Summary

This is a report of a bilateral meeting that took place between the Department of Trade and Industry (DTI) and the European Commission (Commission) on the latest developments in the New Approach Review process, and to re-iterate the United Kingdom’s positions on key issues.

The Commission’s vision to deliver on the New Approach Review to facilitate the single market remains strong. The method to achieve this vision has evolved, however. It is now likely that the proposal will be split between a Regulation and a Commission Decision. There are issues, around the presentation of the proposals, the legal nature of the proposed instrument(s), their relationship with existing legislation, and the scope, to finalise. The Commission was at pains to emphasise that the position was fluid, that thinking might well develop further and that there could be significant changes in the position from what was being said to DTI on 20th October by the time that formal Proposals are eventually made (see below on the timing).

The UK Government believes that the proposed instrument(s) should still broadly meet the UK’s policy objectives. The DTI continues to welcome comments about all aspects of the document already circulated, which is likely to form the basis for much of what will be contained in the instruments, when finally proposed. The DTI is making arrangements to hold an open meeting in January to discuss the Commission proposals and the details will be circulated as soon as possible.

Detail

Legal Nature and Relationship with Existing Legislation

The Commission’s original goal was to create one overarching (directly applicable) EU Regulation. This thinking has evolved and it is now likely that the proposals would be split between a Regulation and a Decision. The intention is that the draft Regulation and draft Decision should proceed alongside each other through the legislative process. The relationship between the two instruments is still being considered.

i) Regulation
The contents of a proposed Regulation have not been finalised, but it will probably contain provisions relating to Accreditation, Market Surveillance and it is likely to define CE marking and allocate responsibility for its affixation (other aspects of CE Marking would be addressed in the Decision).

ii) Decision
A Decision would be addressed to the Community Institutions themselves, not Member States. It would be designed to act as a blueprint for all future proposals for EU product regulation legislation. This would mean, for example, that when existing Directives were amended in the future, or new subsequent Directives were made, any departure from the blueprint would need to be justified by or to the Commission. It is likely that the Decision would contain provisions relating to the criteria for notification of bodies responsible for conformity assessment procedures and for the
safeguard clauses.

Scope of the Proposals
 
The Regulation is likely to have a different scope for each of its three elements. Accreditation will be of universal application; Market Surveillance will apply to all European legislation that affects or impacts on manufactured products so as to capture Old as well as New Approach Directives, and all other legislation falling within this wide formulation, including environmental legislation regulating products. The Commission is also working with its Legal Services to formulate appropriate terminology to capture and ring fence the scope of the Market Surveillance part of the
proposed Regulation. The Commission was clear that certain sectors would be expressly excluded where there was already bespoke Market Surveillance provision, notably for food and medical devices.

The DTI/UK made it clear that the parameters of these provisions need to be clearly defined so that stakeholders can be consulted and so that existing national transposing legislation can be appraised for compliance with the proposed Regulation. The DTI/UK also asked the Commission to consider transitional arrangements for the Accreditation and Market Surveillance provisions, explaining that it may be necessary to clear away, or make some new, national provision, which would require time.

Timing
 
The Commission expects to put forward proposals by 20 December 2006, for the translations to occur by February/March 2007 and for the Commission to propose them formally at that point, under the German Presidency. Subject to the deliberations of the Council and the European Parliament, it should be possible to adopt the measures in about another 2 years. The Commission added that any other legislative Proposals on product regulation made after March 2007, would be expected to adhere
to the principles contained in the proposed draft Decision.

November 2006

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