The skincare market is expanding, but starting your own skincare company in the EU requires more than just producing high-quality goods in eye-catching packaging. It has to do with compliance, safety, and openness.
For good reason, the European Union has some of the most stringent cosmetic laws in the world, driven by consumer protection. Skincare companies must adhere to certain regulations in order to lawfully sell cosmetics in the EU. These regulations include creating a Cosmetic Product Safety Report (CPSR), reporting products on the Cosmetic Product Notification Portal (CPNP), and using the appropriate labeling guidelines.
In order to launch your skincare brand in a way that is compliant, self-assured, and prepared for the EU market, this guide breaks down the essentials.
What is PIF?
Let’s start with the Product Information File (PIF), which is the foundation of EU cosmetic compliance, before delving into CPSR and CPNP.
Your Responsible Person (RP) is responsible for compiling and maintaining the PIF, which is a comprehensive file. It includes all of your product’s technical and safety details, such as:
- The CPSR
- Description of the product
- GMP statement and manufacturing process (often based on ISO 22716)
- Evidence of claims (if any)
- Artwork for labels
- Confirmation of CPNP notification
After the final batch of the product is put on the market, the PIF needs to be kept for a minimum of ten years. Authorities will request it when conducting audits or inspections.
Understanding the CPSR (Cosmetic Product Safety Report)
What Is a CPSR and Why Is It Required?
Under EU Cosmetic Regulation (EC) No. 1223/2009, the Cosmetic Product Safety Report (CPSR) is a required document. Verifying that your skincare product is safe for human health when used as directed is its straightforward but essential goal. No launch without CPSR.
Your skincare product cannot lawfully enter the EU market without this document.
Key Components of a CPSR
There are two sections to a CPSR:
Section A: Safety Data for Cosmetic Products
Included in this section are
- A composition that is both quantitative and qualitative
- Raw materials and the final product’s physical and chemical properties
- Microbiological quality (including, if relevant, the results of tests on the efficacy of preservatives)
- Data on impurities, traces, and packaging materials
- Usage that is typical and reasonably foreseeable
- Assessment of exposure
- Each ingredient’s toxicological profile
- History of undesirable effects and serious undesirable effects (SUE) (if any)
Section B: Safety Evaluation of Cosmetic Products
A certified safety assessor has signed and dated this as the official safety conclusion. It indicates if, in typical circumstances, the product is safe for human use.
When and How to Prepare a CPSR
Before releasing your product onto the market, you must finish the CPSR. Only a certified toxicologist or safety assessor with the appropriate qualifications can prepare it.
- To get a CPSR ready, you’ll need:
- Complete formulation information
- Safety data for ingredients (SDS)
- Results of stability tests
- Test for the effectiveness of a preservative (if water is present)
- Results of microbiological tests
- Details of the label and packaging
From formulation review to final documentation, Certified Cosmetics helps skincare brands streamline this process.
Navigating the CPNP Notification Process
What Is the CPNP?
The EU’s official online platform for notifying consumers about cosmetic products before their sale is called the Cosmetic Product Notification Portal (CPNP).
Although it is required by law, this is not an approval procedure; the EU does not pre-approve cosmetics. The goal is to guarantee that information about your product is accessible to poison control facilities and market surveillance authorities.
Steps to Submit a Product to the CPNP
When you send a product to the CPNP, you usually need to upload the following:
- Name of the product and what it does
- Types of products
- Information about the Responsible Person
- Summary of CPSR
- Artwork for labels (in all languages of sale)
- List of INCI
- Information about nanomaterials (if needed)
- Picture of the product (for reference)
Once you send in your product, it is officially notified and can be sold legally in all EU countries.
Who Should Submit the Notification?
The Responsible Person (RP) is in charge of the notification process. The RP can be:
- The maker (if they are in the EU)
- The importer (for brands not from the EU)
- A third-party compliance provider that has been permitted to act as RP
You need to hire an EU-based RP if your brand is based outside of the EU. For compliance issues, this person or group will be your legal representative.
Mastering EU Cosmetic Labeling Requirements
What Must Appear on the Label?
Your skincare product label needs to say:
- Name of the product and what it does (if not clear)
- List of ingredients (INCI names)
- Net weight (in grams or milliliters)
- Date of expiration or PAO (Period After Opening)
- Code for a batch or lot
- Name and address of the person in charge
- Country of origin (for products not from the EU)
- Warnings or instructions for use (if needed)
Language and Font Requirements
All required label information must be in the official language(s) of the country where the product is sold. For instance, if you sell in France, the labels must be in French.
The text must be clear and easy to read. For small letters, it should be at least 1.2mm tall (unless the container is very small).
Common Labeling Mistakes to Avoid
These are common mistakes that skincare brands make:
- Using the wrong INCI names
- Forgetting the details about the Responsible Person
- Not including information about allergens (if you use scents)
- Making claims that can’t be backed up, like saying something is “hypoallergenic” without proof
If you make these mistakes, you could have to pay a fine or have to recall the product. It’s best to get it right the first time.
Practical Tips Before You Launch
Work with Experts
Starting your own skincare line means more than just making products; you also have to make sure that everything is up to code. Work with:
- Cosmetic safety testers
- Consultants for rules and regulations
- Experts in labeling
Working with professionals helps you avoid expensive delays or legal problems.
Test and Validate Your Product
Make sure you’ve done the following before you send in your CPSR:
- Testing for stability (to find out how long it will last)
- If your product has water in it, you need to do a preservative efficacy test (PET/Challenge Test).
- Microbiological testing, especially for lotions, creams, and serums
These tests back up the CPSR and make sure your product stays safe for its whole life.
Frequently Asked Questions (FAQ)
Q1. Do I need a CPSR for every product I launch?
Yes. Each different formulation needs its own CPSR. You don’t need separate CPSRs for different sizes of packaging, but you do need them for different scents, colors, or active ingredients.
Q2. Can I submit the CPNP notification myself if I’m not in the EU?
No, only a Responsible Person who is based in the EU can send CPNP notifications. You need to hire an RP in the EU if your brand is not in the EU.
Q3. What happens if my label does not meet EU requirements?
You can take products with labels that don’t follow the rules off the market, recall them, or fine them. For both safety and the law, labels must be correct.
Q4. How long does it take to prepare a CPSR and submit the CPNP notification?
CPSR preparation usually takes 5 to 10 business days if all the tests and paperwork are in order. The CPNP notification is faster, usually coming 1–2 business days after the CPSR is done.
Q.5 Do I need microbiological or stability tests to get a CPSR?
Yes. Most skincare products need to be tested for both microbiological and stability to make sure they are safe, especially if they have water in them or will be used over time.
Conclusion: Build a Brand That’s Safe, Compliant, and Trusted
Starting a skincare brand in the EU is more than just selling a product; it’s also about gaining customers’ trust by being safe, open, and following the rules.
We at Certified Cosmetics help brands like yours go through the compliance process with ease. We make it easier to deal with regulatory issues, from getting ready for the CPSR to testing and submitting the CPNP.
Are you ready to start your skincare line in the EU?
Check out our services or our blog for more expert advice.
