Introduction
For a Hazard Analysis and Critical Control Point (HACCP) plan to be robust, it is essential to systematically identify and characterize all potential food safety risks. To facilitate this critical stage of risk assessment, we have developed comprehensive hazard analysis tables addressing various categories of contaminants.
The information provided below focuses specifically on biotoxins, encompassing bacterial toxins, marine biotoxins, and phytotoxins. These are poisonous substances produced by living organisms that can cause acute or chronic adverse health effects when ingested through contaminated food. The following hazard table provides a detailed overview of these biological hazards, outlining their primary sources, typical food vectors, effective mitigation strategies, and the necessary monitoring procedures for their control.
Given the technical density and the number of parameters detailed across the columns, it is recommended to download the full file for an optimal and complete view of the data.
What are bacterial biotoxins?
Bacterial biotoxins are poisonous substances produced by certain microorganisms that can cause severe illness when ingested. Unlike the bacteria themselves, these toxins are chemical byproducts—specifically secondary metabolites or structural components. This category includes potent substances such as botulinum neurotoxins, staphylococcal enterotoxins, and the emetic toxin of Bacillus cereus.
These toxins can enter the food supply chain if bacteria proliferate in raw ingredients or finished products due to temperature abuse. A critical challenge for food safety management is that many of these toxins are heat-stable; while the bacteria may be destroyed during cooking, the pre-formed toxins often remain active and hazardous.
To ensure consumer protection, the food industry implements rigorous preventative controls. These focus on inhibiting bacterial growth and subsequent toxin production through strict cold chain management, acidification, or limiting water activity ($a_w$). By maintaining high standards of process hygiene and adhering to regulatory safety limits, the industry effectively mitigates the risk from these biological hazards.
iMIS Food - Chemical Hazards - Bacterial Toxins Table
| Name | Group | Origin | Food Products | Health Effects | Thresholds | Regulation (EU) | Prevention & Control | Characteristics |
|---|---|---|---|---|---|---|---|---|
| Staphylococcal enterotoxins | Intoxication | S. aureus | Deli salads, cooked ham, pastries. | Food poisoning (vomiting, cramps). | MIDo: <1 ug. | • Reg. (EC) 2073/2005 (vegetative cells) • Reg. (EC) 852/2004 (GHP) |
• Temperature control. • Hand hygiene. |
Extremely heat resistant. |
| Botulinum neurotoxins | Intoxication | C. botulinum | Canned foods, vacuum-packed fish. | Botulism (paralysis). | Lethal dose: 30-100 ng. | • Reg. (EC) 852/2004 (GHP) • Reg. (EC) 853/2004 (GHP) |
• Validated canning. • pH control. |
Destroyed by heat. |
| Cereulide | Intoxication | B. cereus | Rice, pasta, starchy stews. | Emetic syndrome (vomiting). | MIDo: 8-10 ug/kg bw. | • Reg. (EC) 2073/2005 (vegetative cells) • Reg. (EC) 852/2004 (GHP) |
• Rapid cooling. • Hot holding. |
Extremely heat resistant. |
| Shiga toxins | Toxico-infection | STEC/VTEC | Ground beef, sprouts, raw milk. | Haemorrhagic colitis. | MID: 10-100 cells. | • Reg. (EC) 2073/2005 (vegetative cells) • Reg. (EC) 853/2004 (GHP) |
• Cooking meat >70°C. • Farm hygiene. |
Destroyed by heat. |
| Perfringens enterotoxin | Toxico-infection | C. perfringens | Stews, gravies, large meat batches. | Perfringens food poisoning. | TPT: >1,000,000 cells. | • Reg. (EC) 853/2004 (GHP) • Reg. (EC) 852/2004 (GHP) |
• Rapid cooling. • Small portions. |
Destroyed by heat. |
| Histamine | Biogenic amine | Morganella spp. | Tuna, mackerel, fish sauce. | Scombroid poisoning. | NOAEL: 50 mg/meal. | • Reg. (EC) 2073/2005 (toxin) • Reg. (EC) 853/2004 (GHP) |
• Rapid chilling. • Testing. |
Heat resistant. |
Download and Print the Bacterial Biotoxins Hazards Table
What are marine biotoxins?
Marine biotoxins are poisonous substances produced by certain species of algae and cyanobacteria, which can cause acute illness in humans when ingested. These toxins, such as saxitoxin, okadaic acid, and domoic acid, are often categorized by the clinical syndromes they induce, including paralytic shellfish poisoning (psp), diarrhetic shellfish poisoning (dsp), and amnesic shellfish poisoning (asp).
