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[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Arginine
ammonia clearance
blood pressure
endothelium-dependent vasodilation
erectile function
health claims
immune system
intestinal tract
me nerveux
muscle mass
physical performance and condition
red blood cell formation
spermatogenesis
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is L-arginine.
Arginine is an alpha-amino acid present in foods from animal and vegetable origin. The L-form is the most commonly found form in nature and in food supplements. L-arginine is also known as (S)-2- amino-5-guanidinopentanoic acid and (S)-2-amino-5-[(aminoiminomethyl)amino] pentanoic acid. The terms L-arginine and arginine are frequently used interchangeably. The content of L-arginine in foods can be measured by established methods.
Arginine is a conditionally indispensable amino acid provided by mixed dietary protein intakes from different sources. Arginine can also be consumed in the form of food supplements as L-arginine.
The Panel considers that the food constituent, L-arginine, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Funkcje układu odpornościowego (ID 455, 1713)
The claimed effect is “for immune system functions”. The Panel assumes that the target population is 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.
2.2. Wzrost lub utrzymanie masy mięśniowej (ID 456, 1712, 4681)
The claimed effects are “for muscle integrity and haematopoiesis (red blood cells building)”, “structural aminoacid for muscular growth”, and “increases muscle mass”. The Panel assumes that the target population is 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. Failure to increase muscle mass during growth and development, and the loss of muscle mass at any age, will reduce muscle strength and power.
The Panel considers that growth or maintenance of muscle mass is a beneficial physiological effect.
2.3. Prawidłowe tworzenie erytrocytów (czerwonych krwinek) (ID 456, 664, 1443, 1712)
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 Panel assumes that the target population is 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 normal formation of red blood cells.
Panel considers that normal red blood cell formation is a beneficial physiological effect.
2.4. Utrzymanie prawidłowego ciśnienia tętniczego (ID 664, 1443)
The claimed effects are “vascular system (blood pressure, circulation, vessels)” and “vascular health; blood circulation”. The Panel assumes that the target population is 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.
Blood pressure is the pressure (force per unit area) exerted by circulating blood on the walls of blood vessels. Elevated blood pressure, by convention above 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise normal arterial and cardiac function.
The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.
2.5. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 664, 1443, 4680)
The claimed effects are “vascular system (blood pressure, circulation, vessels)”, “vascular health; blood circulation”, and “normal blood circulation as a nitric oxide precursor”. The Panel assumes that the target population is 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.
2.6. Sprawność fizyczna (ID 1820)
The claimed effect is “physical performance and condition”. The Panel assumes that the target population is 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.
2.7. Układ nerwowy (ID 608)
The claimed effect is “système nerveux”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no further details were given in the proposed wordings. No clarifications were provided by Member Sates.
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.
2.8. Utrzymanie prawidłowej erekcji (ID 649, 4682)
The claimed effects are “erection” and “supporting spermatogenesis and local pelvic microcirculation”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effects refer to the maintenance of normal erectile function.
The Panel considers that maintenance of normal erectile function is a beneficial physiological effect.
2.9. Udział w prawidłowej spermatogenezie (tworzeniu plemników) (ID 650, 4682)
The claimed effects are “spermatogenesis” and “supporting spermatogenesis and local pelvic microcirculation”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effects refer to normal spermatogenesis.
The Panel considers that contribution to normal spermatogenesis is a beneficial physiological effect.
2.10. Funkcjonowanie przewodu pokarmowego (ID 740)
The claimed effect is “function of the intestinal tract”. The Panel assumes that the target population is 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.
2.11. Utrzymanie prawidłowego wydalania amoniaku (ID 4683)
The claimed effect is “ureogenesis by increasing ammonia clearance in the body”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal ammonia clearance in the body.
The Panel considers that maintenance of normal ammonia clearance is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Wzrost lub utrzymanie masy mięśniowej (ID 456, 1712, 4681)
A claim on protein and growth and maintenance of muscle has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010).
Arginine is a component of dietary protein, and both endogenous and exogenous arginine contribute to protein synthesis.
