labeling-compliance

# Labeling Compliance Country-specific labeling requirements for physical products. What must be on your label to legally sell in each market. ## MCP Tools for Labeling Compliance ``` # Search for labeling regulation changes by jurisdiction mcp__claude_ai_Cleo_Insight__search_signals(q="labeling", country="FR", limit=25) mcp__claude_ai_Cleo_Insight__search_signals(q="allergen declaration", country="US", limit=25) # Get full details of a specific labeling regulation mcp__claude_ai_Cleo_Insight__get_regulation(id="<regulation-id>") # Search labeling requirements by jurisdiction via Legal API # Use /v2/search endpoint for targeted labeling queries: mcp__claude_ai_CLEO_LEGAL_API__compliance/check product_description: "face cream 50ml" ingredients: ["retinol", "niacinamide"] target_markets: ["EU", "US", "UK"] # Returns substance + labeling flags per market # List all tracked regulations to find labeling-specific ones mcp__claude_ai_Cleo_Insight__list_regulations(limit=100) # Filter results for labeling, packaging, and marking requirements ``` See `compliance-mcp-tools` skill for full tool patterns and authentication. ## The Rule **If your label is wrong, your product cannot be sold -- even if the product itself is perfectly safe and compliant.** Labeling is the #1 reason products get stopped at customs or pulled from shelves. ## Universal Labeling Elements Every physical product in every market needs at minimum: | Element | Description | |---------|-------------| | Product name / identity | What the product is | | Net quantity | Weight, volume, or count (metric in EU/UK, dual in US) | | Responsible entity | Manufacturer, importer, or responsible person with address | | Country of origin | "Made in [country]" -- often legally required, always commercially expected | | Batch/lot number | For traceability and recalls | Beyond these, requirements vary dramatically by product category and market. ## Cosmetics Labeling ### EU (Regulation 1223/2009, Article 19) **Mandatory elements on packaging:** | Element | Requirement | Example | |---------|-------------|---------| | Responsible Person | Name + address, must be in EU | "Cleo Labs SAS, 92200 Neuilly, France" | | Nominal content | Weight or volume in metric | "50 ml" | | Date of minimum durability | "Best before" symbol (hourglass) + date. If >30 months: PAO symbol instead | PAO: "12M" (open jar icon) | | Precautions | Mandatory warnings per Annexes III-VI | "Avoid contact with eyes" | | Batch number | For recall traceability | "LOT 2026A-042" | | Function | What the product does (if not obvious from name) | "Moisturising face cream" | | **INCI ingredients list** | Full list in INCI nomenclature, descending concentration order | "AQUA, GLYCERIN, NIACINAMIDE..." | | Country of origin | If made outside EU | "Made in Korea" | **INCI rules:** - Latin (INCI) names for chemicals: AQUA, not "water" - Botanical names in Latin with common name: ALOE BARBADENSIS LEAF JUICE - Colorants by CI number: CI 77891 (titanium dioxide) - Fragrances as "PARFUM" (or "AROMA" for oral products) - **26 allergens must be listed individually if above threshold**: LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, etc. (0.01% in rinse-off, 0.001% in leave-on) - Concentration >1%: strictly descending order. Below 1%: any order. - Nanomaterials: add "[nano]" after ingredient name **Language**: Official language(s) of the country of sale. Selling in France = French. Germany = German. Multi-country = multi-language. ### US (FDA + FTC) | Element | Requirement | |---------|-------------| | Product identity | Prominent on PDP (Principal Display Panel) | | Net quantity | Lower third of PDP, both metric and US customary | | Ingredient list | Descending concentration, INCI names accepted. "Active ingredients" separate if OTC drug | | Warning statements | Per 21 CFR (e.g., sunscreen: "Sun alert"), Prop 65 if selling in CA | | Distributor/manufacturer | Name + address on info panel | | Directions for use | If not obvious | | **No pre-market approval** | But MoCRA (2024+) requires FDA facility registration + product listing | **FTC claims rules**: "Natural," "organic," "hypoallergenic" -- all have specific FTC/FDA definitions. Unsubstantiated claims = FTC enforcement action. **Prop 65 (California)**: If product contains any listed substance above safe harbor, label must include: "WARNING: This product can expose you to [substance], which is known to the State of California to