EDTA
What Is It?
EDTA (ethylenediamine tetraacetic acid) and its salts, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA and Trisodium EDTA, and the related ingredients HEDTA (hydroxyethyl ethylenediamine triacetic acid) and its trisodium salt, Trisodium HEDTA, are crystalline powders often sold as aqueous solutions.
In cosmetics and personal care products, these ingredients are widely used and can be found in moisturizers, skin care and cleansing products, personal cleanliness products, bath soaps, shampoos and conditioners, hair dyes, hair bleaches, and many other product types.
Why Is It Used?
Disodium EDTA and the related ingredients bind to metal ions which inactivates them. The binding of metal ions helps prevent the deterioration of cosmetics and personal care products. It also helps to maintain clarity, protect fragrance compounds, and prevent rancidity.
Scientific Facts
EDTA, also known as edetic acid, and its salts were developed to counteract the effects of hard water and heavy metalHeavy metals are higher atomic weight elements that have properties of a metallic substance at room temperature. Some heavy metals, such as iron, cobalt, copper, manganese, and zinc are required in small amounts by living organisms. Other heavy metals, such as mercury, lead and cadmium have no known beneficial effects. ions in the manufacture of textiles. These metal chelators are widely used in cosmetics and personal care products, in food, and in medicines.
These ingredients form complexes with calcium, magnesium, and iron, which allows for better foaming and cleaning performance of cosmetics and personal care products. By binding with metal ions, these ingredients prevent the metals from being deposited onto the hair, scalp and skin.
Safety Information
The Food and Drug Administration (FDA) reviewed the safety of Disodium EDTA and Calcium Disodium EDTA and approved the use of these ingredients as food preservatives for direct addition to food.
The safety of Disodium EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, EDTA, HEDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA and Trisodium HEDTA was 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 Disodium EDTA and related ingredients were safe as used in cosmetics and personal care products.
CIR Safety Review: EDTA and the related ingredients at the concentrations used in cosmetic and personal care products were not dermal irritants or sensitizers. Studies indicated that these ingredients were not carcinogens. Because these ingredients bind metals required for normal cellThe basic structural and functional unit of all organisms; cells may exist as independent units of life or may form colonies or tissues as in higher plants and animals. division, some studies that indicated that these compounds were weakly mutagenic. Some studies showed reproductive and developmental effects following oral exposure to large doses of metal chelators, likely an effect of the binding of metals required for normal reproduction and development.
The CIR Expert Panel reviewed data that indicated that EDTA and the related ingredients were not well absorbed through the skin. Therefore, dermal exposures to EDTA or HEDTA from the use of cosmetics and personal care products containing these ingredients would result in very little skin penetration and systemic levels well below those shown to produce adverse effects in oral studies. Because no data were available regarding the absorption of these ingredients following inhalation exposure, the CIR Panel expressed concern about EDTA in products that may be inhaled. They conducted an exposure assessment assuming 25% EDTA in a product. The calculated dose of EDTA via inhalation of an aerosolized product based on this assessment did not raise concerns about adverse effects of EDTA or its salts in cosmetics and personal care products that may be inhaled.
The CIR Expert Panel also recognized that EDTA, HEDTA and their salts are penetration enhancers. Therefore, formulators should be aware of this when combining these ingredients with those found to be safe primarily because they were not significantly absorbed.
More Scientific Information
EDTA (ethylenediamine tetraacetic acid) and its salts are substituted diamines. HEDTA (hydroxyethyl ethylenediamine triacetic acid) and Trisodium HEDTA are substituted amines. All of these ingredients function as chelating agents in cosmetics and personal care products.
Chelating agents, also called sequestrants, are ingredients that have the ability to bind with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products.
Resources
Food Additives by the Food and Drug Administration Food Ingredients and Packaging
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.)
National Toxicology Program Trisodium EDTA
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/”>Search the Code of Federal Regulations