Recent Posts

Cosmetics EU

EU Cosmetics Regulation: Complete Guide to Registering Your Products

Navigating the complex landscape of EU cosmetics regulation is crucial for companies seeking to bring their cosmetic products to the European market. Compliance with these stringent regulations is essential to ensure consumer safety, maintain brand reputation, and avoid costly penalties. This comprehensive guide provides a step-by-step approach to registering your cosmetic products in accordance with the EU Cosmetic Regulation 1223/2009.

By following the registration process outlined in this article, cosmetic manufacturers and distributors can confidently meet all regulatory requirements and gain market access in the EU. The guide will cover key aspects such as understanding the EU regulations for cosmetics, appointing a responsible person, compiling the product information file, and submitting the notification via the CPNP portal. Armed with this knowledge, companies can successfully navigate the complexities of EU cosmetics regulation and bring their products to the European market with confidence.

Understanding the EU Regulations for Cosmetics

The EU Cosmetics Regulation (EC) No 1223/2009 is the main regulatory framework governing finished cosmetic products in the EU market. It aims to ensure the safety of cosmetic products while streamlining procedures for all operators in the sector.

The regulation replaces Directive 76/768/EC and introduces several significant changes, including:

  • Strengthened safety requirements for cosmetic products, obligating manufacturers to prepare a product safety report before placing a product on the market
  • Introduction of the notion of ‘responsible person’, allowing precise identification and clearly outlining their obligations
  • Centralised notification of all cosmetic products placed on the EU market via the EU Cosmetic Products Notification Portal (CPNP)
  • Introduction of reporting serious undesirable effects (SUE) to national authorities, who must share the information with other EU countries
  • New rules for the use of nanomaterials in cosmetic products, requiring explicit authorisation for colourants, preservatives, and UV-filters

The regulation also includes guidelines and claims, such as:

  • Commission Implementing Decision 2013/674/EU on guidelines for the cosmetic products safety report
  • Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
  • Technical document on cosmetic claims (version of 03 July 2017)

Numerous amendments have been made to the cosmetics regulation since its adoption, addressing specific substances and updating annexes.

Apart from the main regulatory framework for finished cosmetic products, additional requirements covered by other EU legislation may apply, such as restrictions on dangerous substances, ozone-depleting substances in aerosol products, aerosol dispensers, nominal quantities for prepackaged products, and packaging waste.

Appointing a Responsible Person (RP)

According to the EU Cosmetics Regulation, every cosmetic product placed on the EU market must have a designated Responsible Person (RP) established within the EU. The RP plays a crucial role in ensuring that the cosmetic products comply with the relevant regulations and are safe for human use.

The RP can be any legal or natural person based in the EU, such as:

  • The manufacturer, if established in the EU
  • The importer
  • The distributor
  • A third party, who accepts this role in writing

The RP must be designated by a written mandate and must accept this role in writing. There can only be one RP per product for the entire EU.

Obligations and Tasks of the Responsible Person

The RP has several obligations to ensure the safety and compliance of cosmetic products with the EU Regulation 1223/2009. These include:

  1. Ensuring product safety and producing a Cosmetic Product Safety Report (CPSR)
  2. Complying with labeling requirements and substantiating product claims
  3. Adhering to Good Manufacturing Practices (GMP)
  4. Maintaining the Product Information File (PIF)
  5. Notifying products via the Cosmetic Product Notification Portal (CPNP)
  6. Managing compliance related to nanomaterials
  7. Monitoring and reporting any undesirable or serious undesirable effects

In case of non-compliance, the RP must take appropriate measures, such as making the product compliant, withdrawing it, or recalling it from the market.

The RP must also cooperate with the competent authorities to eliminate any risks posed by the cosmetic products for which they are responsible.

Responsible Person and CPNP

Before placing a cosmetic product on the market, the RP must submit a notification to the European Commission via the Cosmetic Product Notification Portal (CPNP). The notification should include:

  • Product category and name(s)
  • RP’s name and address
  • Country of origin (for imports)
  • Member State where the product will be marketed
  • Contact details
  • Presence of nanomaterials
  • Name and CAS/EC number of CMR substances
  • Frame formulation

Responsible Person and Product Information File (PIF)

The RP must ensure that a PIF is maintained and readily accessible to the competent authorities at the RP’s address indicated on the product label. The PIF must be kept for 10 years after the last batch of the product has been placed on the market.

The RP must also ensure that the product has undergone a safety assessment, the PIF is kept up-to-date, and the product complies with the relevant regulations.

In conclusion, appointing a Responsible Person is a legal requirement for placing cosmetic products on the EU market. The RP plays a vital role in ensuring product safety,regulatory compliance, and acting as a point of contact for the competent authorities.

Compiling the Product Information File (PIF)

The Product Information File (PIF) is a crucial component of the EU cosmetics regulation, serving as a comprehensive dossier that contains all the essential information about a cosmetic product. According to Article 11 of Regulation 1223/2009, the Responsible Person must keep a PIF for each cosmetic product placed on the EU market, readily accessible to the competent authorities.

The PIF must be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. It should be available in a language easily understood by the competent authorities of the Member State where the file is kept.

Contents of the Product Information File

The PIF must contain the following information and data:

  1. A description of the cosmetic product
  2. The Cosmetic Product Safety Report (CPSR)
  3. A description of the method of manufacturing and a statement on Good Manufacturing Practice (GMP) compliance
  4. Proof of the effect claimed for the cosmetic product, where justified
  5. Data on any animal testing performed

Additionally, the PIF should include the product labeling and the most recent version of the CPSR.

