Scientific Opinion on the safety and efficacy of L‐carnitine and L‐carnitine L‐tartrate as feed additives for all animal species based on a dossier submitted by Lonza Benelux BV

摘要

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 and L‐carnitine L‐tartrate administered via feed or water for drinking are considered safe for the target species. The additives appear to have a wide margin of safety (> 10) at the levels typically used in feed (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 or L‐carnitine L‐tartrate would not substantially increase human exposure to carnitine from food of animal origin. Therefore, the FEEDAP Panel considers that the use of L‐carnitine and L‐carnitine L‐tartrate as additives in animal nutrition is safe for the consumer. L‐Carnitine and L‐carnitine L‐tartrate are not irritant to skin and eyes nor are they skin sensitisers. L‐Carnitine and L‐carnitine L‐tartrate showed limited dust formation. As inhalation toxicity studies were not available, adverse effects in the respiratory tract cannot be fully excluded. The use of L‐carnitine and L‐carnitine L‐tartrate in animal nutrition is not expected to pose a risk to the environment. L‐Carnitine and L‐carnitine L‐tartrate are regarded as an effective source of L‐carnitine in all animal species.