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(b)

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;

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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.