E.U. EFSA approves synthetic astaxanthin in fish and crustaceans

European Food Safety Authority issues Scientific Opinion on the safety and efficacy of synthetic astaxanthin as feed additive for salmon and trout, other fish, ornamental fish, crustaceans
June 26, 2014

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin as feed additive for salmon and trout, other fish, ornamental fish, crustaceans and ornamental birds.

In a separate ruling, EFSA also approved astaxanthin (CAROPHYLL® Pink 10% CWS) for salmonids and ornamental fish.

Astaxanthin is a pigmenting carotenoid occurring naturally in plankton, crustaceans and fish. Astaxanthin under application is a synthetic product characterized by a defined proportion of enantiomers of 25 % 3S,3′S, 50 % 3R,3′S and 25 % 3R,3′R.

The FEEDAP Panel considers synthetic astaxanthin safe for salmonids at concentrations of up to 100 mg/kg complete diet. The conclusion on the safety of astaxanthin for salmonids can be extrapolated to other fish and ornamental fish at the same dose. Dietary concentrations up to 100 mg astaxanthin/kg feed are safe for crustaceans. 

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.

As some formulations of astaxanthin may be dusty, and in the absence of data on inhalation toxicity, it is prudent to regard astaxanthin-containing additives as being potentially hazardous by inhalation. In the absence of any information on irritancy to skin or eyes or on skin sensitisation, astaxanthin-containing additives should be regarded as hazardous by exposure to skin or eyes.

The FEEDAP Panel considers that the use of synthetic ATX (100 mg astaxanthin/kg fish feed) does not pose a significant additional risk to the environment compared with natural astaxanthin.

Astaxanthin is efficacious in coloring the flesh of salmonids and the epidermis of crustaceans. Astaxanthin is efficacious in pigmenting the flesh of food-producing fish other than salmonids and the skin of ornamental fish. 

Download abstract and summary (PDF) from the link below.