cause [cancer/birth defects/other reproductive harm]." ### UK (post-Brexit) Mirrors EU 1223/2009 but: - **UK Responsible Person**: Must be established in UK (cannot be your EU RP) - **UKCA marking**: Not required for cosmetics (no UKCA for cosmetics) - **GB address**: Must appear on label - **Language**: English ### Canada - **Bilingual**: English AND French mandatory on all labels - **Cosmetic Regulations C.R.C., c. 869**: Similar to EU ingredients list - **NHP**: If product makes health claims, classified as Natural Health Product -- different labeling regime entirely ### Japan - **Full Japanese translation** of all label elements - **Positive list system**: Only ingredients on the approved list may be used - **Medicated cosmetics (quasi-drugs)**: Separate approval and labeling path - **Allergen labeling**: Mandatory for specific allergens, different list from EU ### Korea (MFDS) - **Korean language** mandatory - **CGMP compliance** statement if functional cosmetic - **All-ingredients labeling** required - **Expiry date** mandatory (not just PAO) ## Food Labeling ### EU (Regulation 1169/2011) | Element | Requirement | |---------|-------------| | Food name | Legal name, or customary name, or descriptive name | | Ingredients list | Descending weight order, allergenic substances EMPHASIZED (bold, caps, or underline) | | **14 allergens** | Mandatory declaration: cereals with gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, sulphites, lupin, molluscs | | Quantitative declaration (QUID) | % of highlighted ingredients | | Net quantity | Metric | | Date marking | "Use by" (safety) or "Best before" (quality) | | Storage conditions | If special handling needed | | Operator name + address | EU-based food business operator | | Country of origin | Mandatory for certain foods (meat, honey, olive oil, fruits/veg) | | Nutrition declaration | Energy, fat, saturates, carbs, sugars, protein, salt -- per 100g/100ml | | Lot number | For traceability | **Language**: Official language(s) of member state of sale. ### US (FDA 21 CFR 101) | Element | Requirement | |---------|-------------| | Statement of identity | Common name of food | | Net quantity | US customary + metric | | **Nutrition Facts panel** | Standardized format: servings, calories, fat, cholesterol, sodium, carbs, fiber, sugars, protein, vitamins | | Ingredients list | Descending weight | | **9 major allergens** (FALCPA + FASTER Act) | Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame -- must be declared | | Manufacturer/distributor | Name + address | | Country of origin | Required | **Claims**: "Organic" (USDA NOP), "Non-GMO," "Gluten-free" -- all have specific regulatory definitions and verification requirements. ### Supplements (US: DSHEA / EU: Food Supplements Directive 2002/46/EC) | Market | Label Requirements | |--------|-------------------| | **US** | "Supplement Facts" panel (not Nutrition Facts), "dietary supplement" identifier, disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." | | **EU** | "Food supplement" designation, recommended daily dose, "Do not exceed stated dose" warning, "Not a substitute for a varied diet," nutrient amounts as % of reference intake | ## Electronics Labeling ### CE Marking (EU) | Requirement | Detail | |-------------|--------| | CE symbol | Minimum 5mm height, specific proportions (Commission template) | | Directives covered | LVD (2014/35/EU), EMC (2014/30/EU), RED (2014/53/EU), RoHS (2011/65/EU) | | Declaration of Conformity | Must reference all applicable directives, harmonized standards, notified body (if used) | | Importer info | EU importer name + address on product or packaging | | Traceability | Type, batch, serial number | | Instructions | In official language(s) of member state of sale | CE marking without actual conformity assessment = illegal. Self-declaration is allowed for most consumer electronics but requires full technical documentation. ### UKCA Marking (UK) Same principle as CE but: - **UKCA symbol** (different from CE) - **UK Designated Standards** (not EU harmonised standards -- though largely identical for now) - **UK Responsible Person** for importers - **UK conformity assessment** (UK-recognized bodies) - **Transition**: CE marking accepted in GB until indefinite extension -- but UKCA required for new product types ### FCC (US) | Type | Requirement | |------|-------------| | Intentional radiator | FCC ID on label, FCC authorization required | | Unintentional radiator | FCC