17.1.87 Official Journal of the European Communities No C 13/5 
II 
(Preparatory Acts) 
COMMISSION 
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) 
COM(86) 698 final 
(Submitted by the Commission to the Council on 18 December 1986) 
(87/C 13/06) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
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 the protection of 
man, animals and the environment, so called 'good 
laboratory practice' (GLP), contributes to the reas­
surance of Member States as to the quality of the test 
data generated; 
Whereas the Council of the Organization for Economic 
Cooperation and Development has in its decision of 12 
May 1981 on the mutual acceptance of data in the 
assessment of chemicals adopted, in its Annex 2, 
principles of good laboratory practice which are accepted 
within the Community, and are specified in Council 
Directive ../.. ./EEC ('); 
Whereas in the conduct of tests on chemicals, it is 
desirable that resources in specialist manpower and in 
testing laboratories must not be wasted by the need to 
duplicate tests owing to differences in laboratory 
practices from one Member State to another; Whereas, however, in order to ensure that laboratories 
generating testing data in one Member State are also 
recognized by other Member States as working under 
GLP conditions it is necessary to provide for a 
harmonized system of laboratory inspection and study 
audit; 
Whereas it is necessary that Member States designate 
authorities for implementation of GLP monitoring; 
Whereas a committee, the members of which will be 
appointed by the Member States, should help the 
Commission in the technical application of this Directive 
and cooperate in its efforts to encourage the free 
movement of goods by the mutual recognition by 
Member States of procedures for control of compliance 
with GLP; whereas the committee set up by Council 
Directive 67/548/EEC of 27 June 1967 on the approx­
imation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (2), as last amended 
by , 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 of information and 
experience in this field, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive applies to the inspection and verifi­
cation of the organizational processes and the conditions 
under which laboratory studies are planned, performed, 
recorded and reported for the non-clinical testing for 
regulatory purposes of chemicals (e.g. cosmetic, 
industrial, chemical, medicinal product, food additive, 
animal feed additive, pesticide) in order to assess their 
effect on man, animals and the environment. 
0) COM(85) 380 final. O OJNo 196, 16. 8. 1967, p. 1. 
No C 13/6 Official Journal of the European Communities 17. 1.87 
2. For the purposes of this Directive, the organ­
izational processes and conditions referred to in 
paragraph 1 and hereinafter designated 'good laboratory 
practice* (GLP), are described by Directive ../.. ./EEC. 
3. This Directive covers the verification and respect of 
the application of the principles of GLP and is not 
concerned with the interpretation and evaluation of test 
results or their acceptability. 
Article 2 
1. Using the procedure specified in Article 3, Member 
States shall verify the compliance with GLP of any 
testing laboratory situated under its jurisdiction claiming 
to use GLP in the conduct of tests on chemicals. 
2. Where the provisions of paragraph 1 have been 
complied with, the Member State in question may 
endorse a claim by a testing laboratory in respect of a 
specific test method using the form of words 'GLP certi­
fication according to Directive ../.. ./EEC on '. 
Article 3 
1. Member States shall establish or designate the auth­
orities responsible for the inspection of laboratories on 
their territories and for the audit of studies carried out 
by laboratories to ensure compliance with the principles 
of GLP. 
2. The authorities referred to in paragraph 1 shall 
inspect the laboratory and audit the results of studies 
according to the provisions laid down in the Annex. 
Article 4 
1. Each year, Member States shall draw up a report 
relative to the implementation of GLP on their territory. 
This report shall contain in particular a list of labora­
tories inspected and a summary of the conclusions of the 
inspections and of the study audits. 
2. The report shall be transmitted to the Commission 
on request. The Commission shall communicate these 
reports to the Committee referred to in Article 6. 
Article .5 
1. Without prejudice to Article 8, the results of 
laboratory inspections and study audits on GLP 
compliance carried out by a Member State shall be 
binding on the other Member States. 
2. Where a Member State finds that a laboratory on 
its territory claiming GLP compliance does not in fact 
comply with GLP it shall forthwith inform the 
Commission. The Commission shall inform the other 
Member States. Article 6 
1. The committee set up by Article 20 of Directive 
67/548/EEC, hereinafter called 'the committee', may be 
consulted on the adaptation of this Directive to technical 
progress in accordance with the provisions laid down 
herein. Its chairman shall be a representative of the 
Commission. 
2. Any question regarding the implementation of this 
Directive may be submitted to the committee at the 
request of its chairman or of a Member State, in 
particular on: 
— cooperation between designated authorities of the 
Member States relating to technical and 
administrative matters arising from the 
implementation of GLP, 
— exchange of information on the training of 
inspectors. 
