Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and contribution to normal lipid metabolism.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.
The general approach of the NDA Panel for the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on health claim applications and the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.
The food proposed by the applicant as the subject of the health claim is L-carnitine. The Panel considers that, the food/constituent, which is the subject of the health claim, L-carnitine, is sufficiently characterised.
The claimed effect proposed by the applicant is ‘normal lipid metabolism’. The target population proposed by the applicant is the general population. The Panel considers that contribution to normal lipid metabolism is a beneficial physiological effect.
The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient.
The Panel acknowledges that L-carnitine is needed for the transport of long-chain fatty acids across the mitochondrial membrane, and therefore for their use as energy substrate. The Panel notes, however, that the human body is able to synthesise L-carnitine from methionine and lysine, and that there is consensus that L-carnitine is not an essential nutrient. No dietary reference values have been set for L-carnitine.
The Panel notes that L-carnitine is considered an indispensable nutrient for (both preterm and term) infants because of a temporarily insufficient synthesising capacity, and that this is the reason why a minimum L-carnitine content in infant formula has been established. The Panel also notes, however, that this insufficient capacity to synthesise carnitine cannot be extrapolated to any other subgroup of the general healthy population, for which the claim is intended.
Carnitine deficiency understood as clinical symptoms which can be corrected by carnitine administration has not been demonstrated in any other healthy population subgroup. In this context, the references submitted by the applicant on carnitine transporter deficiency syndromes do not provide evidence that dietary L-carnitine is required to maintain normal lipid metabolism in the target population for the claim (general healthy population); no evidence was provided that dietary carnitine could reverse the symptoms developed by the patient on long-term total parenteral nutrition and the supplementation studies with L-carnitine in healthy subjects do not provide information on whether dietary carnitine is required to maintain normal lipid metabolism (including normal fat oxidation), but rather on whether supplemental carnitine could modify the rate of fat oxidation under certain conditions. Therefore, the Panel considers that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population for which the claim is intended.
On the basis of data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population.