Sodium Sulfate

The Food and Drug Administration (FDA) reviewed the safety of Sodium Sulfate and determined that it was 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 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.. The safety of Sodium Sulfate 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 Sodium Sulfate was safe in rinse-off formulations, and safe with limits in leave-on formulations.

CIR Safety Review:

In assessing the safety of Sodium Sulfate, the CIR Expert Panel relied on its GRAS status to preclude the need for many studies. Further, the submission of dermal irritation and sensitization data addressed the CIR Expert Panel’s concerns about the lack of such studies in the published literature. The CIR Expert Panel decided that these data were sufficient to conclude that Sodium Sulfate was safe as used in rinse-off formulations. However, because some of these formulations produced irritation under patch test conditions, the CIR Expert Panel restricted the use of Sodium Sulfate in leave-on products to 1%.

FDA:

Link to Code of Federal Regulations for Sodium Sulfate http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Sodium Sulfate may be used in cosmetic 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..

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

The Joint FAO/WHO Expert Committee on Food Additives has not found it necessary to limit the daily intake of Sodium Sulfate. http://www.inchem.org/documents/jecfa/jecmono/v44jec07.htm