Sunscreens and SPF day creams are among the most heavily scrutinised products you can place on the EU market. They make a measurable protection promise — a number on the front of the pack — that has to be backed by real testing, an approved filter system and carefully worded claims. Getting the CPSR for sunscreen right means treating the product not just as a cream that must be safe, but as a performance product whose SPF, UVA protection and water-resistance statements can each be defended on paper. This guide walks through what your safety assessment and supporting dossier need to cover before an SPF product goes on sale.
Whether you are launching a dedicated sun cream, an after-sun or a “day cream SPF 30” moisturiser, the same rules apply the moment an SPF number appears on the pack.
Key takeaways
- Sunscreens sit firmly as cosmetics in the EU — not medicines or biocides — so they need a full CPSR under Regulation (EC) No 1223/2009, plus sun-specific evidence.
- UV filters may only come from the Annex VI allowed list, each used at or below its stated maximum concentration.
- SPF must be measured (ISO 24444 in vivo or ISO 23675 in vitro) and UVA protection tested (ISO 24443); “broad spectrum” needs UVA-PF of at least one-third of the SPF and a critical wavelength of at least 370 nm.
- Protection-category wording (Low/Medium/High/Very high) and the UVA seal follow Commission Recommendation 2006/647/EC; every claim must meet the common criteria in Regulation (EU) No 655/2013.
- Nano UV filters need a specific Annex VI nano entry, must be declared in the CPNP notification and labelled “[nano]”.
- Photostability and water-resistance claims must be substantiated by recognised test methods before they appear on the label.
Sunscreens are cosmetics in the EU — and high-scrutiny ones
In some markets a sunscreen is an over-the-counter drug. In the EU it is unambiguously a cosmetic, regulated under Regulation (EC) No 1223/2009 like any cream or lotion — and that classification sets your route to market, documentation and liability. If you are unsure where your formula falls, our guide on how to classify a product as cosmetic, medicinal or biocide explains the boundaries; for a topical sun-protection cream that makes no therapeutic disease claim, the answer is cosmetic.
Being a cosmetic does not make life easy, though. Because a sunscreen makes a quantified, health-relevant claim, it draws more market-surveillance attention than most products. The foundation is still the Cosmetic Product Safety Report (Part A safety information and Part B assessment under Annex I), signed off by a qualified safety assessor as required by Article 10 — see our CPSR explained overview. What makes a sunscreen different is the extra layer of efficacy, filter and claims evidence that sits alongside the usual toxicological work.
UV filters: only what Annex VI allows, and never above the cap
The most common reason a sunscreen fails EU review is its UV filters. You may only use organic and inorganic UV filters that appear on the positive list in Annex VI of Regulation (EC) No 1223/2009. If a filter is not on that list, it cannot be used as a UV filter in a cosmetic — full stop. This is why sunscreens formulated for the US or Australian market frequently cannot be sold unchanged in the EU: some filters permitted elsewhere have never been approved here.
Each Annex VI entry carries a maximum authorised concentration in the ready-for-use preparation, and often extra conditions. Your safety assessor will check every filter against its entry and confirm the total system stays within the caps. Keep supplier documentation on file — for naturally derived or botanical additives around the filter system, a Certificate of Analysis (CoA) helps evidence identity and purity in the PIF.
Warning: Never exceed an Annex VI maximum concentration to boost SPF, and never substitute a non-listed “high-performance” filter from an overseas formula. An unapproved or over-concentrated UV filter makes the product non-compliant on placement, exposes your Responsible Person to liability, and can trigger withdrawal or recall by national authorities.
Proving protection: SPF, UVA-PF and broad spectrum
An SPF number is a claim, and claims need substantiation. The labelled SPF must be supported by a reproducible measured value, not an estimate from the filter loading. The standard route is in vivo testing under ISO 24444 on human volunteers; an in vitro alternative, ISO 23675, is increasingly used to reduce human testing. Either way, the tested SPF must justify the category you print on the pack.
SPF alone is not enough. The UVB protection that SPF chiefly reflects must be matched by adequate UVA protection, determined in vitro under ISO 24443. To describe a product as broad spectrum — or to display the UVA seal — Commission Recommendation 2006/647/EC sets two conditions: the measured UVA-PF must be at least one-third of the labelled SPF, and the critical wavelength must be at least 370 nm. Meeting both is what lets you show the “UVA” in a circle. For a deeper walk-through of the methods, see our companion article on sunscreen SPF testing explained.
Note: In vitro SPF (ISO 23675) is a welcome, animal-free and human-free option, but confirm your test laboratory and safety assessor accept the method for your specific formula and claim before relying on it — some brands still commission in vivo SPF for headline claims and use in vitro data to support UVA and stability work.
Labelling categories, the UVA seal and honest claims
You cannot print any SPF figure you like. Commission Recommendation 2006/647/EC groups tested SPF values into four protection categories, and the wording must match the measured result: Low protection (SPF 6 and 10), Medium protection (15, 20, 25), High protection (30, 50) and Very high protection (50+). It also discourages misleading terms — no “sunblock”, “100% protection”, “total protection” or “all-day protection”, because no sunscreen delivers them.
Every SPF, UVA and durability statement is a cosmetic claim and must satisfy the common criteria for claim justification in Regulation (EU) No 655/2013 — evidential support, truthfulness, honesty, fairness and informed decision-making. In practice that means the protection data lives in the Product Information File and the on-pack wording never outruns it. Our guide to what cosmetic claims are allowed in the EU covers the criteria in detail; for a sunscreen, the key discipline is simple: if you cannot evidence it, do not print it.
