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1.

Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements: its active substances, safeners and synergists have been approved; where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location: the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval; its co-formulants are not included in Annex III; its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product; in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3); the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods; its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples; its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.

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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.