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!