3.1. Dossier

The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD). In the case of an active substance, safener or synergist for which one or more representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes. The dossier shall in particular: permit any residue of concern to be defined; reliably predict the residues in food and feed, including succeeding crops; reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing; permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals; permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined. The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.

← 3. Criteria for the approval of an active substance · All articles · anx_II__cpt_1__cpt_3__cpt_1__text_1 →

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