ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part B, entry 18 on 8-hydroxyquinoline is deleted; (2) in Part E, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘16 Quinolin-8-ol CAS No: 148-24-3 CIPAC No: 677 Quinolin-8-ol ≥ 990 g/kg 1 July 2025 30 June 2032 Only uses by drip-irrigation by professional users in permanent greenhouses that allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised. Authorisations shall only be granted for uses where a closed transfer system for loading and mixing the plant protection product into the application equipment is available. A pre-harvest interval of at least 22 days after the last application must be respected and the soil in which crops are grown in permanent greenhouses shall not be re-used outside the greenhouse within 1 year after the last application. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on quinolin-8-ol, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to the necessary personal protective equipment for operators and workers. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-dietary exposure for workers and operators, in particular a study examining exposure to workers and operators under realistic conditions of use; (2) confined rotational crops metabolism data addressing the fate of the parent compound in succeeding crops; (3) studies or information to confirm a lack of clastogenic and aneugenic potential for quinolin-8-ol. The applicant shall submit the information under points 1 and 2 by 2 July 2027 and under point 3 by 2 July 2026. ( 1 ) Further details on the identity and specification of the active substance are provided in the renewal report.’