ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 81 on pyraclostrobin is deleted; (2) in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘182 Pyraclostrobin CAS No: 175013-18-0 CIPAC No: 657 methyl 2-({[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy}methyl)-N-methoxycarbanilate ≥ 980 g/kg The following impurities shall not exceed the following levels in the technical material: — Dimethyl sulfate (DMS): 0,001 g/kg — Toluene: 8 g/kg 1 October 2026 30 September 2041 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 pyraclostrobin, 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 co-formulants present in pyraclostrobin-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in n Implementing Regulation (EU) 2023/574, — the exposure of aquatic organisms to relevant metabolites in water and sediment environmental compartments and the protection of aquatic organisms, — the consumer risk assessment, concerning the exposure to metabolites of pyraclostrobin, in particular 500M07 and 500M54 (for use on grapes), — the risk assessment to the aquatic environment for the metabolites BF 500–15 and 500M58. Conditions of use shall include risk mitigation measures, where applicable. The applicant shall submit confirmatory information as regards: (1) The toxicity profile of the metabolite 500M07 to confirm the residue definitions for risk assessment (commodities of plant and animal origin). (2) The effect of water treatment processes on the nature of residues of both the active substance and its identified metabolites potentially present in surface water, when surface water is abstracted for drinking water. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 12 September 2028.’ ( 1 ) Further details on the identity and specification of the active substance are provided in the renewal report.