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Productividad · SKILL.md

product-compliance

product-compliance

Use when checking if a product is compliant in target markets, running substance checks against ingredient lists, calculating revenue-at-risk, or answering "can I sell this product in [country]?"

Independent GitHub snapshot · Automated classification · Original documentation governs

Documentación de la Skill

GitHub

name: product-compliance description: Use when checking if a product is compliant in target markets, running substance checks against ingredient lists, calculating revenue-at-risk, or answering "can I sell this product in [country]?"

Product Compliance

THE HERO SKILL. Check if your product is compliant in target markets. Full substance check workflow with verdicts per ingredient per jurisdiction.

The Question This Answers

"Can I sell [product] in [market]?" -- with a precise, sourced answer.

Substance Check Workflow

digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  input [label="Ingredients list\n(INCI names or trade names)"];
  cas [label="Resolve CAS numbers\nfor each ingredient"];
  check [label="Check against\n13 substance databases"];
  verdict [label="Verdict per substance\nper jurisdiction"];
  rar [label="Revenue-at-Risk\ncalculation"];
  action [label="Action plan:\ncompliant / reformulate /\nget exemption / needs testing"];
  input -> cas -> check -> verdict -> rar -> action;
}

Step 1: Identify Product Category

CategoryKey RegulationsSubstance Databases
CosmeticsEU 1223/2009, FDA MoCRA, UK Cosmetics Reg, Health Canada NHP, Japan SLR, Korea MFDSCosIng, FDA VCRP, Prop 65, ECHA SVHC
Food & SupplementsEU 2015/2283, FDA DSHEA, EFSA, Codex AlimentariusFDA GRAS, EFSA Novel Food, Prop 65
ElectronicsRoHS, WEEE, FCC Part 15, CE/LVD, UKCA, EN 62368RoHS substance list, REACH SVHC
ToysEN 71, CPSIA, ASTM F963, EU 2009/48EN 71-3 migration limits, CPSIA lead/phthalate
TextilesREACH, OEKO-TEX, EU Ecolabel, CPSIA (children)REACH SVHC, ZDHC MRSL, Prop 65
Cleaning productsEU CLP, EPA, REACH, Biocidal Products RegCLP classification, ECHA SVHC
Medical devicesEU MDR 2017/745, FDA 510(k), UKCA MDRBiocompatibility (ISO 10993)
General consumerEU GPSR 2023/988, CPSC, UK Product SafetyRAPEX alerts, CPSC recalls

Step 2: Resolve CAS Numbers

For each ingredient:

  1. User provides INCI name, trade name, or CAS number
  2. If INCI name: map to CAS using CosIng database or PubChem
  3. If trade name: identify active substances, get CAS for each
  4. If mixture: break down to individual substances with concentrations

Critical: One trade name ingredient can contain multiple regulated substances. Always decompose.

Step 3: Check Against 13 Substance Databases

#DatabaseScopeWhat it tells you
1CosIng (EU)EU cosmeticsBanned (Annex II), restricted with limits (Annex III), allowed colorants (Annex IV), allowed preservatives (Annex V)
2ECHA SVHCEU all productsSubstances of Very High Concern; if >0.1% w/w, must notify ECHA and inform buyers
3REACH Annex XVIIEU all productsRestrictions on manufacture, sale, use; substance-specific conditions
4California Prop 65US CaliforniaKnown carcinogens/reproductive toxins; requires warning label if present above safe harbor level
5FDA (cosmetics)US cosmeticsProhibited/restricted ingredients under MoCRA; color additive approvals
6FDA GRASUS foodGenerally Recognized As Safe; absence = may need food additive petition
7EFSAEU foodNovel food status, health claims, additive approvals
8Health CanadaCanadaCosmetic Ingredient Hotlist (prohibited/restricted), NHP ingredient database
9Japan StandardsJapanPositive list (cosmetics), Standards of Labeling for Allergenic Substances (food)
10Korea MFDSKoreaFunctional cosmetic ingredient restrictions, CGMP requirements
11UK post-BrexitUKUK REACH, UK Cosmetics Reg (mirrors EU but diverging), UKCA
12RoHS substancesEU/UK/CN electronics10 restricted substances with max concentration limits
13CPSIAUS children's productsLead (100ppm), phthalates (8 restricted), third-party testing required