These hazards primarily enter the food supply through the consumption of contaminated filter-feeding shellfish (such as mussels, clams, and oysters) or certain fish species. During harmful algal blooms (habs), shellfish accumulate these toxins in their tissues at concentrations that are dangerous to humans, even if the shellfish themselves appear healthy. A major challenge for food safety management is that most marine biotoxins are heat-stable and are not deactivated by standard cooking, steaming, or freezing processes.
To ensure consumer protection, the food industry and regulatory bodies implement strict monitoring programs for harvesting areas. Controls involve the routine sampling of seawater for toxic algae and the laboratory testing of shellfish meat for toxin levels. If concentrations exceed established regulatory limits, harvesting areas are closed until levels subside. By combining these surveillance measures with sourcing from certified waters, the industry effectively minimizes the risk of shellfish poisoning incidents.
iMIS Food - Chemical Hazards - Marine Biotoxins Table
| Name | Origin | Food Products | Health Effects | Toxicological Thresholds | Regulation (EU) | Prevention | Comments |
|---|---|---|---|---|---|---|---|
| Domoic Acid (DA) |
Diatoms: Pseudo-nitzschia spp. | Bivalve molluscs (mussels, scallops, clams), crustaceans, small fish. | Amnesic Shellfish Poisoning (ASP). Gastrointestinal symptoms followed by severe neurological symptoms and memory loss. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Sets a Maximum Level (ML). | Monitor toxic algae in harvesting areas. Test shellfish raw materials. Close harvesting areas when regulatory limits are exceeded. | Water-soluble and heat-stable; cooking does not destroy the toxin. Accumulates primarily in the guts. |
| Saxitoxins (STXs) |
Dinoflagellates: Alexandrium, Gymnodinium, Pyrodinium spp. | Bivalve molluscs (mussels, scallops, clams, oysters). | Paralytic Shellfish Poisoning (PSP). Severe neurotoxic illness leading to paralysis, respiratory distress, and potential death. | Health-based guidance values exist (ARfD). Total oral dose of 1-4 mg can be lethal. | ∙ Reg. (EC) No 853/2004: Sets a Maximum Level (ML). | Monitor phytoplankton for toxic species. Test shellfish using approved methods. Close harvesting areas immediately if limits are exceeded. | A potent group of neurotoxins. Water-soluble and heat-stable. |
| Okadaic Acid (OA) & Dinophysistoxins (DTXs) |
Dinoflagellates: Dinophysis, Prorocentrum spp. | Bivalve molluscs (mussels, scallops, clams, oysters). | Diarrhetic Shellfish Poisoning (DSP). Severe gastrointestinal symptoms: diarrhoea, nausea, vomiting. Self-limiting. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Sets a Maximum Limit for the DSP group. | Monitor phytoplankton. Test shellfish for toxin content. Close harvesting areas when regulatory limits are exceeded. | Lipophilic (fat-soluble) and heat-stable. These toxins can promote tumour growth. |
| Pectenotoxins (PTXs) |
Dinoflagellates: Dinophysis spp. | Bivalve molluscs (mussels, scallops). | Not linked to diarrhetic illness. Hepatotoxic (toxic to the liver) in animal studies. | No specific human oral threshold established. | ∙ Reg. (EC) No 853/2004: Regulated together with the DSP group. | Monitored as part of the DSP toxin complex. Close harvesting areas when the combined limit is exceeded. | Lipophilic. Often co-occur with OA and DTXs. Regulated due to observed toxic effects. |
| Yessotoxins (YTXs) |
Dinoflagellates: Protoceratium, Lingulodinium, Gonyaulax spp. | Bivalve molluscs (mussels, scallops, clams). | No confirmed human illness from consumption. Cardiotoxic in animals. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Sets a Maximum Limit (ML). | Monitor toxin levels in shellfish. Close harvesting areas when limits are exceeded. | Lipophilic. Regulated as a precaution despite low oral toxicity to humans. |
| Azaspiracids (AZAs) |
Dinoflagellates: Azadinium, Amphidoma spp. | Bivalve molluscs (mussels, oysters, scallops, clams), crustaceans. | Azaspiracid Shellfish Poisoning (AZP). Severe gastrointestinal symptoms similar to DSP, potentially more severe. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Sets a Maximum Level (ML). | Monitor phytoplankton for toxic species. Test shellfish via approved methods. Close harvesting areas immediately. | Lipophilic and heat-stable. A recurring concern in several European countries. |
