CEN/TC 233/WG 3 - Agricultural environmental applications

This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.

This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.

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 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 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 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 gives guidance for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for genetically modified plants. The sampling is to provide material to which subsequent analytical methods for monitoring genetically modified plants of interest can be applied. This European Standard deals only with providing statistically valid samples from the experimental field as identified in a field trial design.

This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms.