(fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) No 355/2013 included maltodextrin 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 maltodextrin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 28 February 2027. 

(4) An application for the renewal of the approval of the active substance maltodextrin was submitted to Ireland, the rapporteur Member State, and France, the co-rapporteur 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 11 November 2022. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of maltodextrin. 

(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 18 February 2025, the Authority communicated to the Commission its conclusion indicating that plant protection products containing maltodextrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) On 9 July 2025, the Commission presented a renewal report to the Standing Committee on Plants, Animals, Food and Feed and on 2 October 2025 a draft of this Regulation. 

(10) 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. 

(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance maltodextrin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(12) The Commission further considers that maltodextrin is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Maltodextrin is not a substance of concern and fulfils the conditions set in point 5 in Annex II to Regulation (EC) No 1107/2009. 

(13) It is therefore appropriate to renew the approval of maltodextrin pursuant to Article 22 of Regulation (EC) No 1107/2009 as a low-risk active substance.

(14) 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 and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of the active substance as manufactured, in order to ensure the safety of the active substance to be used in plant protection products. 

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

(16) Commission Implementing Regulation (EU) 2025/2316 extended the approval period of maltodextrin to 28 February 2027 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 renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. 

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