The Impact of Junk Science on R&D: A Review of the 'Dirty Dozen'

By: David C. Steinberg, Steinberg & Associates

Posted: September 29, 2010, from the October 2010 issue of Cosmetics & Toiletries.

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All colors allowed in the EU and the United States must also be approved for use as colorants in cosmetics. To be approved, colorants undergo a long safety review. The United States divides approved colors into two categories; certified colors and batch certified colors. Most organic dyes are batch certified, which means the FDA tests each batch before it can be used. The other colors are certified by manufacturers that meet the FDA’s published specifications. Table 1 lists the colors with CI numbers that are allowed in the United States and EU; note that lakes are not included in this list. Those colors listed here have been pre-approved for their intended use, i.e. in cosmetics.

In reference to the group’s comments on aluminum, this material is found in lakes. Lakes are batch certified colors that are precipitated to form FDA-approved substrates. These insoluble pigments are used in color cosmetics including lipsticks, eye shadows, etc. In this author’s view, the writer of the report did not understand the major and significant differences between hair dye intermediates and colorants used in cosmetics.

Diethanolamine (DEA)

The foundation also includes DEA on its list, stating that: DEA (diethanolamine) and DEA compounds are used to make cosmetics creamy or sudsy. They irritate the skin and eyes and may be toxic to the immune and nervous systems. DEA compounds can also react with other ingredients in cosmetics to form carcinogenic nitrosamines. The Danish Environmental Protection Agency classifies cocamide DEA as hazardous to the environment because of its acute toxicity to aquatic organisms and potential for bioaccumulation

Facts: DEA, MEA and TEA are not found in cosmetic products. All three are strong bases used to neutralize acids to form salts. Examples of this are TEA stearate, a common emulsifier that is frequently made in situ to form o/w emulsions; and DEA cetyl phosphate, a common emulsifier for sunscreens. MEA and DEA are used as chemical reactants to form alkanolamides such as cocamide DEA and cocamide MEA, which are used in foaming products such as shampoos, cleansers, washes, etc. to increase the viscosity and stability of foam.

The EU has prohibited the use of DEA and its salts in cosmetics, although trace amounts are allowed in alkanolamides. The CIR reviewed these materials and concluded that TEA, DEA and MEA are safe for use in cosmetic formulations designed for discontinuous and brief use, followed by thoroughly rinsing them from the skin.⁵ In products intended for prolonged contact with the skin, ethanolamines should not exceed 5% w/w, and MEA should only be used in rinse-off products. Finally, TEA and DEA should not be used in products containing N-nitrosating agents⁶ but contrary to the foundation’s statement, N-nitrosating agents are not used in cosmetics.