| name | cosmetics-compliance |
| description | Use when selling cosmetics, skincare, haircare, fragrance, or personal care products in any market, checking cosmetic-specific regulations, preparing CPNP/SCPN notifications, commissioning a CPSR, or navigating ingredient restrictions for beauty products |
Cosmetics Compliance
Full regulatory workflow for cosmetics and personal care products across 8 major markets. From formulation to shelf.
Decision Flow
digraph {
rankdir=TB; node [shape=box style=rounded fontsize=10];
cat [label="1. Confirm product is\na cosmetic (not drug/biocide)"];
markets [label="2. List target markets"];
ingredients [label="3. Run ingredient check\nper market (product-compliance)"];
safety [label="4. Commission safety\nassessment (CPSR / equiv.)"];
gmp [label="5. Verify GMP\n(ISO 22716 or equiv.)"];
label [label="6. Prepare market-specific\nlabels (labeling-compliance)"];
rp [label="7. Appoint Responsible\nPerson per jurisdiction"];
notify [label="8. Notify on portals\n(CPNP, FDA, SCPN, etc.)"];
sell [label="9. Place on market"];
cat -> markets -> ingredients -> safety -> gmp -> label -> rp -> notify -> sell;
}
Market-by-Market Requirements
EU -- Regulation 1223/2009
| Requirement | Detail |
|---|
| Legal basis | Regulation (EC) No 1223/2009 on cosmetic products |
| Safety assessment | Mandatory CPSR (Cosmetic Product Safety Report) by a qualified assessor (pharmacist, toxicologist, or equivalent with 5+ years) |
| Product Information File (PIF) | Must contain: product description, CPSR, manufacturing method, GMP evidence, claimed effects evidence, animal testing data |
| GMP | ISO 22716 compliance mandatory (Art. 8). Audit not required but documentation must exist |
| Notification | CPNP (Cosmetic Products Notification Portal): https://ec.europa.eu/growth/tools-databases/cosing/ -- notify BEFORE placing on market |
| Responsible Person | Must be established in the EU. Holds PIF, ensures compliance, contact for authorities |
| Banned substances | 1,698 substances in Annex II. Restricted substances in Annex III (with concentration limits) |
| Animal testing | Banned for finished products AND ingredients (since 2013) |
| Nanomaterials | Must be notified to CPNP 6 months before placing on market |
| Timeline | 6-12 weeks (CPSR is the bottleneck: 4-8 weeks alone) |
| Cost | EUR 1,500-5,000 per product (CPSR: EUR 800-3,000, PIF assembly: EUR 500-1,500, CPNP notification: free) |
US -- FDA MoCRA (Modernization of Cosmetics Regulation Act 2022)
| Requirement | Detail |
|---|
| Legal basis | FD&C Act as amended by MoCRA (Dec 2022). Phased enforcement. |
| Facility registration | Mandatory. Register on FDA portal. Biennial renewal (Oct 1 - Dec 31, even years). Portal: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products |
| Product listing | Mandatory for each marketed product. Submit within 120 days of marketing, update annually Dec 31 |
| Serious adverse event (SAE) reporting | Mandatory within 15 business days of receipt |
| GMP | Mandatory effective December 29, 2026. FDA finalizing rules aligned with ISO 22716 |
| Safety substantiation | Manufacturer must have adequate substantiation of safety. FDA can request records |
| Fragrance/flavor allergens | Disclosure required (effective 2 years after FDA issues rules -- pending) |
| Banned/restricted | ~30 prohibited substances. No Prop 65 at federal level but California applies statewide |
| PFAS | Several states banning intentionally added PFAS in cosmetics (CA, WA, CO, MD -- effective 2025-2026) |
| Labeling | FD&C Act + Fair Packaging and Labeling Act: ingredient declaration (descending order), net quantity, manufacturer/distributor info |
| Timeline | 4-8 weeks |
| Cost | USD 1,500-4,000 (no registration fee, main cost = safety substantiation + labeling) |
UK -- SCPN (Submit Cosmetic Product Notification)
