EN 12685:1998
(Main)Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modified microorganisms, including viruses
Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modified microorganisms, including viruses
This European Standard provides 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 GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release.
Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Überwachungsstrategien bei der absichtlichen Freisetzung gentechnisch veränderter Mikroorganismen einschließlich Viren
Diese Europäische Norm gibt eine Anleitung für Faktoren und Kritirien, die bei der Ermittlung der Eignung und Validität der Planung, Entwicklung und Durchführung einer Überwachungsstrategie für GVM zu berücksichtigen sind. Die Überwachung beinhaltet den Nachweis genotypischer und phänotypischer Eigenschaften wie auch den Nachweis Materials von Viren und/oder von Symptomen, die beim infizierten Wirt spezifisch sind, zur Identifizierung von GVM im Rahmen einer experimentellen Freisetzung.
Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies de surveillance pour les disséminations volontaires de microorganismes génétiquement modifiés, y compris de virus
La présente norme européenne donne des indications relatives aux facteurs et aux critères qui sont pris en considération pour déterminer la conformité et la validité de la conception, de la mise au point et de l'exécution d'une stratégie de surveillance s'appliquant aux microorganismes génétiquement modifiés.
Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za strategije spremljanje in nadzora namernega sproščanja gensko spremenjenih mikroorganizmov, vključno z virusi
General Information
Overview
EN 12685:1998 (CEN) is a European guidance standard for designing and assessing monitoring strategies for deliberate environmental releases of genetically modified microorganisms (GMM), including viruses. The standard focuses on the factors and criteria used to determine the suitability and validity of monitoring design, development and execution. Monitoring, as described in the standard, covers both genotypic and phenotypic detection as well as detection of viral material or host-specific symptoms to identify GMMs in experimental releases.
Key topics
- Scope and purpose: Guidance for monitoring deliberate releases of GMMs in the environment and experimental settings.
- Design criteria: Factors to consider when determining whether a monitoring strategy is appropriate for the release scenario.
- Validity and suitability: Criteria to assess whether monitoring methods and sampling programs will achieve reliable detection and identification.
- Detection endpoints: Monitoring of genotypic characteristics (molecular markers) and phenotypic traits (observable characteristics), plus viral material or host-specific symptoms.
- Execution and documentation: Guidance on implementing monitoring plans, including sampling, data collection, quality control and reporting.
- Risk-informed monitoring: Aligning monitoring intensity and methods with the biological properties of the GMM, release scale, and environmental context.
Applications
EN 12685 is practical for organizations and professionals involved in the deliberate release or field testing of genetically modified microbes and viruses:
- Research institutions planning experimental environmental releases of GMMs.
- Biotechnology companies developing biological products that involve field trials.
- Environmental monitoring laboratories establishing detection and validation workflows for GMM surveillance.
- Regulatory authorities and risk assessors evaluating monitoring plans submitted with release notifications or permits.
- Public health and environmental agencies implementing post-release surveillance and incident response.
Using EN 12685 helps ensure monitoring programs are scientifically justified, reproducible and appropriate to the release scenario, improving environmental safety and regulatory compliance.
Related standards
EN 12685 complements other European and international guidance on biotechnology, environmental monitoring and biosafety. Users should consult relevant CEN/ISO standards and national regulations for detailed analytical methods, laboratory validation requirements and legal obligations when planning deliberate releases of genetically modified organisms.
Keywords: EN 12685, monitoring strategies, genetically modified microorganisms, GMM, deliberate release, environmental monitoring, biotechnology standard, CEN.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.HPHQMHQLKBiotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Überwachungsstrategien bei der absichtlichen Freisetzung gentechnisch veränderter Mikroorganismen einschließlich VirenBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies de surveillance pour les disséminations volontaires de microorganismes génétiquement modifiés, y compris de virusBiotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modif
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Frequently Asked Questions
EN 12685:1998 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 monitoring strategies for deliberate releases of genetically modified microorganisms, including viruses". This standard covers: This European Standard provides 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 GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release.
This European Standard provides 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 GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release.
EN 12685:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.01 - Microbiology in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12685:1998 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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