Health & Consumer
Directorate General
Regulatory Framework for Biotechnology derived Crops
with Specific Focus on New Plant Breeding Techniques in
the European Union
JRC Workshop « Comparative Situation on New Plant Breeding Techniques »
12 – 13 September 2011
Sevilla, Spain
Joachim Bollmann - DG SANCO E1
The European Union
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(01.01.2011)
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Part 3 – DG SANCO
Health and Consumer Protection DG
Europe working for healthier, safer,
more confident citizens
Public Health
Food safety
Consumer Affairs
The European Commission
Regulatory Framework for Biotechnology derived Crops with
Specific Focus on New Plant Breeding Techniques in
the European Union
European Union – Commission – DG-Sanco

How the EU regulates genetically modified
organisms (GMOs)
Activities of the Commission on New Techniques
Scope of regulations – GMO definition
Legal framework
In the EU all GMOs need authorization
before being placed on the market.
Rational for setting the legal framework
novelty of the new methods of genetic modification,
thus lack of experience,
far reaching potential of the techniques,
Need for transparency (food and feed labelling)
„Older“ techniques or natural processes should not be
covered
(excluding mutagenesis, cell fusion between closely
related species, polyploidy induction, in vitro fertilisation;
natural processes as: conjugation, transduction,
transformation).
Regulatory Framework for Genetically Modified Crops in
the European Union
Directive 2001/18/EC of the European Parliament and of the
Council of 12 March 2001 on the deliberate release into the
environment of genetically modified organisms and repealing
Council Directive 220/90/EEC
Regulation (EC) No 1829/2003 of the European Parliament and
of the Council of 22 September 2003 on genetically modified food
and feed
Legal framework
Objectives
In accordance with the precautionary principle to protect
human health and the environment
(Article 1 of Directive 2001/18/EC)
To ensure a high level of protection of human life and
health, animal health and welfare, and
to inform consumers (labelling)
(Article 1 of Regulation (EC)1829/2003)
Legal framework
Scope of the GM legislation in the European
Union is defined by the term
“GMO: genetically modified organism”
Authorisation procedure
Authorisation
Authorisation
Granted for 10 years
Renewable for 10-year periods
Decision to be published in the Official Journal
Authorization holder responsible for safety, post market
monitoring etc.
Authorised products are entered in the Community
register
http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
Regulation on Food and Feed:
a fully integrated approach
GM SEEDS
ENVI
Risk
GM FOOD
GM FEED
- containing or
consisting of GMOs
- containing or
consisting of GMOs
-produced from
GMOs
- produced from
GMOs
Food/Feed
Risk
Labelling rules are essential to
ensure consumer choice
Methods of detection
 MUST be submitted with
each application
 Validation by CRL with ENGL
 Material of reference must be available
Challenge: New Techniques
GMO regulation was introduced in 1990 and adapted 2001
part of GMO definition goes back to 1982
food and feed derived from GMO covered since 2003
since scientific and technical progress
breeding and genetic modification techniques have been
evolving at a rapid pace
Commission approach
1.
JRC work on New plant breeding techniques

IPTS study on adoption and economic impact

IHCP task force on detection challenges
2.
EFSA input on safety aspects
3.
Member States’ Experts to form a Working Group
on New Techniques
(ongoing work on evaluation of the legislation)
1. JRC work on New plant breeding techniques
Current developments: JRC report
Prospects for commercial use and potential impacts of
commercialisation- IPTS
Detection and monitoring issues presented by new
techniques- IHCP
literature on safety is reported

Identification of further research needs
2. EFSA input on safety aspects
Is current guidance appropriate?
Risks related to the use of new techniques

Compare to conventional breeding

Compare to current GMOs
Cisgenesis as a priority
Other techniques to follow
Work is ongoing, first opinions to be expexted end of 2011
3.
Expert Working Group on New Techniques
Established at request of Member States in October 2007
Two experts per Member State (nominated by CAs)
Objective:
examine new techniques in the context of the GMO
legislation
To work on an initial list of new techniques
Nine meetings between December 2008 and April 2011
3.
Expert Working Group on New Techniques
Initial list of techniques
Cisgenesis/Intragenesis
Zinc finger nuclease technology
Oligonuleotide-directed mutagenesis
RNA-dependent DNA methylation
Grafting
Reverse breeding
Agro-infiltration
Synthetic biology
Legal framework
Scope of the GM legislation in the European
Union is defined by the term
“GMO: genetically modified organism”
Legal framework
GMO is defined in Directive 2001/18/EC:
Article 2 (a)
in conjunction with
Annex I A part 1
textual definition
non-exhaustive list
of techniques
Legal framework
“Genetically modified organism (GMO)” as defined in
Article 2 of Directive 2001/18/EC:
GMO means an organism, with the exception of human
beings, in which the genetic material has been altered
in a way that does not occur naturally by mating an/or
natural recombination.
Within the terms of this definition:
(a) genetic modification occurs at least through the
techniques listed Annex I A, part 1;
(b) the techniques listed in Annex I A, part 2, are not
considered to result in genetic modification.
Legal framework: Exclusions
Article 3 in connection with Annex I B
Techniques of genetic modification excluded from the scope
of Directive 2001/18/EC are
(1) mutagenesis,
(2) cell fusion (including protoplast fusion) of plant cells
of organisms which dcan exchange genetic material
through traditional breeding methods.
on the condition that they do not involve the use of
recombinant nucleic acid molecules or genetically
modified organisms […].
Legal framework
Positive GMO-definition by the non exhaustive list
(Annex 2 in conjunction with Annex I A part 1)
At least by:
1. vector mediated gene transfer
2. Direct gene transfer
3. „wide“ cell fusion (including protoplast fusion)
Note: This is a positive list.
Legal framework
Annex I part 1 - Genetic modification occurs through:
1.
Recombinant nucleic acid techniques involving the
formation of new combinations of genetic material by
the insertion of nucleic acid molecules produced by
whatever means outside an organism, into any virus,
bacterial plasmid or other vector system and their
incorporation into a host organism in which they do not
naturally occur but in which they are capable of
continued propagation
(1 of 3)
Legal framework
Annex I part 1 - Genetic modification occurs through:
2.
techniques involving the direct introduction into an
organism of heritable material prepared outside the
organism including micro-injection, macro-injectiion
and micro-encapsulation;
(2 of 3)
Legal framework
Annex I part 1 - Genetic modification occurs through:
3.
cell fusion (including protoplast fusion) or hybridisation
techniques where live cells with new combinations of
heritable genetic material are formed through the
fusion of two or more cells by means of methods that
do not occur naturally.
(3 of 3)
Legal framework
Techniques not considered to result in genetic modification:
(1) in vitro fertilization
(2) natural processes such as: conjugation, transduction,
transformation
(3) polyploidy induction
on condition that they do not involve the use of recombinant
nucleic acid molecules or GMO
Annex IA Part 2 of Directive 2001/18/EC
Legal GMO definition in the European
Union:
textual definition (Article 2 of 2001/18/EC)
positive definition by a non exhaustive list
(Annex I A part 1 to Article 2 of 2001/18/EC)
negative definition by a list (Annex I A part 2 to
Article 2 of 2001/18/EC)
Excluded from scope:
mutagenesis, and cell fusion under specific
conditions (if species involved can exchange
genetic material through traditional breeding
methods) (Article 3 in connection with Annex I
B).
Health and Consumer Protection DG
Europe working for healthier, safer,
more confident citizens
Public Health
Food safety
Consumer Affairs
GMO definition
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Thank you !