name: agricultural-compliance
description: Use when selling fertilizers, pesticides, seeds, plant protection products, biostimulants, organic farming inputs, or agricultural commodities - covers EU CAP, Reg 2019/1009 fertilizers, Reg 1107/2009 pesticides, Reg 2018/848 organic, USDA NOP, JAS, GMO labeling, MRLs, ISPM 15 phytosanitary
Agricultural Compliance
Full regulatory workflow for fertilizers, pesticides, seeds, plant protection products, biostimulants, organic certification. EU CAP, MRLs, GMO rules, phytosanitary trade.
Decision Flow
digraph {
rankdir=TB; node [shape=box style=rounded fontsize=10];
classify [label="1. Classify input:\nfertilizer / biostimulant /\nPPP / seed / GMO"];
authorize [label="2. Authorization:\nEU 1009 / 1107 / 1107 zonal / EPA / PMRA"];
organic [label="3. Organic certification\n(EU 848 / NOP / JAS)"];
gmo [label="4. GMO labeling check"];
mrl [label="5. MRLs verification\n(EU Reg 396/2005)"];
phyto [label="6. Phytosanitary cert\n+ ISPM 15 packaging"];
label [label="7. Label per country\n(CLP, EPA, language)"];
sell [label="8. Place on market"];
classify -> authorize -> organic -> gmo -> mrl -> phyto -> label -> sell;
}
EU -- Fertilizers Reg 2019/1009
| Requirement | Detail |
|---|
| Legal basis | Reg (EU) 2019/1009 -- in force 16 July 2022. Replaced Reg 2003/2003. CE mark for EU-wide circulation; national rules also still valid (dual system) |
| PFC (Product Function Categories) | 7 categories: organic fertilizer, organo-mineral, inorganic macronutrient/micronutrient, inorganic, liming material, soil improver, growing medium, inhibitor, plant biostimulant, fertilizing product blend |
| CMC (Component Material Categories) | 11 CMCs defining permitted input materials -- virgin material substances + mixtures, plants/plant parts/extracts, compost, digestate, animal by-products, recovered phosphate salts, etc. |
| Cadmium limit | Phosphorus fertilizers: 60 mg Cd/kg P2O5 (lowered from earlier proposal of 20 mg/kg) |
| Contaminant limits | Cd, Cr(VI), Hg, Ni, Pb, As, biuret, perchlorate, pathogens limits per PFC |
| CE marking pathway | Module A (self-declaration) for low-risk PFCs. Modules B+C (notified body) for organic + biostimulants |
| Cost | Self-declaration: EUR 5,000-20,000 dossier prep. NB module: EUR 15,000-60,000 |
EU -- Plant Protection Products (Pesticides) Reg 1107/2009
| Requirement | Detail |
|---|
| Legal basis | Reg (EC) 1107/2009 -- placing of PPPs on market |
| Two-step approval | (1) Active substance approval at EU level (EFSA peer review + Commission decision). (2) Product authorization at MS level |
| Zonal authorization | 3 zones: North (8 MS), Centre (12 MS), South (7 MS). Authorization in one MS = mutual recognition possible in zone |
| Endocrine disruptors | Cut-off criteria since 2018: ED actives banned unless derogation |
| SUD (Sustainable Use Directive) | Dir 2009/128/EC -- integrated pest management mandatory. SUR proposal (Sustainable Use Reg) withdrawn 2024, status uncertain |
| Glyphosate | Re-approved Nov 2023 for 10 years (until Dec 2033). Member States can still restrict |
| Cost | Active substance approval: EUR 1-5M + 5-10 years. Product authorization: EUR 100,000-500,000 + 2-3 years |
EU MRLs (Maximum Residue Limits)
| Tool | Detail |
|---|
| Reg 396/2005 | Sets MRLs for pesticides in food + feed. Database at ec.europa.eu/food/plant/pesticides/eu-pesticides-database |
| Default MRL | 0.01 mg/kg if no specific limit set |
| EFSA review | Continuous EFSA opinions trigger MRL updates ~ every 3 months |
| 3rd country exports | Imports must meet EU MRLs. Border rejections in RASFF system |
US -- EPA Pesticides + USDA Inputs
EPA Pesticide Registration
| Pathway | Detail |
|---|
| Legal basis | Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 USC 136 |
| Section 3 | Full federal registration. Requires data: tox, ecotox, environmental fate, residue, efficacy |
| Section 18 | Emergency exemption for specific use |
| Section 24(c) | Special Local Need (state-level additional use) |
| Section 25(b) | Minimum Risk Pesticides -- exempt from registration if active is on EPA 25(b) list (essential oils, etc.) + inert ingredients also on FIFRA exempt list |
| Timeline | New active ingredient: 4-7 years. New use of existing active: 2-3 years |
| Cost | New active: USD 5-15M data + USD 500,000+ EPA fees. New use: USD 500,000-2M |
USDA NOP (National Organic Program)
| Item | Rule |
|---|
| Legal basis | Organic Foods Production Act 1990 + 7 CFR Part 205 |
| Allowed substances | National List (7 CFR 205.601-205.606). Synthetic substances must be on the National List to be used |
