Scientific Opinion on the substantiation of health claims related to foods with reduced amounts of saturated fatty acids (SFAs) and maintenance of
normal blood LDL-cholesterol concentrations (ID 620, 671, 4332) 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:
LDL-cholesterol
Saturated fatty acids
health claims
1. Charakterystyka żywności / składnika
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Spożycie tłuszczów nasyconych zwiększa stężenie cholesterolu we krwi, spożywanie żywności o ograniczonej ilości tłuszczów nasyconych może pomóc w utrzymaniu prawidłowego stężenia cholesterolu we krwi
The food constituents that are the subject of the health claim are “saturated fats/saturated fatty acids (decrease)” and “decrease of saturated fatty acids”.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the food constituent, which is the subject of the health claim, is saturated fatty acids (SFAs). SFAs should be “decreased” or “reduced” in foods in order to obtain the claimed effect.
SFAs are aliphatic monocarboxylic acids with (generally) an even number of carbon atoms (usually from 4 to 20) and no double bonds, that can be liberated by hydrolysis of triacylglycerols from fats and oils. The most prevailing SFAs in the diet are lauric acid (12:0), myristic acid (14:0), palmitic acid (16:0) and stearic acid (18:0).
This opinion applies to mixtures of SFAs as present in foods.
The Panel considers that the food constituent, saturated fatty acids, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Spożycie tłuszczów nasyconych zwiększa stężenie cholesterolu we krwi, spożywanie żywności o ograniczonej ilości tłuszczów nasyconych może pomóc w utrzymaniu prawidłowego stężenia cholesterolu we krwi
The claimed effects are “blood cholesterol and artery/heart health”, and “cardio-vascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer 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 (>4.1 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stężenia cholesterolu we krwi
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Spożycie tłuszczów nasyconych zwiększa stężenie cholesterolu we krwi, spożywanie żywności o ograniczonej ilości tłuszczów nasyconych może pomóc w utrzymaniu prawidłowego stężenia cholesterolu we krwi
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus that a mixture of SFAs increases blood total and LDL-cholesterol concentrations relative to carbohydrates, which are considered neutral regarding their effects on LDL-cholesterol concentrations (EFSA, 2004; EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010; IoM, 2005; Lichtenstein et al., 2006; Mensink et al., 2003; WHO/FAO, 2003). The effect shows a linear dose-response relationship with blood LDL-cholesterol concentrations, indicating that effects are proportional to the amounts of SFAs consumed. It is also well established that consumption of a mixture of SFAs results in increased blood HDL-cholesterol concentrations compared with consumption of mixtures of cis-MUFAs or cis-PUFAs, and that, in comparison with other fatty acids except trans fatty acids (TFAs), SFAs increase the total-to-HDL cholesterol ratio.
SFAs differ in their potential to change blood lipid and lipoprotein concentrations. While lauric, myristic and palmitic acid raise blood total and LDL-cholesterol concentrations, effects of stearic acid and of short and medium chain SFAs (with 4-10 carbon atoms) are similar to those of carbohydrates (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010; Mensink et al., 2003). However, SFAs are present in foods as mixtures, so that stearic acid and short-medium chain SFAs are consumed in foods, which also contain considerable amounts of other long-chain SFAs (with 12 to 16 carbon atoms) and which are known to increase LDL-cholesterol concentrations.
The Panel concludes that a cause and effect relationship has been established between the consumption of mixtures of dietary SFAs and an increase in blood cholesterol concentrations, and that consumption of foods with reduced amounts of SFAs may help to maintain normal blood LDL-cholesterol concentrations.
4. Uwagi do zaproponowanego brzmienia oświadczenia
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Spożycie tłuszczów nasyconych zwiększa stężenie cholesterolu we krwi, spożywanie żywności o ograniczonej ilości tłuszczów nasyconych może pomóc w utrzymaniu prawidłowego stężenia cholesterolu we krwi
The Panel considers that the following wording reflects the scientific evidence: “Consumption of saturated fat increases blood cholesterol concentrations; consumption of foods with reduced amounts of saturated fat may help to maintain normal blood cholesterol concentrations”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
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Spożycie tłuszczów nasyconych zwiększa stężenie cholesterolu we krwi, spożywanie żywności o ograniczonej ilości tłuszczów nasyconych może pomóc w utrzymaniu prawidłowego stężenia cholesterolu we krwi
The Panel considers that in order to bear the claim, foods should contain reduced amounts of saturated fatty acids as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods6 (section 2.2.3).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, saturated fatty acids (SFAs), which is the subject of the health claim, is sufficiently characterised.
The claimed effects are “blood cholesterol and artery/heart health”, and “cardio-vascular system”. 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 been established between the consumption of mixtures of dietary SFAs and an increase in blood cholesterol concentrations, and that consumption of foods with reduced amounts of SFAs may help to maintain normal blood LDL-cholesterol concentrations.
The following wording reflects the scientific evidence: “Consumption of saturated fat increases blood cholesterol concentrations; consumption of foods with reduced amounts of saturated fat may help to maintain normal blood cholesterol concentrations”.
In order to bear the claim, foods should contain reduced amounts of saturated fatty acids as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods.