Written by the Oppenheimer Lab team — Reviewed by Mohamed Arbi Jallali, Partner, Head of Production and Formulator
Published on
9 min read
The cosmetic product information file (PIF) is the technical and regulatory file that the Responsible Person keeps for every product placed on the European Union market, under Article 11 of Regulation (EC) No 1223/2009. It notably contains the product safety report and is kept for ten years after the last batch is placed on the market. For a brand that has its products made in Tunisia, the real question is who supplies what, between the brand and the laboratory.
This article details the contents of the file, its retention period and the sharing of roles with your manufacturer, then the export requirement for the EU and Switzerland. It forms part of the regulation of cosmetic products in Tunisia. It is informative: consult the official texts.
What is a cosmetic product information file?
The PIF is the file that the Responsible Person keeps for every cosmetic product placed on the EU market. It brings together the product description, the safety assessment and the proof of compliance, and remains available to the authorities.
The product information file is a set of technical and regulatory documents attached to a specific product. Its legal basis is Article 11 of Regulation (EC) No 1223/2009. This text requires the Responsible Person to keep it as soon as the product is placed on the market.
The text of Article 11 published by legislation.gov.uk puts it this way:
“When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.” (legislation.gov.uk, The National Archives)
The Responsible Person is the natural or legal person designated as such in the Union for each product. According to the European Parliament’s summary, only products for which such a person is designated may be placed on the market.
The file is therefore not a simple manufacturing binder: it links a product’s formula, safety and compliance to an identified responsible party. This article is informative. For any decision, refer to the official text of Regulation (EC) No 1223/2009 on EUR-Lex.
What must a PIF contain and how long must it be kept?
The PIF contains the product description, the safety report, the manufacturing method with the GMP compliance statement, proof of effect where justified and data on animal testing. It is kept for ten years after the last batch is placed on the market.
The parts of the file
Paragraph 2 of Article 11 of Regulation (EC) No 1223/2009 lists five categories of information. They must make it possible to clearly attribute the file to a given product.
| Part | Purpose | Reference |
|---|---|---|
| Product description | Link the file to a specific product | Article 11, point a |
| Safety report | Document the safety assessment of the product | Article 11, point b; Article 10 |
| Manufacturing method and GMP statement | Describe manufacturing and attest compliance with good practices | Article 11, point c; Article 8 |
| Proof of the claimed effect | Justify the claim, where the nature of the product requires it | Article 11, point d |
| Data on animal testing | Report any testing linked to development or safety | Article 11, point e |
The GMP compliance statement refers to Article 8 of Regulation (EC) No 1223/2009. The ISO 22716 standard is the reference for cosmetic good manufacturing practices on which these statements rely.
The safety report: what it contains and what the laboratory supplies
The cosmetic product safety report (CPSR) is the document that records the safety assessment provided for by Article 10. Its content is set by Annex I of Regulation (EC) No 1223/2009. According to the European Parliament’s summary, the Commission adopts guidelines to help companies apply this annex.
The report has two parts. Part A brings together the safety information:
- the quantitative and qualitative composition;
- the physico-chemical characteristics and stability;
- the microbiological quality;
- impurities, traces and information about the packaging material;
- normal and reasonably foreseeable use, then exposure;
- the toxicological profile of the substances;
- undesirable effects and serious undesirable effects.
Part B contains the safety assessment itself: conclusion, any warnings and reasoning. It is written by a qualified person, based on the data in Part A.
In general, the laboratory supplies the data arising from the formula and production: composition, stability, compatibility with the packaging and microbiological results. The brand provides the intended use, the target audience and the chosen container.
For your brief, ask your laboratory for:
- the complete formula and the precise description of the product;
- the description of the manufacturing method;
- the GMP (ISO 22716) compliance statement;
- the stability and packaging compatibility results;
- the microbiological results and the information on impurities;
- the data useful for the safety assessment, for the Article 10 report;
- the elements available to justify the planned claims.
Retention period and updates
The file is kept for ten years, from the date the last batch is placed on the market. This period therefore runs for as long as the product remains on sale, then for ten years after its last batch.
The file is not fixed. The text provides that its information be updated as necessary. A change of formula, fragrance, colourant or packaging therefore justifies checking the file.
This article remains informative: rely on the official text for any decision.
Who compiles and keeps the PIF when you have your products made in Tunisia?
The Responsible Person, established in the EU for this market, keeps the PIF and makes it accessible to the authorities. The laboratory supplies the manufacturing elements: formula, method, GMP compliance, traceability. The Responsible Person, that is the brand if it is established in the EU or the third party it designates, remains responsible for the complete file, wherever production takes place.
Responsible Person and manufacturer: who supplies what
The Responsible Person is the one who answers for the file before the authorities. According to the European Parliament’s summary, they ensure that the competent authority can easily access the file, in electronic or other format, at the address shown on the label.
The manufacturer does not take on this role by default. It feeds the file with what it controls: composition, manufacturing method, GMP compliance statement and batch traceability. At Oppenheimer Lab, production follows cosmetic Good Manufacturing Practices (ISO 22716 / GMP). All ranges are manufactured at our site in Tunisia, with our own equipment. The full history of a batch is available within 24 hours, and we prepare product information files (PIF) as well as CPNP notifications.
