Scientific Opinion on the substantiation of health claims related to
astaxanthin and protection of the skin from UV-induced damage (ID 1687,
1979), defence against Helicobacter pylori (ID 1686), contribution to normal
spermatogenesis (ID 1688), contribution to normal muscle function
(ID 1685), and “immune system” (ID 1689, 1919, 1980) 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:
Astaxanthin
Helicobacter pylori
UV-induced damage
health claims
immune system
muscle function
skin
spermatogenesis
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is astaxanthin.
Astaxanthin is a red (non-provitamin A) oxygenated carotenoid found in phytoplankton, and is responsible for the colour of certain fish (e.g. salmon) and shellfish (e.g. crab).
Astaxanthin occurs naturally in foods and also in synthetic forms as free astaxanthin or in the form of esters. Astaxanthin is absorbed into the bloodstream as the free form, and bioavailability can be enhanced in lipid matrices. Astaxanthin is measurable in foods by established methods.
The Panel considers that the food constituent, astaxanthin, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1687, 1979)
The claimed effects are “skin health” and “protects skin from UV damage and sun exposure”. 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 protection of the skin from UV-induced damage (sunburn).
The Panel considers that protection of the skin from UV-induced damage is a beneficial physiological effect.
2.2. Ochrona przed Helicobacter pylori (ID 1686)
The claimed effect is “gut health: influence on Helicobacter pylori infection”. The Panel assumes that the target population is the general population.
Influence on Helicobacter pylori infection could be interpreted as defence against Helicobacter pylori.
The Panel considers that defence against Helicobacter pylori is a beneficial physiological effect.
2.3. Udział w prawidłowym tworzeniu plemników (spermatogenezie) (ID 1688)
The claimed effect is “sperms motility”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and references provided, the Panel assumes that the claimed effect refers to normal spermatogenesis.
The Panel considers that contribution to normal spermatogenesis is a beneficial physiological effect.
2.4. Udział w prawidłowym funkcjonowaniu mięśni (ID 1685)
The claimed effect is “muscle function”. The Panel assumes that the target population is the general population.
The references provided in relation to this claim included human intervention studies on the effects of astaxanthin on endurance capacity, endurance performance, muscle strength, and muscle fatigue during exercise, and animal studies on the effects of astaxanthin on exercise-induced skeletal and cardiac muscle damage, and skeletal muscle fatigue. The Panel notes that from the information provided the aspect of muscle function which is the subject of the health claim is unclear.
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.
2.5. Układ odpornościowy (ID 1689, 1919, 1980)
The claimed effects are “immune system” and “supports healthy immune system”. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined, and no further details were given in the proposed wordings or clarifications provided by Member States. The Panel notes that the references provided addressed several outcomes, and that it was not possible to establish which effect is the target for the claim. 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 has not been indicated in the information provided.
The Panel considers that the claimed effects are general and non-specific, and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1687, 1979)
The references provided included narrative reviews on the effects of carotenoids in general and/or of astaxanthin on different health outcomes, including protection of the skin from UV-induced damage, which did not provide any original data which could be used for the scientific substantiation of the claim, or human intervention studies on the effects of carotenoids other than astaxanthin. The Panel
considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One open label, uncontrolled human intervention study which investigated the effects of astaxanthin consumption (4 mg/day) for two weeks on the minimal erythemal dose in 21 healthy male and female subjects (Cheun et al., year not given) was provided. The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
A number of animal and in vitro studies reported on the effects of astaxanthin on UV-induced cellular damage to the skin or cultured cells (e.g. cyst cells and fibroblasts). The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of astaxanthin consumption on protection of the skin from UV-induced damage in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of astaxanthin and protection of the skin from UV-induced damage.
3.2. Ochrona przed Helicobacter pylori (ID 1686)
Among the references provided for the scientific substantiation of the claim were animal and human intervention studies which addressed health outcomes (i.e. markers of oxidative stress in patients with reflux oesophagitis before and after anti-reflux surgery; experimental gastritis, oesophagitis, gastric ulcers in mice, rat and guinea pig models) unrelated to the claimed effect, and one human intervention study which was not accessible to the Panel after every reasonable effort had been made to retrieve it.
Kupcinskas et al. (2008), in a placebo-controlled, randomised, double-blind study, evaluated the effect of astaxanthin (16 or 40 mg/day) given for four weeks on gastrointestinal discomfort assessed with the Gastrointestinal Symptom Rating Scale questionnaire and the SF-36 quality of life questionnaire. The Panel notes that the effect of astaxanthin on Helicobacter pylori infection was not addressed in this study.
The animal studies provided evaluated the effect of astaxanthin on the treatment of Helicobacter pylori infection. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of astaxanthin consumption on defence against Helicobacter pylori infection in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of astaxanthin and defence against Helicobacter pylori.
3.3. Udział w prawidłowym tworzeniu plemników (spermatogenezie) (ID 1688)
Two references were submitted for the scientific substantiation of the claim.
In a randomised, double-blind, placebo-controlled human intervention study, 20 men with infertility for ≥12 months received conventional treatment according to the guidelines of the World Health Organization (WHO), and either astaxanthin (16 mg/day, n=11) or placebo (n=9) for three months. Ten additional patients receiving placebo who had participated in another parallel, placebo-controlled trial were included in the analysis. No statistically significant differences were observed between the astaxanthin and placebo groups with respect to changes in any of the variables used to assess sperm quality (e.g. sperm concentration, linear velocity, grade (a) motility, sperm morphology, ejaculate volume, zona-free hamster oocytes test, spermatozoa firmly attached/oocytes, and decondensed sperm heads/oocytes) during the study. The Panel notes that this study did not show an effect of astaxanthin consumption on sperm quality.
An animal study on the effects of astaxanthin consumption on semen quality and fertility in stallions during the breeding period (Heczko, 2004) was also provided. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of astaxanthin consumption on contribution to normal spermatogenesis in humans.
In weighing the evidence, the Panel took into account that the one human intervention study provided did not show an effect of astaxanthin, compared to placebo, on various measures of sperm quality in males.
The Panel concludes that a cause and effect relationship has not been established between the consumption of astaxanthin and contribution to normal spermatogenesis.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, astaxanthin, which is the subject of the health claim, is sufficiently characterised.
Protection of the skin from UV-induced damage (ID 1687, 1979)
The claimed effects are “skin health” and “protects skin from UV damage and sun exposure”. The target population is assumed to be the general population. Protection of the skin from UV-induced damage is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of astaxanthin and protection of the skin from UV-induced damage.
Defence against Helicobacter pylori (ID 1686)
The claimed effect is “gut health: influence on Helicobacter pylori infection”. The target population is assumed to be the general population. Defence against Helicobacter pylori is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of astaxanthin and defence against Helicobacter pylori.
Contribution to normal spermatogenesis (ID 1688)
The claimed effect is “sperms motility”. 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 astaxanthin and contribution to normal spermatogenesis.
Contribution to normal muscle function (ID 1685)
The claimed effect is “muscle function”. The target population is assumed to be the general population. From the information provided, the aspect of muscle function which is the subject of the health claim is unclear.
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.
“Immune system” (ID 1689, 1919, 1980)
The claimed effects are “immune system” and “supports healthy immune system”. The target population is assumed to be the general population. The references provided addressed several outcomes, and it was not possible to establish which effect is the target for the claim.
The claimed effects are general and non-specific, and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
