| name | labeling-compliance |
| description | Use when checking labeling requirements for a product in a target market, creating compliant labels, verifying INCI nomenclature, checking allergen declarations, or understanding CE/UKCA/FCC marking requirements |
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 paraphrasedPOST /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"
