Cosmetics Regulation (EC) No 1223/2009 Article 11 · PIF

Product Information File (PIF) Review

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Preparation and review of your cosmetic Product Information File (PIF) — the complete technical dossier required under Article 11 of Regulation (EC) No 1223/2009 that your Responsible Person must keep available to authorities for ten years.

 100.00

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Structured to Article 11 — audit-ready and inspection-proof.
Cross-checks your CPSR, GMP statement, claims and labelling.
Highlights gaps before a competent authority finds them.
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Article 11 structure
Built and checked against the legal PIF requirements.
Inspection-ready
Defensible if a competent authority requests it.
Gap analysis
We surface missing or inconsistent data before they do.
Transparent pricing
A fixed, published fee with no extras.

What the Product Information File is

The Product Information File (PIF) is the master dossier for a cosmetic product, mandated by Article 11 of Regulation (EC) No 1223/2009. The Responsible Person must keep it readily accessible — at the address shown on the label — for ten years after the last batch was placed on the market, and produce it on request from market-surveillance authorities.

What a complete PIF contains

A description of the product; the Cosmetic Product Safety Report (CPSR); a description of the manufacturing method and a statement of compliance with Good Manufacturing Practice (GMP / ISO 22716); proof of the claimed effect where justified; and data on any animal testing. A PIF that is missing or disorganised is one of the most common findings in EU inspections.

What our review delivers

We assemble or audit your PIF against the Article 11 checklist, confirm every component is present, current and internally consistent, and flag anything that would fail an inspection — so your documentation stays defensible.

The CPSR is the safety assessment document; the PIF is the full dossier that contains the CPSR plus the product description, GMP statement, manufacturing method and claims evidence. The CPSR lives inside the PIF.
For ten years from the date the last batch of the product was placed on the EU market, kept accessible at the address on the label.
The Responsible Person holds and maintains it. If Lexora is your RP, we keep your PIF ready for inspection.
Your existing documentation — formulation, CPSR, manufacturing and GMP details, labels and claim support. We tell you exactly what is missing.

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A PIF needs a valid CPSR inside it

If your Cosmetic Product Safety Report is not yet done, order it with your PIF and we build the complete, compliant dossier.

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