EN 12305:1997

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

This European Standard gives guidance for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for genetically modified plants. The sampling is to provide material to which subsequent analytical methods for monitoring genetically modified plants of interest can be applied. This European Standard deals only with providing statistically valid samples from the experimental field as identified in a field trial design.

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

Diese Europäische Norm gibt eine Anleitung für die Erarbeitung einer validen Probenahmestrategie, um damit die Zielstellung einer Überwachungsstrategie für gentechnisch veränderte Pflanzen zu erfüllen. Die Probenahme dient der Bereitstellung von Materialien, die in der Folge analytischen Verfahren zur Überwachung gentechnisch veränderter Pflanzen dienen, die hier von Interesse sind. Diese Europäische Norm behandelt nur die Erfassung statistisch abgesicherter Proben aus einem Versuchfeld, wie es in einer Feldversuchsplanung ausgewiesen ist.

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

La présente norme européenne présente un guide pour établir une stratégie d'échantillonnage valide qui réponde aux objectifs d'une stratégie de surveillance des plantes génétiquement modifiées. Le but de l'échantillonnage est de fournir le matériel nécessaire à l'application ultérieure des méthodes d'analyse pour la surveillance des plantes génétiquement modifiées concernées. La présente norme européenne traite uniquement de la récolte d'échantillons statistiquement valables provenant du champ d'expérimentation identifié dans un plan d'essai en champ.

Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za strategijo vzorčenja namernega sproščanja gensko spremenjenih rastlin

General Information

• Status: Published
• Publication Date: 21-Oct-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 12305:1999 - Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified plaints

Overview

EN 12305:1997 (CEN) is a European Standard that provides guidance on designing sampling strategies for deliberate releases and field trials of genetically modified plants (GMP/GMO). The standard focuses on producing statistically valid samples from an experimental field layout so that subsequent analytical methods can reliably detect, quantify or monitor genetically modified material. EN 12305:1997 applies to sampling within the experimental field as identified in the field trial design and supports the objectives of a broader monitoring strategy.

Key topics and requirements

• Purpose-driven sampling: Guidance emphasizes that sampling strategy must meet the specific objectives of monitoring (e.g., presence/absence, frequency, spatial distribution).
• Statistical validity: Samples must be collected in a way that supports unbiased, representative, and reproducible results suitable for statistical analysis.
• Field-trial alignment: Sampling plans should be consistent with the experimental field design and documented trial boundaries.
• Material suitability for analysis: Collected samples must be appropriate for downstream analytical methods used in GMO detection or quantification.
• Traceability and documentation: The standard underscores the need to document sampling locations, timing, methods and chain of custody to ensure data integrity and regulatory defensibility.
• Practical constraints: Guidance considers field heterogeneity and operational factors to balance scientific rigor with feasible sampling logistics.

(Note: EN 12305:1997 deals specifically with providing statistically valid samples from the identified experimental field; it does not prescribe particular laboratory analytical procedures.)

Applications

• Designing and implementing sampling plans for deliberate releases and field trials of genetically modified plants.
• Preparing monitoring programs to meet regulatory requirements and environmental risk assessment needs.
• Supplying representative material for laboratory analysis (e.g., molecular detection or compositional testing).
• Supporting research studies on gene flow, environmental persistence, and agronomic performance of GM plants.

Who should use this standard

• Field trial managers and researchers conducting deliberate releases of GM plants
• Regulatory authorities and environmental monitoring teams assessing compliance
• Contract research organizations (CROs) and seed companies running trials
• Biosafety officers and quality managers responsible for sample integrity
• Laboratories that analyze material collected from field trials

Related standards

• Other CEN/ISO standards and guidance on GMO detection, analytical methods, and field trial design complement EN 12305:1997. Users should consult applicable national and international regulatory guidance to ensure full compliance.

Keywords: EN 12305:1997, CEN, sampling strategies, genetically modified plants, GMO monitoring, field trials, statistical sampling, environmental monitoring, sampling plan.

Standards Content (Sample)

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