Safety Assessment on the Safety and Efficacy of an Additive of Chromium Propionate (KemTRACE Chromium) as a Feed Additive for All Growing Poultry Species (RP634)

An application was submitted to the Food Standards Agency in March 2021 from Kemin (‘the applicant’) for the new authorisation of an additive (KemTRACE Chromium) containing chromium propionate, under the category ‘zootechnical’ additive, functional group ‘other zootechnical additives’. The additive is proposed to be used at an inclusion rate of 0.2 – 0.4 mg/kg of complete feed (12% moisture) for all growing poultry. The Advisory Committee on Animal Feedingstuffs (ACAF) was asked to review the dossier and the supplementary information submitted by the Applicant, and to advise the Food Standards Agency and Food Standards Scotland (FSA/FSS) in evaluating the dossier. The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 24 months at 25 o C at 60% humidity, for 6 months as part of a premixture. Homogeneity in feed was also demonstrated. The mixture was pelleted at 90 o C, but retention time was not given by the applicant, therefore no conclusion could be drawn on pelleting stability. No further concerns were raised for the identity section, Section II, of the dossier. The proposed level of inclusion in feed is safe for the target species, but no margin of safety could be determined. No conclusion could be drawn on the prenatal developmental toxicity potential of the additive, and therefore, on the safety of the additive for consumers. The additive is non-genotoxic, and no concerns about its metabolism were raised, however, no conclusion could be drawn on the applicant’s proposed 0-hour withdrawal period, given the impossibility to conclude on the prenatal developmental toxicity potential of the additive. The active substance is non-irritant to the skin, however another major ingredient, propionic acid, is corrosive to skin and eyes, and the additive should be considered as such. As the active ingredient is corrosive to skin and eyes and it may be sprayed onto the feed, it would be prudent to regard it as potentially harmful by inhalation. The additive is not a skin sensitizer. The additive poses an acceptable risk to the environment. Chromium propionate has the potential to be efficacious for all growing poultry at the maximum proposed dose of 0.4 mg/kg of complete feed with 12% moisture. The views of ACAF have been taken into account in this safety assessment which represents the opinion of the FSA/FSS.