| Certification | Third-party USDA-accredited certifier (e.g., CCOF, Oregon Tilth, QAI) |
| Labels | "100% Organic", "Organic" (95%+), "Made with Organic" (70%+), "Specific Organic Ingredients" (<70%) |
| Equivalence | EU-US Organic Equivalence Arrangement -- bidirectional recognition (with exceptions: apples/pears require non-antibiotic Streptomycin) |
EU -- Organic Reg 2018/848
| Requirement | Detail |
|---|
| Legal basis | Reg (EU) 2018/848 -- in force 1 Jan 2022. Replaced Reg 834/2007 |
| Scope expanded | Now includes salt, cork, rabbits, deer, certain micro-algae |
| Certification | Annual on-site control + unannounced checks. Certifier accredited by national authority |
| Group certification | New under 2018/848 -- smallholder groups |
| Import | Equivalent country list (US, Canada, Japan, Switzerland, etc.) OR control body recognition. Otherwise individual certification |
| EU organic logo | Mandatory for pre-packed organic food >95% organic ingredients. Code of control body + origin (EU/non-EU agriculture) |
| Greenhouse soil | Hydroponics NOT allowed in EU organic (unlike US NOP) |
| Cost | Certifier fees: EUR 500-5,000/year depending on size |
Japan -- JAS Organic
| Item | Rule |
|---|
| Legal basis | Japanese Agricultural Standards Law + JAS Organic Standard |
| Logo | JAS Organic mark mandatory on labelled organic products in Japan |
| Certification | Japan registered certifier OR accredited foreign certifier (RCO) |
| Equivalence | EU-Japan equivalence (for crops + processed plant products). US-Japan partial equivalence |
| Scope | Crops, processed crops, livestock (2020+), aquaculture (2022+) |
Seeds -- EU Reg 2016/1842
| Tool | Detail |
|---|
| EU seed legislation | 12 directives + 4 regulations. Major: 66/401/EEC (fodder), 66/402/EEC (cereal), 2002/53/EC (variety catalogue), Reg 2016/1842 (organic seed) |
| EU Common Catalogue | Varieties registered in any MS automatically marketable across EU |
| Plant variety rights | UPOV Convention 1991. CPVO (EU) issues 30-year (35 for trees/vines) Community Plant Variety Rights |
| GM-free seed marketing | Reg 1829/2003 + 1830/2003 -- traceability + labeling. Adventitious presence: 0.9% threshold for labelling |
| Organic seed | Under Reg 2018/848 -- "in conversion" + "organic" seeds + non-organic derogation register |
| Patents | Plants per se not patentable in EU (EPC Art 53(b)). But traits can be patented if not "essentially biological process". Disputed area |
GMO Labeling
| Market | Rule |
|---|
| EU | Reg 1829/2003 (food/feed) + 1830/2003 (traceability/labeling). Mandatory if GMO or product from GMO >0.9% adventitious. "Contains GMOs" or "Produced from genetically modified [name]" |
| US | Bioengineered (BE) Food Disclosure Standard 2018 (USDA AMS). Labels "Bioengineered Food" or QR/digital link. Threshold 5% inadvertent presence |
| Japan | 33 designated foods + 9 GM crops. Labeling threshold 5% |
| Brazil | "T" symbol mandatory for foods >1% GM |
| CRISPR / gene editing | EU: 2018 ECJ ruling = under GMO law. NGT regulation proposed 2023 (Cat 1 vs Cat 2) -- in trilogue 2025-2026. US: USDA SECURE rule exempts some gene-edited crops if equivalent to conventional breeding |
Phytosanitary -- ISPM 15 + IPPC
| Tool | Detail |
|---|
| IPPC | International Plant Protection Convention (FAO). 184 parties |
| ISPM 15 | International Standard for Phytosanitary Measures No. 15. Wood packaging material (pallets, crates) must be: (1) Heat treated (56C/30min) OR fumigated (methyl bromide -- being phased out). Marked with HT/MB stamp + IPPC logo + country code + producer ID |
| Phytosanitary certificate | Issued by exporting country NPPO. Required for: live plants, plant parts, seeds, soil, grains, fruits, vegetables, wood. Format: ISPM 12 model |
| EU plant passport | Reg 2016/2031 (Plant Health Reg). Plant passport for certain plants/products inside EU. Replaces previous "marketing passport" with broader scope |
| EU PHYTO database | TRACES NT system for phytosanitary imports |
Quarantine Pest Lists
- EU: Reg 2019/2072 lists 320+ EU quarantine pests + RNQPs (Regulated Non-Quarantine Pests)
- US: APHIS PPQ pest databases
- Australia: BICON import conditions database
Biostimulants (New Category under EU 2019/1009)
Plant biostimulants stimulate nutrition processes independently of nutrient content. Categories:
- Humic + fulvic acids
- Protein hydrolysates + amino acids
- Seaweed extracts + botanicals
- Microbial inoculants (mycorrhizal fungi, PGPR bacteria)
These were formerly regulated by some MS as PPPs (Italy), fertilizers (Spain), or nothing (UK). Now harmonized under EU 2019/1009 PFC 6.
