Introduction
Baby and infant product PIFs need clear documentation showing the tighter, age-adjusted exposure and ingredient thresholds applied in the CPSR, plus where relevant evidence supporting any "suitable from birth" or similar claim.
What Your PIF Includes
• Product description and CPSR cross-reference
• Manufacturing method with GMP statement, reflecting the higher hygiene standard typical of infant products
• Age-related restriction evidence, cross-referenced to the tighter Annex III thresholds applied
• Claims substantiation for any "suitable from birth" or hypoallergenic-style claim
• Animal testing declaration
Who This Is For
Baby and infant skincare brands maintaining PIF documentation for washes, balms or moisturisers.
Legal Framework
• Article 11, Regulation (EC) No 1223/2009
• Schedule 34, SI 2019/696
• ISO 22716
• Annex III (age-related restrictions)
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.