Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification

This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.

Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der molekularen Stabilität der Genomveränderung

Diese Europäische Norm gibt eine Anleitung für Faktoren und Kriterien, die vom Experimentator für die zuverlässige Planung, Ausführung und Auswertung einerUntersuchung der molekularen Stabilität der Genomveränderung im Hinblick auf Lebenßyklus, Vererbung und äußere Faktoren zu berücksichtigen sind. Sie beschreibt Schritte, die bei der Charakterisierung eines GVO befolgt werden sollten, um die Validität der Untersuchung der molekularen Stabilität der Genomveränderung sicherzustellen. Die Art der Untersuchung der molekularen Stabilität ist von den Zielen des Versuchs abhängig.

Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la stabilité moléculaire de la modification génomique

La présente norme européenne donne des indications relatives à des facteurs et des critères qui sont pris en considération par l'expérimentateur lors de la conception, de l'exécution et de l'évaluation d'une analyse de la stabilité moléculaire de la modification génomique compte tenu du cycle de vie, du caractère héréditaire et des facteurs extérieurs. Elle décrit les étapes de caractérisation d'un organisme génétiquement modifié qu'il convient de suivre pour garantir la validité de l'analyse de la stabilité moléculaire de la modification génomique.

Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za ugotavljanje značilnosti gensko spremenjenega organizma z analizo molekularne stabilnosti spremenjenega genoma

General Information

Status
Published
Publication Date
21-Jul-1998
ICS
07.080 - Biology. Botany. Zoology
Technical Committee
CEN/TC 233 - Biotechnology
Drafting Committee
CEN/TC 233/WG 3 - Agricultural environmental applications
Current Stage
9093 - Decision to confirm - Review Enquiry
Start Date
11-Apr-2022
Completion Date
14-Apr-2025
Directive
90/219/EEC - Contained use of genetically modified micro-organisms
90/220/EEC - Deliberate release into the environment of genetically modified organisms
90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
Mandate
M/BC/CEN/91/19 - Mandate for CEN on biotechnology
Ref Project
SIST EN 12683:1999 - Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification

Overview

EN 12683:1998 (CEN) - Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification - provides practical guidance for designing, executing and evaluating analyses of the molecular stability of genomic modifications in genetically modified organisms (GMOs). The standard focuses on ensuring valid, reproducible characterization with respect to an organism’s life cycle, heritability of the modification and relevant external factors that can affect genomic stability. The type and scope of molecular stability analysis are determined by the specific objectives of the experiment.

Key topics and requirements

  • Scope of analysis - guidance on matching the molecular stability analysis to experimental objectives (monitoring, risk assessment, registration).
  • Design considerations - factors and criteria experimenters should consider when planning studies to assess genomic modification stability.
  • Execution and sampling - recommended approaches to sampling across life cycle stages and generations to detect possible rearrangements, loss or instability.
  • Heritability assessment - evaluation of transmission of the genomic modification through successive generations.
  • External factors - consideration of environmental or operational conditions (e.g., stresses, selective pressures) that may influence molecular stability.
  • Validity and evaluation - steps for data interpretation, controls, reproducibility and documenting the validity of the stability analysis.
  • Tailored methods - statement that the specific molecular techniques and the depth of analysis depend on study goals; the standard describes procedural steps rather than prescribing individual laboratory methods.

Applications

  • Environmental release studies and post-release monitoring of GMOs.
  • Pre-market characterization for regulatory dossiers and biosafety assessments.
  • Research projects assessing stability and heritability of introduced traits.
  • Quality assurance and validation of molecular monitoring programs for modified organisms used in environmental applications.

Who uses this standard

  • Molecular biologists and environmental biotechnologists conducting GMO characterization.
  • Biotech companies developing environmental GMOs (e.g., bioremediation strains).
  • Regulatory authorities and risk assessors evaluating molecular stability data.
  • Contract research organizations (CROs), environmental monitoring labs and biosafety officers.

