Scientific Opinion on the safety and efficacy of erythrosine in feed for cats and dogs, ornamental fish and reptiles

Erythrosine (E 127), an approved colourant in food, is intended to be used in feedingstuffs for cats, dogs, ornamental fish and reptiles without quantitative limitation. Since the additive is only applied for non food-producing animals, the assessment of safety was limited to the target species and the user. The FEEDAP Panel concludes that the maximum use level indicated by the applicant (500 mg/kg complete feed) is not safe for the target species cats and ornamental fish. Based on data from a two-year study in dogs, with a limited range of endpoints, and applying a safety factor of 10, 1000 mg erythrosine/kg complete feed could be derived as the maximum safe concentration. No conclusion could be drawn on the safety of erythrosine for reptiles. However, since erythrosine contains 56.5 % iodine, compliance with the maximum iodine content established in the EU for feed of different animal species would limit the maximum erythrosine content to 35 mg/kg complete feed for ornamental fish and 18 mg/kg complete feed for the other target species. Erythrosine was not irritant to skin or eyes in rabbits. It was not a skin sensitiser in guinea pigs and mice and was also negative in human skin patch testing. However, dermatological reactions, including photosensitivity, erythroderma and desquamation, have been attributed to erythrosine. Since 90 % of the particles have a diameter < 10 m, an exposure of the lower respiratory tract was considered a hazard. No inhalation toxicity studies were available. A quantitative assessment of the efficacy of erythrosine in adding colour to feedingstuffs appeared necessary considering the variety of feed materials used in the relevant complementary and complete feedingstuffs and the very limited food use. An assessment of efficacy with respect to the variables mentioned was not possible due to the absence of data.