The EEC policy in the hazard assessment of new chemicals.
The sheer number of new chemicals produced each year poses problems to ensure that no dangerous products are brought in to use in the Community. Therefore the Council of Ministers of the European Communities has adopted on September 18, 1979 a Community legislation with respect to the notification of new chemicals. This is the so called sixth amendment of the Council directive of 27 June 1967 relating to the classification, packaging and labelling of dangerous substances. The purpose of this directive is to approximate the laws, regulations and administrative provisions of the ten Member States on: a) the notification of new chemical substances and b) the classification, packaging and labelling of substances dangerous to man and the environment which are placed on the market (including imported products) in the Member States of the Community. When giving this pre-marketing notification, the technical dossier requires, amongst others, the results of tests, of physico-chemical properties and toxicological and ecotoxicological parameters, following a three level hierarchical or step-sequence test system based on the quantities of the substances marketed. The first level concerns a mandatory base-set or level 0, the so called Annex VII, followed by a level 1 and level 2 testsystem (Annex VIII).
D000818:Animals; D002617:Chemical Industry; D004348:Drug Labeling; D005062:European Union; D007753:Laboratories / Q000592:standards; D007878:Legislation as Topic; D004364:Pharmaceutical Preparations / Q000145:classification; D051381:Rats; D014116:Toxicology
D004364:Pharmaceutical Preparations