Safety and efficacy of Panaferd-AX (red carotenoid-rich bacterium Paracoccus carotinifaciens) as feed additive for salmon and trout

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 Panaferd-AX. The product is a feed additive consisting of dried sterilised cells of a red carotenoid-rich bacterium (Paracoccus carotinifaciens) intended to provide farmed Atlantic salmon (Salmo salar) and rainbow trout (Oncorhynchus mykiss) with a source of astaxanthin which confers the characteristic red colour to the flesh. Panaferd-AX contains around 4 % total red carotenoids, predominantly astaxanthin (2.2 %), adonirubin (1.3 %) and canthaxanthin (0.4 %). In salmon and rainbow trout astaxanthin, deposition in flesh from Panaferd-AX was less efficient than that from synthetic astaxanthin. However, equal astaxanthin doses from both sources resulted in a comparable flesh pigmentation in the dose range of 20 to 100 mg astaxanthin kg-1 feed, due to the contribution of the other red carotenoids, mainly adonirubin and canthaxanthin, which are also demonstrated to be deposited in fish flesh. The technological and organoleptic properties of flesh from Panaferd-AX-treated fish were not different from those treated with synthetic astaxanthin. Panaferd-AX, at dietary incorporation rate of 12.5-fold greater than the proposed maximum incorporation rate (0.4 %) is safe for salmonids (trout and salmon). Paracoccus carotinifaciens is not a known pathogen, and no other concerns have been identified either in the limited literature available or in the data submitted in the dossier. Panaferd-AX is a non-genotoxic additive of very low acute and sub-chronic toxicity. No specific risk for the consumer related to compounds arising from the fermentation process (other than red carotenoids) is likely to occur. As consumer exposure to astaxanthin and canthaxanthin after administration of Panaferd-AX at the maximum dose proposed would be at the most equal or lower than that resulting from the use of other astaxanthin or canthaxanthin sources, there is no additional risk for the consumer. The structural proximity of adonirubin, astaxanthin and canthaxanthin, suggests that the toxicological profiles of the three compounds should be similar. However, the studies on genotoxicity and sub-chronic toxicity performed on Panaferd-AX are only indicative of the safety of adonirubin. The possible deposition of crystals of adonirubin in the retina, similar to that occuring with canthaxanthin, cannot be excluded and has to be considered as worst case scenario. The calculated consumer exposure to adonirubin plus canthaxanthin derived from the use of Panaferd-AX in salmon and trout complies with the canthaxanthin ADI (37 %). Therefore, no additional risk due to adonirubin exposure resulting from the use of Panaferd-AX is likely to occur. Panaferd-AX shows very low acute inhalation toxicity and no potential for skin irritation. However, Panaferd-AX is considered as an eye irritant. Considering the nature of the product it should also be considered as a respiratory sensitiser. The FEEDAP Panel does not expect that the use of Panaferd-AX as a source of astaxanthin, canthaxanthin and adonirubin for salmon and trout will pose an added risk to the environment.