Reviewed by Dr Yong Yi Yi, Bionutricia
Mycotoxins are toxic metabolites produced by moulds on plant material, and the ones regulators actually set limits for in botanicals are the aflatoxins (B1, B2, G1, G2) and ochratoxin A. Because extraction concentrates the plant, a botanical extract must be screened on the finished powder — by HPLC-FLD or LC-MS/MS — and the result evidenced on a batch-specific Certificate of Analysis. Here is what a bulk buyer should require.
Quick facts
- The regulated ones: aflatoxin B1 and total aflatoxins (B1+B2+G1+G2), plus ochratoxin A (OTA)
- Key risk: mycotoxins are heat-stable and survive drying, milling and spray drying — and extraction can concentrate them
- Reference frameworks: Regulation (EU) 2023/915, US FDA action level, Codex Alimentarius, Malaysian Food Regulations 1985
- Test methods: HPLC with fluorescence detection (immunoaffinity clean-up) and LC-MS/MS; ELISA for rapid screening only
- Best control: prevention upstream — drying rate, water activity and storage — not testing at the end
What are mycotoxins, and which ones matter for botanical extracts?
Mycotoxins are secondary metabolites produced by moulds — principally Aspergillus, Penicillium and Fusarium species — that colonise plant material in the field, during drying, or in storage. For dried botanicals and their extracts, two groups dominate the regulatory conversation:
- Aflatoxins (B1, B2, G1, G2), produced mainly by Aspergillus flavus and A. parasiticus. Aflatoxin B1 is the most tightly regulated single compound, and limits are usually written twice: once for B1 alone and once for the sum of all four.
- Ochratoxin A (OTA), produced by Aspergillus and Penicillium species, and a common finding in dried spices, liquorice, cocoa and coffee-adjacent materials.
The property that makes them a specification problem rather than a hygiene problem is stability. Mycotoxins are not living organisms. Killing the mould does not remove the toxin: it survives drying, milling, pasteurisation and spray drying largely intact. A microbial count on a COA therefore tells you nothing about mycotoxin status — they are two separate tests answering two separate questions.
Why extraction concentrates mycotoxins
This is the point most buyers miss, and it is the same mechanism that drives the pesticide-residue problem. An extract is a concentrate. A 10:1 extract takes roughly ten parts of dried botanical down to one part of finished powder, and any contaminant that partitions into the extract travels with the actives.
The practical consequence is blunt: a mycotoxin result on the raw material does not clear the extract. A herb that tested comfortably below an aflatoxin limit can, once concentrated, sit above it. Whether it actually does depends on the solubility of the toxin in the extraction system and on the clean-up steps applied — which is precisely why the finished extract has to be tested at the extraction ratio being purchased. Any supplier offering only a raw-material mycotoxin certificate has answered a different question from the one you asked.
Which limits apply in your market?
There is no single global mycotoxin limit for botanicals. The binding figure depends on where the finished product is sold, and on how the material is classified in that market — dried spice, dried herb, food supplement or food ingredient. The frameworks buyers reference most often are:
| Framework | What it covers |
|---|---|
| Regulation (EU) 2023/915 | The consolidated EU regime for contaminants in food, including aflatoxin B1, total aflatoxins and ochratoxin A. Limits are set per commodity category and are among the strictest in world trade. Confirm the current figure for your exact category before you specify. |
| US FDA action level | The United States applies an action level for total aflatoxins in food; ochratoxin A is not subject to an equivalent published limit but is still screened by many buyers. |
| Codex Alimentarius | International reference limits, widely used as a baseline where no national figure exists, and frequently the basis for Gulf-market requirements. |
| Malaysian Food Regulations 1985 | The domestic framework governing mycotoxin limits for food sold in Malaysia, administered by the Ministry of Health. |
The safe practice is the same one that applies to pesticide residues: specify the strictest market you intend to serve and test to it. Material that clears EU limits will in most cases clear looser regimes elsewhere, and you avoid re-testing every time a new export destination appears. Because these limits are revised periodically, a specification should reference the regulation rather than hard-code a number that will quietly go out of date.
How mycotoxins are tested
| Method | Use and limitation |
|---|---|
| HPLC with fluorescence detection (HPLC-FLD) | The classical reference approach for aflatoxins and OTA, using immunoaffinity column clean-up. Sensitive, well established and widely accepted by regulators. |
| LC-MS/MS | Tandem mass spectrometry, able to quantify several mycotoxins in one run with confirmatory identification. The preferred route where a multi-toxin panel is required. |
| ELISA / lateral flow | Rapid immunoassay screening, useful for incoming raw-material triage and high sample throughput. Prone to matrix interference in complex botanicals — a positive should always be confirmed chromatographically. |
Two details separate a meaningful report from a decorative one. The first is sampling: mycotoxin contamination is notoriously heterogeneous, concentrated in a small number of affected particles, so a single grab sample from one corner of a batch is not representative. Composite sampling across the lot is what makes the number defensible. The second is the limit of quantification. A result of “not detected” is meaningless without the LOQ that sits behind it — not detected at 2 µg/kg and not detected at 0.1 µg/kg are very different statements.
