How to sell Korean cosmetics in the EU: CPNP, Responsible Person and labels

Korean skincare sells well in Europe, but a product that is legal in Korea is not automatically legal in the EU. Before the first unit reaches a European shelf, someone in the EU has to take legal responsibility for it, its safety has to be documented, it has to be notified to the European Commission and the label has to follow EU rules. This guide walks through those steps in the order a brand usually meets them.

It is a practical overview, not legal advice. The legal text is Regulation (EC) No 1223/2009 on cosmetic products; the sources are listed at the end.

The legal basis: one regulation for all EU countries

Cosmetic products in the EU are governed by Regulation (EC) No 1223/2009, usually called the Cosmetics Regulation. As a regulation, it applies directly in all 27 Member States, so the core requirements are the same in Germany, France or Poland. Article 3 sets the basic rule: a cosmetic product must be safe for human health when used under normal or reasonably foreseeable conditions.

Everything else in this guide follows from that regulation and the documents built on it.

Step 1: a Responsible Person in the EU

Under Article 4, a cosmetic product may only be placed on the EU market if a legal or natural person established in the EU is designated as its Responsible Person (RP). A Korean manufacturer cannot be the Responsible Person itself, because it is not established in the EU.

Who can be the Responsible Person

For an imported product, the importer is the Responsible Person for that product. The importer may designate another person established in the EU by written mandate, who must accept the role in writing. A distributor becomes the Responsible Person when it places a product on the market under its own name or trademark, or modifies a product in a way that may affect compliance.

What the Responsible Person is responsible for

The Responsible Person ensures that the product meets the obligations of the regulation (Article 5), in particular:

• the safety assessment and the product information file,
• good manufacturing practice,
• the notification in the CPNP,
• the labelling and the claims,
• reporting serious undesirable effects to the authorities.

The name and address of the Responsible Person must appear on the label. For a brand, choosing the Responsible Person is therefore one of the first decisions for Europe.

Step 2: safety report and product information file

Before a product is placed on the market, its safety has to be assessed (Article 10). The result is the cosmetic product safety report, structured as set out in Annex I of the regulation: part A collects the safety information (formula, physical and chemical properties, stability, microbiological quality, impurities, packaging, normal use, exposure), part B contains the assessment and its conclusion. The assessment must be carried out by a qualified person with a diploma in pharmacy, toxicology, medicine or a similar discipline.

The safety report is part of the product information file (PIF, Article 11). The PIF also describes the product, the method of manufacture with a statement on good manufacturing practice (Article 8) and the proof of any claimed effect. The Responsible Person keeps it for ten years after the last batch was placed on the market, at the address on the label, in a language the authorities of that Member State can easily understand.

Korean brands often already have test data and formula documents. In practice, these are the basis for the EU safety report, but they do not replace it.

Step 3: notification in the CPNP

Before a product is placed on the market, the Responsible Person notifies it through the Cosmetic Products Notification Portal (CPNP), the European Commission’s online system (Article 13). One notification covers all Member States. It includes, among other things:

• the category and the name of the product,
• the name and address of the Responsible Person, where the product information file is available,
• the country of origin for imported products,
• the Member State where the product is first placed on the market,
• the presence of nanomaterials and of substances classified as CMR,
• the frame formulation,
• the original label and, where reasonably legible, a photograph of the packaging.

Nanomaterials that are not covered by the annexes have to be notified separately six months before the product is placed on the market (Article 16).

Step 4: labels for the EU market

Article 19 lists what the container and packaging must show, in indelible, easily legible and visible lettering:

1. the name or registered name and the address of the Responsible Person,
2. the country of origin for imported products,
3. the nominal content by weight or volume,
4. the date of minimum durability (“best used before the end of”), or, for products that keep for more than 30 months, the period after opening (the open-jar symbol),
5. particular precautions for use,
6. the batch number or a reference that identifies the product,
7. the function of the product, unless it is clear from its presentation,
8. the list of ingredients, headed “ingredients”, using the common ingredient names (INCI).

Language

Article 19(5) leaves the language of some of this information to the Member State where the product is sold to the end user: nominal content, durability, precautions and the function of the product. In practice, a product sold in Germany needs this information in German, in France in French. The ingredient list uses the same INCI names everywhere; the European Commission’s CosIng database lists them.

A Korean-language label with a sticker is a common solution, as long as all mandatory information is complete, legible and correct.

Fragrance allergens

The EU has extended the list of fragrance allergens that have to be named individually on the label, with transition periods. The European Commission’s page on fragrance allergens labelling gives the current dates.

Step 5: ingredients and claims

Ingredients

The annexes of the regulation decide which substances may be used:

• Annex II lists prohibited substances,
• Annex III lists substances that are allowed only with restrictions,
• Annexes IV, V and VI are positive lists: colourants, preservatives and UV filters may only be used if they are listed there.

Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) are prohibited, with narrow exceptions (Article 15). This is where Korean formulas most often need changes, for example sunscreens whose UV filters are not listed in Annex VI.

Claims

Article 20 forbids labelling and advertising that implies characteristics or functions a product does not have. Commission Regulation (EU) No 655/2013 sets six common criteria for claims: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Every claim on the pack, in the online shop and in retail material needs evidence in the product information file. A cosmetic product must not claim to treat or prevent disease.

Selling in the UK as well

Great Britain applies its own version of the regulation since leaving the EU. According to the UK government’s guidance, a product made available in Great Britain needs a Responsible Person with a UK-established address and must be notified to the Office for Product Safety and Standards through the Submit cosmetic product notifications service before it is sold. For Northern Ireland, the Responsible Person must be established in Northern Ireland or the EU.

Checklist for Korean brands

• Who is our Responsible Person in the EU, and in the UK if we sell there?
• Is there an EU safety report (Annex I) by a qualified safety assessor for every product?
• Is the product information file complete and kept at the Responsible Person’s address?
• Is every product notified in the CPNP before it is sold?
• Do all ingredients comply with Annexes II to VI, especially UV filters, preservatives and colourants?
• Does every label show the Responsible Person, origin, content, durability, precautions, batch, function and INCI list, with the language-dependent parts in the language of each country?
• Can every claim be proven?

How we work with Korean brands

The Incredible Company is a B2B distributor for Korean beauty brands, based in Germany, with its own logistics centre. We bring Korean skincare and cosmetics to retailers in the EU and the UK and check each product for the points above before it enters our range. If you are a Korean brand preparing for Europe, see how a partnership with TIC starts.