Scientific Opinion on the substantiation of health claims related to L arginine and “immune system functions” (ID 455, 1713), growth or maintenance of muscle mass (ID 456, 1712, 4681), normal red blood cell formation (ID 456, 664, 1443, 1712), maintenance of normal blood pressure (ID 664, 1443), improvement of endothelium-dependent vasodilation (ID 664, 1443, 4680), “physical performance and condition” (ID 1820), “système nerveux” (ID 608), maintenance of normal erectile function (ID 649, 4682), contribution to normal spermatogenesis (ID 650, 4682), “function of the intestinal tract” (ID 740), and maintenance of normal ammonia clearance (ID 4683) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Tabs

Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2011;9(4):2051 [30 pp.].
doi
10.2903/j.efsa.2011.2051
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgements

The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhelm Stahl and Henk van den Berg. The members of the Claims Sub-Working Group on Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter Willatts.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-1242
EFSA-Q-2008-1243
EFSA-Q-2008-1395
EFSA-Q-2008-1436
EFSA-Q-2008-1437
EFSA-Q-2008-1451
EFSA-Q-2008-1527
EFSA-Q-2008-2180
EFSA-Q-2008-2448
EFSA-Q-2008-2449
EFSA-Q-2008-2553
EFSA-Q-2010-00633
EFSA-Q-2010-00634
EFSA-Q-2010-00635
EFSA-Q-2010-00636
Adopted
28 January 2011
Published
8 April 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to L-arginine and “immune system functions”, growth or maintenance of muscle mass, normal red blood cell formation, maintenance of normal blood pressure, improvement of endothelium-dependent vasodilation, “physical performance and condition”, “système nerveux”, maintenance of normal erectile function, contribution to normal spermatogenesis, “function of the intestinal tract”, and maintenance of normal ammonia clearance. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food constituent that is the subject of the health claims is L-arginine. The Panel considers that L arginine is sufficiently characterised.

“Immune system functions”

The claimed effect is “for immune system functions”. The target population is assumed to be the general population.

Given the multiple roles of the immune system, the specific aspect of immune function that is the subject of the claim needs to be specified, but it has not been indicated in the information provided.

The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Growth or maintenance of muscle mass

The claimed effects are “for muscle integrity and haematopoiesis (red blood cells building)”, “structural aminoacid for muscular growth”, and “increases muscle mass”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the growth or maintenance of muscle mass by decreasing muscle breakdown, increasing muscle synthesis, or both. The Panel considers that growth or maintenance of muscle mass is a beneficial physiological effect.

A claim on protein and growth and maintenance of muscle has already been assessed with a favourable outcome.

Arginine is a component of dietary protein, and both endogenous and exogenous arginine contribute to protein synthesis. No evidence has been provided that arginine in addition to normal protein intake has an additional role in muscle mass.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and growth or maintenance of muscle mass, apart from the well established role of protein on the claimed effect.

Normal red blood cell formation

The claimed effects are “vascular system (blood pressure, circulation, vessels)”, “vascular health; blood circulation”, and “for muscle integrity and haematopoiesis (red blood cells building)”. The target population is assumed to be the general population. In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the normal formation of red blood cells. The Panel considers that normal red blood cell formation is a beneficial physiological effect.

No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and normal red blood cell formation.

Maintenance of normal blood pressure

The claimed effects are “vascular system (blood pressure, circulation, vessels)” and “vascular health; blood circulation”. The target population is assumed to be the general population. In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal blood pressure. The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that although a small scale short term (one week) only partially controlled intervention study observed an effect of arginine consumption on blood pressure, two small long-term studies did not observe a significant effect, and that the results from the studies assessing the acute effects of arginine consumption on blood pressure are inconsistent.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and maintenance of normal blood pressure.

Improvement of endothelium-dependent vasodilation

The claimed effects are “vascular system (blood pressure, circulation, vessels)”, “vascular health; blood circulation”, and “normal blood circulation as a nitric oxide precursor”. The target population is assumed to be the general population. In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the improvement of endothelium-dependent vasodilation. The Panel considers that an improvement of endothelium dependent vasodilation may be a beneficial physiological effect.

In weighing the evidence, the Panel took into account that one study did not show an effect of L arginine consumption on endothelium-dependent vasodilation, and that in a second study the observed changes in endothelium-dependent vasodilation could have been due to an acute effect of arginine rather than to a sustained effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and improvement of endothelium-dependent vasodilation.

“Physical performance and condition”

The claimed effect is “physical performance and condition”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined, and no further details were given in the proposed wordings. No further clarifications were provided by Member States.

The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

“Système nerveux”

The claimed effect is “système nerveux”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined, and no further details were given in the proposed wordings. No further clarifications were provided by Member States.

The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Maintenance of normal erectile function

The claimed effects are “erection” and “supporting spermatogenesis and local pelvic microcirculation”. The target population is assumed to be the general male population. The Panel considers that maintenance of normal erectile function is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that the two human intervention studies which investigated the effect of L-arginine consumption on erectile function did not show a significant effect of arginine on erectile function.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and maintenance of normal erectile function.

Contribution to normal spermatogenesis

The claimed effects are “spermatogenesis” and “supporting spermatogenesis and local pelvic microcirculation”. The target population is assumed to be the general male population. The Panel considers that contribution to normal spermatogenesis is a beneficial physiological effect.

No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and contribution to normal spermatogenesis.

“Function of the intestinal tract”

The claimed effect is “function of the intestinal tract”. The target population is assumed to be the general population.

The claimed effect is not sufficiently defined, and no further details were given in the proposed wordings or the clarifications provided by Member States.

The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Maintenance of normal ammonia clearance

The claimed effect is “ureogenesis by increasing ammonia clearance in the body”. The target population is assumed to be the general population. The Panel considers that maintenance of normal ammonia clearance is a beneficial physiological effect.

Arginine participates in the detoxification of ammonia via the urea cycle, which takes place in the liver. Arginine may be obtained from the diet or from endogenous synthesis, and dietary arginine contributes to the claimed effect.

The Panel concludes that a cause and effect relationship has been established between the consumption of L-arginine in a protein adequate diet and maintenance of normal ammonia clearance.

No evidence has been provided that the protein supply in the diet of the European population is not sufficient to fulfil this function of the amino acid.

The Panel considers that no conditions of use can be defined for L-arginine.

Keywords
Arginine, immune system, muscle mass, red blood cell formation, blood pressure, endothelium-dependent vasodilation, physical performance and condition, système nerveux, erectile function , spermatogenesis, intestinal tract, ammonia clearance, health claim
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