Related standards and guidance

  • Complements other CEN/ISO and national standards and regulatory frameworks on biotechnology, biosafety and molecular analysis. Users should consult applicable local GMO regulations and relevant molecular-method standards when implementing EN 12683:1998.

Keywords: EN 12683:1998, molecular stability analysis, genomic modification, GMO characterization, heritability, life cycle, environmental biotechnology, CEN standard.

Frequently Asked Questions

EN 12683:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification". This standard covers: This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.

This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.

EN 12683:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 12683:1998 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der molekularen Stabilität der GenomveränderungBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la stabilité moléculaire de la modification génomiqueBiotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically
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記事のタイトル：EN12683：1998 - 環境への適用のための生物技術 - 分子安定性の分析による遺伝子組換え生物の特性化のためのガイドライン 記事内容：この欧州標準は、生物のライフサイクル、遺伝的継承性および外部要因に関する遺伝子組換え生物の分子安定性の分析において、実験者が考慮すべき要素や基準に関するガイドラインを提供しています。これは、遺伝子組換え生物の分子安定性の分析の有効な設計、実行、評価を確保するために、従うべき手順を説明しています。分子安定性の分析のタイプは、実験の目的に応じて異なる場合があります。

記事タイトル: EN 12683:1998 - バイオテクノロジー - 環境応用のための改変生物 - 分子安定性解析による遺伝子組み換え生物の特性評価のためのガイド 記事の内容: この欧州標準は、遺伝子組み換え生物（GMO）の分子安定性解析を行う際に、実験者が考慮すべき要素と基準についてのガイドを提供します。ライフサイクル、遺伝性、外部要因に関する遺伝子組み換えの分子安定性解析の有効な設計、実施、評価のための手順について説明しています。分子安定性解析のタイプは、実験の目的に応じて異なります。

기사 제목: EN 12683:1998 - 생명공학 - 환경적용을 위한 수정된 유전자 조작 생물의 특성화를 위한 분자 안정성 분석 가이드 기사 내용: 이 유럽 표준은 생명주기, 유산성 및 외부 요인과 관련하여 유전자 조작 생물의 분자 안정성 분석에 대해 실험자가 고려하는 요소와 기준에 대한 지침을 제공합니다. 이는 유전자 조작 생물의 분자 안정성 분석의 유효한 설계, 실행 및 평가를 위한 절차를 설명합니다. 분자 안정성 분석의 유형은 실험의 목적에 따라 다를 수 있습니다.

The article, titled "EN 12683:1998 - Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification," provides guidance on how to analyze the molecular stability of genetically modified organisms (GMOs). The standard outlines factors and criteria to consider when designing, executing, and evaluating the analysis. It emphasizes the importance of following specific steps to ensure the validity of the analysis, and notes that the type of molecular stability analysis will depend on the experiment's objectives.

기사 제목: EN 12683:1998 - 생물공학 - 환경 적용을 위한 수정된 유기체 - 유전자 수정의 분자 안정성 분석에 대한 가이드 기사 내용: 이 유럽 표준은 생물공학에서 수정된 유기체의 분자 안정성 분석을 위한 실험자가 고려해야 할 요소와 기준에 대한 지침을 제공합니다. 수명주기, 유전성 및 외부 요인에 대한 유전자 수정의 분자 안정성 분석의 유효한 설계, 실행 및 평가를 위한 단계를 설명합니다. 유전자 수정의 분자 안정성 분석의 유형은 실험의 목적에 따라 다릅니다.

The article is about a European Standard called EN 12683:1998, which provides guidance for the analysis of the molecular stability of genetically modified organisms (GMOs) in the environment. The standard helps experimenters in designing, executing, and evaluating the analysis of the genomic modification's stability. It outlines the steps that should be followed to ensure the validity of the analysis, which may vary depending on the objectives of the experiment.