SIST EN 13441:2002

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



SIST EN 13441:2002



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



EN 13441:2001 (E)2ContentspageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54Risk assessment.65Containment measures.6Bibliography.10SIST EN 13441:2002



EN 13441:2001 (E)3ForewordThis European Standard has been prepared by Technical Committee CEN/TC 233 "Biotechnology", the secretariatof which is held by AFNOR.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by May 2002, and conflicting national standards shall be withdrawn at the latest byMay 2002.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,Switzerland and the United Kingdom.SIST EN 13441:2002



EN 13441:2001 (E)4IntroductionThe measures described in this European Standard are designed to contain genetically modified plants, where thisis required. Genetically modified plants include those in which the introduced genetic material is derived fromanother plant or from a non-plant source, for example a virus or other microorganism. Containment of geneticallymodified microorganisms, the subject of Directive 98/81/EC (including 90/219/EEC) [1] and/or genetically modifiedsmall animals associated with plants is not included in this standard; their containment may require differentmeasures from those mentioned here.The containment principles described apply both to greenhouses, including growth tunnels, and to the morecomplex containment facilities required when greenhouses do not provide the degree of containment required.Risk analysis is required to determine any hazard and its magnitude as well as the containment measures neededto minimize the risk.The selection of containment measures for plants classified in a given group requires identification of the meansincluding work practices, by which particular plants may be dispersed in the relevant situation. Containmentmeasures used for one species may be irrelevant to another, which is dispersed by different mechanisms.Containment measures are therefore selected for the particular situation.In many cases, containment by biological rather than structural means will be appropriate. The use of male sterileplants and maternally inherited genetic modifications are examples of potential biological containment measures.Users of this European Standard may be involved with hazards associated with materials, operations andequipment. This European Standard does not address all off these safety problems. It is the responsibility of theuser of this European Standard to establish appropriate safety and health practices and determine the applicabilityof regulatory limitations for the proposed work.SIST EN 13441:2002



EN 13441:2001 (E)51 ScopeThis European Standard gives biological, physical and procedural containment measures for work with geneticallymodified plants including plants where the transferred genetic material is derived from a non-plant source. It definesmeasures 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 inthis standard. Containment of microorganisms in laboratories is covered in EN 12128.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 12128, Biotechnology — Laboratories for research, development and analysis — Containment levels ofmicrobiology laboratories, areas of risk, localities and physical safety requirements.EN 12741, Biotechnology — Laboratories for research, development and analysis — Guidance for biotechnologylaboratory operations.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1biological containmentuse of plants which are unable to remain viable in natural environmental conditions in the area of the containmentfacility, or which lack reproductive mechanisms required for dispersal3.2genetically modified plantplant in which the genetic material has been altered in a way that does not occur naturally by mating and/or naturalrecombinationNOTEWithin the terms of this definition, genetic modification occurs at least by the use of the techniques listed in Directive98/81/EC, Annex 1 Part A ([1]).3.3greenhousestructure with a wall, a roof and a floor designed and used principally for growing plants in a controlled andprotected environment [Directive 98/81/EC]NOTEAn alternative definition in prEN 13031-1 dealing with structural aspects of greenhouses is: a structure used for thecultivation and/or protection of plants and crops which promotes solar radiation transmission under controlled conditions toimprove the growing environment, and which is of a size that enables people to work within it [prEN 13031-1].3.4hazardintrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm[EN 1620]NOTEHarm is an injury or damage to health of people and/or the environment.3.5physical containmentsystem for confining a microorganism and/or organism or other entity wit
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