the free movement of non-harmonised goods within the EEA.
Market surveillance is an essential tool to ensure product safety. It needs to function effectively in order to provide the following guarantees: uniform application of EU law, equal protection for all citizens, and maintenance of a level playing field for enterprises. Market surveillance implies that national surveillance authorities ensure that products placed on the market comply with the provisions of the applicable national legislation transposing the EU law and, when necessary, take action to establish conformity. The border protection agencies also have an important role to play in ensuring that only safe and compliant products are made available on the market.
The EEA EFTA States participate actively in the work of PROSAFE, the product safety enforcement forum of Europe, consisting of an informal network of market surveillance enforcement authorities.
General product safety
The General Product Safety Directive aims at ensuring that only safe consumer products are placed on the market. The EEA EFTA States participate as observers in the European Commission's Committee on General Product Safety, which issues opinions on draft European Commission decisions related to products presenting serious and immediate risks.
European standardisation – notification of national draft technical regulations.
Standardisation is a market-based tool in which industry produces standards in order to agree on technical specifications for health, safety and the environment and to achieve interoperability. The development of European standards and the withdrawal of conflicting national standards has played a leading role in the achievement of a Single Market for goods. This partnership between EU/EEA legislation and standardisation is an important element of the ‘New Approach'.
Through Regulation EU No 1025/2012, the three European Standardisation Organisations (CEN, CENELEC and ETSI) are recognised as organisations that may be mandated to produce European harmonised standards in support of sectoral harmonised product legislation or for specific policy purposes. The Regulation aims to modernise and improve the European standards setting, to make it faster and, at the same time, more inclusive. It opens up for standardisation requests from the EU and EFTA in the area of services and facilitate the participation of specific stakeholder representation in the development in European standards (Annex III Organisations).
The Product Liability Directive sets out uniform rules of liability to ensure a high level of consumer protection against damage caused to health or property by defective products marketed within the EEA. This Directive has been incorporated into Annex III of the EEA Agreement, which is dealt with by the Expert Group on Product Safety, Market Surveillance and Product Liability.
Further information and resources: