1. 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

2. 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

3. 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

4. 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: Non- exhaustive 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

5. Initial list of techniques
Cisgenesis
Zinc finger nuclease technology
Oligonuleotide-directed mutagenesis
RNA-dependent DNA methylation
Grafting
Reverse breeding
Agro-infiltration
Synthetic biology

6. Commercial developments: JRC report
Prospects for commercial use and potential impacts of commercialisation- IPTS
Detection and monitoring issues presented by new techniques- IHCP
Preliminary considerations on Safety aspects
Identification of further research needs

7. Scientific publications on new techniques
Public institutions
118
Private institutions 16
Mixed 13
TOTAL
147

8. 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

9. Evaluation of the GMO legislation
Is the EU legislative framework on GMOs fit for purpose?
Objectives in line with the needs of the EU society?
Appropriate scope?
Procedures fit for purpose?

10. Gathering a comprehensive view
Commercial developments: JRC report published:
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

11. Looking backward …

12. Looking forward … Assessment of GM legislation & new techniques Safety
Innovation
Consumer
Information

13. Thank you!