Safety and efficacy of ethyl ester of β-apo-8’-carotenoic acid

Lingua Undefined

EFSA Panel on EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Ethyl ester of β-apo-8’-carotenoic acid (β-apo-8-ester) at a concentration of 8 mg/kg complete feed for laying hens and of 15 mg/kg complete feed for chickens for fattening is safe for the target animals. No safety conclusion could be made for 80 mg β-apo-8-ester/kg complete feed for laying hens. β-Apo-8-ester was devoid of genotoxic potential. Repeat dose toxicity studies and the two-generation reproduction toxicity study showed toxicity of β-apo-8-ester by adverse effects on the liver, spleen and mesenteric lymph nodes. An acceptable daily intake (ADI) of 0.015 mg β-apo-8-ester/kg body weight (bw) was set by applying a safety factor of 200 to the lowest no observed adverse effect level (NOAEL) of 3 mg/kg bw per day from the subchronic toxicity study based on the absence of lymphoid hyperplasia and granulomas in the mesenteric lymph nodes. Compliance of consumers with the ADI could be reached at maximum concentration of 5 mg/kg feed for layers and 15 mg/kg feed for chickens for fattening. Maximum residue levels (MRLs) were proposed: 20 mg β-apo-8-ester/kg egg yolk, 8 mg β-apo-8-ester/kg liver and 2.5 mg β-apo-8-ester/kg skin/fat. β-Apo-8-ester is not an irritant to skin and eyes, and not a dermal sensitiser. Owing to the absence of information, no conclusions could be made on the risk of users by inhalation. The use of β-apo-8-ester in poultry feed at a maximum of 80 mg/kg would not likely pose a risk to the environment. β-Apo-8-ester is effective as a yellow colourant for egg yolk, and skin and shank of broilers. The equally effective doses of β-apo-8-ester in water for drinking are half of those in feed. Conclusions on safety and efficacy for chickens were extended to minor poultry species and categories. No conclusion can be made for turkeys since no data were provided for this major animal species.