PIF Checklist: Section-by-Section Template

PIF Checklist: Section-by-Section Template

Quick Answer

This is a section-by-section PIF checklist you can copy into your own files. It follows the five content areas in Article 11 of the Cosmetics Regulation and the structure of the safety report in Annex I, then adds the supporting items that make a file easy to defend: notification, labelling, undesirable effects, change control and retention. The legal structure comes from the Regulation; the exact fields and layout are practical suggestions you can adapt to your own products.

How to Use This Checklist

Print it, paste it into your quality system, or run it as a pre-launch gate. Work through one product at a time, tick each item only when you can point to the document, and note the version and date beside it. The five main sections come from Article 11; the EU text is available on EUR-Lex. If you are new to the file, read our guide to the Product Information File first, and our step-by-step build guide for the order of work.

Section 0: File Control

Not a legal heading, but the part inspectors notice first.

  • ☐ Product name, code and formula version on the cover page
  • ☐ Responsible Person name and address that match the notification
  • ☐ Index listing every section, document, version and date
  • ☐ Named file owner and backup owner
  • ☐ Language check: whole file in English for Great Britain

Section 1: Product Description

Article 11(2)(a): a description that lets the file be clearly attributed to the product.

  • ☐ Trade name exactly as on the pack
  • ☐ Internal and manufacturer product codes
  • ☐ Category, function and intended use
  • ☐ All shades, scents and sizes covered by the file
  • ☐ Primary and secondary packaging described
  • ☐ Dated copy of final label and artwork

Our guide to the PIF product description explains each field.

Section 2: Safety Report, Part A (Safety Information)

Article 11(2)(b) refers to the safety report; Annex I sets out its content. Part A has ten headings.

  • ☐ 1. Quantitative and qualitative composition
  • ☐ 2. Physical and chemical characteristics and stability
  • ☐ 3. Microbiological quality, including challenge test results
  • ☐ 4. Impurities, traces and information about packaging material
  • ☐ 5. Normal and reasonably foreseeable use
  • ☐ 6. Exposure to the cosmetic product
  • ☐ 7. Exposure to the substances
  • ☐ 8. Toxicological profile of the substances
  • ☐ 9. Undesirable effects and serious undesirable effects
  • ☐ 10. Information on the cosmetic product

For items 2 and 3, see our article on stability and challenge testing; for the supplier paperwork behind items 1, 4 and 8, see the 16 sections of an SDS.

Section 3: Safety Report, Part B (Safety Assessment)

  • ☐ 1. Assessment conclusion
  • ☐ 2. Labelled warnings and instructions of use
  • ☐ 3. Reasoning
  • ☐ 4. Assessor's credentials and approval of Part B
  • ☐ Assessor qualified as required by Article 10; report signed and dated
  • ☐ Formula and pack in the report match the product on sale

Section 4: Manufacturing Method and GMP

Article 11(2)(c): a description of the manufacturing method and a statement of GMP compliance.

  • ☐ Short process description (batching, filling, packing)
  • ☐ Manufacturing site name and address
  • ☐ GMP statement, supported by a certificate, audit summary or signed declaration
  • ☐ Change-control arrangement with the manufacturer

See our guide to GMP and ISO 22716 for what the evidence should contain.

Section 5: Proof of Claimed Effects

Article 11(2)(d): proof of the effect claimed, where justified by the nature or effect of the product.

  • ☐ List of every claim on pack, website and adverts
  • ☐ Evidence matched to the exact wording of each claim
  • ☐ Test reports naming the formula and version tested
  • ☐ Date of last claims review

Our guide to claims substantiation covers the standard to meet.

Section 6: Animal Testing Data

Article 11(2)(e): data on animal testing by the manufacturer, its agents or suppliers, including tests for third-country requirements.

  • ☐ Own declaration on testing of the finished product
  • ☐ Supplier statements for ingredients
  • ☐ Note of any testing done for third-country requirements
  • ☐ Dates and sources recorded

See our guide to the animal testing ban.

Section 7: Notification and Labelling

Not part of the five legal sections, but the file must agree with them.

  • ☐ Notification submitted before the product was placed on the market (Article 13)
  • ☐ Notified address is where the file is kept
  • ☐ Label, ingredient list and warnings match the file and safety report
  • ☐ Date of minimum durability or PAO supported by stability data (Article 19)

Section 8: After Launch

  • ☐ Complaints and undesirable effects log, with reviews dated
  • ☐ Procedure for reporting serious undesirable effects
  • ☐ Change log for formula, supplier, packaging and claims
  • ☐ Notification updated without delay when notified details change
  • ☐ Annual file review diarised

Our guides on keeping a PIF up to date and SUE reporting cover this stage in detail.

Section 9: Retention

  • ☐ Date the last batch is placed on the market recorded for each version
  • ☐ Ten-year earliest deletion date diarised
  • ☐ Superseded versions archived with dates
  • ☐ Electronic master plus independent backup
  • ☐ At least two people can retrieve and explain the file

See our guide to PIF retention.

Scoring Your File

Result What it suggests Next step
Every legal section ticked, with documents File is structurally complete Run the cross-check across documents
A section ticked but no document you can point to Assumed, not evidenced Obtain or create the document
Any legal section empty Gap that needs closing before sale Speak to your assessor or Responsible Person

Once every box is ticked, run the six-item cross-check in our article on common PIF mistakes, and keep the result in the file.

Frequently Asked Questions

Is there an official PIF template?

No. The Regulation sets the required content areas and the structure of the safety report, but not a form. This checklist is a practical way to organise the same content.

How many sections does a PIF have?

Article 11 lists five content areas: the product description, the safety report, the manufacturing method and GMP statement, proof of claimed effects, and animal testing data.

Can I use one checklist for all my products?

You can use the same checklist, but each product needs its own completed copy, because formula, pack, claims and evidence differ by product.

When should I run the checklist?

Before launch, after any formula, supplier, pack or claim change, and as part of a scheduled annual review.

Final Word

A PIF checklist will not make a weak file strong, but it will stop a good file from having silent gaps. Use it as a gate: nothing goes on sale until every box can be ticked with a document behind it.

Want the file built, not just checked? NestQual prepares complete Product Information Files alongside CPSR, notification and Responsible Person services.

Get a CPSR for your product See the Complete Compliance Pack

Sources

  1. Regulation (EC) No 1223/2009, Article 10 — Safety assessment (as it applies in the UK) — legislation.gov.uk
  2. Regulation (EC) No 1223/2009, Article 11 — Product information file — legislation.gov.uk
  3. Regulation (EC) No 1223/2009, Article 13 — Notification — legislation.gov.uk
  4. Regulation (EC) No 1223/2009, Article 19 — Labelling — legislation.gov.uk
  5. Regulation (EC) No 1223/2009, Annex I — Cosmetic product safety report — legislation.gov.uk
  6. European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products — eur-lex.europa.eu
  7. Related guides on this site: PIF explained, How to build a PIF, Common PIF mistakes

This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.

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