Regulatory Review: The Impact of REACH on the United States

By: David C. Steinberg, Steinberg & Associates

Posted: November 26, 2008, from the December 2008 issue of Cosmetics & Toiletries.

page 4 of 6

• Lead di(acetate) (INCI: Lead acetate)³
• Dibutyl phthalate (INCI: Dibutyl phthalate)
• Triclosan (INCI: Triclosan)
• Octamethylcyclotetrasiloxane (INCI: Cylcotetrasiloxane)

The use of lead acetate, a FDA-permitted colorant, has probably disappeared from cosmetics in the United States since it is on California’s Proposition 65 list. Dibutyl phthalate is also disappearing after its ban in the EU and its listing on Proposition 65,⁴ even though it has safely been used for years in nail polish. Cyclotetrasiloxane, which is the D₄ version of cyclomethicone, has faced problems in Canada,¹ thus most users in the United States have formulated without it.

It is critical that companies use its specific name instead of the old INCI name of cyclomethicone because ChemSec lists cyclomethicone as an alternative name for octamethylcyclotetrasiloxane; thus using cyclomethicone or the incorrect term could cause NGOs to focus on a mislabeled cosmetic.

Triclosan is a commonly used ingredient in deodorants and in US over-the-counter (OTC) drugs, such as health care antiseptics and toothpaste. This action by ChemSec could put additional focus on formulating without triclosan. The ingredient has come under fire for reasons such as accumulating in sewage treatment plants and causing bacterial resistance and possible endocrine disruption. Also on the SIN list are ethylene oxide and formaldehyde (anhydrous gas), which are frequently used as building blocks for many cosmetic ingredients.

The anhydrous gas formaldehyde is the starting material for methylene glycol, which is used in nail hardeners and preservatives such as imidazolidinyl urea, quaternium-15, DMDM hydantoin and diazolidinyl urea. It is one of the critical starting materials for Reppe chemistry, which is used to create many ingredients such as preservatives, hair fixatives, thickeners and solvents. Ethylene oxide (EO) is the starting material for preservatives such as phenoxyethanol, alkanolamines (including triethanolamine) and ethyloxylated chemicals that act as emulsifiers, surfactants, thickeners, humectants and so forth. It would be nearly impossible to formulate cosmetic products without EO-derived ingredients.