1. Charakterystyka żywności / składnika

The food that is the subject of the health claims is wheat germ oil.
In the context of the references provided (Alessandri et al., 2006; Kahlon, 1989; Ostlund et al., 2003), the Panel assumes that wheat germ oil is extracted from the germ of the wheat kernel, that is rich in n-6 fatty acids, mainly linoleic acid (~60 %), and that also contains oleic acid (~10-12 %), alpha- linolenic acid (~7-9 %) and saturated fatty acids (~20 %), mainly palmitic acid. Wheat germ oil also contains vitamin E (~150 mg/100 g), octacosanol (a very-long-chain fatty alcohol present in plant waxes), phytosterols (~550 mg/100 g), vitamin K (~ 25 μg/100 g) and choline (~20 mg/100 g).
The Panel notes that wheat germ oil contains about 60 % of linoleic acid (LA) and 7-9 % alpha- linolenic acid (ALA). Claims on LA and on ALA, both related to the maintenance of normal cholesterol concentrations in the context of article 13 claims under Regulation (EC) 1924/2006 have already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009a,b). Therefore the Panel will address in the present opinion whether consumption of wheat germ oil has an effect on blood cholesterol concentrations beyond what could be expected from its content in LA and ALA.
The Panel considers that the food, wheat germ oil, which is the subject of the health claims is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 1386)

The claimed effect is “cardiovascular system”. 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 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 the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.

2.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 599, 2618)

The claimed effects are “cholesterol” and “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claim refers to the maintenance of normal blood 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. High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver).
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

2.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2618)

The claimed effect is “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. 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 concentrations of triglycerides.
Triglycerides in plasma are either derived from dietary fats or synthesised in the body from other energy sources like carbohydrates. In fasting conditions, serum triglycerides are mainly transported in very-low-density lipoproteins (VLDL) synthesised in the liver. Excess energy intake with a meal is converted to triglyceride and transported to the adipose tissue for storage. Hormones regulate the release of triglycerides from adipose tissue in order to meet energy needs between meals. Normal values for blood concentrations of triglycerides have been defined.
The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.

2.4. Ochrona skóry przed uszkodzeniem promieniami ultrafioletowymi (UV) (ID 600)

The claimed effect is “skin hydration/skin protection”. 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 the skin from photo-oxidative (UV-induced) damage.
The Panel considers that the protection of the skin from photo-oxidative (UV-induced) damage is a beneficial physiological effect.

2.5. Utrzymanie prawidłowego nawilżenia skóry (ID 600, 1390)

The claimed effect is “skin hydration/skin protection” and “skin health”. 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 maintenance of normal skin hydration.
The Panel considers that maintenance of normal skin hydration is a beneficial physiological effect.

2.6. Utrzymanie prawidłowego stanu kości (ID 1389)

The claimed effect is “metabolism”. 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 bone.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.

2.7. Udział w prawidłowym przebiegu funkcji neurologicznych (ID 1387)

The claimed effect is “nervous system”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the contribution to normal neurological function.
The Panel considers that contribution to normal neurological function is a beneficial physiological effect.

2.8. Udział w prawidłowym przebiegu procesów poznawczych (ID 1394)

The claimed effect is “mental health”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to cognitive function. Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.

2.9. Udział w utrzymaniu prawidłowej płodności (ID 1392)

The claimed effect is “fertility”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal fertility is a beneficial physiological effect.

2.10. Ulga w bólach miesiączkowych (ID 1395)

The claimed effect is “menstrual health”. The Panel assumes that the target population is women of the child-bearing age.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the relief of menstrual pain.
The Panel considers that relief of menstrual pain is a beneficial physiological effect.

2.11. Układ pokarmowy / trawienny (ID 1388)

The claimed effect is “digestive system”. The Panel assumes that the target population is the general population.
“Digestive system” is not sufficiently defined. No clarifications were provided by Member States and no more details were contained in the proposed wording which could be used to define the claimed effect. 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.

2.12. Ochrona komórek przed przedwczesnym starzeniem (ID 1393, 2616)

The claimed effects are “antioxidant, source de vitamine E” and “antioxidant properties”. The Panel assumes that the target population is the general population.
The proposed wordings include “fights against cellular aging”, and “retards the aging process”.
No definition has been provided of “cellular aging” or of “aging process” in relation to the antioxidant properties of foods.
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. Utrzymanie prawidłowego ciśnienia tętniczego (ID 1386)

One randomised double-blind parallel trial in humans was provided for the substantiation of the claim (Alessandri et al., 2006). No data on blood pressure were provided in this study. The Panel considers that no conclusions can be drawn from this study 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 wheat germ oil and maintenance of normal blood pressure.

3.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 599, 2618)

Most of the references provided for the scientific substantiation of the claim reported on foods other than wheat germ oil (wheat germ, sterols/stanols, wheat bran). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One randomised double-blind parallel intervention in humans on the effects of wheat germ oil on blood lipids was provided (Alessandri et al., 2006). A total of 32 hypercholesterolaemic men and
women were randomly allocated to consume one tablespoon per day of either maize oil or wheat germ oil for two months. The oils differed inter alia in the amount of alpha-linolenic acid, with 0.63 % in maize oil vs. 8.6 % in wheat germ oil. No significant changes in the blood lipid profile were observed between groups during the study.
The Panel concludes that a cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal blood cholesterol concentrations beyond the hypocholesterolaemic effects that could be expected from its fatty acid composition (e.g. primarily from its content of linoleic acid and alpha-linolenic acid).
Claims on linoleic acid and on alpha-linolenic acid and maintenance of blood cholesterol concentrations have been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009a,b).

