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World Progress in Cosmetics Regulation

By: David C. Steinberg, Steinberg & Associates

Posted: December 13, 2005, from the April 2005 issue of Cosmetics & Toiletries.

There have been several important changes from the U.S. Food and Drug Administration (FDA), Japan and the European Union (EU) which will affect cosmetics sold in these countries. The additions in Japan and the safety issues raised by the Scientific Committee on Consumer Products (SCCP) in the EU will impact formulators worldwide by permitting once-restricted ingredients, requesting more safety evaluations or changing labeling requirements.

United States ANPRMs from the FDA: The FDA issued some unusual announcements on Nov. 26. In a “housekeeping” announcement, the Agency withdrew a series of Advance Notices of Proposed Rule Making (ANPRMs). These were proposals, some of which affected cosmetics, that were issued more than fi ve years ago. They are being withdrawn because the FDA did not fi nalize them and does not plan to do so in the near future. This does not prohibit the FDA from re-issuing them sometime in the future. Labeling issues are critical, so it is important for the FDA to resolve them.
1. Cosmetic products containing certain hormones (1993). The FDA says you can still use them at levels below the drug level as long as you do not make drug claims.
2. Color additives labeling for Foods, Drugs, Cosmetics and Medical Devices (1985). This regulation allows the labeling of products with shortened INCI names, such as Blue 1 instead of FD&C Blue No. 1.
3. Proposed metric labeling: Quantity of contents to be listed in metric only (1993).

This is only an excerpt of the full article that appeared in Cosmetics & Toiletries, but you can purchase the full-text version.