August 12, 2009
In its opinion
on “Guidance for the risk assessment of
genetically modified plants used for
non-food or non-feed purposes”,
EFSA’s
Panel on Genetically Modified Organisms
(GMO) discusses risk assessment issues and
defines the specific requirements that
applicants need to follow to allow efficient
risk assessment of GM plants used for other
purposes than food or feed. This will
complement EFSA’s existing “Guidance on the
safety evaluation of GM plants”, initially
conceived for the assessment of GM plants
used for food and feed purposes.
GM plants developed for non-food or non-feed
purposes are plants which may be used for a
wide range of applications such as the
production of: industrial enzymes; raw
materials for bio-fuels, paper and starch;
medicinal products (such as vaccines and
antibodies); as well as other uses which can
range from energy production to helping to
address environmental issues (for instance
the take-up of contaminants present in soil
through phytoremediation).
In its opinion, the GMO Panel advocates – as
for GM plants used for food and feed - a
comparative approach whilst highlighting
that it should be applied carefully. The
Panel considered that existing guidance for
environmental risk assessment is adequate
but that additional emphasis should be given
to issues such as gene transfer and the
exposure of non-target organisms,
particularly wildlife feeding on these GM
plants. When in certain cases the applicant
proposes confinement strategies to reduce
exposure of humans, animals or the
environment, the GMO Panel has specified the
information requirements needed to carry out
the exposure assessment. Where new potential
GM plant risks are identified, the plants
are likely to require more specific risk
management conditions.
The Guidance benefited from the contribution
of selected experts in the field of GM
plants for non-food or non-feed purposes and
in the field of risk assessment of
pharmaceutical products. Legal advice was
also given by the European Commission and
the European Medicines Agency (EMEA). EFSA
received comments during a 3-month public
consultation which have been taken into
account in finalising the opinion.
EFSA’s role is to evaluate the safety of GM
plants for human and animal health and the
environment. Guidance documents aim at
ensuring that applications for marketing GM
plants contain all information and data
required to support a comprehensive risk
assessment, so that applications can be
efficiently evaluated by EFSA and other
competent authorities in Europe.