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.
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Article 9 Article 10
W h e r e the procedure laid d o w n in this Article is M e m b e r States shall bring into force the laws, regu-
invoked, the Commission shall decide after consulting lations or administrative provisions necessary to comply
the committee. T h e commit tee shall discuss matters on with this Directive no t later than 1 July 1988. T h e y shall
which the Commission has requested an opinion. W h e n forthwith inform the Commission thereof.
seeking the opinion of the commit tee , the Commission
may set a t ime limit within which such opinion shall be
given. N o 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 M e m b e r States.
ANNEX
PROGRAMME FOR T H E 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.
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