Article 10

Risk evaluation of the substances on the priority lists at the level of the Member State designated as rapporteur 1. For each substance on the priority lists a Member State shall be given responsibility for its evaluation in accordance with the procedure laid down in Article 15, whilst ensuring fair burden sharing between Member States. The Member State shall designate a rapporteur for that substance from among the competent authorities referred to in Article 13. The rapporteur shall be responsible for evaluating the information submitted by the manufacturer(s) or importer(s) in conformity with the requirements of Articles 3, 4, 7 and 9 and any other available information, and for identifying, after consultation of the producers or importers concerned, whether, for the purpose of the risk evaluation, it is necessary to require the above manufacturers or importers of priority substances to submit further information and/or to carry out further testing. 2. Where the rapporteur considers it necessary to request further information and/or testing, it shall inform the Commission accordingly. The decision to impose on the above importers or manufacturers a request for further information and/or testing and the time limits for responding to that request shall be taken in accordance with the procedure laid down in Article 15. 3. The rapporteur for a given priority substance shall evaluate the risk of that substance to man and the environment. Where appropriate, it shall suggest a strategy for limiting these risks, including control measures and/or surveillance programmes. Where such control measures include recommendations for restrictions on the marketing or use of the substance in question, the rapporteur shall submit an analysis of the advantages and drawbacks of the substance and of the availability of replacement substances. The recommended risk evaluation and strategy shall be forwarded to the Commission by the rapporteur. 4. The real or potential risk to man and the environment shall be assessed on the basis of principles adopted, by 4. June 1994, in accordance with the procedure laid down in Article 15. These pinciples shall be regularly reviewed and, where appropriate, revised in accordance with the same procedure. 5. When manufacturers or importers are asked for further information and/or testing, they must also check, in view of the need to limit practical experiments on vertebrates, whether the information needed to evaluate the substance is not available from former manufacturers or importers of the declared substance and cannot be obtained, possibly against payment of costs. Where experiments are essential, it must be checked whether tests on animals cannot be replaced or limited by using other methods. Necessary laboratory tests must be performed with due respect for the principles of 'good laboratory practice' as laid down in Directive 87/18/EEC and for the provisions of Directive 86/609/EEC.

← 3. · All articles · art_10__para →

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