Sodium Saccharin

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.

Scientific Facts

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.

Safety Information

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 general provisions of the Cosmetics Regulation of the European Union.

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 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.

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): 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/