The references provided for the scientific substantiation of the claim included a textbook, narrative reviews, a web page, a monograph and opinion papers with no reference to the role of arginine on growth or maintenance of muscle mass, intervention studies on foods/food constituents other than L-arginine, and studies on the effects of arginine consumption on health outcomes other than growth or maintenance of muscle mass (e.g. immunity, endothelial function and hormonal modification). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No references were provided which addressed the effects of arginine on growth or maintenance of muscle. No evidence has been provided that arginine in addition to normal protein intake has an additional role in muscle mass.
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.
3.2. Prawidłowe tworzenie erytrocytów (czerwonych krwinek) (ID 456, 664, 1443, 1712)
The references provided for the scientific substantiation of the claim included narrative reviews and opinion papers with no reference to the role of arginine on red blood cell formation, references on food constituents other than arginine, intervention studies using intravenous arginine administration, which is not relevant to human nutrition, and studies on the effects of arginine consumption on health outcomes other than red blood cell formation. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
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.
3.3. Utrzymanie prawidłowego ciśnienia tętniczego (ID 664, 1443)
The references provided for the scientific substantiation of the claim included narrative reviews and opinion papers with no original data on the effects of arginine intake on blood pressure, references on food constituents other than arginine, intervention studies using intravenous arginine administration, which is not relevant to human nutrition, and studies on the effects of arginine administration on health outcomes other than blood pressure (e.g. endothelial function, clinical course of myocardial infarction, insulin sensitivity, wound healing, immune parameters and erectile function). The Panel
considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Miller (2006) investigated the effects of L-arginine (1,050 mg, as sustained-release preparation) twice daily (total 2.1 g daily) for one week on blood pressure in 29 healthy subjects in an open-label, single-arm intervention. The Panel notes the short duration and uncontrolled nature of the study, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
Clarkson et al. (1996) performed a randomised, double-blind, cross-over study in 27 hypercholesterolaemic subjects aged 19-40 years. Subjects taking HMG CoA reductase inhibitors in a stable dose for >6 months who met the entry criteria for blood cholesterol concentrations (>162 mg/dL) were recruited. Subjects on vasoactive medications were excluded. Subjects received 3x7 g L-arginine daily or placebo during four-week periods, separated by a four-week wash-out period. Plasma arginine concentrations rose from 115 to 231 μmol/L during L-arginine intake. No significant changes in supine blood pressure during the L-arginine or placebo treatment phases were observed. Blood pressure values (systolic/diastolic) before and after treatment did not show any difference. The Panel notes that this study does not show an effect of L-arginine consumption on blood pressure.
Lerman et al. (1998) performed a randomised, double-blind, placebo-controlled parallel intervention to assess the effect of 3 g/day of L-arginine on blood pressure in 26 patients (age ≈49 years) with non-obstructive coronary artery disease. Patients were on cardiovascular treatment during the study, but all medication (except for study treatment) was discontinued one week prior to the measurements. During six months of treatment, no statistically significant difference was observed in mean arterial blood pressure. Data on systolic and diastolic blood pressure were not reported. The Panel notes that this study does not show an effect of L-arginine consumption on blood pressure.
Siani et al. (2000) performed a randomised, single-blind, cross-over intervention study in six healthy men, aged ≈39 years, who received three isocaloric diets during one week each with no wash-out period between the diets. Diet 1 (control) was relatively low in L-arginine (3.4–4 g/day). Diet 2 was an L-arginine-enriched diet (10 g/day) based on natural foods, mainly lentils and nuts. Diet 3 was identical to the control diet, but was supplemented with 10 g/day of an oral L-arginine preparation given three times a day. During Diet 2, potassium and fibre intakes were considerably higher (+0.9 g and +25 g, respectively) than during Diets 1 and 3, because of dietary changes. Blood pressure was significantly lower after the L-arginine diets compared to Diet 1 (control), i.e. -6.2 mmHg (95% CI, -0.5 to -11.8) systolic and -5.0 mmHg (95% CI, -2.8 to -7.2) diastolic for Diet 2, and -6.2 mmHg (95% CI, -1.8 to -10.5) systolic and -6.8 mmHg (95% CI, -3.0 to -10.6) diastolic for Diet 3. The Panel notes the small number of subjects included in the study, the lack of assessment of carry-over effects between interventions, and the short duration of the intervention, which does not allow conclusions to be drawn on the sustainability of the effect. The Panel considers that only limited conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
Evans et al. (2004) studied the effect on blood pressure of different doses of arginine (3, 9, 21 and 30 g/day) given for consecutive periods of one-week each to 12 healthy subjects. No significant changes in systolic or diastolic blood pressure were observed during the study. The Panel notes that this study does not show an effect of L-arginine consumption on blood pressure.
