The Product Information File - what the RP must hold

The Product Information File - what the RP must hold

The Responsible Person must hold a Product Information File (PIF) for every product they're responsible for. This isn't submitted anywhere proactively but it must be available in English if the OPSS requests it.

A compliant PIF contains:

1. Product description and intended use

2. Cosmetic Product Safety Report (CPSR) prepared by a qualified safety assessor, covering the product formula, ingredient safety, and assessment of safety for intended use

3. Description of the manufacturing method and GMP compliance statement

4. Evidence for any claims made on the label or in marketing

5. Animal testing data (or statement that none was performed)

6. The PIF must be updated whenever the formulation changes. A CPSR based on an old formulation does not cover your current product. This is one of the most commonly identified gaps when brands face OPSS scrutiny.

Disclaimer: We are not a lawyer or regulatory consultant. Cosmetic regulations can be subject to change and specific nuances. For formal business decisions or if you are facing enforcement action, you should consult with a professional regulatory compliance service or legal advisor.