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 documentation 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 European Commission maintains the EU regulatory framework and manages the CPNP. However, national competent authorities in EU Member States take care of market surveillance and enforcement.
Cosmetics Classification in the EU
Before starting CPNP notification, brands should check:
- Product classification
- Ingredient compliance
- Product claims
- Restricted ingredients
- Labelling requirements
Delays, relabelling, or other compliance issues can be avoided by doing this early.
Article 2 of Regulation (EC) No 1223/2009 gives the definition of a cosmetic product. It says that it is a substance or mixture intended to come into contact with the external parts of the human body. These include the following:
- Skin
- Hair
- Nails
- Lips
- External genital organs
It also includes products intended for contact with the teeth and the mucous membranes of the oral cavity. These products must be intended exclusively or mainly to do the following:
- Clean
- Perfume
- Change appearance
- Protect
- Keep these body parts in good condition
- Correct body odours
Products that aim to treat or prevent disease may fall under EU medicinal product legislation and not cosmetics legislation. Classification depends on the product’s aimed purpose, composition, presentation and claims.
CPNP Notification Step-by-Step for EU Cosmetics
The procedure given below is for cosmetic notification in the EU.
Step 1: Ensure the Accuracy of Product Classification and Ingredients
Classify the product into the cosmetic category according to EU regulations. Review the formula against the prohibited and restricted substances that are listed in the Regulation. Also check the conditions for using preservatives, colourants and UV filters in its annexes.
Step 2: Appoint an EU Responsible Person
For products manufactured outside the EU, the importer is generally the Responsible Person. That is, unless another EU-established person is appointed through a written mandate and accepts the role in writing. The Responsible Person has a legal responsibility for product compliance. They must maintain the Product Information File (PIF).
Step 3: Complete Product Testing and Safety Assessment
A qualified safety assessor must complete the safety assessment and prepare the CPSR before sending the product to the market. The assessor must hold the qualifications specified in Article 10(2). Not every cosmetic product needs the same lab tests per the Regulations. The assessor determines which tests and supporting data are needed to establish product safety.
Step 4: Prepare the Product Information File
The PIF must contain the following:
- Product description
- CPSR
- Manufacturing method
- GMP compliance statement
- Evidence to support product claims where required
- Data on animal testing carried out in connection with the product or its ingredients
Step 5: Check EU labelling requirements
Make the product’s label compliant with EU rules. 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). Cosmetic products containing nanomaterials may also require additional notification under Article 16. Generally, submit this notification through the CPNP at least six months before the product is placed on the market. Specific exceptions are applicable to nanomaterials used as colourants, preservatives or UV filters. There, they are regulated under the relevant annexes.
Step 7: Keep Post-Launch Compliant
After marketing the product, maintain the documents. Ensure the proper management of product changes, and report Serious Undesirable Effects (SUEs) to the competent authority in the Member State where they occurred. Ensure no delays.
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
- Statement confirming compliance with Good Manufacturing Practice (GMP)
- Label artwork and packaging details
- Claims support documents
- Data on animal testing done by the manufacturer, its agents or suppliers. This is in connection with the product or its ingredients, where such testing has been performed
The PIF should be made accessible by the Responsible Person to the competent authority. It should be at the address shown on the product label. Retain it for 10 years after the date of the last batch of the cosmetic product on the market.
- Stability and compatibility test reports
- Microbiological and challenge test reports
- Responsible Person agreement
These records may be needed to support the safety assessment, depending on the product. However, Article 11 does not prescribe them as separate mandatory PIF documents for every cosmetic product. When another person is appointed as the Responsible Person under Article 4, a written mandate is required.
Cosmetics Labelling Requirements in the EU
Product labelling comes under Article 19 of Regulation (EC) No 1223/2009. It requires the following:
- Responsible person’s name and address. Highlight the address at the location where the PIF is readily accessible. Do so when several addresses are provided.
- Country of origin for imported cosmetic products.
- Nominal content at the time of packaging, expressed by weight or volume. Some exceptions apply, including to packages containing less than 5 g or 5 ml, free samples and single-application packs.
- Minimum durability date for products with a durability of 30 months or less. Products with a durability exceeding 30 months must generally display the period after opening (PAO), unless this information is not relevant.
- Precautions and warnings required by the Regulation.
- Batch number or reference identifying the product.
- Product function, unless it is clear from the product’s presentation.
- Ingredient list, using the common ingredient names in the EU glossary. Ingredients must be listed in descending order of weight at the time they are added. Ingredients below 1% and colourants should follow special ordering rules.
Make the label information visible, legible and indelible. Member States decide the language requirements for certain particulars. It includes nominal content, durability information, precautions and product function. Businesses must therefore check the language rules in each country where they intend to sell the product.
Claims such as “natural” and “organic” are not automatically prohibited. However, they must meet the common criteria for cosmetic claims under EU law. Businesses must also have evidence to support their claims. Claims such as “chemical-free” should be assessed carefully because they may mislead consumers.
Do Cosmetics Need Registration in the EU?
Cosmetic products must be notified through the CPNP before they are placed on the EU market. However, CPNP notification is not a product approval or marketing authorisation. All the EU requirements before selling must be met by the Responsible Person. However, do know that the EU does not issue cosmetic licences or pre-market approvals.
Latest EU Cosmetics Regulatory Updates
The EU has provided the following regulatory updates in recent times:
A. Expanded fragrance allergen labelling requirements
Commission Regulation (EU) 2023/1545 expanded the list of fragrance allergens. These must be individually declared on cosmetic product labels. It is when their concentrations go over 0.001% in leave-on products. Or, it’s 0.01% in rinse-off products.
July 31, 2026, is the deadline for placing products on the market under the previous labelling rules. From 1 August 2026, newly placed products must adhere to the expanded requirements. Products provided in the market before 31 July 2026 may continue to be made available until 31 July 2028. It is under the transitional provisions.
B. Commission Regulation (EU) 2026/909
This rule of 27 April 2026 amends Annexes II, III, V and VI of the EU Cosmetics Regulation. It introduces changes to the use of several substances. This includes Benzyl Salicylate, Triphenyl Phosphate, aluminium-containing ingredients, water-soluble zinc salts, Citral, certain hair dye substances and DHHB.
The Regulation entered into force on 18 May 2026. However, some restrictions have later transition dates. For example, some non-compliant products containing Triphenyl Phosphate and DHHB cannot be newly placed on the EU market from 1 January 2027. They cannot be made available from 1 July 2028. Businesses should review the specific substance entries and transition dates before updating their formulas.
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. Our regulatory professionals provide European Union regulatory services to assist with product notification, labelling, and ingredient requirements and make the compliance process easier. For further information, please contact us at info@artixio.com.
FAQs
1. What is the cost of cosmetic notification 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
- Labelling review
- Product Information File (PIF) preparation
2. What is the CPNP notification timeline?
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.
