Approved UV Filters in Annex VI for EU Sunscreens

Here's something that catches makers off guard the first time they compare markets side by side: sunscreen sold in the EU is a cosmetic product. Sunscreen sold in the US is a drug. Same basic product function, protecting skin from UV radiation, two completely different regulatory categories depending on which side of the Atlantic you're selling into. If you're building a formula with UV filters and thinking about more than one market, this distinction shapes almost everything downstream.

Why the EU treats sunscreen as a cosmetic

Under Regulation (EC) No 1223/2009, the EU's cosmetics framework, sunscreen products fall within the definition of a cosmetic because their function, protecting and caring for the skin, sits within what the regulation considers cosmetic purposes. That doesn't mean UV filters are unregulated or treated casually. It means they're regulated through the cosmetics framework's own restricted-substance mechanism rather than through a separate drug approval pathway. The EU maintains Annex VI to the cosmetics regulation specifically as the list of UV filters permitted in cosmetic products, along with the maximum concentration each one is allowed at.

What Annex VI actually is

Annex VI is a positive list. That's an important structural point: it means only UV filters explicitly named on that list, at or below the concentration specified, may be used as UV filters in an EU cosmetic. This is different from a restricted-ingredient list elsewhere that names things you can't exceed a cap on, while otherwise leaving the field open. With UV filters in the EU, if a substance isn't on Annex VI, it's not an approved UV filter for cosmetic use, full stop.

Because Annex VI is periodically updated as new filters are assessed and approved, or as concentration limits get revisited for existing ones, the exact current list and limits are genuinely the kind of detail to confirm directly against the current published Annex VI rather than relying on a fixed list here. UV filter chemistry and its permitted concentrations are actively managed and do shift.

What this means practically for a formula

• Every UV filter in your sunscreen formula needs to be checked against the current Annex VI list, by INCI name, confirming both that it's permitted and that your concentration sits at or under its specific limit.
• A UV filter permitted at one concentration for one function may carry a different limit if it's also being used for a secondary purpose, since some substances serve double duty, appearing as both a UV filter and, in smaller amounts, an ingredient serving another function like a stabilizer. Where that applies, check which limit governs your actual use.
• Notification still runs through CPNP, the standard EU cosmetic notification portal, and you'll still need a Responsible Person established in the EU, a Product Information File, and a Cosmetic Product Safety Report signed by a qualified safety assessor, the same core requirements that apply to any EU cosmetic, sunscreen included.

Why the US comparison matters if you sell in both markets

If you're formulating a sunscreen for the EU and also want to sell in the US, don't assume the same finished product transfers over. In the US, sunscreen is regulated as an over-the-counter drug, not a cosmetic, which means it falls under a completely different framework than MoCRA's cosmetic-focused facility registration and product listing requirements. Drug regulation in the US involves its own approved active ingredient list, its own testing and monitoring expectations, and its own labeling rules that don't map onto cosmetic labeling at all.

Practically, this usually means makers either maintain genuinely separate formulas for each market, using UV filters and concentrations appropriate to each system, or they accept that a product formulated for one market needs real rework, not just a label swap, before it's appropriate for the other.

	EU	US
Regulatory category	Cosmetic	Over-the-counter drug
Filing mechanism	CPNP notification	Drug-specific requirements, not cosmetic listing
UV filter list	Annex VI, positive list with concentration limits	Separate drug monograph system
Responsible party	EU-established Responsible Person	Different drug-specific obligations apply

A practical starting point

If you're building or reviewing a sunscreen formula for the EU, start by listing every UV filter by INCI name and its intended concentration, then check each one individually against the current Annex VI entry rather than assuming a filter you've used before is still listed at the same limit. Annex VI updates are exactly the kind of regulatory change that can quietly age out a formula that was compliant a couple of years ago.

Cosmetic Comply's ingredient screening approach, matching each substance to its INCI identity and checking it against the relevant market's restricted or permitted lists, is built around this ingredient-by-ingredient logic. The EU is on the roadmap alongside the US and Australia, with Canada live today, so this same discipline will extend to EU-specific lists like Annex VI as that market comes online.