| Brevetoxins (BTXs) |
Dinoflagellates: Karenia spp. (mainly K. brevis) | Bivalve molluscs (oysters, clams, mussels). | Neurotoxic Shellfish Poisoning (NSP). Gastrointestinal and neurological symptoms. Respiratory irritation from aerosol exposure. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Prohibits marketing of fish containing biotoxins. | Monitor for Karenia blooms ("red tides"). Test shellfish in affected areas. Close harvesting areas. | Lipophilic and heat-stable. Considered an emerging risk in Europe. |
| Ciguatoxins (CTXs) & Maitotoxins (MTXs) |
Dinoflagellates: Gambierdiscus, Fukuyoa spp. | Large predatory reef fish (barracuda, grouper, snapper). | Ciguatera Fish Poisoning (CFP). Complex illness with gastrointestinal, cardiovascular, and neurological symptoms. Symptoms can persist for months. | Health-based guidance values exist (ARfD). | ∙ Reg. (EC) No 853/2004: Prohibits marketing of fish containing biotoxins. | Strict sourcing controls. Avoid sourcing fish from known endemic areas. Do not use fish viscera (guts). | Lipophilic, heat-stable, and stable to freezing; cooking does not destroy them. A tropical risk emerging in Europe. |
| Tetrodotoxin (TTX) |
Marine bacteria (e.g., Vibrio, Pseudoalteromonas spp.). | Pufferfish (Tetraodontidae). Also found in some bivalves and crabs. | Pufferfish Poisoning. Potent neurotoxin causing paralysis, respiratory failure, and death. High mortality rate. | Health-based guidance values exist (ARfD). A total oral dose of 1-2 mg can be lethal. | ∙ Reg. (EC) No 853/2004: Prohibits marketing of Tetraodontidae (pufferfish). | Strict prohibition on sourcing/sale of pufferfish. Monitor shellfish in high-risk areas. | Water-soluble and heat-stable. An emerging risk in Europe, found in invasive pufferfish species. |
| Palytoxin (PlTX) & Ostreocins |
Dinoflagellates: Ostreopsis spp.; Soft corals: Palythoa spp. | Shellfish (mussels, clams, sea urchins), crabs, and fish. | Palytoxin Poisoning. Extremely potent. Severe gastrointestinal symptoms, muscle breakdown, respiratory distress, potentially fatal. | No official human threshold established. | ∙ Reg. (EC) No 853/2004: Prohibits marketing of fish containing biotoxins. | Monitor coastal waters for Ostreopsis blooms. Close harvesting areas. Advise staff on handling raw materials. | Heat-stable. One of the most potent non-protein toxins known. An emerging issue in the Mediterranean. |
| Cyclic Imines (CIs) |
Dinoflagellates: Alexandrium, Karenia, Vulcanodinium spp. | Bivalve molluscs (clams, mussels, scallops, oysters). | No confirmed human poisoning. Act as fast-acting neurotoxins in animals. Human symptoms unknown. | No human thresholds established due to lack of data. | No specific EU-wide limits. Currently under research. | Sourcing from areas with phytoplankton monitoring. Risk is currently considered low. | Lipophilic. A diverse group of "emerging toxins" detected at low levels in European shellfish. |
* More in detail regulations and specific limits available on our platform, check iMIS Food for more information 
Download and Print the Marine Biotoxins Hazards Table
What are plant biotoxins?
Phytotoxins are naturally occurring poisonous substances produced by plants, often as a defense mechanism against herbivores or microbial pathogens. This broad category includes hazardous compounds such as pyrrolizidine alkaloids (pas), glycoalkaloids (found in potatoes), and cyanogenic glycosides (present in cassava or stone fruit pits), which can cause acute or chronic health effects in humans.
These toxins can enter the food supply chain through various pathways. Some are inherent to the edible plant itself and may increase due to poor storage or physical damage, while others, like pas, enter the food chain as contaminants when toxic weeds are accidentally harvested alongside food crops like cereals, herbs, or tea. A major challenge for food safety management is that many phytotoxins are heat-stable, meaning standard domestic cooking or industrial processing does not always eliminate the risk.
