---
title: "We want to sell a cosmetic product in the EU"
description: "Under Regulation (EC) No 1223/2009, a cosmetic product may only be placed on the EU market if a responsible person established in the EU is designated for it. Before launch, that person ensures a safety assessment by a qualified assessor, keeps a product information file, checks the ingredients against the regulation's annexes and notifies the product to the Commission electronically."
type: "problem"
url: "https://www.conphora.com/solutions/problem/cosmetic-product-launch/"
markdown: "https://www.conphora.com/solutions/problem/cosmetic-product-launch.md"
locale: "en"
language: "en"
updated: "2026-10-04"
author: "Conphora compliance team"
publisher: "Conphora"
source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"
tags: ["CosR", "placing-on-market"]
license: "Free to quote with attribution and a link to the page"
---

# We want to sell a cosmetic product in the EU

Under Regulation (EC) No 1223/2009, a cosmetic product may only be placed on the EU market if a responsible person established in the EU is designated for it. Before launch, that person ensures a safety assessment by a qualified assessor, keeps a product information file, checks the ingredients against the regulation's annexes and notifies the product to the Commission electronically.

## Why this happens

The Cosmetics Regulation, Regulation (EC) No 1223/2009, applies from 11 July 2013 (Article 40) and covers any cosmetic product made available on the market (Article 1). A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours (Article 2(1)(a)). A substance or mixture intended to be ingested, inhaled, injected or implanted is not a cosmetic (Article 2(2)), and the Medical Devices Regulation in turn does not apply to products covered by the Cosmetics Regulation (Regulation (EU) 2017/745 Article 1(6)(e)). [1] [2]

The regulation is built around one person. Only cosmetic products for which a legal or natural person is designated within the EU as responsible person may be placed on the market (Article 4(1)). For a product made in the EU, the EU manufacturer is that person; for an imported product, each importer is responsible for the products it places on the market; either can designate another EU person by written mandate accepted in writing (Article 4(3)–(5)). A distributor becomes the responsible person if it markets the product under its own name or modifies it in a way that may affect compliance, but translating the information is not such a modification (Article 4(6)). [1]

The responsible person ensures the duties that must be met before launch (Article 5(1)). The product must be safe for human health under normal or reasonably foreseeable use (Article 3). It undergoes a safety assessment, and a cosmetic product safety report is set up in accordance with Annex I, by a person with a qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10(1)–(2)). Manufacture complies with good manufacturing practice, presumed when harmonised standards are followed (Article 8). A product information file is kept for ten years after the last batch is placed on the market and made readily accessible at the address on the label (Article 11). [1]

The formulation is checked against the annexes. Cosmetics must not contain the prohibited substances of Annex II or restricted substances used outside the conditions of Annex III, and colorants, preservatives and UV filters must be listed in Annexes IV to VI and used within their conditions (Article 14). Substances classified as CMR are prohibited unless the narrow exceptions apply (Article 15), and products containing nanomaterials are notified six months before being placed on the market, subject to exceptions (Article 16(3)). Article 18(1) prohibits animal testing in the EU to meet the regulation and the placing on the market of products whose final formulation or ingredients were tested on animals for that purpose; Article 18(2) limited the period for implementing those bans to 11 March 2009, and to 11 March 2013 for tests on repeated-dose toxicity, reproductive toxicity and toxicokinetics. The Court of Justice has held that the marketing ban can cover ingredients tested on animals outside the EU to sell in third countries, if the data are used to prove safety for the EU market (C-592/14). [1] [3]

Before launch, the responsible person notifies the Commission electronically of the product category and name, its own name and address, the country of origin for imports, the Member State where the product is placed on the market, a contact person, nanomaterials, CMR substances and the frame formulation (Article 13(1)), and, once the product is placed on the market, the original labelling (Article 13(2)). The label must carry the information of Article 19, and claims must not imply characteristics the product does not have (Article 20(1)). The Commission has proposed amendments to the regulation (COM(2025) 531); that is a proposal, not law. [1]

