1988L0320 — EN — 14.06.1988 — 000.001 — 1
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►B COUNCIL DIRECTIVE
►C1 of 7June 1988 ◄
on the inspection and verification of Good Laboratory Practice (GLP)
(88/320/EEC)
(OJ L 145, 11.6.1988, p. 35)
Corrected by:
►C1Corrigendum, OJ L 174, 6.7.1988, p. 55 (88/320)
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COUNCIL DIRECTIVE
▼C1
of 7June 1988
▼B
on the inspection and verification of Good Laboratory Practice
(GLP)
(88/320/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100A thereof,
Having regard to the proposal from the Commission(1),
Incooperationwith the EuropeanParliamen t(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas the application of standardized organizational processes and
conditions under which laboratory studies are planned, performed,recorded and reported for the non-clinical testing of chemicals for theprotection of man, animals and the environment, hereinafter referred toas ‘Good Laboratory Practice'(GLP), contributes to the reassurance ofMember States as to the quality of the test data generated;
Whereas, inAn n ex 2 to its Decisionon12 May 1981 onthe mutual
acceptance of data in the assessment of chemicals, the council of theOrganization for Economic Cooperation and Development (OECD)adopted principles of good laboratory practice which are acceptedwithin the Community and are specified in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulationsand administrative provisions relating to the application of the princi-ples of good laboratory practice and the verification of their applicationsfor tests onchemical substan ces(
4);
Whereas, inthe con duct of tests onchemicals, it is desirable that
specialist manpower and testing laboratory resources should not bewasted owing to the need to duplicate tests because of differences inlaboratory practices from one Member State to another; whereas thisapplies especially for animal protection which requires that the numberof experiments on animals be restricted in accordance with CouncilDirective 86/609/EEC of 24 November 1986 onthe approximationoflaws, regulations and administrative provisions of the Member Statesregarding the protection of animals used for experimental and otherscientific purposes(
5); whereas mutual recognition of the results of tests
obtained using standard and recognized methods is an essential condi-tion for reducing the number of experiments in this area;
Whereas, however, in order to ensure that test data generated by labora-
tories in one Member State are also recognized by other Member States,it is necessary to provide for a harmonized system for study audit andinspection of laboratories to ensure that they are working under GLPconditions;
Whereas Member States designate the authorities responsible for
carrying out monitoring on compliance with GLP;
Whereas a committee, the members of which will be appointed by the
Member States, would be of assistance to the Commission in thetechnical application of this Directive and would cooperate in its effortsto encourage the free movement of goods by the mutual recognition byMember States of procedures for monitoring compliance with GLP;
(1) OJ No C 13, 17. 1. 1987, p. 5.
(2) OJ No C 156; 15. 6. 1987, p. 190 and OJ No C 122, 9. 5. 1988.
(3) OJ No C 232, 31. 8. 1987, p. 1.
(4) OJ No L 15, 17. 1. 1987, p. 29.
(5) OJ No L 358, 18. 12. 1986, p. 1.
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whereas the committee set up by Council Directive 67/548/EEC of 27
June 1967 on the approximation of laws, regulations and administrativeprovisions relating to the classification, packaging and labelling ofdangerous substances(
1), as last amended by Directive 87/432/EEC (2),
may be used for this purpose;
Whereas this committee may assist the Commission not only in the
application of this Directive but also in contributing to the exchange ofinformation and experience in this field,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive applies to the inspection and verification of the
organizational processes and the conditions under which laboratorystudies are planned, performed, recorded and reported for the non-clin-ical testing, carried out in accordance with the rules and regulations, ofall chemicals (e. g. cosmetics, industrial chemicals, medicinal products,food additives, animal feed additives, pesticides) in order to assess theeffect of such products on man, animals and the environment.
2. For the purposes of this Directive, the GLP, is described in
Directive 87/18/EEC.
3. This Directive is not concerned with the interpretation and evalu-
ationof test results.
Article 2
1. Usin g the procedure laid downinArticle 3, Member States shall
verify the compliance with GLP of any testing laboratory within theirterritory claiming to use GLP in the conduct of tests on chemicals.
2. Where the provisions of paragraph 1 have been complied with,
and the results of the inspection and verification are satisfactory, theMember State inquestionmay provide en dorsemen t of a claim by alaboratory that it and the tests that it carries out comply with GLP, usingthe formula ‘Assessment of conformity with GLP according toDirective 88/320/EEC on… (date)'.
Article 3
1. Member States shall designate the authorities responsible for the
inspection of laboratories within their territories and for the audit ofstudies carried out by laboratories to assess compliance with GLP.
