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Recent ATPs and Their Effect in the EU and Abroad

By: David C. Steinberg, Steinberg & Associates
Posted: April 14, 2009, from the June 2009 issue of Cosmetics & Toiletries.

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Discussion
In the described ATPs, the EU has banned a number of hair dye ingredients in formulations that the industry does not use, and for which it does not submit safety data. Therefore, the EU has prohibited what is not being used based on nonexistant safety data.

The EU also has added a significant number of fragrance ingredients to its restricted list that reflect the standards of the International Fragrance Association (IFRA). Adding all these fragrance components to the restricted list and establishing limits on their use and trace contaminants really does not add to the safety of cosmetics. It does, however, add clutter to Annex III and another document that fragrance suppliers must provide-a statement attesting to their conformance with IFRA and now Annex III standards.

The addition of PABA to the prohibited list is another example of an ingredient that is not used. At one time it was the only UV filter allowed in the EU, Japan, the United States, Canada and Australia, but the relentless “PABA-free” drive, married to the fact that it is not a good UV filter, has succeeded in eliminating its use in the EU. NGOs will likely campaign at the FDA to ban PABA from US sunscreens as well.

The banning of diethylene glycol is in response to adulterated toothpaste exported from China. When ingested, it is toxic but most cosmetics are not ingested, so why not just prohibit it from oral care products? Only seven formulations currently registered with the FDA contain it, so its loss would have minimal impact. Additionally, it was used safely as a solvent for some fragrances.

Vitamin K1 is a different story. Here, severe allergic reactions and even death resulted from exposure to parts-per-millions of this material in creams.1 Since its primary cosmetic function was “it sounds good on the label,” this is a case where the risks justify its removal from cosmetics. It’s interesting to note there have not been any calls from the NGOs to ban this ingredient. The Environmental Working Group’s Web site, www.cosmeticsdatabase.com, gives it a rating of 2—their lowest hazard ranking, where 0 is best and 10 is worst.