delSRPS CR 13426:2012

Biotechnology - Microorganisms - Report on the criteria used to classify Group I genetically modified microorganisms

Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.