## How to solve it

1. **Confirm the product is a cosmetic** A cosmetic is a substance or mixture placed in contact with the external parts of the body, the teeth or the mucous membranes of the mouth, mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours. Products meant to be ingested, inhaled, injected or implanted are not cosmetics.
2. **Designate the responsible person** For an EU-made product the EU manufacturer is the responsible person; for an imported product, each importer is. Either may designate another person established in the EU by written mandate, accepted in writing. A manufacturer outside the EU must designate one for products made in the EU.
3. **Check the formulation against the annexes** Screen every ingredient against the prohibited substances of Annex II, the restrictions of Annex III and the positive lists for colorants, preservatives and UV filters in Annexes IV to VI. Check CMR classifications, and notify nanomaterials six months before placing on the market unless an exception applies.
4. **Have the safety assessment done and the report set up** Before launch, a person with a diploma in pharmacy, toxicology, medicine or a similar discipline carries out the safety assessment, and a cosmetic product safety report is set up in line with Annex I. It takes the intended use and the systemic exposure to each ingredient into account and is kept up to date.
5. **Build the product information file and follow good manufacturing practice** The file holds a product description, the safety report, the manufacturing method with a statement on good manufacturing practice, proof of claimed effects where justified, and data on any animal testing. Make it readily accessible at the address on the label.
6. **Notify the product and label it before launch** Submit the notification electronically to the Commission before placing the product on the market: category and name, responsible person, country of origin for imports, the Member State of launch, a contact person, nanomaterials, CMR substances and the frame formulation. When it is placed on the market, notify the original labelling and, where reasonably legible, a photograph of the packaging. Label it as Article 19 requires.

## What you need to show

- **The written mandate and acceptance where the responsible person is not the manufacturer or importer** — The manufacturer or importer and the designated person (Regulation (EC) No 1223/2009 Article 4(3)–(5))
- **The cosmetic product safety report** — The responsible person, with a qualified safety assessor (Regulation (EC) No 1223/2009 Article 10 and Annex I)
- **The product information file** — The responsible person (Regulation (EC) No 1223/2009 Article 11)
- **The electronic notification to the Commission** — The responsible person (Regulation (EC) No 1223/2009 Article 13(1)–(2))

## If you do nothing

- **No responsible person, no market access** — Only cosmetic products for which a person is designated within the EU as responsible person may be placed on the market (Regulation (EC) No 1223/2009 Article 4(1)).
- **Distributors hold back non-conforming products** — A distributor that considers or has reason to believe a cosmetic is not in conformity must not make it available until it has been brought into conformity, and must inform the responsible person and authorities where it presents a risk to human health (Regulation (EC) No 1223/2009 Article 6(3)).
- **Serious undesirable effects must be reported** — The responsible person and distributors notify serious undesirable effects without delay to the competent authority of the Member State where they occurred, with the product name and any corrective measures taken (Regulation (EC) No 1223/2009 Article 23(1)).
- **Claims must match the product** — Text, names, trade marks, pictures and other signs may not be used to imply characteristics or functions the product does not have, in labelling, making available or advertising (Regulation (EC) No 1223/2009 Article 20(1)).

## Questions

### Can a non-EU brand be the responsible person?

No. The responsible person is a legal or natural person designated within the EU (Regulation (EC) No 1223/2009 Article 4(1)). A non-EU manufacturer designates an EU person by written mandate, or the importer is the responsible person for the products it places on the market (Article 4(4) and (5)).

### Who may carry out the safety assessment?

A person with a diploma or other evidence of formal qualifications from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent (Regulation (EC) No 1223/2009 Article 10(2)). Each Member State may determine which disciplines are similar and which qualification levels suffice (Court of Justice, C-13/17).

### Do we notify every country separately?

The responsible person submits one electronic notification to the Commission before placing on the market, naming the Member State of launch (Article 13(1)). A distributor that, on its own initiative, translates labelling to sell in another Member State submits its own information (Article 13(3)).

### Is a food supplement or an injectable filler a cosmetic?

No. A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body is not a cosmetic product (Regulation (EC) No 1223/2009 Article 2(2)).

### Can our supplier test ingredients on animals?

The regulation prohibits placing on the market cosmetics whose final formulation or ingredients were tested on animals to meet its requirements, and such testing in the EU (Regulation (EC) No 1223/2009 Article 18(1)–(2)). Tests outside the EU for other markets can fall under the ban if the data are used to prove safety for the EU market (Court of Justice, C-592/14).

## Regulations involved

CosR

## Sources

1. [Regulation (EC) No 1223/2009 on cosmetic products (consolidated text of 18 May 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518) — EUR-Lex, 2026-10-04
2. [Regulation (EU) 2017/745 on medical devices (consolidated text of 19 July 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719) — EUR-Lex, 2026-10-04
3. [Judgment of the Court of Justice of 21 September 2016, European Federation for Cosmetic Ingredients, C-592/14](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62014CJ0592) — EUR-Lex, 2026-10-04
4. [Judgment of the Court of Justice of 12 April 2018, Fédération des entreprises de la beauté, C-13/17](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62017CJ0013) — EUR-Lex, 2026-10-04