Anyone planning to put cosmetics on the EU market must notify the products in accordance with Regulation (EC) No 1223/2009. The majority of the delays in launching occur when the products do not conform to the documents and regulatory requirements. The products need to be notified through the Cosmetic Products Notification Portal (CPNP) prior to launch in the EU market.
As a non-EU manufacturer, you also require an EU-based Responsible Person, a Cosmetic Product Safety Report (CPSR), compliant labelling, and a Product Information File (PIF).
We have discussed in detail what all these requirements mean and how to get cosmetic products notified to the EU market in this guide.
Cosmetic Regulatory Authority in the EU
Regulation (EC) No 1223/2009 regulates cosmetic products in the European Union. The Cosmetic Products Notification Portal (CPNP) is the official notification system for cosmetic products. The overall body responsible for the framework is the European Commission.
Cosmetics Classification in the EU
Before starting CPNP notification, brands should check:
- Product classification
- Ingredient compliance
- Product claims
- Restricted ingredients
- Labeling requirements
Doing this early helps avoid delays, relabeling, or compliance issues later.
Under the EU Regulation, a product is called a cosmetic according to its use, where it is used, and the claims it makes. Generally, these include products used on the:
- Skin
- Hair
- Nails
- Lips
- Teeth
The uses should be:
- Cleansing
- Protecting
- Or improving the appearance
Products that make medical claims may need to meet other regulations.
CPNP Notification Step-by-Step for EU Cosmetic Registration
For cosmetic notification in the EU, follow the procedure outlined below.
Step 1: Ensure Product Classification and Ingredients are correct.
Make sure the product is classified into the cosmetic category according to EU regulations. Additionally, review the formula to see if it contains any ingredients that are not allowed or recommended.
Step 2: Appoint an EU Responsible Person
For non-EU brands, a very important decision to make before any sale in the EU market is the appointment of an EU-based Responsible Person. The Responsible Person has a legal responsibility for product compliance and the maintenance of the Product Information File (PIF).
Step 3: Complete product testing and safety assessment
It has to be tested, and then a qualified assessor must prepare the Cosmetic Product Safety Report (CPSR).
Step 4: Prepare the Product Information File (PIF)
The Product Information File contains product safety, manufacturing, labeling, and product claims documents.
Step 5: Check EU labelling requirements
The label on the product should comply with the requirements of the EU. This includes ingredient listing, warnings, Responsible Person information, and language requirements.
Step 6: Complete CPNP notification
Submit information on the product before the product is placed on the market in the EU via the Cosmetic Products Notification Portal (CPNP).
Step 7: Keep Compliant Post Launch
Once the product is marketed, it is essential to maintain the documents, ensure the proper management of product changes, and report Serious Undesirable Effects (SUEs) when necessary.
Documents Required for EU Cosmetic Compliance
Before selling cosmetic products in the EU, brands need to have the following documents:
- Cosmetic Product Safety Report (CPSR)
- Product Information File (PIF)
- Full ingredient and formula details
- Stability and compatibility test reports
- Microbiological and challenge test reports
- GMP or ISO 22716 compliance records
- Label artwork and packaging details
- Claims support documents
- Responsible Person agreement
Ensure that an EU-based Responsible Person is maintaining the Product Information File (PIF). They should remain available for EU authorities for 10 years after the last batch is placed on the market.
Cosmetics Labeling Requirements in the EU
The label of the product must comply with Article 19 of Regulation (EC) No 1223/2009.
EU cosmetic labels should include:
Name and address of Responsible Person.
The origin of imports is the place where the product was made.
Nominal content
The date at which the minimum durability is expected.
Precautions and warnings
Batch number
Product function
Ingredient list (INCI names, CI names for colorants)
Information on the label needs to be legible, easy to read, and accessible in the language needed by the EU country in which it will be sold.
Words like “natural,” “organic,” and “chemical-free” must also be used with caution, as they can create problems for the regulator.
Do Cosmetics Need Registration in the EU?
Yes, you need to get the cosmetic products notified through the Cosmetic Products Notification Portal (CPNP). Only then are they eligible to be sold in the EU market. But, it is important to note that the EU does not issue cosmetic licenses or pre-market approvals.
For brands and importers, below is an important checklist that you need to meet to sell cosmetics in the EU.
EU Cosmetic Compliance Checklist
It is important to make sure that the following requirements are met before launching your cosmetic product in the EU market:
- Ensure ingredients are in accordance with Regulation (EC) No 1223/2009.
- Have a Responsible Person based in the EU.
- Fill out a Cosmetic Product Safety Report (CPSR)
- Create a Product Information File (PIF)
- Follow GMP requirements, it is usually aligned with ISO 22716
- Check the product label as per EU guidelines
- Fill the CPNP notification before the product is available to the market
Restricted ingredients, preservatives, colourants, UV filters, and nanomaterials are also regulated by the EU. This means products already in the market in other countries might have to be re-labelled or reformulated before they can be marketed in the EU.
Conclusion
Brands must prepare for and follow up on CPNP notification, as well as the requirements of Regulation (EC) No 1223/2009, in order to sell cosmetics in the EU. This encompasses not only the appointment of an EU Responsible Person, but also the preparation of a CPSR and PIF, and the compliance of product labelling and ingredients with EU regulations.
An early start to the compliance process ensures that the project is not delayed, labelled correctly for market entry, and that no issues are experienced.
Artixio simplifies cosmetic regulatory affairs in the EU to help you enter the cosmetic market in the EU. Our regulatory professionals are here to assist you with product notification, labelling, ingredient requirements, and to make the process easier for you. For further information, please contact us at info@artixio.com.
FAQs for EU Cosmetics Registration Process
1.What is the cost of cosmetic registration in the EU?
The EU does not charge a government fee for CPNP notification. However, brands still need to pay for CPSR preparation, product testing, Responsible Person services, labeling review, and Product Information File (PIF) preparation.
2.What is the timeline for CPNP notification?
The EU does not have a formal approval timeline because cosmetic products are not pre-approved before entering the market. Once the required documents are ready, the CPNP notification can usually be completed before the product is placed on the market.
