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.

2.2. Utrzymanie prawidłowej wielkość prostaty i możliwości oddawania moczu (ID 714, 1467, 1635)

The claimed effects are “prostate health” and “kidney and prostate health”. The Panel assumes that the target population is adult males.
In the context of the proposed wordings, the references submitted and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of a normal prostate size and normal urination.
An increase in size of the prostate (i.e. benign prostatic hyperplasia) is common in middle-aged and elderly men and may lead to abnormal storage and voiding of urine, which is characterised by a decrease in the peak urinary flow rate and by an increase in the residual urinary volume. Prostate size and urinary flow as well as storage (increase in urinary frequency, urgency, incontinence and nocturia) and voiding (weak urinary stream, hesitancy, intermittency, straining to void and dribbling) symptoms can be measured by established methods.
The Panel considers that maintenance of normal prostate size and normal urination 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.

3.2. Utrzymanie prawidłowej wielkość prostaty i możliwości oddawania moczu (ID 714, 1467, 1635)

The references provided included narrative reviews, in vitro and animal studies on the mechanisms by which phytochemicals (including plant sterols) could protect against prostate cancer, case control and prospective cohort studies in humans on the relationship between the intake of various phytochemicals (including plant sterols) and the incidence of prostate cancer, and narrative reviews on the role of dietary factors other than plant sterols on prostate cancer risk. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two meta-analyses of randomised, placebo-controlled trials (Wilt et al., 1999, 2000) and two randomised, placebo-controlled trials (Berges et al., 1995; Klippel et al., 1997) on the effects of beta-sitosterols on prostate size, urinary flow and lower urinary tract symptoms (LUTS) in subjects with benign prostatic hyperplasia (BPH) were provided, together with a publication reporting on the follow-up of one of the studies (Berges et al., 2000). Both randomised controlled trials (Berges et al., 1995; Klippel et al., 1997) have been considered in the meta-analyses, and both meta-analyses are by the same authors and report on the same randomised controlled trials (Wilt et al., 1999, 2000).
In the meta-analyses by Wilt et al. (1999, 2000), four double-blinded randomised controlled trials (RCTs) including 519 men with BPH were identified and met the inclusion criteria (Berges et al., 1995; Fischer et al., 1993; Kadow and Abrams, 1986; Klippel et al., 1997). Three of the studies used non-glucosidic beta-sistosterol mixtures (beta-sistosterol-beta-D-glucoside <5 %) from different plant
extracts at concentrations of 50 % (Berges et al., 1995) and 70 % (Fischer et al., 1993; Klippel et al., 1997) and daily doses of 60 to 195 mg per day of beta-sitosterol. The Panel notes that beta- sitosterol has been proposed as the active constituent of certain plant preparations which have been investigated in humans with respect to their effects on LUTS in BPH, and that a number of mechanisms by which beta-sitosterol could exert the claimed effect in BPH tissues have been investigated in vitro. However, only a small amount of beta-sitosterol is absorbed (<5 %) and no evidence of a plausible mechanism by which it could exert a systemic effect in BPH has been provided. The Panel also notes that the exact composition of the plant preparations used in these studies has not been provided, and therefore the potential contribution of food constituents other than beta-sitosterol to the claimed effect cannot be evaluated. The Panel considers that no conclusions can be drawn from these studies (Berges et al., 1995; Fischer et al., 1993; Kippel et al., 1997) or the meta- analyses (Wilt et al., 1999, 2000) for the scientific substantiation of the claimed effect in relation to plant sterols or beta-sitosterol.
The RCT by Kadow and Abrams (1986) was conducted in 62 males (mean age 67 years, age range 53-81 years) with symptomatic BPH using pure beta-sistosterol-beta-D-glucoside at a dose of 0.30 mg per day as intervention for 24 weeks. Nine subjects dropped out after randomisation. No significant differences between groups were observed with respect to prostate size, peak urinary flow rate (Qmax) or post-void residual urine volume (PVR). Lower urinary tract symptom scores were not assessed.
No evidence of a biologically plausible mechanism by which plant sterols and plant stanols could exert the claimed effect has been provided.
In weighing the evidence, the Panel took into account that the only intervention study using pure beta-sitosterol from which conclusions could be drawn found no effect on prostate size, peak urinary flow rate (Qmax) or post-void residual urine volume (PVR) .
The Panel concludes that a cause and effect relationship has not been established between the consumption of plant sterols and plant stanols and maintenance of normal prostate size and normal urination.

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.