cosmetics-compliance

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

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.