Scientific Opinion on the safety and efficacy of L-carnitine as a feed additive for all animal species based on a dossier submitted by EUROPE-ASIA Import Export GmbH

Abstract

L-Carnitine has a key role in the metabolism of fatty acids as a "substrate" for the reversible acetylation of coenzyme A and as a carrier for the transport of long chain fatty acids from cytosol across the inner mitochondrial membrane. L-Carnitine administered via feed or water for drinking is considered safe for the target species. The additive appears to have a wide margin of safety (> 10) at the levels typically used (10-50 mg/kg feed). Very little information is available on the toxicology of L-carnitine. Nevertheless, based on residue data obtained from multi-fold doses of the typical use levels, the FEEDAP Panel concluded that typical supplementation of feed with L-carnitine would not substantially increase human exposure to carnitine from food of animal origin. Therefore, the FEEDAP Panel considers that the use of L-carnitine as an additive in animal nutrition is safe for the consumer. No data were provided to address user safety. In the absence of data, L-carnitine should be considered as potentially irritant to skin and eye, and as a potential skin sensitiser and inhalatory toxicant. The use of L-carnitine in animal nutrition is not expected to pose a risk to the environment. L-Carnitine was regarded as an effective source of L-carnitine in all animal species. SUMMARYFollowing 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 L-carnitine as an additive to feed and water for drinking for all animal species.L-Carnitine has a key role in the metabolism of fatty acids as a "substrate" for the reversible acetylation of coenzyme A and as a carrier for the transport of long chain fatty acids from cytosol across the inner mitochondrial membrane. Adult animals can synthesise carnitine from its precursor lysine; however, the endogenous synthesis might be insufficient in juvenile animals. Nutritional requirement data for the different animal species and categories have not been established.Oral administration routes of L-carnitine via feed or water for drinking are considered bioequivalent. L-Carnitine is safe for the target species. The additive appears to have a wide margin of safety (> 10) at the levels typically used (10-50 mg L-carnitine/kg feed).Very little information is available on the toxicology of L-carnitine. Nevertheless, based on residue data obtained from multi-fold doses of the typical use levels, the FEEDAP Panel concluded that typical supplementation of feed with L-carnitine would not substantially increase human exposure to carnitine from food of animal origin. As the absorption rate declines with increasing L-carnitine intake the endogenous carnitine pool may not significantly increase. Therefore, the FEEDAP Panel considers that the use of L-carnitine as an additive in animal nutrition is safe for the consumer.No data were provided to address user safety. In the absence of data, L -carnitine should be considered as potentially irritant to skin and eye, and...