The core compliance principles for cosmetic ingredients are Prohibited/Restricted Substance List + Safety Assessment + CMR/SVHC Control + Special Regulation for Preservatives/Colorants + GMP Standard + Documentation & Traceability. Global regulations focus on safety risks and ingredient transparency with stricter standards than ordinary food. Detailed explanations are as follows.
Every market implements a clear prohibited and restricted substance list; out-of-scope or over-dose products result in full-batch return, serving as the primary compliance red line.
EU (EC 1223/2009): Over 1,600 prohibited substances (Hydroquinone, Retinoic Acid, heavy metals Lead/Mercury/Arsenic); restricted list specifies concentration ceilings (e.g. Phenoxyethanol preservative ≤1%). Category 1A/1B CMR (Carcinogenic/Mutagenic/Reproductive Toxic) substances are banned. 12 new nano raw materials banned and Homosalate restricted under 2025 new regulations.
US (FDA + MoCRA): Colorants must be on the FDA approved list with batch certification and restricted application areas (certain colorants prohibited for eye use). Preservatives and active substances require GRAS or NDI qualification; 2025 MoCRA mandates raw material filing and safety assessment.
China (CSAR): Over 1,300 prohibited substances specified in Technical Specification for Cosmetic Safety; restricted list refines concentration and application scope. New raw materials require registration/filing; high-risk raw materials (nano, biosynthetic) require mandatory registration.
Japan, South Korea & ASEAN: Independent lists implemented by Japan MHLW and South Korea MFDS with strict limits on preservatives and heavy metals; ASEAN references EU standards with inconsistent enforcement.
Procurement Principle: Require suppliers to provide CAS Number, INCI Name, target market list compliance declaration and concentration limit description; reject unlisted products completely.
Cosmetic ingredients directly contact human skin; toxicological test data is mandatory with incomplete data leading to customs clearance failure.
CMR Screening: EU bans Category 1A/1B CMR substances (Benzene, Formaldehyde releasers); Category 2 substances require strict dosage limits and mandatory labeling.
REACH SVHC: Mandatory disclosure for SVHC content >0.1%; notification required for annual volume >1 ton; common substances include Phthalates and certain siloxanes.
Sensitization / Irritation / Phototoxicity: EU/US require skin irritation, eye irritation, sensitization and phototoxicity test reports. Flavors, preservatives and colorants are high-risk categories requiring negative test results.
Nano Ingredients: EU/US mandate declaration and labeling for nano raw materials (e.g. Nano Titanium Dioxide) with particle size distribution, toxicology and exposure assessment reports required.
Procurement Action: Mandatorily require third-party toxicological reports (SGS/Intertek) covering CMR, sensitization and phototoxicity; reject internal self-inspection reports.
Different types of cosmetic ingredients have unique compliance risks requiring targeted verification.
Preservatives: EU restricts dosage of Phenoxyethanol, Parabens and Formaldehyde releasers with strict concentration ceilings; China prohibits specific Paraben esters; US requires dual efficacy and safety data.
Colorants: US requires FDA approved list, batch certification and application area restrictions (eye-use ban for certain colorants); EU mandates CI number, purity and heavy metal limits; China restricts colorants to the Cosmetic Safety Technical Specification list.
Active Substances (Pro-Xylane, Retinol, etc.): EU requires safety assessment and concentration limits; US classifies Retinol as pharmaceutical-grade with only low concentrations permitted in cosmetics; China registers new active substances as new cosmetic raw materials.
Nano Ingredients: Mandatory declaration for particle size <100nm with dispersion stability and toxicological data required; EU added new banned nano raw materials in 2025.
Cosmetic ingredients worldwide must be produced under cosmetic-grade GMP standards with mandatory raw material filing in some markets.
EU: EU GMP (ISO 22716) required with designated EU Responsible Person (RP) and CPNP product notification.
US: FDA registration + GMP (21 CFR Part 111); MoCRA mandates raw material supplier filing and safety assessment.
China: Cosmetic production license (Cosmetics Grade); new raw materials require registration/filing and must be included in the Inventory of Existing Cosmetic Ingredients.
Japan & South Korea: Japan MHLW certification + GMP; South Korea MFDS GMP + raw material filing.
Procurement Action: Verify and retain stamped copies of supplier ISO 22716 certificate, production license and raw material filing certificate.
Complete documentation and accurate labeling are mandatory for cosmetic ingredients; any missing document causes customs clearance delays.
INCI Name: Global unified naming standard; labels must list all ingredients in descending order of content.
16-section SDS: Specifies composition, purity, impurities, toxicology, storage and transportation; bilingual in English and the destination country's language.
COA: Batch-specific third-party test report specifying purity, impurities, heavy metals, microorganisms and pH value.
CPSR (Cosmetic Product Safety Report): Mandatory in the EU covering ingredient risks, exposure dosage and toxicological conclusions.
Packaging Labeling: Must specify product name, INCI, CAS, purity, batch number, shelf life, storage conditions, manufacturer and signal words; multi-language labeling required.
Excessive impurities are a prevalent issue for cosmetic ingredients with strict global inspection.
Heavy Metals: Lead ≤10ppm, Arsenic ≤2ppm, Mercury ≤1ppm, Cadmium ≤5ppm; stricter limits for infant products.
Microorganisms: Total bacterial count ≤100CFU/g; pathogens (Salmonella, Staphylococcus Aureus) must be undetectable.
Dioxane / Formaldehyde: Surfactants prone to Dioxane excess (≤10ppm); preservatives prone to Formaldehyde release (≤0.1%).
Driven by the EU Green New Deal and US EPA regulations, environmental compliance has become a new market access threshold.
Microplastics: EU bans microplastic particles (exfoliating microbeads).
PFAS (Per- and Polyfluoroalkyl Substances): EU restricts PFAS usage in cosmetics with strengthened inspections starting in 2025.
VOC: EU/US limit volatile organic compound emissions requiring low-VOC raw materials.
For global B-end buyers of cosmetic ingredients, the core compliance logic is List Compliance → Safety Assessment → Special Ingredient Control → GMP Qualification → Complete Documentation → Zero Impurity Tolerance → Environmental Compliance:
List Compliance: Only purchase ingredients on target market prohibited/restricted lists; verify CAS and INCI information;
Safety Assessment: Conduct CMR/SVHC screening, sensitization/phototoxicity testing and nano raw material declaration;
Special Ingredient Control: Follow exclusive red lines for preservatives, colorants, active substances and nano materials;
GMP Qualification: Comply with ISO 22716, cosmetic production license and raw material filing requirements;
Complete Documentation: Prepare full INCI list, SDS, COA, CPSR and multi-language labeling;
Zero Impurity Tolerance: Ensure compliance of heavy metals, microorganisms, dioxane and formaldehyde;
Environmental Compliance: Comply with new regulations on microplastics, PFAS and VOC limits.
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