THE COUNCIL,

Having regard to Articles 2 a), 2 b), 2 d), 3, and 5 b) of the Convention on the Organisation for Economic Co-operation and Development of 14th December 1960;

Having regard to the Recommendation of the Council of 14th November 1974, on the Assessment of the Potential Environmental Effects of Chemicals [C(74)215];

Having regard to the Recommendation of the Council of 7th July 1977, Establishing Guidelines in Respect of Procedure and Requirements for Anticipating the Effects of Chemicals on Man and in the Environment [C(77)97(Final)];

Having regard to the Decision of the Council of 21st September 1978, concerning a Special Programme on the Control of Chemicals and the Programme of Work established there in, and the extension of the duration of the Programme by the Council of 12th May 1981 [C(78)127(Final) and C/M(81)7(Final), Item 86];

Having regard to the Decision of the Council of 12th May 1981, concerning the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30 (Final)] and Addendum 1 to that Decision [C/M(82)22(Final), Item 215];

Having regard to the instructions of the Council to the Management Committee for the Special Programme on the Control of Chemicals to pursue its work in such a manner as to facilitate internationally harmonized approaches to assuring compliance with the OECD Principles of Good Laboratory Practice [C(81)30 Part II (Final), paragraph 3];

Having regard to the conclusions of the First High Level Meeting of the Chemicals Group of May 1980, on the importance and urgency of developing internationally harmonized approaches to assuring compliance with the OECD Principles of Good Laboratory Practice [ENV/CHEM/HLM/80.M/1];

Having regard to the conclusions of the Second High Level Meeting of the Chemicals Group of November 1982, concerning Mutual Recognition of Compliance with Good Laboratory Practice [ENV/CHEM/HLM/M/82.1];

Considering the need to minimize the cost burden associated with the unnecessary duplicative testing of chemicals and the need to utilise more effectively scarce test facilities and specialist manpower and to reduce the number of animals used in testing;

Considering that national Good Laboratory Practice Compliance Procedures, sharing common characteristics, would provide the basis for the mutual recognition of such Compliance Procedures among Member countries;

Considering that internationally harmonized approaches to Good Laboratory Practice Compliance Procedures and the recognition by Member countries of the assurance, by another Member country using such Procedures, that test data have been developed in accordance with the OECD Principles of Good Laboratory Practice would significantly facilitate mutual acceptance of data [C(81)30 (Final)] generated in the testing of chemicals in Member countries for purposes of assessment and for other uses relating to the protection of man and the environment;

On the proposal of the Second High Level Meeting of the Chemicals Group, endorsed by the Environment Committee;

1.            RECOMMENDS that, for the mutual recognition of Good Laboratory Practice Compliance Procedures among Member countries, national Compliance Procedures should have the following characteristics:

a)         application of the OECD Principles of Good Laboratory Practice [C(81)30(Final), Annex II];

b)         implementation of Compliance Procedures based on laboratory inspections and study audit;

c)         certification by the test facilities that each study was carried out pursuant to provisions set by national legislation or administrative procedures dealing with Good Laboratory Practice;

d)         establishment or designation of a national authority or authorities to monitor compliance and discharge other such functions related to Good Laboratory Practice as may be nationally determined.

2.            RECOMMENDS that Member countries recognise the assurance by another Member country that test data have been generated in accordance with the OECD Principles of Good Laboratory Practice if the other Member country used compliance procedures having the characteristics set out in paragraph 1.

3.            NOTES that Member countries will establish their Compliance Procedures progressively according to national priorities.

4.            INVITES Member countries to notify the Organisation as they establish national Good Laboratory Practice Compliance Procedures conforming with the characteristics set out in paragraph 1 above.

5.            INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to foster direct communications between national authorities and to provide a forum (at present the Chemicals Group Forum) within the Organisation to discuss technical and administrative matters related to Good Laboratory Practice Compliance Procedures.

6.            INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to pursue a programme of work designed to facilitate the implementation of this Recommendation, with a view towards Member countries developing bilateral and multilateral arrangements for the mutual recognition of national Good Laboratory Practice Compliance Procedures.

7.            INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to review actions taken by Member countries in pursuance of this Recommendation and to report thereon to the Council.

In adopting this Recommendation, the Council:

1.            NOTED the Note by the Secretary-General [C(83)95] and the statements made by Members of the Council;

2.            APPROVED its derestriction.