Scientific Opinion on the substantiation of health claims related to oleic
acid intended to replace saturated fatty acids (SFAs) in foods or diets and
maintenance of normal blood LDL-cholesterol concentrations (ID 673, 728,
729, 1302, 4334) and maintenance of normal (fasting) blood concentrations
of triglycerides (ID 673, 4334) 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
Oleic acid
health claims
replacement
saturated fatty acids
triglycerides
1. Charakterystyka żywności / składnika
The foods/food constituents that are the subject of the health claims are “monounsaturated fatty acids (mainly oleic acid)”, “oleic acid” and “extravirgin olive oil”.
In the context of the proposed wordings, clarifications provided by Member States and references submitted for the scientific substantiation of the health claims, the Panel assumes that the food constituent that is the subject of the health claims is oleic acid, which should replace saturated fatty acids (SFAs) in foods or diets in order to obtain the claimed effects.
Oleic acid is the monounsaturated fatty acid (MUFA) with 18 carbon atoms and the double bond in the 9-cis position. It is found in varying amounts in dietary fats. Beef tallow contains about 43 % oleic acid and 47 % SFAs, lard about 44 % oleic acid and 43 % SFAs, palm oil about 40 % oleic acid and 45 % SFAs, rapeseed oil about 60 % oleic acid and 6 % SFAs. A high proportion of oleic acid is found in olive oil, 71 %, together with 15.5 % SFAs and 12 % polyunsaturated fatty acids (PUFAs). High-oleic acid varieties of sunflower oil and rapeseed oil contain about 75-85 % oleic acid.
Saturated fatty acids (SFAs) are aliphatic monocarboxylic acids with (generally) an even number of carbon atoms (usually from 4 to 20) and no double bonds which 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 the replacement of mixtures of SFAs as present in foods or diets with oleic acid.
The Panel considers that the food constituent, oleic acid intended to replace saturated fatty acids (SFAs) in foods or diets, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 673, 728, 729, 1302, 4334)
The claimed effects are “cardiovascular system”, “support healthy cholesterol levels”, “blood cholesterol levels” and “oleic acid helps to maintain healthy blood cholesterol levels, and phenolic compounds help to protect LDL cholesterol by the oxidation”. 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.
2.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 673, 4334)
The claimed effect is “cardiovascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wording and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal (fasting) 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. 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.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 673, 728, 729, 1302, 4334)
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus that a mixture of SFAs increases total and blood LDL-cholesterol concentrations relative to mixtures of cis-MUFAs (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), and that there is a linear dose-response relationship between blood LDL-cholesterol concentrations and the amounts of long-chain 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 (e.g. oleic acid), and that in comparison with other fatty acids, except trans fatty acids (TFAs), SFAs increase the total–to-HDL cholesterol ratio (Mensink et al., 2003).
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 short and medium chain SFAs (with 4-10 carbon atoms) are similar to those of carbohydrates and oleic acid (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 and medium chain SFAs, are consumed in foods that also contain other long-chain SFAs (with 12-16 carbon atoms), which are known to increase LDL-cholesterol concentrations.
A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011). The scientific conclusions in that opinion apply to the replacement of mixtures of SFAs as present in foods or diets with oleic acid.
3.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 673, 4334)
The references provided were narrative reviews, opinions of scientific bodies, and reports on intervention studies which assessed the effects of various fatty acids on health outcomes unrelated to the claimed effect. No studies have been provided which addressed independent effects of oleic acid on blood concentrations of triglycerides. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
When carbohydrates are replaced with fats, fasting triglyceride concentrations are reduced, but there is no difference between the effects of different fatty acid classes. Mensink and Katan (1992) found in a meta-analysis of 27 trials that an isocaloric exchange between carbohydrates and fats resulted in similar predicted effects on triglyceride concentrations for SFA, MUFA and PUFA. The Panel notes that carbohydrates are not neutral with respect to their effects on blood concentrations of triglycerides.
The Panel concludes that a cause and effect relationship has not been established between oleic acid replacing saturated fatty acids (SFAs) in foods or diets and maintenance of normal (fasting) blood concentrations of triglycerides.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, oleic acid intended to replace saturated fatty acids (SFAs) in foods or diets, which is the subject of the health claims, is sufficiently characterised.
Maintenance of normal blood LDL-cholesterol concentrations (ID 673, 728, 729, 1302, 4334)
The claimed effects are “cardiovascular system”, “support healthy cholesterol levels”, “blood cholesterol levels” and “oleic acid helps to maintain healthy blood cholesterol levels, and phenolic
compounds help to protect LDL cholesterol by the oxidation”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, it is assumed that the claimed effects refer to the maintenance of normal blood LDL-cholesterol concentrations. Maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome. The scientific conclusions in that opinion apply to the replacement of mixtures of SFAs as present in foods or diets with oleic acid.
Maintenance of normal (fasting) blood concentrations of triglycerides (ID 673, 4334)
The claimed effect is “cardiovascular system”. The target population is assumed to be the general population. In the context of the proposed wording and clarifications provided by Member States, it is assumed that the claimed effect refers to the maintenance of normal (fasting) blood concentrations of triglycerides. Maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.
A cause and effect relationship has not been established between oleic acid replacing saturated fatty acids (SFAs) in foods or diets and maintenance of normal (fasting) blood concentrations of triglycerides.