ISO 21569:2005 PDF

Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods

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Title (English):

ISO 21569:2005

Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 69
Publication date:: June 20, 2005
Edition:: ISO IS 21569 edition 1 version 1
ICS:: 67.050

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Description (English):

ISO 21569:2005 describes the procedure to qualitatively detect genetically modified organisms (GMOs) and derived products by analysing the nucleic acids extracted from the sample under study. The main focus is on polymerase chain reaction (PCR) based amplification methods. It gives general requirements for the specific detection and identification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified DNA sequence. Guidelines, minimum requirements and performance criteria laid down in ISO 21569:2005 are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories. ISO 21569:2005 has been established for food matrices, but could also be applied to other matrices (e.g. feed and plant samples from the environment). Specific examples of methods are provided in Annexes A to D.

Technical details

Technical committee: ISO/TC 34/SC 16 - Horizontal methods for molecular biomarker analysis
SKU: ISO 21569:2005

Abstract

Overview

ISO 21569:2005 - Foodstuffs: Methods of analysis for the detection of genetically modified organisms and derived products - Qualitative nucleic acid based methods - defines standardized procedures to qualitatively detect GMOs by analysing nucleic acids extracted from food matrices. The standard focuses on PCR-based amplification methods and provides guidelines, minimum requirements and performance criteria to ensure comparable, accurate and reproducible results across laboratories. Annexes A–D give concrete method examples (target-taxon-specific, screening, construct-specific and event-specific).

Key topics and technical requirements

Scope and principle
- Qualitative detection gives a clear presence/absence answer for target DNA sequences relative to controls and method detection limits.
- Main emphasis on conventional and real-time PCR methods.
Sample and nucleic acid quality
- Extracts must be free of PCR inhibitors; integrity and amplifiability influence detection limits, especially in processed foods.
PCR design and reagents
- Recommended primer characteristics: 18–30 nucleotides, optimal annealing ~60 °C, balanced GC content; product size chosen to match DNA degradation (e.g., 60–150 bp for highly degraded material).
- Use of hot-start PCR is recommended to improve specificity.
- Note: dUTP use can interfere with subsequent restriction analyses.
Performance and validation
- Performance criteria and method-specific values are provided in the annexes.
- Optimized PCR should detect ~100 copies of template DNA within 40 cycles under ideal conditions.
- Primer validation: (1) theoretical (sequence similarity search, e.g., BLAST), and (2) experimental specificity testing.
Detection and confirmation
- PCR products may be detected by gel electrophoresis or real-time PCR; identity confirmation by restriction analysis, hybridization or DNA sequencing.
Quality assurance
- Inclusion of appropriate positive/negative and inhibition controls, method reporting requirements and inter-laboratory comparability measures.

Practical applications and users

Who uses it:
- Food and feed testing laboratories, regulatory agencies, contract analytical labs, environmental monitoring groups, seed and ingredient suppliers, and academic researchers.
Practical uses:
- Regulatory compliance and labeling verification for GMO content.
- Routine surveillance and screening of raw materials and processed foods.
- Method development and validation for laboratories implementing qualitative GMO detection.
- Event- or construct-specific identification for traceability and enforcement.

Related standards

ISO 21571 - Nucleic acid extraction (complementary procedures)
ISO 21570 - Quantitative nucleic acid based methods
ISO 21568 - Sampling for GMO analysis
ISO 24276 - General requirements and definitions for nucleic-acid based GMO methods

Keywords: ISO 21569:2005, GMO detection, qualitative PCR, nucleic acid based methods, food analysis, primer validation, event-specific, construct-specific, screening methods.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope and principle
- Qualitative detection gives a clear presence/absence answer for target DNA sequences relative to controls and method detection limits.
- Main emphasis on conventional and real-time PCR methods.
Sample and nucleic acid quality
- Extracts must be free of PCR inhibitors; integrity and amplifiability influence detection limits, especially in processed foods.
PCR design and reagents
- Recommended primer characteristics: 18–30 nucleotides, optimal annealing ~60 °C, balanced GC content; product size chosen to match DNA degradation (e.g., 60–150 bp for highly degraded material).
- Use of hot-start PCR is recommended to improve specificity.
- Note: dUTP use can interfere with subsequent restriction analyses.
Performance and validation
- Performance criteria and method-specific values are provided in the annexes.
- Optimized PCR should detect ~100 copies of template DNA within 40 cycles under ideal conditions.
- Primer validation: (1) theoretical (sequence similarity search, e.g., BLAST), and (2) experimental specificity testing.
Detection and confirmation
- PCR products may be detected by gel electrophoresis or real-time PCR; identity confirmation by restriction analysis, hybridization or DNA sequencing.
Quality assurance
- Inclusion of appropriate positive/negative and inhibition controls, method reporting requirements and inter-laboratory comparability measures.

Practical applications and users

Who uses it:
- Food and feed testing laboratories, regulatory agencies, contract analytical labs, environmental monitoring groups, seed and ingredient suppliers, and academic researchers.
Practical uses:
- Regulatory compliance and labeling verification for GMO content.
- Routine surveillance and screening of raw materials and processed foods.
- Method development and validation for laboratories implementing qualitative GMO detection.
- Event- or construct-specific identification for traceability and enforcement.

Related standards

ISO 21571 - Nucleic acid extraction (complementary procedures)
ISO 21570 - Quantitative nucleic acid based methods
ISO 21568 - Sampling for GMO analysis
ISO 24276 - General requirements and definitions for nucleic-acid based GMO methods

Keywords: ISO 21569:2005, GMO detection, qualitative PCR, nucleic acid based methods, food analysis, primer validation, event-specific, construct-specific, screening methods.

ISO 21569:2005 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

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