Introduction
Because depilatory actives (thioglycolic acid, oxidising agents) are tightly concentration-restricted, the PIF for Hair Removal & Depilatories manufacturing documentation should clearly demonstrate batch-to-batch consistency of the active concentration, supporting the exposure conclusion reached in your cosmetic product safety report.
What Your PIF Includes
- Raw material documentation and CPSR cross-reference
- Manufacturing method, including active-ingredient dosing/mixing controls, with GMP statement
- Batch consistency documentation for the depilatory or bleaching active
- Claims substantiation for "gentle," "fast-acting" or similar functional claims
- Animal testing declaration
Who This Is For
Brands maintaining PIF for Hair Removal Cream & Depilatories documentation for chemical depilatory creams, waxes or hair bleach products sold in the European market.
Legal Framework
- Article 11, Regulation (EC) No 1223/2009
- Schedule 34, SI 2019/696
- ISO 22716
A product information file is required under Article 11 for each cosmetic product before it can be placed on the market, forming a most important part of demonstrating ongoing regulatory compliance for depilatory and hair-bleaching products.
Why Brands Choose Spectra Cosmetic Compliance for Your PIF
- Built directly from your cosmetic product safety data, so your safety assessment 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.
- Reviewed by specialists with backgrounds across pharmacy, toxicology and cosmetic science, ensuring your product safety data holds up to scrutiny.
Your PIF Deliverables
- Product description name, category, function and any variant/shade codes, clearly linking the file to your cosmetic product
- CPSR (Parts A & B) cross-referenced from your existing safety assessment, signed off by a qualified safety assessor
- 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
- 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.