Cyanotoxin Quality controlled standards and Certified Reference Materials

Cyanobacteria produce toxic secondary metabolites — microcystins, cylindrospermopsin, anatoxin-a, nodularin — that pose direct risks to human health, livestock and aquatic ecosystems. As monitoring requirements tighten under the EU Drinking Water Directive (2020/2184), WHO guidelines and national frameworks across the Americas and Asia-Pacific, the traceability of the reference material behind every result is no longer optional.

CIFGA produces certified cyanotoxin reference materials at its facility in Lugo, Spain. As a reference materials producer accredited by ENAC (Nº 2/PMR003), every material is supplied with full metrological traceability and a certificate of analysis reflecting characterised values — not nominal estimates.

ENAC-accredited producer

Nº 2/PMR003
Catalogue

Our cyanotoxin catalogue

CIFGA’s cyanotoxin range covers the principal hepatotoxic and neurotoxic compound classes identified in freshwater monitoring programmes. All materials are produced using biotechnological processes from biological source material and characterised using validated methods including HPLC-MS/MS, UV spectroscopy and NMR. The range spans regulatory-priority compounds such as Microcystin-LR through to structurally related variants increasingly required for comprehensive monitoring programmes and method validation work.

(+)-Anatoxin-a

CRM-03-ATXa
Conc.[ATXa] = (5.3 ± 0.3) µg/g
Purity≥ 99%

3-desmethyl microcystin-LF

00-3dmMCLF
Conc.( 10.3 ± 0.7) µg/mL
Purity≥ 98%

3-desmethyl microcystin-LR

CRM-00-3dmMCLR
Conc.( 10.9 ± 1.1) µg/g
Purity≥ 99%

3-desmethyl microcystin-LY

00-3dmMCLY
Conc.(10.2 ± 0.7) µg/mL
Purity≥ 99%

Cylindrospermopsin

CRM-03-CYN
Conc.[CYN] = (10.6 ± 0.5) µg/g
Purity≥ 99%

L-BMAA hydrochloride

CRM-03-BMAA
Conc.100 ±8 ug/g
Purity≥ 99%

Microcystin-LF

CRM-00-MCLF
Conc.[MCLF] = (12.8 ± 0.9) µg / g
Purity≥ 98%

Microcystin-LR

CRM-03-MCLR
Conc.[MCLR] = (11.0 ± 0.8) µg/g
Purity≥ 98%

Microcystin-LY

CRM-00-MCLY
Conc.[MCLY] = (12.9 ± 0.9) µg / g
Purity≥ 99%

Microcystin-RR

CRM-00-MCRR
Conc.[MCRR] = (11.3 ± 0.8) µg/g
Purity≥ 97%

Microcystin-YR

00-MCYR
Conc.(10.9 ± 0.5) µg/mL
Purity≥ 97%

Nodularin

CRM-03-NOD
Conc.[NOD] = (13.0 ± 0.7) µg/g
Purity≥ 99%
Application areas

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Built for regulated marine toxin testing

Compliance testing requires validated methods — and method validation requires reference materials with documented measurement uncertainty.

Compliance

Regulatory context: why cyanotoxin monitoring is expanding

Regulatory pressure on cyanotoxin monitoring has increased substantially over the past five years, and the trend is accelerating across multiple jurisdictions.

In Europe, the recast EU Drinking Water Directive (2020/2184) introduced microcystins as a watch-list parameter for the first time, requiring member states to monitor their presence in water intended for human consumption. This has driven demand for validated analytical methods and, consequently, for certified reference materials capable of supporting those methods under accreditation.

Outside Europe, the picture is similar. Australia and New Zealand have established guideline values for microcystin-LR, cylindrospermopsin and anatoxin-a in drinking water and recreational water. In Latin America, regulators in Brazil, Chile, Argentina and Uruguay have introduced or are actively developing national standards for cyanotoxin limits in water supplies — a market where demand for reliable analytical standards is growing rapidly. The United States EPA has published health advisories for microcystins and cylindrospermopsin, and several states have adopted formal action levels that trigger mandatory monitoring.

For laboratories operating in any of these contexts, using a reference material from a producer without ISO 17034 accreditation creates a traceability gap that cannot be closed with method validation alone.

Accreditation

ISO 17034 accreditation: what it means for your lab

ISO 17034 is the international standard governing the production of reference materials. It is distinct from — and more demanding than — ISO/IEC 17025, which covers laboratory testing. Accreditation under ISO 17034 requires a producer to demonstrate that every certified value is supported by a statistically valid characterisation study, that homogeneity and stability have been assessed, and that measurement uncertainty is calculated and reported transparently on the certificate.

