Sun Protection

Sun protection is one of the most demanding cosmetic categories, because three hard requirements meet in a single product: the UV filters are tightly controlled actives, the SPF is a measured performance claim that has to be substantiated, and the product sits on the cosmetic-versus-drug line differently in different countries.

UV filters and the Annex VI positive list

Only UV filters listed in Annex VI may be used, each at a maximum concentration and under set conditions, and that list has been moving. Homosalate was restricted by Commission Regulation (EU) 2022/2195 to face products only (excluding propellant sprays) at a maximum of 7.34%, applying from 1 January 2025. Benzophenone-3 and octocrylene were cut by Commission Regulation (EU) 2022/1176: benzophenone-3 to 6% in face, hand and lip products and 2.2% in body products, with lower limits again where it is also used at 0.5% to protect the formulation, and a “contains Benzophenone-3” warning in that case. The UV filter 4-methylbenzylidene camphor has been banned. These changes followed SCCS opinions raising endocrine-disruption concerns, and because each filter is capped, reaching a high SPF means combining several filters so that each stays within its limit.

Nano filters

Nanoform titanium dioxide and zinc oxide are widely used mineral filters, but the nanoform requires notification to the Commission under Article 16 six months before marketing and is permitted only under the specific conditions in the Annex VI nano entries, not in sprayable or otherwise inhalable applications. The physical form of the filter is therefore part of the assessment, not a formulation detail.

SPF and UVA testing

The protection claim has to be earned by testing. SPF is determined in vivo to ISO 24444, UVA protection in vitro to ISO 24443, and water resistance by its own method. The European Commission Recommendation 2006/647/EC frames the claims: UVA protection should be at least a third of the labelled SPF, shown by the UVA-in-a-circle symbol, and SPF is communicated through the low, medium, high and very high categories rather than misleading figures. The label has to match the tested performance.

International divergence

A sunscreen compliant in the EU is not automatically sellable elsewhere. In the United States sunscreens are over-the-counter drugs regulated under an FDA monograph with its own, older list of permitted filters, and in Australia they are therapeutic goods under the TGA. The same formula can therefore need a different filter system and a different regulatory route per market, which is central to planning an international sun-care launch.

How we help

We assess the filter system against the current Annex VI limits, advise on combining filters to reach the target SPF, handle the Article 16 notification for nanoforms, and make sure the SPF, UVA and water-resistance claims rest on the right tests under the right standards. Where a sunscreen is destined for the US or Australia, we flag the drug or therapeutic-goods pathway early so the filter choice suits every market from the outset.