The Cosmetic Product Information File (PIF) is a comprehensive document that serves as a central repository of information related to a cosmetic product. It is a mandatory requirement under the European Union (EU) Cosmetic Regulation (Regulation (EC) No 1223/2009). The PIF is intended to provide competent authorities with access to key details about a cosmetic product and its safety assessment.

This bundle will provide :

• Product Information File (PIF)
• Safety Assessment  (CPSR)
• Cosmetic label review
• CPNP

All required laboratory testing results should be available for this bundle. If no lab test have been done, please use our bundle with lab testing included:

• Cosmetic Product Safety Assessment
• Full Cosmetic Product Safety Assessment

How the Process Works

1. Order your assessment
   Buy this package and complete your purchase on our website.
2. Receive secure access
   After purchase, you’ll receive login details to our secure portal.
3. Complete the intake form
   Provide your product details and upload available documentation.
4. Receive your PIF
   Our safety assessor will prepare your Product Information File (PIF), including Parts I, II, and III.
5. CPNP Notification
   We handle the EU registration for you and deliver the complete documentation.

Label revieuw options

1. Standard Label Review

This option is perfect for brands seeking a rapid regulatory review to ensure their labels meet basic compliance standards for the desired region(s).

What’s included:

• Evaluation of mandatory consumer information on the primary label, secondary label, and leaflet.
• Review of marketing communication to ensure claims align with regulatory requirements.

2. Extended Label Review

Our Global Label Review is a comprehensive option designed for brands aiming to perfect their labels for international markets.

What’s included:

• Everything in the Standard Review, plus:
  • Validation of tests used to substantiate claims.
  • Advanced recommendations for updating problematic claims while maintaining their original intent.
  • Creation of the list of ingredients in the required format for each country.
  • Verification of warnings and directions for use to align with regulations.

What is a Cosmetic Product Information File (PIF)

1. Product Information: This section includes details such as the product name, category, and intended use. It also specifies the name and address of the Responsible Person—the entity or person responsible for placing the cosmetic product on the market.
2. Cosmetic Product Safety Report (CPSR): The PIF contains the full Cosmetic Product Safety Report, which is a comprehensive assessment of the safety of the cosmetic product. The CPSR includes information on the product’s composition, exposure assessment, toxicological profile, safety assessment, and other relevant details.
3. Method of Manufacturing: Information about the manufacturing process, including details about the facilities, equipment, and quality control measures, is provided in this section.
4. Good Manufacturing Practices (GMP) Compliance: The PIF includes documentation to demonstrate that the cosmetic product is manufactured in accordance with Good Manufacturing Practices to ensure its safety and quality.
5. Data on Animal Testing: Details regarding any animal testing conducted on the cosmetic product or its ingredients, including justifications for such testing, are included in the PIF. However, it’s essential to note that animal testing for cosmetics is prohibited in the EU, and alternative testing methods are encouraged.
6. Stability Data: Information on the stability of the cosmetic product under various conditions (e.g., temperature, light) is included to ensure that the product remains safe and effective throughout its shelf life.
7. Labeling Information: The PIF includes details on the labeling of the cosmetic product, ensuring that it complies with the relevant labeling requirements outlined in the EU Cosmetic Regulation.

The PIF is a confidential document, and its availability is essential for regulatory compliance and market surveillance. The Responsible Person must keep the PIF updated and accessible to the competent authorities for a period of 10 years after the last batch of the cosmetic product has been placed on the market. The PIF provides a comprehensive overview of the cosmetic product’s safety and compliance with regulatory requirements.