31. 12. 85 Official Journal of the European Communities No C 354/5 
Opinion on the proposal for a Council Directive on the approximation of the laws, 
regulations and administrative provisions relating to the application of the principles of good 
laboratory practice and the verification of their application for tests on chemical substances (*) 
(85/C 354/04) 
Procedure 
On 12 August 1985, the Council decided, in accordance with Article 100 of the Treaty establishing 
the European Economic Community, to ask the Economic and Social Committee for an opinion 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 3 December 
1985. Mr Vercellino was Rapporteur. 
At its 232nd Plenary Session (meeting of 18 December 1985), the Economic and Social Committee 
adopted unanimously the following opinion: 
1. General Comments 
1.1. The Committee recalls that Directive 67/548/EEC 
on the classification, packaging and labelling of dangerous 
substances requires that tests be conducted on chemical 
substances before these are marketed, in order to provide 
high quality and comparable data on the properties of 
chemical products and on their safety as far as human 
health and the environment are concerned. 
1.2. The Committee also recalls — and agrees with — 
the definition drawn up by the OECD, according to which 
good laboratory practice concerns the procedures for 
organizing tests and the conditions under which laboratory 
tests are planned, conducted, checked, recorded and the 
results distributed. 
1.3. The Committee agrees with the Commission that to 
bring this about, it is necessary for the principles of good 
laboratory practice (GLP) to be identical and applied in all 
the Member States, so as to avoid the repetition of tests 
resulting from differences in such practice, reduce the cost 
(!) OJ No C 219, 29. 8. 1985, p. 6. 
Done at Brussels, 18 December 1985. 
Gerd MUHR and duration of such tests and eliminate all obstacles to the 
free circulation of products at Community and world level. 
1.4. The Committee also agrees with the suggestion put 
forward in Article 2 of the proposal that the Member States 
should ensure compliance with the principles of good 
laboratory practice by carrying out on-the-spot inspections 
and verifications of tests using procedures that they have 
laid down themselves. 
1.5. The Committee therefore approves the present 
proposal, which merely seeks to take the principles of good 
laboratory practice and the relevant monitoring procedures 
adopted by the OECD in 1981 and 1983 and make them 
compulsory throughout the Community. 
1.6. The Committee feels that, as a matter of urgency, 
the Community should comply with these international 
agreements, which have been endorsed by all the Member 
States, especially as they fit in nicely with the Community's 
moves to bring about a mutual acceptance and recognition 
of national procedures in this field and thereby prevent the 
present gap in Community legislation from harming the 
EEC chemical industry on the world market. 
The Chairman 
of the Economic and Social Committee