(1)

Commission Directive 2008/127/EC (2) included fat distillation residues as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

In accordance with Article 78(3) of Regulation (EC) No 1107/2009, 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 (4).

(3)

The approval of the active substance fat distillation residues, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2024.

(4)

An application for the renewal of the approval of the active substance fat distillation residues was submitted to Czechia, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicant 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 25 February 2021. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of fat distillation residues.

(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 5 January 2023, the Authority communicated to the Commission its conclusion (6), according to which fat distillation residues 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 Regulation regarding fat distillation residues to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 25 May 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 fat distillation residues that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

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

(13)

It is therefore appropriate to renew the approval of fat distillation residues 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 fat distillation residues and a maximum amount of the impurity nickel in the fat distillation residues as manufactured in order to ensure the safety of the active substance when used in plant protection products.

(15)

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

(16)

Commission Implementing Regulation (EU) 2023/1446 (7) extended the approval period of fat distillation residues to 15 December 2024 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,