(fra kommisjonsforordningen)

(1) Commission Directive 2007/6/EC included spinosad as an active substance in Annex I to Council Directive 91/414/EEC.

(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011. 

(3) The approval of the active substance spinosad, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 October 2026. 

(4) An application for the renewal of the approval of the active substance spinosad was submitted to the Netherlands, the rapporteur Member State, and France, the corapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 and within the time period provided for in that Article. 

(5) The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. 

(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 30 March 2017. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of spinosad. 

(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. 

(8) On 4 April 2018, the Authority communicated to the Commission its conclusion6 on whether spinosad can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) In its conclusion, the Authority proposed that spinosad be classified as toxic for reproduction category 2 according to Regulation (EU) No 1272/2008 of the European Parliament and of the Council. Furthermore, adverse effects were observed on multiple organs including endocrine organs. On this basis, the Authority concluded that the interim criteria for the consideration of endocrine disrupting properties concerning human health of point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, as it stood at that time, may be met, leading to a critical area of concern. 

(10) The Commission presented a draft renewal report for spinosad to the Standing Committee on Plants, Animals, Food and Feed on 24 October 2018. 

(11) Since it was not possible for risk managers to conclude whether spinosad is an endocrine disruptor in accordance with the new scientific criteria for the determination of endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605, the Commission requested the Authority on 14 January 2019 to re-assess the existing information, to request additional information from the applicant if needed and to update its conclusion on the endocrine disrupting potential of spinosad pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. 

(12) In July 2024, the rapporteur Member State made an updated draft renewal assesment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered, upon request of the Authority, the additional information regarding the criteria to identify endocrine disrupting properties and proposed renewing the approval of spinosad. 6 Conclusion on pesticides peer review of the pesticide risk assessment of the active substance spinosad;

(13) On 12 December 2024, the Authority communicated to the Commission its updated conclusion indicating that, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing spinosad can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that, based on the scientific evidence, spinosad does not meet the criteria for endocrine disruption. 

(14) The Commission presented an updated renewal report on 11 March 2025 and a draft of this Regulation on 9 July 2025 to the Standing Committee on Plants, Animals, Food and Feed. 

(15) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration. 

(16) It has been established with respect to one or more representative uses of at least one plant protection product containing spinosad that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of spinosad. 

(17) Although the risk assessment for the renewal of the approval of the active substance spinosad is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing spinosad may be authorised. It is therefore appropriate not to maintain the restriction to use as an insecticide. 

(18) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge as well as the outcome of the risk assessment, it is, however, necessary to provide for certain conditions. 

(19) It is, in particular, appropriate that the Member States 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; and the protection of wild mammals, aquatic organisms, bees and non-target arthropods. 

(20) In addition, to increase confidence in the decision, the applicant should submit to the Commission, the Member States and the Authority the following confirmatory information: an in vitro interspecies comparative metabolism study; an overall assessment of DNT (developmental neurotoxicity), including the submission of data from an in vitro DNT test battery; 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; the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water; as well as information regarding the chronic effects on honeybees (adults and larvae). 

(21) Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(22) Commission Implementing Regulation (EU) 2025/9910 extended the approval period of spinosad to 31 October 2026 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on the renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date. 

(23) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,