Nano UV filters and the extra notification step
Several of the most popular inorganic filters — titanium dioxide and zinc oxide — are frequently used in nano form for better cosmetic feel and transparency. Nanomaterials carry their own rules. A nano UV filter may only be used if there is a specific Annex VI entry that authorises the nano form, with its own particle-size, coating and use conditions; the non-nano listing does not cover it.
On top of the standard notification, the nanomaterial must be declared in the CPNP notification’s dedicated nanomaterials section (identity, specification and safety data), and Article 16 sets out the wider nanomaterial notification regime for nano ingredients not already regulated as filters. The nano ingredient must also be labelled with “[nano]” after its INCI name under Article 19. If nanotechnology is part of your formula, read our overview of what CPNP notification is so the declarations are handled correctly at submission.
Photostability, water resistance and stability over time
A sunscreen that degrades in sunlight stops protecting the wearer, so photostability is part of the evidence set: the filter system should retain its performance after realistic UV exposure. This is especially relevant for organic filter blends, where one filter can protect another against photodegradation.
Water-resistance claims are equally regulated. “Water resistant” and “very water resistant” are substantiated with recognised immersion protocols (the Cosmetics Europe / ISO methods), where the product must retain at least 50% of its SPF after the defined immersion cycles. Ordinary shelf-life and packaging compatibility still apply too — for many sunscreens, formal stability and preservation data underpins the whole file.
Sunscreen assessment requirements at a glance
The table below summarises what a compliant SPF product needs to demonstrate and where each requirement comes from. Treat it as a pre-launch checklist to review with your safety assessor.
| Requirement | Detail / limit | Test or reference |
|---|---|---|
| Permitted UV filters | Only substances on the allowed list, each at or below its maximum concentration | Reg. (EC) No 1223/2009, Annex VI |
| SPF value | Measured, reproducible SPF that supports the labelled figure | ISO 24444 (in vivo) or ISO 23675 (in vitro) |
| UVA protection | UVA-PF at least one-third of the labelled SPF | ISO 24443 |
| Critical wavelength | At least 370 nm to support “broad spectrum” | Recommendation 2006/647/EC |
| Protection category | Low / Medium / High / Very high wording tied to the tested SPF | Recommendation 2006/647/EC |
| Photostability | Filter system stays effective after UV exposure | Laboratory photostability testing |
| Water-resistance claim | At least 50% of SPF retained after the immersion cycles | Cosmetics Europe / ISO immersion methods |
| Nanomaterials | Nano filter needs an Annex VI nano entry; declared in CPNP and labelled “[nano]” | Articles 13, 16 & 19; Annex VI |
| Claim substantiation | Every SPF, UVA and water-resistance claim evidenced in the PIF | Reg. (EU) No 655/2013 |
| Overall safety | Formula and exposure assessed and signed by a qualified assessor | Article 10 & Annex I (CPSR) |
Bringing it all together
A sunscreen or SPF day cream needs everything a normal cosmetic needs plus a full performance and filter dossier: Annex VI-compliant filters within their caps, measured SPF and UVA data, a defensible protection category, photostability and water-resistance evidence, correct nano handling, and claims that never outrun the file. All of it is drawn together and signed off in the safety report — which is where a specialist assessment saves you from an expensive relaunch.
Lexora prepares sun-protection safety reports every day, so if you want the filter check, efficacy data review and claims substantiation handled correctly the first time, our Cosmetic Product Safety Report (CPSR) service covers it end to end. If you would like to understand the workflow first, our practical guide on how to get a CPSR for your cosmetic product is a good next step.
Frequently asked questions
Do I need a CPSR for a sunscreen or SPF day cream?
Yes. Every cosmetic placed on the EU market needs a Cosmetic Product Safety Report before sale, and a sunscreen is no exception — in fact it needs more, because the report must also incorporate the SPF, UVA and filter evidence. Read our CPSR explained guide for the fundamentals.
Can I sell a US or Australian sunscreen in the EU without reformulating?
Often not. Every UV filter must appear on Annex VI and stay within its maximum concentration, and several filters used abroad are not approved in the EU. A sunscreen here is a cosmetic rather than a drug, as our guide on cosmetic vs medicinal vs biocide explains, but the filter list is strictly enforced.
What SPF testing does the EU require?
The labelled SPF must be substantiated by measurement — in vivo under ISO 24444 or in vitro under ISO 23675 — and UVA protection must be tested in vitro under ISO 24443. Our article on sunscreen SPF testing explained walks through the methods.
What makes a sunscreen “broad spectrum” in the EU?
Under Commission Recommendation 2006/647/EC a product can claim broad-spectrum UVA protection — and show the UVA seal — only when the measured UVA-PF is at least one-third of the labelled SPF and the critical wavelength is at least 370 nm. Both conditions must be met and evidenced in the file.
Are nano UV filters like nano zinc oxide allowed?
Yes, but only where Annex VI contains a specific entry authorising the nano form under its stated conditions. The nanomaterial must also be declared in the CPNP notification and labelled “[nano]” after the INCI name — see what CPNP notification is.
Does a moisturiser with an SPF claim need the same testing as a dedicated sunscreen?
Yes. The moment an SPF number appears on any product — day cream, tinted base or after-sun — it triggers the same testing and substantiation obligations, and the wording must comply with the EU rules on cosmetic claims under Regulation (EU) No 655/2013.
