Hydrated Silica

The Food and Drug Administration (FDA) permits Silica to be directly added to food as an anticaking agent. It is also permitted as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. as a component of filters and polyester resins. Aluminum Calcium Sodium Silicate (as sodium calcium aluminosilicate, hydrated) is considered Generally Recognized as Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) as anticaking agent in food.

The safety of Silica, Hydrated Silica, Alumina Magnesium Metasilicate, Aluminum Calcium Sodium Silicate, Aluminum Iron Silicates and Sodium Potassium Aluminum Silicate 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 these ingredients were safe as used in cosmetics and personal care products.

The CIR Expert Panel has also reviewed the safety of other silicate ingredient including Calcium Silicate, Potassium Silicate, Sodium Silicate and Zeolite. Please search this website for these ingredients for more information on their safety.

CIR Safety Review:

The CIR Expert Panel reveiwed data indicating that inhaling large doses of amorphous Silica can result in irritation of the respiratory tract. Once inhalation exposure to Silica stops, Silica is removed from the respiratory tract, and recovery is observed. Long-term oral exposure to Silica has not resulted in any adverse effects, including effects on reproduction and development. Amorphous Silica is not genotoxic or carcinogenic. When placed on the skin, Silica is not irritating, nor does it result in sensitization.

Based on the available data, the CIR Expert Panel concluded that Silica, Hydrated Silica, Alumina Magnesium Metasilicate, Aluminum Calcium Sodium Silicate, Aluminum Iron Silicates and Sodium Potassium Aluminum Silicate were safe as used in cosmetics and personal care products.

Link to Code of Federal Regulations for Silica and silica compounds

• FDA Regulation #1
• FDA Regulation #2
• FDA Regulation #3
• FDA Regulation #4

Silica, Hydrated Silica, Alumina Magnesium Metasilicate, Aluminum Calcium Sodium Silicate, Aluminum Iron Silicates and Sodium Potassium Aluminum Silicate 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..