Quick Answer
An EU cosmetic Product Information File (PIF) must identify the exact product and contain its Cosmetic Product Safety Report (CPSR), manufacturing method and GMP statement, evidence for claims where justified, and relevant animal-testing data. The EU Responsible Person keeps the file accessible to authorities and updates it when the product or evidence changes. Supporting records should make each required element traceable.
This is a working document checklist for brand owners and importers, not a second overview of the EU PIF concept. The legal baseline is Article 11 of Regulation (EC) No 1223/2009; check the current consolidated version and product-specific amendments before market entry.
The five legally required PIF components
Article 11(2) defines five categories. A convenient binder index is useful, but it is the underlying evidence—not a decorative cover page—that matters. The file must be clearly attributable to the product placed on the EU market, including its formula and label version.
| Article 11 component | Practical records to assemble | Review question |
|---|---|---|
| Product description | Product identity, formula/version reference, pack and label identifiers | Can an inspector match this file to the exact marketed item? |
| Cosmetic Product Safety Report | Signed CPSR with Annex I Parts A and B and supporting evidence | Does the assessment reflect the final formulation and intended use? |
| Manufacturing method and GMP statement | Process description, site details and a statement of GMP compliance | Is the documented process the one used for the marketed product? |
| Claim substantiation where justified | Study reports or other appropriate evidence for relevant effects | Can each material performance claim be supported? |
| Animal-testing data | Relevant data from manufacturer, agents or suppliers, including third-country regulatory testing | Have applicable data been requested across the supply chain? |
The legal text does not require every brand to use identical folder names or to attach every possible laboratory report. It requires the specified information and data, updated when needed. Organise the evidence so an authority can follow the chain from finished product to safety conclusion without guesswork.
What belongs inside the CPSR section?
The CPSR is not a one-page certificate. Article 10 and Annex I distinguish Part A, cosmetic product safety information, from Part B, the safety assessment. The Commission’s 2013/674/EU guidelines explain how to present and justify the assessment. The qualified safety assessor must be able to evaluate the finished product, foreseeable use, exposure and ingredient information; a supplier’s generic statement is not a substitute.
Gather the quantitative and qualitative composition, physical and chemical characteristics, stability information, microbiological quality, impurities and traces, packaging information, normal and reasonably foreseeable use, exposure, toxicological profiles, undesirable effects and other relevant information. Part B records the conclusion, labelled warnings and instructions, reasoning and assessor credentials. Not every dataset has the same shape for every product; the assessor must explain the basis for the conclusion.
For the detailed evidence handoff, see our CPSR required-documents checklist. For the distinction between the safety report and the broader file, read the CPSR guide.
Who provides which document?
The EU Responsible Person owns the legal duty to keep the PIF. A non-EU brand commonly depends on its manufacturer and raw-material suppliers for reliable technical inputs, while a qualified assessor prepares the safety assessment. Contracts can allocate the work, but they do not erase the Responsible Person’s statutory accountability. The Responsible Person guide for non-EU brands explains the role in more detail.
| Party | Typical contribution | Key handoff control |
|---|---|---|
| Manufacturer / OEM-ODM partner | Exact formula, INCI composition, manufacturing method, GMP evidence, batch and quality records, available stability and microbiology data | Confirm final production and pack versions match the assessed sample. |
| Ingredient and packaging suppliers | Specifications, impurity and relevant safety data, packaging compatibility information | Track supplier revisions and missing data. |
| Qualified safety assessor | Annex I CPSR assessment and signed conclusion | Resolve evidence gaps before signing. |
| Brand owner / importer | Claims, artwork, intended use, market and commercial product identity | Do not change claims or packaging without review. |
| EU Responsible Person | Maintains accessible PIF, coordinates updates and responds to competent authorities | Keep one controlled, current file at the label address. |
A practical collection sequence for a new product
- Freeze product identity. Record the final formulation code, shade or variant, pack format, intended use and label artwork. Decide whether variants can be covered by one assessment or need distinct treatment with the assessor.
