The EU Responsible Person: Who Signs Off and What They Carry

Every cosmetic product placed on the EU market must have a responsible person established within the Union. The responsible person is the legal entity accountable for compliance: they hold the product information file, they answer to the authority, and their name and address appear on the label.

1. Who can be the responsible person

A manufacturer established in the EU, an importer established in the EU, or a brand that is established in the EU. A brand outside the EU cannot be the responsible person and must appoint one. An authorised representative or a fulfilment service provider can take the role if they are established in the Union and accept it in writing.

2. What they hold

The product information file: the description, the CPSR, the manufacturing statement, the proof of claims, the animal testing statement and the labelling artwork. The file must be available to the authority on request and must be kept for ten years after the last unit is placed on the market.

3. The CPSR

The cosmetic product safety report is written by a qualified safety assessor and covers the formula, the exposure, the toxicological data and the conclusion. Without a CPSR the product cannot be placed on the market, whatever its origin or price.

4. Labelling

The responsible person’s name and address must appear on the label, along with the nominal content, the batch code, the ingredient list, the PAO or the minimum durability date, and any warnings. A product sold in the EU without these elements is non-compliant even if everything else is correct.

5. Notification

Products must be notified through the EU cosmetic products notification portal before they are placed on the market. The notification is made by the responsible person and includes the product name, the category, the INCI list and the responsible person’s details.

6. Importer obligations

An importer that brings a product from outside the EU becomes responsible for compliance unless a responsible person is already appointed. Many small importers do not realise this, which is why imported products are a common source of non-compliance findings.

7. Serious undesirable effects

The responsible person must report serious undesirable effects to the authority and maintain a record of the reports. This obligation is separate from the distributor’s obligation to pass complaints up the chain.

8. Withdrawal and recall

If a product is non-compliant, the responsible person must withdraw or recall it and inform the authority. The obligation is on the legal entity, not on the brand team, which is why the identity of the responsible person matters in a crisis.

9. Cost and contracts

A responsible person service typically charges an annual retainer plus a per-product fee, and it may require the brand to hold insurance. The contract should state who writes the CPSR, who maintains the file and who responds to an authority enquiry within the deadline.

10. UK and other markets

The UK has its own responsible person requirement post-Brexit, and other markets have analogous roles under different names. A brand selling into several markets needs a responsible person per jurisdiction, and the product information file has to be available in each.

11. Where it fits

Compliance planning runs across the face care range; the safety file detail continues in the CPSR entry.