Modification of the terms of authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%) for breeder hens to include canthaxanthin produced with Yarrowia lipolytica CBS 146148 (DSM Nutritional Products Ltd.)

Abstract

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%), regarding the addition of a new production route, by the yeast Yarrowia lipolytica CBS 146148 and to modify the additive specifications by substituting ethoxyquin by 4.4% butylated hydroxytoluene (BHT) and increasing the limit for dichloromethane to 80 mg/kg. The additive is already authorised as zootechnical feed additive for breeder hens. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded. CAROPHYLL® Red 10% containing canthaxanthin produced by fermentation with Yarrowia lipolytica CBS 146148 is safe for the target species, consumer and environment under the current authorised conditions of use for CAROPHYLL® Red 10%. Regarding user safety, canthaxanthin is not irritant to skin and eyes and unlikely to be a skin sensitiser. No conclusion can be reached on the respiratory sensitisation of canthaxanthin. In the absence of data with the additive CAROPHYLL® Red 10%, no conclusions can be reached regarding the safety of the additive for the user. CAROPHYLL® Red 10%, containing canthaxanthin produced by fermentation with Yarrowia lipolytica CBS 146148, is efficacious in breeder hens at 6 mg/kg complete feed.