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New Legislative Framework for EU Community Harmonisation for Products

BIS has responsibility for co-ordinating the Market Surveillance (and CE Marking) aspects of two of the three new EU measures relating to Community Harmonisation Legislation for products that are sometimes referred to as the “Goods Package”:

  • A directly applicable EC Regulation, 765/2008/EC that sets out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation EEC 339/93.
  • A Decision, 768/2008/EC on a common framework for the marketing of products and repealing Decision 93/465/EEC is a toolbox of other regulatory provisions for legislators when revising existing or drafting future Community harmonisation legislation for products.
  • The third measure is a directly applicable EC Regulation, 764/2008/EC that 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. It is often referred to as the Mutual Recognition Regulation. The European & International Trade Directorate (EITD) is responsible in BIS for this measure.

The Regulation on Accreditation and Market Surveillance (often referred to by its acronym – “RAMS”) applies from 1 January 2010. Although as a European Regulation, it is directly applicable as law in the UK and other Member States, it requires BIS to fulfil a programme of work for the UK to be compliant with its provisions, and this work is underway.

The Regulation will establish a European Framework for Accreditation – the process of ensuring the competence of bodies concerned with conformity assessment of goods and services e.g. product certification systems or the certification of management systems or which perform inspection or calibration . The Regulation also spells out what Member States must do to fulfil their obligations to ensure that only compliant goods are allowed onto the market (“Market Surveillance”). These obligations include having authorities in place with the ability to deal with non-compliance and the development of a National Market Surveillance Programme. Please see the NMSP paper and Annexes in the related documents section on the right. Those bodies must also co-operate with other Member State authorities and with the Commission. There are also provisions on Border Controls in regard to products from non-EU sources, and new financial provisions. The Regulation also specifies general principles for the proper affixing of the well-known “CE Marking” required by certain very important pieces of EU product legislation – “New Approach” legislation.

The Decision is a serious policy commitment by the European Commission, the Member States and the European Parliament to adopt its provisions in sectoral Community Harmonization Legislation on products when it is subsequently revised (unless the sectors can demonstrate a strong need for departing from them).

The Decision aims to develop a consistent policy framework for such future legislation that includes: harmonised provisions on procedures for conformity assessment; harmonised procedures notifying the EU of the appointment of independent bodies that undertake certain of those conformity assessment procedures (“Notified Bodies”); harmonised provisions on the duties of everyone in the product supply chain from manufacturer to distributor; harmonised definitions; and certain rules and conditions for affixing CE marking.

The measures are very wide in scope and are of major importance to the Internal Market.

We initiated a 12-week Consultation on 9 March 2007 which closed on 1 June 2007. This sought the views and information on the likely effects of the original Commission proposals. An independent firm of consultants carried out a UK Impact Assessment on our behalf (please see link in related documents).


Lead official on the Market Surveillance and CE Marking aspects of RAMS: Richard Lawson, richard.lawson@bis.gsi.gov.uk
Alternative contact on Market Surveillance: Jeff Asser, jeff.asser@bis.gsi.gov.uk