Scientific Opinion on the substantiation of a health claim related to
L-ornithine and contribution to the regulation of the urea cycle (ID 4270)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
L-Ornithine
health claims
urea cycle
1. Charakterystyka żywności / składnika
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Udział w regulacji przebiegu cyklu mocznikowego
The food constituent that is the subject of the health claim is L-ornithine.
L-Ornithine is a non-proteinogenic amino acid that plays a role in the urea cycle. L-Ornithine is also known as (+)-(S)-2,5-diaminovaleric acid.
The Panel considers that the food constituent, L-ornithine, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Udział w regulacji przebiegu cyklu mocznikowego
The claimed effect is “ornithine helps to normalize liver function”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claim refers to the role of L-ornithine in the regulation of the urea cycle.
The Panel considers that contribution to the regulation of the urea cycle is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Udział w regulacji przebiegu cyklu mocznikowego
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Udział w regulacji przebiegu cyklu mocznikowego
The references provided in relation to the claim were narrative reviews on the management of urea cycle disorders. These reviews did not provide original data for the scientific substantiation of the claim.
In the liver, ammonia is converted to urea by a system of carrier molecules and enzymes (i.e. the urea cycle) where L-ornithine is synthesised from L-arginine and converted into citrulline by the enzyme ornithine transcarbamylase. This cycle allows the disposal of excess nitrogen by converting the highly toxic ammonia into urea, which is removed from the circulation by the kidneys and excreted in the
urine. L-ornithine is synthesised de novo in the intestine from the dispensible amino acids glutamine/glutamate and arginine (Matthews DE, 2006).
No evidence has been provided for a contribution of dietary L-ornithine to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L-ornithine and contribution to the regulation of the urea cycle.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, L-ornithine, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “ornithine helps to normalize liver function”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claim refers to the role of L-ornithine in the regulation of the urea cycle. Contribution to the regulation of the urea cycle is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of L-ornithine and contribution to the regulation of the urea cycle.
