Potassium Hyaluronate

The safety of Hyaluronic Acid, Sodium Hyaluronate and Potassium Hyaluronate has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Hyaluronic Acid, Sodium Hyaluronate and Potassium Hyaluronate were safe as cosmetic ingredients.

CIR Safety Review: The CIR Expert Panel noted that Hyaluronic Acid penetrated to the dermis and can moderate the penetration of other chemicals. The amount of Hyaluronic Acid normally found in the skin was compared to the maximum amount of Hyaluronic Acid applied to the skin by cosmetics and personal care products (2% of product). The CIR Expert Panel found that the contribution of Hyaluronic Acid to the skin via application of such a product to be negligible. The CIR Expert Panel reviewed acute, short-term and chronic toxicological studies and concluded that they did not demonstrate any cause for concern. Hyaluronic Acid did not cause reproductive or developmental toxicity. There was no genotoxicity found in reverse mutation tests, micronucleus tests and chromosomal aberration tests. There were no skin reactions in an immunogenicity test of Sodium Hyaluronate on humans. Hyaluronic Acid also has medical uses in which it is injected into the body.

In 2000, there were 144 reported adverse reactions from medical injection use of Hyaluronic Acid out of a possible 262,000 uses. Most reactions were resolved within 2 weeks. In the case reports of adverse effects from Hyaluronic Acid that have appeared, most were related to its use as a treatment for osteoarthritis or for tissue augmentation, and all these cases were from injections and not topical use. Moreover, there were no reported reactions to topically applied Hyaluronic Acid, further supporting that Hyaluronic Acid at levels currently used in cosmetics and personal care products applied to the skin should not be of concern.

Hyaluronic Acid, Sodium Hyaluronate and Potassium Hyaluronate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions.. Ingredients of animal origin must comply with European Union animal by-products regulations.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…