ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 242 on rape seed 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 ‘54 Rape seed oil CAS No: 8002-13-9 (Rape seed oil) 93165-31-2 (Rape seed oil – low erucic acid) CIPAC No: Not available Rape seed oil The purity complies with the European Pharmacopeia 7.0 and Deutscher Arzneimittel-Codex 1986, 6. Erg. 1994 and ph. Eur. 5, 2005. The active substance is a mixture of triglycerides of fatty acids and the mode of action is mechanical rather than chemical: 100 % of the technical active substance is considered as an active substance. The specifications are based on the composition as fatty acids and some physical and chemical parameters. The impurity erucic acid shall not exceed 2 %. 1 November 2025 31 October 2040 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 rape seed oil, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms, honey bees, and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate.’ ( 1 ) Further details on the identity and specification of the active substance are provided in the renewal report.