Cosmetic Product Safety Report (CPSR)

The CPSR is the most extensive and critical part of the PIF. It contains all the information, specifications, and tests related to the raw materials, finished product, and packaging. The CPSR consists of two parts:

  • Part A: Cosmetic product safety information
    • Quantitative and qualitative composition
    • Physical/chemical characteristics and stability
    • Microbiological quality
    • Impurities, traces, and information about the packaging material
    • Normal and reasonably foreseeable use
    • Exposure to the cosmetic product
    • Toxicological profile of the substances
    • Undesirable effects and serious undesirable effects
    • Information on the cosmetic product
  • Part B: Cosmetic product safety assessment
    • Assessment conclusion
    • Labeled warnings and instructions for use
    • Reasoning
    • Assessor’s credentials and approval

Keeping the PIF Up-to-Date

As the EU Cosmetics Regulation is frequently updated, it is essential to ensure that the PIF remains current. The Responsible Person must continuously update the PIF whenever new scientific data or regulatory requirements become available.

Common Challenges in Compiling the PIF

  • Ensuring consistency in ingredient names, CAS numbers, and INCI designations across all documentation
  • Providing adequate evidence to support product claims
  • Obtaining GMP compliance certification or statements from manufacturers
  • Conducting necessary tests, such as stability and microbiological quality tests
  • Engaging aqualified safety assessor to prepare the CPSR

By carefully compiling and maintaining the Product Information File, cosmetic companies can demonstrate their compliance with the EU Cosmetics Regulation and ensure the safety of their products for consumers.

Submitting the Notification via CPNP

The Cosmetic Products Notification Portal (CPNP) is a free online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. The responsible persons and, under certain circumstances, the distributors of cosmetic products must submit information about the products they place or make available on the European market through the CPNP. This eliminates the need for further notification at the national level within the EU.

The CPNP makes this information electronically available to:

  • Competent authorities for market surveillance, analysis, evaluation, and consumer information
  • Poison centres or similar bodies established by EU countries for medical treatment purposes

The following entities have access to the CPNP:

  • Competent authorities
  • European poison centres
  • Cosmetic products responsible persons
  • Distributors of cosmetic products

Notification Requirements

Article 13 of the Cosmetic Products Regulation requires responsible persons to submit the following information via the CPNP before placing a cosmetic product on the market:

  • The cosmetic product’s category and name(s) for identification
  • The responsible person’s name and address
  • The product’s country of origin (for imported cosmetic products)
  • The member state where the cosmetic product will be sold
  • A physical person’s contact details
  • The presence of nanomaterial substances and their conditions of exposure
  • CAS or EC numbers of CMR substances of category 1A or 1B
  • The frame formulation for medical emergencies
  • The product’s original labelling and packaging photo

Creating a CPNP Account

New users should follow these steps to create a CPNP account:

  1. Create an EU Login account by filling out the form on the CPNP website
  2. Create an organisation profile in SAAS by requesting access and following the instructions
  3. Log in to the CPNP using the login button near the top of the page

There are three different user profiles:

  • Responsible Person profile for notifying cosmetic products
  • Distributor profile for distributing cosmetic products in the EU
  • Delegate for nanomaterials profile for entering data on nanomaterial-containing products

Entering Information in CPNP

The European Commission has published a manual titled “Guide to Using Cosmetic Products Notification Portal For Responsible Persons and Distributors” detailing how to notify a product using the CPNP. The basic steps involve:

  1. Logging in and selecting “Notify a product” from the “Products” menu
  2. Selecting the type of product to notify (single or multi-component)
  3. Adding the relevant product information
  4. Saving the notification

Notification Requirements for Nanomaterials

Cosmetic products containing nanomaterials require an additional notification under Article 16 of the regulation. This notification must include:

  • The nanomaterial’s identification and IUPAC name
  • Specification and characteristics of the nanomaterial
  • Estimated quantity used per year in cosmetic products
  • The nanomaterial’s toxicological profile and safety data
  • Reasonably predictable exposure conditions

The European Commission has also published a user manual specifically for notifying cosmetic products containing nanomaterials, which can be found on the CPNP website.

By carefully following these notification requirements and procedures, responsible persons can ensure compliance with the EU Cosmetics Regulation and facilitate the safe marketing of their cosmetic products within the European Union.

Conclusion

The EU Cosmetics Regulation provides a comprehensive framework for ensuring the safety and compliance of cosmetic products in the European market. By understanding the regulations, appointing a responsible person, compiling the product information file, and submitting the necessary notifications via the CPNP portal, cosmetic companies can successfully navigate the registration process. Adherence to these requirements not only guarantees consumer safety but also enables businesses to establish a strong presence in the EU cosmetics market.

As thecosmetics industry continues to evolve, staying informed about updates to the EU Cosmetics Regulation remains crucial. By staying proactive and maintaining compliance with the latest regulatory standards, cosmetic companies can confidently bring their products to market while prioritizing consumer well-being and trust. Embracing the EU Cosmetics Regulation as a guide for best practices will undoubtedly lead to long-term success in this dynamic and competitive industry.

 

Need support with your cosmetic registration in Europe?

Picture of Sobel Consultancy

Sobel Consultancy

Do Not Sell My Personal Information

© 2023 | All Rights Reserved

LOCATION

Brazil
Alameda Santos, 1165
01419-002 Sao Paulo - SP

USA
1309 Coffeen Avenue STE 1200
Sheridan, Wyoming 82801

Portugal
Av. Engenheiro Duarte Pacheco, n 19 RC 54
1070-100 Lisboa

Select Your language