CIFGA holds ISO 17034 accreditation from ENAC (Nº 2/PMR003) for cyanotoxin reference materials. In practical terms, this means a laboratory using CIFGA materials can cite an unbroken metrological chain from the certified value on the CoA back to primary production — a requirement for laboratories operating under ISO/IEC 17025 accreditation.

Unaccredited standards, regardless of supplier size or market presence, cannot demonstrate this chain. For quality managers selecting a supplier under scrutiny from an accreditation body, this distinction is not marginal. It is the difference between a traceable calibrant and an estimate.

Independently audited — not a self-declaration
Working with CIFGA

Produced in Europe, dispatched to over 40 countries

CIFGA operates as a primary producer, not a distributor. Every material in the cyanotoxin catalogue is produced, characterised and certified in-house at our Lugo facility — which means full control over production timelines, characterisation data and certificate content, with no dependency on third-party suppliers.

For European customers, this translates into straightforward logistics: no customs procedures, no import documentation burden, and shipments that move within the EU regulatory framework. Selected materials are held in permanent stock, enabling fast, agile delivery.

Laboratories in the Americas, Asia-Pacific and other regions have been sourcing cyanotoxin reference materials from CIFGA for over 15 years. Our export process covers the documentation requirements for international shipments, including full regulatory compliance where applicable.

If a compound, concentration or mixture format is not currently listed in the catalogue, our team can evaluate feasibility through our contract purification and custom standards service.

FAQ

Frequently asked questions

Cyanotoxins are toxic compounds produced by cyanobacteria during bloom events in freshwater and brackish environments. Laboratories monitoring drinking water, recreational water or aquaculture systems require certified reference materials to calibrate analytical methods and demonstrate traceability under regulatory frameworks such as the EU Drinking Water Directive or WHO guidelines. A certified reference material (CRM) produced by an ISO 17034-accredited producer provides a characterised value with stated measurement uncertainty and full metrological traceability documented in the certificate of analysis.

CIFGA’s catalogue covers the principal cyanotoxin classes relevant to water quality monitoring: multiple microcystin congeners (LR, RR, LF, LY, YR and 3-desmethyl variants), cylindrospermopsin, (+)-anatoxin-a, nodularin and saxitoxin. Saxitoxin and other compounds are available as CRMs.

What does ISO 17034 accreditation mean for a reference material producer?

ISO 17034 is the international standard specifically governing reference material producers. It requires that certified values are supported by a statistically valid characterisation study, with homogeneity and stability assessed and measurement uncertainty calculated and reported on the certificate. CIFGA holds ISO 17034 accreditation from ENAC (Nº 2/PMR003) for cyanotoxin materials.

CIFGA is a primary producer, not a distributor. Every material is produced, characterised and certified in-house, providing an unbroken traceability chain from source to certificate. For EU customers this means shorter lead times, no customs procedures and direct technical support from the production team.

Yes. For compounds, concentrations or mixture formats not listed in the catalogue, CIFGA can evaluate feasibility through its contract purification and custom standards service. Contact our team with specific requirements.

Yes. Laboratories operating under ISO/IEC 17025 are required to demonstrate the metrological traceability of their calibrants. Materials from CIFGA, produced by an ENAC-accredited reference materials producer (Nº 2/PMR003), provide that traceability chain. Each certificate of analysis includes the characterised value and measurement uncertainty.

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Bespoke mixtures, on-demand concentrations and contract purification, developed by CIFGA’s analytical production team.

Research workflows rarely fit a standard catalogue. A method under development may need a mixture of analytes at ratios that do not exist commercially. A validation study may require a concentration outside the available range. A novel compound may need isolation and characterisation before it can be used as a working standard.

These are the situations CIFGA’s tailored services are built for. Using CIFGA’s biotechnology production infrastructure and analytical expertise, we design and produce custom standards, bespoke mixtures and on-demand analytical solutions to meet the specific requirements of your laboratory.

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The batches obtained for standards defined as Quality Controlled Standards (QCSs) do not allow carrying out all the study requirements due to the limited size. However, they have been developed following the guidelines of ISO Guides Series 30, and the analytical method for quantification and assignment of purity is liquid chromatography coupled to ESI-MS/MS.

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Accurate mycotoxin analysis starts with the reference material behind it. CIFGA designs and produces Quality Control Standards and Certified Reference Materials for mycotoxin testing, certifying CRMs through a production process with full metrological traceability from source to Certificate of Analysis. A focused catalogue from a European primary producer.

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This section includes those materials standing for the matrixes where the analytes of interest are usually present. It has been designed to check the behavior of the matrix with your method of analysis.

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