Gluconolactone

What Is It?

Gluconolactone, also called glucono delta-lactone, is an esterAn organic compound formed by the reaction of an acid with an alcohol. of Gluconic Acid. Pure Gluconolactone is a white, odorless crystalline powder. Gluconolactone is formed by the removal of water from Gluconic Acid. Gluconic Acid is a carboxylic acid. Barium Gluconate, Calcium Gluconate, Cobalt Gluconate, Cooper Gluconate, Ferrous Gluconate, Lithium Gluconate, Magnesium Gluconate, Manganese Gluconate, Potassium Gluconate, Sodium Gluconate and Zinc Gluconate are salts of Gluconic Acid. In cosmetics and personal care products, Gluconic Acid and its derivatives may be used in the formulation of mouthwashes, bath products, cleansing products, skin care products and shampoo.

Why Is It Used?

The following functions have been reported for Gluconolactone, Gluconic Acid and its salts.

Chelating agentIngredients that inactivate metallic ions so as to prevent the deterioration of cosmetic products.: Gluconolactone, Gluconic Acid, Calcium Gluconate, Potassium Gluconate, Sodium Gluconate
Cosmetic biocideIngredients that help to cleanse the skin or to prevent odor by destroying or inhibiting the growth of microorganisms.: Zinc Gluconate
Skin conditioning agent – miscellaneous: Gluconolactone, Calcium Gluconate, Potassium Gluconate, Sodium Gluconate, Zinc Gluconate

Scientific Facts

Gluconic Acid its derivatives are naturally occurring substances. In mammals, Gluconic Acid is an important intermediate in carbohydrate metabolism. Gluconate is a metabolite of glucose oxidation.

Safety Information

The Food and Drug Administration (FDA) includes Gluconolactone (glucono delta-lactone), Calcium Gluconate, Copper Gluconate, Ferrous Gluconate and Manganese Gluconate on its list of direct food substances affirmed as 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.). The FDA considers Sodium Gluconate GRAS for use in food as a sequestrant, and Zinc Gluconate GRAS for use in food as a nutrient. Ferrous Gluconate is also permitted for use in food as a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. exempt from certification.

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

As part of the Organization for Economic Cooperation and Development (OECD) High Production Volume (HPV) chemical program, safety information available on Gluconolactone, Gluconic Acid, Sodium Gluconate, Calcium Gluconate and Potassium Gluconate was reviewed. These compounds were not skin or eye irritants, nor were they skin sensitizers. Mutagenicity and reproductive and developmental toxicity data were negative. The reviewers concluded that Gluconic Acid and its derivatives were of low priority for additional work.

Link to the OECD summary: http://www.chem.unep.ch/irptc/sids/oecdsids/gluconates.pdf

Gluconic Acid, Gluconolactone, Calcium Gluconate, Cobalt Gluconate, Copper Gluconate, Ferrous Gluconate, Lithium Gluconate, Magnesium Gluconate, Potassium Gluconate and Sodium Gluconate 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.. Water-soluble zinc compounds, including Zinc Gluconate, are permitted to be used in cosmetics and personal care products at a maximum concentration of 1% zinc (see Annex III). Barium salts (excluding barium sulfide and barium sulfate) such as Barium Gluconate are not permitted to be used in cosmetics and personal care products in Europe (see Annex II).

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

More Scientific Information

Gluconate is produced in the body. It is estimated that about 450 mg Gluconate/kg is produced per day by a 60 kg person. The gluconate forms of some essential metals, such as Copper Gluconate, Ferrous Gluconate, Magnesium Gluconate and Zinc Gluconate, are used as nutrients in food because the gluconate form is more readily absorbed from the gastrointestinal tract than other forms of these metals.

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/