2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1316, 1332)

The claimed effects are “health of the cardiovascular system, general population” and “improves blood lipid profile”. 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 effects refer to the maintenance of normal 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 trójglicerydów we krwi na czczo (ID 1316, 1332)

The claimed effects are “health of the cardiovascular system, general population” and “improves blood lipid profile”. 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 effects refer 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.

2.3. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 1316, 1332)

The claimed effects are “health of the cardiovascular system, general population” and “improves blood lipid profile”. 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 effects refer 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.

2.4. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 4244)

The claimed effect is “permet de réguler le glucoses dans le sang”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect refers to the maintenance of normal blood glucose concentrations.
The Panel considers that long-term maintenance of normal blood glucose concentrations is a beneficial physiological effect.

3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1316, 1332)

Mensink et al. (2003) found in a meta-analysis of 60 controlled trials, that replacing carbohydrates with SFAs in an amount representing 1 E% increased LDL-cholesterol concentrations by 0.032 mmol/L. Replacement with cis-MUFAs (oleic acid) reduced LDL-cholesterol concentrations only by 0.009 mmol/L. The corresponding reduction in LDL-cholesterol concentrations by PUFAs was significantly larger (i.e. 0.019 mmol/L).
A number of human intervention studies comparing the effects of olive oils vs. other vegetable oils were provided.
Pedersen et al. (2000) investigated the effect of olive oil (35 % of daily energy intake as fat (11 E% SFAs, 21 E% MUFAs, 3 E% PUFAs)), rapeseed oil (35 % of daily energy intake as fat (9 E% SFAs, 18 E% MUFAs, 7 E% PUFAs)), and sunflower oil (35 % of daily energy intake as fat (10 E% SFAs, 9 E% MUFAs, 15 E% PUFAs)) based diets on blood lipids and lipoproteins in 18 healthy subjects in a double-blind, randomised, cross-over study (3-week intervention period) with 50 g oil/10 MJ incorporated into a constant diet. Total and LDL-cholesterol concentrations were significantly higher after consumption of the olive oil diet compared with the rapeseed oil and sunflower oil diets. Lichtenstein et al. (1993) compared rapeseed oil (about 6 % SFAs, 62 % oleic acid, 20 % linoleic acid (LA) and 10 % alpha-linolenic acid (ALA)), maize oil (about 60 % LA, 28 % oleic acid and 13 % SFAs) and olive oil (about 70 % oleic acid, 15 % SFAs, and 11 % PUFAs, mainly LA) as part of the National Cholesterol Education Program (NCEP) Step 2 diet with the average US diet in a randomised cross-over study in 15 persons. Both rapeseed oil and maize oil reduced serum total cholesterol levels more (-12 and -13 %, respectively) than olive oil (-7 %). In the randomised, cross-over intervention by Nydahl et al. (1995), 22 hyperlipidaemic subjects consumed either low erucic acid rapeseed (canola) oil or olive oil in the context of a “lipid-lowering” diet for 3.5 weeks each. LDL-cholesterol concentrations decreased significantly more during the canola oil diet (-17%) than during the olive oil diet (-13%). The Panel notes that the different effects of different oils on blood cholesterol concentrations could be explained by the fatty acid composition of these oils.
The only study presented which assessed the effects of olive oil while controlling for its fatty acid composition was a multicentre (six centres in Finland, Denmark, Germany, Italy and Spain) randomised, cross-over, controlled human intervention study in which olive oils with high (366 mg/kg oil, i.e. 8.0 mg/day), moderate (164 mg/kg oil, i.e. 3.6 mg/day), and low (2.7 mg/kg oil, i.e. 0.1 mg/day) polyphenol content were consumed by 200 male subjects for three weeks (25 mL/day) each (Covas et al., 2006). Changes in LDL-cholesterol concentrations were not significantly different between olive oil treatments.
In weighing the evidence, the Panel took into account that the evidence provided did not establish that olive oil consumption had an effect on blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of olive oil, and that the only study which assessed the effects of olive oil while controlling for its fatty acid composition did not find any significant changes in LDL-cholesterol concentrations when comparing olive oils with high, moderate and low polyphenol content.
The Panel concludes that a cause and effect relationship has not been established between the consumption of olive oil and maintenance of normal blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of olive 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), 2011a).
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), 2009).

3.2. Utrzymanie prawidłowego stężenia trójglicerydów we krwi na czczo (ID 1316, 1332)

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 levels for SFAs, MUFAs and PUFAs. The Panel notes that carbohydrates are not neutral with respect to their effects on blood concentrations of triglycerides.
In clinical trials, no differences have been observed between olive oil, rapeseed oil, corn oil and sunflower oil with respect to their effects on blood concentrations of triglycerides (Lichtenstein et al., 1993; Nydahl et al., 1995; Pedersen et al., 2000).
The Panel concludes that a cause and effect relationship has not been established between the consumption of olive oil and maintenance of normal (fasting) blood concentrations of triglycerides.

3.3. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 1316, 1332)

Mensink et al. (2003) concluded in a meta-analysis of 60 controlled trials that all types of fatty acids except trans fatty acids increase HDL-cholesterol concentrations as compared with carbohydrates. The effect of SFAs on increasing HDL-cholesterol concentrations is reduced by increasing chain length. Replacement of 1 E% of SFAs with an equal E% of cis-MUFAs was predicted to lower HDL-cholesterol by 0.002 mmol/L, and a similar decrease was expected when replacing the same amount of MUFAs with PUFAs. The Panel notes that oleic acid reduces HDL-cholesterol concentrations as compared with SFAs with 12-16 carbon atoms, but less than a similar amount of PUFAs. The Panel also notes that carbohydrates are not neutral with respect to their effects on HDL-cholesterol concentrations.
In clinical trials no statistically significant differences have been observed when comparing olive oil with rapeseed oil, sunflower oil or corn oil with respect to their effects on HDL-cholesterol concentrations (Lichtenstein et al., 1993; Nydahl et al., 1995; Pedersen et al., 2000).
The only study presented which assessed the effects of olive oil while controlling for its fatty acid composition was the multicentre study described in section 3.1. A significant linear dose-dependent increase in HDL-cholesterol concentrations was observed for low- (+0.025 mmol/L, 95 % CI = 0.003 to 0.05 mmol/L), medium- (+0.032 mmol/L, 95 % CI = 0.005 to 0.05 mmol/L), and high-polyphenol olive oil (p per trend 0.018). The total-to-HDL-cholesterol ratio decreased linearly with the polyphenol content of the olive oils (p per trend 0.013).
A claim on olive polyphenols and maintenance of normal blood HDL-cholesterol concentrations has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b).
In weighing the evidence, the Panel took into account that based on its fatty acid composition olive oil is not expected to have an effect on HDL-cholesterol concentrations, that a linear dose-response effect of olive oil polyphenols on HDL-cholesterol concentrations was observed in one study only, and that
no evidence on a plausible mechanism by which olive oil polyphenols could exert an effect on HDL-cholesterol concentrations has been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of olive oil and maintenance of normal HDL-cholesterol concentrations.

3.4. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 4244)

Only one reference was provided for the scientific substantiation of the claimed effect which was a narrative review on the relationship between impaired fatty acid and phospholipid metabolism, and depression and bipolar disorder in the context of different chronic diseases. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of olive oil and maintenance of normal blood glucose concentrations.