| Requirement | Detail |
|---|
| Legal basis | The Cosmetics Regulation (retained EU law), UK Product Safety regulations |
| Notification | UK SCPN portal (separate from CPNP): https://www.gov.uk/guidance/submit-cosmetic-product-notification |
| Responsible Person | Must be established in the UK. Separate from EU RP |
| Safety assessment | Equivalent to CPSR. Must be completed before notification |
| GMP | ISO 22716 compliance expected |
| Divergence from EU | UK is slowly diverging: different SVHC assessments, own substance evaluations under UK REACH |
| Timeline | 6-10 weeks |
| Cost | GBP 2,000-6,000 per product |
Japan -- MHLW (Ministry of Health, Labour and Welfare)
| Requirement | Detail |
|---|
| Classification | "Cosmetics" (general, notification only) vs. "Quasi-drugs" (medicated cosmetics with active claims -- pre-approval required) |
| Cosmetics notification | File notification with PMDA. Must use ingredients from the positive list only (Comprehensive Licensing Standards) |
| Quasi-drug approval | Pre-market approval required. Timeline: 6-12 months. Much heavier path |
| Marketing Authorization Holder (MAH) | Must be a Japan-based entity. Foreign companies need a local MAH |
| JCIA standards | Japan Cosmetic Industry Association voluntary standards widely treated as de facto requirements |
| Labeling | Japanese language mandatory. Full ingredient list in Japanese names |
| Timeline | Cosmetics: 6-10 weeks. Quasi-drugs: 6-18 months |
| Cost | JPY 200,000-1,000,000 (cosmetics), JPY 2,000,000-10,000,000 (quasi-drugs) |
Korea -- MFDS (Ministry of Food and Drug Safety)
| Requirement | Detail |
|---|
| Classification | "Cosmetics" (general) vs. "Functional cosmetics" (13 categories: sunscreen, anti-wrinkle, whitening, hair dye, etc. -- require review) |
| General cosmetics | Notification to MFDS. Manufacturer/importer registration required |
| Functional cosmetics | Pre-market review by MFDS. Must submit efficacy data. Timeline: 3-6 months |
| Ingredient restrictions | Positive list for UV filters, preservatives, colorants, hair dyes. Negative list similar to EU |
| CGMP | Recommended (ISO 22716 equivalent). Mandatory for functional cosmetics manufacturers |
| Labeling | Korean language. Full INCI ingredient list. Manufacturing date or expiry date mandatory |
| Timeline | General: 4-8 weeks. Functional: 3-6 months |
| Cost | KRW 3,000,000-15,000,000 (general), KRW 10,000,000-50,000,000 (functional) |
China -- NMPA (National Medical Products Administration)
| Requirement | Detail |
|---|
| Classification | "General cosmetics" (filing) vs. "Special cosmetics" (registration: hair dye, perm, sunscreen, whitening, anti-hair-loss, new ingredients) |
| General cosmetics | File with NMPA. Timeline: 3-5 months |
| Special cosmetics | Full registration with NMPA. Timeline: 12-18+ months |
| New ingredients | Must register with NMPA before use. Safety assessment required. Timeline: 12-24 months |
| Animal testing | Required for most imported products. Exemptions exist for general cosmetics from Good Manufacturing Practice-certified countries (since May 2021, CSAR reform). Must submit ISO 22716 GMP certificate |
| Chinese domestic RP | Mandatory. Called "registrant" or "filer" -- must be a China-registered entity |
| Labeling | Simplified Chinese mandatory. Chinese ingredient names. Production date + shelf life or period-after-opening |
| CSAR 2021 | Cosmetic Supervision and Administration Regulation -- tightened requirements since Jan 2021 |
| Timeline | General: 5-8 months. Special: 14-24 months |
| Cost | CNY 50,000-200,000 (general), CNY 200,000-800,000+ (special) |
Canada -- Health Canada
| Requirement | Detail |
|---|
| Legal basis | Food and Drugs Act, Cosmetic Regulations (C.R.C., c. 869) |
| Notification | Cosmetic Notification Form (CNF). Must be submitted within 10 days of first sale in Canada |
