Ochratoxin A (OTA) is a mycotoxin produced by Aspergillus and Penicillium species, commonly associated with improper drying and storage conditions in coffee and cocoa supply chains. For global food manufacturers and importers, OTA remains one of the most operationally relevant contaminants due to its persistence, trade sensitivity, and tightening regulatory scrutiny—especially in the EU.
This article provides a compliance-first view of OTA limits in coffee and cocoa products across the EU, United States, and China, focusing on what is legally required today, how enforcement works in practice, and what QA and regulatory teams should prepare for next.
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European Union: The EU applies binding maximum levels (MLs) for OTA in roasted coffee, instant coffee, and cocoa powder under Regulation (EU) 1881/2006 as amended. Non-compliance leads directly to border rejections and withdrawals.
United States: No federal maximum limits exist for OTA in coffee or cocoa. However, FDA can consider products with OTA as adulterated and take enforcement action.
China: China has established OTA limits for coffee (roasted and instant) under GB 2761, but no limits for cocoa or chocolate products.
For exporters and importers, the EU remains the strictest and most predictable jurisdiction, while the US operates on a case-by-case enforcement model, and China applies product-specific limits.
|
Product |
EU |
USA |
China |
|---|---|---|---|
|
Green coffee beans |
No ML |
No ML |
No ML |
|
Roasted / ground coffee |
3 µg/kg |
No ML |
5 µg/kg |
|
Instant (soluble) coffee |
5 µg/kg |
No ML |
10 µg/kg |
|
Product |
EU |
USA |
China |
|---|---|---|---|
|
Cocoa beans |
No ML |
No ML |
No ML |
|
Cocoa powder |
3 µg/kg |
No ML |
No ML |
|
Chocolate / cocoa-based products |
No ML |
No ML |
No ML |
Key point: Absence of a legal ML does not mean absence of enforcement risk, particularly in the US.
In the European Union, OTA enforcement is systematic and highly standardized. Coffee and cocoa products are routinely sampled at border control points and during market surveillance, using statistically defined sampling plans. Analytical testing is performed by accredited laboratories, typically using HPLC or LC-MS methods, and results are treated as legally decisive.
When OTA levels exceed the applicable maximum limits, consignments are rejected, withdrawn from the market, or destroyed. Notifications through the Rapid Alert System for Food and Feed (RASFF) are common, particularly for roasted coffee, instant coffee, and cocoa powder. As a result, EU maximum levels function not only as legal thresholds but also as de facto trade standards. Even products not destined for the EU are frequently tested against EU limits upstream, given their influence on global sourcing and redistribution.
The United States takes a fundamentally different approach. There are no federal numeric maximum limits for OTA in coffee or cocoa products. Instead, FDA operates under general food safety provisions, where products containing OTA may be considered adulterated if they pose a potential health risk.
Enforcement is discretionary and risk-based. FDA may detain shipments, including under Import Alerts that allow detention without physical examination, depending on contamination levels, exposure considerations, and the importer’s compliance history. Because of this regulatory ambiguity, enforcement outcomes can vary from case to case. In practice, many operators use EU limits as internal reference points to manage uncertainty, even though these limits are not legally binding in the US.
China applies explicit OTA limits for coffee products under national food safety standards, and these limits are enforced at import inspection. Roasted and instant coffee are subject to defined thresholds, providing relative clarity for exporters.
For cocoa and cocoa-derived products, however, no specific numeric OTA limits are established. In these cases, authorities may still assess contamination under general food safety provisions. As a result, exporters often default to EU compliance levels as a conservative benchmark when supplying cocoa products to the Chinese market, despite the absence of formal limits.
Green coffee beans are the primary risk carrier
Critical factors: slow drying, high humidity, poor warehouse ventilation
OTA is partially heat-stable; roasting reduces but does not eliminate it
Instant coffee concentrates OTA if contaminated raw material is used
OTA forms during fermentation, drying, and storage
Poor turning practices and delayed drying increase risk
Cocoa powder concentrates OTA relative to beans
Chocolate generally presents lower risk due to dilution, but contaminated powder remains a concern
The EU has completed recent updates to OTA limits; no immediate revisions are pending, but enforcement intensity is increasing
The US continues to rely on discretionary enforcement rather than numeric limits
China may expand mycotoxin coverage in future GB standard revisions
Codex Alimentarius remains a reference point but not legally binding
For global operators, OTA in coffee and cocoa remains a trade-critical contaminant, not a theoretical risk. The companies that treat OTA proactively—rather than reactively—are best positioned to avoid costly disruptions.
European Commission — Regulation (EU) 1881/2006 and amendments (including 2022/1370)
EFSA — Scientific opinions on Ochratoxin A
US Food and Drug Administration (FDA) — Mycotoxin monitoring and import enforcement
National Health Commission of China / SAMR — GB 2761 National Food Safety Standards
Codex Alimentarius — Mycotoxin codes of practice (reference benchmark only)