It’s not just about coming up with new products or meeting consumer demand when introducing a sunscreen or day cream with SPF to the European Union (EU) market. Legal, scientific, and regulatory frameworks play a significant role in this process to ensure that products claiming to protect against the sun are both safe and effective. SPF products are different from regular moisturizers because they can affect your health. They directly protect people from skin damage, premature aging, and skin cancer caused by UV rays. Because of this, the EU has strict rules about how they are made, tested, labeled, and sold.
This guide gives brands and Responsible Persons a full picture of what they need to know before bringing SPF-containing products into the EU. It goes over the whole process of following the rules, from safety checks to efficacy tests to rules about labels and claims, as well as the unique problems that come up with day creams that have SPF.
Why SPF Products Face Stricter Oversight
Like all cosmetics, SPF products are covered by the Cosmetics Regulation (EC) 1223/2009. However, because they protect against UV rays, they are also subject to extra rules and recommendations. Authorities are aware that consumers may suffer significant harm if these products fail. So, the EU says that manufacturers must not only make sure that their cosmetics are safe in general, but they must also show that their products provide the levels of protection they say they do.
In particular, Commission Recommendation 2006/647/EC sets the scientific and consumer protection standards for sunscreens. It says that the SPF must be at least 6, the UVA protection must be at least one-third of the SPF value, and the critical wavelength must be at least 370 nanometers. This framework also says that claims like “sunblock,” “100% protection,” or “all-day protection” are not allowed. These rules, along with ISO testing standards, make sure that every sunscreen or SPF day cream sold in the EU meets a certain level of safety and performance.
The Regulatory Framework in Practice
When creating sunscreen or day cream with SPF for sale, companies must consider three interconnected legal pillars. The first is Regulation (EC) 1223/2009, which sets the basic rules for all cosmetics. These rules include the Cosmetic Product Safety Report (CPSR), the Product Information File (PIF), and the requirement to notify the Cosmetic Products Notification Portal (CPNP). The second is Commission Recommendation 2006/647/EC, which lays down clear rules for how well SPF works, how well it protects against UVA, and how to label it. The third item is a set of international ISO standards that outline standardized methods for laboratories to test SPF, UVA, and water resistance. These frameworks work together to make the compliance roadmap that all SPF products must follow.
Safety Assessment: CPSR and PIF
CPSR Part A: Data Collection
The Cosmetic Product Safety Report is what makes compliance possible. Part A requires the Responsible Person to give all the details about the formulation, such as the amounts of UV filters. You must choose these filters from the list of approved ones in Annex VI of the Cosmetics Regulation. If you use nanomaterials, you must also make it clear and provide safety data. You also need toxicological profiles, information about impurities, and expected levels of exposure. A day cream with SPF that is only put on the face will protect the skin differently than a sunscreen that is meant to be used all over the body.
CPSR Part B: Safety Assessment
Part B of the CPSR is the professional review of the information gathered in Part A. A qualified safety assessor looks at the toxicology, figures out the Margin of Safety (MoS) for each ingredient, and thinks about how stable UV filters are when exposed to light. The assessor must make sure that no harmful breakdown products are made because sunscreens are directly exposed to sunlight. The report also talks about possible dangers from fragrance allergens or preservatives and decides if the product is safe to use as directed.
The Product Information File (PIF) and CPNP
The CPSR is one part of the bigger Product Information File. This file also has information about how the product is made, proof of GMP compliance, proof of claims, and the final labeling artwork. You have to let the Cosmetic Products Notification Portal know about the product before you can sell it. The notice has pictures of the product, information about the formula, and any use of nanomaterials. Without this notice, the product cannot be sold in the EU legally.
Efficacy Testing: SPF, UVA, and Water Resistance
SPF Testing
Any product that claims to protect against the sun must go through SPF testing. ISO 24444 is the best standard because it tests how well UVB protection works on real people. Products are put into groups based on their SPF levels: low (SPF 6–10), medium (SPF 15–25), high (SPF 30–50), and very high (SPF 50+). These groups are included on the packaging to help people understand the level of protection they receive.
