Scientific Opinion on the substantiation of health claims related to silicon and protection against aluminium accumulation in the brain (ID 290), “cardiovascular health” (ID 289), forming a protective coat on the mucous membrane of the stomach (ID 345),

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Article
EFSA Journal 2011;9(6):2259 [28 pp.].
doi
10.2903/j.efsa.2011.2259
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
Acknowledgement

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 Bone/Teeth/Connective Tissue: Rikke Andersen, Olivier Bruyère, Albert Flynn, Ingegerd Johansson, Jukka Meurman and Hildegard Przyrembel. The members of the Claims Sub-Working Group on Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter Willatts

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2008-1074
EFSA-Q-2008-1075
EFSA-Q-2008-1076
EFSA-Q-2008-1077
EFSA-Q-2008-1120
EFSA-Q-2008-1121
EFSA-Q-2008-1122
EFSA-Q-2008-1132
EFSA Q 2008-2142
EFSA-Q-2008-2388
EFSA-Q-2008-2454
EFSA-Q-2008-2455
EFSA-Q-2008-2678
Adopted
25 March 2011
Published
30 June 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (326.35 KB)326.35 KB
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 silicon and protection against aluminium accumulation in the brain, cardiovascular health, forming a protective coat on the mucous membrane of the stomach, neutralisation of gastric acid, contribution to normal formation of collagen and connective tissue, maintenance of normal bone, maintenance of normal joints, maintenance of normal appearance and elasticity of the skin, and contribution to normal formation of hair and nails. 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 subject of the health claims is silicon. The Panel considers that silicon is sufficiently characterised.

Protection against aluminium accumulation in the brain

The claimed effect is “mental health”. The target population is assumed to be 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.

No human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.

On the basis of the data presented, 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.

“Cardiovascular health”

The claimed effect is “cardiovascular health”. The target population is assumed to be the general population. The claimed effect is not sufficiently defined and no further details were provided in the proposed wording. No further clarifications were provided by Member States.

The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Forming a protective coat on the mucous membrane of the stomach

The claimed effect is “gut health”. The target population is assumed to be the general population. From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to forming a protective coat on the mucous membrane of the stomach. The Panel considers that forming a protective coat on the mucous membrane of the stomach is not a beneficial physiological effect per se, but needs to be linked to a beneficial physiological or clinical outcome. The Panel considers that no evidence has been provided to indicate in which context the claimed effect could be considered to be a beneficial physiological effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and a beneficial physiological effect related to forming a protective coat on the mucous membrane of the stomach.

Neutralisation of gastric acid

The claimed effect is “gut health”. The target population is assumed to be the general population. From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the neutralisation of gastric acid. The Panel considers that the evidence provided does not establish that the neutralisation of gastric acid is a beneficial physiological effect for the general population.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and a beneficial physiological effect for the general population related to the neutralisation of gastric acid.

Contribution to normal formation of collagen and connective tissue

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 target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to 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.

No human studies which addressed the effects of silicon intake on collagen or connective tissue formation have been provided.

On the basis of the data presented, 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 or connective tissue.

Maintenance of normal bone

The claimed effects are “silicon is required for normal bone and connective tissue formation”, “maintenance and promotion of healthy connective tissue in bone by stimulating bone collagen synthesis”, “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”, 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 target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal bone. The Panel considers that maintenance of normal bone is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that a randomised, double-blind, placebo controlled, human intervention study did not show an effect of silicon administration (as ch-OSA) on bone mineral density at any site in post-menopausal women, that the findings of a cross-sectional study on the association between silicon intakes and bone mineral density were inconsistent, and that no evidence for a mechanism by which silicon could exert the claimed effect has been provided.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and maintenance of normal bone.

Maintenance of normal joints

The claimed effects are “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”, 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 target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal joints. The Panel considers that maintenance of normal joints is a beneficial physiological effect.

No human studies which addressed the effects of silicon withdrawal or silicon intake on joint function have been provided.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and maintenance of normal joints.

Maintenance of normal appearance and elasticity of the skin

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 target population is assumed to be the general population.

In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of 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.

Contribution to normal formation of hair and nails

The claimed effects are “helps support hair quality by helping to maintain healthy connective tissue in the dermis”, “essential part of the connective tissues, skin and hair”, and “helps support hair quality by helping to maintain healthy connective tissue in the dermis, healthy women and men”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the contribution to normal formation of hair and nails. The Panel considers that contribution to normal formation of hair and nails is a beneficial physiological effect.

No references were provided from which conclusions could be drawn for the scientific substantiation of the claim.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of silicon and contribution to normal formation of hair and nails.

 

Keywords
Silicon, aluminium, cardiovascular, stomach, collagen, connective tissue, bone, joints, skin, hair, nails, health claims.
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Number of Pages
28