Sunscreen testing: ethics, limits and critical points



Elena Bocchietto
Director of the testing facility – Abich

Stefano Todeschi
CEO Abich

Biological and chemical analysis, research and services Verbania  and Milano,
Montreal, QB, Canada


Sunscreens are very complex products, the formulation of which requires technical expertise. They are classified as cosmetics or OTC drugs according to the different markets and regulations: cosmetics in Europe, OTCs in the USA, Japan, Australia and Canada. In Canada, they can also be defined as Natural Products (a way in between cosmetics and drugs) if they only contain mineral filters (TiO2 or ZnO). Different regulations describe the labeling features, the allowed claims and the testing protocols.

The SPF (Sun Protection Factor) test is both an efficacy and a safety assay. In Europe, the testing method is described by the ISO 24444:2010 standard, while in USA and Canada the reference method is FDA CFR21 part 201 (subpart G, section 201.327). These are the most used methods required in the EU and North American markets.

Basically, the testing methods aim to measure the Sun protection factor against UVB rays. The methods consist in the ... ...