Scientific Opinion on the substantiation of health claims related to taurine
and “immune system protection” (ID 611), “metabolism processes”
(ID 613), contribution to normal cognitive function (ID 1659), maintenance
of normal cardiac function (ID 1661), maintenance of normal muscle
function (ID 1949) and delay in the onset of physical fatigue during exercise
(ID 1958) 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:
Taurine
cognitive function
exercise
fatigue
health claims
heart
immune system
metabolism
muscle
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is taurine (2-amino-ethanesulfonic acid). Taurine is a well recognised nutrient and is measurable in foods by established methods.
Taurine occurs naturally in foods of animal origin and is generally absent from foods of plant origin.
The Panel considers that the food constituent, taurine, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Ochrona układu immunologicznego (ID 611)
The claimed effect is “for immune system protection”. 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 wording or the clarifications provided by Member States. Given the multiple roles of the immune system, the specific aspect of immune function that is the subject of the health 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. Procesy przemiany materii (wykorzystanie glukozy i kofeiny) (ID 613)
The claimed effect is “for metabolism processes (glucose/caffeine uptake)”. 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 wording 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.
2.3. Udział w prawidłowym przebiegu procesów poznawczych (ID 1659)
The claimed effect is “cognitive function/mental health”. The Panel assumes that the target population is the general population.
Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and which can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.
2.4. Utrzymanie prawidłowego funkcjonowania serca (ID 1661)
The claimed effect is “for cardiovascular system health”. 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 effect refers to the maintenance of normal cardiac function.
The Panel considers that maintenance of normal cardiac function is a beneficial physiological effect.
2.5. Utrzymanie prawidłowego funkcjonowania mięśni (ID 1949)
The claimed effect is “fonctionnement musculaire”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect refers to the maintenance of normal muscle function. The Panel notes that from the information provided it is unclear which aspect of muscle function is the subject of the health claim, and none of the references provided for this claim addressed any aspect of muscle function.
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.
2.6. Opóźnienie wystąpienia zmęczenia podczas ćwiczeń fizycznych (ID 1958)
The claimed effect is “tonus/vitality”. The Panel assumes that the target population is active individuals in the general population.
In the context of the proposed wordings and clarifications provided by Member States, and in the context of the references provided, the Panel assumes that the claimed effect refers to a delay in the onset of physical fatigue during exercise.
The Panel considers that a delay in the onset of physical fatigue during exercise is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
Taurine is synthesised in the body from sulphur containing amino acids, especially from cysteine, by oxidation of the sulphur function and decarboxylation. This last step is rate limiting. Compensatory
mechanisms for dietary taurine deprivation (e.g. in vegans) include alteration of the bile salt glycine/taurine ratio, decrease in whole body taurine turnover and reduction of urinary excretion of taurine (Kendler, 1989). Taurine concentrations in tissues, particularly in the brain, are largely independent of taurine intakes. However, endogenous synthesis and usual consumptions can be insufficient to meet the metabolic needs in certain pathological conditions, so that taurine is considered to be a conditionally indispensable amino acid, particularly in preterm infants (Lourenco and Camilo, 2002).
3.1. Udział w prawidłowym przebiegu procesów poznawczych (ID 1659)
The references cited for the substantiation of the claimed effect included a website from a government body and narrative reviews on taurine metabolism and outcomes not related to the claimed effect. The majority of papers addressed outcomes unrelated to the claimed effect such as the management of alcohol dependence, chlorination of taurine by human neutrophils, epilepsy, taurine transport in the heart, heart failure, cell volume regulation, taurine requirements in infants or during long-term parenteral nutrition, insulin-dependent diabetes, fat malabsorption in cystic fibrosis, taurine and exercise in humans and rats, liver injury in rats, hamster sperm, age-related reduction in plasma taurine in rats, retinal degeneration in mice, growth in infant monkeys and nitrogen dioxide lung injury in hamsters. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Two studies investigated the effect of a drink containing taurine, glucuronolactone and caffeine on reaction time, concentration, memory, subjective alertness and physical endurance (Alford et al., 2001), and on cognitive function and mood (Seidl et al., 2000). The Panel considers that no conclusions can be drawn from studies on a fixed combination for the scientific substantiation of a claim on taurine alone.
