The European Union, as one of the largest coffee importers in the world, enforces stringent food safety regulations to protect consumer health. Among the most critical of these is the regulation of mycotoxins, specifically Ochratoxin A (OTA), in imported food products such as green and roasted coffee. Ochratoxin A (OTA) is a toxin produced by molds that can contaminate coffee at multiple points in the supply chain.
For exporters, the stakes are high. Shipments failing to comply with OTA limits set by the European Union face border rejection, costly financial loss, reputational damage and potentially trade restrictions.
This article provides an exploration of OTA, the EU regulatory framework and practical suggestions to prevent costly rejections. To get all of our recommendations, we strongly encourage you to download our free white paper titled “Avoiding EU Border Rejection – A Coffee Exporter’s Guide to Ochratoxin A Compliance”. Download the white paper.
Understanding Ochratoxin A
Ochratoxin A is a naturally occurring mycotoxin produced primarily by Aspergillus ochraceus and Penicillium verrucosum. These molds thrive in warm, humid conditions-precisely the environments where coffee is cultivated, stored and shipped. Once established, OTA infiltrates beans and persists throughout the supply chain. Critically, roasting and processing reduce but do not reliably eliminate the toxin. OTA is classified by the International Agency for Research on Cancer (IARC) as a Group 2B carcinogen, meaning it is possibly carcinogenic to humans. OTA can develop at multiple points during drying, storage and transportation. Because roasting may only reduce OTA levels by 30-70% depending on conditions, prevention is the most reliable safeguard.
The EU Regulatory Landscape
The EU has among the strictest OTA regulations globally. The maximum permitted levels are:
- Roasted coffee (beans or ground): 3 μg/kg
- Instant (soluble) coffee: 5 μg/kg
Although no numeric limit exists for green coffee beans, the European Coffee Federation recommends a maximum 12.5% moisture content, since keeping beans dry is effectively a proxy for preventing OTA growth.
These EU limits are among the strictest in the world and compliance is actively monitored by national food safety authorities in all EU member states. Shipments of coffee entering the EU may be sampled and tested at the border for OTA. As regulations evolve, we recommend checking the appropriate government websites for the latest information.
Ensuring OTA Compliance
Below you will find some of the best practices for ensuring OTA compliance.
1. Follow Good Agricultural Practices (GAP): When drying, target a uniform moisture level of 10-12%. Additionally, during processing, remove any moldy, discolored, or insect-damaged beans, as these defects can allow fungi to grow.
2. Follow Good Storage Practices (GSP): Keep warehouses dry, cool, and well-ventilated, for example, by using pallets to keep coffee bags off the floor and away from walls (this prevents wicking of moisture). Also, install simple hygrometers and thermometers, check them daily and if humidity begins to rise (e.g., during the rainy season), use dehumidifiers or improve ventilation.
3. Pre-Shipment Testing
3.1 Test every lot or batch before shipping.
3.2 Use validated methods: High-Performance Liquid Chromatography (HPLC) is among the most established analytical methods for sensitivity and regulatory acceptance, while Liquid Chromatography-Mass Spectrometry (LC-MS/MS) offers high specificity and enables multi-mycotoxin profiling. Enzyme-Linked Immunosorbent Assay (ELISA) provides an efficient option for batch screening, and Lateral Flow Devices (rapid tests) deliver portable, fast results within a few minutes, making them suitable for field-level screening. A two-tier testing strategy is recommended, with rapid screening of all lots using ELISA or lateral flow tests, followed by confirmatory testing with HPLC or LC-MS/MS for positive or borderline results.
3.3 Use proper sampling methods: Collect incremental samples from across the lot and combine them into a single laboratory sample that accurately reflects the lot’s overall OTA level.
3.4 Record keeping and traceability: Maintaining thorough records of pre-shipment testing is not only a good practice but often a legal requirement.
4. Train your supply chain: Conduct training on proper harvesting (e.g., not picking up cherries that fell on moldy ground), drying and storage. Reinforce these practices with clear Standard Operating Procedures (SOPs) for each stage (drying, storage, sampling, etc.) focusing on mold prevention.
5. Investing in the Right Tools
Coffee exporters need rapid, sensitive and validated tools tailored to coffee matrices.
Symmetric Ochratoxin Coffee by ProGnosis Biotech:
- High sensitivity: LOD 0.6 ppb; LOQ 0.9 ppb; quantification range 0.9-20 ppb
- Validated for green and roasted coffee.
- Rapid results: About 10 minutes.
- Portable reader and digital records: The 3PR Mini portable reader can be connected via Bluetooth with an Android mobile app. It offers instant GPS-tagged results that can be easily shared anywhere, anytime. This helps in record-keeping and traceability. The 3PR Mini can scan 3 strips at a time, allowing for the analysis of multiple samples in a short period while the S-Flow reader can scan 6 strips at the same time.
By integrating rapid testing with robust Standard Operating Procedures (SOPs), exporters can:
- Detect issues before shipment.
- Provide buyers with documented proof of compliance.
- Strengthen trust and secure long-term trade relationships.
Next Steps:
Ochratoxin A contamination is invisible to the naked eye, yet highly visible to regulators and buyers. Exporters who implement proactive OTA control systems protect not only their shipments but also their reputation, financial stability and long-term access to premium markets.
The EU-and other global markets-reward exporters who demonstrate diligence, reliability and traceability. By embedding OTA testing into routine operations, coffee businesses can transform compliance from a regulatory burden into a competitive advantage.
What’s covered here is only a small part of our full set of recommendations. For more useful information and recommendations, we strongly encourage you to download our free white paper titled “Avoiding EU Border Rejection – A Coffee Exporter’s Guide to Ochratoxin A Compliance”. Inside, you’ll find practical strategies, expert insights, and comprehensive guidance to help safeguard your exports and ensure compliance with international regulations.
Learn more about Symmetric Ochratoxin Coffee.
References
European Coffee Federation (ECF) – OTA Code of Practice & Moisture Recommendations
European Commission Regulation (EU) 2022/1370 – Updated OTA limits for coffee, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1370
European Union Commission Regulation, Laying Down the Methods of Sampling and Analysis for the Official Control of the Levels of Mycotoxins in Foodstuffs, https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R0401:20100313:EN:PDF
European Union General Principles and Requirements of Food Law, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002R0178
European Union Regulation No 178/2002 (updated version of 2024), Laying down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority, and Laying Down Procedures in Matters of Food Safety, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002R0178
European Union Regulation 2023/915, Maximum Levels for Certain Contaminants in Food, https://eur-lex.europa.eu/eli/reg/2023/915/oj/eng
International Agency for Research on Cancer – Classification of Ochratoxin A as Group 2B carcinogen
ProGnosis Biotech – Symmetric Ochratoxin Coffee product data
Rapid Alert System for Food and Feed (RASFF), https://food.ec.europa.eu/food-safety/rasff_en – Recent alert for OTA in coffee
The Food and Agriculture Organization (FAO) of the United Nations, Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Coffee, https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B69-2009%252FCXC_069e.pdf
The U.S. Food and Drug Administration, Information on Mycotoxins, https://www.fda.gov/food/natural-toxins-food/mycotoxins