The CPNP is the European portal for the notification of cosmetic products. Our advice: define the countries of sale from the brief. Manufacturing in Tunisia does not exempt you from the requirements of the destination market. For the European Union, you notably need:
- a Responsible Person established in the EU;
- a product information file with a safety assessment;
- a compliant composition and labelling;
- a notification on the CPNP portal before marketing.
This notification is neither an authorisation nor a quality certification. It does not replace the PIF.
Checklist of documents to request from your laboratory
Beyond the manufacturing documents, check that each document is tied to the final formula, and not to an earlier version. Ask your laboratory for:
- the validated formula and the corresponding INCI list;
- the description of the manufacturing method;
- the production certificate under GMP (ISO 22716);
- the traceability data of a batch, with the time needed to obtain them;
- the elements useful for the safety report of the final formula;
- written confirmation of what is supplied by the laboratory and what remains the responsibility of your Responsible Person.
If you want to start from an already documented base, our ready-to-launch private label formulas make it possible to frame these exchanges from the outset.
Is a PIF mandatory to export to the EU or Switzerland?
Yes for the EU: every cosmetic product placed on the market requires a PIF kept by the Responsible Person. In Switzerland, the PIF has been required since 1 May 2021 before first placing on the market, with exceptions for certain local artisanal products.
Manufacturing in Tunisia does not exempt you from the requirements of the destination market. It is useful to identify the country of sale before starting production, because it determines the documents to prepare. To position your target, you can read the article on promising markets and export access requirements.
European Union market
In the EU, the PIF derives from Article 11 of Regulation (EC) No 1223/2009. The Responsible Person keeps it as soon as the product is placed on the market.
The CPNP notification falls under Article 13 of the same regulation. It is made before marketing, but it does not replace the PIF: they are two separate steps. The PIF documents the product, the notification announces it on the European portal.
No source for this file allows us to assert an equivalent Tunisian obligation. For the Tunisian market, refer to the official texts and to the pillar article of this cluster.
Swiss market
The Swiss PIF is the product information file required by Switzerland, also called PIF. According to the State of Geneva, each product must have one before it is first placed on the market.
According to the same source, the file is written in French, German, Italian or English. It is kept for at least ten years after the sale of the last batch.
A file drawn up abroad can be reused if it complies with Swiss legislation. The importer or distributor must also be able to present it to the authorities on request.
Artisanal cosmetics made and sold locally on a small scale are exempt from the PIF, unless they are intended for children under three or applied near the eyes or mucous membranes. A brand that exports from Tunisia does not fall within this local logic. This article remains informative: check the official texts.
What mistakes should you avoid and how do you prepare your file?
Define the countries of sale from the brief, check that the safety report is drawn up by a qualified person for the final formula, and update the file with every change of formula or packaging. An incomplete PIF delays placing on the market.
The first mistake is choosing the market after the formulation. Our advice: set the countries of sale from the brief, so as to prepare the corresponding supporting documents and packaging.
The second mistake is letting the file become outdated. According to the State of Geneva, a reformulation with new fragrances or colourants, or a change of design or packaging, requires the PIF to be updated.
The third mistake concerns the safety report. In Switzerland, it must be drawn up by a qualified person holding a university degree in pharmacy, toxicology, medicine or an equivalent discipline. In the EU, Article 10 of Regulation (EC) No 1223/2009 also requires the safety assessment to be carried out by a person holding a university degree in pharmacy, toxicology, medicine or a similar discipline.
The fourth mistake is expecting the authorities to validate the file. According to the same source, they neither write it nor validate it.
Finally, do not order your bottles before validating their compatibility with the formula: we recommend testing the formula-container pairing before placing the order.
To frame your project, you can request a free quote: we reply within 48 working hours. This article remains informative: refer to the official texts for any decision.
Sources
- Regulation (EC) No 1223/2009, Article 11 – Product information file (in French), legislation.gov.uk (The National Archives), undated
- Cosmetic products. Recast. “Regulation on cosmetic products”, European Parliament (Observatoire législatif), undated
- Créer un dossier d’information sur le produit – DIP ou PIF (in French), État de Genève, August 2026
Frequently asked questions
What is a cosmetic PIF?
The PIF, or product information file, is the file that the Responsible Person keeps for every cosmetic placed on the EU market. It links the product to its description, its safety assessment and its proof of compliance, and remains accessible to the competent authorities.
How long must the PIF be kept?
The PIF is kept for ten years, from the date the last batch of the product was placed on the market. This period applies while the product is sold, and then after its last batch. The file must also be updated as often as necessary.
What must a product information file contain?
The file contains five categories of information set out in Article 11: the product description, the safety report, the manufacturing method with the GMP compliance statement, proof of the claimed effect where justified, and data on animal testing.
Who must compile and keep the PIF?
In the EU, the Responsible Person keeps the PIF and makes it accessible to the authorities. The laboratory supplies the manufacturing elements, such as the formula, the method and GMP compliance. In Switzerland, the file is compiled by the manufacturer, the importer or a Responsible Person.
Is a PIF needed to export cosmetics made in Tunisia to Europe?
Yes, a cosmetic product placed on the EU market requires a PIF, even if it is made in Tunisia. You also need a Responsible Person established in the EU, a compliant composition and labelling, and a CPNP notification before marketing, which does not replace the file.
Can a PIF drawn up abroad be reused in Switzerland?
Yes, under conditions: according to the State of Geneva, a PIF drawn up abroad can be used if it complies with Swiss legislation. The importer or distributor must be able to present it to the authorities on request, prove that a complete and compliant file exists, and have access to it at all times.
