Expert Panel for Cosmetic Ingredient Safety

The safety of 40 alkoxylated fatty amides was reviewed by the Expert Panel for Cosmetic Ingredient Safety (formerly the Cosmetic Ingredient Review Expert Panel) in 2019. The Expert Panel evaluated available scientific data and concluded that the following ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-irritating to skin:

*Not reported to be in current use. Were the ingredient in this group not in current use to be used in the future, the expectation is that it would be used in product categories and at concentrations comparable to others in this group.

Skin absorption and skin toxicity data were lacking for these ingredients. However, the Expert Panel stated that the oral 28-day toxicity studies on PEG-4 rapeseedamide and PPG-2 hydroxyethyl cocamide, as well as the developmental and reproductive toxicity data on PEG-4 rapeseedamide, provide sufficient information on the systemic toxicity potential of these ingredients. Since oral administration is expected to result in higher concentrations in the blood than would occur with dermal absorption of these ingredients and the dermal use concentrations are relatively low, concerns regarding potential dermal toxicity (i.e., toxicity resulting from skin applications) were mitigated.

The Expert Panel determined that the information on PEG-4 rapeseedamide and PPG-2 hydroxyethyl cocamide (the two ingredients with the highest reported frequency of use) could be read-across to the entire group. The Expert Panel also determined that the information on the mono-N-alkoxyl-substituted ingredients informs the safety of the di-N,N-alkoxyl-substituted ingredients that were included in its review.

The Expert Panel noted the lack of carcinogenicity data. However, sufficient negative genotoxicity studies (i.e., that assess potential damage to genetic material) and lack of structural alerts for carcinogenicity mitigated any potential concerns.

The Expert Panel was also concerned about the potential for skin irritation with the use of products formulated using alkoxylated fatty amides. The Expert Panel specified that products containing these ingredients must be formulated to be non-irritating.

The Expert Panel also previously conducted safety assessments on the component parts of these ingredients. Specifically, the PEGs and PPGs were found to be safe in the present practices of use and concentration and safe as used when formulated to be non-irritating, respectively. Mono- and diethanolamides (e.g., cocamide MEA and cocamide DEA) were determined to be safe in the present practices of use and concentration when formulated to be non-irritating and these ingredients should not be used in cosmetic products in which N-nitroso compounds (i.e., nitrosamines) can be formed. For the diethanolamides, the levels of free diethanolamine (DEA) are not to exceed the present practices of use and concentration of DEA itself.

The Expert Panel also discussed the impurity issues that could be of concern with this group of ingredients, such as the possible presence of 1,4-dioxane (an impurity that may be present as a byproduct formed during the manufacturing process of certain ethoxylated cosmetic ingredients). The Expert Panel stressed that the cosmetics industry should continue to use the necessary procedures to limit this impurity in alkoxylated fatty amide ingredients before blending them into cosmetics formulations. Additionally, manufacturers should minimize primary amine impurities and the Expert Panel specified that these ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Expert Panel acknowledged that some alkoxylated fatty amides may be formed from plant- or animal-derived constituents, stressing that the cosmetics industry should continue to use necessary procedures to limit amounts of potential pesticide residues and heavy metal impurities before blending them into cosmetic formulations.

Additionally, the Expert Panel considered the risks inherent in using animal-derived ingredients, namely the transmission of infectious agents (i.e., BSE). While tallow is clearly animal-derived and may be used in the manufacture of some ingredients in this safety assessment, the Expert Panel noted that tallow is highly processed and tallow derivatives even more so. The Expert Panel agreed with determinations by the FDA that tallow derivatives do not pose a risk for transmitting infectious agents.

All alkoxylated fatty amides reviewed by the Expert Panel are all listed in the EU’s Cosmetic Ingredient Database (CosIng) and may be used safely under the rules governing cosmetic products in the European Union.