Opinion of the European Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (text with EEA relevance) (codified version)"

(COM(2002) 530 final - 2002/0231 (COD))

(2003/C 85/30)

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 preparing the Committee's work on the subject and 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 unanimously.

1. Introduction

1.1. If Community law is to be clear and transparent, rules which have been frequently amended, at times in an unsystematic manner, must be codified.

1.2. The revision process must be based on existing law, but must also look to the future. It must be geared towards simplification and improving methods.

2. Principles

2.1. This directive seeks to harmonise, unify and streamline provisions in this area to produce a single codified version of legal instruments based on the principle of coherence, clarity and correct interpretation of Community law.

2.2. The codification process must make existing law demonstrably simpler, less ambiguous and more transparent.

2.3. This proposal thus seeks to bring together legislation adopted over more than 15 years, making only those formal changes required by the simplification process.

2.4. The codified, unified and simplified text was prepared by the Office of Official Publications of the European Communities using a data processing system. The end result is a genuine consolidation of the legal instruments in force in this area which is more reader-friendly and accessible.

3. Scope

3.1. While the purpose of efforts to agree and systematically implement good laboratory practice is to achieve high-quality test results, the aim of making such practice compulsory is to ensure that test results are acceptable in all European Union Member States, to produce savings in time and resources and avoid both technical barriers - at times artificial - and unnecessary duplicative testing. The sectors in question, which include public health and the environment, are highly sensitive as far as public opinion is concerned.

- good laboratory practice applies to items contained in pharmaceutical, cosmetic and veterinary products, pesticides and all kinds of food additives and industrial chemical products,

- it also applies to research conducted in the laboratory, in greenhouses and in the field,

- properly codified good laboratory practice is required in response to public opinion, which is well-informed, highly demanding and very much alive to these issues.

4. General comments

4.1. The European Economic and Social Committee fully endorses the move to reaffirm the principles which govern respect for the implementation of good laboratory practice.

- Good laboratory practice is a general requirement which applies to all laboratories in the European Union which carry out these tests, particularly and/or especially those designed to assess human, animal and/or environmental safety.

4.2. The Committee endorses the Commission's view that there is a need for inspections and monitoring of compliance with good laboratory practice. Such measures are also recommended by the Organisation for Economic Cooperation and Development (OECD).

The Committee notes, however, that the OECD's scope is wider, which could lead to ambiguities.

4.3. The Committee welcomes the fact that specific provision is made for adjustment of the principles of good laboratory practice.

4.4. The Committee notes the safeguard clauses which a Member State may apply if it believes that the principles of good laboratory practice and monitoring are inadequate and decides to temporarily ban the product, informing the Commission and Member States of its decision.

4.5. The Committee hopes that the directive will come into force as soon as possible.

5. Specific remarks on the OECD principles of good laboratory practice

5.1. The description of good laboratory practice in Annex 1 is detailed and condensed. The terminology used defines specifically:

- good laboratory practice,

- the organisation of a test facility,

- safety problems which can and/or must be resolved,

- the test itself: reference item, batch or vehicle.

5.2. Good laboratory practice itself:

- the competence and level of responsibility of all those involved in the tests,

- the guidelines for the proper conduct of tests, particularly those on quality assurance, which have a decisive role in the conduct of tests,

- the presence of independent persons responsible for quality assurance,

- the intervention of external assessors throughout the process,

- the quality of documentation, which must be precise, detailed, transparent and publicly displayed,

- the rules governing test facilities, which must be respected, in particular those concerning the waste disposal procedure and storage and retention of records and materials,

- the test systems used, particularly biological test systems, the traceability, identification and use of which must be the subject of particular attention,

- standardisation of the entire operating procedure to enable the test to be interpreted horizontally, which must include compliance with quality assurance requirements,

- tests must be carried out according to a plan, the details of which (identification, date, methods and specific points) must be set out in a clear, comprehensible statement,

- although the registration and documentation may remain confidential, the conduct of the test, and in particular the report on the results must be set out in a publication which complies with certain rules (publicity, method, precision, presentation of results, summary), to provide for the possibility of a critical study which may result in a positive and/or contradictory dialogue.

6. Specific comments

6.1. The European Economic and Social Committee welcomes this process. The proposed directive is a positive and necessary step.

6.2. The Commission:

- is legislating because it is essential in this area,

- has chosen the appropriate instrument and is taking steps to speed up the legislative process,

- is calling for rapid transposition and effective implementation,

- is speeding up simplification and codification of existing legislation.

6.3. While the Committee welcomes the above moves, it questions whether the mechanisms designed to put them into practice are efficient enough.

6.4. The final aim of the proposal is not deregulation but better regulation: its effectiveness will depend on its quality, accessibility, necessity, relevance, objective, simplicity, stability and transparency.

6.5. The Committee believes that the rules set out in this directive are also mutually compatible, effective and cost-effective.

Brussels, 23 January 2003.

The President

of the European Economic and Social Committee

Roger Briesch