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Global regulations of sunscreens

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On June 1, 2006, the trade associations representing the personal care industry of the European Union, the U.S., Japan and South Africa agreed on an International Sunscreen Protection Method. What will this mean? Sunscreens are regulated throughout the world either as cosmetics, over-the-counter (OTC) drugs which do not require a governmental pre-approval or OTC drugs that require a pre-approval before they are placed on the market. Regardless of how they are regulated, all of these product regulations are very similar concerning sunscreens! Each country has a pre-approved list of permitted UV filters, an accepted method of running efficacy by SPF determination, and regulated labels. Some countries have approved methods for UVA claims and water-resistance testing. The latest changes are in Australia, where some sunscreens will be regulated as cosmetics based on SPF and claims, and Canada, where some sunscreens will be regulated as Natural Health Products depending on their actives! And now here comes a new variable, the harmonized SPF method.

What confusion! This paper will cover the different SPF test methods (Harmonized, Australia, and US-FDA) along with the formulations of reference standards, currently approved UVA methods, water-resistant testing, some labeling requirements and finally a brief review of cGMPs and other requirements for the U.S. It will have an update of the recent changes in regulations and cover the approved UV filters permitted in the U.S., EU, Japan, Canada and Australia as well as their maximum use level and correct ingredient designation. There is also a master cross reference list by INCI designation.
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Document Type: Abstract

Publication date: October 1, 2007

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