Article 7 
1. Where a Member State has sufficient reason to 
believe that a laboratory claiming GLP compliance has 
not carried out a test according to GLP, it may request 
further detailed information from the designated 
authority in the Member State and in particular may 
request that a study audit, possibly in conjunction with a 
new inspection, be carried out. 
Should it not be possible for the authorities concerned to 
reach agreement, they shall immediately inform the other 
Member States and the Commission thereof and give 
reasons for their decision. 
2. The Commission shall examine as soon as possible 
the grounds given by the Member States within the 
committee, and shall then deliver its opinion forthwith 
and take the appropriate measures. It may in this 
connection ask experts from the designated authorities in 
the Member States to give an opinion. 
3. If the Commission considers that amendments to 
this Directive are necessary in order to resolve the 
matters mentioned in paragraph 1, it shall initiate the 
procedure laid down in Article 9 with a view to adopting 
these amendments. 
Article 8 
The following shall be determined in accordance with 
the procedure laid down in Article 9: 
— modification to the claim referred to in Article 2 (2), 
— amendments necessary for adapting the Annex to 
technical progress. 
17.1.87 Official Journal of the European Communities No C 13/7 
Article 9 Article 10 
Where the procedure laid down in this Article is Member States shall bring into force the laws, regu-
invoked, the Commission shall decide after consulting lations or administrative provisions necessary to comply 
the committee. The committee shall discuss matters on with this Directive not later than 1 July 1988. They shall 
which the Commission has requested an opinion. When forthwith inform the Commission thereof. 
seeking the opinion of the committee, the Commission 
may set a time limit within which such opinion shall be 
given. No vote shall be taken. However, any member of A t' 1 n 
the committee may demand that his views be set down in 
the minutes. This Directive is addressed to the Member States. 
ANNEX 
PROGRAMME FOR THE INSPECTION OF LABORATORIES AND AUDIT OF STUDIES 
1. The inspection programme is concerned with the laboratory and the results of studies. The inspection 
concerns the structures that have been used and the persons who are involved in the conduct of studies 
in the laboratory. The inspection may address in a general and overall way many of the criteria that are 
addressed specifically and in more detail in relation to the study audit. The inspection and the study 
audit are not alternatives. They are complementary aspects of different degrees of examination of the 
laboratory and its test results. 
2. An initial.assessment of a laboratory should comprise both an inspection and a study audit. Subsequent 
inspections should be carried out every two to four years. The designated authority should determine 
the frequency or necessity of study audits thereafter. 
3. In summary, the inspection programme should address all the criteria of 'good laboratory practice' 
identified in the text describing such principles and verify the compliance of the laboratory with these 
principles and should draw extensively on OECD provisions relating to these questions. 
4. The results of the inspection visit take the form of a written report which will cover all aspects of the 
inspector's observations. The format of the report should parallel the sequence of items found in the 
principles of 'good laboratory practice' contained in the OECD decision of 12 May 1981. 
A. Testing facility 
(a) A control of the organization of the testing facilities, particularly: 
1. a check of the qualifications of individuals that are designated 'study directors'; 
2. a check of the training programmes performed for the personnel involved in the studies; 
3. a check, where possible, of the ratio between the studies performed and the available personnel. 
(b) A control of the testing laboratory where the study or studies have been performed, particularly the 
test substances storage area, animal rooms, environmental conditions and their monitoring systems. 
B. Standard operating procedures 
(a) A control of the 'Standard Operating Procedures', with particular regard to the adequacy of the 
procedures involved in the study, their modifications, if any, in the time and relative justifications. 
No C 13/8 Official Journal of the European Communities 17.1.87 
(b) A control of apparatus employed in the study, particularly the records of the operations of 
maintenance, standardization and calibration. 
(c) A control of the identification and storage conditions of reagents and materials. 
(d) A control of conditions of storage, maintenance and identification of the test systems used. 
(e) A control of the conditions of storage maintenance and identification of test substances and the 
other substances, if and when used as reference standards (particularly important here are the data 
relative to the purity, composition, stability of the pure substances and the data relative to the 
stability of substance in the medium of administration). 
C. Quality assurance programme 
A control of internal Quality Assurance Unit (QAU) organization, such that it is possible to understand 
what are, or have been, the methods performed by QAU in the monitoring of the experimental work. 
D. Performance and reporting of the study 
(a) A control of adherence of final report of the study to the study protocol and/or to the 
modifications, if any, and relative justifications. 
(b) A comparison of raw data (and the manner employed for their registration by the personnel and 
study director) and data reported in the final report. 
E. Storage of records 
A control of all materials in the archives and the system of archivization. 
F. Completion of the inspection 
The inspection visit ends with a consultation between the inspector and representatives of the test 
facility on the inspectional observations.