1.2 New Legal Framework for marketing products

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1 The Electromagnetic Compatibility Regulations 2006 (2006 No. 3418) that implement the new EMC Directive 2004/108/EC revoke and replace the Electromagnetic Compatibility Regulations 2005 (SI 2005/281). The new regulations consolidate the previous regulations and also incorporate further amendments. These rescind the regulations in respect of certain types of apparatus, specifically covered by other directives, and provide for a new enforcement authority, OFCOM, to act in place of the Radiocommunications Agency in so far as enforcement relates to the protection and management of the radio spectrum. The regulations require that all electrical and electronic apparatus marketed in the UK, including imports that satisfy the requirements of the EMC Directive must carry CE marking. A guide has been published by the Department for Business, Innovation and Skills (BIS) to assist UK manufacturers and suppliers of electronic and electrical equipment to understand the effect of the regulations. The guide is included for reference in Appendix VI of this guide, and can also be obtained from the BIS website: National implementations of the directive National implementations of the directive and the transposition of the directive into national law have been achieved to different stages depending on a number of factors within each Member State. The national provisions communicated by the Member States concerning Directive 2004/108/EC on the approximation of the laws of Member States relating to electromagnetic compatibility are available for reference via the Commission s website: New Legal Framework for marketing products The modernization of the New Approach for marketing products was adopted on 9 July 2008, published in the OJ on 13 August 2008, and resulted in a New Legal Framework for the provision of accreditation services across Europe. The framework is designed to remove the remaining obstacles to the free circulation of products between EU Member States. The New Legislative Framework comprises of two complementary instruments: Regulation 765/2008/EC on accreditation and market surveillance, and Decision 768/2008/EC establishing a common framework for marketing products. The Regulation (765/2008/EC), agreed by The Council of the European Union and the European Parliament, applied from January 2010 and covers the operation of accreditation in support of voluntary conformity assessment and also conformity July 2010 BSI 1.7

2 The Electromagnetic Compatibility Directive assessment required by legislation. When carried out against recognized harmonized standards, accreditation is regarded as a public authority activity and EU Member States will be required to appoint a single national accreditation body. Within the framework, existing market surveillance systems for industrial products will be strengthened and aligned with import controls. These measures will reinforce the role and credibility of CE marking. In addition, trade in goods that do not fall under EU legislation will be improved. A Member State that intends to refuse market access will be obliged to give detailed objective reasons for any refusal. The objective is to facilitate the functioning of the internal market for goods, and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market. The framework builds on existing mechanisms and is intended to introduce clear Community policies that will strengthen the application and enforcement of internal market legislation. Improved rules on market surveillance are introduced, designed to provide protection from unsafe products, including imports from third countries. In particular, this applies to procedures for products, which can be a hazard for health or the environment. The quality of conformity assessments of products is enhanced through stronger and clearer rules on the requirements for notification of conformity assessment bodies, e.g. testing, certification and inspection laboratories, including the increased use of accreditation. The regulation also recognizes the European co-operation for Accreditation (EA) as the organization responsible for coordinating the national European accreditation infrastructure. National accreditation bodies will be required to be members of the EA and participate in the peer evaluation programme as a means of demonstrating compliance with the legal requirements. The regulation sets common requirements for national accreditation bodies, which are to be monitored by Member State governments. As such, the regulation seeks to improve the consistency of accreditation services across Europe and will require national accreditation bodies: not to compete with other national accreditation bodies, or offer services offered by conformity assessment bodies, to be independent of the conformity assessment bodies they accredit, and to be objective and impartial, to operate on a not for profit basis, and employ competent personnel for tasks to be carried out. The credibility and meaning of CE marking is enhanced and clarified and will be protected as a community collective trademark. This will give authorities and competitors additional means to take legal action against manufacturers who abuse it. A common legal framework for industrial products is established in the form of a set of measures for use in future legislation. This includes provisions to support market surveillance and application of CE marking, and sets out simple common definitions of 1.8 BSI July 2010

