31. 8. 87 Official Journal of the European Communities No C 232/1 
II 
(Preparatory Acts) 
ECONOMIC AND SOCIAL COMMITTEE 
Opinion on the proposal for a Council Directive on the inspection and verification of the 
organizational processes and conditions under which laboratory studies are planned, performed, 
recorded and reported for the non-clinical testing of chemicals (Good Laboratory Practice) 
(87/C 232/01) 
On 14 January 1987 the Council decided to consult the Economic and Social Committee, under 
Article 100 of the Treaty establishing the European Economic Community, on the abovementioned 
proposal. 
The Section for the Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 1 June 1987 in 
the light of the report of Mr Rolao Concalves. 
At its 247th plenary session (meeting of 1 July 1987) the Economic and Social Committee 
unanimously adopted the following opinion: 
1. General comments 
1.1. The Commission endorses the views expressed in its 
previous opinion (J) on the proposal for a Council Directive 
on the application of the principles of good laboratory 
practice (2) namely that the principles of Good Laboratory 
Practice (GLP) should be implemented and their application 
in tests on chemicals verified. 
1.2. The Committee also endorses the ESC's support for 
Article 2 of the proposal, which requires Member States to 
ensure compliance with GLP principles by inspecting 
laboratories and by verifying tests using procedures that they 
themselves have devised. 
1.3. The Committee is pleased that the present proposal 
(COM(86) 698) seeks to introduce a standard procedure for 
inspecting and verifying the processes and conditions under 
which laboratory studies are planned, performed, recorded 
(») OJ No C 354, 31. 12. 1985, p. 5. 
(2) OJ No C 219, 29. 8. 1985, p. 6. and reported when they involve the non-clinical testing of 
chemicals to assess their effect on people, animals and the 
environment. Such a move is in line with the ESC's previous 
opinion and the guidelines of the OECD. 
1.4. The Committee hopes that use of the procedure in 
non-EEC countries such as EFTA will leasd to it being 
extended to EFTA and other. OECD countries, as well as to 
other lands outside the Community. This would facilitate 
international trade in chemicals, and the Committee urges 
the Commission to work towards agreements in this area. 
2. Specific comments 
2.1. The Commission considers that the recommended 
mutual recognition of Member States' inspection and 
verfications would prove to be as effective a scheme as it has 
in other sectors, such as pharmaceuticals; it should therefore 
be introduced more rapidly, bearing in mind that the Internal 
Market is due to be completed by 1992. 
2.2. The Committee admits that a centralized inspection 
system operating in a consultative capacity would not be 
viable at the moment, but it hopes that such a scheme might 
be considered in the future. 
No C 232/2 Official Journal of the European Communities 31. 8. 87 
2.3. The Committee suggests setting up a central list of 
the various approved laboratories on EEC territory; such a 
list should be easily accessible to the public, should indicate 
each laboratory's fields of activity and could be run by the 
'Committee' referred to in Article 6 of the present 
proposal. 
2.4. The Committee also considers that, in line with 
previous Commission statements, laboratories should not be 
allowed to refuse inspection, although their legitimate rights 
should be preserved, especially their right of appeal. The 
proposed Directive should therefore include: 
Done at Brussels, 1 July 1987. 
1. General comments 
1.1. The Committee is pleased to see that parts I and II of 
Directive 76/464/EEC are to be merged into a single 
Directive, which will make for a more systematic 
approach. 
1.2. In the Committee's view, however, the text is too 
long-winded (and even confused in parts) — there are so 
many recitals that they outnumber the actual articles. It is not 
necessary to reproduce all the articles and Annex I of the (a) the right of appropriate bodies to have access to 
inspection reports and related documents; 
(b) the right to appeal when such inspections may lead to a 
laboratory being struck off the GLP list; and 
(c) the appointment of an appeal authority (possibly the 
'committee' referred to in Article 6 of the proposal). 
2.5. The Committee therefore welcomes and endorses the 
present proposal, and feels that it is essential if GLP is to be 
guaranteed. 
The Chairman 
of the Economic and Social Committee 
Alfons MARGOT 
original proposal. It would have been better to make the text 
simpler. 
1.3. The Committee feels that the proposal is too limited 
in its scope. Not all uses of the drins are covered and the 
Committee points out that environmental problems could 
arise from these other uses, e.g. leather and wood 
protection. 
The Committee also emphasizes the need for preventive 
measures by avoiding the introduction into the Community 
of commodities which can give rise to releases of the drins 
into the aquatic environment of the Community. Opinion of the Economic and Social Committee on the modified proposal for Council Directives 
concerning limit values for discharges of aldrin, dieldrin and endrin in the aquatic environment and 
quality objectives for aldrin, dieldrin and endrin in the aquatic environment 
(87/C 232/02) 
On 23 April 1987 the Council decided to consult the Economic and Social Committee, under Article 
198 of the Treaty establishing the European Economic Community, on the abovementioned 
proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 1 June 1987 in 
the light of the report by Mr Rolao Concalves. 
At its 247th plenary session (meeting of 1 July 1987) the Economic and Social Committee 
unanimously adopted the following Opinion: 
The Committee endorses the proposal and has the following comments to make: