What Is It?
Saccharin, Calcium Saccharin and Sodium Saccharin are sweeteners that have been used in food for many years. In cosmetics and personal care products, Saccharin, Calcium Saccharin and Sodium Saccharin are used in the formulation of dental products, mouthwashes and lipstick.
Why Is It Used?
Saccharin, Calcium Saccharin and Sodium Saccharin are used in cosmetic and personal care products as flavoring agents.
Saccharin is about 300 times as sweet as sugar. Saccharin is stable when heated, even in the presence of acids, does not react chemically with other food ingredients, and stores well. In its acidic form, Saccharin is not particularly water-soluble. The form used as an artificial sweetener is usually its sodium salt, Sodium Saccharin. The calcium salt, Calcium Saccharin, is also sometimes used, especially by people restricting their dietary sodium intake.
The Food and Drug Administration (FDA) permits Saccharin and its ammonium, calcium and sodium salts to be used in foods. The use of Saccharin and its salts in food has been reviewed and determined to be safe by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization (WHO).
Link to FDA Code of Federal Regulations for Saccharin and its salts: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Link to the summary of the JECFA review: http://www.inchem.org/documents/jecfa/jeceval/jec_2103.htm
Saccharin, Calcium Saccharin and Sodium Saccharin may be used in cosmetics and personal care products marketed in Europe according to the Under 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
Based on studies of Saccharin in rats resulting in bladder cancer, the National Toxicology Program (NTP) previously considered Saccharin and its salts “reasonably anticipated to be human carcinogens.” Additional research by scientists led to the conclusion that Saccharin and its salts cause bladder cancer in rats by a mechanism that is not relevant to humans. Therefore, in 1998 the NTP deleted Saccharin from its Report on Carcinogens.
Link to information about the delisting of Saccharin from the NTP Report on Carcinogens: http://ntp.niehs.nih.gov/ntp/roc/eleventh/append/appb.pdf
The State of California delisted Saccharin from its Proposition 65 is a California citizens initiative that was enacted as “The Safe Drinking Water and Toxic Enforcement Act of 1986.” Proposition 65 requires the State to publish a list of chemicals known to the state of California to cause cancer or birth defects or other reproductive harm. Businesses are then required to notify Californians about these chemicals if they are present in the products they purchase, in their homes or workplaces, or that are released into the environment. list of carcinogens in 2001, and delisted Sodium Saccharin from its Proposition 65 list of carcinogens in 2003.
Link to California’s Proposition 65: http://www.oehha.ca.gov/prop65.html
Because of concerns about cancer, the United States considered banning the use of Saccharin in food. Rather than banning this ingredient which was especially helpful to diabetics, the U.S. Congress required that all products containing Saccharin carry a health warning. In 1991, the FDA formally withdrew its 1977 proposal to ban the use of Saccharin, and in 2000, the U.S. Congress repealed the law requiring Saccharin products to carry health warning labels.
More Scientific Information
Saccharin is the oldest synthetic sweetener. The substance was first produced in 1878. Although Saccharin was commercialized not long after its discovery, it was not until sugar shortages during World War I that its use became widespread. Its popularity further increased during the 1960s and 1970s among dieters, since Saccharin is a calorie-free sweetener.
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” 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/