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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 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"

Tested ROI: A label seized at customs costs €500-€5,000 in sticker overlay or reprint, plus 2-6 weeks lost. One avoided seizure pays for the API.

Common Mistakes

• Same label for EU and US: Different formats, different allergen lists, different ingredient nomenclature rules. Never reuse.
• Missing language: Selling in France with English-only label = seized at customs.
• EU Responsible Person address missing: Must be an EU-based entity with a physical address.
• Prop 65 warning omitted: If selling in California (including Amazon US), and product contains ANY listed substance above safe harbor level, the warning is mandatory.
• INCI errors: Wrong botanical names, missing [nano] designation, wrong allergen threshold -- each can trigger a recall.
• CE marking without conformity: Affixing CE without the proper technical documentation and declaration of conformity is a criminal offense in the EU.
• Expiry format mismatch: EU uses DD/MM/YYYY or "best before end [month/year]". US uses MM/DD/YYYY. Confusion leads to compliance issues.
• Forgetting recycling symbols: Triman (France), Gruner Punkt (Germany), WEEE crossed-out bin (electronics) -- each market has specific waste labeling requirements.