Three randomised, placebo-controlled, human intervention studies assessed the acute effects of L-arginine intake on blood pressure (i.e. arginine consumption lasting up to three days, Huynh and Tayek, 2002; Lekakis et al., 2002; Nagaya et al., 2001). Whereas L-arginine consumption acutely decreased brachial systolic and diastolic blood pressure (Huynh and Tayek, 2002) and mean pulmonary arterial blood pressure (Nagaya et al., 2001) in two studies, no effect on brachial systolic or diastolic blood pressure was observed in the third study (Lekakis et al., 2002). The Panel considers that results obtained in these studies are inconsistent with respect to the acute effects of arginine
consumption on blood pressure, and that no conclusions can be drawn from these studies for a sustained effect of L-arginine on blood pressure.
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 (Siani et al., 2000), two small longer-term studies did not observe a significant effect (Clarkson et al., 1996; Lerman et al., 1998), and that the results from the studies assessing the acute effects of arginine consumption on blood pressure are inconsistent.
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.
3.4. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 664, 1443, 4680)
The references provided for the scientific substantiation of the claim included narrative reviews and opinion papers with no original data on the effects of arginine intake on vasodilation, references on food constituents other than arginine, intervention studies using intravenous arginine administration, which is not relevant to human nutrition, and studies on the effects of arginine administration on health outcomes other than endothelium-dependent vasodilation (e.g. blood pressure, clinical course of myocardial infarction, insulin sensitivity, wound healing, immune parameters and erectile function). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
In one study in hypertensive patients, only the acute effect of arginine intake on endothelium-dependent vasodilation was assessed, and no information on sustained effects was provided (Lekakis et al., 2002). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
Miller (2006) investigated the effects of L-arginine (1,050 mg, as sustained-release preparation) twice daily (total 2.1 g daily) for one week on endothelial function in 29 healthy subjects in an open-label, single-arm intervention. The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
Lerman et al. (1998) performed a six-month randomised, double-blind, placebo-controlled parallel intervention to assess the effect of 3 g/day of L-arginine on coronary blood flow and epicardial coronary artery diameter in response to selective infusion of acetylcholine in 26 patients (age ≈49 years) with non-obstructive coronary artery disease. Patients were on cardiovascular treatment during the study, but all medication (except for study treatment) was discontinued at least 72 hours prior to the measurements. None of the subjects received cholesterol-lowering medications. All the patients were referred for the evaluation of stable exertional chest pain suspected to be of cardiac origin. Before the coronary angiogram, 10 patients (77 %) from each group underwent a non-invasive functional test, which was positive and consistent with myocardial ischemia in six patients from group 1 and five patients from group 2. Measures of peripheral endothelial function, for example flow-mediated dilation of the brachial artery, were not obtained in this study. The Panel considers that the evidence provided does not establish that patients with non-obstructive coronary artery disease including myocardial ischemia are representative of the general population with respect to the endothelial function of the coronary arteries. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
Blum et al. (2000) provided 9 g/day of L-arginine or placebo to ten healthy post-menopausal women (aged 55±5 years) in a randomised cross-over study. Intervention periods lasted one month and were separated by a one-month wash-out period. The study was powered to detect a difference of 1.7 % in flow-mediated (endothelium-dependent) dilation after hyperaemia between the study periods. Plasma L-arginine concentrations significantly increased during the intervention, whereas no significant changes were observed in serum nitric oxide or soluble cell adhesion molecules (E-selectin, ICAM-1
and VCAM-1). No significant differences between treatment periods were observed on endothelium-dependent vasodilation. The Panel notes that this study does not show an effect of L-arginine consumption on the improvement of endothelium-dependent vasodilation.
