Introduction
As the broadest-application category, Product Information File for Body Care documentation holds stability evidence matched to format (emulsion, whipped butter, oil or solid bar), plus the full-body exposure data that sets the most conservative fragrance/active concentration ceiling in your cosmetic product safety report for this cosmetic product category.
What Your PIF Includes
- Product description and CPSR cross-reference
- Manufacturing method with GMP statement, matched to format
- Stability test data, appropriate to your specific format
- Full-body exposure evidence, cross-referenced from your CPSR
- Animal testing declaration
Who This Is For
Bodycare brands maintaining Product Information File for Body Care documentation for lotions, butters, oils, moisturisers or solid lotion bars.
Legal Framework
- Article 11, Regulation (EC) No 1223/2009
- Schedule 34, SI 2019/696
- ISO 22716
- Annex III/V
Under Article 11, your Responsible Person must retain the product information files for each cosmetic product for 10 years from the date of the last batch of the cosmetic product placed on the market.
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, counted from the last batch of your product placed on the market.
Your PIF Deliverables
- Product description name, category, function and any variant/shade codes, clearly linking the file to your cosmetic product
- Cosmetic product safety report (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 product information 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 Product Information File for Body Care, ready to hold at your Responsible Person's address for inspection.