Regulatory Review—US and Canada Updates: Canadian Cosmetic Harmonization and the FDA's Claim Crackdown

By: David C. Steinberg, Steinberg & Associates

Posted: January 4, 2013, from the January 2013 issue of Cosmetics & Toiletries.

page 2 of 5

The cosmetics industry also will be impacted by Health Canada’s finalization of the Guidance for Heavy Metal Impurities.¹ The maximum levels of heavy metal impurities are as follows: lead, 10 ppm; arsenic, 3 ppm; cadmium, 3 ppm; mercury, 3 ppm and antimony, 5 ppm. These levels have been deemed safe from extensive scientific reviews including exposure levels, comparisons to allowable levels in drinking water, and levels adopted by the German government. These guidelines will be helpful in combating constant proclamations of “toxic” chemicals in cosmetics by nongovernmental organizations (NGOs); if the FDA would adopt these, perhaps the “lead in lipstick" scare would disappear.

Sometime in early 2013, Canada will begin online electronic notifications for cosmetics. Currently, cosmetics manufacturers are required to notify Health Canada by completing a PDF and mailing it within 10 days of placing the product on the market. The levels of each ingredient are submitted using Canada’s ranges, unlike the exact amounts required in the EU and elsewhere. The forthcoming electronic system will eliminate these mailings. Still under debate is whether notification would be required before entering the market and how far in advance. Also under debate is whether exact amounts should be required or only exact amounts of ingredients found on Health Canada’s Hot List. Finally, Health Canada is debating the listing of EU fragrance allergens.

Important to note is that Health Canada’s Hot List will be revised soon. The plan is to change the format to separate prohibited items and restricted items, similar to the EU, which will make it more user-friendly. A further breakdown of prohibited ingredients that have never been or may have been used in cosmetics would really be helpful to formulators.

Environmental issues: The long review of D-4 (INCI: Cyclotetrasiloxane) and D-5 (INCI: Cyclopentasiloxane) will finally conclude for non-Canadian producers of cosmetics. D-4 will be restricted under Environment Canada’s regulations to control its bulk shipping and use, which leaves imported product makers free to use it as an ingredient. This would not allow Canadian producers to use it, however, as they must buy it in bulk. D-5 will have no such restrictions. It is best to wait until the final rules are released, as Environment Canada may make additional changes.

In relation, since REACH in the EU may place more restrictions on all uses of D-4 and D-5, it is still recommended not to use the generic term “cyclomethicone” on an ingredient listing. Environment Canada’s agenda for the future includes dealing with triclosan and VOC limits, where it is leaning toward following California.