The sunscreen market in the European Union is growing rapidly because more people are becoming aware of the importance of protecting their skin from UV rays, staying young, and maintaining healthy skin. But before you start making or selling sunscreen, you need to know that selling it in the EU is more than just a business opportunity; it’s a legal obligation.
This guide will show you how to start selling sunscreen cosmetics in the EU from start to finish. We’ll talk about everything, from what the law says about sunscreen to SPF testing, CPSR, CPNP, and labeling rules.
Understanding EU Cosmetic Regulation (EC) No. 1223/2009
Regulation (EC) No 1223/2009 is the main law that governs the sale of cosmetics in the EU, including sunscreens. This rule says that a cosmetic product is a substance or mixture that is meant to be put on different parts of the body to clean, scent, change the look of, protect, keep in good condition, or fix body odors.
The main job of sunscreen is to protect you from UV rays. This rule says that all sunscreen that says it protects against UV rays, like “SPF 30” or “broad-spectrum protection,” must meet all of the safety standards for cosmetics.
This law’s Annex VI is very important. It lists all the UV filters that are safe to use in cosmetics and the highest concentrations that are safe to use. Your product can’t be sold in the EU if it doesn’t have a UV filter on this list or if it has too much of one.
Classifying Your Sunscreen Product Correctly
You need to put your product in the right category first. Sunscreens are considered cosmetics in the EU, not medical products, unless they say they are for medical use.
To make sure your product is a cosmetic:
- Don’t make claims like “prevents skin cancer” or “treats sunburn.”
- Follow the rules for SPF and UVA labeling that are allowed by law.
- Make sure that the main purpose is to protect the skin in cosmetic terms.
The European Commission also says that SPF labels should be the same for all products (for example, “SPF 15,” “SPF 30,” and “SPF 50+”) so that people don’t get confused.
Compliance Checklist Before Market Entry
Ingredient Verification & UV Filter Approvals
Every sunscreen sold in the EU must only have UV filters that are listed in Annex VI of Regulation (EC) No 1223/2009. These include chemical filters like Octocrylene and physical (mineral) filters like Titanium Dioxide.
The list of ingredients in your product must:
- Follow the naming rules set by the INCI (International Nomenclature of Cosmetic Ingredients)
- Do not have any substances from Annex II or Annex III that are banned or limited
- Make sure that UV filters are used only at the levels that are allowed.
The CosIng database can help you make sure that your ingredients are safe.
SPF Testing and Efficacy Standards
One of the most important things you can do to sell sunscreen is to show that it works as promised. The European Commission Recommendation 2006/647/EC tells the EU how to test and label sun protection products. You can read the whole recommendation here.
Your sunscreen needs to go through:
- Standardized methods for SPF testing to make sure the level of UVB protection
- UVA testing, either in vitro or in vivo, to make sure that the UVA protection is at least one-third of the SPF value on the label.
- Testing for water resistance, if it’s on the label
The recommendation also includes important rules for:
- Correctly labeling SPF values, such as SPF 15, SPF 30, and SPF 50+
- When you can put the UVA logo on packaging
- Clear instructions on how to use and reapply to avoid confusing customers
Only certified labs can do SPF and UVA tests using proven methods like ISO 24443:2021 or something similar. If these test results don’t support your claims, you could face regulatory rejection or a product recall.
Creating the Product Information File (PIF) & CPSR
You need to put together a full Product Information File (PIF) before you can sell your sunscreen in the EU. EU authorities must be able to easily access this file, which must include:
Description of the product
- CPSR: Cosmetic Product Safety Report
- Proof of good manufacturing practices (GMP)
- Proof of claims about effects (like SPF test results)
- Copy and art for the label
- Statement about testing on animals
The CPSR is the most important part and has two parts:
Part A: Information about the safety of cosmetic products, such as ingredient information, exposure data, and toxicological profiles
Part B: An assessment of the safety of the cosmetic product, signed by a qualified safety assessor
The CPSR must have information about the toxicity of UV filters and links to SPF test results for sunscreens. Certified Cosmetics can help you put together and review all of your CPSR and PIF paperwork.
