Product Information File (PIF) Review

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Product Information File (PIF)

The Product Information File (PIF) is a mandatory compilation of data and documentation required under EU Cosmetic Regulation (EC) No 1223/2009. This file must be kept by the Responsible Person (RP) for competent authorities to access at the address specified on the product label.

Our PIF Review Service is designed to ensure your existing documentation is complete, compliant, and correctly organized according to regulatory requirements, minimizing the risk of non-compliance during an inspection.

What is Included in Our PIF Review?

Our service systematically checks all required elements of the PIF:

  1. Product Description & Manufacturing Method: Verification that the product description, quantitative and qualitative formula, and manufacturing methods comply with Good Manufacturing Practice (GMP) (ISO 22716).

  2. Safety Assessment (CPSR): Confirmation that the Cosmetic Product Safety Report (CPSR) is present, signed by a qualified assessor, and based on adequate toxicological data.

  3. Product Efficacy Data: Review of claims substantiation data, including stability, microbial purity (PET), and compatibility tests.

  4. Animal Testing Data: Verification of compliance with the EU’s animal testing ban for both ingredients and the finished product.

  5. Labeling Review: Check that all required labeling elements (ingredients list, warnings, net quantity, RP name, CPNP notification number) are correct and comply with the regulation.

Key Benefits of a PIF Review

  • Risk Mitigation: Identify and correct documentation gaps before an official inspection.
  • Audit Readiness: Ensure your PIF is complete and instantly accessible, as required by law.
  • Compliance Assurance: Guarantee adherence to the strict requirements of EU Regulation 1223/2009.

FAQs About The Service

There are many questions about the service, we have selected frequently asked questions about this service. If you do not see your answer, please contact us.

What is the main purpose of the PIF?
The PIF serves as a complete historical record and scientific justification for the safety, efficacy, and legal compliance of a cosmetic product marketed in the EU. It is the first document requested during a regulatory inspection.
Who is legally required to maintain the PIF?
The Responsible Person (RP) named on the product must maintain the PIF and ensure it is kept for a period of ten years after the last batch of the product has been placed on the market.
What happens if my PIF is incomplete during an inspection?
An incomplete or non-compliant PIF is a serious regulatory violation. This can lead to sanctions such as mandated product recalls, withdrawal from the market, fines, or other penalties imposed by the competent authorities.
Does the PIF only contain the CPSR?
No. The CPSR (Part B of the PIF) is the most critical element, but the PIF must also contain the detailed product description (Part A), the manufacturing method, evidence of effects/claims, and all raw material and packaging data.

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