ID 1235 - Sterole roślinne

PL: Sterole roślinne
EN: Beta sitosterol
Pdf:

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is plant sterols and plant stanols.
In the context of this opinion, the term plant sterols (present as free sterols or esterified) refers specifically to plant sterols from natural sources with a composition as specified in the Commission Decisions authorising the placing on the market of food products with added plant sterols under Regulation (EC) No 258/976. The term “plant stanol ester” refers to a blend of the plant stanols sitostanol and campestanol, which are obtained from the reduction of plant sterols from food grade plant oils (mainly soybean oil) or tall oil or blends thereof.
The Panel notes that claims ID 1234 and 1235 refer to polyphenols present or extracted from Maritime Pine (Pinus pinaster Aiton). However, the only reference cited in the list referring to procyanidins (a type of polyphenol) from French maritime pine bark was not accessible to the Panel after having made every reasonable effort to retrieve it (Assouad and Piriou, 2007), and no references on the effects of polyphenols present or extracted from Maritime Pine on blood lipids or any other health outcome were provided.
The Panel considers that the food constituent, plant sterols and plant stanols, that is the subject of the health claims, is sufficiently characterised.

2.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 549, 550, 567, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140)

The claimed effects are “cholesterol”, “cholesterol levels”, “cholesterol metabolism”, “heart health and artery health because of LDL cholesterol maintenance”, “cardiovascular system”, “cholesterol metabolism”, “effet sur le taux de cholestérol sanguin”, “heart health” and “helps to keep normal cholesterol level”. The Panel assumes that the target population is adults.
In the context of the proposed wordings, the Panel notes that the claimed effects refer 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 >160 mg/dL (>4,14 mmol/L), may compromise the normal structure and function of the arteries. 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).
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

3.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 549, 550, 567, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140)

In the context of the procedure for the authorisation of health claims, EFSA has issued two opinions on applications for plant sterols (EFSA, 2008a) and plant stanol esters (EFSA, 2008b) pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA has also issued a general opinion regarding the conditions of use for health claims under Article 14 of Regulation (EC) No 1924/2006 in relation to the consumption of plant sterols and stanols and the reduction of LDL-cholesterol concentrations as a risk factor for coronary heart disease (EFSA, 2009).
The NDA Panel concluded that a clinically significant LDL-cholesterol lowering effect of between 7 % and 10.5 % could be expected by a daily intake of 1.5 - 2.4 g of plant sterols/plant stanols in an appropriate food matrix (e.g. margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts and cheese) (EFSA, 2009). The Panel also considered that the source of the sterols (vegetable or tall oil), the actual ratio between the most abundant sitosterol and campesterol and the source of fatty acids (butter or vegetable oil) do not have a relevant impact on the size of the blood LDL-cholesterol lowering effect (EFSA, 2008a, b), and that the efficacy in lowering LDL- cholesterol is similar for plant sterols and stanols in the intake range of 1.5 - 2.4 g per day (Katan et al., 2003; Demonty et al., 2009; EFSA, 2009).
In the most recent meta-analysis on the LDL-cholesterol lowering effects of plant sterols/stanols, 84 clinical trials were included (Demonty et al., 2009). In nine of the studies, daily doses of 0.80-1.0 g had been used. In seven of these studies a statistically significant reduction of LDL-cholesterol concentrations (range -0.19 to -0.33 mmol/L) was found (Beer et al., 2001; Hendriks et al., 1999; Hironaka et al., 2006; Niittynen et al., 2007; Sierksma et al., 1999; Ishizaki T, 2003; Vanhanen, 1994). In one study (Matsuoka et al., 2004) no effect was found with free sterols, and in the study by Miettinen and Vanhanen (1994) the reduction in LDL-cholesterol of 0.26 mmol/L was not statistically significant. Plant sterols were used in seven studies, stanols in one study and in another study a mixture of sterols and stanols was tested. The results of these studies indicate statistically significant lowering of LDL-cholesterol concentrations by consuming moderate doses (0.8-1.0 g per day) of plant sterols or stanols in subjects with normal or mildly elevated LDL-cholesterol concentrations. All but one (Hironaka et al., 2006) of the studies mentioned above were conducted with plant sterols or stanols added to foods such as margarine-type spreads, mayonnaise, and dairy products such as milk and yoghurts including low-fat yoghurts (Demonty et al., 2009; EFSA, 2009).
The Panel concludes that a cause and effect relationship has been established between the consumption of plant sterols and plant stanols and reduction of blood cholesterol concentrations.

4.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 549, 550, 567, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140)

The Panel considers that the following wording reflects the scientific evidence: “Plant sterols/stanols contribute to the maintenance of normal blood cholesterol levels”.

5.1. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 549, 550, 567, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140)

The Panel considers that in order to bear the claim, a food should provide at least 0.8 g per day of plant sterols/stanols in one or more servings. These amounts can be reasonably achieved in the context of a balanced diet. The target population is adults. The considerations regarding the food matrix expressed by the Panel in a previous opinion (EFSA, 2009) in relation to the blood LDL-cholesterol lowering effect of plant sterols and stanols also apply to the present opinion.
With respect to the specified conditions of use, it is suggested that the labelling provisions outlined in Commission Regulation (EC) No 608/20047 shall continue to apply for products making the proposed claim.
Food products containing plant sterols and/or plant stanols may not be nutritionally appropriate for pregnant and breastfeeding women, and for children under the age of five years.

Warunki i możliwe ograniczenia stosowania oświadczenia

350 mg de stérols et 30 mg de polyphénols (OPC) par comprimé. 4 comprimés par jour à prendre de façon régulière