Article 4
1. Manufacturers or importers of substances defined in Article 2, which are situated in the territory of the former German Democratic Republic and have to notify the substance, have to submit to the German competent authorities a provisional notification as soon as possible, but not later than 31 March 1992. The provisional notification shall include: (a) a declaration concerning the unfavourable effects of the substance in terms of the various foreseeable uses; (b) the proposed classification and labelling of the substance in accordance with Directive 67/548/EEC; (c) proposals for any recommended precautions relating to the safe use of the substance; (d) a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose. 2. The technical dossier referred to in Article 4 (1) (d) shall contain as a minimum the information and results of the studies referred to in Annex VII, Section 1 and 2, Section 3 points 3.1, 3.2, 3.6, 3.8, 3.9 and 3.10, and Section 4 points 4.1.1, 4.1.5 and 4.1.6 of Directive 67/548/EEC; in addition, it shall contain a mutagenicity test, in which the substance should be examined in a bacteriological (reverse mutation) test with and without metabolic activation. Where information and results of studies additional to these minimal requirements are available they shall also be submitted; this includes also studies referred to in Annex VIII of Directive 67/548/EEC. The results of studies shall be submitted together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them. Studies which have been initiated before 3 October 1990 and which have not been carried out in accordance with the methods laid down in Annex V of Directive 67/548/EEC and the principles of good laboratory practice provided for in Directive 87/18/EEC (5), may be accepted, if the data are adequate for the purpose of risk assessment. 3. Substances defined in Article 2 which have not been provisionally notified according to paragraph 1 and 2 may not be placed on the market in the territory of the former German Democratic Republic after 31 March 1992.