The Working Group on Technical Barriers to Trade and the Expert Group on Product Safety, Market Surveillance and Product Liability are responsible for legislation on product sectors contained in Annex II and III of the EEA Agreement.
The New Legislative Framework for the marketing of products (NLF)
The New Legislative Framework (NLF) consists of Regulation (EC) 765/2008 setting out the requirements for accreditation and the market surveillance of products and Decision 768/2008 on a common framework for the marketing of products, which are incorporated into Chapter XIX of Annex II to the EEA Agreement.
The aims of the NLF are to strengthen accreditation at national level, as a tool for assessing the competence of notified bodies, and to strengthen the protection of the CE marking. Further, the NLF constitutes a general framework of a horizontal nature for new legislation harmonising the conditions for the marketing of products.
The provisions on market surveillance in Regulation (EC) 765/2008 have been replaced by Regulation 2019/1020, which is being processed for incorporation into Chapter XIX of Annex II to the EEA Agreement. For more information, see “Market surveillance” below.
Harmonisation of technical regulation
In the sectors subject to harmonised product requirements, common rules adopted at the European level apply throughout the EEA. Harmonised product requirements create a clear and predictable legal framework for businesses and manufacturers and preclude the adoption of possibly divergent national rules, and at the same time protects health, safety and the environment.
Two regulatory methods have been applied; the Old Approach and the New Approach. Products regulated under the ‘Old Approach’ are subject to detailed, exhaustive, technical rules contained in an EU legal act which is incorporated into the EEA Agreement. Through the ‘New Approach’, essential product rules (such as health, safety and environmental requirements) are adopted by law whereas more detailed technical requirements are set out in harmonised European standards. CE marking is an important element in most of the New Approach legislation.
The principle of mutual recognition
Where no harmonised product requirements are in place, EEA States may set their own national technical requirements. However, the national requirements must be applied in accordance with 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. According to the principle of mutual recognition, an EEA State cannot restrict 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 which 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 it is the means of ensuring the free movement of non-harmonised goods within the EEA.
Regulation 2019/515 on the mutual recognition of goods lawfully marketed in another Member State clarifies how to apply the principle of mutual recognition. Regulation 2019/515 is incorporated into Chapter XIX of Annex II to the EEA Agreement.
Market surveillance
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 EEA 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 EEA 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 EU has adopted Regulation 2019/1020 on market surveillance and compliance of products. The objective of this Regulation is to improve the function of the Internal Market and keep non-compliant products from being placed on the Internal Market by strengthening market surveillance of products and promoting closer cross-border cooperation among enforcement authorities, including customs authorities. Rules and procedures for economic operators are laid down in the Regulation and a system for their cooperation with supervisory authorities is established.
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. This Directive is incorporated into Chapter XIX of Annex II to the EEA Agreement.
European standardisation
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 an Internal Market for goods. This partnership between EEA law 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).
Please consult the Standardisation page for more information.
Notification of national draft technical regulations
Regulation (EU) 2015/1535 sets out a procedure whereby national authorities are obliged to notify national draft technical regulations and allow other Member States’ authorities to comment on them. The aim is to prevent creating barriers in the Internal Market before they materialise. For this purpose, the European Commission has set up a database called TRIS (Technical Regulation Information System) where all national draft technical regulations are uploaded and can be examined by other Member States. The EFTA countries participate in this system. The EEA EFTA states notify their draft technical regulations to the EFTA Surveillance Authority (ESA), which uploads the draft regulations into TRIS. The EFTA Secretariat acts on behalf of Switzerland and uploads draft Swiss regulations into TRIS.
Product liability
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.
Further information and resources:
DG Internal Market, Industry, Entrepreneurship and SMEs (DG GROWTH)
Regulatory Policy - Single Market for goods
General Product Safety Directive (GPSD)
Rapid Alert System for non-food consumer products (RAPEX)
European Standardisation Policy