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Scientific Opinion on the substantiation of health claims related to plant sterols and plant stanols and maintenance of normal blood cholesterol concentrations (ID 549, 550, 567, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140), and maintenance of normal prostate size and normal urination (ID 714, 1467, 1635) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

EFSA Journal 2010;8(10):1813 [22 pp.]. doi:10.2903/j.efsa.2010.1813
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Acknowledgment The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhelm Stahl and Henk van den Berg. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2008-1337 , EFSA-Q-2008-1500 , EFSA-Q-2008-2203 , EFSA-Q-2008-2370 , EFSA-Q-2008-3642 , EFSA-Q-2008-3872 , EFSA-Q-2008-1336 , EFSA-Q-2008-1354 , EFSA-Q-2008-1972 , EFSA-Q-2008-1973 , EFSA-Q-2008-2717 , EFSA-Q-2008-1501 , EFSA-Q-2008-2204 , EFSA-Q-2008-2371 Adopted: 10 September 2010 Published: 19 October 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to plant sterols and plant stanols and maintenance of normal blood cholesterol concentrations, and maintenance of normal prostate size and normal urination. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food constituent that is the subjects of the health claims is plant sterols and plant stanols. The Panel considers that plant sterols and plant stanols are sufficiently characterised.

Maintenance of normal blood cholesterol concentrations

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 target population is assumed to be adults. In the context of the proposed wordings, the Panel notes that the claimed effects refer to the maintenance of normal blood cholesterol concentrations. The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

The Panel concludes that a cause and effect relationship has been established between the consumption of plant sterols and plant stanols and the reduction of blood cholesterol concentrations.

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 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 608/2004 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.

Maintenance of normal prostate size and normal urination

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. The Panel considers that maintenance of normal prostate size and normal urination is a beneficial physiological effect.

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).

On the basis of the data presented, 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.

Keywords

Plant sterols, plant stanols, blood cholesterol concentrations, prostate size, urination, health claims