1276.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to linoleic acid and maintenance of normal blood cholesterol concentrations (ID 489) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Linoleic acid   blood cholesterol   health claims   n-6 fatty acids  
ID:    489  
Produkty: Kwas linolowy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is linoleic acid (LA) which is a polyunsaturated omega-6 fatty acid with 18 carbon atoms and two double bonds, and is present in various vegetable oils and legumes. In humans, LA is elongated and desaturated to arachidonic acid that is further metabolised into eicosanoids of the 2-series. LA is bioavailable and can be measured in foods by established methods.
The Panel considers that the food constituent, linoleic acid (LA), which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “blood cholesterol”. 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 relates 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 >160mg/dL, may compromise the normal function of the arteries.
The Panel considers that the maintenance of normal blood cholesterol concentrations is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie stężenia cholesterolu we krwi

In a meta-analysis of 60 randomised controlled clinical trials, polyunsaturated fatty acids (PUFA), mainly as LA, significantly reduced serum LDL-cholesterol concentrations. Replacing 1% of energy from carbohydrates with PUFA reduced LDL-cholesterol concentrations by 0.02 mmol/L (Mensink et al., 2003). The estimated change in the total/high-density lipoprotein (HDL) cholesterol ratio was - 0.032. LA was the main source of PUFA in the studies. Smaller amounts of alpha-linolenic acid were used in some of the studies, but the effects on lipoproteins of LA and alpha-linolenic acid are similar and the n-6/n-3 ratio of dietary PUFA does not affect the serum lipid profile (Goyens and Mensink, 2005).
No specific data on the effects of LA intake on cholesterol concentrations have been presented for children, but there is no scientific evidence for different effects in children as compared to adults.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of LA and the reduction of blood cholesterol concentrations.

4. Uwagi do zaproponowanego brzmienia oświadczenia

The Panel considers that the following wording reflects the scientific evidence:
“Linoleic acid may help to maintain normal blood cholesterol concentrations”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claim a food should contain at least 15% of the proposed labeling reference intake values of 10 g of LA per day. Such an amount can be easily consumed as part of a balanced diet. The target population is the general population.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, linoleic acid (LA), which is the subject of the health claims, is sufficiently characterised.
The claimed effect is “blood cholesterol”. The target population is assumed to be the general population. Maintenance of normal blood cholesterol concentrations is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of LA and the reduction of blood cholesterol concentrations.
The following wording reflects the scientific evidence: “Linoleic acid may help to maintain normal blood cholesterol concentrations”.
Conditions and possible restrictions of use
In order to bear the claim a food should contain at least 15% of the proposed labeling reference intake values of 10 g LA per day. Such an amount can be easily consumed as part of a balanced diet. The target population is the general population.