food-compliance

# Food Compliance Full regulatory workflow for food, beverages, and dietary supplements across major markets. From recipe to retail shelf. ## Decision Flow ```dot digraph { rankdir=TB; node [shape=box style=rounded fontsize=10]; cat [label="1. Classify: conventional food,\nnovel food, supplement,\nor food additive"]; novel [label="2. Novel food check\n(new ingredient = heavy path)"]; haccp [label="3. HACCP plan in place?"]; allergens [label="4. Allergen assessment\n(different lists per market)"]; label [label="5. Nutrition panel +\nmandatory label elements"]; facility [label="6. Facility registration\n+ import permits"]; import [label="7. Import docs: health cert,\nphytosanitary, prior notice"]; sell [label="8. Place on market"]; cat -> novel -> haccp -> allergens -> label -> facility -> import -> sell; } ``` ## Market-by-Market Requirements ### EU -- General Food Law + Labeling | Regulation | Scope | |------------|-------| | **178/2002 (General Food Law)** | Traceability, RASFF notification, withdrawal/recall obligations. Applies to ALL food. | | **1169/2011 (Food Information to Consumers)** | Mandatory labeling: name, ingredients, allergens (bold), net quantity, date marking, storage, origin (for certain products), nutrition declaration, operator name/address | | **2015/2283 (Novel Foods)** | Any food not significantly consumed in EU before May 1997 needs EFSA authorization. Timeline: 18-24 months. Cost: EUR 50,000-300,000 for full dossier | | **1333/2008 (Food Additives)** | Positive list only. If additive not listed = cannot be used. E-numbers | | **1881/2006 (Contaminants)** | Maximum levels for lead, cadmium, mercury, mycotoxins, acrylamide, etc. | | **2073/2005 (Microbiological criteria)** | Process hygiene criteria + food safety criteria. Listeria, Salmonella, E. coli limits | | **Allergens (14 mandatory)** | Cereals with gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, sulphites (>10mg/kg), lupin, molluscs | **HACCP**: Mandatory for all food business operators (Regulation 852/2004). Must document hazard analysis, CCPs, monitoring, corrective actions. **Nutrition declaration**: Energy, fat, saturates, carbohydrate, sugars, protein, salt. Per 100g/100ml mandatory; per portion optional. ### US -- FDA FSMA | Requirement | Detail | |-------------|--------| | **FSMA (Food Safety Modernization Act)** | Preventive controls for human food (21 CFR 117). Written food safety plan with hazard analysis, preventive controls, monitoring, verification | | **Facility registration** | Every facility that manufactures/processes/packs/holds food for US consumption must register with FDA. Biennial renewal (Oct-Dec, even years) | | **Prior notice** | FDA must receive prior notice of imported food shipments. Submit via PNSI (Prior Notice System Interface) or ABI | | **GRAS** | Generally Recognized As Safe. New substances need either GRAS self-determination or FDA food additive petition (12-24 months, USD 50,000-500,000) | | **Nutrition Facts panel** | Mandatory format per 21 CFR 101.9. Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbs, dietary fiber, total sugars, added sugars, protein, Vitamin D, calcium, iron, potassium | | **Allergens (9 mandatory)** | Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame (added 2023 by FASTER Act) | | **State laws** | California Prop 65 (lead, acrylamide, etc.), state-specific labeling | | **Dietary supplements** | Regulated under DSHEA. Supplement Facts panel (not Nutrition Facts). NDI (New Dietary Ingredient) notification for new ingredients -- 75 days before marketing | **Import process**: Prior notice (15 days before arrival for non-express shipments) -> FDA may examine/sample -> Entry at customs -> Release or detention. ### UK -- FSA (Food Standards Agency) | Requirement | Detail | |-------------|--------| | **Legal basis** | Retained EU food law (Regulation 178/2002, 1169/2011 equivalents) | | **Allergens** | Same 14 allergens as EU. Natasha's Law (Oct 2021): pre-packed for direct sale must have full ingredient list with allergens | | **Labeling** | Must show UK business operator address. UKCA marking not required for food but "UK" origin marking rules apply | | **Novel foods** | FSA manages UK novel food authorisations (separate from EFSA since Brexit) | | **Import** | IPAFFS (Import of Products, Animals, Food and Feed System) for pre-notification. Health certificates required for products of animal origin | ### Japan -- Food Sanitation Act | Requirement | Detail | |-------------|--------| | **Legal basis** | Food Sanitation Act, JAS Act (quality labeling), Health Promotion Act (nutrition) | | **Allergens** | 8 mandatory (shrimp, crab, wheat, buckwheat, egg, milk, peanut, walnut) + 20 recommended (abalone, squid, salmon roe, orange, cashew, kiwi, beef, sesame, salmon, mackerel, soybean, chicken, banana, pork, matsutake, peach, yam, apple, gelatin, almond) | | **Food additives** | Positive list. Only additives designated by MHLW can be used. Japan's approved list is significantly shorter than EU/US | | **Import procedure** | Import notification to MHLW quarantine station. Inspection (document check, visual, lab test). First-time imports require lab testing | | **JAS standards** | Japanese Agricultural Standards. Voluntary for most categories but mandatory labeling format (quality labeling standards) | | **Nutrition labeling** | Mandatory: energy, protein, fat, carbohydrate, sodium (expressed as salt equivalent) | ### Codex Alimentarius International food standards developed by FAO/WHO. Not legally binding but: - WTO reference standards for trade disputes - Basis for national regulations in 180+ countries - Codex MRLs (Maximum Residue Limits) for pesticides used as default where national standards don't exist - Key standards: CODEX STAN 1-1985 (labeling), CAC/RCP 1-1969 (general hygiene/HACCP) ## HACCP Requirements Summary | Market | HACCP Mandatory? | Standard | Audit Required? | |--------|-----------------|----------|----------------| | EU | Yes (Reg 852/2004) | Codex-based 7 principles | Official controls by competent authority | | US | Yes (FSMA preventive controls) | 21 CFR 117 (goes beyond HACCP) | FDA inspection | | UK | Yes (retained EU law) | Same as EU | Local authority inspection | | Japan | Yes for certain categories; expanding | Codex-based | Prefectural health center | | Canada | Yes (Safe Food for Canadians Act) | SFCR preventive controls | CFIA inspection | ## Import Procedures Checklist ``` FOOD IMPORT READINESS -- [Product] -- [Market] -- [Date] DOCUMENTATION: [ ] Health certificate (products of animal origin) [ ] Phytosanitary certificate (plant products) [ ] Certificate of analysis (microbiological, chemical) [ ] Certificate of origin [ ] Free sale certificate (some markets require proof of legal sale in origin country) [ ] Lab test reports (pesticide residues, contaminants, allergens) FACILITY: [ ] Origin facility registered with destination authority (FDA, EU approved establishment, etc.) [ ] HACCP plan documented and current [ ] Third-party audit (GFSI-benchmarked: BRC, IFS, SQF, FSSC 22000 -- not always mandatory but buyers require it) CUSTOMS: [ ] HS code for food product [ ] Duty rate checked (check FTA eligibility) [ ] Prior notice filed (US: PNSI; UK: IPAFFS) [ ] Import permit obtained (if required by destination) LABELING: [ ] Nutrition panel in destination format [ ] Allergens declared per destination rules [ ] Local language [ ] Operator/importer address in destination country [ ] Date marking in destination format (DD/MM/YYYY vs MM/DD/YYYY) [ ] Lot/batch number ``` ## Shelf Life and Microbiological Testing | Test | When Required | Typical Cost | |------|---------------|-------------| | **Shelf life study** | Before launch. Accelerated (6-8 weeks) or real-time | EUR 1,000-5,000 | | **Microbiological testing** | Per batch or per shipment (depends on product risk) | EUR 200-800 per panel | | **Pesticide residue** | Required for plant-based products, especially imports | EUR 300-1,000 | | **Heavy metals** | Lead, cadmium, mercury, arsenic | EUR 150-500 | | **Mycotoxins** | Aflatoxins, ochratoxin (cereals, nuts, spices, coffee) | EUR 100-400 | | **Allergen testing** | Verify absence of undeclared allergens (ELISA or PCR) | EUR 50-200 per allergen | ## MCP Integration ``` # Monitor food safety signals: mcp__claude_ai_Cleo_Insight__search_signals query: "food safety regulation" # Track novel food authorizations: mcp__claude_ai_Cleo_Insight__list_regulations # Filter for food-related regulations # Check food ingredient compliance: mcp__claude_ai_CLEO_LEGAL_API__compliance/check product_description: "protein bar with hemp seeds" ingredients: ["hemp protein", "oat flour", "cocoa butter"] target_markets: ["EU", "US", "UK", "JP"] ``` ## Power This With the Cleo Legal API Food compliance hinges on positive lists (Japan additives, EU Novel Food, FDA GRAS), allergen rules that differ by market, and shifting MRLs/contaminant limits. The API consolidates all of it. **With the Cleo Legal API at https://legaldata-public.cleolabs.co:** - `GET /v2/catalog/regulations?vertical=food&country=EU,US,UK,JP,CA` — pull General Food Law, FSMA, Food Sanitation Act, SFCR with current articles and effective dates - `POST /v2/compliance/check` — screen ingredients against EFSA Novel Food Catalogue + FDA GRAS + Japan MHLW positive list in one call (the "is CBD legal?" question answered correctly per market) - `GET /v2/search?q=allergen+declaration&country=EU,US,JP` — current allergen lists (14 EU / 9 US / 8 JP) — these get amended (sesame added to FALCPA in 2023, walnut in JP) and missing one triggers immediate recall - `GET /v2/search?q=MRL&type=substance` — pesticide MRLs and contaminant limits per regulation 396/2005, 2023/915 — no need to scrape EUR-Lex annexes manually **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: One avoided novel-food blunder (CBD, hemp, insect protein launched without EFSA authorization) saves €50k-€300k in dossier costs. For a small food brand expanding to JP, the API surfaces the additive gap before the shipment is built. ## Common Mistakes - **Novel food blindspot**: CBD, hemp extracts, insect protein, many botanical extracts are novel foods in the EU. Selling without authorization = illegal. Check the EU Novel Food Catalogue first. - **Allergen list mismatch**: EU has 14 allergens, US has 9, Japan has 8 mandatory + 20 recommended. A product compliant in the US may need label changes for EU (celery, lupin, mustard, molluscs, sulphites). - **US Nutrition Facts vs EU Nutrition Declaration**: Different nutrients, different units (sodium vs salt), different formats. You cannot use the same panel. - **Forgetting prior notice**: FDA can refuse entry for missing prior notice. File BEFORE the shipment arrives. - **GFSI audit assumption**: BRC/IFS/SQF certification is not legally mandatory in most markets, but major retailers (Walmart, Tesco, Carrefour) require it. Budget EUR 5,000-15,000 for initial certification. - **Japan additive gap**: Many additives legal in EU/US are not approved in Japan. Always cross-check Japan's positive list before exporting.