CR 13426:1998

CR 13426:1998 is a standardization document published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Microorganisms - Report on the criteria used to classify Group I genetically modified microorganisms". This standard covers: 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 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.

CR 13426:1998 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.

CR 13426:1998 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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