Europe
Manufacturing in Korea for the European Union
The EU has the most prescriptive cosmetic framework of the markets on this site, and also the most predictable. Everything is written down: which ingredients are permitted, at what levels, in which product types. A formula developed against the annexes from the start rarely runs into trouble.
The framework
- Regulator
- European Commission and national competent authorities
- Governing law
- Regulation (EC) No 1223/2009
- Before you can sell
- CPNP notification and a completed Product Information File before placing on the market.
- Must be established locally
- A Responsible Person established in the EU.
- Sunscreen is
- Regulated as a cosmetic, with UV filters restricted to Annex VI.
From formula to first shipment.
- 01
Check the formula against the annexes
Annex II lists prohibited substances, Annex III restricted ones with their conditions, and Annexes IV to VI the permitted colourants, preservatives and UV filters. This check belongs at the start of formulation, not at the end — a substitution after stability testing means repeating it.
- 02
Appoint an EU Responsible Person
Every product placed on the EU market needs a Responsible Person established within the EU, named on the label. This can be the importer, the distributor or a contracted service provider, and the role carries real legal obligations.
- 03
Compile the Product Information File
The PIF holds the product description, the safety report, manufacturing method and GMP statement, evidence for the claimed effects, and animal testing data where relevant. It is kept accessible to authorities for a defined period after the last batch.
- 04
Commission the safety assessment
A Cosmetic Product Safety Report must be prepared by an appropriately qualified safety assessor. This is not a formality and it is the step that most often reveals a formulation problem late.
- 05
Notify through CPNP
Notification is made through the Cosmetic Products Notification Portal before the product is placed on the market, and covers the formulation frame, labelling and responsible person details.
- 06
Prepare compliant labelling
INCI ingredient list, nominal content, batch number, durability or period-after-opening, function, warnings and the Responsible Person address — in the languages required by each member state where you sell.
What catches brands out here.
UV filters are restricted to Annex VI
The EU permits several modern UV filters that the US does not, and Korea permits some that the EU does not. A Korean sunscreen is closer to EU-compatible than to US-compatible, but the filter system still has to be checked filter by filter against Annex VI before anything else is decided.
No animal testing, including for ingredients
The testing and marketing bans apply to finished products and to ingredients. A raw material with animal test data generated for cosmetic purposes is a problem regardless of where the testing happened.
Products of human origin are prohibited
Annex II prohibits cells, tissues and products of human origin. This rules out human stem cell-derived exosomes and human cell conditioned media in EU cosmetics, even where they are permitted in Korea under its own safety standard.
Fragrance allergen labelling is expanding
The list of fragrance allergens requiring individual declaration has been extended, with transition periods. Artwork planned against the older list will need revision, so confirm the current requirement before printing.
Claims must satisfy the common criteria
Claims need evidential support and must not imply a medicinal effect. Botanical heritage is not, by itself, evidence for a claim about the finished product.
We document. Your local entity registers.
- Full quantitative formula and raw material specifications
- Manufacturing method description and GMP statement
- Stability, challenge and compatibility test reports
- Certificates of analysis by batch
- Allergen, CMR and nanomaterial statements
- Non-animal-testing declarations
- The EU Responsible Person
- The Cosmetic Product Safety Report and qualified safety assessor
- CPNP notification
- Per-member-state language labelling
- Claim substantiation for marketing copy
Manufacturing through contracted Korean partners, matched to your product — every order made in Korea. Certifications depend on the selected manufacturing partner and project requirements.
Why this market
Europe is one of the largest destinations for Korean cosmetics, with the strongest growth in Central and Eastern Europe rather than in the traditional Western markets.
EU distribution is fragmented by language and channel, which favours brands that pick two or three member states rather than treating the bloc as one launch.
The regulatory work is front-loaded but transferable: a compliant PIF and safety report support sale across all member states, which is why the EU is often the cheapest second market to add.
Selling in European Union
Do we need an EU Responsible Person if we only sell online?
Yes. Placing a product on the EU market through any channel, including direct e-commerce into the EU, triggers the requirement. The Responsible Person must be established in the EU and be named on the label.
Can a Korean manufacturer act as our EU Responsible Person?
No. The Responsible Person must be established within the EU. It is usually the importer, the distributor or a specialist service provider. We supply the manufacturing documentation the Responsible Person needs for the Product Information File.
Can we sell a Korean sunscreen in the EU?
Often yes, and more easily than in the US, because sunscreen is a cosmetic in the EU. But every UV filter has to appear on Annex VI at a permitted concentration for the intended use. Check the filter system before anything else — it is the constraint that most often forces a reformulation.
How long does EU market entry take?
The variable is the safety assessment and any reformulation it triggers, not the notification itself, which is quick once the file is complete. Brands that check the formula against the annexes during development rather than after usually avoid the longest delay in the process.
Sources
- Regulation (EC) No 1223/2009 on cosmetic products — EUR-Lex, European Union
- CosIng — Cosmetic Ingredient Database — European Commission
- CosIng — Annex VI: List of UV Filters Allowed in Cosmetic Products — European Commission
- CosIng — Annex II: List of Substances Prohibited in Cosmetic Products — European Commission
Requirements differ by market and by product, and they keep changing. Cross-check the current position as your project moves, and confirm it with a qualified regulatory consultant in European Union before committing to a formula or a launch date. We review these pages against the sources above as the rules move.
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What’s Next in Beauty.
Tell us you are selling into European Union at the brief stage rather than after. It changes the formula, not just the label.
Start Your Project →This page is general information for manufacturing planning. It is not legal or regulatory advice, it has no legal effect, and no rights can be derived from it. Requirements change by market and over time — before acting on anything here, confirm the current position with the authority concerned or with qualified counsel.