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Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance)

EU Directive 2004/10 · Adopted 11 February 2004 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Directive 2004/10/EC of the European Parliament and of the Council

of 11 February 2004

on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committeef1,

Acting in accordance with the procedure laid down in Article 251 of the Treatyf2,

Whereas:

(1)

Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substancesf3 has been significantly amended. In the interests of clarity and rationality the said Directive should be codified.

(2)

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substancesf4 requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined.

(3)

When the active substances in pesticides undergo tests they should do so in accordance with Directive 67/548/EEC.

(4)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsf5 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human usef6 lay down that non-clinical tests on pharmaceutical products are to be carried out in accordance with the principles of good laboratory practice (GLP) in force in the Community for chemical substances, compliance with which is also required by other Community legislation.

(5)

The methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC.

(6)

It is necessary to comply with the principles of GLP in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality.

(7)

The resources devoted to the tests should not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another.

(8)

The Council of the Organisation for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products. It issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with GLP. The principles of GLP have been modified by OECD Council Decision (C(97) 186 (final)).

(9)

Animal protection requires that the number of experiments conducted on animals be restricted. Mutual recognition of the results of tests obtained using standard and recognised methods is an essential condition for reducing the number of experiments in this area.

(10)

It is necessary to set up a procedure allowing rapid adaptation of the principles of GLP.

(11)

This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition of the directives set out in Annex II, part B,

HAVE ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1

OJ C 85, 8.4.2003, p. 138.

f2

Opinion of the European Parliament of 1 July 2003 (not yet published in the Official Journal) and Decision of the Council of 20 January 2004.

f3

OJ L 15, 17.1.1987, p. 29. Directive as amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p. 8).

f4

OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

f5

OJ L 311, 28.11.2001, p. 1.

f6

OJ L 311, 28.11.2001, p. 67. Directive as amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 3aArticle 3a
  5. 4Article 4
  6. 5Article 5
  7. 6Article 6
  8. 7Article 7
  9. 8Article 8
  10. Annex I: THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)
  11. INTRODUCTION
  12. Preface
  13. 1Scope
  14. Definition of terms
  15. 2.1Good laboratory practice
  16. Terms concerning the organisation of a test facility
  17. 1Division 1
  18. 2Division 2
  19. 3Division 3
  20. 4Division 4
  21. 5Division 5
  22. 6Division 6
  23. 7Division 7
  24. 8Division 8
  25. 9Division 9
  26. 10Division 10
  27. Terms concerning the non-clinical health and environmental safety study
  28. 1Division 1
  29. 2Division 2
  30. 3Division 3
  31. 4Division 4
  32. 5Division 5
  33. 6Division 6
  34. 7Division 7
  35. 8Division 8
  36. 9Division 9
  37. 10Division 10
  38. 11Division 11
  39. 12Division 12
  40. Terms concerning the test item
  41. 1Division 1
  42. 2Division 2
  43. 3Division 3
  44. 4Division 4
  45. GOOD LABORATORY PRACTICE PRINCIPLES
  46. Test facility organisation and personnel
  47. Test facility management's responsibilities
  48. 1Division 1
  49. 2At a minimum it should:
  50. 3Division 3
  51. Study director's responsibilities
  52. 1Division 1
  53. 2These responsibilities should include, but not be limited to, the following functions. The study director should:
  54. 1.3Principal investigator's responsibilities
  55. Study personnel's responsibilities
  56. 1Division 1
  57. 2Division 2
  58. 3Division 3
  59. 4Division 4
  60. Quality assurance programme
  61. General
  62. 1Division 1
  63. 2Division 2
  64. 3Division 3
  65. 2.2Responsibilities of the quality assurance personnel
  66. Facilities
  67. General
  68. 1Division 1
  69. 2Division 2
  70. Test system facilities
  71. 1Division 1
  72. 2Division 2
  73. 3Division 3
  74. Facilities for handling test and reference items
  75. 1Division 1
  76. 2Division 2
  77. 3.4Archive facilities
  78. 3.5Waste disposal
  79. Apparatus, material, and reagents
  80. 1Division 1
  81. 2Division 2
  82. 3Division 3
  83. 4Division 4
  84. Test systems
  85. Physical/chemical
  86. 1Division 1
  87. 2Division 2
  88. Biological
  89. 1Division 1
  90. 2Division 2
  91. 3Division 3
  92. 4Division 4
  93. 5Division 5
  94. 6Division 6
  95. 7Division 7
  96. Test and reference items
  97. Receipt, handling, sampling and storage
  98. 1Division 1
  99. 2Division 2
  100. 3Division 3
  101. Characterisation
  102. 1Division 1
  103. 2Division 2
  104. 3Division 3
  105. 4Division 4
  106. 5Division 5
  107. 6Division 6
  108. Standard operating procedures
  109. 1Division 1
  110. 2Division 2
  111. 3Division 3
  112. 4Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.
  113. Performance of the study
  114. Study plan
  115. 1Division 1
  116. 2Division 2
  117. 3Division 3
  118. 8.2Content of the study plan
  119. Conduct of the study
  120. 1Division 1
  121. 2Division 2
  122. 3Division 3
  123. 4Division 4
  124. 5Division 5
  125. Reporting of study results
  126. General
  127. 1Division 1
  128. 2Division 2
  129. 3Division 3
  130. 4Division 4
  131. 5Division 5
  132. 9.2Content of the final report
  133. Storage and retention of records and materials
  134. 10.1Division 10.1
  135. 10.2Division 10.2
  136. 10.3Division 10.3
  137. 10.4Division 10.4
  138. Annex II
  139. APart A
  140. BPart B
  141. Annex IIIAnnex III