| Hot List | List of Prohibited and Restricted Cosmetic Ingredients. ~600 entries. Updated regularly. Similar to EU Annex II/III but not identical |
| Labeling | Bilingual (English + French). INCI ingredient list. Net quantity in metric |
| Timeline | 3-6 weeks |
| Cost | CAD 1,500-4,000 per product |
ASEAN -- Harmonized Cosmetic Directive
| Requirement | Detail |
|---|
| Legal basis | ASEAN Cosmetic Directive (ACD). Implemented locally by each member state |
| Notification | Country-specific. e.g., Philippines FDA, Malaysia NPRA, Indonesia BPOM, Thailand FDA, Singapore HSA |
| ASEAN Cosmetic Ingredient Annex | Harmonized annexes (modeled on EU): banned substances, restricted substances, UV filters, colorants, preservatives |
| GMP | ASEAN GMP Guidelines for Cosmetic (based on ISO 22716) |
| Labeling | Local language required per country. INCI ingredient list |
| Timeline | 4-12 weeks per country (Indonesia and Thailand are slowest) |
| Cost | USD 2,000-8,000 per country |
Notification Portal Directory
MCP Integration
# Monitor regulatory changes for cosmetics:
mcp__claude_ai_Cleo_Insight__search_signals
query: "cosmetics regulation"
# Track specific regulations:
mcp__claude_ai_Cleo_Insight__list_regulations
# Filter for cosmetics-related regulations
# Check ingredient compliance via Cleo Legal API:
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
product_description: "face moisturizer"
ingredients: ["retinol", "niacinamide", "hyaluronic acid"]
target_markets: ["EU", "US", "UK", "JP", "KR", "CN"]
Power This With the Cleo Legal API
Cosmetics compliance touches CosIng (EU), FDA VCRP, Health Canada Hotlist, NMPA inventory, MHLW positive list, MFDS functional list — 6 ingredient databases minimum. The API queries all of them in one shot.
With the Cleo Legal API at https://legaldata-public.cleolabs.co:
GET /v2/catalog/regulations?vertical=cosmetics&country=EU,US,UK,JP,KR,CN,CA — pull the full regulatory map per market (1223/2009, MoCRA, SCPN, CSAR, Hotlist…) with current article referencesPOST /v2/catalog/match-product — classify a product as cosmetic vs quasi-drug (JP), functional cosmetic (KR), special-use (CN), or OTC drug (US) — the single classification that breaks every downstream step if wrongPOST /v2/compliance/check — batch-check INCI list against CosIng Annex II/III/IV/V, Hot List, MFDS functional list, NMPA Inventory in one composite callPOST /v2/webhooks?topic=cosmetics_substance — subscribe to Annex II updates (the 1,698 banned substances list grows ~30/year — miss one and you have a recall)
Get started:
# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then €349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
--header "Authorization: Bearer ld_live_YOUR_KEY"
Tested ROI: For a brand with 20 SKUs in 6 markets (120 product-market combinations), the API eliminates ~8 hours/month of CosIng/MFDS/NMPA lookups — and catches new restrictions before they become recalls.
Common Mistakes
- Assuming "cosmetic" everywhere: Sunscreen is cosmetic in EU, OTC drug in US, quasi-drug in Japan. Classification determines the entire regulatory path.
- One CPSR for all EU countries: The CPSR is market-wide but labeling must be in local language(s). France requires French, Germany requires German.
- Ignoring China animal testing: Despite 2021 reforms, most imported special cosmetics still require animal testing. ISO 22716 GMP certificate is needed for exemption on general cosmetics.
- Using EU RP for UK: Separate Responsible Person required post-Brexit.
- Forgetting MoCRA deadlines: US facility registration is biennial. Miss the window = illegal to manufacture/distribute.
- Korea functional cosmetics: Claiming "anti-wrinkle" or "whitening" without MFDS functional cosmetics review = illegal. Check the 13 functional categories before making claims.
