This presentation clarifies the regulation of genome editing in the European Union, with a view to discussing approaches to address them.

1. Genome editing:
Regulatory aspects
Country 4: European Union
Chantal Bruetschy
European Commission
Directorate General Health and Food Safety
Head of Unit Biotechnology

2. Authorisation
Risk assessment
Traceability
Labelling
Deliberate release of
GMOs
Experimental
release
Placing on the
market
Contained use of GMM
GM food and feed
The EU GMO legislation

3. Case C-528/16
Request for a preliminary ruling of
the Court of Justice of the EU
Date of delivery
25/07/2018

4. COMMISSION HIGH-LEVEL CONFERENCE
MODERN BIOTECHNOLOGIES IN
AGRICULTURE
PAVING THE WAY FOR RESPONSIBLE
INNOVATION
Brussels 28 September 2017
#BIOTECHEU

5. Key messages of the Conference (1)
• High level of safety
• Consumer confidence
• Member States’ role
• Innovation alone not sufficient

6. Key messages of the Conference (2)
• Risk-benefit analysis
• Responsibility of all stakeholders
• Different types of farming
• Legal certainty

7. Scientific Advice Mechanism
(SAM) Explanatory Note on
New techniques in
agricultural biotechnology
• Key characteristics of the various
new techniques
• Comparison with established
techniques
Published in April 2017

8. Further scientific work
• Three Scientific Committees Opinions on
synthetic biology
• Two European Food Safety Authority (EFSA)
opinions on site-directed nucleases type 3
techniques and cisgenesis/intragenesis
• Two mandates sent to EFSA on synthetic
biology and gene drive engineered organisms

9. Research
The EU has supported,
through the FP7 and
Horizon 2020 framework
programmes, ambitious
research projects that
are at the forefront of
biotech developments
and new discoveries
within the Agri-Food
sector.

10. Food
system
Food
values
Social
cohesion
Technology
uptake
Depletion
of natural
resources
Climate
change
EU
economic
growth
Global
trade
Agro-food
chain
structure
World
population
growth
From Mylona, K., Maragkoudakis, P., Bock, A.-K.,
Wollgast, J., Caldeira, S. and Ulberth, F., Delivering on
EU Food Safety and Nutrition in 2050 – Future
challenges and policy preparedness, EUR27957 EN,
Publications Office of the European Union,
Luxembourg, 2016, ISBN 978-92-79-58916-4,
doi:10.2787/625130.
Drivers to
the EU food
system of
2050

11. Thank you