ID 290 -
Krzem
PL: Krzem
EN: Silicon
Pdf: silicon
1. Charakterystyka żywności / składnika
The food constituents that are the subjects of the health claims are “silicon”, “silicon (as stabilised oligomeric orthosilicic acid (OSA))”, “choline-stabilised orthosilicic acid (ch-OSA)”, “Mineral- wasser/Kieselsäure (Silizium)”, “silica/silicious earth”, and “monométhylsilanetriol”.
From the references and conditions of use provided in relation to the health claims considered in this opinion, the Panel assumes that the food constituent under evaluation is silicon.
Silicon is authorised for addition to foods (Annex I of Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to silicon naturally present in foods and added to foods.
Silicon occurs naturally in foods as silicon dioxide (silica, SiO2) and silicates, and may also be added to foods as an anti-caking and anti-foaming agent in the form of silica, silicates and dimethylpolysiloxane. Silicate-containing antacids have been widely used for a number of decades.
Orthosilicic acid [Si(OH)4] or mono-silicic acid is a water soluble form of silicon. A saturated solution contains 0.1 % silicic acid. Silicic acid can also exist as an oligomer and as polysilicic acid (EFSA, 2004). Oligomeric silica (oligomeric orthosilicic acid) is formed as a meta-stable intermediate in the progressive polymerisation of silicic acid in saturated solutions. Monomethylsilanetriol, also called organic silicon (CH3-Si-(OH)3), and choline-stabilised orthosilicic acid (ch-OSA) are usually added to food supplements as a source of silicon (EFSA, 2009a, 2009b).
The Panel considers that the food constituent, silicon, which is the subject of the health claims, is sufficiently characterised.
2.1. Ochrona przed akumulacją glinu w mózgu (ID 290)
The claimed effect is “mental health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to protection against aluminium accumulation in the brain.
The Panel considers that protection against aluminium accumulation in the brain might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Silicon is considered an ultra-trace element for which a functional role in humans has not been identified. As the essentiality of silicon for humans has not been established, a dietary reference value for silicon has not been set (IoM, 2000).
A number of narrative reviews on the health effects of silicon containing no original data for a scientific evaluation, post-mortem studies in humans assessing the content of silicon in various tissues (e.g. blood vessels), and human intervention studies on silicon supplementation for the treatment of acne were provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
The vast majority of the references provided for the scientific substantiation of the claims reported on animal studies which addressed the effects of silicon-free diets and/or the effects of reintroducing silicon into the diet on the structure and morphology of various tissues and/or organs, including collagen and bone. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of silicon withdrawal or silicon intake in humans.
3.1. Ochrona przed akumulacją glinu w mózgu (ID 290)
In one intervention study, patients with Alzheimer's disease were asked to drink 1.5 L of a silicic acid-rich mineral water each day for five days (Exley et al., 2006). Patients’ urinary excretion of
aluminium was determined pre- and post-intervention. The Panel notes that no measures of aluminium retention in the body or accumulation in the brain were undertaken. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
One epidemiological study examined the association between silicon dioxide (silica) and aluminium concentrations in drinking water and the risk of cognitive impairment using data from a population-based survey in 3,777 French subjects aged 65 years and older (Jacqmin-Gadda et al., 1996). In an eight-year follow up of the same cohort, the relationship between aluminium and silica concentrations in drinking water and the risk of dementia and Alzheimer's disease was investigated (Rondeau et al., 2000). A further epidemiological study explored the association between the composition of drinking water and cognitive function and the risk of Alzheimer's disease in women taking part in the Epidemiology of Osteoporosis (EPIDOS) study (n=7,598) (Gillette-Guyonnet et al., 2005). The Panel notes that no endpoint directly related to aluminium accumulation in the brain was measured in these epidemiological studies. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One animal study examined the effect of silicon supplementation on tissue aluminium retention in rats, and one in vitro study examined the chemistry of aluminium binding by silicic acid. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of silicon consumption on protection against aluminium accumulation in the brain in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and protection against aluminium accumulation in the brain.
Warunki i możliwe ograniczenia stosowania oświadczenia
5-10 mg of OSA
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.