Common Compliance Traps
- CE marking optional, national mandatory: EU 2019/1009 CE marking optional. Selling without CE mark still requires national fertilizer approval per MS.
- Glyphosate in formulations: Glyphosate re-approved at EU level but France, Germany, Austria restrict use. Product authorization per MS.
- MRL exceedance on imports: Default 0.01 mg/kg if no MRL set. Imported produce frequently rejected for active substances banned in EU but used in country of origin.
- Organic logo without certifier code: EU organic logo requires control body code + EU/non-EU origin statement. Logo alone not enough.
- ISPM 15 for any wood packaging: All wood pallets/crates entering EU/US/Japan must have ISPM 15 mark. Mark must be visible on at least 2 opposite sides.
- Seed marketing without variety listing: Selling seed of a variety NOT on EU Common Catalogue (or equivalent) = illegal. Heirloom/conservation varieties have separate route.
MCP Integration
mcp__claude_ai_Cleo_Insight__search_signals(q="glyphosate", country="EU")
mcp__claude_ai_Cleo_Insight__search_signals(q="organic equivalence")
mcp__claude_ai_Cleo_Insight__get_regulation(id="2018/848") # EU Organic
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
product_description: "potassium humate biostimulant"
target_markets: ["EU", "US"]
Power This With the Cleo Legal API
Agricultural compliance touches the EU Pesticides Database (1,400+ active substances), Reg 396/2005 MRL database (470+ pesticides x 800+ crops), EPA PPLS (registered pesticides), USDA National List (organic), EU Common Catalogue (40,000+ varieties), EUR-Lex 2019/1009 CMC tables. Updates roll out monthly.
With the Cleo Legal API at https://legaldata-public.cleolabs.co:
GET /v2/catalog/regulations?vertical=agri&country=EU,US,UK,JP — Fertilizer + PPP + Organic + Seed regs mappedPOST /v2/agri/mrl-check — feed crop + active substance + market, get MRL + EFSA review statusGET /v2/agri/active-substance?cas=... — active substance approval status across EU, US, UK, Japan (with expiry dates)GET /v2/agri/organic-equivalence?from=US&to=EU — current equivalence rules between organic systemsPOST /v2/webhooks?topic=mrl,active_substance,organic_list — monthly MRL changes + EU active substance non-renewals + USDA National List sunset reviews
Get started:
# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then EUR 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: For an agri input company with 30 SKUs across EU + US, the API replaces ~30 hours/month of EFSA + EPA + PPP zonal + USDA NOP lookups.
Common Mistakes
- Biostimulant treated as PPP: In Italy until 2022, biostimulants were under PPP regime. Now under 2019/1009 but old national approvals still need transition.
- Calling PPP "biostimulant": Selling a fungicide as "biostimulant" to skip authorization = product seizure + criminal.
- Forgetting hydroponic organic ban (EU): NOP allows hydroponic certified organic; EU 848 does NOT. Cannot sell EU product as organic if hydroponic.
- MRL set in zero: Default MRL is 0.01 mg/kg. Many active substances banned in EU have default MRL = effectively must be undetectable.
- Plant passport on B2C sales: Plant passport required for B2B sales of certain plants. B2C end consumer sales = no passport but certification may still apply (Heritage varieties).
- US Bioengineered Disclosure missing on imports: Imports of US-bound food containing detectable bioengineered ingredients must have BE disclosure even if foreign brand.
Cross-references
food-compliance -- MRLs in food, novel foods, organic crossoversubstance-screening -- active substance regulatory status, CAS lookupcustoms-and-trade -- HS chapter 31 (fertilizers), 38.08 (pesticides), 12 (seeds)sustainability-compliance -- EUDR (cocoa, coffee, palm, beef, soy, wood)claims-substantiation -- "natural", "organic", "biodynamic", carbon-neutral claims