Don’t Let a Disorganized PIF Delay Your EU Market Access
A PIF must be complete, structured, and accessible at the RP’s address for 10 years. We organize your documents into a clear, Article 11–aligned file so your Responsible Person can produce it without gaps or last-minute rework.
Compliance Starts With a Proper PIF
- When your documentation is scattered and needs structure to meet Article 11
- When your RP must produce the PIF quickly during an inspection or authority request
- When your product is ready for the EU market but your PIF still isn’t
- When multiple SKUs require consistent documentation standards
- When your evidence exists — but isn’t organized into a proper, accessible file
Once your PIF is clear and complete, every part of EU compliance becomes more predictable.
The Role of a Clean PIF in Your Regulatory Strategy
Under Regulation (EC) No 1223/2009, the PIF is not optional. It must contain all evidence described in Article 11 (a–e) and be accessible at the Responsible Person’s address at all times.
Any missing files, inconsistent naming, unsupported claims, or unclear cross-links can lead to non-compliance findings — especially during inspections or market surveillance.
A correct PIF is more than a folder: it’s a structured safety and compliance package that shows clarity, traceability, and preparedness.
A Clean and Defensible File You Can Rely On.
We assemble an inspection-ready PIF for each product, mapping your documents to Article 11, organizing evidence into a clear structure, and ensuring accessibility and retention requirements are met.
We collect CPSR, GMP statement, claims evidence, and declarations to identify early gaps. Each requirement (a–e) is linked to concrete files for clarity and traceability.
We create the index and folder structure and add placeholders for missing items.
We check naming, versions, and alignment between claims and label text.
We verify accessibility at the label address and 10-year retention expectations.
You receive an organized PIF with editable structure, PDFs, and clear guidance.
Your PIF, Fast and Without Rework
To build a PIF that truly supports your compliance, we organize every required document into a clear, traceable structure aligned with Article 11.
Structured EU PIF Index:
- A complete PIF index and folder structure built according to Article 11, ready for your RP to navigate without confusion or rework.
Organized Evidence Package:
- All CPSR, GMP, claims, supplier and animal-testing documents reorganized into a clean evidence pack.
PIF Quality & Compliance Review:
- A final QA pass that verifies completeness, accessibility at the RP address, 10-year retention requirements, and documentation clarity for authority review.
PIFs Built for Real EU Compliance
We combine deep regulatory expertise with structured documentation practices — delivering a PIF that aligns with Article 11, satisfies RP requirements, and stands up to authority scrutiny.
Start Your EU PIF Assembly With Confidence
A well-structured, Article 11–aligned PIF saves time, prevents rework, and gives your RP the confidence to respond to any authority request. Give your product the documentation clarity it needs to move forward.
Talk to Sobel!
FREQUENTLY ASKED QUESTIONS
Article 11 lists five required elements:
(a) product description;
(b) CPSR (Part A + Part B reference);
(c) manufacturing method and GMP statement;
(d) proof of claimed effects;
(e) animal-testing statement.
For 10 years after the last batch is placed on the EU market, accessible at the address of the Responsible Person.
The Responsible Person, designated under the EU Cosmetics Regulation, is legally required to maintain the PIF and keep it accessible for 10 years after the last batch is placed on the market.
Sobel can also act as the Responsible Person in Europe when needed, ensuring full compliance and continuity.
Yes. Article 11(c) requires the manufacturing method and a GMP statement (often ISO 22716-aligned).
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