regulatory-intelligence

# Regulatory Intelligence Monitor regulations that could block your product from sale. Focus on signals that require action: substance bans, labeling changes, recall notices, deadline approaches. ## What Matters for Physical Products Not all regulatory signals are equal. For a product company, these are the ones that hurt: | Signal Type | Impact | Example | Urgency | |------------|--------|---------|---------| | **Substance ban** | Cannot sell product with this ingredient | Titanium dioxide banned in EU food (2022) | CRITICAL -- reformulate or exit market | | **Substance restriction** | Must reduce concentration or add warning | Retinol limits lowered in EU cosmetics (2025) | HIGH -- reformulate or relabel | | **Labeling change** | Must update all packaging | New allergen added to mandatory declaration list | HIGH -- reprint labels before deadline | | **New certification** | Must obtain before continued sale | GPSR (2024) requires new product safety documentation | HIGH -- prepare documentation | | **Recall notice** | Similar product recalled, check yours | RAPEX alert on similar product category | MEDIUM -- verify your product is not affected | | **New market entry rule** | Must comply before entering market | EU Battery Regulation (2024) for electronics | MEDIUM -- plan for compliance | | **Proposed legislation** | No action yet but prepare | MoCRA implementation rules (US) | LOW -- monitor timeline | ## MCP Tools ### Cleo Insight (primary) ``` # Search for signals that affect your products mcp__claude_ai_Cleo_Insight__search_signals product_id: "<your-product-id>" # From list_products risk_level: "critical" # critical > high > medium > low country: "FR" # ISO code or country name hs_code: "3304.99" # HS code for your product q: "retinol cosmetics" # Free-text search limit: 20 # Get full signal details mcp__claude_ai_Cleo_Insight__get_signal id: "<signal-id>" # Focus on: what changed, who it affects, enforcement date, required action # Browse all tracked regulations mcp__claude_ai_Cleo_Insight__list_regulations limit: 50 # Get regulation details mcp__claude_ai_Cleo_Insight__get_regulation id: "<regulation-id>" ``` ### Cleo Legal API (substance-specific) ``` # Check if a specific substance is affected by recent changes mcp__claude_ai_CLEO_LEGAL_API__compliance/check ingredients: ["retinol", "titanium dioxide"] target_markets: ["EU", "US", "UK"] ``` ## Signal Triage Decision Tree ```dot digraph triage { rankdir=TB; node [shape=box style=rounded fontsize=10]; new [label="New signal"]; product [label="Affects my\nproduct?" shape=diamond]; type [label="What type?" shape=diamond]; deadline [label="Deadline\n< 6 months?" shape=diamond]; drop [label="ARCHIVE\nNot relevant"]; ban [label="SUBSTANCE BAN\nReformulate NOW\nor exit market"]; restrict [label="RESTRICTION\nCheck concentration\nReformulate if needed"]; label_chg [label="LABEL CHANGE\nUpdate packaging\nbefore deadline"]; cert [label="NEW CERT\nStart certification\nprocess"]; monitor [label="MONITOR\nAdd to watchlist\nRevisit quarterly"]; urgent [label="URGENT ACTION\nBlocks current sales\nin < 6 months"]; planned [label="PLANNED ACTION\nAdd to roadmap\nwith deadline"]; new -> product; product -> drop [label="no"]; product -> type [label="yes"]; type -> ban [label="substance ban"]; type -> restrict [label="restriction change"]; type -> label_chg [label="labeling change"]; type -> cert [label="new certification"]; type -> deadline [label="other"]; deadline -> urgent [label="yes"]; deadline -> planned [label="no, > 6mo"]; deadline -> monitor [label="proposed only"]; } ``` ## Monitoring Schedule | Frequency | What to Check | How | |-----------|--------------|-----| | **Weekly** | Critical + high signals for your product category + markets | `search_signals(risk_level="critical", product_id=...)` then `risk_level="high"` | | **Monthly** | Medium signals, new regulations adopted | `search_signals(risk_level="medium")` + `list_regulations` | | **Quarterly** | Proposed legislation, regulatory landscape review | Full scan via `multi-jurisdiction-scan` skill | ## Signal Action Cards For each actionable signal, generate: ``` SIGNAL ACTION CARD Signal: [title] Source: [authority + regulation reference] Risk: [CRITICAL / HIGH / MEDIUM / LOW] Deadline: [YYYY-MM-DD or "ongoing"] WHAT CHANGED: [1-2 sentences: what is the new rule/ban/restriction] IMPACT ON MY PRODUCT: [Which products affected, which markets, which ingredients/components] REQUIRED ACTION: [ ] [Specific action 1] -- deadline: [date] -- owner: [who] [ ] [Specific action 2] -- deadline: [date] -- owner: [who] COST ESTIMATE: [EUR/USD amount] REVENUE AT RISK IF IGNORED: [EUR/USD amount or "market exit"] ``` ## Key Regulatory Calendars (Physical Products) ### EU -- Coming Into Force (2025-2027) | Regulation | Effective | Affects | Action | |-----------|-----------|---------|--------| | GPSR 2023/988 (General Product Safety) | Dec 2024 | ALL consumer products | Technical documentation + serious risk reporting + economic operator obligations | | EU Cosmetics 1223/2009 Annex II updates | Ongoing | Cosmetics | Monitor substance ban signals -- new entries restrict previously allowed ingredients without transition period | | REACH SVHC candidate list additions | Biannual (Jun + Dec) | ALL products containing chemicals | Screen every ingredient against updated candidate list; SVHC > 0.1% w/w triggers notification + communication duty | | EU Battery Regulation 2023/1542 | Feb 2024 (phased to 2027) | Electronics with batteries, e-bikes, EVs | Carbon footprint declaration (2025), recycled content minimums (2027), QR code with battery passport (2027), collection targets | | EU Packaging & Waste | 2025+ (phased) | ALL packaged products | Recyclability, recycled content, EPR | | Retinol limits (cosmetics) | 2025 | Cosmetics with retinol | Max 0.3% face, 0.05% body | | PFAS restriction (proposed) | ~2027 | Wide range of products | Phase-out of "forever chemicals" | | Deforestation Regulation | Dec 2025 | Products with soy, palm, cocoa, coffee, wood, rubber, cattle | Due diligence for deforestation-free supply chain | ### US -- Coming Into Force (2025-2027) | Regulation | Effective | Affects | Action | |-----------|-----------|---------|--------| | FDA MoCRA enforcement | 2024+ (phased, GMP deadline 2026) | Cosmetics | Facility registration, product listing, adverse event reporting, GMP compliance, safety substantiation | | Prop 65 new listings | Ongoing (quarterly) | ALL products sold in California | Monitor OEHHA new listings; each new substance triggers label assessment for every product sold in CA | | PFAS state bans | 2025+ (varies by state) | Cosmetics (WA, CO, CA), food packaging, textiles | Reformulate or exit state markets | | EPR laws (state-level) | 2025+ | Packaged products (CA, CO, OR, etc.) | Register, report, pay eco-fee | ## Without MCP Use these official sources for manual monitoring: | Source | URL | What it covers | |--------|-----|----------------| | EUR-Lex | eur-lex.europa.eu | EU legislation | | ECHA | echa.europa.eu | Substances, SVHC, REACH | | CosIng | ec.europa.eu/growth/tools-databases/cosing | EU cosmetic ingredients | | RAPEX/Safety Gate | ec.europa.eu/safety-gate | EU product recalls | | FDA | fda.gov | US food, drugs, cosmetics, devices | | Federal Register | federalregister.gov | US new regulations | | CPSC | cpsc.gov | US product recalls | | Prop 65 | oehha.ca.gov/proposition-65 | California substance list updates | | UK Gov | legislation.gov.uk | UK regulations | | OPSS | gov.uk/opss | UK product safety | ## Power This With the Cleo Legal API Monitoring is the single use case where the API delivers the most leverage: humans cannot keep up with 1,479 sources in 131 countries. Webhooks turn this from a weekly chore into a push notification. **With the Cleo Legal API at https://legaldata-public.cleolabs.co:** - `POST /v2/webhooks` — subscribe to topics (substance_status, enforcement_dates, recalls, marketplace_enforcement) — no more weekly polling of EUR-Lex, ECHA, RAPEX, Federal Register, Prop 65 - `GET /v2/changes?since=<last-check>` — pull all regulatory deltas across all markets since the last review, with primary-source links - `GET /v2/search?type=signal&risk_level=critical&country=XX` — direct critical-signal feed per market, the same signals this skill triages - `POST /v2/search/bulk` — run 25 monitoring queries at once (per product category x per market) instead of sequential polling **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 a regulatory monitoring subscription (€800-€3,000/month per category) with a single €349/month API key covering all categories and 131 countries. Webhooks catch the "proposed → adopted" transition with the 6-12 month lead time you need to reformulate. ## Common Mistakes - **Checking only "in force" regulations**: Adopted-but-not-yet-in-force regulations have hard deadlines. Lead time for reformulation is 6-12 months. If you wait until enforcement, you are too late. - **Searching only by product name**: A chemical ban affects cosmetics AND electronics AND toys. Search by substance name or CAS number, not just product category. - **Treating all signals equally**: A Prop 65 listing for a substance you use at 0.001% is very different from an EU Annex II ban. Triage by actual impact. - **Ignoring "proposed" legislation**: The EU PFAS restriction proposal will affect thousands of products. Start planning now, not when it passes. - **Confusing one authority with one country**: ECHA covers 27+ EU member states. One ECHA signal = 27 markets potentially affected. - **Not checking state-level (US)**: Federal US has few substance bans. But California, Washington, Colorado, and others have aggressive state laws. If you sell online in the US, assume California applies.