Astaxanthin (2a161j)

In the current application a renewal of authorisation is sought under Article 14 for astaxanthin (2a161j) under the category 2 “sensory additives”, functional group (a) ”colourants”, according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the renewal of authorisation is sought for the use of the feed additive for fish, crustaceans and ornamental fish. The feed additive contains astaxanthin as active substance with a minimum purity of 96 % of total colouring matter. The present application specifically refers to the renewal of the authorisation for astanxanthin and its formulation into solid or liquid preparations. The Applicant proposes a maximum content of astaxanthin corresponding to 100 mg/kg of active substance in compound feed. For the determination of astaxanthin in the feed additive preparations, the Applicant proposed a ring-trial validated spectrophotometric method. The following performance characteristics were reported: a relative standard deviation for repeatability (RSD_r) ranging from 0.45 to 1.10 %, a relative standard deviation for reproducibility (RSD_R) ranging from 1.0 to 3.3 % and a recovery rate (R_Rec) of 99.9 %. The method was positively evaluated by the EURL in the frame of the first authorisation. Based on the available performance
characteristics, the EURL recommends for official control the ring-trial validated methods based on spectrophotometry for the determination of astaxanthin in the feed additive preparations. For the determination of astaxanthin in premixtures and compound feed, the Applicant proposed a ring-trial validated method based on normal-phase high-performance liquid chromatography (NP-HPLC). Nevertheless, the EURL is aware of the recent publication of the multi-analyte, ring-trial validated method EN 17550 based on reversed-phase HPLC coupled with UV detection (RP-HPLC-UV) dedicated for the determination of carotenoids in animal feedingstuffs. In particular, the method allows the determination of astaxanthin in fish compound feed and fish premixtures. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated EN 17550 method based on reversed-phase high performance liquid chromatography with UV detection (RP-HPLC-UV) for the determination of astaxanthin in premixtures and compound feed. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.