90/220/EEC - Deliberate release into the environment of genetically modified organisms

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 specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for valves used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the valve includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for sampling and inoculation devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the sampling and inoculation device includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for piping and instrumentation used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for tubes and pipes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the tubes and pipes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

This European Standard specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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 specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for tubes and pipes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the tubes and pipes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for valves used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the valve includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for sampling and inoculation devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the sampling and inoculation device includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for piping and instrumentation used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies basic requirements for microbiological safety cabinets (MSCs) with respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with microorganisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 610101-1, EN 292-1 and EN 292-2 (see Bibliography (1), (2) and (3)).

This European Standard gives guidance to the manufacturer of sampling and inoculation devices on providing instructions in the manufacturer's documentation accompanying his products in accordance with prEN 13312-3. It has the purpose of pointing out to him, which hazards can occur during operation, s so that he can take these into account in an adequate way during construction and will be in a positive to formulate information for use giving adequate consideration of safety...

This European Standard specifies performance criteria for off-gas systems used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the off-gas system includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard specifies basic requirements for microbiological safety cabinets (MSCs) with respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with microorganisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 610101-1, EN 292-1 and EN 292-2 (see Bibliography (1), (2) and (3)).

This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard gives guidance to the manufacturer of sampling and inoculation devices on providing instructions in the manufacturer's documentation accompanying his products in accordance with prEN 13312-3. It has the purpose of pointing out to him, which hazards can occur during operation, s so that he can take these into account in an adequate way during construction and will be in a positive to formulate information for use giving adequate consideration of safety...

This European Standard specifies performance criteria for off-gas systems used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the off-gas system includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.

This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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 specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.

This European Standard gives guidance on general testing procedures to assess the leaktightness for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the leaktightness of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

This European Standard provides guidance concerning the procedures for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for GMMs released into the environment. Since monitoring methods of microorganisms in environmental samples usually require pretreatment of the samples, for example the extraction and isolation of GMMs and/or their nucleic acid, this is included in scope of this European Standard. The sampling is to provide material to which subsequent analytical or biological methods for monitoring of GMMs can be applied.

This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.

This European Standard provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution.

This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.

This European Standard gives guidance on the steps that should be followed during the analysis of the genetic modification of interest: - to analyse and describe the genetic modification of interest as it exists in the GMO (genomic modification); - to detect and/or identify the GMO accurately. This European Standard gives guidance on the factors and criteria considered by the experimenter for the selection of the appropriate method(s) and the validity of experimental results for the analysis of the genetic modification of interest.

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.

This European Standard specifies performance criteria for shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

This European standard gives guidance on control procedures for raw materials u used in the biotechnological processes. This European standard does not list individual materials, but provides criteria against which raw materials used in industrial biotechnology processes can be checked. This European standard is applicable to all materials used during production of products by means of a biotechnological process. It is not applicable to equipment.

This European Standard specifies general requirements for management and organization of procedures for conservation of microorganisms used for large-scale process and production. It is intended to secure safe handling and also to ensure that reproducible results are obtained in biotechnology processes.

This European Standard gives guidance on the assessment and the selection of procedures for treatment of waste process microorganisms from biotechnological plant to ensure the safety of people and environment. This European Standard applies to wastes and effluents (solid, liquid and gaseous) emitted from biotechnological processes which include traditional processes such as brewing or food processing, fermentation of pharmaceutical and chemical products as well as biotechnological processes for environmental and agricultural application.