Appointing a Responsible Person (RP) in the EU
Every cosmetic sold in the EU must have a Responsible Person (RP) who is based in the EU. This person or legal entity is in charge of:
- Making sure the product meets EU rules
- Making the PIF available for ten years
- Handling CPNP alerts
- Taking action to fix problems that come up
You need to hire an outside RP if you are not in the EU. Certified Cosmetics offers RP services to make it easier for non-EU brands to get into the market.
Cosmetic Products Notification Portal (CPNP) Protocol
Before your sunscreen goes on sale, the next step is to register it with the Cosmetic Products Notification Portal (CPNP). EU authorities must use this online platform to keep track of cosmetic products.
To sign up:
- Make an account or give your RP permission
- Upload information about the product, such as its name, function, and category.
- Add a picture of the product and information about its packaging.
- Please send in the INCI list and reference numbers.
- Get a CPNP notification ID
You don’t have to wait for approval; just getting the notification is enough. However, you can’t sell the product until this step is done.
GMP Certification & Labeling Rules
ISO 22716:2007 says that making sunscreen products must follow Good Manufacturing Practices (GMP). This makes sure that the quality and hygiene standards of the products are always the same.
Your labels must also have:
- Name and use of the product
- Nominal content (like 50ml)
- Date of minimum durability (or PAO symbol)
- Precautions and warnings
- Ingredients (in INCI format)
- Number of the batch
- Name and EU address of the Responsible Person
Sunscreen labels can’t say things like “sunblock,” “100% protection,” or “sweatproof.” You can only make claims that are backed up by SPF and UVA test data.
Market Strategy: Positioning Your Sunscreen in the EU
Market Size & Growth Trends
By 2024, the EU sunscreen market is expected to be worth more than €2.5 billion. This growth will be driven by higher temperatures, more awareness of skin cancer, and a desire for high-quality skin care.
People are looking for SPF products that they can use every day, not just beachwear sunscreens. Many EU markets are seeing a rise in searches for terms like “moisturizer with SPF,” “tinted sunscreen,” and “mineral SPF.”
Consumer Preferences & Product Formats
People today want more than just UV protection. Some of the most popular features of products are:
- Formulas that don’t clog pores and are light
- Packaging that is safe for coral reefs and the environment
- Claims of being vegan and not hurting animals
- Can do more than one thing (like protect against UV rays and fight aging)
There are also more types of products available, like sprays, gels, powders, and sticks, which are becoming more popular, especially with younger people.
Label and Claims Strategy
To market your product, you need to be clear and consistent and follow the rules. Make sure your SPF and UVA protection levels are clear. Only make claims that are backed up by test results.
Stay away from these:
- “Sunblock”
- “Waterproof” (use “water-resistant” if you tested it)
- “Protection all day”
Instead, use these:
- “SPF 30 – Broad Spectrum Protection”
- “UVA logo” (if the criteria are met)
- “Tested on skin” (if there is clinical data to back it up)
FAQ: Selling Sunscreen in the EU
Q1. Do I need a different CPSR for each type of SPF?
Yes. You need a different CPSR and PIF entry for each version of your sunscreen formula, such as SPF 15, 30, or 50+.
Q2. Is it okay to test SPF on animals?
No. The EU does not allow any animal testing for cosmetics. There must be other ways to test SPF that don’t involve animals.
Q3. Is it okay to sell sunscreen that was made outside the EU?
Yes, but only if you choose a Responsible Person in the EU, register your product with CPNP, and follow all safety and labeling rules.
Q4. How long does it take to get everything in order?
It usually takes 4 to 8 weeks, depending on how long it takes for the CPSR to review the documents, how often the lab tests are scheduled, and how ready the documents are.
Q5. Where can I go to get SPF tests done?
Certified Cosmetics can help you find EU-approved labs that do SPF, UVA, and water resistance testing.
Conclusion: Ready to Launch Your SPF Line?
If you know the rules and follow the right steps, you can sell sunscreen in the EU, even if it’s your first time. There are many steps, such as limiting UV filters, testing SPF, CPSR, and labeling, but each one makes sure that the product is safe and that consumers can trust it.
Need help with your PIF or CPSR? Start using Certified Cosmetics. Need more guides on how to follow the rules? Explore our blog posts.
