Planning to launch a sun cream, spray or stick? Sunscreen testing requirements are stricter than for almost any other cosmetic, because the product makes a protection promise that customers rely on. This guide lists the tests and documents a sunscreen usually needs before it goes on sale in the EU, and shows how they fit together in your safety file.
Contents
- The short answer
- Why sunscreens are treated differently
- Which UV filters can you use?
- Proving the SPF: the in vivo test
- Proving UVA protection
- Claims and label wording
- Microbiological quality and preservation
- Stability and packaging
- Skin tolerance
- The CPSR for a sunscreen
- What about the US and other markets?
- Checklist before launch
- Frequently asked questions
- Key takeaways
The short answer
In the EU a sunscreen is a cosmetic product under Regulation (EC) No 1223/2009. It therefore needs a CPSR signed by a qualified safety assessor, a product information file and a CPNP notification, like any other cosmetic. On top of that, the sun protection claim must be supported by in vivo SPF and UVA protection data, and the product needs the usual microbiological, challenge and stability evidence. A patch test is strongly recommended.
Why sunscreens are treated differently
Most cosmetics are judged mainly on safety. A sunscreen is also judged on performance: if a product labelled SPF 30 delivers far less, the user can get burnt, and a burn is a health problem rather than a disappointed customer. That is why the European Commission published a Recommendation (2006/647/EC) on the efficacy of sunscreen products and the claims made about them. It is a recommendation, not a regulation, but authorities and safety assessors treat it as the benchmark.
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Which UV filters can you use?
UV filters are regulated ingredients. In the EU, only the filters listed in Annex VI of the Cosmetics Regulation may be used, each with its own maximum concentration and conditions of use. Nano-form filters must be authorised and labelled with “(nano)” after the ingredient name. Filters are revised regularly, so check the current annex, or ask your safety assessor, before you finalise a formula. A filter that is allowed in another market is not automatically allowed in the EU.
Proving the SPF: the in vivo test
The sun protection factor is measured on human volunteers. The reference method is ISO 24444, which exposes small areas of skin to a controlled UV source, with and without the product, and compares the dose needed to cause minimal redness. Results are reported as the labelled SPF. The test is performed by specialised clinical centres with ethical approval, not in an ordinary chemistry laboratory, so plan time for it in your launch schedule.
Proving UVA protection
SPF mainly describes protection against UVB. The Commission Recommendation therefore asks for broad-spectrum protection: the UVA protection factor should be at least one third of the labelled SPF, and the critical wavelength should be 370 nm or higher. UVA protection is commonly shown with an in vitro method (ISO 24443), sometimes with an in vivo method (ISO 24442). Products that meet the requirement may carry the UVA logo, the letters “UVA” in a circle. Check the current text of the Recommendation for the exact thresholds before printing your label.
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Claims and label wording
The Recommendation limits how protection is described:
- Protection is given as four categories – low, medium, high and very high – usually together with the SPF number.
- SPF values above 50 should be shown as “50+”.
- Claims such as “sunblock”, “total protection” or “all-day protection” should not be used, because no sunscreen blocks all UV.
- The label should tell users to apply generously and re-apply, and should include a warning about avoiding excessive exposure.
Water resistance claims need their own supporting data. If you want to say “water resistant”, you will need a test that measures protection after water immersion, normally following ISO 16217.
Microbiological quality and preservation
Sunscreens are often emulsions, sprays or lotions with a high water content, so they need effective preservation. A challenge test shows that the preservative system protects the product during use. A microbiological specifications test confirms that the finished product meets accepted limits. Both belong in the CPSR. Some UV filters and oils can make preservation harder, so test the final formula, not a similar one.
Stability and packaging
A sunscreen has to keep working for its whole shelf life. Emulsions can separate, filters can degrade and the SPF can drop in heat or sunlight. A stability and compatibility test checks appearance, odour, viscosity and pH over time under accelerated conditions, and checks the product in its final packaging. Sunscreens are often kept in hot beach bags and cars, so ask for elevated temperature conditions in your plan. This test also supports the period-after-opening symbol or the date of minimum durability on the label.
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Skin tolerance
Sunscreen is spread over large areas of the body and used repeatedly, often on skin that is already stressed. Irritation and sensitisation matter. A patch test on human volunteers supports claims like “dermatologically tested” or “suitable for sensitive skin”, and gives your assessor real tolerance data, especially for products with fragrance or many filters. Claims about sensitive skin must be backed by evidence under the Claims Regulation (EU) No 655/2013.
The CPSR for a sunscreen
The safety assessor evaluates every ingredient and the exposure to the product. For sunscreens, exposure is large: a big body area and repeated application. The assessor will also look at filter concentrations against Annex VI, the risk of inhalation for sprays, impurities, and the stability and microbiological data. Our CPSR is signed by a qualified assessor, takes about 10 business days after we have complete data, and needs stability, microbiological and challenge test results. Sunscreens often fall into the Standard or Complex tier because of the number of ingredients and the fragrance.
What about the US and other markets?
Rules differ widely outside the EU. In the United States, for example, sunscreens are generally regulated as over-the-counter drugs rather than cosmetics, with their own monograph and labelling rules. Other markets use their own lists of filters and test methods. If you plan to export, check the requirements for each market early and do not assume an EU file will be accepted without changes.
Checklist before launch
- Choose filters from the current EU Annex VI list and respect maximum concentrations.
- Run in vivo SPF and UVA protection testing on the final formula.
- Order challenge, microbiological and stability tests on the final formula and packaging.
- Consider a patch test for tolerance and claims.
- Have a qualified assessor sign the CPSR and complete the product information file.
- Notify the product in the CPNP and check the label wording against the Recommendation.
Any change in filters or the base formula can change the SPF, so repeat testing after significant reformulation.
Frequently asked questions
Do I need a CPSR for a sunscreen?
Yes. In the EU every cosmetic product placed on the market needs a safety report signed by a qualified assessor, and sunscreens are no exception.
Can I use SPF values from my ingredient supplier?
Supplier data helps with development, but the SPF on your label should be supported by testing of your finished product. SPF depends on the whole formula and cannot simply be added up from ingredients.
Which tests does Cosmetic Testing Lab offer for sunscreens?
We provide the challenge test, the microbiological specifications test, the stability and compatibility test, the patch test, the CPSR and the SDS. In vivo SPF testing is done at specialised clinical centres, which your assessor can help you choose.
Key takeaways
- A sunscreen is a cosmetic in the EU and needs a CPSR, a product file and a CPNP notification.
- SPF and UVA protection must be proven on the finished product, following the Commission Recommendation.
- Challenge, microbiological and stability tests protect both the product and the claim.
- Plan for the in vivo studies early, because they take the longest.