Subsection 4

An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met. Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: a copy of the authorisation of the plant protection product; any new information required as a result of amendments in data requirements or criteria; evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; a report on the monitoring information, where the authorisation was subject to monitoring. Member States shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20. The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone. Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2). Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied. A Member State shall review an authorisation where it concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information. The Member State shall withdraw or amend the authorisation, as appropriate, where: the requirements referred to in Article 29 are not or are no longer satisfied; false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; a condition included in the authorisation has not been met; on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or the authorisation holder fails to comply with the obligations resulting from this Regulation. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate. An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request. Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met. Article 46 shall apply where appropriate. Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks. Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.

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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.