Undesirable effects and cosmetovigilance after product launch
How to receive, assess, document and report undesirable and serious undesirable effects associated with cosmetic products in the EU.
Read the guide →Service area 03 · specialist support
Product Information File and regulatory documentation
The PIF must be complete, internally consistent and readily accessible to the Responsible Person. EUCRI organises technical, safety and substantiation documents around the product that is actually placed on the market.
Scope of support
What we can deliver for your project
Preparation, review and maintenance of the Product Information File, including the CPSR, GMP information, evidence of effect and change control.
- 21Preparation of a complete Product Information File
- 22Review and completion of an existing PIF
- 23Organisation of supplier documentation
- 24Preparation of the product description and manufacturing method
- 25Integration of the CPSR and evidence of effect
- 26Review of the GMP statement
- 27Alignment of the PIF, formula, labelling and CPNP notification
- 28Digital structuring of PIF documentation
- 29Version and change control for regulatory documentation
- 30Periodic maintenance and review of PIFs and product portfolios
Project outcomes
From a question to an actionable regulatory solution
The exact scope is confirmed after reviewing the product, target markets and available documentation.
01
Structured and review-ready PIF
02
Consistency between formula, CPSR, label and CPNP
03
Version and change control
04
List of missing supplier documents
Frequently asked questions
Before the project starts
How long must the PIF be retained?+
For ten years following the date on which the last batch of the cosmetic product was placed on the market.
Can you review an existing PIF?+
Yes. A PIF audit identifies gaps, inconsistencies and priority corrective actions.
Must the PIF be kept up to date?+
Yes. It must reflect the current product, safety data, labelling and relevant changes.
New fragrance allergen labelling requirements: 2026 and 2028 deadlines
What Regulation (EU) 2023/1545 changes for fragrance allergen labelling, which thresholds apply and how to prepare formulas and labels for 2026 and 2028.
Read the guide →Reformulating a cosmetic product after regulatory change
How to plan reformulation after an ingredient restriction and align testing, CPSR, PIF, labelling, CPNP and packaging stocks.
Read the guide →Next step
Do you have a product or portfolio for the EU market?
Send us the essential product details, target markets and available documentation. We will respond by email.