Guidelines for molecular characterisation of GM plants
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 plants and (ii) the scientific rigour with which this should be done. These guidelines may develop further in function of the biotechnological developments and regulatory demands.
Background information on molecular guidelines for commercial release
In 2000, a EU working group prepared a document aimed at providing technical guidelines for the biosafety evaluation of transgenic plants at the molecular level, in view of their submission under EU directive 90/220/EEC (Part C, commercialisation). This initiative was inspired by efforts of the competent authorities of the US and Canada to harmonise their review processes for transgenic plants regarding the molecular genetic characterisation. The member states had the opportunity to amend the EU draft. However, a consensus was not reached and initiatives to further discuss the document have not been taken.
Using the last version of the EU working document as a starting point, the drafting of the guidelines for molecular characterisation of transgenic plants was initiated in 2000 by the Division of Biosafety and Biotechnology (SBB). With the assistance of scientific experts, a first draft was finalised in the beginning of 2001. This draft was forwarded to EuropaBio in order to obtain input by the biotech companies. The guidelines for commercialisation presented here are the result of the discussion within the SBB Working Group and EuropaBio.
Background information on Part B guidelines
There are two categories of Part B notifications. Some notifications are processed under standard procedure (Article 6 of Directive 2001/18/EC), others under the simplified procedure (Article 7 of Directive 2001/18/EC). If genetically modified plants have been released under a standard procedure and sufficient experience has been obtained of these releases concerning the safety of human health and the environment, one may request for a simplified procedure for the release of such types of GM plants. An application under a simplified procedure therefore excludes the release of new transgenes and those with unknown modes of action.
Article 6 and Article 7 of Directive 2001/18/EC state that a Part B notification should contain the information given in Annex III B of the Directive. Interesting to note is that the molecular information requirements of Annex III B apply both to Part B (research and developments) and Part C (marketing) applications. The level of detail required for Part B applications, however, could be less compared to marketing notifications.
In 2002, the SBB with the help of scientific experts, commenced discussing which molecular data are relevant for Part B releases. The document on ‘molecular characterisation of transgenic plants to be placed on the market’ served as a reference point to decide which molecular data should be included or omitted in a Part B consent in comparison to a Part C consent. The guidelines presented here are the result of the discussion within the SBB Working Group.