Disodium EDTA
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 Expert Panel on Ingredient Safety.
The Expert Panel evaluated the scientific data and concluded that disodium EDTA and related ingredients were safe as used in cosmetics and personal care products.
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 cell 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 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 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 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.
EDTA and its salts, as well as HEDTA and Trisodium HEDTA 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..
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Disodium 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.
Why Is It Used?
Scientific Facts
EDTA, also known as edetic acid, and its salts were developed to counteract the effects of hard water and heavy metal 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.
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.