(1)

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

(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 (4).

(3)

The approval of the active substance Fish oil, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2023.

(4)

An application for the renewal of the approval of the active substance Fish oil was submitted to the Czech Republic, the 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 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 Czech Republic prepared a draft renewal assessment report in consultation with France, the co-rapporteur Member State, and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 10 September 2020. In its draft renewal assessment report the Czech Republic proposed to renew the approval of Fish oil as a low-risk substance.

(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. On 16 December 2021, the Authority communicated to the Commission its conclusion (6) which indicated that Fish oil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented a renewal report and a draft of this Regulation regarding Fish oil to the Standing Committee on Plants, Animals, Food and Feed on 30 March 2022 and on 17 May 2022, respectively.

(8)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) 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 where appropriate.

(9)

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

(10)

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

(11)

It is therefore appropriate to renew the approval of Fish oil as a low-risk substance.

(12)

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 set a minimum purity of the active substance as manfactured in order to underpin the safety of the active substance to be used in plant protection products.

(13)

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

(14)

Commission Implementing Regulation (EU) 2022/708 (7) extended the approval period of Fish oil to 31 August 2023 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 shall apply as soon as possible.

(15)

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