Parma, Italy
June 18, 2008
Deadline: 16/09/2008
EFSA’s Panel on
Genetically Modified Organisms (GMO Panel) has launched an open
consultation on the draft Opinion concerning “the risk
assessment of genetically modified plants used for non-food or
non-feed purposes”. This draft Opinion is an EFSA self-tasking
issue (see Register of Questions (EFSA-Q-2007-176).
EFSA’s role in the GMO authorisation process in Europe is to
provide science-based risk assessment opinion for each
authorisation application to the European Commission. Based on
this opinion and other information the Commission presents a
draft decision to the EU Member States who then can take
decision on the GMO authorization.
The elements for the safety assessment procedure for genetically
modified (GM) plants are provided in Directive 2001/18/EC. For
GM plants and derived food and feed the data requirements and
risk assessment criteria to be used by the applicant for the
preparation and presentation of their authorisation application
are further detailed in the EFSA GM plant Guidance document.
These data requirements and risk assessment criteria were now
evaluated and further elaborated where needed, for the safety
assessment of GM plants with uses for non-food or non-feed
purposes. In order not to duplicate information, this EFSA
Guidance document applies and in addition, the present opinion
is to be applied for plants developed for non-food or non-feed
purposes.
Examples of GM plants used for non-food or non-feed purposes
include plants producing medically useful biologically active
molecules, such as vaccines and antibodies, diagnostic products,
industrial enzymes or raw materials for the production of
biopolymers, biofuels, paper or starch. Other non-food or
non-feed purposes of GM plants include energy production,
phytoremediation, landscape improvement and ornamentals.
In line with EFSA’s policy on openness and transparency and in
order for EFSA to receive comments from the scientific community
and stakeholders on its work, EFSA engages in public
consultations on key issues. In this respect EFSA would be
grateful to receive relevant comments on its draft scientific
Opinion on “the risk assessment of genetically modified plants
used for non-food or non-feed purposes”.
Comments must be related to the safety of GM plants used for
non-food or non-feed purposes and their scientific/technical
nature should be supported by appropriate scientific
argumentation, justification and/or references.
Interested parties are invited to submit written comments by 16
September 2008. The outcome of this consultation will be taken
into account for the revision of this Opinion before its
adoption by the GMO panel. Please exclusively use the electronic
template provided with the documents to submit comments and
refer to the line numbering. Comments submitted by email or via
surface mail cannot be taken into account.
Draft Scientific Opinion on the risk assessment of genetically
modified plants used for non-food or non-feed purposes (PDF
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