Scientific Opinion on the substantiation of health claims related to
n-3 polyunsaturated fatty acids (n-3 PUFAs) and “nutrient tasks and
interactions” (ID 574), increase in calcium absorption leading to
an increase in calcium retention (ID 606), and maintenance of normal bone
(ID 607) 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:
bone
calcium retention
health claims
n-3 PUFAs
n-3 polyunsaturated fatty acids
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is n-3 polyunsaturated fatty acids (PUFAs).
n-3 PUFAs are polyunsaturated fatty acids with one of the double bonds located at the third carbon atom from the methyl end. The quantitatively most important n-3 PUFAs in the diet are 18:3 (alpha-linolenic acid, ALA), 20:5 (eicosapentaenoic acid, EPA), 22:5 (docosapentaenoic acid, DPA), and 22:6 (docosahexaenoic acid, DHA) (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010). EPA, DPA and DHA are classified as long-chain PUFAs (LC-PUFAs).
n-3 PUFAs are recognised nutrients and are measurable in foods by established methods; they are well absorbed when consumed in the form of triglycerides. This evaluation applies to n-3 PUFAs from all sources with appropriate bioavailability in the specified amounts.
The Panel considers that the food constituent, n-3 PUFAs, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Funkcje i interakcje składników odżywczych (ID 574)
The claimed effect is “nutrient tasks and interactions”.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effect refers to children’s development and health.
The Panel notes that claims related to children’s development and health are outside the scope of Article 13 of Regulation (EC) No 1924/2006.
2.2. Wzrost wchłaniania wapnia prowadzący do zwiększenia ilości wapnia w organizmie (ID 606)
The claimed effect is “métabolisme du calcium”. 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 an increase in calcium absorption. The Panel notes that the claimed effect (improved nutrient absorption) is only considered beneficial where absorption is a limiting factor for the maintenance of adequate status of the nutrient, and where increased absorption leads to increased retention.
The Panel considers that an increase in calcium absorption leading to an increase in calcium retention might be a beneficial physiological effect.
2.3. Utrzymanie prawidłowego stanu kości (ID 607)
The claimed effect is “fonctionnement osseux”. 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 through the promotion of calcium absorption.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Wzrost wchłaniania wapnia prowadzący do zwiększenia ilości wapnia w organizmie (ID 606)
Among the references provided for the scientific substantiation of the claim was a narrative review on the potential role of n-3 PUFAs on calcium and bone metabolism which did not provide original data for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
One in vitro study on the effect of n-3 fatty acids on calcium absorption, and one animal study on the effect of LC-PUFAs on calcium bioavailability, were also provided. The Panel considers that human studies are required for the substantiation of a claim, and that evidence provided in animal and in vitro studies alone is not sufficient to predict the occurrence of an effect of n-3 PUFA intake on calcium absorption and utilisation in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of n-3 PUFAs and an increase in calcium absorption leading to an increase in calcium retention.
3.2. Utrzymanie prawidłowego stanu kości (ID 607)
The references provided for the scientific substantiation of the claim were narrative reviews which addressed the potential role of n-3 PUFAs and other nutrients on bone metabolism, and which did not provide 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 concludes that a cause and effect relationship has not been established between the consumption of n-3 PUFAs and maintenance of normal bone.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, n-3 PUFAs, which is the subject of the health claims, is sufficiently characterised.
“Nutrient tasks and interactions” (ID 574)
The claimed effect is “nutrient tasks and interactions”. The claimed effect refers to children’s development and health.
Claims related to children’s development and health are outside the scope of Article 13 of Regulation (EC) No 1924/2006.
Increase in calcium absorption leading to an increase in calcium retention (ID 606)
The claimed effect is “métabolisme du calcium”. 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 an increase in calcium absorption. An increase in calcium absorption leading to an increase in calcium retention might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of n-3 PUFAs and an increase in calcium absorption leading to an increase in calcium retention.
Maintenance of normal bone (ID 607)
The claimed effect is “fonctionnement osseux”. 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 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 n-3 PUFAs and maintenance of normal bone.
