Free tool
Cosmetics Regulatory Requirements Checker
Selling Korean OEM cosmetics in the US, EU, UK, or the Gulf? Pick your product and target markets to see exactly what compliance each market requires — and, crucially, whether your Korean manufacturer or you (the brand) handles each step.
United States
FDA / MoCRASince MoCRA (2022), the US requires facility registration, product listing, and a US Responsible Person. Roughly 70% of the work sits with your Korean OEM, 30% with you as the brand of record.
FDA facility registrationOEM
Your Korean OEM factory registers with the FDA and receives an Establishment Registration Number. Export-ready factories are already registered — ask for the number.
ISO 22716 / cGMP manufacturingOEM
Your OEM manufactures under ISO 22716 and Korean CGMP, which meet or exceed the forthcoming MoCRA GMP rules.
Safety test dataOEM
Your OEM provides stability, microbial (challenge), and any patch-test data that backs your product's safety.
Product listing (FDA Cosmetics Direct)You
You list each product through the free FDA Cosmetics Direct portal, using the INCI list and facility number your OEM provides.
US Responsible Person on the labelYou
A US-based Responsible Person — your US entity, a distributor, or a paid RP service — must be named with a US address on the label. Korean OEMs generally won't act as RP.
Safety substantiation records (6 years)You
Keep the safety records on file for 6 years after the last sale. Your OEM supplies the test data; you retain and can produce the file on FDA inquiry.
Adverse event reporting systemYou
Maintain a process to report serious adverse events to the FDA within 15 business days (e.g. a monitored support inbox with escalation).
Compliant labelingYou
Final label must show the Responsible Person's US address, INCI in descending order, and net weight. Your OEM provides a compliant base; you verify artwork before launch.
European Union
EU Regulation 1223/2009 (CPNP)The strictest framework of any major market. Pre-market CPNP notification, an EU-based Responsible Person, a PIF dossier, and a CPSR by a qualified assessor are all required before sale.
Annex compliance (formulation)OEM
Formulation must comply with EU Annexes — restricted preservatives, permitted UV filters and colorants, acid limits. Export-ready Korean OEMs run a pre-export Annex review.
ISO 22716 / cGMP + technical dataOEM
Your OEM provides the ISO 22716 GMP certificate plus the formulation, INCI list, stability, microbial, toxicological, and allergen-content data the dossier needs.
EU-based Responsible Person on the labelYou
An EU/EEA-based Responsible Person — a subsidiary, distributor, or RP service — must be named with an EU address on every label. Your Korean OEM cannot serve as RP.
CPNP notification (pre-market)You
Notify each product through the CPNP portal before it goes on sale. The portal is free; your OEM supplies the frame formulation and tox data, the RP submits.
Product Information File (PIF, 10 years)You
The Responsible Person assembles and maintains a PIF for 10 years after the last batch. Your OEM provides most of the technical content.
Cosmetic Product Safety Report (CPSR)You
A qualified EU safety assessor must produce the CPSR. Your OEM provides input data; the assessor writes the report (commonly via an RP service).
Compliant multilingual labelingYou
Label needs the RP address, the PAO 'open jar' symbol, declarations for the 26 fragrance allergens, and country-language translations. OEM provides a compliant base; the RP verifies.
United Kingdom
UK Cosmetics Regulation (SCPN)Post-Brexit, the UK mirrors EU 1223/2009 but is administered separately. If you sell in both the EU and UK you need both notifications and both a UK and EU Responsible Person.
UK Cosmetics Regulation compliance (formulation)OEM
Formulation must meet UK Cosmetics Regulation restrictions, which are functionally aligned with the EU Annexes. Export-ready Korean OEMs handle this in the same review.
ISO 22716 / cGMP + technical dataOEM
Same technical package as the EU: GMP certificate, formulation, INCI, stability, microbial, toxicological, and allergen data from your OEM.
