Cosmetic product information file (PIF) checklist: EU requirements
Every cosmetic product placed on the EU market needs a product information file (PIF), kept by the responsible person. The checklist below lists each item Regulation (EC) No 1223/2009 asks for, with its legal basis. Download it as a spreadsheet and note where each item sits in your own file.
Checked against the sources on 2 November 2026
Regulation (EC) No 1223/2009 on cosmetic products, Articles 8, 10 and 11 and Annex I
Checked against the sources on 2 November 2026
A blank spreadsheet with the rows above and an empty column to note where each item is in your file. Opens in Excel or any spreadsheet.
What the file must contain
Article 11(2) lists five items and says they are updated as necessary. The safety report is the largest: Annex I splits it into Part A, the safety information, and Part B, the safety assessment.
| Item | What it must contain | Legal basis |
|---|---|---|
| Product description | A description of the cosmetic product that enables the file to be clearly attributed to it | Article 11(2)(a) |
| Safety report | The cosmetic product safety report, Parts A and B below | Article 11(2)(b), Article 10(1) |
| Manufacturing | A description of the method of manufacturing and a statement on compliance with good manufacturing practice | Article 11(2)(c), Article 8 |
| Proof of claims | Where justified by the nature or the effect of the product, proof of the effect claimed | Article 11(2)(d) |
| Animal testing data | Data on any animal testing by the manufacturer, its agents or suppliers for the development or safety assessment of the product or its ingredients, including tests for the rules of non-EU countries | Article 11(2)(e) |
| Part A, 1 | Quantitative and qualitative composition: each substance with its chemical identity (chemical name, INCI, CAS, EINECS/ELINCS where possible) and intended function; for perfume compositions, the name, code number and supplier | Annex I, Part A |
| Part A, 2 | Physical/chemical characteristics of the substances and the product, and the stability of the product under reasonably foreseeable storage conditions | Annex I, Part A |
| Part A, 3 | Microbiological quality: specifications of the substances and the product, and the results of the preservation challenge test | Annex I, Part A |
| Part A, 4 | Impurities, traces, packaging: purity of the substances, evidence that traces of prohibited substances are technically unavoidable, and the relevant characteristics of the packaging material | Annex I, Part A |
| Part A, 5 | Normal and reasonably foreseeable use, justified in particular by the warnings and other explanations on the label | Annex I, Part A |
| Part A, 6 | Exposure to the product: sites and surface areas of application, amount applied, duration and frequency of use, exposure routes and target populations, including secondary exposure | Annex I, Part A |
| Part A, 7 | Exposure to the substances, for the relevant toxicological endpoints | Annex I, Part A |
| Part A, 8 | Toxicological profile of each substance for all relevant endpoints, with the margin of safety based on a NOAEL, and the sources of the information | Annex I, Part A |
| Part A, 9 | Undesirable effects and serious undesirable effects of the product or, where relevant, of other products, including statistics | Annex I, Part A |
| Part A, 10 | Other relevant information on the product, such as studies with human volunteers | Annex I, Part A |
| Part B, 1 | Assessment conclusion: statement on the safety of the product in relation to Article 3 | Annex I, Part B |
| Part B, 2 | Labelled warnings and instructions of use needed under Article 19(1)(d) | Annex I, Part B |
| Part B, 3 | Reasoning: the scientific reasoning from the Part A data to the conclusion and the warnings | Annex I, Part B |
| Part B, 4 | Assessor's credentials and approval: name and address, proof of qualification, date and signature of the safety assessor | Annex I, Part B |
Who keeps it, where and for how long
- The responsible person keeps the file for 10 years after the last batch of the product was placed on the market (Article 11(1)).
- It is readily accessible, in electronic or other format, at the responsible person's address on the label, to the competent authority of the Member State where it is kept (Article 11(3)).
- The information is available in a language the competent authorities of that Member State easily understand (Article 11(3)).
Who writes Part B
Only a person with a diploma or other formal qualification from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent, may carry out the safety assessment (Article 10(2)). Commission Implementing Decision 2013/674/EU gives the guidelines for the safety report.
After the file
Notify the product in the Cosmetic Products Notification Portal before placing it on the market: CPNP notification. The cosmetics PIF kit writes the file index, the Part A sheets with your composition, the Part B pages for your assessor, a label check and the CPNP data as Word files.
The checklist names what the Regulation asks for; it does not assess a product. The spreadsheet is a blank list: nothing you write in it reaches us.