BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2009/153/EC included hydrolysed proteins 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 hydrolysed proteins, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 April 2025. 

(4) An application for the renewal of the approval of the active substance hydrolysed proteins was submitted to Spain, the rapporteur Member State, and Greece, 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 applicants submitted the supplementary dossiers 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 24 June 2020. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of hydrolysed proteins. 

(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 30 May 2023, the Authority communicated to the Commission its conclusion6 which indicated that hydrolysed proteins can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 12 July 2023 and 11 December 2023 respectively. 

(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 hydrolysed proteins that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(12) The Commission further considers that hydrolysed proteins is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009, given that hydrolysed proteins is not a substance of concern and fulfils the conditions set in point5 of Annex II to Regulation (EC) No 1107/2009. 

(13) It is therefore appropriate to renew the approval of hydrolysed proteins as a low-risk 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, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to set maximum limits for toxicologically relevant impurities in the technical material. 

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

(16) Commission Implementing Regulation (EU) 2023/1446 extended the approval period of hydrolysed proteins to 15 April 2025 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,