3 terms and procedures that will allow future legislation to become more consistent and easier to implement. The provisions of the decision will be fed into existing directives as and when they are revised and in effect form the basis for future regulation. The related EU Decision (768/2008/EC) adopted at the same time as the regulation sets a common framework for future EU directives relating to the marketing of products, and repealing Council Decision 93/465/EEC. The decision covers: the use of standards, CE marking, conformity assessment procedures and the appointment of conformity assessment bodies, e.g. notified bodies. The decision also places greater emphasis on the use of accreditation in the assessment of notified bodies with the intention of improving consistency across Europe. The texts of the Regulation and Decision were published in the Official Journal of the European Union on the 13 July 2008 as Regulation (EC) No 765/2008 and Decision No 768/2008. Copies can be obtained from the European Commission s website: The Regulation No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) No 339/93 : The Decision (768/2008/EC) on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC : A Regulation (764/2008/EC) laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision 3052/95/EC, relates to the practice of mutual recognition i.e. the application of certain national technical rules to products lawfully marketed in another Member State. The package of measures strengthens the internal market of a wide range of products, which are not subject to EU harmonization e.g. various types of foodstuffs, furniture, bicycles, ladders and precious metals, etc. The new mutual recognition Regulation covers these products: The principle of mutual recognition Within the EU, mutual recognition is the principle that a product lawfully marketed in one Member State should be allowed to be marketed in any other Member State; even in cases where the product may not fully comply with the rules of the destination Member State. The destination Member State may refuse the marketing of a product in its current form only where it can demonstrate that this is necessary for the protection of e.g. public safety, July 2011 BSI 1.9

4 The Electromagnetic Compatibility Directive health or the environment. However, the destination Member State must demonstrate that any measure taken is the least trade-restrictive measure. The mutual recognition principle is a main driver for facilitating the market access in other Member States. To make the mutual recognition principle fully operational, the European Parliament and the Council adopted Regulation (EC) No 764/2008, which applied from 13 May The Regulation (764/2008) defines the rights and obligations of the national authorities, and also commercial enterprises wishing to sell products in a Member State that have been lawfully marketed in another Member State, in cases where the competent authorities intend to take restrictive measures regarding the product in accordance with national technical rules. The Regulation sets out the procedural requirements for denying mutual recognition. Further information regarding the principle of mutual recognition, and the Regulation 764/2008, can be obtained from the Commission s website: Implementation in the UK In the UK, The Department for Business Innovation and Skills (BIS) is responsible for co-ordinating the Market Surveillance and CE Marking aspects of two of these three new measures; EC Regulation (765/2008/EC); sets out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation EEC 339/93, and Decision (768/2008/EC); on a common framework for the marketing of products and repealing Decision 93/465/EEC. The European & International Trade Directorate (EITD) within BIS is responsible for EC Regulation (764/2008/EC), which lays down procedures relating to the application of certain technical rules to products lawfully marketed in another Member State and repealing Decision 3052/95/EC. Although the Regulation on accreditation and market surveillance (765/2008/EC) is directly applicable as law in all EU Member States, it requires BIS to fulfil a programme of work for the UK to be compliant with its provisions. The Regulation establishes a European framework for accreditation, and also outlines what Member States must do to fulfil their obligations to ensure that only compliant goods are allowed onto the market i.e. market surveillance. These obligations include having authorities in place with the ability to deal with noncompliance, and the development of a national market surveillance programme. There are also provisions on border controls with regard to products from non-eu sources, 1.10 BSI July 2011

5 and new financial provisions. The Regulation also specifies general principles for the appropriate affixing of CE Marking. BIS have published The general national market surveillance programme for the United Kingdom 2010, which forms the UK s annual general national market surveillance programme for the legislation that implement Community harmonisation legislation as required by Article 18(5) of Regulation (EC) No. 765/2008. A copy of The general national market surveillance programme for the United Kingdom 2010 can be obtained from the BIS website: Further information, including points of contact for the market surveillance and CE marking aspects of this new legislation, can be obtained from the BIS website: Alignment of selected product harmonization directives with Decision 768/2008 The Regulation (765/2008) on marketing products became applicable from 1 January The provisions of the Decision (768/2008) can be used immediately, but to be operational they need to be incorporated into existing Directives as and when they are revised. The Commission is therefore conducting a consultation concerning the marketing of: electrical and electronic products, lifts, pressure equipment, measuring instruments, civil explosives, pyrotechnic articles and equipment for use in potentially explosive atmospheres. The Commission has envisaged aligning ten directives to the new standards set by Decision 768/2008. These directives are: Low Voltage Directive: 2006/95/EEC Simple Pressure Vessels Directive: 2009/105/EC Non-automatic Weighing Instruments Directive: 2009/23/EC Civil Explosives Directive: 93/15/EEC ATEX Directive: 94/9/EC Lifts Directive: 95/16/EC Pressure Equipment Directive: 97/23/EC Measuring Instruments Directive: 2004/22/EC Electromagnetic Compatibility Directive: 2004/108/EC Pyrotechnic articles Directive: 2007/23/EC Information about the New Legislative Framework for marketing of products and the Commission s consultation, can be obtained from the Commission s website: July 2011 BSI 1.11