Safety Assessment RP597-600 Carophyll

Two applications were submitted to the Food Standards Agency in November 2021 from DSM Nutritional Products (“the applicant”) for the authorisation of an additive (canthaxanthin-Carophyll® Red 10%), under the categories of ‘zootechnical and sensory-colourant’. The additive is proposed to be used in breeder hens, poultry, ornamental birds and ornamental fish at a range level of 6-100 mg/kg of complete feed with a moisture content of 12%, depending on target species. Canthaxanthin synthesised chemically has previously been authorised. This modification of authorisation application concerns an additional production process, wherein canthaxanthin is produced through fermentation using Yarrowia lipolytica. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The AFFAJEG concluded that the fermented product has a similar high purity to the synthetic canthaxanthin, therefore there were no further concerns regarding Section II. The applicant conducted a literature review to cover the period since the last authorisation and found no negative effects had occurred in this time. Members evaluated the safety for the target species, consumer and the environment, concluding that the additive should continue to be considered safe. The additive is not considered to be irritant to skin and eyes and not thought to be a skin sensitiser. It is potentially harmful by inhalation, and some batches have been shown to very dusty. No demonstration of efficacy was required for the modification of authorisation. For the extension of use, the AFFAJEG concluded that previous data demonstrating efficacy could be extrapolated to breeder hens. Members also concluded that the new production method of fermentation is not expected to negatively affect the efficacy of the additive. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.