Magnesium Trisilicate

The Food and Drug Administration (FDA) has approved Pyrophyllite as a color additive exempt from certification. Pyrophyllite is allowed to be used as a color in externally applied cosmetics and personal care products and drugs if it conforms to FDA specifications. It is not allowed to be used in products intended for the lips or the eye area. The Food and Drug Administration (FDA) has reviewed the safety of Calcium Silicate and Bentonite and determined that they are 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.) for use as direct food additives (Calcium Silicate at up to 2% of weight of food) and that Kaolin is GRAS for use 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..

Aluminum Silicate is approved for use in polymers with incidental contact with food. Magnesium Aluminum Silicate (antacid), Magnesium Trisilicate (antacid), and Kaolin (skin protectantAn ingredient that temporarily protects injured or exposed skin from harmful or annoying stimuli, and that may provide relief to such skin. In the United States, skin protectants are regulated as Over-The-Counter (OTC) drug ingredients., anorectal) are used in Over-the-Counter (OTC) drug products. The safety of Aluminum Silicate, Calcium Silicate, Magnesium Aluminum Silicate, Magnesium Silicate, Magnesium Trisilicate, Sodium Magnesium Silicate, Zirconium Silicate, Attapulgite, Bentonite, Fuller’s Earth, Hectorite, Kaolin, Lithium Magnesium Silicate, Lithium Magnesium Sodium Silicate, Montmorillonite, Pyrophyllite and Zeolite 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 all seventeen ingredients were safe as used in cosmetics and personal care products.

CIR Safety Review:

The CIR Expert Panel determined that the data provided in the report were sufficient to assess the safety of Aluminum Silicate, Calcium Silicate, Magnesium Aluminum Silicate, Magnesium Silicate, Magnesium Trisilicate, Sodium Magnesium Silicate, Zirconium Silicate, Attapulgite, Bentonite, Fuller’s Earth, Hectorite, Kaolin, Lithium Magnesium Silicate, Lithium Magnesium Sodium Silicate, Montmorillonite, Pyrophyllite and Zeolite. The CIR Expert Panel noted that issues of safety were similar among these ingredients and were broadly applicable to the two types of ingredients reviewed in the report: the silicates and the silicate clays/clay materials. These ingredients were generally non-irritating to the skin.

Because of their solid particle form, some studies showed that these ingredients were irritating if placed in the eyes. These ingredients were not genotoxic or significantly toxic in oral acute or short-term oral or injection toxicity studies. Occupational exposure to mineral dusts has been studied extensively. Fibrosis and pneumoconiosis have been documented in workers involved in the mining and processing of Aluminum Silicate, Calcium Silicate, Zirconium Silicate, Fuller’s Earth, Kaolin, Montmorillonite, Pyrophyllite and Zeolite.

The CIR Expert Panel concluded that the pulmonary damage in humans was the result of direct occupational inhalation of the dusts. The CIR Expert Panel considers that most formulations containing these mineral ingredients will not be inhaled and of the preparations that have fractions that might be inhaled, the concentration of the ingredient is very low. The CIR Expert Panel considered that any sprays containing these mineral ingredients should be formulated to minimize their inhalation. Susbsequently, the CIR Expert Panel concluded that these ingredients were safe as currently used in cosmetic and personal care formulations. All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations.

In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.

You can find out more about FDA regulation of colors at: http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistorica…

Link to FDA Code of Federal Regulations for the color uses of Pyrophyllite

• FDA Regulation #1 
• FDA Regulation #2

For the food uses of Calcium Silicate, Bentonite, Clay (Kaolin) and Aluminum Silicate

For the OTC uses for Magnesium Aluminum Silicate, Magnesium Trisilicate, and Kaolin

Bentonite (a Natural Hydrated Aluminium Silicate) is listed in the Cosmetics Directive of the European Union (Annex IV, Part I) as CI 77004, and may be used in all cosmetics and personal care products. When used as a color in cosmetic products in the European Union, this ingredient must be called CI 77004. Aluminum Silicate, Calcium Silicate, Magnesium Aluminum Silicate, Magnesium Silicate, Magnesium Trisilicate, Sodium Magnesium Silicate, Attapulgite, Fuller’s Earth, Hectorite, Kaolin, Lithium Magnesium Silicate, Lithium Magnesium Sodium Silicate, Montmorillonite, Pyrophyllite, and Zeolite may be used in cosmetics and personal care products marketed in the European Union 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..

EU Cosmetic Regulation

The Joint FAO/WHO Expert Committee on Food Additives did not consider it necessary to specify a daily intake value for the group consisting of Silicon Dioxide, Aluminum Silicate, Calcium Silicate, Calcium Aluminum Silicate and Sodium Aluminosilicate.