ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 139 on spinosad 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 ‘177 Spinosad CAS No: Spinosad: 168316-95-8 Spinosyn A: 131929-60-7 Spinosyn D: 131929-63-0 CIPAC No: 636 Spinosyn A: (50–95 %) (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione Spinosyn D: (50–5 %) (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione ≥ 850 g/kg with 50–95 % of spinosyn A and 5–50 % of spinosyn D 1 April 2026 1 April 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 spinosad of 11 December 2025, 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 assessment of the consumer intake, taking into account the residues of the metabolites of spinosad and considering the impact of storage and processing; — the protection of operators, in particular for hand-held applications in low crops; — the protection of wild mammals, aquatic organisms, bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) an in vitro interspecies comparative metabolism study; (2) an overall assessment of DNT (developmental neurotoxicity) including the submission of data from an in vitro DNT test battery; (3) the toxicity and magnitude of residues in plant and animal matrices of spinosyn B and K, PsA and MET A-Li-4(5b) to confirm the residue definitions for risk assessment; (4) the effect of water treatment processes on the nature of residues present in drinking water; (5) chronic effects on honeybees (adults and larvae). The applicant shall submit the information referred to in point 1, 3, and 4 to the Commission, the Member States and the Authority by 11 March 2028. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 2 within two years after adoption of a guidance document on assessing DNT. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 5 within two years after the adoption of a guidance document with a revised risk assessment methodology for honeybees.’ ( 1 ) Further details on the identity and specification of the active substance are provided in the renewal report.