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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According to the FDA database, the current number of formulations containing these materials is: 30 with DEA, 0 with MEA and 4,012 with TEA. In addition, the number of formulas containing ingredients with these materials in their INCI name is: 1,732 with DEA, mostly alkanolamides; 1,721 with MEA, again, mostly alkanolamides; and 778 with TEA, and most are salts used as soaps or other foaming agents. While many other neutralizing agents can be used in place of these materials, they typically are more expensive.

Dibutyl Phthalate

According to the foundation, dibutyl phthalate is mainly used in nail products as a solvent for dyes and as a plasticizer that prevents nail polishes from becoming brittle. Phthalates are also unlisted fragrance ingredients in many other cosmetics. Dibutyl phthalate is absorbed through the skin. It can enhance the capacity of other chemicals to cause genetic mutations, although it is not a mutagen itself. In laboratory experiments, it has been shown to interfere with hormone function (endocrine disruption) causing reproductive and developmental problems. Dibutyl phthalate is banned in cosmetics in the EU, but not in Canada.

Facts: Dibuthyl phthalate was a popular plasticizer for nail polish but was prohibited by the EU and added to California’s Proposition 65 list even though it was deemed safe for this use. The CIR found⁷ the material to be safe in 1985 and in 2005, decided that there was no reason to review this opinion again. Although dibutyl phthalate is not absorbed through the nail,⁸ since the state of California requires a warning on the label for products containing it, most companies are phasing out its use. Currently, the FDA database lists 42 formulations including the material.

Formaldehyde-releasing Preservatives

Next on the foundation’s list are preservatives including: DMDM hydantoin, diazolidinyl urea, imidazolidinyl urea, methenamine, quarternium-15 and sodium hydroxymethylglycinate. According to the report, these formaldehyde-releasing agents are used as preservatives in cosmetics. Formaldehyde is a recognized human carcinogen. DMDM hydantoin and quarternium-15 can irritate skin and eyes and trigger allergies at low doses. They are also toxic to aquatic organisms.

Facts: Formaldehyde (CAS 50-00-0, EINECS 200-001-8) is an anhydrous gas that is not found in cosmetics and not released by any of the listed preservatives.⁹ What is released is a completely different chemical known as methylene glycol (CAS CAS 463-57-0, EINECS 207-339-5), which has different chemical and safety profiles. All the listed preservatives have been reviewed by the CIR and found to be safe for use as preservatives in cosmetics.¹⁰ These materials have also been reviewed by the EU and are on the list of permitted preservatives. The FDA database currently lists the following numbers of formulas containing these materials: 2,035 with DMDM hydantoin; 1,644 with diazolidinyl urea; 2,007 with imidazolidinyl urea; 6 with methenamine; 389 with quaternium-15 and 90 with sodium hydroxymethylglycinate.

Fragrance (parfum)