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EU Cosmetics Registration Procedure (2024)

✅ 1. Appointment of a Responsible Person (RP)

• You must have an RP (Responsible Person) who resides in the EU or has a legal entity there.

• The RP bears overall responsibility for ensuring the cosmetic complies with EU regulations.

• Korean manufacturers cannot act as the RP directly and must appoint one through a local subsidiary or a professional agency.

✅ 2. Preparation of the Product Information File (PIF)

The RP must prepare and maintain a Product Information File (PIF) that includes:

• Product description

• Cosmetic Product Safety Report (CPSR)

• Information on ingredient functions, manufacturing process, microbiological testing, etc.

• Information on animal testing and nano materials

• Evidence supporting product claims

• Proof of compliance with GMP (ISO 22716)

📌 The PIF must be kept for 10 years after the product has been placed on the market.

✅ 3. Ingredient Review

• All ingredients must be checked against Annexes II–VI of the EU Cosmetics Regulation:

o Annex II: Prohibited substances

o Annex III: Restricted substances (limits, area of application, etc.)

o Annexes IV–VI: Lists of approved colorants, preservatives, UV filters

• Products containing nano materials are subject to specific labeling and regulatory requirements.

✅ 4. CPNP Registration (Cosmetic Products Notification Portal)

• The CPNP is an online notification portal operated by the European Commission.

• The RP must complete the CPNP registration before the product can be marketed in the EU.

Required information:

• Product name and type (e.g., Shampoo, Cream)

• Ingredient list (INCI)

• Country of manufacture, RP address, and contact information

• Animal testing status

• Nano material status

• Label image and product photo (digital file)

✔ There is no fee for CPNP registration, and products can be marketed immediately after registration without a separate approval process.

✅ 5. Labeling Requirements

Labels for products sold in the EU must include the following in the local language(s):

• Product name

• Net contents (e.g., 100ml)

• Expiration date or PAO (Period After Opening)

• RP name and address

• Batch number

• Directions for use (if necessary)

• Warning statements (e.g., “Avoid contact with eyes”)

✅ 6. Compliance with Animal Testing Ban

• The EU strictly prohibits animal testing for both ingredients and finished products.

• You may be required to document the use of alternative testing methods.

📋 Summary Table of Registration Steps

Step Description

1. RP Appointment Must have an EU-based legal entity or agency

2. Ingredient Review Check prohibited/restricted substances under EU Annexes

3. PIF Preparation Technical file including safety assessment

4. CPNP Registration Mandatory online pre-marketing notification

5. Labeling Include language, batch number, RP info, etc.

6. Post-Market Obligations Keep documentation for 10 years after marketing

📎 Notes

• Functional products such as whitening, sunscreen, and anti-acne products may be classified as medicinal products or OTC drugs in the EU, so extra caution is needed.

• Claims must be backed by scientific evidence, and false or exaggerated claims (e.g., “cures,” “medical effects”) are prohibited.

• Even sample products must be registered and labeled.

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