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EFSA not in favour of Lonza claim on L-carnitine for lipid metabolism
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Friday, 19 January, 2018, 08 : 00 AM [IST]
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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 claim 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 considered that the food/constituent was 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 considered that contribution to normal lipid metabolism is a beneficial physiological effect.
The applicant proposed that the claim submitted with this application was based on the essentiality of a nutrient.
The panel acknowledged 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.
It noted, however, that the human body was able to synthesise L-carnitine from methionine and lysine, and that there was consensus that L-carnitine was not an essential nutrient. No dietary reference values were set for L-carnitine.
The panel added that L-carnitine is considered an indispensable nutrient for (both pre-term 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.
However, it noted that this insufficient capacity to synthesise carnitine cannot be extrapolated to any other sub-group 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 sub-group.
In this context, the references submitted by the applicant on carnitine transporter deficiency syndromes did not provide evidence that dietary L-carnitine was 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 considered that the evidence provided does not establish that dietary L-carnitine was required to maintain normal lipid metabolism in the target population for which the claim was intended.
On the basis of data presented, the panel concluded that a cause-and-effect relationship had not been established between the consumption of L-carnitine and the contribution to normal lipid metabolism in the target population.
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