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Cosmetic Product Information File (PIF) Preparation – UK & EU Compliance

Launching a cosmetic product in the UK or EU requires a Product Information File (PIF) that complies with UK Cosmetics Regulation and EU Regulation (EC) No. 1223/2009.
 We prepare a fully structured, audit-ready PIF so your brand can legally place products on the market with confidence.

What Is a Cosmetic PIF?

A Product Information File (PIF) is the mandatory legal dossier that must be maintained by the Responsible Person (RP) for every cosmetic product sold in the UK or EU. Under Regulation (EC) No. 1223/2009 and the UK Cosmetics Regulation, this file acts as the central repository for all technical, safety, and traceability data.

PIFs must be kept at the labeled address for 10 years after the last batch. We ensure your dossier is audit-ready for Trading Standards to prevent recalls or fines.

What’s Included in Our PIF Preparation Service

  • Full compilation of your cosmetic regulatory documentation

  • Product description and intended use definition

  • Complete formula and raw material specifications review

  • Manufacturing method and Good Manufacturing Practice (GMP) evidence

  • Packaging suitability and material compliance assessment

  • Labelling verification aligned with regulatory requirements

  • Claims substantiation file organisation

  • Safety documentation cross-reference (linked to CPSR)

  • Final structured PIF delivered in digital inspection-ready format

Documents We Will Request From You

To build your PIF, we will need:

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1. Product Description

Make sure you have

  • Product name and any variants (shade, fragrance, size)

  • Product category and intended use (e.g., face cream, shampoo, lip balm)

  • Target consumer group (adults, children, professional use, etc.)

  • Method of application (rinse-off / leave-on)

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2. Full Formulation Details

Provide us with: 

  • Complete formula with exact percentages (w/w%)

  • INCI names for all ingredients

  • CAS numbers (where available)

  • Ingredient functions

  • Fragrance allergen breakdown (if applicable)

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3. Raw Material Documentation

For each ingredient, provide:

  • Safety Data Sheet (SDS/MSDS)

  • Certificate of Analysis (CoA)

  • Allergen declaration (if applicable)

  • IFRA certificate (for fragrance materials)

  • TSE/BSE statement (if applicable)

  • Non-animal testing declaration (if available)

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4. Finished Product Testing Reports

Reports you should have: 

  • Stability test report

  • Preservative efficacy (Challenge) test report (for water-based products)

  • Microbiological test report

  • Physical-chemical test results (pH, appearance, odour, etc.)

  • Compatibility testing (product & packaging interaction, if available)

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5. Cosmetic Product Safety Report (CPSR)

Make sure you have: 

  • Signed and dated CPSR (Part A & Part B) from a qualified safety assessor

    (This is a mandatory component of the PIF.)

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6. Manufacturing Information

For each product, provide:

  • Manufacturer name and address

  • GMP compliance statement (ISO 22716 or equivalent)

  • Batch coding system explanation

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7. Packaging Information

Provide us with: 

  • Primary packaging material specifications

  • Secondary packaging details (if applicable)

  • Food-grade / cosmetic-grade declarations (if available)

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8. Labelling & Artwork

Make sure you have: 

  • Final label artwork (all sides)

  • INCI ingredient listing

  • Responsible Person details

  • Batch coding format

  • PAO or expiry information

  • Warnings and directions for use

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9. Claims Substantiation

For each product, provide:

  • Evidence supporting marketing claims

  • Test reports or technical justification

  • Literature references where applicable

10. Animal Testing Compliance

  • Declaration confirming compliance with UK/EU animal testing bans
IMPORTANT ! info@nativeformulas.co.uk

Why Choose Our PIF Service?

  • Fully aligned with UK & EU cosmetic legislation

  • Prepared for Trading Standards or regulatory inspection

  • Structured to support SCPN / CPNP notification

  • Designed to simplify long-term compliance management

If you’re unsure about any of the documents or need guidance on what to provide, please email us at info@nativeformulas.co.uk or contact@nativeformulas.co.uk. We’re happy to assist and make the process as easy as possible for you.

How can Native Formulas help?

Organizing complex technical data is time-consuming and high-risk. We streamline your path to UK and EU compliance by transforming fragmented documentation into a professionally structured, audit-ready Product Information File.

Complete Management:

We consolidate your safety data, GMP evidence, and formula specs into a fully compliant, audit-ready format. Our management ensures your Product Information File is ready for immediate review by UK or EU authorities.

Efficiency:

Our structured approach ensures no regulatory detail is overlooked, saving you weeks of administrative work. We streamline the PIF preparation process, allowing you to hit your launch dates without the stress of paperwork.

Cost-Effective Solutions:

Access professional regulatory consultancy at a fraction of the cost of an in-house team. We provide high-level PIF management and support tailored specifically for startups and growing indie beauty brands.

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