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.cfsan.fda.gov/~dms/cos-col.html

Link to FDA Code of Federal Regulations for the color uses of Pyrophyllite
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
For the food uses of Calcium Silicate, Bentonite, Clay (Kaolin) and Aluminum Silicate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
For the OTC uses for Magnesium Aluminum Silicate, Magnesium Trisilicate, and Kaolin
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

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 Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

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. http://www.inchem.org/documents/jecfa/jeceval/jec_333.htm
http://www.inchem.org/documents/jecfa/jeceval/jec_175.htm

The silicates are typically used as abrasives, opacifying agents, viscosity increasing agents, anticaking agents, emulsion stabilizers, binders and surfactant - suspending agents in cosmetics and personal care products. The clay silicates primarily function as adsorbents, opacifiers and viscosity increasing agents - aqueous. Pyrophyllite is also used as a colorant in externally applied cosmetics and personal care products, as well as externally applied drugs.