Scientific Opinion on the substantiation of health claims related to the raw
fruit of Emblica officinalis Gaertn. and maintenance of normal blood
LDL-cholesterol concentrations (ID 4041) and protection of DNA, proteins
and lipids from oxidative damage (ID 4042) 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:
Emblica officinalis Gaertn
1. Charakterystyka żywności / składnika
The food that is the subject of the health claims is “Emblica officinalis fruit rind”.
Emblica officinalis Gaertn. (synonym of the species Phyllanthus emblica L., also know as Indian gooseberry) is a tree of the Phyllanthaceae family (genus Phyllanthus) and it is known for its edible, round, light green fruits of the same name. The proposed conditions of use refer to powder and aqueous extract (ID 4041, 4042) and to raw fruit and raw fruit extract (ID 4041). The Panel notes that no information on the composition or manufacturing process of the powder and aqueous extract, or of the raw fruit extract, has been provided. However, the Panel notes that, from the references provided (Jacob et al., 1988), the raw fruit of Emblica officinalis Gaertn. can be characterised for its content of ascorbic acid, pectins, tannins and fibre in relation to the claimed effects.
The Panel considers that the food, the raw fruit of Emblica officinalis Gaertn., which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 4041)
The claimed effect is “cardiovascular”. 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 blood LDL-cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.14 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.
2.2. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 4042)
The claimed effect is “antioxidant, immunity”. 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 protection of DNA, proteins and lipids from oxidative damage.
The Panel considers that claims made on the antioxidant capacity/content of foods based on their capability of scavenging free radicals in vitro refer to a property of the food/food constituent measured in model systems, and that the information provided does not establish that this exerts a beneficial physiological effect in humans as required by Regulation (EC) No 1924/2006.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation, pollutants). These reactive intermediates damage molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers such as antioxidant nutrients.
The Panel considers that protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 4041)
Among the references provided were a number of textbooks and monographs which did not provide any original data for the scientific substantiation of the claim. One narrative review on antioxidant properties was not related to the claimed effect. A number of references provided were in Japanese and the translation into a EU language was not available to the Panel. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One reference reported on an uncontrolled human intervention study which investigated the effect of 50 g of the raw fruit Emblica officinalis Gaertn. consumed for four weeks on total, HDL- and LDL-blood cholesterol concentrations in 20 hypercholesterolaemic and 15 normocholesterolaemic subjects (Jacob et al., 1988). The Panel notes that this study was uncontrolled and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of the claim. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of Emblica officinalis Gaertn. consumption on maintenance of normal blood LDL-cholesterol concentrations in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the raw fruit of Emblica officinalis Gaertn. and maintenance of normal blood cholesterol concentrations.
3.2. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 4042)
Among the references provided for the scientific substantiation of the claim were two references which were not accessible to the Panel even after every reasonable effort had been made to retrieve them, and a number of textbooks which did not include any original data for the scientific
substantiation of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel notes that no human studies which addressed outcomes related to the claimed effect have been provided. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of Emblica officinalis Gaertn. consumption on protection of DNA, proteins and lipids from oxidative damage in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the raw fruit of Emblica officinalis Gaertn. and protection of DNA, proteins and lipids from oxidative damage.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, the raw fruit of Emblica officinalis Gaertn., which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
Maintenance of normal blood LDL-cholesterol concentrations (ID 4041)
The claimed effect is “cardiovascular”. The target population is assumed to be the general population. Maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the raw fruit of Emblica officinalis Gaertn. and maintenance of normal blood LDL-cholesterol concentrations.
Protection of DNA, proteins and lipids from oxidative damage (ID 4042)
The claimed effect is “antioxidant, immunity”. The target population is assumed to be the general population. Protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the raw fruit of Emblica officinalis Gaertn. and protection of DNA, proteins and lipids from oxidative damage.
