Product Information File (PIF): what a cosmetic product file contains

What the PIF is for

Regulation (EC) No 1223/2009 does not require prior approval for cosmetics. In exchange, it asks whoever sells them to be able to prove, at any time, that the product is safe. The PIF is that proof: a file the market surveillance authorities of each Member State can ask to consult.

The PIF is linked to the other two mandatory steps:

• the CPNP notification, which tells the authorities the product exists and where the PIF is kept;
• the label, which shows the name and address of the Responsible Person, the same address where the PIF is available.

What the PIF contains: Article 11

Article 11 of the Regulation lists five mandatory elements.

The safety report in detail: CPSR parts A and B

Annex I splits the report into two parts.

The assessment must be signed by a qualified safety assessor: Article 10 requires a university qualification in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent.

Two points that are often underestimated:

• Packaging is part of the assessment. The material in contact with the product and its compatibility with the formula fall under Part A. Changing a bottle or tube can mean updating the report.
• Stability must be demonstrated. You need data on how the formula behaves over time, which also supports the date of minimum durability or period after opening shown on the label.

Who prepares the PIF

The PIF is the responsibility of the Responsible Person, the party established in the EU who places the product on the market and whose name appears on the label. In practice the file is the work of several people:

• the manufacturer, who provides the formula, manufacturing method, stability data and batch controls;
• raw material suppliers, with technical and safety data sheets for the ingredients;
• the safety assessor, who signs the report;
• the laboratories that run stability, microbiological or efficacy tests.

When you manufacture with us, we prepare the EU documentation with our in-house expertise and external regulatory experts. We produce according to GMP (ISO 22716), and every batch is tested by our in-house laboratory and by external accredited laboratories, including for heavy metals: data that feeds into the file. Details on controls and certifications are on our quality and certifications page.

Where it is kept and for how long

• Where: at the address of the Responsible Person shown on the label. It must be readily accessible to the authorities, in electronic or other format.
• In which language: one that the competent authorities of the Member State where it is kept can easily understand.
• For how long: 10 years from the date the last batch of the product was placed on the market.

The PIF is not a document you file and forget. It must be updated when the formula, an ingredient, the packaging in contact with the product, the claims or the rules on ingredients change.

The product information file in the UK

Great Britain applies the UK Cosmetics Regulation, the British version of Regulation 1223/2009, with an equivalent requirement: a product information file containing the same kind of information, including a safety report. In the UK the file is held by the UK Responsible Person, at the UK address shown on the label, and must be available to the UK authorities on request.

In practice, much of the work done for the EU file can be reused, but the UK file and its Responsible Person must be organised separately. The UK Responsible Person and SCPN notification are available through our partners; see our EU and UK compliance service.

What to ask your contract manufacturer

If you outsource production, agree from the start who does what on the file. Some useful questions:

• Who prepares the safety report, and who signs it?
• Who keeps the PIF, and at which address, given that it must match the label?
• How are updates handled if a raw material supplier changes?
• Which checks are carried out on each batch, and how are they documented?
• Who prepares the proof for the claims you want to use?
• If you sell in the UK, who acts as UK Responsible Person and holds the UK file?

Put the answers in the contract or the quote: they avoid surprises at the first inspection or when you decide to sell in a new channel or country.

Common mistakes

• A generic report: the assessment must refer to the specific product, with its formula and packaging, not to a “similar” product.
• Claims without proof: every effect stated on the label or online must be documented in the file.
• Inconsistent address: the address where the PIF is kept must match the label and the CPNP notification.
• No updates: a PIF frozen at the first batch does not follow changes of supplier, formula or packaging.
• Keeping it too briefly: the 10 years start from the last batch placed on the market, not the first.

Frequently asked questions