Starting a cosmetic business in the European Union is an exciting opportunity—but it also comes with clear legal responsibilities. Whether you are developing your first formulation or planning to launch a brand, understanding the regulatory framework is essential from day one.
In the EU, cosmetic products are governed by Regulation (EC) No 1223/2009, which ensures that all products placed on the market are safe for consumers. Below is a practical and approachable overview of the minimum requirements you need to meet before selling cosmetics.
1. Make sure your product is actually a cosmetic
Before investing time and resources, confirm that your product legally qualifies as a cosmetic.
A cosmetic product is intended for external use (skin, hair, nails, lips, teeth) and is designed to clean, perfume, protect, maintain in good condition or modify appearance. If your product claims to treat or prevent a disease, it may fall under pharmaceutical or medical device regulations instead—bringing very different requirements.
Check your ingredients – Not all ingredients are allowed in cosmetics, as EU legislation defines:
- Substances that are completely banned (Annex II)
- Substances that are restricted (Annex III)
- Lists of permitted colorants, preservatives, and UV filters (Annex IV to VI)
As a new business, always verify your formulation against these annexes to avoid costly reformulations later.
2. Appoint a Responsible Person (RP)
Every cosmetic product sold in the EU must have a Responsible Person (RP) based in the EU.
If you are starting a business, this will often be:
- The manufacturer, if established in the EU
- The importer (if manufacturing outside the EU)
- A specialized third party
The RP is legally accountable for compliance, so this role is central to your business.
3. Ensure product safety (CPSR)
Before selling, your product must undergo a safety assessment carried out by a qualified expert.
The result is the Cosmetic Product Safety Report (CPSR), which evaluates ingredient safety, expected exposure and overall risk
This is not just a formality—it is one of the most critical steps in bringing a product to market.
4. Prepare your Product Information File (PIF)
Think of the Product Information File (PIF) as your product’s regulatory “passport.”
It must include product description, CPSR, Manufacturing method and GMP compliance, evidence supporting claims (if any) and animal testing data.
You must keep this file available for authorities for 10 years after the last batch is sold.
5. Manufacture according to GMP
Cosmetics must be produced following Good Manufacturing Practices (GMP), typically aligned with ISO 22716.
For new businesses, this means working with certified manufacturers or implementing proper procedures if producing in-house
GMP ensures consistency, hygiene, and traceability—key for both compliance and brand credibility.
6. Notify your product (CPNP)
Before selling your product, you must register it in the Cosmetic Products Notification Portal (CPNP).
This is an online EU system where you submit key information about your product, including product identity, Responsible Person and ingredients of concern (if applicable).
This process is mandatory and must be completed before commercialization.
7. Get your labeling right
Labeling is one of the most visible (and commonly underestimated) requirements.
Your product label must include:
- Name and address of the Responsible Person
- Product content
- Expiry date or PAO (Period After Opening)
- Precautions for use
- Batch number
- Product function
- Full ingredient list (INCI format)
Make sure labels are in the language(s) of the country where you sell. Besides, some countries have aditional labelling requirements.
8. Be careful with claims
Marketing is key—but claims must be compliant.
You can say what your product does, but you must ensure that claims are truthful, evidence-based and are not misleading.
For example, avoid implying medical effects unless your product is regulated accordingly.
9. Cosmetovigilance – Monitor your product after launch
Your responsibility does not end once the product is on the market.
You must track customer feedback and complaints, evaluate any undesirable effects and report serious issues to authorities.
This process, known as cosmetovigilance, is essential for maintaining compliance and consumer trust.
Legal requirements for new cosmetic businesses
Selling cosmetics in the European Union requires more than just a good formulation—it demands a structured approach to safety, documentation, and compliance.
While Regulation (EC) No 1223/2009 may seem complex at first, its purpose is clear: to protect consumers while enabling innovation within a harmonized market.
Understanding and implementing these minimum legal requirements is the first essential step toward building a compliant and successful cosmetic product.
If you are just starting out, consider collaborating with regulatory experts, safety assessors, and experienced manufacturers. Getting compliance right from the beginning will save time, money, and potential setbacks as your business grows.
