rec_12

(12) In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety OJ L 31, 1.2.2002, p. 1. (the Authority). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process.

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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.