Korean Manufacturer EU Compliance Audit · 2026

Korean Manufacturer EU Compliance

Due diligence checklist for vetting Korean OEM partners supplying formulations for the EU market. Covers ISO 22716 GMP, EU Cosmetics Regulation (EC) No 1223/2009 compliance, CPNP requirements, PPWR packaging, and the complete handover documentation package.

Responsible party: Formula Mfr Packaging Mfr EU Resp. Person All Parties
01 Manufacturing Credentials Formula Mfr Facility audit · GMP
ISO 22716 (Good Manufacturing Practices for Cosmetics) certification current and dated within 3 years
This is the international GMP standard for cosmetic manufacturing — required for EU PIF credibility
KFDA (Korea Ministry of Food and Drug Safety) manufacturing licence — valid and in good standing
EU export experience confirmed — manufacturer has supplied EU-market products before
Quality management system documented — batch records, QC protocols, deviation handling
Dedicated R&D team with EU Cosmetics Regulation expertise or documented EU regulatory consultant relationship
Clean room classification documented for relevant production areas
02 Formula Compliance Formula Mfr EU Cosmetics Reg (EC) No 1223/2009
Full INCI list with exact concentrations (%) for all ingredients — proprietary blends must declare total %; full breakdown available for regulatory review on request
All ingredients cross-checked against Annex II (~1,730 prohibited substances) — written confirmation of zero hits required
Salicylic acid (Annex III): leave-on max 0.5% / rinse-off max 2.0%; pH ≥ 3.5 required; not for children under 3 (except shampoo)
Retinol / retinyl acetate / retinyl palmitate (Annex III): face max 0.3% RE, body max 0.05% RE — mandatory Vitamin A warning label required on all product formats
Alpha-arbutin (if present): face cream max 2%, body lotion max 0.5% — hydroquinone impurity levels controlled and documented
Kojic acid (if present): max 1% — face and hand products only per Annex III
All other Annex III restricted ingredients verified within permitted limits for intended product category
Colorants — Annex IV listed substances only
Preservatives — Annex V listed only, at or below maximum concentration. Methylisothiazolinone (MI) banned in leave-on; max 0.0015% rinse-off. Isobutyl-, isopropyl-, phenyl-, benzyl-, pentylparaben prohibited in all product types
UV filters — Annex VI listed only. Homosalate max 7.34% face (endocrine concern). Octocrylene max 10%. All UV filter concentrations at or below permitted limits
Nanomaterials: absent — or if present, INCI includes [nano]; handled via Article 13 CPNP notification (Annex VI nano UV filters do not require separate Article 16 pre-notification); PIF/CPSR include particle size, coating, purity, and exposure data
Fragrance allergens reviewed per Regulation (EU) 2023/1545 — 82 substances from 1 August 2026 (expanded from 26). Mandatory labelling: leave-on >0.0001% (1 ppm), rinse-off >0.001% (10 ppm)
Expanded 82-allergen list takes effect 1 August 2026 — all formulas being developed or updated for EU market after this date must screen against the full list
REACH compliance confirmed — SVHC content below 0.1% (w/w) in all raw materials. Written SVHC declarations obtained from every ingredient supplier
COSING database cross-checked for every ingredient — EU's official status database; Korean MFDS approval does not equal EU permitted status
COSING: ec.europa.eu/growth/tools-databases/cosing — use this to verify EU permitted status and concentration limits, not the Korean MFDS database
CMR substances screened per CLP Reg. (EC) 1272/2008 — Category 1A/1B prohibited under Art. 15; Category 2 requires documented safety justification
Most common compliance gap: many MFDS-approved ingredients are CMR-classified under EU CLP. Cross-check every active, solvent, and fragrance component against the EU C&L Inventory
Microplastics confirmed absent per EU Reg. 2023/2055 — no solid synthetic polymer particles <5mm; rinse-off restriction from Oct 2023, leave-on from 2035
03 Required Testing Formula Mfr Per SKU before EU market entry
ISO 11930 preservative efficacy challenge test — passing result for each formulation
Accelerated stability study (minimum 12 weeks at 40°C/75% RH) completed per formulation
Real-time stability study initiated or on file (required for PIF completeness)
Microbiological quality testing (ISO 17516 or equivalent) — total viable count within limits
Patch test or repeated insult patch test (RIPT) data available or in-use data documented
No animal testing conducted on finished product or ingredients destined for EU market post-2013
EU Regulation 1223/2009 Article 18: full animal testing ban. Manufacturer must provide written confirmation
04 EU Market Entry Requirements EU Resp. Person Responsible Person · CPNP
EU Responsible Person (RP) designated for each product — must be EU-based legal entity
Korean manufacturer cannot self-register on CPNP — an EU RP is mandatory for every product placed on the EU market
RP identity confirmed in writing — name, address, EU registration number
CPNP notification submitted and notification number obtained before any product ships to EU
CPNP notification covers specific product as supplied (not just base formulation)
Custom label variants — including SOSOO-branded or property-branded versions — require separate CPNP notifications
Cosmetic Product Safety Report (CPSR) — Part A (safety profile) completed by manufacturer
CPSR Part B (safety assessment) completed and signed by EU-qualified Cosmetic Safety Assessor

The CPSR safety assessor must hold a pharmacy, medicine, toxicology, or equivalent degree recognised in the EU. A Korean-qualified assessor is not sufficient for EU CPSR Part B sign-off. Budget for EU assessor engagement per SKU: typically €800–€1,500.

05 Labelling & Claims Formula Mfr Packaging Mfr EU Cosmetics Reg Annex I · language rules
INCI ingredient list in full — descending order of concentration — on all packaging
Net weight or volume stated in metric units (g or ml)
Date of minimum durability shown as "Best before end…" — OR PAO (period after opening) symbol for products stable 30+ months
Batch reference number on packaging — traceable to manufacturing records
Country of origin stated: "Made in Korea" or "Fabriqué en Corée" etc. as required by destination market
Responsible Person name and EU address on packaging
All mandatory label text in official language(s) of EU destination country
Performance and efficacy claims substantiated — supporting data available in PIF
Claims such as "clinically proven," "dermatologist tested," or "barrier-repairing" require documented evidence
06 Packaging — PPWR Packaging Mfr Regulation (EU) 2025/40 · Aug 2026
Primary packaging material confirmed recyclable by design OR has a documented recycling pathway in EU waste infrastructure Aug 2026
No SVHC (Substances of Very High Concern) present in packaging material above PPWR threshold
Recycling information label present on packaging (where applicable per PPWR labelling requirements)
No single-use plastic format in hotel miniature size range planned for post-2030 supply Jan 2030
07 Handover Documentation Package All Parties Per SKU · required before production sign-off
Formula Full INCI with % concentrations, phase structure, processing notes
Safety CPSR Part A + B, signed by EU-qualified assessor
Stability 12-week accelerated study results + real-time initiation date
Microbiology ISO 11930 challenge test + ISO 17516 total count results
Regulatory CPNP notification number, RP declaration, Annex compliance summary
Manufacturing ISO 22716 certificate, batch record template, QC spec sheet
Declarations Annex II–VI compliance declarations + written SVHC statements from all raw material suppliers
Allergens Fragrance allergen analysis — 82 substances (Reg. (EU) 2023/1545); concentration data per identified allergen