EU cosmetic regulation: who is responsible, and what gets filed
The EU system is easier to follow as a chain of responsibility than as a list of article numbers. One entity has to be established in the EU and stand behind the product; everything else hangs off that.
The chain of responsibility
- The brand decides to place the product on the EU market.
- The responsible person must be established in the EU and is named on the label. It is the entity the authorities hold to account.
- The safety assessor produces the safety assessment, which must exist before the product goes on the market.
- The product information file is kept by the responsible person and must be available to the authorities on request.
- CPNP notification is filed by the responsible person before the product is placed on the market.
The governing instrument is Regulation (EC) No 1223/2009. The full text, including the annexes that set out permitted and restricted substances including colourants, is published at EUR-Lex.
What the EU label has to carry
The EU regime sets out required label information, and the practical items buyers trip over are:
- The name and address of the responsible person, which must be in the EU.
- The nominal content at the time of packaging.
- Any warnings and, where relevant, use-by or period-after-opening information.
- An ingredient list using the international naming convention.
Notification is not authorisation
Filing through CPNP tells the authorities that the product exists. It does not mean the product has been reviewed or approved, and it does not transfer responsibility away from the responsible person. Treating the notification as a green light is one of the most common misunderstandings about the EU system — the same distinction that applies to US registration, explained in who files what in cosmetics compliance.
Where this meets manufacturing
The safety assessment depends on the formula, and the formula depends on the factory. If the product contains colour, the permitted list becomes a manufacturing constraint as well as a labelling one — see colour cosmetics requirements.
Related reading
- Cosmetic Compliance: Who Files What, in the US and the EUA responsibility matrix for cosmetics sold into the US and the EU: which obligations sit with the factory and which sit with the brand, with links to the primary sources.
- Colour Cosmetics Manufacturing Requirements — Makeup Is Not Skincare in a Different ColourWhy colour cosmetics carry requirements that skincare does not: colour additives are the one cosmetic ingredient needing pre-market approval, and every pack change can force new compatibility testing.
Frequently asked questions
Does an EU cosmetic need approval before it can be sold?
No. The EU system is based on notification and self-assessment rather than pre-market approval. A responsible person must be established in the EU, a safety assessment must exist, and the product must be notified before it is placed on the market.
Who can be the responsible person for the EU?
The responsible person must be established in the EU and is named on the product label. It is the entity the authorities hold accountable, so brands outside the EU need an EU-established representative.
What is the CPNP notification?
It is the portal through which the responsible person notifies a product. It confirms the product has been notified; it is not a marketing authorisation and does not constitute approval.
What is the product information file?
The file the responsible person must keep, including the safety assessment and supporting data, and must make available to the authorities on request.
Are US-approved colours valid in the EU?
Not automatically. The EU uses a positive list of permitted colourants set out in the regulation's annexes, so a colour lawful in the US may not be lawful in the EU. Check the annex rather than a supplier summary.
What has to be on the EU cosmetic label?
The required information includes the responsible person's name and address in the EU, the nominal content, any warnings and use-by or period-after-opening information, and an ingredient list in the international naming convention.