The Comprehensive Guide to the EU Cosmetics Market

The European Union represents one of the world's largest and most attractive markets for the cosmetics industry. However, companies seeking to enter this market must comply with stringent regulations and procedures, most notably the Cosmetic Products Regulation (EC) No 1223/2009. This comprehensive guide will navigate you through the process of entering the EU cosmetics market.

CPNP - Cosmetic Products Notification Portal

1. Appointment of a Responsible Person (RP)

According to EU cosmetic regulations, a Responsible Person (RP), which can be a natural or legal person established within an EU member state, must be appointed. The RP will be responsible for ensuring your products' compliance with EU regulations and will communicate with the competent authorities.

2. Product Information File (PIF) Preparation

A detailed Product Information File (PIF) must be prepared for each cosmetic product. The PIF is a comprehensive document that contains all information related to the product's safety, composition, manufacturing, and labeling.

Key components of the PIF:

• Product information: Product name, intended use, target user group, etc.

• Safety information: Safety assessment report, safety data on ingredients, toxicological data, etc.

• Manufacturing information: Manufacturing method, formulation, raw material specifications, quality control procedures, etc.

• Labeling information: Draft of the product label, explanation of all information presented on the label, etc.

• Cosmetovigilance information: Information on the cosmetovigilance system, procedure for reporting undesirable effects, etc.

3. Labeling

Cosmetic product labels must comply with EU regulations. The following information must be included on the labels:

• Product name

• List of ingredients (INCI)

• Net quantity

• Date of minimum durability

• Batch number

• Manufacturer/RP information

• Instructions for use

• Warnings

• Country of origin

4. Notification

Before being placed on the market, cosmetic products must be notified electronically via the Cosmetic Products Notification Portal (CPNP). During the notification process, the product's PIF and labeling information are uploaded to the system.

5. Safety Assessment

All cosmetic products must undergo a safety assessment before being placed on the market. This assessment takes into account the product's ingredients, intended use, method of application, and potential risks. The assessment must be conducted by a qualified safety assessor.

6. GMP Compliance

Cosmetic products must be manufactured in accordance with Good Manufacturing Practices (GMP). GMP defines the rules to be followed during the manufacturing processes to ensure product quality and safety. ISO 22716 is an internationally recognized GMP standard for the cosmetics industry.

7. Cosmetovigilance

Cosmetovigilance is the process of monitoring the safety of cosmetic products after they have been placed on the market. Undesirable effects and complaints related to the products are collected, evaluated, and reported to the competent authorities.

Enter the EU Market with Kompass Europe

Entering the European Union cosmetics market can be a complex process. Kompass Europe is here to guide you through this process and ensure your products comply with EU regulations. With our expert team and comprehensive services, we help you achieve success in the EU market.

Contact us today and unlock the European Union cosmetics market!

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