Formulation & PIF Review for UK Cosmetics

Under the UK Cosmetics Regulation, every cosmetic product must have a compliant Product Information File (PIF) complete with a Safety Assessment Report (SAR), lab data, GMP proof, label artwork, and claim substantiation before being placed on the UK market. The PIF contains critical safety and compliance documentation, including the Safety Assessment Report (SAR), laboratory testing results, GMP proof, label artwork, and substantiation of cosmetic claims.

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Why You Need a UK-Compliant PIF to Sell Cosmetics Legally

Legal background

With increasing updates to the annexes and ingredient restrictions, staying compliant in the UK is no longer as simple as duplicating your EU strategy. A thorough cosmetic product formulation and review of cosmetic ingredients is vital to ensure your product remains compliant and risk-free in the UK market. By working with the right partner, you ensure your formulation and PIF meet UK regulatory standards, avoid non-compliance risks, and maintain your product’s readiness for inspection.

Failure to review and update your formulation and PIF can result in:
    • Market access denial for non-compliant cosmetic products.
    • Delays in product notification to the SCPN (UK Cosmetic Product Notification Portal).
    • Regulatory penalties or product recalls if banned substances are present.
    • Reputational risk due to claims without supporting evidence or inaccurate labels.
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Obelis Ensures Your Cosmetic Formulation & PIF Meet UK Requirements

We act as your UK Responsible Person, guiding you through the entire UK compliance process. Our regulatory experts verify your formula against current UK ingredient restrictions, ensure that labelling meets all legal requirements, and assist in compiling a complete and compliant PIF in English. We coordinate with trusted partners for lab testing, support the Safety Assessment Report (SAR) preparation through certified assessors with UK-recognized qualifications, and ensure all documents are properly formatted and ready for inspection. With Obelis, your product is backed by expertise and ready for smooth SCPN notification and lawful market placement.

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FAQ

Frequently Asked Questions

A Product Information File (PIF) is a mandatory dossier under the UK Cosmetics Regulation. It includes safety and compliance documentation such as the Safety Assessment Report (SAR), ingredient details, lab testing results, GMP evidence, label artwork, and proof of cosmetic claims.

No. While similar, the UK has its own regulatory requirements and ingredient annex updates. Simply duplicating your EU PIF may result in non-compliance if the formulation includes ingredients banned or restricted under UK law.

A compliant PIF must contain:

  • Safety Assessment Report (SAR) by a UK-qualified safety assessor
  • Full formulation with ingredient concentrations
  • Evidence of GMP (Good Manufacturing Practice) compliance
  • Product labelling and artwork
  • Substantiation of product claims (e.g. “anti-aging,” “dermatologically tested”)
  • Description of manufacturing process (if applicable)

Failing to maintain a compliant Product Information File can lead to:

  • Delays in SCPN notification
  • Regulatory investigations or market removal
  • Legal penalties
  • Loss of retail and consumer trust
  • Claims being deemed misleading or unsubstantiated

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Compliance for Cosmetics in the United Kingdom

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