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.’