A product information file (PIF) is the mandatory dossier kept for each cosmetic product, proving it is safe, made to good manufacturing practice (GMP) and backed by evidence for its claims. Its technical core is the Cosmetic Product Safety Report (CPSR), which a qualified safety assessor must prepare. You must keep the file for ten years after the last batch reaches the market.
TL;DR:
- Give the assessor the locked formula, full ingredient names, fragrance allergen references, and final packaging; changes after Part B is signed usually require reassessment.
- Match every label or online claim to dated evidence in a claims matrix; supplier brochures alone rarely support claims during inspection.
- Keep the indexed PIF accessible at the address printed on the label for ten years after the last batch reaches the market.
- Before supply, submit product notification, then renew it annually; notification acknowledgment is not endorsement, and the PIF itself is not required at initial notification.
- Secure supplier specifications and the manufacturer’s GMP statement early, then time stability testing so results reach the assessor before Part B drafting.
Table of Contents
- What does a cosmetic PIF contain?
- What goes into the CPSR, Part A and Part B?
- Which manufacturing records and GMP documents are required?
- What evidence proves your product claims?
- How do you assemble a compliant PIF step by step?
- How long must you keep a PIF, and where?
- Quick self-audit: what should your PIF checklist cover?
- Why the PIF should be an operating tool, not an archive
- How we help you finish your PIF and launch with confidence
- FAQ
- Sources
What does a cosmetic PIF contain?
A standard PIF built to EU and ASEAN frameworks has five parts:
- Product description: name, function and a clear link between the file and the finished product.
- CPSR: Part A (safety information) and Part B (the assessor’s conclusion).
- Manufacturing method and GMP statement: how the product is made and a manufacturer’s confirmation of GMP compliance.
- Proof of claimed effects: evidence behind every claim made on pack or online.
- Animal testing data: declarations covering the finished product and its ingredients.
Behind these parts sit the documents auditors actually ask to see: raw-material specifications, packaging specifications, stability and microbiology reports, and supplier certificates of analysis (COAs). Signed manufacturing agreements and packaging technical data belong here too.
Organisation matters as much as content. The file should be indexed so that any document can be pulled up the moment an inspector asks.
What goes into the CPSR, Part A and Part B?
Part A gathers the facts. It covers quantitative and qualitative composition, physical and chemical properties, stability, microbiological quality, impurities, exposure estimates and the toxicological profile of each ingredient. Part B is the reasoned safety assessment: the assessor’s conclusion, the reasoning behind it, labelled warnings, and the assessor’s name with documented qualifications in pharmacy, toxicology, medicine or a similar discipline.
Weak assessor credentials are a classic cause of delay, so check them before commissioning the report. Three other failings recur:
- Formula ranges that are too wide for the assessor to evaluate.
- Missing INCI (ingredient) names, so substances cannot be matched to toxicological data.
- Absent references for fragrance allergens.
Pro Tip: Give your assessor the final, locked formula and final packaging details at the start. Changing either after Part B is signed usually means paying for a reassessment.
Which manufacturing records and GMP documents are required?
Authorities expect manufacturing documentation that lets them trace any unit back to its production run. The ASEAN and HSA GMP guidance sets out what the master formula and batch records must hold. In practice, assemble these items:
- Master formula: the approved formula with intended packaging, storage conditions and every pack variant.
- Batch Manufacturing Records (BMRs): the product name, batch formula, processing dates and equipment used.
- Test records: in-process checks and release tests, filed against each batch number.
- GMP statement: a written declaration from the manufacturer that production follows cosmetic GMP, such as the ISO 22716 style of guidance.
If you want to see how these expectations play out on a factory floor, our overview of HSA GMP and skincare manufacturing standards is a good companion read.
What evidence proves your product claims?
Every claim a customer can read, from “reduces the look of wrinkles” to “suitable for sensitive skin”, needs a file behind it. Auditors accept several kinds of evidence, chosen to fit the strength of the claim:
- Clinical or consumer studies: for claims about visible results on real users.
- In-vitro data: for claims about ingredient activity in the lab.
- Instrumental measurements: for hydration, elasticity and similar measurable effects.
- Supplier test reports: for ingredient-level claims, kept with chain-of-custody records showing the report covers the material you actually bought.
