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    HCPC Brands EuropeProduct Information File (PIF)

    Complete, audit-ready compliance dossiers — Regulation (EC) 1223/2009, Article 11

    The Product Information File is the master compliance record for every cosmetic product placed on the EU market — the document a competent authority will ask for first in the event of an inspection. HCPC Brands Europe B.V. compiles, structures, and keeps your PIF audit-ready for the full ten-year retention period required by law.

    What a PIF Contains

    • Product description — detailed enough to clearly and specifically attribute the file to the exact product it covers.
    • Cosmetic Product Safety Report (CPSR) — the safety information and safety assessment at the core of the file.
    • Manufacturing method description & GMP statement — confirming production follows recognised Good Manufacturing Practice standards.
    • Proof of claimed effect — evidence substantiating any marketing claim made for the product, where the nature of the claim requires it.
    • Animal testing data — records of any animal testing performed by the manufacturer, its agents, or suppliers relating to the product or its ingredients, including testing conducted to satisfy non-EU regulatory requirements.

    What's Included in Our Service

    • PIF compilation from scratch — structured to Article 11 requirements from your formulation, manufacturing, and testing data.
    • PIF review & remediation — for existing files with missing sections, outdated information, or structural gaps.
    • Ongoing maintenance — updates whenever formulation, labelling, claims, or supporting data change.
    • Audit-ready access — held and made available to competent authorities in the language they require, on request.

    Regulatory Framework

    Reg. (EC) 1223/2009 — Article 11
    10-Year Retention
    CPSR (Annex I)
    GMP Statement

    Our Process

    • 1. Intake — you provide formulation data, manufacturing details, claims, and any existing documentation via our Product Intake Form.
    • 2. Structuring — we assemble each required section against Article 11, flagging any gaps.
    • 3. CPSR integration — the safety report is incorporated as the file's core section.
    • 4. Delivery & custody — you receive the completed PIF, held and maintained for the full retention period.

    Frequently Asked Questions

    What is a Product Information File (PIF)?

    The Product Information File is the complete compliance dossier a Responsible Person must hold for each cosmetic product, retained for ten years from the date the last batch was placed on the market. It brings together the product description, the safety report, a description of the manufacturing method with a GMP statement, evidence for any claimed effect where relevant, and any related animal-testing data.

    How long must a PIF be kept, and from what date does the retention period start?

    A PIF must be retained for ten years, counted from the date the last batch of that specific product was placed on the market — not from the date the file was first compiled.

    Does the PIF need to be available in a specific language?

    The PIF must be available in a language that can be easily understood by the competent authority of the Member State where the file is kept, which in practice usually means the language of that authority rather than English by default.

    Can the PIF be kept in electronic format only?

    Yes. The Regulation allows the file to be kept in electronic or other format, provided the Responsible Person can make it readily accessible to the competent authority at the address indicated on the product label.

    Does every cosmetic product need its own separate PIF?

    Yes. A PIF must clearly and specifically be attributable to the individual cosmetic product it covers — a single generic file cannot substitute for product-specific documentation.

    See also our CPSR and Responsible Person pages, or our full Cosmetics Glossary & FAQ.

    Need a Product Information File compiled or reviewed?

    Get in touch →
    HCPC Brands Europe

    HCPC Brands Europe B.V. — specialist regulatory services for Home Care and Personal Care products entering the EU market.

    Services

    • Responsible Person (RP)
    • Product Information File (PIF)
    • CPSR Safety Assessment
    • Cosmetovigilance
    • SDS Management
    • UFI / PCN Notification

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