Regulation of sunscreens, their classification efficacy support still remains complex, but the work of ISO has brought most sides to the table and allowed science based collaboration, resulting in greatly improved opportunities for test method harmonisation.
Sunscreen classification – cosmetic or therapeutic?
Differences in classification of sunscreens as either cosmetics or therapeutics have existed for at least 40 years, particularly in the US, which first introduced FDA proposed rules in 19781 and Australia, which had licensed some sunscreens since 19422 the classification of sunscreens as therapeutics was initiated very early in their product category existence. At the other end of the classification scale, the same products are considered in markets such as EU, Japan and South America to be cosmetics.
Discussion on the treatment of sunscreens is always ongoing, with arguments on the level of risks associated with their use being the main consideration. For example, the Cosmetics Europe currently is consistent with the EU. PCPC in the US recognises the importance of industry working co-operatively with FDA3 as well as defending against over-regulation. In Australia, the distinction between primary and secondary sunscreens is supported by ACCORD4 and ASMI.5
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