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))
Date: 2003-01-23
Institutions: European Economic and Social Committee
Subjects: OECD, approximation of laws, chemical product, codification of EU law, environmental risk prevention, health control, research body, testing

C 85/138

EN

Official Journal of the European Union

8.4.2003

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

3. Scope

If Community law is to be clear and transparent,
1.1.
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.

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.

2.4.
The codified, unified and simplified text was prepared
by the Office of Official Publications of the European Com-
munities 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.

— 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.

8.4.2003

EN

Official Journal of the European Union

C 85/139

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 rec-
ommended 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.

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

The Committee notes the safeguard clauses which a
4.4.
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.

The Committee hopes that the directive will come into

4.5.
force as soon as possible.

5. Specific remarks on the OECD principles of good

laboratory practice

— the quality of documentation, which must be precise,

detailed, transparent and publicly displayed,

— the rules governing test facilities, which must be respect-
ed,
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
in a clear, comprehensible
points) must be set out
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.

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

6. Specific comments

— good laboratory practice,

— the organisation of a test facility,

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

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

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

6.2.

The Commission:

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
quality assurance,

independent persons responsible for

— 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 implemen-

tation,

— is speeding up simplification and codification of existing

legislation.

— the intervention of external assessors throughout the

process,

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

C 85/140

EN

Official Journal of the European Union

8.4.2003

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

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the
European Parliament and of the Council amending Council Directives 78/660/EEC, 83/349/EEC
and 91/674/EEC on the annual and consolidated accounts of certain types of companies and
insurance undertakings’

(COM(2002) 259 final — 2002/0112 (COD))

(2003/C 85/31)

On 19 July 2002, the Council decided to consult the European Economic and Social Committee, under
Article 44(1) 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 Ravoet as rapporteur-general.

At its 396th plenary session (meeting of 22 January 2003), the European Economic and Social Committee
adopted the following opinion, with 72 votes in favour and one vote against.

1.

Introduction

1.2.
The Commission communication is split into two
parts: the introduction of IAS in the EU and the alignment of
the existing EU Accounting Directives on IAS.

1.1.
In its communication of 13 June 2000 entitled ‘The
EU’s Financial Reporting Strategy: The Way Forward’ the
Commission proposes that all EU listed companies should be
required to prepare their consolidated accounts in accordance
with International Accounting Standards (IAS) from 2005 at
the latest. The aim of this measure is to enhance overall market
efficiency, thereby reducing the cost of capital for companies.
The communication is in keeping with the Financial Services
Action Plan, which the Lisbon European Council of 23 and
24 March 2000 required to be completed before 2005. The
communication allows the Member States the option of
extending the application of IAS to unlisted financial insti-
tutions and insurance companies in order to enhance compara-
bility throughout the sector and ensure efficient and effective
supervision.

1.3.
To implement the first part, the Regulation of the
European Parliament and of the Council on the application of
International Accounting Standards was adopted on 19 July
2002. This regulation sets out the mechanism for recognising
IAS in the EU.

1.4.
The regulation lays down that from 1 January 2005 all
listed companies should prepare their consolidated financial
statements in accordance with IAS approved for use in the EU.
Member States are allowed the option of permitting or
requiring the application of adopted IAS by the above com-
panies, or by other companies, in the preparation of their