UK-based Responsible Person on the labelYou
A UK-based Responsible Person with a UK address is required, separate from any EU RP. Your Korean OEM cannot serve as RP.
SCPN notification (pre-market)You
Notify each product through the UK SCPN portal before sale — a separate submission from the EU's CPNP.
Product Information File (PIF)You
The UK Responsible Person maintains a PIF available for inspection, the same as the EU requirement.
Safety assessment (CPSR equivalent)You
A qualified assessor must produce a safety report. Your OEM provides input data; the assessor writes it.
Compliant labelingYou
Label needs the UK RP address, PAO symbol, and allergen declarations. OEM provides a compliant base; the RP verifies artwork.
Middle East (Gulf)
GCC standard · UAE & Saudi SFDAThe Gulf states run national registration systems built on a shared GCC technical standard. The largest markets are the UAE and Saudi Arabia. Each requires product registration, a locally registered importer or representative, and Arabic labeling.
GCC-compliant formulation & GMPOEM
Your Korean OEM manufactures to ISO 22716 and formulates within the GCC cosmetics technical standard's restricted-substance limits (broadly aligned with EU rules).
Conformity & test documentationOEM
Your OEM provides the product specification, safety and test data, GMP certificate, and any certificates needed for conformity assessment and customs.
Halal certification (often expected)OEM
Halal certification isn't always legally mandatory but is commercially important across the region and sometimes required by retailers. Korean OEMs can produce halal-certified lines on request.
Local importer / authorized representativeYou
Each market needs a locally registered importer or authorized representative to hold the product registration — for example in the UAE and Saudi Arabia.
Product registration / notificationYou
Register each product with the national authority before sale — such as the relevant UAE registration system and Saudi Arabia's SFDA cosmetic notification.
Arabic labelingYou
Labels must include Arabic (typically alongside English): product name, ingredients, country of origin ('Made in Korea'), net content, batch code, and shelf life / PAO.
Import & shelf-life documentationYou
Registration and customs require production/expiry dates and supporting documents (certificate of origin, and a certificate of free sale where requested).
This is planning guidance, not legal advice. Cosmetic regulations change and depend on your exact formulation, claims, and channels. Confirm requirements with a qualified regulatory consultant for each market before you import or sell. Where a step is the manufacturer's, we match you with Korean OEMs who already handle it.
Frequently asked questions
Do I need to register with the FDA to sell Korean cosmetics in the US?
Your Korean OEM factory registers its facility with the FDA. You, as the brand of record, list each product through the free FDA Cosmetics Direct portal and designate a US-based Responsible Person on the label. Sunscreens are the exception — they're regulated as OTC drugs with stricter rules.
Can my Korean manufacturer act as my Responsible Person?
Almost never. The Responsible Person must be based in the market you sell into — the US for FDA, the EU/EEA for the EU, and the UK for the UK. Korean OEMs generally decline the role because the legal liability sits with the Responsible Person. Most international brands use a third-party RP service.
Is selling Korean sunscreen different from other skincare?
Yes. In the US, sunscreen is regulated as an OTC drug, not a cosmetic, so it needs FDA-approved UV filters, a Drug Facts panel, and an NDC number. In the EU and UK, sunscreen UV filters must appear on the permitted list. Select 'Sunscreen' above to see the specifics.
Do I need separate registrations for the EU and the UK?
Yes, since Brexit. The EU uses CPNP notification with an EU-based Responsible Person; the UK uses the SCPN portal with a UK-based Responsible Person. If you sell in both, you need both notifications and both Responsible Persons.
Can I sell Korean cosmetics in the Middle East / Gulf?
Yes. The Gulf states run national registration systems on a shared GCC technical standard. In practice you register each product with the national authority (for example in the UAE and via Saudi Arabia's SFDA), appoint a locally registered importer or representative, and provide Arabic labeling. Halal certification is often commercially expected. Confirm the current requirements per country before importing.