2. The authorities referred to inparagraph 1 shall in spect the labora-
tory and audit the studies in accordance with the provisions laid downin the Annex.
Article 4
1. Each year, Member States shall draw up a report relating to the
implementation of GLP within their territory.
This report shall contain a list of laboratories inspected, the date on
which such inspection was carried out and a brief summary of theconclusions of the inspections.
2. The reports shall be forwarded to the Commissioneach year, n ot
later than31 March. The Commissionshall commun icate them to thecommittee referred to inArticle 7. The committee may request in forma-tioninadditionto those elemen ts men tion ed inparagraph 1.
3. Member States shall ensure that commercially sensitive and other
confidential information to which they gain access as a result of GLPcompliance monitoring activities is made available only to the Commis-
(1) OJ No 196, 16. 8. 1967, p. 1/67.
(2) OJ No L 239, 21. 8. 1987, p. 1.
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sion, to national regulatory and designated authorities and to a labora-
tory or study sponsor directly concerned with a particular inspection orstudy audit.
4. The names of laboratories subject to inspection by a designated
authority, their GLP compliance status and the dates upon which labora-tory inspections or study audits have been conducted shall not beconsidered to be confidential.
Article 5
1. Without prejudice to Article 6, the results of laboratory inspec-
tions and study audits on GLP compliance carried out by a MemberState shall be binding on the other Member States.
2. Where a Member State considers that a laboratory within its
territory claiming GLP compliance does not in fact comply with GLP tothe extent that the integrity or authenticity of the studies it performsmight be compromised, it shall forthwith inform the Commission. TheCommissionshall in form the other Member States.
Article 6
1. Where a Member State has sufficient reason to believe that a
laboratory in another Member State claiming GLP compliance has notcarried out a test according to GLP, it may request further informationfrom that Member State and in particular may request a study audit,possibly in conjunction with a new inspection.
Should it not be possible for the Member States concerned to reach
agreement, the Member States in question shall immediately inform theother Member States and the Commission, giving reasons for theirdecision.
2. The Commission shall examine as soon as possible the reasons put
forward by the Member States withinthe Committee; it shall thentakethe appropriate measures inaccordan ce with procedure laid downinArticle 8. It may in this connection ask for expert opinions from thedesignated authorities in the Member States.
3. If the Commission considers that amendments to this Directive are
n ecessary inorder to resolve the matters to inparagraph 1, it shallin itiate the procedure laid downinArticle 8 with a view to adoptin gthose amendments.
Article 7
1. The committee set up by Article 20 of Directive 67/548/EEC,
hereinafter called ‘the Committee',may examine any question which isreferred to it by its chairmaneither onhis ownin itiative or at therequest of a representative of a Member State, concerning the imple-mentation of this Directive and in particular regarding:
— cooperationbetweenthe authorities design ated by the Member
States in technical and administrative matters arising from theimplementation of GLP, and
— the exchange of information on the training of inspectors.
2. The amendments necessary for the adaptation of the formula
referred to in Article 2 (2) and of the Annex to this Directive to takeaccount of technical progress shall be adopted in accordance with theprocedure set out inArticle 8.
Article 8
1. The representative of the Commission shall submit to the
Committee a draft of the measures to be adopted. The Committee shalldeliver its opin iononthe draft withina time limit which the chairmanmay lay down according to the urgency of the matter. The opinion shallbe delivered by the majority laid downinArticle 148 (2) of the Treatyin the case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of the
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Member States withinthe Committee shall be weighted inthe man n erset out inthat Article. The chairmanshall n ot vote.
2. The Commissionshall adopt the measures en visaged if they are in
accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall, withoutdelay, submit to the Council a proposal relating to the measures to betaken. The Council shall act by a qualified majority.
3. If within three months of submission of the proposal the Council
has not acted, the proposed measures shall be adopted by the Commis-sion.
Article 9
Member States shall bring into force the laws, regulations or adminis-
trative provisions necessary to comply with this Directive not later than1 January 1989. They shall forthwith inform the Commission thereof.
Article 10
This Directive is addressed to the Member States.
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ANNEX
Programme for the inspection of laboratories and audit of studies
The provisions concerning the inspection of laboratories and audit of studies are
those contained in Annexes 4 (Guide for Compliance of Monitoring Proceduresfor Good Laboratory Practice) and 6 (Guidance for the Conduct of LaboratoryInspections and Study Audits) of the final report of the Working Party of theOECD Environment Committee on the mutual of recognition of compliance withGLP (OECD ENV/CHEM/CM/87.7).