To ensure consumer protection, the food industry and regulatory bodies implement strict preventative controls. These focus on good agricultural practices (GAP) to manage weed contamination, specialized sorting and cleaning processes, and the development of plant varieties with lower toxin levels. Regulatory agencies also establish maximum levels for specific toxins in high-risk commodities. By combining these field-to-fork measures with rigorous laboratory testing, the industry effectively mitigates the risk posed by these natural plant hazards
| Name | Origin | Food Products | Health Effects | Toxicological Thresholds | Regulation (EU) | Prevention | Comments |
|---|---|---|---|---|---|---|---|
| Pyrrolizidine Alkaloids (PAs) |
Natural toxins from various weed species (e.g., Senecio, Echium). Contamination occurs via co-harvesting. | Herbal teas, tea, honey, spices, salads, grains. | Genotoxic carcinogens. Primary target is the liver, causing severe liver disease. | No Tolerable Daily Intake (TDI) established. Health-based guidance values exist (BMDL). | ∙ Reg. (EU) 2023/915: Sets Maximum Levels (MLs) for various foods. | GAP to control weeds in the field. Physical sorting of raw materials (e.g., tea leaves, seeds). | Heat-stable and survive processing/cooking. A large family of toxins monitored in the EU. |
| Tropane Alkaloids (TAs) |
Natural toxins from Solanaceae plants (e.g., Datura stramonium). Contamination via co-harvested seeds. | Grains (millet, sorghum), cereal-based foods, herbal infusions. | Potent anticholinergic agents. Acute symptoms: dry mouth, dilated pupils, confusion, hallucinations. | Acute Reference Dose (ARfD) exists. | ∙ Reg. (EU) 2023/915: Sets MLs for the sum of atropine and scopolamine. | GAP to control weeds. Physical cleaning and sorting of grains to remove seeds. | The hazard is acute toxicity, especially for infants. The toxins are heat-stable. |
| Cyanogenic Glycosides (e.g., Amygdalin, Linamarin) |
Natural plant components that release hydrogen cyanide (HCN) when the plant tissue is crushed. | Raw apricot kernels, bitter almonds, cassava, linseeds. | Acute cyanide poisoning. Blocks cellular respiration. Can lead to respiratory failure and death. | Acute Reference Dose (ARfD) exists for cyanide. | ∙ Reg. (EU) 2023/915: Sets MLs for hydrocyanic acid (HCN). | Critical: Processing (peeling, grating, soaking, boiling) is essential to release and eliminate HCN, especially for cassava. | The hazard is the volatile HCN, not the original compound. Proper processing is the critical control step. |
| Glycoalkaloids (Solanine & Chaconine) |
Natural toxins produced by potatoes (Solanum tuberosum). Levels increase when tubers are exposed to light (greening). | Potatoes and potato products. Also found in green tomatoes. | Acute toxicity. Gastrointestinal disorders (nausea, vomiting, diarrhoea) and neurological symptoms. | Toxic dose established at >1 mg/kg bw. Potatoes >200 mg/kg are considered unsafe. | No specific MLs. Monitoring levels is recommended. | Proper storage in dark, cool conditions. Peeling, removing green parts and sprouts before consumption. | Heat-stable; cooking methods do not destroy them. They concentrate in the skin and green parts. |
| Phytohaemagglutinin (Lectins) |
Natural toxic protein (lectin) found especially high in red kidney beans (Phaseolus vulgaris). | Raw or improperly cooked beans (red kidney, cannellini, broad beans). | Acute gastrointestinal illness. Rapid onset of extreme nausea, profuse vomiting, diarrhoea. | As few as 4-5 raw beans can cause illness. | No specific MLs. | Soaking beans for >5 hours, discarding water, and then **boiling vigorously** for at least 30 minutes. | The toxin is heat-labile (destroyed by heat). Slow cookers may not reach a high enough temperature. |
| Erucic Acid | Natural fatty acid in the oils of plants from the Brassicaceae family (rapeseed, mustard). | Vegetable oils (rapeseed oil, mustard oil), fats, baked goods, infant formula. | High long-term intake is associated with myocardial lipidosis (fat accumulation in heart muscle) in animal studies. | Tolerable Daily Intake (TDI) exists. | ∙ Reg. (EU) 2023/915: Sets Maximum Levels (MLs) for oils and fats. | Sourcing low-erucic acid rapeseed (LEAR) varieties (canola). | Not a contaminant. Levels are controlled through plant breeding. |
| Opium Alkaloids (e.g., Morphine, Codeine) |
Natural compounds from the opium poppy (Papaver somniferum). Contamination is on the seed surface. | Poppy seeds (for baking), bakery products containing poppy seeds. | Opioid effects: drowsiness, nausea, dizziness. High doses can lead to respiratory depression. | Acute Reference Dose (ARfD) exists. | ∙ Reg. (EU) 2023/915: Sets MLs for the sum of morphine and codeine. | Food processing (washing, heating) can reduce alkaloid content. Sourcing seeds with certified low alkaloid content. | The toxins are heat-stable. Consumption can result in a positive drug test for opiates. |