- Request technical inputs. Obtain formula composition, raw-material specifications, manufacturing and GMP records, stability and microbiology evidence, packaging information and any relevant adverse-event history.
- Commission the CPSR. Give the qualified assessor the complete evidence set. Resolve questions on exposure, impurities, warnings and foreseeable use before signing.
- Substantiate claims. Identify claims needing proof; link each to appropriate evidence. Marketing language should not outrun the data.
- Assemble and index the PIF. Put the five Article 11 components under version control and record the owner of each update.
- Check market handoff. Verify the Responsible Person’s label address and separately handle CPNP notification under Article 13 before placing the product on the market. Notification is not the PIF itself.
How long must the PIF be kept and where?
Article 11(1) requires retention for ten years after the date the last batch was placed on the market—not merely ten years after the first launch. Under Article 11(3), the Responsible Person must make the file readily accessible, electronically or otherwise, at the address shown on the label to the competent authority of the Member State where it is kept. The information must be in a language easily understood by that authority. A cloud folder is useful only if access, completeness and version control actually work when an inspection occurs.
What changes require a PIF review?
Review the file when the formula, supplier specification, manufacturing site or process, packaging, intended use, warnings, claims or relevant safety evidence changes. A label redesign can affect product identification and claims even when the formula is unchanged. Keep a change log showing the old version, new version, affected sections, assessment decision and implementation date. An assessor may need to revise the CPSR; do not assume an old report automatically covers a materially changed product.
Common PIF gaps to catch before launch
- A CPSR prepared for a prototype formula rather than the manufactured version.
- Missing supplier information for fragrances, colorants, preservatives or packaging interactions.
- A generic GMP certificate filed without a manufacturing-method description or product-site traceability.
- Clinical-sounding or performance claims added after the evidence review.
- The Responsible Person’s address on the label not matching the place where the PIF is readily accessible.
- CPNP notification treated as if it replaces the PIF.
These are practical quality-control examples, not an exhaustive list of legal violations. The exact evidence needed depends on product composition, use and claims.
What can a cosmetic manufacturer provide?
A capable OEM/ODM manufacturer can help compile the final INCI and quantitative formula, specifications, COA or SDS where relevant, manufacturing documentation, stability and microbiological reports, quality records, packaging-compatibility information and batch traceability. The brand and Responsible Person should specify the evidence package in the project brief and verify that documents refer to the correct product version. Manufacturing support does not itself constitute an EU safety assessment or transfer the Responsible Person’s legal duties.
FAQ
Is a PIF the same as a CPSR?
No. The CPSR is one required component of the broader Article 11 PIF.
Does CPNP notification replace the PIF?
No. CPNP is a separate pre-market notification process. The Responsible Person must still maintain the PIF.
Must the PIF be a paper binder?
No. Article 11 allows electronic or other formats, provided the file is readily accessible as required.
Can the factory keep the PIF for the brand?
The factory can supply and help organise evidence, but the EU Responsible Person has the legal duty to keep the PIF accessible at the label address.
When can we delete an old PIF?
Not before ten years have passed after the last batch of that product was placed on the market, subject to any other applicable retention obligations.
Sources and review
- EUR-Lex: Regulation (EC) No 1223/2009, Articles 8, 10, 11 and Annex I; check current consolidated text.
- EUR-Lex: Commission Implementing Decision 2013/674/EU, guidelines on Annex I and the CPSR.
- European Commission: Cosmetic Products Notification Portal, Article 13 notification overview.
Last reviewed: 26 September 2026. Editorial responsibility: MOOYAM technical content team; regulatory source review against the official EU materials above. This article is general information, not legal advice. Regulatory requirements may change. Brands should verify current requirements with the relevant authority or a qualified compliance professional before placing cosmetics on the market.
MOOYAM provides cosmetic OEM/ODM manufacturing and technical-documentation support for international beauty brands. If you are assembling the evidence package for an EU launch, contact our team with your product category, formula stage and target markets.