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.
2. The notification shall include an assessment of whether and how the new information would result in the plant protection product or the active substance, its metabolites, a safener, or synergist or co-formulant no longer complying with the requirements set out in Article 29 and Article 4 or Article 27, respectively.
3. Without prejudice to the right of Member States to adopt interim protective measures, the Member State which first granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44.
That Member State shall inform the other Member States and the Commission where it considers that the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled or whether in the case of a co-formulant it has been considered unacceptable and propose that the approval be withdrawn or the conditions amended.
4. The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment.