EN ISO 24276:2006/A1:2013 defines general requirements and definitions for methods used to detect genetically modified organisms (GMOs) and derived products in foodstuffs. This 2013 amendment (A1) updates the 2006 International Standard and clarifies how to use the associated method standards for nucleic acid extraction, qualitative and quantitative nucleic acid analysis, and protein-based detection. It was prepared by ISO/TC 34 in collaboration with CEN/TC 275 and adopted as a European Standard (EN).
Key topics and technical requirements
- Scope and relationships: Specifies how to apply ISO 21571 (nucleic acid extraction), ISO 21569 (qualitative nucleic acid methods), ISO 21570 (quantitative nucleic acid methods) and ISO 21572 (protein-based methods) together in a complete GMO testing workflow.
- Definitions and terminology: Standardizes laboratory terms such as laboratory sample, test sample, test portion, screening method, construct-specific method, event-specific method, LOD (limit of detection), LOQ (limit of quantification), trueness, precision, repeatability and reproducibility.
- Performance characteristics: Describes measurement uncertainty, applicability range (linearity/quantification range), fitness for purpose, and practicability (sample throughput and costs).
- Validation basis: Limits of detection and quantification, and other method performance parameters, are expected to be demonstrated by collaborative trials or appropriate validation studies; LOD values in relevant annexes are based on collaborative trial data.
- Workflow diagram: Illustrates interrelationships between extraction, DNA/protein detection, screening, identification and quantification steps for GMO analysis.
Applications and who uses this standard
- Food testing laboratories performing GMO screening, identification, and quantification in raw materials, ingredients and finished foodstuffs.
- Regulatory bodies and food safety authorities defining compliance testing and sampling programs.
- Method developers and kit manufacturers validating and documenting nucleic acid- or protein-based GMO assays.
- Accreditation bodies and proficiency-testing providers evaluating laboratory performance, repeatability and reproducibility.
- Food producers and import/export quality teams verifying labeling, traceability and supply-chain compliance.
Related standards
- ISO 21571 - Nucleic acid extraction methods
- ISO 21569 - Qualitative nucleic acid-based methods (screening/identification)
- ISO 21570 - Quantitative nucleic acid-based methods
- ISO 21572 - Protein-based detection methods
- ISO 5725 - Accuracy (trueness and precision) of measurement methods
EN ISO 24276:2006/A1:2013 is essential for harmonized, validated GMO detection in foodstuffs, ensuring consistent terminology, proven method performance (LOD/LOQ), and clear linkage between extraction, DNA/protein detection and quantitative reporting.