Prevention beats testing
Testing tells you whether a lot passed. It does not stop the toxin forming, and by the time a mycotoxin is present there is no practical way to remove it from a finished extract. Control therefore sits upstream, in the raw-material chain:
- Speed of drying after harvest. Mould growth happens in the window between harvest and stable moisture. The narrower that window, the lower the risk.
- Water activity, not just moisture. Below roughly 0.70 aw, toxigenic moulds cannot grow. Moisture content alone can be misleading; water activity is the parameter that governs microbial growth.
- Storage and transport. Temperature swings cause condensation inside packaging, creating localised high-humidity pockets where mould establishes even in a lot that was dry on despatch.
- Supplier qualification and incoming testing. Screening incoming raw material by rapid method, with chromatographic confirmation of any suspect lot, keeps contaminated material out of the process instead of discovering it in the finished goods.
- A HACCP plan that names mycotoxins as a hazard at the raw-material step, with a defined control and verification — which is what a certified food-safety management system requires.
What to require on the spec and COA
| Require | What “good” looks like |
|---|---|
| Analytes named individually | Aflatoxin B1 and total aflatoxins reported separately, plus ochratoxin A where the commodity warrants it — not a single line reading “mycotoxins: complies”. |
| Tested on the finished extract | The result is generated on the extract at the purchased ratio, not carried over from the raw botanical. |
| Method and LOQ stated | The analytical method (HPLC-FLD or LC-MS/MS) and the limit of quantification for each analyte. |
| Reference limit named | The market limit the result is judged against, cited to the regulation rather than an unattributed number. |
| Batch-specific and traceable | The COA carries the actual lot number you are receiving, with the test date and the issuing laboratory. |
| Accredited laboratory | Confirmatory testing performed by an ISO/IEC 17025-accredited third-party laboratory. |
How Bionutricia handles mycotoxin risk
Bionutricia has manufactured standardised botanical extracts in Malaysia since 2006, with more than 20 years of R&D and 15 years of manufacturing behind the current operation at our Sungai Buloh, Selangor facility. Mycotoxin risk is managed as a raw-material hazard inside a certified food-safety system — FSSC 22000, GMP, HACCP, JAKIM Halal, US FDA registration and MeSTI — rather than as an end-of-line test.
Screening is risk-based rather than universal, and we say so plainly: not every botanical, fruit or vegetable we handle is routinely tested for aflatoxins and ochratoxin A, because not every matrix carries meaningful mycotoxin risk. Where a material is susceptible, or where a buyer’s market requires it, that material is screened and confirmed by accredited third-party laboratories. If you need mycotoxin data for a specific extract, ask at the enquiry stage and we will confirm what testing is already in place for that material and arrange it where it is not.
Our patented enzymatic and ultrasonic extraction process (MY-188945-A) is designed for high, controlled active yield, which lets us characterise each lot precisely and release it against a batch-specific Certificate of Analysis. Bionutricia supplies the bulk ingredient for B2B formulation; brand owners and manufacturers formulate it into their chosen finished format, and full specification and documentation packs, including any mycotoxin data held for a given material and market, are available to qualified buyers on request.
Need mycotoxin data for a specific extract and market?
Related guides
Frequently asked questions
What is a mycotoxin?
A mycotoxin is a toxic compound produced by certain moulds that grow on plant material before or after harvest. In botanicals the regulated ones are the aflatoxins (B1, B2, G1 and G2) and ochratoxin A. They are heat-stable, so they are not destroyed by ordinary processing.
Why test the extract instead of the raw botanical?
Extraction concentrates the plant. A 10:1 extract reduces roughly ten parts of raw material to one part of powder, and mycotoxin residues can travel with it. A raw herb that met the limit can exceed it once extracted, so the screen must be run on the finished extract at the ratio you are buying.
Which mycotoxin limits apply to my market?
It depends on where the finished product is sold. The EU sets limits in Regulation (EU) 2023/915, the United States applies an FDA action level for total aflatoxins, and Codex figures are used as a baseline where no national limit exists. Specify the strictest market you intend to serve and test to it.
How are aflatoxins and ochratoxin A measured?
The reference approaches are HPLC with fluorescence detection after immunoaffinity clean-up, and LC-MS/MS. ELISA kits are useful for rapid screening but a positive should be confirmed by a chromatographic method. A credible report states the method, the limit of quantification and the reference limit applied.
Does Bionutricia provide mycotoxin data?
Testing is risk-based rather than universal. Not every botanical, fruit or vegetable is routinely screened, because not every matrix carries meaningful mycotoxin risk. Where a material is susceptible, or where the buyer market requires it, it is screened and confirmed by an accredited third-party laboratory and the result is evidenced on a batch-specific Certificate of Analysis. Ask at the enquiry stage and we will confirm what testing is in place for a specific extract, and arrange it where it is not.
