Scientific Opinion on the safety and efficacy of astaxanthin (CAROPHYLL® Pink 10% CWS) for salmonids and ornamental fish
Meta data
Note: This scientific opinion has been edited following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections are indicated in the text.
Abstract
Astaxanthin is a pigmenting carotenoid naturally occurring in plankton, crustaceans and fish. The FEEDAP Panel considers synthetic astaxanthin safe for salmonids up to 100 mg/kg complete diet. This conclusion is extrapolated to ornamental fish at the same dose. Based on a BMDL10 of 3.4 mg/kg bw per day (calculated for liver hypertrophy in female rat in a carcinogenicity study) and applying an uncertainty factor of 100, it is possible to set an ADI of 0.034 mg ATX/kg bw (equivalent to 2.0 mg ATX per 60 kg person per day). The use of astaxanthin up to the maximum permitted dietary level for salmon and trout is of no concern for the safety of the consumer. Skin or eye exposure to astaxanthin is unlikely to be irritant to workers. Sensitisation is unlikely to occur subsequent to skin exposure. The risk of inhalation toxicity is minimal for the formulation under assessment, but the risk for other formulations cannot be assessed. The FEEDAP Panel considers that the use of synthetic astaxanthin (100 mg astaxanthin/kg fish feed) does not pose a significant additional risk to the environment compared with natural astaxanthin. Astaxanthin is efficacious in colouring the flesh of salmonids and in pigmenting the skin of ornamental fish.