52003AE0074

Opinion of the European Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council on the inspection and verification of good laboratory practice (GLP) (codified version)"

(COM(2002) 529 final - 2002/0233 (COD))

(2003/C 85/29)

On 28 November 2002, the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption was responsible for the Committee's work on the subject. The Committee appointed Mr Bedossa as rapporteur-general.

At its 396th plenary session (meeting of 23 January 2003), the European Economic and Social Committee adopted the following opinion by a unanimous vote.

Introduction

EU legislation clearly needs to be reviewed on a regular basis.

With this aim in view, the draft directive's objectives are clear and simple. They are geared, above all, to securing tangible results.

The formal review of the draft directive with a view to codification, even the inspection and verification of good laboratory practice (GLP). The document, which focuses not only on the future but also on existing law, is designed to simplify and improve the methods employed.

Specific comments

The EESC endorses the initiative behind the draft directive for the following reasons:

- Whilst the main concern should of course be to remove obsolete provisions, simplification of legislation must also bring benefits by enhancing the clarity and transparency of EU law.

- Regular updating and codification ensures legal certainty at any given moment in respect of the law on a given issue.

- Simplification is important in the context of the single market: failure to harmonise legislative instruments, constitutes a major obstacle which may trigger a large number of disputes in respect of GLP.

- Simplification is being introduced at the right time, namely on the eve of EU enlargement.

- Although the draft directive dealing with GLP is purely a formal provision, it is nonetheless necessary as legislation in this field is essential.

- Finally, the draft directive is a step in the right direction as it speeds up the simplification and codification of existing provisions, whilst enabling the legislation to be reviewed.

The consolidated presentation is also excellent.

Brussels, 23 January 2003.

The President

of the European Economic and Social Committee

Roger Briesch