The Product Information File: Contents and Custody (Article 11)

The Product Information File is the dossier that stands behind every cosmetic, and Article 11 of Regulation (EC) No 1223/2009 places the duty to hold it on the Responsible Person. It must exist before the product is placed on the market and be producible to a competent authority on request.

Required contents (Article 11(2))

The file must contain five elements:

1. A description of the cosmetic product that allows the file to be clearly attributed to it.
2. The Cosmetic Product Safety Report required by Article 10 and structured per Annex I, Parts A and B.
3. A description of the method of manufacture and a statement of compliance with Good Manufacturing Practice under Article 8, for which conformity with ISO 22716 confers a presumption.
4. Proof of the effect claimed, where the nature of the effect or the claim justifies it, linking the file to Article 20 and Commission Regulation (EU) No 655/2013.
5. Data on any animal testing carried out by the manufacturer, its agents or suppliers in developing or assessing the safety of the product or its ingredients, including testing performed to meet the requirements of a third country.

What a complete file contains in practice

Article 11 sets a floor, not a ceiling. Those five elements are the legal minimum, and a file built only to that minimum is compliant but thin: it leaves the Responsible Person exposed the moment an enforcement authority, a retailer audit or an acquirer’s due diligence tests it. The files we compile are organised into discrete, indexed sections, each kept as a working part of the dossier rather than a one-off attachment.

The product and how it is made

• Product name and description: the identifier that attributes the file unambiguously to the product (Article 11(2)(a)).
• Formulation: the full qualitative and quantitative formula, every ingredient by INCI name with its percentage and function, which is the basis the entire safety assessment rests on.
• Method of manufacture: how the product is made, with the statement of compliance with Good Manufacturing Practice to ISO 22716 (Article 11(2)(c) and Article 8).

Safety and supporting evidence

• Cosmetic Product Safety Report: the Annex I document in Parts A and B, the assembled safety data and the assessor’s reasoned conclusion, the document at the centre of the file (Article 11(2)(b)).
• Stability and compatibility: shelf-life and packaging-compatibility data that substantiate the date of minimum durability or the period after opening.
• Certificates of Analysis: raw-material and finished-product test certificates confirming each input meets its specification.
• Material Safety Data Sheets: data sheets for the finished product and the relevant raw materials, to REACH Annex II and the CLP Regulation.
• Batch records: the manufacturing and packaging records that make any individual batch reconstructable.
• Traceability: the chain linking a finished unit back through its batch to raw materials and suppliers, the spine of any recall (Article 7).
• Claim substantiation: proof held for every claimed effect that requires it, to the common criteria of Commission Regulation (EU) No 655/2013 (Article 11(2)(d)).
• Animal testing declaration: the data and statement confirming compliance with the testing and marketing prohibitions (Article 11(2)(e) and Article 18).

Labelling, packaging and notification

• Labelling: the artwork checked against the Article 19 mandatory particulars and any market-specific additions.
• Packaging: packaging specifications and the compatibility of the product with its pack.
• Notification: the record of notification, through the CPNP in the European Union or the SCPN in Great Britain (Article 13).

Complaints, vigilance and corrective action

This is the part of a file that separates a maintained dossier from a launch-day snapshot, and it is where thoroughness shows. We hold both the procedures and the live logs:

• Complaints procedure and log: how complaints are received, assessed and closed, with the running record of them.
• Undesirable effects (UEs): an undesirable effect is an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a product (Article 2(1)(o)). Each is logged, assessed for causality and trended.
• Serious undesirable effects (SUEs): a serious undesirable effect is one that leads to temporary or permanent functional incapacity, disability, hospitalisation, a congenital anomaly, an immediate vital risk or death (Article 2(1)(p)). These are reportable to the competent authority without delay under Article 23, and the file carries both the procedure and the log for doing so.
• Recall procedure and log: the documented process for withdrawing or recalling product, tied to the traceability data, with the record of any action taken.
• Corrective and preventive action (CAPA): the closed loop that turns a complaint, an undesirable effect or a non-conformity into a documented correction and a preventive change that stops it recurring. CAPA is the evidence that the quality system works in practice, not merely that it exists on paper.

A file assembled to this depth answers an enforcement authority, a retailer’s technical audit and an acquirer’s due diligence from a single, current source. That is the standard we hold every file to.

Custody and retention (Article 11(3) and (4))

The Responsible Person keeps the file at the address shown on the label and retains it for ten years from the date the last batch of the product was placed on the market. It must be readily accessible, electronically or otherwise, to the competent authority of the territory in which the file is kept, and the information must be in a language that authority can readily understand.

Keeping it current

The file is not static. It must be updated when the formulation, the claims or the applicable regulation changes, and the complaints and vigilance logs described above are kept live within it. A file that reflects the product only as first launched ceases to be compliant once the product has moved on.

Common deficiencies

The recurring failures are an absent or unsigned GMP statement; no proof held for a claim that requires it; a CPSR missing a dermal absorption value, a challenge test or a Margin of Safety calculation; and an assessment that has not been revisited after a formulation or regulatory change. Each renders the file incomplete in the precise sense an authority will test.

We compile and maintain the file as part of our Responsible Person service, or prepare it for your own retention through our PIF compilation service. For the document at its core, see our technical guide to the CPSR.