Overview
EN ISO 21570:2005 (ISO 21570:2005) defines a standardized framework for quantitative nucleic acid based methods to detect and quantify genetically modified organisms (GMOs) and derived products in foodstuffs. The standard is centered on polymerase chain reaction (PCR)–based approaches and sets out general requirements to ensure accurate, comparable and reproducible quantitation of GMO-derived DNA across different laboratories. Although established for food matrices, the scope also covers feed and environmental plant samples.
Key topics and technical requirements
- Principle: Quantitative PCR-based amplification, detection and confirmation of specific DNA target sequences to determine relative GMO content.
- Specific amplification and identity confirmation: Requirements to ensure target-specific PCR amplification and verification of the amplified sequence.
- Calibration and quantitation: Guidelines for calibration strategies, use of reference materials and methods to express relative GMO-derived DNA content.
- Performance criteria and minimum requirements: Laboratory performance parameters intended to deliver comparable, accurate and reproducible results between laboratories.
- Quality assurance: Requirements for QA, including controls, validation, and documentation to support reliable quantitative results.
- Interpretation and reporting: Guidance on result interpretation, expression of results, and the contents of a test report.
- Practical method examples: Informative annexes (A–D) provide example methods - target taxon-specific, screening, construct-specific and event-specific methods - including real-time PCR examples for maize and soybean events (e.g., Bt11, MON 810, GTS 40-3-2).
Applications
- Regulatory compliance and labeling: Quantitative determination of GMO content to support food labeling and legal thresholds.
- Quality control and supplier verification: Routine screening and quantitation in food and feed supply chains.
- Surveillance and monitoring: Detection and measurement of GMO presence in environmental plant samples and commodities.
- Method development and validation: Reference framework for laboratories developing or validating quantitative PCR assays for GMO analysis.
Who should use this standard
- Food, feed and environmental testing laboratories
- National and regional regulatory authorities enforcing GMO labeling and import controls
- Contract testing organizations and quality assurance teams in the food supply chain
- Method developers, assay manufacturers and research laboratories working on GMO detection
Related standards (recommended)
- ISO 21569 - qualitative nucleic acid based methods (GMO detection)
- ISO 21571 - nucleic acid extraction methods for GMO testing
- ISO 24276 - general requirements and definitions for GMO analysis
- ISO Guide 32 - calibration and use of certified reference materials
EN ISO 21570:2005 is a practical, laboratory-focused standard for quantitative PCR-based GMO testing, providing the technical basis needed for consistent, defensible results across testing programs.