CEN/TC 233/WG 1 - Research development and microbiological analysis in laboratories

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 guidance on methods for handling, inactivating and testing of waste containing organisms arising from biotechnology laboratory activities and processes. It is concerned with methods to reduce the risks arising from exposure to waste derived from laboratory-scale activities which contains organisms hazardous or potentially hazardous to humans, animals, plants or the environment.

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 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 specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.

This CEN Report reviews the safety criteria for hosts, vectors, inserts and genetically modified microorganisms (GMM’s) used by the competent authorities of Member States of the European Union to classify GMM's as intrinsically safe, i.e. as Group I GMM’s. The report may assist both users and regulatory authorities in classifying GMM’s, including mammalian and plant cells, as safe for human health and the environment.
This CEN Report covers Group I GMM’s that are applied in research and development activities and those applied in industrial applications, which are frequently activities on a larger scale. Although most of the information available relates to GMM’s that are to be used for research and development, the safety criteria for GMM’s to be used for the latter kind of activities show much overlap. No listings of hosts and vectors are given, because such lists are readily available and are inevitably incomplete due to the continuous addition of newly classified biological agents.

This European Standard describes the principles which guide the selection of equipment to be used in a biotechnology laboratory.

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