Guidelines for molecular characterisation of genetically modified higher plants for a standard part B consent according to Annex III B of Directive 2001/18/EC

Last updated on 22-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph

SCIENSANO

Résumé:

Applications handed in for experimental release (Part B) or commercial release of a genetically modified (GM) plant, require information for risk assessment, including molecular data. In carrying out its assessments, the SBB has noted a variation among dossiers in both quantity and quality of the molecular data. In order to provide applicants with practical guidelines concerning the molecular genetic data for Part B and Part C releases, guidelines on molecular characterisation were prepared. The objectives were to provide guidance on (i) the extent of the molecular data required for GM plan…

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