Commission Directive 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC 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 (Text with EEA relevance)

• Coming into Force: 12 April 1999
• End of Effective Date: 10 March 2004
• Celex Number: 31999L0011
• ELI: http://data.europa.eu/eli/dir/1999/11/oj
• Published date: 23 March 1999
• Date: 08 March 1999
• Official Gazette Publication: Official Journal of the European Communities, L 77, 23 March 1999

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Commission Directive 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC 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 (Text with EEA relevance)

Official Journal L 077 , 23/03/1999 P. 0008 - 0021

COMMISSION DIRECTIVE 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC 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 (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 87/18/EEC of 18 December 1986 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 (1), and in particular Article 4 thereof,

Whereas the principles of good laboratory practice (GLP) referred to in Directive 87/18/EEC have been modified by OECD Council Decision [C(97)186(Final)];

Whereas it is necessary to adapt the reference to the principles of GLP as specified in Directive 87/18/EEC so as to take account of these modifications, and, by publishing the full text of the revised principles of GLP, to facilitate the uniform interpretation and application thereof;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives concerning the elimination of technical barriers to trade in dangerous substances and preparations,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Article 1(1) of Directive 87/18/EEC is replaced by the following:

'1. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice as laid down in the Annex to this Directive.`

Article 2

The Annex hereto is added as Annex to Directive 87/18/EEC.

Article 3

1. Member States shall adopt the laws, regulations and administrative provisions necessary in order to comply with this Directive not later than 30 September 1999 and shall forthwith inform the Commission thereof.

2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such a reference shall be adopted by Member States.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 8 March 1999.

For the Commission

Martin BANGEMANN

Member of the Commission

(1) OJ L 15, 17. 1. 1987, p. 29.

ANNEX

THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)

Contents

Section I

INTRODUCTION

Preface

1. Scope

2. Definitions of terms

2.1. Good laboratory practice

2.2. Terms concerning the organisation of a test facility

2.3. Terms concerning the non-clinical health and environmental safety study

2.4. Terms concerning the test item

Section II

GOOD LABORATORY PRACTICE PRINCIPLES

1. Test facility organisation and personnel

1.1. Test facility management's responsibilities

1.2. Study director's responsibilities

1.3. Principal investigator's responsibilities

1.4. Study personnel's responsibilities

2. Quality assurance programme

2.1. General

2.2. Responsibilities of the quality assurance personnel

3. Facilities

3.1. General

3.2. Test system facilities

3.3. Facilities for handling test and reference items

3.4. Archive facilities

3.5. Waste disposal

4. Apparatus, material, and reagents

5. Test systems

5.1. Physical/chemical

5.2. Biological

6. Test and reference items

6.1. Receipt, handling, sampling and storage

6.2. Characterisation

7. Standard operating procedures

8. Performance of the study

8.1. Study plan

8.2. Content of the study plan

8.3. Conduct of the study

9. Reporting of study results

9.1. General

9.2. Content of the final report

10. Storage and retention of records and materials

Section I

INTRODUCTION

Preface

Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member countries have established criteria for the performance of these studies.

To avoid different schemes of implementation that could impede international trade in chemicals, OECD Member countries have pursued international harmonisation of test methods and good laboratory practice. In 1979 and 1980 an international group of experts, established under the special programme on the control of chemicals, developed the 'OECD principles of good laboratory practice` (GLP), utilising common managerial and scientific practices and experience from various national and international sources. These principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council Decision on the mutual acceptance of data in the assessment of chemicals. [C(81)30(Final)].

In 1995 and 1996, a new group of experts was formed to revise and update the principles. The current document is the result of the consensus reached by that group. It cancels and replaces the original principles adopted in 1981.

The purpose of these principles of good laboratory practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment.

1. Scope

These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.

Non-clinical health and environmental safety studies covered by the principles of good laboratory practice include work conducted in the laboratory, in greenhouses, and in the field.

Unless specifically exempted by national legislation, these principles of good laboratory practice apply to all non-clinical health and environmental safety studies required by regulation for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.

2. Definition of terms

2.1. Good laboratory practice

Good laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

2.2. Terms concerning the organisation of a test facility

1. Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multisite studies, those which are conducted at more than one site, the test facility comprises the site at which the study director is located and all individual test sites, which individually or collectively can be considered to be test facilities.

2. Test site means the location(s) at which a phase(s) of a study is conducted.

3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.

4. Test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these principles of good laboratory practice.

5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and...