Create PIF for Cosmetics
The Product Information File (PIF) is mandatory for every cosmetic product in the EU. Learn what it must contain, which mistakes to avoid and how INCIkit helps you.
PIF records
Prepare records in one place
Example product: face cream
- Product description
- Available
- CPSR preparation
- Available
- Manufacturing method
- Available
- Stability evidence
- Pending
- Toxicological profile
- Pending
Example: 3 of 5 records available. Available information does not replace professional review.
What is a PIF?
The Product Information File (PIF) is the legally required product documentation for every cosmetic product in the EU. It is regulated in Art. 11 of Regulation (EC) No 1223/2009.
Without a complete PIF, a product may not be placed on the market. The PIF must be accessible at the premises of the Responsible Person and must be available for authority enquiries at short notice. The retention obligation is 10 years after the last placing on the market.
What a PIF must contain
Art. 11 of the EU Cosmetics Regulation defines five mandatory components. Each one is required for the product's marketability.
Product description
Name, intended use, dosage form and labelling of the product.
Safety assessment (CPSR)
Toxicological assessment by a qualified person — Part A and Part B.
Manufacturing description
GMP-compliant documentation of the manufacturing process per ISO 22716.
Proof of effect
Evidence for claimed effects (claims) through tests or studies.
Animal testing data
Proof that no animal testing was conducted (EU animal testing ban).
Common PIF mistakes
These mistakes regularly lead to objections in audits — and are easily avoidable with the right structure.
Review records
Example review points
Review CPSR records
Gather the external safety report and supporting evidence.
Review stability evidence
Compare the available records with the current product version.
Document the manufacturing method
Add the description and manufacturing records.
Records organised. Prepared for review.
Missing documents
Safety assessment or stability data are missing — most common reason for objections.
Wrong structure
Documents are stored without structure, connections between formula and assessment are missing.
No batch records
Batch records are missing or incomplete — traceability is not ensured.
Outdated safety assessment
Formula was changed but the CPSR was not updated — PIF is therefore invalid.
Example structure of a complete PIF
A well-structured PIF contains these 10 sections. This makes you audit-ready and fulfils all requirements of the EU Cosmetics Regulation.
- 01Product description & labelling
- 02Qualitative & quantitative composition
- 03Safety report (CPSR Part A + B)
- 04Stability & compatibility tests
- 05Manufacturing method & GMP evidence
- 06Efficacy evidence (claims)
- 07Animal testing data
- 08CPNP notification (confirmation)
- 09Batch records & batch traceability
- 10INCI declaration & labelling
How INCIkit helps with PIF
INCIkit is the software for cosmetic manufacturers who want to manage their PIF documentation in a structured and digital way.
PIF documentation
- External CPSR document
- Available
- Formulation and INCI declaration
- Available
- Stability report
- Available
- Toxicological profile
- Pending
Example: 3/4 available
Export formulation-based PIF documentation as PDF. External evidence remains separate documentation.
Formula management
Manage all formulas centrally — ingredients, quantities and INCI automatically linked.
Batch record generator
Complete batch records with target/actual documentation at the click of a button.
Batch traceability
Every batch traceable with LOT number, raw material batches and production date.
PDF export
Export GMP-compliant documents as PDF — professionally structured.
Raw material master data
INCI names, CAS numbers, suppliers and LOT numbers centrally maintained.
10-year archiving
All production data securely archived — as required by Art. 11 EU Regulation.
In your daily workflow
Share selected product records
Create a fixed handover version from selected files, optionally the current formulation and one saved label version. Keep track of questions and receipt; acknowledging receipt is not professional approval.
Access requires the verified recipient email. The link alone is not enough.
The easiest way to get started with INCIkit
We'll show you by email how to document your first production in minutes — step by step.
Create your PIF in a structured way with INCIkit
Formulas, batch records, batch traceability and PIF documentation — all in one app. 14-day free trial, no credit card required.