PIF (Product Information File): what it contains and who drafts it for you
The Product Information File (PIF) is the most important technical-regulatory document for a cosmetic. Foreseen by Article 11 of EU Regulation 1223/2009, it's mandatory for every product sold in the European Union. Without a PIF, the cosmetic is illegal: no exceptions.
What the PIF is for
The PIF is a dossier that gathers all information necessary to demonstrate that the product is safe for human health under intended conditions of use. It's shown during inspections by health authorities (Ministry of Health, local health units) within 72 hours of request.
It's kept by the "responsible person" (manufacturer or importer) for at least 10 years after the last batch is placed on the market.
What a complete PIF contains
A compliant PIF includes ten main sections:
- Product description: commercial name, category, function, form, recipients (adults, children, sensitive skin).
- Qualitative-quantitative formula: complete list of ingredients with exact percentages, INCI name and CAS number.
- Physical-chemical characteristics: pH, viscosity, specific weight, appearance, odor, color.
- Stability tests: product resistance to temperature, light, humidity conditions over time.
- Microbiological tests: challenge test to verify preservative system efficacy.
- Packaging compatibility tests: absence of substance migration from container to product.
- Safety assessment (CPSR): Cosmetic Product Safety Report signed by a qualified assessor (toxicologist, pharmacologist or chemist with specialization).
- Manufacturing method: description of production process with reference to GMP (Good Manufacturing Practice) ISO 22716.
- Proposed labeling: draft label with claims, precautions, minimum durability.
- Undesirable effects: any reported adverse reactions and corrective actions.
Who drafts the PIF
The PIF can be compiled internally only if the company has a qualified safety assessor (CPSR safety assessor). Otherwise, the safety assessment must be entrusted to qualified external professionals.
The complete PIF is typically prepared by the manufacturer (production laboratory) in agreement with the brand that markets it. For White Label brands, the manufacturer provides a base PIF that the brand integrates with specific label and positioning data.
Times and costs
For a new product, complete PIF drafting requires:
- Stability tests: 3 months (accelerated) or 12 months (real time).
- Microbiological tests: 28 days of challenge test.
- CPSR drafting: 2-4 weeks after data collection.
- Final PIF assembly: 1-2 weeks.
Costs range from 800-1,500 euros for White Label products (most tests are already done on the base formula) up to 4,000-8,000 euros for new Proprietary Formulas.
Most common PIF errors
Authorities regularly sanction incomplete or outdated PIFs. Typical errors are:
- CPSR signed by a consultant without recognized qualifications.
- Only accelerated stability tests, without real-time confirmation.
- Declared formula not perfectly aligned with INCI on label.
- Failure to update the PIF after formula modifications (raw material supplier change).
- Absence of GMP documentation of the production site.
Bellanova and the PIF
Bellanova Cosmetics internally manages all tests and PIF drafting for every White Label and Proprietary Formula product. The PIF is delivered to the client brand upon shipment of the first batch and updated with every formula modification.
For brands buying from multiple manufacturers, we also offer regulatory consultancy to verify compliance of PIFs received from third-party suppliers. The PIF is not a "cover" document: it's proof of your product's safety and it's the first thing an inspector asks for.
