ISO 21570-2005 amd1-2013 PDF

Full title and description

ISO 21570:2005/Amd 1:2013 — Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods (Amendment 1 to ISO 21570:2005). The amendment publishes updates and clarifications that apply to the 2005 quantitative nucleic acid‑based framework for GMO detection in food and related matrices.

Abstract

This standard (ISO 21570:2005) establishes the overall framework for quantitative nucleic‑acid based methods (principally PCR/qPCR) used to detect and quantify genetically modified organism (GMO)‑derived DNA in foodstuffs and related matrices. It defines general requirements for specific amplification, calibration and reporting to ensure comparable, accurate and reproducible results between laboratories. Amendment 1 (2013) provides additional changes and clarifications to the 2005 text.

General information

• Status: Published (ISO 21570:2005 with Amendment 1 published as ISO 21570:2005/Amd 1:2013).
• Publication date: Main standard published 3 November 2005; Amendment 1 published 10 April 2013.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 67.050 — General methods of tests and analysis for food products.
• Edition / version: Edition 1 (2005) with Amendment 1 (2013).
• Number of pages: Main standard: 103 pages; Amendment 1: 18 pages.

Scope

Applies to quantitative nucleic‑acid based analytical methods for the detection and relative quantification of GMO‑derived DNA in foodstuffs and other matrices (for example feed and plant samples). The document sets out minimum requirements, performance criteria, and reporting conventions aimed at achieving comparable and reproducible quantitative results across laboratories. Amendment 1 supplies updates and clarifications to the original 2005 text.

Key topics and requirements

• Framework for quantitative PCR (qPCR) assays for GMO detection and quantification.
• Requirements for assay specificity, sensitivity (LOD/LOQ) and calibration/standards.
• Validation and performance criteria (trueness, precision, measurement uncertainty) and recommended acceptance criteria.
• Control materials, negative/positive controls and quality assurance measures for routine testing.
• Guidance on sample preparation, DNA extraction (cross‑referenced to dedicated extraction standards), and matrix considerations.
• Data analysis, result expression (relative GMO‑derived DNA content) and reporting requirements to ensure traceability and comparability.

Typical use and users

Used by food‑testing laboratories, regulatory agencies, accreditation bodies, food manufacturers and contract testing providers performing quantitative GMO analysis; also used by method developers and researchers working on nucleic‑acid based detection and quantification for food and feed matrices.

Related standards

Closely related ISO standards include the companion documents on nucleic acid extraction and general requirements/definitions for GMO testing (for example ISO 21571 and ISO 24276 and their respective amendments). These related standards address sample preparation and broader definitions and requirements used together with ISO 21570 methods.

Keywords

GMO, genetically modified organism, qPCR, quantitative PCR, nucleic acid methods, foodstuffs analysis, ISO 21570, amendment 2013, detection, quantification, method validation, LOD, LOQ, calibration, reference materials.

FAQ

Q: What is this standard?

A: ISO 21570:2005 (with Amendment 1:2013) is an international standard specifying the framework and minimum requirements for quantitative nucleic‑acid based methods used to detect and quantify GMO‑derived DNA in food and related matrices.

Q: What does it cover?

A: It covers the overall approach to assay design and execution, calibration, performance criteria (sensitivity, trueness, precision), quality controls, data analysis and reporting conventions for quantitative GMO testing. The 2013 amendment provides specific updates and clarifications to the 2005 text.

Q: Who typically uses it?

A: Accredited testing laboratories, regulatory and enforcement bodies, food producers, method developers and researchers involved in GMO detection and quantification in food, feed and environmental samples.

Q: Is it current or superseded?

A: The 2005 edition and its Amendment 1 (2013) are published and have been confirmed in ISO’s catalogue; the main 2005 edition was last reviewed/confirmed by ISO in 2020. Users should check the ISO catalogue or national standards body for any newer revisions or additional amendments after 2013.

Q: Is it part of a series?

A: Yes — ISO 21570 is part of a group of ISO standards addressing GMO detection and analysis; companion documents include standards on nucleic acid extraction (e.g., ISO 21571) and general requirements and definitions for GMO analysis (e.g., ISO 24276). These are intended to be used together for complete laboratory workflows.

Q: What are the key keywords?

A: GMO, qPCR, quantitative nucleic‑acid based methods, food analysis, LOD, LOQ, validation, calibration, reference material, ISO 21570.