Di-C12-15 Alkyl Fumarate

What Is It?

Fumaric Acid is a four carbon dicarboxylic acid (a carbohydrate) that is an intermediate of the citric acid cycle. The citric acid cycle is the main pathway used by cells (including cells in the human body) to produce energy. Disodium Fumarate, Sodium Fumarate and Ferrous Fumarate are salts of Fumaric Acid. Dibehenyl Fumarate, Di-C12-15 Alkyl Fumarate, Diethylhexyl Fumarate and Diisostearyl Fumarate are diesters of Fumaric Acid. Sodium Stearyl Fumarate is a salt of a monoester of Fumaric Acid. In cosmetics and personal care products, Fumaric Acid, Disodium Fumarate, Sodium Fumarate, Dibehenyl Fumarate, Di-C12-15 Alkyl Fumarate, Diethylhexyl Fumarate, Diisostearyl Fumarate, Sodium Stearyl Fumarate and Ferrous Fumarate may be used in bath products, hair and skin care products, and makeup.

Why Is It Used?

When used in cosmetics and personal care products, the following functions for these ingredients have been reported.

BinderIngredients that hold together the ingredients of a compressed tablet or cake. – Sodium Stearyl Fumarate
Buffering agentIngredients that minimize the change in the pH of a solution when an acid or a base is added to the solution. – Disodium Fumarate, Sodium Fumarate
Bulking agentNon-reactive, solid ingredients that are used to dilute other solids, or to increase the volume of a product. – Sodium Stearyl Fumarate
pH adjusterIngredients that are used to control the pH of cosmetic products. – Fumaric Acid, Disodium Fumarate, Sodium Fumarate
Skin conditioning agent – emollient – Di-C12-15 Alkyl Fumarate, Diethylhexyl Fumarate, Diisostearyl Fumarate
Viscosity increasing agent – nonaqueous – Dibehenyl Fumarate

Scientific Facts

Fumaric Acid is structurally related to Maleic Acid which has also been reviewed by CIR and determined to be safe as used in cosmetic and personal care products. Fumaric Acid and maleic acid contain the same atoms in the same number, but the atoms are arranged in a different manner.

Safety Information

The Food and Drug Administration (FDA) includes Fumaric Acid and its salts (including sodium and ferrous) on its list of food additives permitted for direct addition to food for human consumption. The FDA also permits Fumaric Acid to be used 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 adhesives, resinous and polymeric coatings, and paper and paperboard in contact with food. The safety of Fumaric Acid, Disodium Fumarate, Sodium Fumarate, Dibehenyl Fumarate, Di-C12-15 Alkyl Fumarate, Diethylhexyl Fumarate, Diisostearyl Fumarate, Sodium Stearyl Fumarate and Ferrous Fumarate 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 for use in cosmetics and personal care products.

CIR Safety Review: The CIR Expert Panel noted that Fumaric Acid is a normal constituent of the body and plays an important role in the production of energy by cells. In laboratory studies, no significant effects were reported following oral exposure to Fumaric Acid and its salts and esters. Chronic oral studies of Fumaric Acid and its sodium salt also did not result in significant adverse effects. Fumaric Acid was not a reproductive or developmental toxicant, nor was it genotoxic. Diisosteryl Fumarate and Di-C12-15 Alkyl Fumarate also tested negative for genotoxicity in bacteria. Smaller fumarate esters, such as dimethyl fumarate, which are not used in cosmetics and personal care products, have been shown to be potent dermal sensitizers in humans. Therefore, the CIR Expert Panel was concerned about the sensitization potential of the larger fumarate esters used in cosmetics and personal care products. Diisostearyl Fumarate was not a sensitizer.

Studies of products containing Di-C12-15 Alkyl Fumarate or Diisostearyl Fumarate showed that these products have a low potential for sensitization to humans. Based on the available data, the CIR Expert Panel concluded that Fumaric Acid, Disodium Fumarate, Sodium Fumarate, Dibehenyl Fumarate, Di-C12-15 Alkyl Fumarate, Diethylhexyl Fumarate, Diisostearyl Fumarate, Sodium Stearyl Fumarate and Ferrous Fumarate were safe for use in cosmetics and personal care products. The Joint FAO/WHO Expert Committee on Food Additives estimated an acceptable daily intake for Fumaric Acid of up to 6 mg/kg body weight.

http://www.inchem.org/documents/jecfa/jecmono/v06je04.htm

FDA: Link to Code of Federal Regulations for Fumaric Acid and its salts and esters

Fumaric Acid and its salts and esters 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..

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

More Scientific Information

Fumaric Acid is found in many plants including starfruit, onions, chives, celery, cauliflower, cabbage, carrots and potatoes.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm

Substances 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.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/