ID 284 -
Selen
PL: Selen
EN: Selen
Pdf: selenium
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is selenium, which is a well recognised nutrient and is measurable in foods by established methods.
Selenium occurs naturally in foods and is authorised for addition to foods and for use in food supplements (Annex I of the Regulation (EC) No 1925/20064 and Annex I of Directive 2002/46/EC5). This evaluation applies to selenium naturally present in foods and to those forms authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, selenium, which is the subject of the health claims is sufficiently characterised.
2.5. Funkcjonowanie prostaty (ID 284)
The claimed effect is “prostate health”. The Panel assumes that the target population is the general male population.
The Panel considers that normal prostate function is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Selenium is an essential trace element. Twenty-five selenoprotein genes have been identified in the human genome (Kryukov et al., 2003). Selenoproteins have a number of functions, comprising various catalytic roles (glutathione peroxidases, thioredoxin reductases, and iodothyronine
deiodinases), structural roles, detoxifying functions (e.g. selenoprotein P) and storage and transport activities. Selenium is present in foods mainly as selenomethionine and selenocysteine. It is absorbed efficiently by the intestine over a wide range of concentrations and across a variety of different molecular forms (Bates, 2005).
3.5. Funkcjonowanie prostaty (ID 284)
A total of 11 references were provided in the consolidated list to support this claim. These included four reviews, one opinion from a scientific body, three human studies and three in vitro studies.
Nine references provided in the consolidated list dealt with selenium as a potential chemopreventive agent against prostate cancer. Two references were concerned with the general requirements of selenium in human nutrition. It has been suggested that selenium may have chemoprotective effects that are mediated through the antioxidant properties of selenoenzymes (Peters et al., 2007). However, expert reviews of the evidence show that there is no consensus about the role of selenium in prostate cancer prevention (Burk and Levander, 2006; Combs, 2005; Gupta, 2007; Thomson, 2004). A recent large randomised placebo-controlled trial in men aged ≥ 50 years (n=35,533) showed that daily supplementation with selenium (200 µg) had no significant effect on risk of development of prostate cancer over three years with a median overall follow-up of 5.5 years (Lippman et al., 2009).
In weighing the evidence, the Panel took into account that the evidence provided by expert reviews shows that there is no consensus about the role of selenium in prostate cancer prevention and that a recent large randomized controlled trial in men aged ≥ 50 years showed no significant effect of selenium on risk of development of prostate cancer over three years with a median overall follow-up of 5.5 years.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of selenium and normal prostate function.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
The Panel considers that in order to bear the claims a food should be at least a source of selenium as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. Tolerable Upper Intake Levels (UL) have been established as 300 µg/day for adults and for pregnant and lactating woman. For children and adolescents UL were established as 60 µg/day for 1-3 years, 90 µg/day for 4-6 years, 130 µg/day for 7-10 years, 200 µg/day for 11-14 years and 250 µg/day for 15-17 years (SCF, 2000).
Warunki i możliwe ograniczenia stosowania oświadczenia
30 -50 µg selenium
Must meet minimum requirements for use of the claim "source of [name of vitamin/s] and/or [name of mineral/s]" as per Annex to Regulation 1924/2006.