anx_IV__cpt_1__cpt_3__cpt_1

3.1. Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available. In that case, the following conditions shall be met: An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought. If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies. The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained. However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing. If relevant, the Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the criteria established in accordance with Article 6(4) and Article 21(3).

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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.