Introduction
Lip product PIF for Lip Products documentation holds documentation reflecting the stricter oral-proximity safety standard applied in the CPSR, with particular attention to colourant purity given ingestion risk, and flavour/fragrance allergen evidence.
What Your PIF Includes
- Product description and CPSR cross-reference
- Manufacturing method (moulding, filling) with GMP statement
- Colourant purity documentation, reflecting the oral-ingestion-adjusted standard
- Flavour and fragrance allergen evidence
- Animal testing declaration
Who This Is For
Lip care and colour cosmetics brands maintaining PIF for Lip Products documentation for balms, lipsticks, glosses or pencils, sold in the UK or the EU.
Legal Framework
- Article 11, Regulation (EC) No 1223/2009
- Schedule 34, SI 2019/696
- ISO 22716
- Annex IV
- SCCS Notes of Guidance
A product information file is required for all cosmetic products under these regulations, and Spectra structures each file with the specific regulatory information your Responsible Person needs to keep the product market-ready and compliant.
Why Brands Choose Spectra Cosmetic Compliance for Your PIF
- Built directly from your CPSR, so your safety data and PIF are consistent from day one no re-entering formulation data, with full safety assessment integration across both documents.
- GMP documentation reviewed against ISO 22716, the recognised UK and EU cosmetic manufacturing standard.
- Claims substantiation flagged and structured, covering labelling and claims compliance so "proof of effect" is ready before an authority asks for it.
- Held to a single, consistent format your Responsible Person can present at inspection without last-minute assembly, keeping your maintaining records obligation straightforward.
- Retained and managed for the full statutory 10-year period, built from fully compliant PIFs that always meets legal requirements.
- Every file is tailored to your product, its format and its specific colourant and flavour profile, so nothing generic slips through.
Your PIF Deliverables
- Product description name, category, function and any variant/shade codes, clearly linking the file to your product
- CPSR (Parts A & B) cross-referenced from your existing safety assessment
- Manufacturing method description and GMP statement structured to ISO 22716
- Claims substantiation file evidence behind any effect claimed on your labelling and claims, where applicable
- Animal testing declaration confirming testing status for the product and its ingredients, as required under Article 18
- Delivered in a single, inspection-ready file, held at your Responsible Person's address
How It Works
- Share your CPSR and formulation records if Spectra prepared your CPSR, this step is largely automatic.
- We compile the manufacturing and GMP documentation working from your production records or manufacturer's GMP statement.
- We structure your claims evidence matching each label or marketing claim to its supporting data.
- We confirm your animal testing declaration checked against Article 18 requirements.
- You receive your complete PIF, ready to hold at your Responsible Person's address for inspection, via a submission process designed to be smooth and professional from start to finish.