Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the Maximum Residue Limits for canthaxanthin in foodstuffs coming from animals fed with canthaxanthin used as a feed additive in accordance with Council Directive 70/524/EEC

The European Food Safety Authority (EFSA) received a request from the European Commission to issue an opinion on the Maximum Residue Limits (MRLs) of canthaxanthin in foodstuffs coming from animals fed with canthaxanthin as a feed additive in accordance with Council Directive 70/524/EEC. Canthaxanthin (CTX) is a colouring agent used in animal feed to colour food of animal origin. Its authorisation was revised at Community level by Commission Directive 2003/7/EC for salmon, trout, laying hens and other poultry, amongst others. It is also approved as a food additive (E161g). Oral administration of canthaxanthin is followed by canthaxanthin deposition in tissues. Liver appears as the target tissue in poultry, moreover the skin/fat and the egg could be considered as further target tissues. In fish, both salmon and trout, skin is the target tissue. However, for practical reasons, flesh should be considered as the target tissue. Canthaxanthin is by far the major component of residues in target tissues of poultry and fish. The FEEDAP Panel considers canthaxanthin only as the residue of concern and therefore retains CTX (measured as the all-trans isomer) as the marker residue. The data set used for residue calculation resulting from the maximum approved canthaxanthin contents in feed comes from literature, mostly published, as well as from company reports. Based on the worst case intake scenario given by Directive 2001/79/EC, the human canthaxanthin exposure would amount for egg consumption to 39 % of the ADI, for tissues from chickens for fattening to 104 % of the ADI, for salmon flesh to 120 % of the ADI, for large trout to 60 % and for portion trout to 35 % of the ADI. Refinement of human exposure by the more realistic intake data from SCOOP reduces the above figures considerably. Egg consumption, accounting for 14 % of the ADI, and poultry consumption, accounting for 36 %, result in a total of 50 % of the ADI. Consumption of salmon and large trout (56 % of the ADI) together with eggs (14 % of the ADI) results in a total of 70 % of the ADI. The FEEDAP Panel therefore concludes that the current approved practice of feeding canthaxanthin to layers, chickens for fattening and salmonids does not raise a safety concern for the consumer. The following MRL values are proposed: egg yolk 30 mg CTX kg-1, liver as target tissue for poultry 15 mg CTX kg-1, skin/fat as target tissue for poultry 2.5 mg CTX kg-1, salmon 10 mg CTX kg-1 flesh and for trout 5 mg CTX kg-1 flesh. Adopting these MRL values, the consumption of animal products from CTX-treated poultry and salmonids would result in a total CTX intake below the ADI.