SIST EN 13441:2002
(Main)Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants
Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants
This European Standard gives biological, physical and procedural containment measures for work with genetically modified plants including plants where the transferred genetic material is derived from a non-plant source. It defines measures to minimize hazards identified by risk analysis.
Containment may be provided in a greenhouse or in a growthroom, laboratory or other containment facility.
Containment of genetically modified microorganisms and/or small animals associated with plants is not included in this standard. Containment of microorganisms in laboratories is covered in EN 12128.
Biotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für die Einschließung von gentechnisch veränderten Pflanzen
Diese Europäische Norm beschreibt biologische, physikalische und verfahrenstechnische Sicherheitsmaßnahmen für Arbeiten mit gentechnisch veränderten Pflanzen, einschließlich Pflanzen, bei denen das übertragene genetische Material von einer nichtpflanzlichen Quelle stammt. Sie legt Maßnahmen zur Verringerung der Gefährdung fest, die durch eine Risikoanalyse bestimmt werden.
Die Einschließung kann in einem Gewächshaus oder Anzuchtraum, Laboratorium oder anderen Sicherheitsbereichen erfolgen.
Die Einschließung von gentechnisch veränderten Mikroorganismen und/oder Kleintieren, die mit den Pflanzen in Verbindung stehen, werden in dieser Norm nicht behandelt. Die Einschließung von Mikroorganismen in Laboratorien wird in EN 12128 behandelt.
Biotechnologie - Laboratoires de recherche, développement et analyse - Guide pour le confinement des plantes génétiquement modifiées
La présente norme européenne précise les mesures de confinement biologique, physique et opératoire relatives au travail avec des plantes génétiquement modifiées, y compris des plantes dont le matériel génétique introduit provient d'une source non végétale. La présente norme définit les mesures permettant de réduire au minimum les dangers identifiés lors de l'analyse du risque.
Le confinement peut être mis en place dans une serre, dans une chambre de culture, dans un laboratoire ou dans toute autre installation de confinement.
Le confinement des micro-organismes et/ou des petits animaux génétiquement modifiés associés à des plantes n'est pas traité dans la présente norme. Le confinement des micro-organismes en laboratoire est traité dans l'EN 12128.
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Biotehnologija - Raziskovalni, razvojni in analitski laboratoriji - Navodilo za zadrževanje gensko spremenjenih rastlin
General Information
- Status
- Published
- Publication Date
- 31-Aug-2002
- Technical Committee
- BTH - Biotechnology
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Sep-2002
- Due Date
- 01-Sep-2002
- Completion Date
- 01-Sep-2002
Overview
EN 13441:2001 - "Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants" is a CEN standard that provides guidance on biological, physical and procedural containment measures for work with genetically modified plants. The standard applies to containment in greenhouses, growthrooms, laboratories or other facilities and is driven by a case‑by‑case risk assessment to minimize hazards from modified plants (including those with non‑plant-derived genetic material). Note: containment of genetically modified microorganisms and small animals is excluded (see EN 12128).
Key Topics and Requirements
- Risk assessment: Evaluate environmental, regional and climatic factors and identify dispersal mechanisms (pollen, seed/fruit, vegetative parts) to determine containment needs.
- Containment approaches: Combination of biological, physical and procedural measures tailored to the plant species and work practices.
- Biological containment: Use of male‑sterile or maternally inherited traits, sexually sterile plants or other genetic measures to limit dispersal.
- Physical containment: Structural measures in greenhouses and growthrooms such as sealed floors, below‑ground barriers, sealed penetrations, pollen‑retaining filters, bird/animal exclusion, and air filtration.
- Engineering controls for higher containment: Growthrooms and cabinets may require negative pressure, airlocks, specified air change and filtration systems, sealability for fumigation, and facility design in consultation with regulators.
- Control of specific dispersal routes:
- Pollen: flower bags, pollen filters, timing/plant selection, access control, inward airflow, disinfection of runoff.
- Seeds/fruit: solid floors, filtered or sterilized runoff, sterilization/steaming of outgoing material (autoclaves per EN 12347), wildlife exclusion.
- Vegetative spread: underground walls, containerized transfers, fumigation, herbicide control, wash facilities.
- Good work practices: Written procedures, staff training, restricted access, signage, protective clothing and changing areas, hand‑washing/disinfection, and emergency plans.
- Operational safeguards: Regular inspection and maintenance of ventilation and filter systems; ensure access controls comply with safety (fire escape) regulations. Example guidance mentions negative pressure differentials (e.g., ~30 Pa) as a design consideration.
Applications and Users
Who uses EN 13441:2001:
- Biotech researchers and laboratory managers conducting plant genetic modification trials
- Greenhouse operators and designers implementing containment for experimental crops
- Health & safety officers and biosafety committees developing SOPs and emergency plans
- Facility architects and engineers planning growthrooms, airlocks and HVAC for containment
- Regulatory authorities and auditors assessing compliance with containment requirements
Practical uses:
- Designing containment strategies for transgenic plant research
- Selecting combined biological and physical controls to prevent environmental release
- Developing staff training, signage and access control for contained plant facilities
Related Standards
- EN 12128 - Containment levels for microbiology laboratories (microorganisms)
- EN 12741 - Guidance for biotechnology laboratory operations
- EN 12347 - Performance criteria for autoclaves and steam sterilizers
- prEN 13031-1 - Design and construction of commercial production greenhouses
- Relevant EU Directives on contained use of genetically modified organisms
Keywords: EN 13441:2001, containment of genetically modified plants, greenhouse containment, biological containment, risk assessment, CEN standard, biotechnology laboratories, biosafety.
Frequently Asked Questions
SIST EN 13441:2002 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants". This standard covers: This European Standard gives biological, physical and procedural containment measures for work with genetically modified plants including plants where the transferred genetic material is derived from a non-plant source. It defines measures to minimize hazards identified by risk analysis. Containment may be provided in a greenhouse or in a growthroom, laboratory or other containment facility. Containment of genetically modified microorganisms and/or small animals associated with plants is not included in this standard. Containment of microorganisms in laboratories is covered in EN 12128.
This European Standard gives biological, physical and procedural containment measures for work with genetically modified plants including plants where the transferred genetic material is derived from a non-plant source. It defines measures to minimize hazards identified by risk analysis. Containment may be provided in a greenhouse or in a growthroom, laboratory or other containment facility. Containment of genetically modified microorganisms and/or small animals associated with plants is not included in this standard. Containment of microorganisms in laboratories is covered in EN 12128.
SIST EN 13441:2002 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.
SIST EN 13441:2002 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.Biotehnologija - Raziskovalni, razvojni in analitski laboratoriji - Navodilo za zadrževanje gensko spremenjenih rastlinBiotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für die Einschließung von gentechnisch veränderten PflanzenBiotechnologie - Laboratoires de recherche, développement et analyse - Guide pour le confinement des plantes génétiquement modifiéesBiotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13441:2001SIST EN 13441:2002en01-september-2002SIST EN 13441:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13441November 2001ICS 07.080English versionBiotechnology - Laboratories for research, development andanalysis - Guidance on containment of genetically modifiedplantsBiotechnologie - Laboratoires de recherche,développement et analyse - Guide pour le confinement desplantes génétiquement modifiéesBiotechnik - Laboratorien für Forschung, Entwicklung undAnalyse - Leitfaden für die Einschließung von gentechnischveränderten PflanzenThis European Standard was approved by CEN on 29 September 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13441:2001 ESIST EN 13441:2002
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