Introduction
Oral care PIFs carry a particular emphasis on claims substantiation, since this category sits closest to the cosmetic/medicinal borderline. Evidence supporting any whitening, freshening or protective claim needs to be clearly filed and distinguishable from a therapeutic claim that would require different regulatory treatment entirely.
What Your PIF Includes
• Product description and CPSR cross-reference
• Manufacturing method (mixing, filling, tube/bottle production) with GMP statement
• Claims substantiation for whitening, freshening or protective claims, with clear separation from any therapeutic-adjacent wording
• Fluoride concentration documentation, cross-referenced to your CPSR
• Animal testing declaration
Who This Is For
Oral care brands maintaining PIF documentation for toothpaste, mouthwash or breath spray.
Legal Framework
• Article 11, Regulation (EC) No 1223/2009
• Schedule 34, SI 2019/696
• ISO 22716
• MHRA borderline-products guidance (claims positioning)
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.
• GMP documentation reviewed against ISO 22716, the recognised UK/EU cosmetic manufacturing standard.
• Claims substantiation flagged and structured, 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.
• Retained and managed for the full statutory 10-year period.
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 label or marketing, 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
1. Share your CPSR and formulation records if Spectra prepared your CPSR, this step is largely automatic.
2. We compile the manufacturing and GMP documentation working from your production records or manufacturer's GMP statement.
3. We structure your claims evidence matching each label or marketing claim to its supporting data.
4. We confirm your animal testing declaration checked against Article 18 requirements.
5. You receive your complete PIF ready to hold at your Responsible Person's address for inspection.