EU cosmetic notification is the entry ticket to a market of 27 countries, and the process is more predictable than most brands expect. The regulation requires a Responsible Person established in the EU, a Product Information File for every product, a notification via CPNP before the product is placed on the market, and compliance with Good Manufacturing Practice. None of it is optional, and all of it is documentable in advance.
1. The Responsible Person
The Responsible Person is the legal entity accountable for compliance: a brand with an EU establishment, an importer, or a designated authorised representative. Its name and address must appear on the label. A non-EU brand selling direct to EU consumers needs to appoint one, and the appointment is a contract, not a formality – the Responsible Person must be able to access the Product Information File on request.
2. The Product Information File
The PIF contains the product description, the safety assessment, the manufacturing and conformity statement, the labelling, the claims evidence, and the data on animal testing. It must be kept for ten years after the last batch is placed on the market. A PIF assembled after the launch is a PIF that will be rewritten, because the claims and the artwork have to match the evidence inside it.
3. The safety assessment
The safety assessment is written by a qualified assessor and covers every ingredient at its use level, the exposure route, the target population and the product’s intended use. For a product used near the eye or on the lip, the assessment has to consider the specific route. A stock formula from a supplier usually comes with a generic assessment; it still has to be adapted to the brand’s own pack, claims and intended use.
4. CPNP notification
The notification is filed through the CPNP portal by the Responsible Person, and it takes a few days once the file is complete. It is not an approval, but the information has to be accurate, including the product name, the categorisation, the frame formulation, the presence of nanomaterials and the CMR substances. A notification filed against a formula that later changes requires an update.
5. Labelling and the allergen rules
The EU label requires the Responsible Person, the nominal content, the batch code, the ingredient list in INCI order, the allergen declarations above the threshold, and any warnings. A fragrance with an undeclared allergen is the most common labelling failure found at retail, and it is usually caused by a late fragrance substitution rather than by carelessness.
6. Claims and the common technical document
Every claim on the pack has to be supported by evidence in the PIF, and the evidence has to match the wording. A product that says tested under dermatological control needs the test report, the panel size and the date. The common technical document that many brands now maintain is the practical way to keep the claims, the tests and the labels in one place.
7. Commercial profile
EU-bound launch, 10 to 14 weeks including the safety assessment and the notification. See the skincare set range and the US filing guide for the other major market.