3.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2618)

3.4. Ochrona skóry przed uszkodzeniem promieniami ultrafioletowymi (UV) (ID 600)

None of the references provided addressed the effects of wheat germ oil consumption on the protection of the skin from photo-oxidative (UV-induced) damage. The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of wheat germ oil and the protection of the skin from photo-oxidative (UV-induced) damage.

3.5. Utrzymanie prawidłowego nawilżenia skóry (ID 600, 1390)

None of the references provided addressed the effects of wheat germ oil consumption on skin hydration. The Panel considers that no conclusions can be drawn from these references 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 wheat germ oil and maintenance of normal skin hydration.

3.6. Utrzymanie prawidłowego stanu kości (ID 1389)

None of the references provided addressed the effects of wheat germ oil consumption on bone outcomes. The Panel considers that no conclusions can be drawn from these references 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 wheat germ oil and maintenance of normal bone.

3.7. Udział w prawidłowym przebiegu funkcji neurologicznych (ID 1387)

None of the references provided addressed the effects of wheat germ oil consumption on neurological function. The Panel considers that no conclusions can be drawn from these references 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 wheat germ oil and contribution to normal neurological function.

3.8. Udział w prawidłowym przebiegu procesów poznawczych (ID 1394)

None of the references provided addressed the effects of wheat germ oil consumption on cognitive function. The Panel considers that no conclusions can be drawn from these references 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 wheat germ oil and contribution to normal cognitive function.

3.9. Udział w utrzymaniu prawidłowej płodności (ID 1392)

Only one reference (Watson, 1936) was provided for the scientific substantiation of this claim. The reference reported on cases of women with previous multiple spontaneous abortions (n=19) or primary sterility (n=4) who delivered normal children after supplementation with wheat germ oil. The Panel considers that no conclusions can be drawn from these case reports 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 wheat germ oil and contribution to normal fertility.

3.10. Ulga w bólach miesiączkowych (ID 1395)

None of the references provided addressed the effects of wheat germ oil consumption on the relief of pain during menstruation.
The Panel concludes that a cause and effect relationship has not been established between the consumption of wheat germ oil and relief of menstrual pain.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food, wheat germ oil, which is the subject of the health claim is sufficiently characterised.
Maintenance of normal blood pressure (ID 1386)
The claimed effect is “cardiovascular system”. The target population is assumed to be the general population. Maintenance of normal blood pressure is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal blood pressure.
Maintenance of normal blood cholesterol concentrations (ID 599, 2618)
The claimed effects are “cholesterol” and “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. The target population is assumed to be the general population. Maintenance of normal cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal blood cholesterol concentrations beyond the hypocholesterolaemic effects that could be expected from its fatty acid composition (e.g. primarily from its content of linoleic acid and alpha-linolenic acid).
Claims on linoleic acid and on alpha-linolenic acid and maintenance of blood cholesterol concentrations have been assessed with a favourable outcome.
Maintenance of normal (fasting) blood concentrations of triglycerides (ID 2618)
The claimed effect is “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. The target population is assumed to be the general population. Maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal (fasting) blood concentrations of triglycerides.
Protection of the skin from photo-oxidative (UV-induced) damage (ID 600)
The claimed effect is “skin hydration/skin protection”. The target population is assumed to be the general population. The protection of the skin from photo-oxidative (UV-induced) damage is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and the protection of the skin from photo-oxidative (UV-induced) damage
Maintenance of normal skin hydration (ID 600, 1390)
The claimed effect is “skin hydration/skin protection” and “skin health”. The target population is assumed to be the general population. Maintenance of normal skin hydration is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal skin hydration.
Maintenance of normal bone (ID 1389)
The claimed effect is “metabolism”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to the maintenance of normal bone. Maintenance of normal bone is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal bone.
Contribution to normal neurological function (ID 1387)
The claimed effect is “nervous system”. The target population is assumed to be the general population. Contribution to normal neurological function is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and contribution to normal neurological function.
Contribution to normal cognitive function (ID 1394)
The claimed effect is “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 wheat germ oil and contribution to normal cognitive function.
Contribution to normal fertility (ID 1392)
The claimed effect is “fertility”. The target population is assumed to be the general population. Contribution to normal fertility is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and contribution to normal fertility.
Relief of menstrual pain (ID 1395)
The claimed effect is “menstrual health”. The target population is assumed to be women of child-bearing age. Relief of menstrual pain is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of wheat germ oil and relief of menstrual pain.
“Digestive system” (ID 1388)
The claimed effect is “digestive system”. The target population is assumed to be the general population. “Digestive system” is not sufficiently defined. No clarifications were provided by Member States and no more details were contained in the proposed wording which could be used to define the claimed effect.
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.
Protection of cells from premature aging (ID 1393, 2616)
The claimed effects are “antioxidant, source of vitamin E” and “antioxidant properties”. The target population is assumed to be the general population. No definition has been provided of “cellular aging” or of “aging process” in relation to the antioxidant properties of foods.
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.

Oświadczenia zdrowotne

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