EC updates Directive for Good Laboratory Practice
The European Commission has recently published a Directive (1999/11/EC), which brings up to date a previous EC ruling on Good Laboratory Practice (GLP). The new Commission Directive adapts to technical progress GLP, 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 GLP and the verification of their application for tests on chemical substances. The amendments result from government and industry concern about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. The Directive relates to established criteria that the OECD (Organisation for Economic Cooperation and Development) Member countries have set for the implementation of these studies. To avoid different schemes of implementation of non-clinical health and safety, the measures taken in the Commission's Directive conform with the opinion of the Committee for the adaptation to technical progress of the Directive concerning the elimination of technical barriers to trade in dangerous substances and preparation. The principles of GLP laid out in the Directive are intended to be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products and veterinary drugs as well as food additives, feed additives, and industrial chemicals. The legislation covers work carried out in the laboratory, in greenhouses and in the field. The adaptations, which cancel and replace the original principles of the Directive adopted in 1981, are given in Annex to the newly published legislation, which the Commission requires Member States to adopt by 30 September 1999.