Your EU Responsible Person for cosmetics under Regulation (EC) No 1223/2009

The Product Information File (PIF): what it must contain

The Responsible Person must keep a Product Information File for every cosmetic product placed on the EU market (Article 11). It is the first thing a market surveillance authority asks for.

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Article 11 Kept for 10 years after the last batch Held at the address on the label Language the authority understands

The five required elements

Product description that allows the file to be clearly attributed to the product
Cosmetic Product Safety Report (CPSR) under Article 10 and Annex I - see our CPSR guide
Description of the method of manufacturing and a statement of compliance with Good Manufacturing Practice (Article 8)
Proof of the effect claimed, where justified by the nature or effect of the product
Data on any animal testing performed by the manufacturer, its agents or suppliers relating to the development or safety assessment of the product or its ingredients, including testing carried out to meet the legislative requirements of third countries

Good Manufacturing Practice (GMP)

Manufacturing must comply with GMP. Compliance with the harmonised standard EN ISO 22716 gives a presumption of conformity, which is why most PIFs contain an ISO 22716 certificate or a written GMP statement from the manufacturer, backed by the factory's own documentation.

Where the PIF is kept, for how long, and in which language

The file must be readily accessible in electronic or other format at the Responsible Person's address shown on the label, and kept for 10 years following the date on which the last batch of the product was placed on the market. It must be in a language that can be easily understood by the competent authorities of the Member State where it is kept - check which languages that authority accepts before translating supplier documents.

Claims evidence

Product claims must meet the common criteria of Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. If the label says "reduces wrinkles in 4 weeks" or "dermatologically tested", the evidence for it belongs in the PIF.

Typical gaps we see

No GMP evidence

Contract manufacturers outside the EU often have a quality certificate that is not ISO 22716.

Incomplete supplier data

Missing impurity data or fragrance composition blocks the safety assessment.

Unsupported claims

Marketing claims without test reports behind them.

File held abroad

The PIF must be accessible at the EU Responsible Person's address, not only at the factory.

Frequently asked questions

How long must the PIF be kept?

For 10 years following the date on which the last batch of the product was placed on the market (Article 11(1)).

Where must the PIF be kept?

At the address of the Responsible Person indicated on the label, in electronic or other format, so it is readily accessible to the competent authority.

Is the PIF submitted to CPNP?

No. CPNP receives a notification with specific information (Article 13). The full PIF stays with the Responsible Person and is shown to authorities on request.

Does the PIF need an ISO 22716 certificate?

The Regulation requires compliance with Good Manufacturing Practice. EN ISO 22716 gives a presumption of conformity, so a certificate or equivalent evidence is the usual way to show it.

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