Article 9

Data to be supplied for substances appearing on the priority lists 1. For the substances included in the priority lists referred to in Article 8 (1), manufacturers and importers who have submitted information on a substance in accordance with Articles 3 and 4 shall, within six months of publication of the list, submit to the rapporteur designated in accordance with Article 10 (1) all relevant available information and corresponding study reports for risk assessment of the substance concerned. 2. In addition to the requirement specified in paragraph 1, and without prejudice to the testing which may be required under Article 10 (2), if any of the particulars listed in Annex VII A to Directive 67/548/EEC are not available for a given priority substance, the manufacturers and importers who have submitted information on a substance in accordance with Articles 3 and 4 shall be obliged to carry out the testing necessary to obtain the missing data and to provide the test results and test reports to the rapporteur within 12 months. 3. By way of derogation from paragraph 2, manufacturers and importers may request of the rapporteur that they be exempted from some or all of the additional testing on the grounds that a given piece of information is either unnecessary for risk assessment or is impossible to obtain; they may also request a longer period where circumstances so require. Full justification must be provided to support such derogation and the rapporteur shall decide whether the request should be accepted. Where derogations are allowed in conformity with this Article, the rapporteur shall immediately inform the Commission of his decision. The Commission shall inform the other Member States. If the decision of the rapporteur is contested by one of the other Member States, a final decision shall be taken in conformity with the committee procedure laid down in Article 15. PART 2 RISK EVALUATION

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.