Clarkson et al. (1996) performed a randomised, double-blind, cross-over study in 27 hypercholesterolaemic subjects aged 19-40 years. Those taking HMG CoA reductase inhibitors in a stable dose for >6 months who met the entry criteria for blood cholesterol concentrations (>162 mg/dL) were recruited. Subjects on vasoactive medication were excluded. Subjects received 3x7 g L-arginine daily or placebo during four-week periods, separated by a four-week wash-out period. The non-invasive assessment of endothelium-dependent dilation was performed before and at the end of each treatment period. Post-treatment studies were performed between 1 and 2 h after the last dose of L-arginine or placebo. Plasma arginine concentrations rose from 115 to 231 μmol/L during L-arginine intake. There was a significant improvement in flow-mediated dilation in subjects while taking L-arginine (1.7±1.3 % to 5.6±3.0 %) compared with placebo (2.3±1.9 % to 2.3±2.4 %). The change with L-arginine was 3.9±3.0 % vs. 0.1±2.2 % with placebo (p<0.001). No significant differences were observed in endothelium-independent vasodilation (i.e. in response to nitroglycerine). Flow-mediated dilation improved, by more than 2 %, in 67 % of the subjects who consumed L-arginine. The Panel notes that the observed changes in endothelium-dependent vasodilation could have been due to an acute effect of arginine occurring 1-2 hours after intake in the second flow-mediated dilation test. The Panel also notes that the evidence provided does not establish that acute changes in endothelium-dependent vasodilation constitute a beneficial physiological effect per se.
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.
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.
3.5. Utrzymanie prawidłowej erekcji (ID 649, 4682)
The references provided for the scientific substantiation of the claim included general reviews, a web page, a monograph, human intervention studies, animal studies and in vitro experiments on food/food constituents other than L-arginine, and/or effects other than erectile function (i.e. oligoasthenospermia, asthenospermia and sperm motility). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
Two human intervention studies examined the effect of L-arginine glutamate or L-arginine aspartate alone or in combination with other compounds (i.e. yohimbine hydrochloride and pine bark extract) on erectile function. The Panel considers that no conclusions can be drawn from studies using a fixed combination for the substantiation of a claim on arginine alone.
Chen et al. (1999), in a randomised, double-blind, placebo-controlled study investigated the ability of L-arginine to improve erections in 50 male subjects with confirmed organic erectile dysfunction of >6 months duration. The first two weeks of the study were a single-blind, placebo run-in phase; at the end of this period the patients were randomised and received 5 g of L-arginine monohydrochloride or placebo daily for six weeks. A penile haemodynamic test assessing peak systolic velocity, end diastolic velocity and resistance index was used as an objective measure of erectile function. Subjective measures included the O'Leary questionnaire, which contained 11 questions on sexual drive, erectile function and overall sexual satisfaction, and a questionnaire on sexual function which addressed the number and quality of the erections, libido and sexual performance. No significant differences between groups were observed in either the objective measures or the subjective estimates of erectile function. The Panel notes that this study does not show an effect of L-arginine consumption on erectile function.
Klotz et al. (1999), in a randomised, placebo-controlled, cross-over study, investigated the effects of 500 mg L-arginine three times daily in 32 subjects with erectile dysfunction of >12 months duration. Between changes in treatment, the subjects had a wash-out phase of one week. Efficacy was assessed using the validated Köln Questionnaire of Erectile Dysfunction (KEED). No significant differences on erectile function between groups were observed. The Panel notes that this study does not show an effect of L-arginine consumption on erectile function.
The remaining reference was a study on the long-term oral administration of L-arginine on rat erectile response (Moody et al., 1997). The Panel considers that while effects shown in animal studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of arginine consumption on normal erectile function in humans.
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.
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.
3.6. Udział w prawidłowej spermatogenezie (tworzeniu plemników) (ID 650, 4682)
The references provided for the scientific substantiation of the claim included general reviews, a web page, a monograph, human intervention studies, animal studies and in vitro experiments on foods/food constituents other than L-arginine, and/or effects other than spermatogenesis (i.e. erectile function). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
One human intervention study (De Aloysio et al., 1982) investigated the effect of arginine aspartate (providing arginine and aspartic acid) in subjects with asthenospermia or oligoasthenospermia. The Panel considers that no conclusions can be drawn from a study using a fixed combination for the substantiation of a claim on arginine alone.
