Commission Implementing Regulation (EU) 2022/2305 of 24 November 2022 renewing the approval of the low-risk active substance Fish oil in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Renewal of the approval of the active substance

Article 1

The approval of the active substance Fish oil, as specified in Annex I to this Regulation, is renewed subject to the conditions laid down in that Annex.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force and date of application

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 March 2023.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Fish oil CAS No: 8016-13-5 CIPAC No: 918 Not applicable Minimum purity of the active substance as manufactured: Fish oil 100 %. Identity of relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured: Maximum levels according to Commission Directive 2002/32/EC  ( 2 ) for the following impurities, proportionate to a fish oil with a moisture content of 12 %:   5 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)  ( 3 )   20 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin like polychlorinated biphenyls (PCBs)  ( 4 )   0,5 mg/kg of mercury   2 mg/kg of cadmium   10 mg/kg of lead   175 μg/kg of non-dioxin-like PCBs 1 March 2023 28 February 2038 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fish oil, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ( OJ L 140, 30.5.2002, p. 10 ). ( 3 )   Expressed in World Health Organisation (WHO) toxic equivalents. ( 4 )   Expressed in World Health Organisation (WHO) toxic equivalents.

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 248 on fish oil is deleted; (2) in Part D, the following entry is added: No. Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘41 Fish oil CAS No: 8016-13-5 CIPAC No: 918 Not applicable Minimum purity of the active substance as manufactured: Fish oil 100 % Identity of relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured: Maximum levels according to Commission Directive 2002/32/EC  ( 2 ) for the following impurities, proportionate to a fish oil with a moisture content of 12 %:   5 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)  ( 3 )   20 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin like polychlorinated biphenyls (PCBs)  ( 4 )   0,5 mg/kg of mercury   2 mg/kg of cadmium   10 mg/kg of lead   175 μg/kg of non-dioxin-like PCBs 1 March 2023 28 February 2038 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fish oil, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ( OJ L 140, 30.5.2002, p. 10 ). ( 3 )   Expressed in World Health Organisation (WHO) toxic equivalents. ( 4 )   Expressed in World Health Organisation (WHO) toxic equivalents.’