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Accurate marine toxins analysis starts with the reference material. CIFGA designs and produces CRMs, quality controlled standards, and matrix materials for shellfish toxin monitoring, method validation, and research — certifying CRMs under its accreditation as a reference materials producer accredited by ENAC (Nº 2/PMR003). Every certified value carries full metrological traceability from source to Certificate of Analysis.
CIFGA is the reference materials producer accredited by ENAC (Nº 2/PMR003) for marine biotoxin CRMs. CRMs, QCSs, and matrix reference materials across the full DSP, PSP, ASP, and NSP spectrum, produced in-house and available from stock for fast, agile delivery.
Custom concentrations, mixed-toxin formulations and contract purification are handled directly by our production team.
Compliance testing requires validated methods — and method validation requires reference materials with documented measurement uncertainty.
Marine biotoxins are secondary metabolites synthesized by certain microalgae species. Filter-feeding bivalves, including mussels, oysters, scallops, and clams, accumulate these compounds through feeding, concentrating them in edible tissue at levels capable of causing acute human illness. Harmful algal blooms (HABs), the events that drive this contamination, are increasing in frequency and geographic range.
Four main toxin groups define the analytical and regulatory landscape: DSP toxins (okadaic acid, dinophysistoxins, azaspiracids, yessotoxins), PSP toxins (saxitoxin and more than 50 structural congeners), ASP toxins (principally domoic acid), and NSP toxins (brevetoxins). Each presents distinct analytical challenges, including structural complexity, thermal instability, and low natural abundance, which make certified reference materials with documented measurement uncertainty essential, not optional.
EU Regulation 853/2004 and Implementing Regulation 2074/2005 set maximum limits for DSP, PSP, and ASP toxins in live bivalve molluscs placed on the market. Compliance testing requires validated analytical methods, and method validation requires certified reference materials with documented measurement uncertainty. A material from a producer without ISO 17034 accreditation introduces an unquantified source of error into the compliance chain, a risk that regulatory auditors are increasingly scrutinizing.
Beyond Europe, marine toxin testing programs operate across North America, Asia-Pacific, and South America, each with their own testing requirements and export audit standards. For laboratories supporting international shellfish trade, the accreditation status of the producer supplying materials used in routine marine toxins testing is a documented requirement, not a secondary concern.
ISO 17034 is the international standard governing reference material producers. Accreditation requires an independent technical audit by an external accreditation body. It is not a self-declaration. CIFGA is a reference materials producer accredited by ENAC (Nº 2/PMR003) for a defined scope of marine biotoxins.
In practice, every CRM in the accredited listing carries a certified value traceable to SI units, with certified value determined by NMR and measurement uncertainty supported by homogeneity and stability studies using HPLC-MS/MS. For laboratories operating under ISO 17025, using a CRM from an accredited producer is the most auditable approach available.
CIFGA supplies laboratories in over 40 countries. Shipping from Lugo means intra-EU deliveries carry no customs complications and arrive faster than equivalent shipments from North American suppliers, which is relevant for the significant volume of shellfish monitoring conducted under EU regulatory frameworks.
Custom requirements, including specific concentrations, mixed-toxin formulations, and contract purification, are handled through our tailored services, with technical support provided directly by the production and characterisation team.
Contact our team to discuss your requirements, or request a quote for specific catalogue references.
A certified reference material (CRM) carries a certified value with a stated measurement uncertainty, determined through a rigorous production process and documented in a Certificate of Analysis. The certification is issued by a reference materials producer accredited by ENAC (Nº 2/PMR003) under ISO 17034, meaning the process has been independently audited. An analytical standard may provide a nominal concentration without documented uncertainty or accredited traceability. For regulatory compliance testing under EU Regulation 853/2004, where results must be defensible under audit, a CRM from an ISO 17034 accredited producer is the appropriate choice.
EU Implementing Regulation 2074/2005 requires monitoring for DSP toxins (okadaic acid group), PSP toxins (saxitoxin group), and ASP toxins (domoic acid) in live bivalve molluscs. Compliance testing requires validated analytical methods, and method validation requires reference materials with documented measurement uncertainty. Yessotoxins and pectenotoxins are also monitored under EU frameworks. CIFGA produces CRMs for all of these compound groups as a reference materials producer accredited by ENAC (Nº 2/PMR003).
ISO 17034 is the international standard that defines requirements for reference material producers. Accreditation requires an independent technical audit by an external accreditation body — in CIFGA’s case, ENAC, operating within the European co-operation for Accreditation (EA) multilateral agreement. It covers manufacturing, homogeneity and stability testing, and the certification process itself. A producer cannot self-declare ISO 17034 conformity. The compounds covered by the accreditation are listed in a scope document available on request.
CIFGA is a reference materials producer accredited by ENAC (Nº 2/PMR003) for a specific scope of marine biotoxins, including okadaic acid, azaspiracids, yessotoxin, dinophysistoxins, and saxitoxin, among others. No other producer holds an equivalent ISO 17034 accreditation for this scope of marine biotoxin reference materials worldwide.
CIFGA produces marine toxin reference materials from natural biological sources using biotechnological processes developed over more than 15 years. Certified values are determined in-house by NMR, with homogeneity and stability studies performed using HPLC-MS/MS, UV, and fluorescence methods. As a primary producer, CIFGA does not redistribute materials from third-party manufacturers — metrological traceability runs from the source material through every step of production to the certified value on the Certificate of Analysis.
CIFGA offers tailored services for laboratories requiring specific concentrations, mixed-toxin formulations, or reference materials in matrix formats not available in the standard catalogue. Contract purification of novel or emerging marine toxin compounds is also available. Custom requirements are handled directly by the production and characterisation team.
Core catalogue references are held in permanent stock at CIFGA’s facility in Lugo, Spain, enabling fast, agile delivery. For intra-EU shipments, delivery avoids customs delays that affect materials shipped from non-EU producers. Export to laboratories in the Americas, Asia-Pacific, and the Middle East is supported with full documentation required for certified reference materials.
Explore the full range of solutions we produce, from marine biotoxins to contract purification services.
Add references to your quote as you browse, or contact our team to discuss your analytical requirements.
