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Genome editing:
Regulatory aspects
Country 4: European Union
Chantal Bruetschy
European Commission
Directorate General Hea...
Authorisation
Risk assessment
Traceability
Labelling
Deliberate release of
GMOs
Experimental
release
Placing on the
market...
Case C-528/16
Request for a preliminary ruling of
the Court of Justice of the EU
Date of delivery
25/07/2018
COMMISSION HIGH-LEVEL CONFERENCE
MODERN BIOTECHNOLOGIES IN
AGRICULTURE
PAVING THE WAY FOR RESPONSIBLE
INNOVATION
Brussels ...
Key messages of the Conference (1)
• High level of safety
• Consumer confidence
• Member States’ role
• Innovation alone n...
Key messages of the Conference (2)
• Risk-benefit analysis
• Responsibility of all stakeholders
• Different types of farmi...
Scientific Advice Mechanism
(SAM) Explanatory Note on
New techniques in
agricultural biotechnology
• Key characteristics o...
Further scientific work
• Three Scientific Committees Opinions on
synthetic biology
• Two European Food Safety Authority (...
Research
The EU has supported,
through the FP7 and
Horizon 2020 framework
programmes, ambitious
research projects that
are...
Food
system
Food
values
Social
cohesion
Technology
uptake
Depletion
of natural
resources
Climate
change
EU
economic
growth...
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Regulatory aspects on genome editing in the European Union - Chantal Bruetschy

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

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Regulatory aspects on genome editing in the European Union - Chantal Bruetschy

  1. 1. Genome editing: Regulatory aspects Country 4: European Union Chantal Bruetschy European Commission Directorate General Health and Food Safety Head of Unit Biotechnology
  2. 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. 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. 4. COMMISSION HIGH-LEVEL CONFERENCE MODERN BIOTECHNOLOGIES IN AGRICULTURE PAVING THE WAY FOR RESPONSIBLE INNOVATION Brussels 28 September 2017 #BIOTECHEU
  5. 5. Key messages of the Conference (1) • High level of safety • Consumer confidence • Member States’ role • Innovation alone not sufficient
  6. 6. Key messages of the Conference (2) • Risk-benefit analysis • Responsibility of all stakeholders • Different types of farming • Legal certainty
  7. 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. 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. 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. 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. 11. Thank you

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