ID 714 - Sterole roślinne

PL: Sterole roślinne
EN: Beta sitosterol
Pdf:

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.

2.2. 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.

3.2. 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.

Warunki i możliwe ograniczenia stosowania oświadczenia

280 mg/day