In a randomised human intervention study by Aydin et al. (1995), 45 subjects with various degrees of oligospermia and asthenospermia were treated with L-arginine (2x5 g/day, n=15), the anti-inflammatory agent indomethacin (75 mg/day, n=15) or the enzyme kallikrein (100 Ku/day, n=15) for three months to encompass a complete cycle of spermatogenesis. The Panel notes the absence of an appropriate control group in this study, and considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
In the study described by Scibona et al. (1994) L-arginine-HCL (80 mL of 10 % L-arginine-HCL administered for 6 months daily) was administered to 40 asthenospermic subjects to assess its effects on sperm motility. The Panel notes the absence of a control group in this study, and considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claimed effect.
In an in vitro study the effects on sperm motility of adding L-arginine to sperm cell suspensions from idiopathic or diabetic asthenozoospermic subjects was assessed (Morales et al., 2003). The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of arginine consumption on normal spermatogenesis in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and contribution to normal spermatogenesis.
3.7. Utrzymanie prawidłowego wydalania amoniaku (ID 4683)
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 references provided for the scientific substantiation of the claim included a monograph, a general review, two in vitro experiments on the control of the urea cycle by factors other than arginine, and one animal study demonstrating the synthesis of urea from arginine and uric acid in the kidney of the frog. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claimed effect.
No references were provided which addressed the effects of arginine on ammonia clearance.
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. However, 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.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Utrzymanie prawidłowego wydalania amoniaku (ID 4683)
The Panel considers that the following wording reflects the scientific evidence: “arginine contributes to the maintenance of normal ammonia clearance”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
5.1. Utrzymanie prawidłowego wydalania amoniaku (ID 4683)
The Panel considers that no conditions of use can be defined for L-arginine.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, L-arginine, which is the subject of the health claims, is sufficiently characterised.
“Immune system functions” (ID 455, 1713)
The claimed effect is “for immune system functions”. The target population is assumed to be the general population.
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 (ID 456, 1712, 4681)
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, it is assumed that the claimed effects refer to the growth or maintenance of muscle mass by decreasing muscle breakdown, increasing muscle synthesis, or both. Growth or maintenance of muscle mass is a beneficial physiological effect.
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 (ID 456, 664, 1443, 1712)
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, it is assumed that the claimed effects refer to normal formation of red blood cells. Normal red blood cell formation is a beneficial physiological effect.
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 (ID 664, 1443)
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, it is assumed that the claimed effects refer to the maintenance of normal blood pressure. Maintenance of normal blood pressure is a beneficial physiological effect.
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 (ID 664, 1443, 4680)
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, it is assumed that the claimed effects refer to the improvement of endothelium-dependent vasodilation. Improvement of endothelium-dependent vasodilation may be a beneficial physiological effect.
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” (ID 1820)
The claimed effect is “physical performance and condition”. The target population is assumed to be the general population.
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” (ID 608)
The claimed effect is “système nerveux”. The target population is assumed to be the general population.
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 (ID 649, 4682)
The claimed effects are “erection” and “supporting spermatogenesis and local pelvic microcirculation”. The target population is assumed to be the general male population. Maintenance of normal erectile function is a beneficial physiological effect.
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 (ID 650, 4682)
The claimed effects are “spermatogenesis” and “supporting spermatogenesis and local pelvic microcirculation”. The target population is assumed to be the general male population. Contribution to normal spermatogenesis is a beneficial physiological effect.
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” (ID 740)
The claimed effect is “function of the intestinal tract”. The target population is assumed to be the general population.
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 (ID 4683)
The claimed effect is “ureogenesis by increasing ammonia clearance in the body”. The target population is assumed to be the general population. Maintenance of normal ammonia clearance is a beneficial physiological effect.
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 following wording reflects the scientific evidence: “Arginine contributes to the maintenance of normal ammonia clearance”.
No conditions of use can be defined for L-arginine.
