Cosmetic Product Information File (PIF): contents, duties and checklist

The Regulation lists the contents in paragraph 2. First, a description of the cosmetic product that allows the file to be clearly attributed to it. Second, the cosmetic product safety report under Article 10 and Annex I. Third, a description of the method of manufacturing and a statement on compliance with good manufacturing practice under Article 8.

Fourth, proof of the effect claimed, where the nature or the effect of the product justifies it. Fifth, data on any animal testing performed by the manufacturer, his agents or suppliers relating to the development or safety assessment of the product or its ingredients, including testing performed to meet the requirements of third countries.

The responsible person is in charge. For a product manufactured in the EU that is the manufacturer, and under the Regulation the manufacturer is whoever manufactures a product, or has it designed or manufactured, and markets it under their own name or trademark. For imported products it is the importer. Both may designate another person established in the EU by written mandate. A distributor becomes the responsible person when placing a product on the market under their own name or trademark.

The file must be readily accessible at the responsible person’s address shown on the label, to the competent authority of the Member State in which the file is kept. The format is open: electronic or other. The information must be available in a language that authority can easily understand.

The retention period is ten years. It starts on the date on which the last batch of the product was placed on the market. As long as a product is still being sold, the period has not yet begun to run.

The Regulation requires the information and data to be updated “as necessary”. In practice: when the formula, a raw material, the supplier, the packaging, the manufacturing or a claim changes, you check which parts of the file are affected. That applies in particular to the safety report, which the responsible person must keep up to date under Article 10 even after the product is on the market.

First, describe the product unambiguously: name, product type, intended use and the formula version the file refers to. Second, assemble the data for the safety report and have the safety assessment carried out by a qualified person. Third, describe the method of manufacturing and attach the statement on good manufacturing practice.

Fourth, collect the evidence for claims, such as test results or studies. Fifth, obtain animal-testing information from suppliers. Sixth, define who maintains the file and how product changes reach it. Without this last step the file is out of date with the first formula change.

When a contract manufacturer develops and produces for a brand, much of the data sits with the manufacturer: formula, method of manufacturing, batches, often test results too. The responsible person, however, is usually the brand, because it has the product manufactured and places it on the market under its own name. It therefore needs contractual and practical access to everything that belongs in the file.

Clarify early who supplies which document, in which version, and how the brand learns of changes. A shared project view or a customer portal saves sending individual files back and forth.

The file refers to a formula that is no longer produced in that form. The safety report was written for an earlier version and not reviewed after a raw-material change. Evidence for claims is missing or belongs to a different product. The statement on good manufacturing practice comes from the contract manufacturer but is not held by the responsible person.

All four cases have one thing in common: the data is created in different places and only copied together at the end. Linking formula version, tests and documents from the start means the file does not have to be reconstructed later.

Is there a description naming the product, the product type and the formula version? Has the safety report been written for exactly that version, with the date and signature of the safety assessor? Is there a description of the method of manufacturing and a statement on good manufacturing practice, even when a contract manufacturer produces?

Are all claims on label, packaging and website backed by documents? Do you hold animal-testing information from the raw-material suppliers? Does the address on the label match the place where the file is accessible? And is it settled who maintains the file after launch?

A brand has a hand cream developed by a contract manufacturer and places it on the market under its own name. That makes it the manufacturer within the meaning of the Regulation, and the responsible person. The contract manufacturer supplies the formula, the method of manufacturing and the GMP statement; the test lab the stability and microbiology data; the safety assessor the safety report; marketing the evidence for the moisturising claim.

A year later the emulsifier is replaced. The brand checks with the assessor whether the safety report needs an addendum and updates the description and manufacturing details. The file stays available for ten years after the last batch of the cream was placed on the market.

A development system can collect the data, attach it to the right formula version and show what is missing or needs review after a change. Whether a document is sufficient and legally correct is still decided by the people responsible for it. The safety assessment remains the task of a person with the qualification required by Article 10.