Scientific Opinion on the substantiation of health claims related to rapeseed
oil and maintenance of normal blood LDL-cholesterol concentrations
(ID 580, 581, 1408) and maintenance of normal blood HDL-cholesterol
concentrations (ID 1408) 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:
HDL-cholesterol
LDL-cholesterol
Rapeseed oil
health claims
1. Charakterystyka żywności / składnika
The food that is the subject of the health claims is rapeseed oil.
Rapeseed oil is produced from the seeds of oilseed rape (Brassica napus L.) and turnip rape (Brassica rapa L.). It contains low amounts (about 6 %) of saturated fatty acids (SFAs), about 60 % oleic acid, 20 % linoleic acid (LA) and 11 % alpha-linolenic acid (ALA).
The Panel considers that the food, rapeseed oil, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 580, 581, 1408)
The claimed effects are “cardiovascular system” and “Einfach ungesättigte Fettsäuren senken im Austausch gegen gesättigte Fettsäuren das Gesamt- und LDL-Cholesterin signifikant. Der LDL/HDL- Quotient sinkt bei einer monoensäurereichen Kost signifikant”. 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 HDL we krwi (ID 1408)
The claimed effect is “Einfach ungesättigte Fettsäuren senken im Austausch gegen gesättigte Fettsäuren das Gesamt- und LDL-Cholesterin signifikant. Der LDL/HDL-Quotient sinkt bei einer monoensäurereichen Kost signifikant”. 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 effect relates to the maintenance of normal HDL-cholesterol concentrations.
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). Conversely, low- density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries.
The Panel considers that maintenance of normal HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 580, 581, 1408)
In two studies comparing the effects of rapeseed oil and olive oil (about 70 % oleic acid, 15 % SFAs, and 11 % polyunsaturated fatty acids (PUFAs), mainly LA) on serum lipids, 10-20 % lower LDL- cholesterol concentrations were found with the rapeseed oil diet (Nydahl et al., 1995; Pedersen et al., 2000). In the study by Lichtenstein (1993) rapeseed oil (about 6 % SFAs, 60 % oleic acid, 20 % LA and 11 % ALA), maize oil and olive oil (about 15 % SFAs, 70 % oleic acid, and 11 % PUFAs, mainly LA) as part of the National Cholesterol Education Program (NCEP) Step 2 diet were compared with the average US diet in a randomised, cross-over study in 15 subjects. Both rapeseed oil (-12 %) and maize oil (-13 %) reduced serum total cholesterol concentrations significantly more than olive oil (-7 %). In the study by Valsta et al. (1992), a diet based on rapeseed oil produced significantly lower LDL-cholesterol concentrations compared with a similar diet based on sunflower oil.
In a meta-analysis of 60 clinical trials, Mensink et al. (2003) estimated, on the basis of the fatty acid composition, the effects of different dietary fats on the total-to-HDL cholesterol ratio and concluded that rapeseed oil induced the lowest total-to-HDL cholesterol ratio of all the dietary fats considered. The effect was due to the low amount of SFAs together with the relatively high amount of PUFAs.
The Panel notes that rapeseed oil reduces LDL-cholesterol concentrations compared with most other dietary fats and that the effect is likely due to the high PUFA (i.e. linoleic acid and alpha-linolenic acid) content and to the low amount of SFAs in rapeseed oil.
No studies that investigated whether rapeseed oil has an LDL-cholesterol-lowering effect beyond what could be expected from its fatty acid composition have been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of rapeseed oil and maintenance of normal blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of rapeseed oil.
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).
A claim on linoleic acid and maintenance of normal blood cholesterol concentrations has also already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009a).
A claim on alpha-linolenic acid and maintenance of normal blood cholesterol concentrations has also already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009b).
3.2. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 1408)
The meta-analysis of 60 studies (Mensink et al., 2003) indicated that SFAs increase HDL-cholesterol concentrations compared with monounsaturated fatty acids (MUFAs) and PUFAs. The replacement of 1 E% from SFAs with an equal percentage of MUFAs is predicted to lower HDL-cholesterol concentrations by 0.002 mmol/L. A similar decrease is expected when 1 E% from MUFAs is replaced with an equal amount of PUFAs. All fatty acid classes except trans fatty acids increase HDL-cholesterol concentrations in comparison with dietary carbohydrates.
In the studies comparing the effects of rapeseed oil with olive oil or sunflower oil on blood lipids, no significant differences in HDL-cholesterol concentrations were found between the oils (Nydahl et al., 1995; Pedersen et al., 2000; Valsta et al., 1992).
In weighing the evidence, the Panel took into account that MUFAs and PUFAs, when replacing SFAs, tend to decrease HDL-cholesterol concentrations, and that rapeseed oil does not significantly increase HDL-cholesterol concentrations compared to other oils (e.g. olive oil or sunflower oil).
The Panel concludes that a cause and effect relationship has not been established between the consumption of rapeseed oil and maintenance of normal blood HDL-cholesterol concentrations.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food, rapeseed oil, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
Maintenance of normal blood LDL-cholesterol concentrations (ID 580, 581, 1408)
The claimed effects are “cardiovascular system” and “Einfach ungesättigte Fettsäuren senken im Austausch gegen gesättigte Fettsäuren das Gesamt- und LDL-Cholesterin signifikant. Der LDL/HDL-Quotient sinkt bei einer monoensäurereichen Kost signifikant”. 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 cause and effect relationship has not been established between the consumption of rapeseed oil and maintenance of normal blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of rapeseed oil.
A claim on the replacement of mixtures of SFAs with cis-MUFA and/or cis-PUFA in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome. A claim on linoleic acid and maintenance of normal blood cholesterol concentrations and a claim on alpha-linolenic acid and maintenance of
normal blood cholesterol concentrations have also already been assessed with favourable outcomes.
Maintenance of normal blood HDL-cholesterol concentrations (ID 1408)
The claimed effect is “Einfach ungesättigte Fettsäuren senken im Austausch gegen gesättigte Fettsäuren das Gesamt- und LDL-Cholesterin signifikant. Der LDL/HDL-Quotient sinkt bei einer monoensäurereichen Kost signifikant”. 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 effect relates to the maintenance of normal HDL-cholesterol concentrations. Maintenance of normal HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of rapeseed oil and maintenance of normal blood HDL-cholesterol concentrations.