| Coumarin | Natural flavouring compound found in high concentrations in "Cassia" cinnamon (Cinnamomum cassia). | Cassia cinnamon powder, bakery products, desserts, teas containing Cassia. | Liver toxicity with chronic high exposure in sensitive individuals. | Tolerable Daily Intake (TDI) exists. | ∙ Reg. (EC) 1334/2008 (Flavourings): Sets MLs for coumarin in specific food categories. | Sourcing Ceylon cinnamon (Cinnamomum verum), which has negligible coumarin content. | Regulated as a natural undesirable substance in flavourings. |
| Furocoumarins (e.g., Psoralens) |
Natural toxins produced by plants (e.g., Apiaceae family) as a defence mechanism when stressed. | Celery, parsnips, citrus fruits (grapefruit, bergamot), and their juices. | Phototoxic. Causes skin inflammation when exposed to UV light after contact. | No human threshold established. | ∙ Reg. (EC) 1334/2008: Restricts levels in certain beverages. | Moderation of intake. Peeling root vegetables (toxins are highest in the peel). | Known for the "grapefruit juice effect," where they interfere with drug metabolism. |
| Oxalates (Oxalic Acid) |
Natural organic acid found as soluble and insoluble salts. | Rhubarb (especially leaves), spinach, beet greens, tea, cocoa. | Antinutrient. Reduces mineral (calcium, iron) absorption. Can form calcium oxalate kidney stones in susceptible individuals. | Acute toxic dose estimated at 2-5 grams. | No specific MLs. Rhubarb leaves are considered unfit for consumption. | Discarding rhubarb leaves. Blanching and boiling reduces soluble oxalate content. | Insoluble crystals in some plants cause immediate mouth irritation. |
| Goitrogens (Glucosinolates) |
Natural compounds in cruciferous vegetables (Brassicaceae family) and soy. | Raw broccoli, cabbage, kale, Brussels sprouts, soy products. | Antinutrient. Interferes with iodine uptake by the thyroid, potentially leading to goiter. | No specific toxic dose established. Effect is conditional on iodine status. | No specific MLs. Hazard is considered negligible with adequate iodine intake. | Cooking (boiling, steaming) deactivates the enzyme that releases the active goitrogenic compounds. Ensuring adequate iodine intake. | Risk is negligible for healthy individuals. Compounds are also studied for beneficial health effects. |
| Phytic Acid (Phytates) |
The primary storage form of phosphorus in the bran and hull of grains and seeds. | Whole grains (wheat bran), beans, legumes, raw nuts, and seeds. | Antinutrient. Binds strongly to essential minerals (iron, zinc, calcium), reducing their absorption. | Not acutely toxic. Adverse effects are chronic and related to overall diet. | No specific MLs. | Processing methods like soaking, sprouting, and fermentation activate the enzyme phytase, which breaks down phytic acid. | Impact is most significant in diets heavily reliant on unrefined cereals. Can also have beneficial antioxidant properties. |
| Saponins | Diverse group of natural glycosides that have soap-like properties. | Quinoa (coating on the seed), beans, lentils, chickpeas, soy. | Poorly absorbed. High concentrations impart a bitter taste and can cause local gastrointestinal irritation. | No specific toxic dose for food. | No specific MLs. Hazard is managed by processing. | Rinsing quinoa thoroughly under running water to remove the bitter coating. Soaking and cooking legumes also reduces content. | Responsible for the foaming characteristic of soaked legume water (aquafaba). |
| Grayanotoxins (GTXs) |
Natural neurotoxins produced by Rhododendron species. Bees collect nectar from these flowers. | "Mad honey" (honey produced from Rhododendron nectar). | "Mad Honey Poisoning" (Deli Bal). Acute onset of dizziness, low blood pressure, slow heart rate, nausea, vomiting. | A single teaspoon of highly toxic honey can cause illness. | No specific MLs. Managed under General Food Law (Reg. (EC) 178/2002). | Sourcing honey from trusted suppliers. Diluting/blending honey from high-risk regions. | Rare intoxication. The toxins are heat-stable and survive pasteurization. Known risk in honey from specific regions. |
| Quinolizidine Alkaloids (QAs) |
Natural toxins produced by Lupinus (lupin) plants. | "Bitter" lupin seeds and flour. "Sweet" lupins are low-level varieties. | Acute neurotoxicity. Symptoms include dizziness, confusion, nausea, and potential respiratory paralysis. | Tolerable Daily Intake (TDI) established. | No specific MLs. Industry standards are used for "sweet" lupin varieties. | Sourcing "sweet" lupin varieties. "Bitter" lupins require traditional processing (soaking/boiling) to leach out the water-soluble toxins. | The hazard is from unprocessed "bitter" lupins. The toxins are water-soluble. |
Download and Print the Plant Biotoxins Table
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