Using MCP Tools

# If Cleo Legal API is available:
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
  product_description: "face moisturizer"
  ingredients: ["water", "glycerin", "niacinamide", "retinol"]
  target_markets: ["EU", "US", "UK"]
# Returns: per-ingredient, per-market compliance status

# Cross-reference with Cleo Insight for recent changes:
mcp__claude_ai_Cleo_Insight__search_signals
  product_id: "<product-id>"
  risk_level: "critical"
# Check if any substance was recently banned or restricted

Without MCP

Use WebSearch against official sources: EUR-Lex, FDA database, ECHA, CosIng. Structure findings in the same verdict format below.

Step 4: Verdict System

Each substance gets a verdict per jurisdiction:

VerdictMeaningVisualAction Required
COMPLIANTMeets all limits in this jurisdictionGREENNone
FLAGClose to threshold, data incomplete, or warning label neededORANGERetest concentration, check recent amendments, add safety margin to formulation
FAILExceeds limit, banned substance, or missing approvalREDCannot sell. Reformulate, get exemption, or drop this market
NEEDS_REVIEWConfidence < 0.5, conflicting sources, or no data foundYELLOWManual expert review required before any decision

Verdict Output Format

PRODUCT COMPLIANCE CHECK -- [Product Name] -- [Date]

Product: [name]
Category: [cosmetics / food / electronics / ...]
Ingredients: [count]
Markets checked: [EU, US, UK, CA, JP, KR]

SUBSTANCE MATRIX:
| Ingredient | CAS | EU | US | US-CA | UK | CA | JP | KR |
|------------|-----|----|----|-------|----|----|----|-----|
| Retinol | 68-26-8 | FLAG | COMPLIANT | FLAG | FLAG | COMPLIANT | FLAG | COMPLIANT |
| CBD | 13956-29-1 | FAIL | FLAG | FAIL | FAIL | FLAG | FAIL | FAIL |
| Niacinamide | 98-92-0 | COMPLIANT | COMPLIANT | COMPLIANT | COMPLIANT | COMPLIANT | COMPLIANT | COMPLIANT |

DETAILS (non-COMPLIANT only):
- Retinol / EU: Restricted under 1223/2009 Annex III entry 223a. Max 0.3% in face, 0.05% in body (new 2025 limits). FLAG -- verify concentration.
- CBD / EU: Novel food if ingested. Cosmetics: not in Annex II but EFSA safety assessment pending. FAIL -- no clear path to market currently.
- Retinol / US-CA: Prop 65 listed (reproductive toxin). Requires warning if above safe harbor. FLAG -- check concentration vs NSRL.

MARKET SUMMARY:
| Market | COMPLIANT | FLAG | FAIL | NEEDS_REVIEW | Verdict |
|--------|-----------|------|------|-------------|---------|
| EU | 1 | 1 | 1 | 0 | BLOCKED -- CBD |
| US | 2 | 0 | 0 | 1 | REVIEW NEEDED |
| US-CA | 1 | 1 | 1 | 0 | BLOCKED -- CBD |
| UK | 1 | 1 | 1 | 0 | BLOCKED -- CBD |

Step 5: Revenue-at-Risk (RAR)

RAR(product, market) = trailing_90d_sales(product, market)
  WHERE verdict = FAIL
  AND regulation.status = in_force OR effective_within_180d

Rules:

