Cosmetic & Consumer Compliance
Product information file (PIF) preparation and review
A product information file (PIF) is the complete technical record of a cosmetic product, kept ready for inspection by the authorities. We compile new PIFs and review existing ones so that every required element is present, current and consistent.
- Legal basis EU Regulation 1223/2009 Article 11; ASEAN Cosmetic Directive
- Typical inputs Product description, CPSR, GMP statement, claim and test data
- You receive Indexed, inspection-ready PIF
Overview
About Product Information File
In the EU and UK, the PIF must contain a description of the product, the CPSR, a description of the manufacturing method with a statement of GMP compliance, proof of the claimed effects and data on any animal testing. In ASEAN, a PIF with its own defined structure must be available after notification.
We assemble the PIF, check that each element meets the requirement and identify anything missing or out of date — for example claim support that no longer matches the label.
Use cases
When this service helps
New market entry
Compile a PIF before placing a product on the EU, UK or ASEAN market.
Authority request
Prepare the PIF quickly when an authority asks to see it.
Change of Responsible Person
Review the file when responsibility transfers.
Portfolio review
Check PIF completeness across a range of products.
Scope
What the service covers
- PIF structure for the target market (EU/UK or ASEAN)
- Product description and qualitative/quantitative formula
- CPSR or safety assessment (prepared or reviewed)
- Manufacturing method and GMP (ISO 22716) statement
- Claim substantiation review
- Animal-testing statement and supporting declarations
- Gap report and maintenance plan
Who does what
The PIF is kept by the Responsible Person (EU/UK) or product owner (ASEAN). Globaxa compiles and reviews it; we are not the Responsible Person.
How long must a PIF be kept?
In the EU, the PIF must be kept for ten years after the last batch of the product was placed on the market.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Confirm requirementsMarket and PIF structure are agreed.
- Collect documentsFormula, safety report, GMP and claim data.
- ReviewEach element is checked for completeness and consistency.
- CompileAn indexed PIF and maintenance plan are delivered.
Deliverables
What you receive
Product information file
Complete, indexed and ready for inspection.
Gap report
Missing or outdated elements and how to address them.
Technical basis
Guidelines we work to
- Regulation (EC) No 1223/2009, Article 11Contents of the EU product information file.
- ASEAN Cosmetic DirectiveNotification and PIF requirements in ASEAN member states.
- ISO 22716Cosmetics good manufacturing practice guidelines.
What we need from you
- Product formula and specifications
- CPSR or existing safety assessment
- Manufacturer GMP statement or ISO 22716 certificate
- Claim substantiation data and label artwork
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
EU and UK: PIF kept by the Responsible Person at the address on the label. ASEAN: PIF must be available to the authority, with a defined set of parts. Requirements in other markets vary, and some ask for selected PIF elements during registration.
FAQs
Product Information File (PIF): frequently asked questions
Can you prepare the CPSR as part of the PIF?
Yes — see Cosmetic Product Safety Reports.
Does the PIF have to be in English?
In the EU it must be in a language easily understood by the competent authority of the member state where it is kept. We can advise on language for each market.
How often should a PIF be updated?
Whenever the product, its formula, its claims or the supporting data change.
Talk to us about Product Information File
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
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+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST