cosmetics-compliance

# Cosmetics Compliance Full regulatory workflow for cosmetics and personal care products across 8 major markets. From formulation to shelf. ## Decision Flow ```dot 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 | Market | Portal | URL | |--------|--------|-----| | EU | CPNP | https://ec.europa.eu/growth/tools-databases/cosing/ | | US | FDA MoCRA | https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products | | UK | SCPN | https://submit-cosmetic-product-notification.service.gov.uk/ | | Canada | CNF | https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification.html | | China | NMPA | https://www.nmpa.gov.cn/ | | Korea | MFDS | https://nedrug.mfds.go.kr/ | | Japan | PMDA | https://www.pmda.go.jp/ | ## 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 references - `POST /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 wrong - `POST /v2/compliance/check` — batch-check INCI list against CosIng Annex II/III/IV/V, Hot List, MFDS functional list, NMPA Inventory in one composite call - `POST /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.