Health & Consumer Protection Directorate General

Report
Health & Consumer
Directorate General
New biotechnology techniques applied
in plant breeding
Ongoing work by the Commission
Hearing on Cisgenesis in plant breeding
21 June 2011
Sébastien Goux & Paula Rey García - DG SANCO E1
Context
Breeding and genetic modification
techniques evolve at a rapid pace
GMO legislation introduced in 1990
Unclear regulatory status of some of the
techniques
Possible arguments for exclusion from GMO
legislation in some cases
New techniques & GMO legislation
Working group established at
request of 2001/18/EC CAs in
October 2007
Two experts per Member State
(nominated by CAs)
Objective: examine new
techniques in the context of the
GMO legislation
Legislative framework
GMO defined as “an organism… in which
the genetic material has been altered in
a way that does not occur naturally by
mating and/or natural recombination”
Annex IA Part 1 of Directive 2001/18/EC: Nonexhaustive list of techniques that lead to
genetic modification
Techniques not considered to result in genetic
modification or excluded from the scope of the
GMO legislation also listed
Initial list of techniques
Cisgenesis
Zinc finger nuclease technology
Oligonuleotide-directed mutagenesis
RNA-dependent DNA methylation
Grafting
Reverse breeding
Agro-infiltration
Synthetic biology
Commercial developments:
JRC report
Prospects for commercial use and
potential impacts of commercialisationIPTS
Detection and monitoring issues
presented by new techniques- IHCP
Preliminary considerations on Safety
aspects

Identification of further research needs
Scientific publications on new
techniques
Other
countries
11%
North America
32%
Asia
11%
EU
46%
Public
institutions
118
Private
institutions
16
Mixed
13
TOTAL
147
Safety aspects: EFSA mandate
Is current guidance appropriate?
Risks related to the use of new
techniques
Compared to conventional breeding
Compared to current GMOs
Cisgenesis as a priority
Evaluation of the GMO legislation
Is the EU legislative framework on
GMOs fit for purpose?
1. Objectives in line with the needs of
the EU society?
2. Appropriate scope?
3. Procedures fit for purpose?
Gathering a comprehensive view
Commercial developments: JRC report published:
http://ftp.jrc.es/EURdoc/JRC63971.pdf
Legal analysis: WG to finalise its report and
present its findings as advice to Member States
Safety assessment:
EFSA input on cisgenesis  by summer
Consumer perceptions
Eurobarometer: a regular monitoring
Evaluation of the GMO legislation  by summer
Looking backward …
Looking forward …
Assessment of
GM legislation &
new techniques
Safety
Innovation
Consumer
Information
Thank you!

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