Ethanolamine and Ethanolamine Salts
Safety Information
Expert Panel for Cosmetic Ingredient Safety
The safety of MEA and MEA-containing salts have been assessed on several occasions by the Expert Panel for Cosmetic Ingredient Safety (Expert Panel).
In 1983, the Expert Panel evaluated available scientific data and concluded that MEA was safe for rinse-off cosmetics and personal care products when designed for brief use followed by thorough rinsing from the skin’s surface.
In 2012, the Expert Panel reviewed the scientific data supporting the safety of MEA and 12 MEA salt ingredients. The Expert Panel concluded that MEA and the following 12 MEA salts are safe in the present practices of use and concentration (rinse-off products only) when formulated to be non-irritating. The Expert Panel cautioned that these ingredients should not be used in cosmetics where N-nitroso compounds (i.e., nitrosamines) can be formed. This opinion supersedes the previous one from 1983.
Ethanolamine (MEA) | MEA-laureth-6 carboxylate* | MEA-salicylate* |
Ethanolamine HCl* | MEA-laureth sulfate | MEA-sulfite* |
MEA-benzoate* | MEA-lauryl sulfate | MEA-tallowate |
MEA-cocoate | MEA-PPG laureth-6 carboxylate* | |
MEA-undecylenate* | MEA-PPG-8-steareth-7 carboxylate* |
*Ingredients not currently in use. If these ingredients are used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group.
FDA
The U.S. Food and Drug Administration (FDA) allows the use of ethanolamine (MEA) as an indirect additive for use as a component of adhesives in contact with food (21CFR175.105). It is also approved as an inactive ingredient in drugs in delayed-action tablets, with a maximum potency of one milligram. Meanwhile, ethanolamine HCl is approved for use in intravenous drugs, with a maximum potency of 0.15%.
Ethanolamine and all 12 of the ethanolamine salts listed above and reviewed by the Expert Panel are listed in the EU cosmetics ingredients database (CosIng). These ingredients may be used in cosmetics subject to certain restrictions listed in entry 61 of Annex III of the Cosmetics Regulation. It is cautioned that these ingredients should not be used in cosmetics products in which N-nitroso compounds (i.e., nitrosamines) can be formed.
The Expert Panel noted that MEA may contain small amounts of secondary amines (diethanolamine – DEA) as an impurity. They expressed concern about the potential conversion of secondary amines (like DEA) in the presence of N-nitrosating agents into carcinogenic (i.e., cancer-causing) N-nitrosamines. Therefore, the Expert Panel recommended that MEA and its salts should not be used when N-nitrosating agents are present in formulations. The Expert Panel also stated that the levels of free, residual DEA present in MEA as a contaminant from the manufacturing process must be limited to present practices of use and concentration of DEA itself, as reported in the DEA safety assessment.
Similarly, the EU restricts the maximum secondary amine content in MEA and prohibits MEA from being used with nitrosating systems setting a maximum nitrosamine content.
Resources
Learn more about the regulation of food additives by the FDA