Overview
EN ISO 20813:2022 (ISO 20813:2019) defines general requirements and definitions for molecular biomarker analysis used to detect, identify and quantify animal species DNA in foods and food products. Adopted by CEN from ISO, the standard sets minimum performance characteristics for nucleic acid–based methods such as conventional PCR, real‑time PCR, probe‑based assays and post‑PCR detection techniques. It covers DNA targets from mammals, birds, reptiles, amphibians, fishes, molluscs, crustaceans and insects (typical examples listed in Annex A).
Key topics and technical requirements
- Performance characteristics: requirements for method scope, scientific basis, units of measurement and applicability.
- Specificity: inclusivity (detection of target taxa) and exclusivity (avoidance of cross‑reactivity) test requirements.
- Sensitivity: definition and determination of limit of detection (LOD) for qualitative assays.
- Quantitative requirements: limit of quantification (LOQ), dynamic range, precision and trueness evaluation for quantitative methods.
- Validation: procedures for single‑laboratory validation and interlaboratory (collaborative) studies to demonstrate method robustness and reproducibility.
- Robustness: assessment by collaborative studies or multifactorial experimental designs.
- Laboratory practices: general laboratory and procedural requirements including facilities, materials/equipment, sample preparation, DNA extraction, use of controls, data analysis and expression of results.
- Reporting: guidance on test reports, expression of positive/negative/quantitative results and conversion methods (e.g., DNA copy number to mass ratio examples in Annex B).
Applications and practical value
EN ISO 20813 is essential for reliable food authenticity testing, species identification and food fraud prevention. Typical practical applications:
- Verification of meat, seafood and processed food labeling (species substitution detection).
- Authentication for religious, allergen control and regulatory compliance (e.g., halal/kosher, undeclared species).
- Support for traceability and supply‑chain due diligence in food manufacturing.
- Development and validation of new PCR‑based assays by test developers and kit manufacturers.
Who should use this standard
- Food testing and diagnostic laboratories performing DNA‑based species analysis.
- Method developers, kit manufacturers and assay vendors.
- Regulatory agencies and enforcement laboratories.
- Accreditation bodies and quality managers responsible for method validation and interlaboratory studies.
Related standards (if applicable)
- ISO 20813 is consistent with ISO technical committee work on food methods. Laboratories will commonly align validation and competence with standards such as ISO/IEC 17025 (laboratory accreditation) when implementing EN ISO 20813.