Build a claims matrix: one row per claim, pointing to a specific evidence file and its location in the PIF. Keep third-party reports complete and dated. A bare supplier brochure rarely survives an inspection.
How do you assemble a compliant PIF step by step?
Work in three phases and you avoid most rewrites:
- Gather: collect the formula, quantitative composition, raw-material specifications and supplier certificates.
- Test and verify: run stability and microbiological testing, then gather packaging specifications and final artwork and check the label against them. Our stability testing and QC services cover this stage.
- Assess and collate: commission the Part B assessment, secure the GMP statement from the manufacturer, then check that the file matches what you notified.
The labelling check is worth taking seriously. HSA’s guidance lists the ingredient list, responsible person’s address, batch number and manufacturing or expiry date among the label requirements.
Pro Tip: Date and version every document as it enters the file. A clean revision trail is the fastest way to show an auditor the file reflects the product on shelf.
How long must you keep a PIF, and where?
The rules on retention and access are short but strict:
- Location: the file must be readily accessible at the address on the product label, even though HSA does not require it to be submitted at initial notification.
- Language: write it, or provide it, in a language the competent authority understands.
- Notification link: notification is an administrative e-service, while the PIF is the documentary proof behind it. HSA states that notification must be made before supply, that acknowledgement is not an endorsement, and that re-notification is required each year to keep marketing a product.
The legal basis for the file’s content is Regulation 1223/2009, whose full text is on EUR-Lex.
Quick self-audit: what should your PIF checklist cover?
Run this check before any inspector does:
- Clear product identification and a complete quantitative formula.
- A signed Part B with the assessor’s qualifications attached.
- A GMP statement from the manufacturer.
- Stability and microbiology reports.
- Claim evidence mapped to each claim.
- Traceable batch records.
The usual gaps are missing supplier declarations, vague composition ranges, absent GMP confirmation and unsupported claims. Fix them in order of who holds the document: ask the supplier for declarations first, the manufacturer for the GMP statement second, and your assessor for formula clarifications last.
Pro Tip: Store the file as a single indexed folder with one master contents page. If you cannot find a document promptly, an inspector will notice.
Why the PIF should be an operating tool, not an archive
Most teams treat the PIF as paperwork to finish before launch, then forget it. That is the wrong way round. The files that survive audits are the ones updated whenever a formula tweak, new supplier or new claim appears, because a reformulation quietly makes the old safety report describe a different product.
From a manufacturer’s viewpoint, sequence is everything. Chase supplier specifications and the GMP confirmation first, since these cause the longest delays. Then time stability testing so its results are ready when the assessor writes Part B, which saves a second round of comments. If your team is small, bringing in a manufacturer or regulatory consultant to finalise and stress-test the dossier is cheaper than a failed inspection.
— Edmund
How we help you finish your PIF and launch with confidence
Many brands stall at the documentation stage, not the formulation stage. We support you with product development, so the file is ready when your product is. See our skincare product development service and the skincare launch roadmap, then contact our team to discuss your PIF.
FAQ
What is a PIF document?
A PIF is the dossier a cosmetic brand keeps for each product, proving it is safe, made under GMP and supported by evidence for its claims. It is not usually submitted at notification, but it must be available for inspection.
What is a safety assessment for cosmetic products?
It is the CPSR, which has two parts: Part A collects safety data on the formula and Part B records a qualified assessor’s reasoned conclusion. The assessor must hold documented qualifications such as pharmacy, toxicology or medicine.
Do all ingredients have to be listed in cosmetics?
Ingredient listing is a labelling requirement, and HSA’s guidance names the ingredient list among the mandatory label items. Your PIF should hold the full composition behind that list.
How long must a PIF be kept?
Keep it for ten years after the last batch is placed on the market, at the responsible person’s address stated on the label.
Sources
For the legal text, read Regulation 1223/2009 on EUR-Lex. For local guidance, HSA’s ASEAN Cosmetic Directive page lists the PIF guidelines alongside the other cosmetic product requirements.
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) (c. 1223)
- Regulatory overview of cosmetic products | Health Sciences Authority
- Submit notification and re-notification | Health Sciences Authority
- GMP GUIDELINES FOR MANUFACTURERS OF COSMETIC PRODUCTS