  • Each (product, market) pair counted once regardless of how many substances fail
  • Use trailing 90-day sales only, not projections
  • If no sales data: estimate from market size and product category benchmarks
  • Confidence >= 0.5 gate on all verdicts feeding into RAR
REVENUE AT RISK:
| Product | Market | 90d Sales | Failing Substances | RAR |
|---------|--------|-----------|-------------------|------|
| Face Cream | EU | EUR 45,000 | CBD | EUR 45,000 |
| Face Cream | US-CA | USD 12,000 | CBD | USD 12,000 |
| Face Cream | US (excl. CA) | USD 28,000 | -- | USD 0 |
Total RAR: EUR 45,000 + USD 12,000 = ~EUR 56,000

Multi-Jurisdiction Quick Checks

For common product types, here are the key differences:

Cosmetics: EU vs US vs UK

RequirementEUUSUK
Pre-market registrationCPNP notification requiredFDA registration (MoCRA, mandatory from 2024)UK SCPN notification
Safety assessmentMandatory CPSR by qualified assessorManufacturer responsibility; FDA can requestMandatory (same as EU for now)
Banned substances1,698 in Annex II~30 prohibited; MoCRA expandingMirrors EU (diverging post-Brexit)
Animal testingBanned (including for ingredients)Not required but not bannedBanned (mirrors EU)
Responsible personRequired, must be in EUUS agent for foreign firmsRequired, must be in UK
Labeling languageOfficial language of country of saleEnglishEnglish

Electronics: EU vs US

RequirementEUUS
Safety markCE marking (LVD + EMC)FCC (EMC), UL/NRTL (safety, voluntary but de facto required)
Substance restrictionsRoHS (10 substances)No federal RoHS; some state laws
WasteWEEE (producer registration + take-back)State-level e-waste laws
BatteryEU Battery Regulation 2023/1542State-level (CA, NY)
RadioRED (Radio Equipment Directive)FCC Part 15

Power This With the Cleo Legal API

This is THE hero skill, and /v2/compliance/check is THE killer endpoint. Everything in this skill — 13 databases, per-market verdicts, RAR calculation — runs in one composite API call.

With the Cleo Legal API at https://legaldata-public.cleolabs.co:

  • POST /v2/catalog/match-product — auto-classify into the correct vertical (cosmetics / food / electronics / toys / textile) before screening
  • POST /v2/compliance/check — the headline endpoint: ingredients × markets → verdict matrix from 13 importers (CosIng, ECHA, REACH Annex XVII, Prop 65, FDA, EFSA, Health Canada, NMPA, K-REACH, MHLW, RoHS, CPSIA, CLP) in one shot, with confidence scores per verdict
  • GET /v2/search?type=substance&cas=... — deep-dive on any FLAG or NEEDS_REVIEW substance to fetch primary source (annex, article, transition period)
  • POST /v2/webhooks?topic=substance_status — get notified when a substance you use becomes restricted or banned, before you ship the next batch

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: Replaces 2 hours of manual substance lookup per product per market with 1 API call (≈1 unit). For a brand with 15 SKUs in 6 markets, that is ~180 hours/year — the most expensive analyst time in the org.

Common Mistakes

  • Checking only one market: EU/US/UK have different banned substance lists. Always check per jurisdiction.
  • Ignoring Prop 65: Applies to any product sold in California, not just "California products." Most US e-commerce = exposed.
  • Missing SVHC notification: If any substance is on the SVHC Candidate List at >0.1% w/w, you must notify ECHA within 6 months and inform downstream users. This applies to articles, not just chemicals.
  • Assuming UK = EU: Post-Brexit divergence is real and increasing. UK REACH has its own substance evaluations.
  • Trade name vs substance: "Parfum" or "Fragrance" can contain 100+ individual substances. Get the IFRA certificate for full breakdown.
  • Concentration assumptions: A substance may be compliant at 0.1% but banned at 0.5%. Always verify actual concentration against the specific limit.
  • Ignoring transition periods: New restrictions often have 12-18 month transition periods. Check effective date, not publication date.
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