The Panel concludes that a cause and effect relationship has not been established between the consumption of taurine and contribution to normal cognitive function.
3.2. Utrzymanie prawidłowego funkcjonowania serca (ID 1661)
Fourteen references have been provided for the substantiation of the claim; five of them were not available to the Panel despite reasonable efforts made to retrieve them. Among the available references there were four narrative reviews in which the health relationship was stated without providing original data, two animal studies, two in vitro studies and one human study. Among them, only the human study (Azuma et al., 1992), one ex vivo animal study (Raschke et al., 1995) and one in vitro study (Takahashi et al., 1997) addressed the claimed effect.
The study by Azuma et al. (1992) was an uncontrolled intervention in 10 patients suffering from congestive heart failure who received 3 g/day of taurine (above the proposed condition of use of 75 to 500 mg/day) for 6 weeks while continuing their usual pharmacological treatment. The Panel considers that no conclusion can be drawn from this small uncontrolled study.
The study by Raschke et al. (1995) used a model of ischemia-reperfusion injury in the isolated guinea pig heart, and the study by Takahashi et al. (1997) assessed the effect of taurine on calcium overload in cultured cardiomyocytes. The Panel considers that evidence provided in ex vivo animal studies and in in vitro studies is not sufficient to predict the occurrence of an effect of taurine consumption on maintenance of normal cardiac function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of taurine and maintenance of normal cardiac function.
3.3. Opóźnienie wystąpienia zmęczenia podczas ćwiczeń fizycznych (ID 1958)
The references provided for the substantiation of the claim include two narrative reviews on the health effects of taurine, all unrelated to the claimed effect, and a number of human intervention studies using taurine in combination with other food constituents, including caffeine and glucuronolactone. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
In one single arm, uncontrolled study (Zhang et al., 2004), the effect of taurine supplementation on exercise time to exhaustion was studied in 11 young men (aged 18-20 years). Subjects performed a bicycle ergometer test (rate of 60 rpm with an increased workload of 20 W/min) until exhaustion. After the first exercise test, subjects received supplemental taurine powder at a daily dose of 6 g (2 g three times a day) for 7 days prior to the second exercise test, which was identical to the first test. Maximal oxygen uptake, the exercise time to exhaustion and maximal workload were assessed after each test. The Panel notes that this study was not controlled, and that the study design does not allow controlling for a possible training effect between the first and second cycling tests. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of taurine and a delay in the onset of physical fatigue during exercise.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, taurine, which is the subject of the health claims, is sufficiently characterised.
“Immune system protection” (ID 611)
The claimed effect is “for immune system protection”. 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.
“Metabolism processes” (ID 613)
The claimed effect is “for metabolism processes (glucose/caffeine uptake)”. 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.
Contribution to normal cognitive function (ID 1659)
The claimed effect is “cognitive function/mental health”. The target population is assumed to be the general population. Contribution to normal cognitive function is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of taurine and contribution to normal cognitive function.
Maintenance of normal cardiac function (ID 1661)
The claimed effect is “for cardiovascular system health”. 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 claimed effect is assumed to refer to the maintenance of normal cardiac function. Maintenance of normal cardiac function is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of taurine and maintenance of normal cardiac function.
Maintenance of normal muscle function (ID 1949)
The claimed effect is “fonctionnement musculaire”. The target population is assumed to be the general population. It is assumed that the claimed effect refers to the maintenance of normal muscle function. From the information provided, it is unclear which aspect of muscle function is the subject of the health claim, and none of the references provided for this claim addressed any aspect of muscle function.
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.
Delay in the onset of physical fatigue during exercise (ID 1958)
The claimed effect is “tonus/vitality”. The target population is assumed to be active individuals in the general population. In the context of the proposed wordings and clarifications provided by Member States, and in the context of the references provided, the claimed effect is assumed to refer to a delay in the onset of physical fatigue during exercise. A delay in the onset of physical fatigue during exercise is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of taurine and a delay in the onset of physical fatigue during exercise.