UVA Testing
Along with UVB, products must also show that they protect against UVA. EU law says that UVA protection must be at least one-third of the SPF value and that the critical wavelength of absorption must be at least 370 nm. You can use two ISO methods: ISO 24442, which tests UVA protection in vivo, and ISO 24443, which tests it in vitro. Products that meet these standards can show the UVA logo, which tells customers that they offer broad-spectrum coverage.
Water Resistance Testing
More testing is needed if a brand wants to say that its product is water-resistant. ISO 16217 tells you how to do immersion tests, and ISO 18861 tells you how to figure out how much SPF is still there after being in water. A product can only say it is “water-resistant” or “very water-resistant” if the tests show that it is still protected enough. This stops false advertising and makes sure that things work as they should in the real world.
Special Considerations for Day Creams with SPF
Day creams with SPF have to follow the same rules as regular sunscreens, even though they are mostly sold as moisturizers. If a product says it protects against SPF, it has to follow the rules for sunscreen. This means that day creams must pass full SPF and UVA tests, follow labeling rules, and not make false claims.
The hard part for formulators is mixing hydrating ingredients, anti-aging actives, and SPF filters while keeping the product stable. The Responsible Person must also make sure that the safety assessment takes into account the planned exposure scenario, which is usually just the face and neck. Marketing teams need to be careful not to overstate how much protection a product offers. For instance, saying that an SPF 15 day cream is good enough for the beach would be misleading and could even be against the rules.
Still, SPF day creams are a big chance for brands. If they follow the rules, they can give customers easy daily protection and build trust in their brand.
Labeling and Claims Compliance
Proper labeling is crucial for SPF products because it ensures both transparency and safe use. Packaging must clearly state the SPF value, indicate whether the product offers low, medium, high, or very high protection, and include the UVA circle logo if the product meets the necessary criteria. In addition, certain warnings are mandatory. These include instructions to apply the sunscreen before sun exposure, to reapply it frequently, and to keep babies and young children out of direct sunlight. Such requirements exist to remind consumers that sunscreen is part of an overall sun-safe behavior and not a substitute for other protective measures.
The EU also strictly prohibits misleading or exaggerated wording on labels. Claims such as “sunblock,” “total protection,” “100% protection,” or “once-a-day protection” are not allowed under Commission Recommendation 2006/647/EC. These phrases create an unrealistic impression of safety and may encourage risky behavior in the sun. Instead, all claims must be factual, evidence-based, and consistent with the results of SPF and UVA testing.
Ingredient declarations form another essential part of compliance. All UV filters must be listed with their correct INCI names, and if they are used in nano form, they must be followed by “[nano],” e.g., Titanium Dioxide [nano]. This rule highlights the EU’s commitment to transparency and ensures that consumers are informed about the presence of nanomaterials in their products.
Frequently Asked Questions
Q1. Do day creams with SPF have to be as good as sunscreens?
Yes. All products that say they protect against SPF or UVA must go through the same tests, labeling, and effectiveness checks as sunscreens.
Q2. Is it okay to use the word “sunblock” on EU labels?
No. Claims like “sunblock,” “total protection,” and “100% protection” are not allowed because they are misleading.
Q3. What test shows SPF in the EU?
The ISO 24444 in vivo method is the accepted way to prove SPF claims.
Q4. How can I show that I protect against UVA?
The SPF value must be at least one-third of the UVA protection value, and this must be shown by either ISO 24442 or ISO 24443. The product must also reach a critical wavelength of at least 370 nm.
Q5. What do I need to do to say that something is water-resistant?
You need to do the ISO 16217 and ISO 18861 tests, which check how much SPF is left after being in water. You can only make claims if the results show that the level of protection is correct.
Conclusion
One of the strictest compliance processes in the cosmetics industry is for sunscreens and day creams with SPF. Every step, from safety checks and efficacy tests to labeling and claims regulation, is designed to keep consumers safe and ensure that products do what they claim to do. The process may seem complicated, but it lets brands sell their goods in all 27 EU Member States with just one compliance path.
By making sure they follow the rules, brands not only avoid fines from the government but also earn customers’ trust. At Certified Cosmetics, we help brands make sure their sunscreen and SPF products meet all the rules at every step. We know to help you launch products with confidence, from getting your CPSR and PIF ready to setting up ISO-standard testing.
Check out our compliance services for SPF and sunscreen products to get rid of any confusion about EU rules.
