What is a PIF, and do you need one to sell handmade cosmetics in the EU?

A PIF, the Product Information File, is the dossier every cosmetic product needs before it can legally be sold in the EU. There is no small-business or handmade carve-out in EU cosmetics law — the size of your kitchen table has no bearing on whether Regulation (EC) No 1223/2009 applies to the balm you're selling at Saturday's market.

What counts as a cosmetic

Anything applied to skin, hair, nails, lips or teeth to clean, perfume, protect or keep in good condition is a cosmetic under Article 2 of the regulation. Lip balms, body butters, lotions, bath bombs, and skin-cleansing soap all qualify — a candle or a jar of jam doesn't, because neither is applied to the body in that sense.

What's actually inside a PIF

Article 11(2) lists five things:

• A description of the product — what it is, how it's used.
• The Cosmetic Product Safety Report (CPSR) — Part A, the safety data you and your assessor gather (ingredients, exposure, toxicology), and Part B, the assessor's conclusion on safety.
• Method of manufacture, plus a statement that it complies with good manufacturing practice — ISO 22716 is the standard usually pointed to for this.
• Proof of the effect claimed, where the product's nature or the claim you make about it needs justifying.
• Data on any animal testing — a statement that none was carried out is normal for most small makers, but the file still needs the statement.

Who has to have one, and for how long

Article 4 makes a "Responsible Person" accountable for the product — for a maker producing and selling their own products from inside the EU, that's usually you. Article 11(1) requires the PIF to be kept for ten years after the last batch of that product is placed on the market, in electronic or paper form, at the address on the label, and made available to the competent authority on request.

PIF and CPNP are two different mandatory steps

Before you can sell a cosmetic at all, Article 13 requires notifying it through the CPNP (Cosmetic Products Notification Portal) — a separate online submission. Neither step substitutes for the other: notify before selling, and keep the PIF for as long as you sell.

The part that costs real money

The CPSR's Part B has to be signed off by a "qualified safety assessor" — someone holding a specific pharmacy, toxicology, medicine or related qualification (Article 10(2)). Gathering the ingredient and exposure data for Part A is work you can do yourself with good recipe and supplier records; the Part B sign-off is professional judgement you generally have to pay for, and it's usually the single biggest compliance cost a small cosmetics maker faces before their first legal sale.

This is a starting map, not legal advice — check the current consolidated text of Regulation (EC) No 1223/2009 on EUR-Lex, and talk to a qualified safety assessor about your specific products before you rely on any of it.