EU cosmetic
regulations

EU - CPNP Requirements

Legislation in EU

The EU cosmetic regulation (EC No. 1223/2009) applies to the 27 EU countries, plus Norway, Iceland, and Liechtenstein (EEA), requiring compliance for cosmetics sold within these regions. Post-Brexit, Great Britain follows its own cosmetics regulation, while Northern Ireland continues under EU law.

How to submit CPNP in EU?

Want to learn more about the CPNP and how you can register your products in the European Union? Click the button to find out more about Regulation (EC) No 1223/2009

Product Information File (PIF) in EU Cosmetics Regulation

The Product Information File (PIF) is essential for compliance with EU cosmetics regulations. This comprehensive document must contain all necessary information to demonstrate the safety and efficacy of each cosmetic product. From descriptions and safety assessments to manufacturing methods and labeling, the PIF ensures that all cosmetics marketed in the EU are completely safe and effective. Maintaining an updated and detailed PIF is mandatory for all cosmetic manufacturers and distributors within the European Union.

What Should Be Included in a PIF?

  • Product Description: Includes the name, brand, and intended use.
  • Composition: Lists all ingredients, their concentrations, functions, and sources.
  • Manufacturing Method: Describes the production process, equipment used, batch size, and quality controls.
  • Stability Testing: Provides data on product stability to ensure quality and safety.
  • Packaging: Details the packaging materials used and their compatibility with the cosmetic product.
  • Safety Assessment: Analyzes potential risks and the steps taken to mitigate them.
  • Claims: Outlines all product claims, including efficacy and any therapeutic benefits.
  • Labeling: Ensures compliance with EU and UK labeling regulations and includes a copy of the product label.

Maintaining Compliance: PIF Challenges and Updates

Examples of Non-Compliant PIFs and the Importance of Updates

  • Missing or Incomplete Information: A PIF without a full ingredient list or safety assessment is considered non-compliant.
  • Incorrect Information: Including misleading or incorrect details in the PIF can lead to compliance issues.
  • Outdated Information: Data that no longer reflects the current product formulation can render a PIF invalid.

 

Keeping Your PIF Updated It’s crucial to regularly update your PIF with the latest product information and regulatory changes. This not only ensures compliance with EU and UK regulations but also safeguards consumer safety. Regular updates can help avoid the risks associated with non-compliance, such as fines and product recalls.

FAQS

The European Union (EU) cosmetic regulation mandates the presence of a European Responsible Person (RP). The RP ensures that cosmetic products marketed in the EU comply with the established regulations and requirements. They must establish themselves in the EU and fulfill various legal obligations, including maintaining records and being available to the competent authorities.

The European Commission establishes the EU cosmetics regulation as a set of standards and laws to ensure the safety and quality of cosmetic products sold in the European market. This regulation is mandatory and applies to all cosmetic products marketed in the EU.

Manufacturers of cosmetic products marketed in Europe must ensure that their products meet a series of requirements, including: not causing harm to human health, providing a clear and legible label in the language of the country where they are marketed, and adhering to the safety and quality guidelines established by the European Commission.

Manufacturers and distributors of cosmetic products have the responsibility to ensure that their products comply with European regulations. Additionally, EU member states are obligated to oversee the market and take action in case of non-compliance.

Regulatory non-compliance by manufacturers or distributors with European regulations can result in sanctions, including fines, withdrawal of products from the market, and even legal actions by affected consumers. Additionally, the company’s reputation may suffer, and customers may be lost due to failure to comply with established safety and quality standards.

As soon as you have CPNP notifications, product information file (PIF) and the corresponding distributor,they must designate the responsable person of the products by written mandate. After this moment, the products can be marketed in EU.

The product information file (PIF) has an expiry date of 10 years. After that, if the product continues in the market, the responsible party must conduct a new evaluation to update it.

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