ID 288 -
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.
2.5. Udział w prawidłowym tworzeniu kolagenu i tkanki łącznej (ID 287, 288, 333, 334, 335, 1405, 1652, 1718, 1719, 1945)
The claimed effects are “silicon is required for normal bone and connective tissue formation”, “normal skin, hair and nails”, “maintenance and promotion of healthy connective tissue in skin by stimulating collagen synthesis in the dermis”, “helps support hair quality by helping to maintain healthy connective tissue in the dermis”, “maintenance and promotion of healthy connective tissue in bone by stimulating bone collagen synthesis”, “stability of the connective/cell tissue; strengthening the joint cartilage and the intervertebral disks, protection against”, “essential part of the connective tissues, skin and hair”, “maintenance and promotion of healthy connective tissue in bone by stimulating bone collagen synthesis, healthy women and men”, “helps support hair quality by helping to maintain healthy connective tissue in the dermis, healthy women and men”, and “bioavailable silicon form, silicon is an essential element for normal structure of connective tissues such as skin, hair, joints, bone and blood vessels”. The Panel assumes that the target population is the general population.
Collagen is a structural component of several tissues in the body including bone, cartilage, gums, skin, tendons and blood vessels.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the contribution to normal formation of collagen and connective tissue.
The Panel considers that contribution to normal formation of collagen and connective tissue is a beneficial physiological effect.
2.8. Utrzymanie prawidłowego wyglądu i elastyczności skóry (ID 288, 333)
The claimed effects are “normal skin, hair and nails”, and “maintenance and promotion of healthy connective tissue in skin by stimulating collagen synthesis in the dermis”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of the normal appearance and elasticity of the skin. The Panel notes that the evidence provided does not establish that changes in the appearance or elasticity of the skin relate to changes in skin function.
The Panel considers that the claim does not refer to a function of the body as required by Regulation (EC) No 1924/2006.
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.
3.2. Udział w prawidłowym tworzeniu kolagenu i tkanki łącznej (ID 287, 288, 333, 334, 335, 1405, 1652, 1718, 1719, 1945)
No evidence has been provided that silicon plays a role in collagen formation in humans, and no human studies which addressed the effects of silicon intake on collagen or connective tissue formation have been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and contribution to normal formation of collagen and connective tissue.
Warunki i możliwe ograniczenia stosowania oświadczenia
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
5-10 mg of OSA