KANBrief 3/11

Alignment of 10 directives to the New Legislative

The Internal Market Package adopted in 2008 contains not only Regulation 765/2008/EC on accreditation and market surveillance (Regulation 765/2008/EC setting out the requirements for accreditation and market surveillance relating to the marketing of products), but also Decision 768/2008/EC (Decision 768/2008/EC establishing a common framework for the marketing of products ). This decision sets out the agreed provisions governing how directives are to be formulated in the future in order for the Single Market to be regulated more uniformly and effectively. In the course of implementation of the New Legislative Framework, the European Commission presented proposals for the alignment of ten directives.

This alignment package includes directives which – unlike for example the PPE Directive – are not due for a thorough revision in any case. Of the ten directives, those of greatest importance from an occupational safety and health perspective concern low-voltage products, pressure equipment, lifts, and products for use in potentially explosive atmospheres. The Council and the European Parliament will begin discussion of the Commission's proposals on 25 October 2011.

Essentially, the aims of the European legislature are:

  • To reduce the number of non-compliant products on the market
  • To simplify the task of market surveillance
  • To improve the performance and quality of the conformity assessment bodies
  • To eliminate discrepancies between different directives
  • To improve legal certainty overall
  • Implications for stakeholders

Whereas Regulation 765/2008/EC resulted in changes, in some cases considerable, for market surveillance and accreditation, the overall effects of the alignment of directives that is now taking place are doubtless less substantial. In many cases, it involves simplification, particularly for parties dealing with multiple sectors. Definitions are for example now being harmonized and formulated more clearly (e.g. ”manufacturer“, ”making available on the market“), and new definitions also added where necessary (such as further ”economic operators“ and their responsibilities).

Even newly introduced obligations, such as stricter requirements for the traceability of a product, can be expected to receive majority support, since they ensure fairer conditions for competition and are intended to combat disreputable economic operators. New harmonized obligations for importers and distributors may at first sight appear to be a hindrance. Since however they are comparable with the provisions in the General Product Safety Directive (GPSD), they make the legislative framework clearer and more uniform.

The notification procedure for conformity assessment bodies has been reformulated; it is now to be based upon an accreditation. In addition, and in contrast to the practice to date, Member States and the European Commission may challenge the notification of a body should it fail to fulfil its duties. For this purpose, the responsibilities of the notifying authorities have been defined more clearly: prior to notification, they are required actually to assess the bodies, and following notification also to monitor them. This also encompasses new information obligations: each Member State must now inform the Commission of its procedures for assessment, notification and monitoring, and of any changes made to them. The Commission for its part is required to publish this information.

In order to improve market surveillance, the information obligations for market players have also been extended. One purpose of these is to facilitate the identification of manufacturers in third countries, and the inspection of technical documentation. In future, identical procedures will apply for this purpose in all sectors.

The conformity procedures (modules) to be applied in all directives are being taken largely uniformly from the Decision; sector-specific aspects will however necessitate the retention of some differences.

Transition periods and transposition

A transition period has not yet been defined; the Commission is however expected to propose a transition period of two years. The ten directives concerned will be issued anew as fully consolidated texts; the national legislation transposing them in each Member State must therefore also be reformulated. Since the overall legislative framework has now changed appreciably, revision of the guide to the implementation of Single Market directives (Blue Guide) is also planned.

Corrado Mattiuzzo
mattiuzzo@kan.de