Sunscreen & SPF Product Compliance: UV Filters, Testing

Quick Answer

In the EU and UK a sunscreen is a cosmetic, so it needs the full file: Responsible Person, CPSR, PIF, labelling and notification. Three things make it harder than a face cream. First, UV filters are a closed list (Annex VI), so you can only use listed filters within their limits. Second, the SPF and UVA claims must be tested, not estimated. Third, the Commission's sunscreen Recommendation sets minimum efficacy levels and says which claims to avoid, such as "sunblock" or "total protection". Get these right and the rest of the file looks like any other cosmetic.

1. UV Filters: Only What Annex VI Lists

The Regulation keeps a positive list of UV filters in Annex VI. If a filter is not on the list, it cannot be used as a UV filter, however safe it may look, and a new filter needs a positive assessment by the EU's scientific committee and approval by the Commission before it can be used. Each listed filter has its own maximum concentration and conditions of use, so check every filter, in every product, against the current entry. Our guide to Annexes II to VI shows how to read the lists, and a background summary is available from Coslaw.

A day cream or foundation with SPF is in the same position: the moment it claims sun protection, its UV filters are subject to the same rules.

2. The Commission Recommendation on Sunscreens

The Commission's Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made for them is the key reference text. As a Recommendation it is guidance rather than a regulation, but it is the benchmark authorities and assessors use. In the text I reviewed, it sets out:

The Recommendation also says claims should not imply 100% protection (for example "sunblock", "sunblocker" or "total protection") or that reapplication is never needed (for example "all day prevention"). It gives example warnings, such as not staying too long in the sun even while using a sunscreen and keeping babies and young children out of direct sunlight, and recommends a warning that applying less than the tested quantity will reduce protection significantly. Treat those as the minimum conversation with your assessor, not a complete label.

3. Testing: SPF and UVA Are Measured

An SPF number on a label must be backed by test data in the PIF. The Recommendation points to the UVA protection factor and critical wavelength methods, and standard test methods exist for SPF and UVA, such as ISO 24443:2021 for in vitro UVA photoprotection. Agree with your lab and assessor, before testing, which methods apply to your market. Test the final formula in its final form; a change of emulsifier, filter or film-former can alter the result. Water-resistance claims need their own supporting tests. Our guide to claims substantiation explains how evidence should sit in the PIF.

4. What the CPSR Must Cover

• Each UV filter: Annex VI status, concentration and the safety profile, including exposure from whole-body use.
• Formulation stability, because filters can degrade or separate. See stability and challenge testing.
• Intended users: adults, children, face or body, spray or lotion. Sprays raise additional questions about inhalation, so tell the assessor.
• Label wording for SPF category, warnings and quantity.

Common Mistakes

Mistake #1 — Printing an SPF without test data. A calculated or "expected" SPF is not evidence.

Mistake #2 — Absolute claims. "Sunblock", "total protection" and "all-day" claims are the ones the Recommendation says to avoid.

Mistake #3 — Forgetting the "SPF" in daily products. A moisturiser or foundation with an SPF claim is a sunscreen for these purposes.

Mistake #4 — Reformulating without retesting. A new filter ratio or base can change both SPF and UVA protection.

Frequently Asked Questions

Is a sunscreen a cosmetic or a medicine?

In the EU and UK, sunscreens are regulated as cosmetics, under the Cosmetics Regulation, with UV filters controlled through Annex VI.

Can I use any UV filter I like?

No. Only filters listed in Annex VI may be used as UV filters, within the limits and conditions stated for each one.

Can I say my sunscreen gives total protection?

The Commission Recommendation says claims implying 100% protection, such as "sunblock" or "total protection", should not be made, nor claims that reapplication is never needed.

Does my moisturiser with SPF need testing?

Yes. If it makes an SPF or sun-protection claim, that claim needs supporting test data in the PIF, like any sunscreen.

Final Word

Sun care is a category where claims and chemistry meet. Use only listed UV filters, test the finished formula, avoid absolute claims, and keep the evidence in the PIF where an inspector can find it.

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Sources

1. Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto (2006/647/EC) — eur-lex.europa.eu
2. Coslaw, Sunscreen products and claims: a guidance to the EU regulatory framework (commentary) — coslaw.eu
3. ISO 24443:2021, Determination of sunscreen UVA photoprotection in vitro (catalogue entry) — standards.iteh.ai
4. Related guides on this site: Annexes II to VI, claims substantiation

This article is for general information and does not constitute legal advice. The Recommendation is an EU instrument; confirm how it and the Annex VI limits apply in Great Britain and in your target markets with a qualified safety assessor or Responsible Person.