compliance statement on label or in manual | | Label text | "This device complies with Part 15 of the FCC Rules" + interference statements | ### RoHS Marking No mandatory symbol in EU (CE covers it), but many markets use the "RoHS compliant" crossed-out wheelie bin or custom marks. China RoHS requires specific marking with substance content tables. ## Toys Labeling | Requirement | EU (2009/48/EC) | US (CPSIA/ASTM F963) | |-------------|-----------------|----------------------| | Age warning | "Not suitable for children under 36 months" + specific hazard | Age grading label | | CE mark | Required | Not applicable | | ASTM mark | Not applicable | Not mandatory but widely used | | Small parts warning | Mandatory for toys with detachable parts < 36mm | Mandatory (choking hazard) | | Importer info | EU address | US importer or domestic manufacturer | | Tracking info | Batch, manufacturer, model | Permanent distinguishing mark, batch info | | Third-party testing | EU-type examination for some categories | **Mandatory** for all children's products | ## Textile Labeling | Requirement | EU (Reg 1007/2011) | US (FTC Textile Act) | |-------------|---------------------|----------------------| | Fiber composition | Mandatory, by % weight | Mandatory, generic fiber names | | Country of origin | Recommended | Mandatory | | Care instructions | Recommended (ISO 3758 symbols) | Mandatory (ASTM D5489 or care symbols) | | Manufacturer/importer | Mandatory | Mandatory (RN or WPL number) | | Flammability | Required for clothing textiles (EN ISO 14116) | 16 CFR 1610 compliance label | ## Multi-Language Requirements | Market | Required Language(s) | |--------|---------------------| | France | French | | Germany | German | | Spain | Spanish (+ regional in some autonomous communities) | | Italy | Italian | | Netherlands | Dutch | | Belgium | French + Dutch (+ German in some areas) | | Switzerland | German, French, Italian (whichever market you target) | | Canada | English + French (bilingual mandatory) | | US | English (Spanish recommended for some markets) | | UK | English | | Japan | Japanese | | Korea | Korean | | China | Simplified Chinese | | EU multi-country | One label with ALL target country languages, or country-specific stickering | **Practical tip**: For small packaging, use a fold-out label or booklet label to fit multiple languages. The outer packaging must still show the mandatory elements in the correct language. ## Label Review Checklist Before printing labels, verify: ``` LABEL REVIEW -- [Product] -- [Market] -- [Date] UNIVERSAL: [ ] Product name/identity present [ ] Net quantity in correct units (metric for EU/UK, dual for US) [ ] Batch/lot number [ ] Country of origin [ ] Responsible entity name + address (in correct jurisdiction) CATEGORY-SPECIFIC: [ ] Ingredients list in correct format and order [ ] Allergens declared per local requirements [ ] Required warnings present [ ] Required symbols present (CE, UKCA, recycling, PAO) [ ] Nutrition/supplement facts panel (if food/supplement) [ ] Claims substantiated per local rules LANGUAGE: [ ] Text in official language(s) of country of sale [ ] Bilingual where required (Canada, Belgium) [ ] Technical terms (INCI) in correct nomenclature FORMATTING: [ ] Minimum font size met (EU: 1.2mm x-height for <80cm2 packages, 0.9mm if <10cm2) [ ] Required elements on correct panel (PDP vs info panel for US) [ ] Symbols at minimum required dimensions ``` ## Power This With the Cleo Legal API Labeling is where regulations differ market-by-market in ways web search badly handles: mandatory font sizes, language, allergen thresholds, symbol templates. The API returns the live ruleset per country. **With the Cleo Legal API at https://legaldata-public.cleolabs.co:** - `GET /v2/search?country=XX&q=labeling+requirements` — current mandatory label elements per market (font size, language, RP address rules, batch number) - `GET /v2/documents?regulation=1223/2009&article=19` — pull the actual Article 19 text plus annexes (26 allergens list, prohibited claims) — primary source, not paraphrased - `POST /v2/compliance/check` — flags label-driving issues from the ingredient list (allergens above threshold, [nano] designation needed, Prop 65 warning required) - `GET /v2/authorities/:slug` — for each market, returns the responsible authority + notification portal URL (CPNP, SCPN, FDA MoCRA, CNF…) for label review and address requirements **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" ```