EN 12468:1997

Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modified plants

This European Standard gives guidance on factors and criteria considered for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for genetically modified plants. Monitoring encompasses detection of genes and traits, as well as the identification of genetically modified plants in an experimental release. This European Standard provides the person conducting a monitoring programme with factors and criteria that should be considered in determining the validity of the proposed monitoring strategy.

Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Überwachungsstrategien bei der absichtlichen Freisetzung gentechnisch veränderter Pflanzen

Diese europäische Norm gibt eine Anleitung für Faktoren und Kriterien, die bei einer Ermittlung der Eignung und Validität der Planung, Entwicklung und Durchführung einer Überwachungsstrategie für gentechnisch veränderte Pflanzen berücksichtigt werden. Die Überwachung beinhaltet den Nachweis von Genen und Merkmalen wie auch die Identifizierung gentechnisch veränderter Pflanzen in einer experimentellen Freisetzung.

Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies de surveillance pour les disséminations volontaires de plantes génétiquement modifiées

La présente norme européenne donne des indications relatives à une série de facteurs et de critères qui sont pris en considération pour la détermination de la conformité et de la validité de la conception, de la mise au point et de l'exécution d'une stratégie de surveillance s'appliquant aux plantes génétiquement modifiées. Cette surveillance inclut la détection des gènes et des caractères, ainsi que l'identification des plantes génétiquement modifiées dans une dissémination expérimentale.

Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za strategije spremljanja in nadzora namernega sproščanja gensko spremenjenih rastlin

General Information

• Status: Published
• Publication Date: 16-Dec-1997
• 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
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 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 12468:1999 - Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modified plants

Overview

EN 12468:1997 (CEN) provides guidance for the design, development and execution of monitoring strategies for the deliberate release of genetically modified plants (GM plants) into the environment. The standard focuses on assessing the suitability and validity of monitoring programmes, covering detection of genes and traits and the identification of GM plants during experimental releases. EN 12468 helps those conducting monitoring programmes determine appropriate factors and criteria to demonstrate that a proposed monitoring strategy is fit for purpose.

Key topics and requirements

The standard advises on the critical elements to consider when establishing monitoring for deliberate releases of GM plants. Key topics include:

• Monitoring objectives - defining the purpose, scope and endpoints of a monitoring programme (e.g., detection, containment verification, environmental impact signals).
• Strategy design and validation - criteria to judge the suitability and validity of monitoring approaches and their expected performance.
• Detection and identification - considerations for methods that detect introduced genes, expressed traits and the presence of genetically modified individuals in the environment.
• Sampling and survey design - factors that influence sampling strategy, spatial and temporal coverage, and representativeness.
• Data quality and interpretation - criteria for analytical reliability, control measures, thresholds for action, and interpretation of monitoring results.
• Execution and documentation - guidance on implementing monitoring plans, record-keeping, reporting and review processes.
• Risk-context integration - aligning monitoring design with risk assessment outcomes and regulatory obligations.

Note: EN 12468 provides high-level guidance; it does not prescribe specific laboratory protocols or numerical thresholds.

Applications

EN 12468:1997 is intended for practical use in:

• Regulatory and environmental authorities designing or reviewing post-release and experimental release monitoring programmes.
• Biotechnology developers and sponsors preparing monitoring plans for field trials or deliberate releases of GM plants.
• Contract laboratories and environmental monitoring organizations tasked with implementing detection, sampling and reporting.
• Risk assessors and compliance officers who need to evaluate whether monitoring strategies are adequate for environmental protection and regulatory compliance.

Practical uses include planning experimental release monitoring, validating monitoring approaches, demonstrating compliance with permit conditions, and informing adaptive management after release.

Related standards

For comprehensive monitoring and compliance frameworks, EN 12468 is typically used alongside other CEN/ISO standards and regional guidance on environmental monitoring, laboratory methods for GMO detection, and biosafety/regulatory compliance. Users should consult national and EU regulatory guidance for legal requirements relevant to deliberate releases of genetically modified organisms.

Keywords: EN 12468:1997, CEN, monitoring strategies, genetically modified plants, GM plants, deliberate release, detection of genes and traits, monitoring programme.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.HPHQMHQLKUDVWOLQBiotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Überwachungsstrategien bei der absichtlichen Freisetzung gentechnisch veränderter PflanzenBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies de surveillance pour les disséminations volontaires de plantes génétiquement modifiéesBiotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for
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