EN 12682:1998
(Main)Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the functional expression of the genomic modification
Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the functional expression of the genomic modification
This European Standard provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution.
Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der funktionellen Ausprägung der Genomveränderung
Diese Europäische Norm gibt eine Anleitung für die Planung und Durchführung von Versuchen zur Untersuchung der funktionellen Ausprägung der Genomveränderung. In dieser Europäischen Norm werden Kriterien für die Erstellung eines Versuchsplans und für die Bestimmung der Zuverlässigkeit seiner Durchführung gegeben.
Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de l'expression fonctionnelle de la modification génomique
La présente norme européenne donne des indications pour la conception et l'exécution d'expériences en vue d'analyser l'expression fonctionnelle de la modification génomique. Elle donne des critères pour établir un plan expérimental et pour déterminer la validité de son exécution.
Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za ugotavljanje značilnosti gensko spremenjenega organizma z analizo funkcionalne ekspresije spremenjenega genoma
General Information
- Status
- Published
- Publication Date
- 21-Jul-1998
- 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
Overview - EN 12682:1998 (CEN)
EN 12682:1998 is a European standard from CEN titled Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the functional expression of the genomic modification. It offers practical guidance for designing and executing experiments that assess the functional expression of a genomic modification in genetically modified organisms (GMOs) intended for environmental use. The standard sets out criteria for experimental setup and for determining whether the execution and results are valid for characterization purposes.
Key topics and requirements
The standard focuses on the experimental characterization of GMOs with emphasis on:
- Experimental design: principles for planning studies that link genomic changes to biological function and phenotype.
- Assay selection: guidance on choosing appropriate molecular, biochemical or phenotypic assays to detect functional expression of the modification.
- Controls and comparators: use of proper negative/positive controls and unmodified reference organisms to attribute effects to the genomic modification.
- Sampling and replication: considerations for representative sampling and sufficient replication to support reliable interpretation.
- Data quality and validation: criteria for assessing the validity of experimental execution, reproducibility, and data integrity.
- Interpretation of results: guidance on linking measured functional outcomes to the genomic change for characterization and reporting.
- Documentation and reporting: requirements for transparent documentation so results can support environmental assessment and regulatory review.
Practical applications
EN 12682:1998 is useful where robust evidence of a modification’s functional expression is required:
- Environmental risk assessment and regulatory dossiers for GMO release or field trials
- Product development and characterization by biotech companies developing GMOs for environmental applications (e.g., bioremediation, plant traits)
- Research laboratories studying genotype–phenotype relationships in modified organisms
- Contract testing laboratories preparing validated experimental reports for clients
- Institutional biosafety committees and regulators evaluating experimental design and validity
Who should use this standard
- Biotechnology developers and R&D teams
- Environmental risk assessors and regulatory authorities
- Laboratory managers and quality assurance personnel
- Biosafety officers and institutional review boards
Related standards and guidance
EN 12682:1998 complements national and international biosafety and GMO guidance (EU regulatory guidance, ISO and other CEN standards) addressing environmental release, containment, and risk assessment. Users should consult regional GMO regulations and other technical standards for compliance and integrated assessment.
Keywords: EN 12682:1998, biotechnology standard, genetically modified organism, GMO characterization, functional expression, genomic modification, experimental design, environmental release.
Frequently Asked Questions
EN 12682:1998 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 functional expression of the genomic modification". This standard covers: This European Standard provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution.
This European Standard provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution.
EN 12682:1998 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 12682:1998 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 funktionellen Ausprägung der GenomveränderungBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de l'expression fonctionnelle de la modification génomiqueBiotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified
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기사 제목: EN 12682:1998 - 생물공학 - 환경 적용을 위한 수정된 유기체 - 유전자변형생물체의 기능적 발현 분석을 위한 가이드라인 기사 내용: 이 유럽 표준은 유전자변형생물체의 기능적 발현 분석을 위한 실험의 디자인과 실행에 대한 지침을 제공합니다. 이 표준은 실험의 설정과 실행의 타당성 결정에 대한 기준을 제시합니다.
記事のタイトル：EN 12682:1998 - バイオテクノロジー - 環境への適用を目的とした改変生物体 - ゲノム修飾の機能的発現の分析のためのガイドライン 記事内容：この欧州標準では、ゲノム修飾の機能的発現の分析の実験の設計と実行に関する指針を提供しています。実験の設定や実行の妥当性の判断基準も示されています。
The article discusses the European Standard EN 12682:1998, which provides guidance on how to analyze the functional expression of genomic modifications in biotechnology. It outlines criteria for designing and executing experiments and determining the validity of their execution.
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