lexiara

1.

The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively. In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, its metabolites, a safener, synergist or co-formulant contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified. To this end the authorisation holder shall record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the plant protection product. The obligation to notify shall include relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries.

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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.