Commission Implementing Regulation (EU) 2026/351

Contents

Article 1Renewal of the approval of the active substance#

The approval of the active substance spinosad, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3Entry into force and date of application#

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 April 2026.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
SpinosadCAS No:Spinosad: 168316-95-8Spinosyn A: 131929-60-7Spinosyn D: 131929-63-0CIPAC 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-dioneSpinosyn 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/kgwith 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 21 January 2026, 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.

Annex II

(1)in Part A, entry 139 on spinosad is deleted;

(2)in Part B, the following entry is added:^noteNoCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘177SpinosadCAS No:Spinosad: 168316-95-8Spinosyn A: 131929-60-7Spinosyn D: 131929-63-0CIPAC No: 636Spinosyn 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-dioneSpinosyn 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/kgwith 50–95 % of spinosyn A and 5–50 % of spinosyn D1 April 20261 April 2041For 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 21 January 2026, and in particular, Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:

(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 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: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.’

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

Commission Implementing Regulation (EU) 2026/351

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Connections

History · 1 version

Key facts

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II