2.

Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies: the data are not necessary owing to the exposure associated with the proposed uses; it is not scientifically necessary to supply the data; or it is not technically possible to generate the data. However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the evaluating competent authority under Article 8(2).

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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.