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National and Community legislation
on genetically modified plants
in Europe
Svend Pedersen
13 December, 2005
Presentation, The Danish Plant Directorate
24-05-2017
1
General rules on the approval of plant varieties
• National rules on variety listing
• Directive 2002/53/EC on the common catalogue of varieties
of agricultural plant species
• Directives on marketing of seed
Presentation, The Danish Plant Directorate
24-05-2017
2
In addition to the general rules,
GM plants must comply with:
• Directive 2001/18/EC on the deliberate release into the
environment of genetically modified organisms
• Regulation 1829/2003/EC on genetically modified food and
feed
• Regulation 1830/2003/EC concerning the traceability and
labelling of genetically modified organisms
• Regulation 1946/2003 on transboundary movements of
genetically modified organisms
• National rules on co-existence
Presentation, The Danish Plant Directorate
24-05-2017
3
Marketing of conventional
plant varieties
Conventional
plant
Official variety testing
(min. 2 years)
Variety approval
Variety listing &
seed certification
Cultivation
Use
(food, feed,industry)
Presentation, The Danish Plant Directorate
24-05-2017
4
Marketing of genetically modified
plant varieties
GMplant
Official variety testing
(min. 2 years)
Experimental release
(Directive 2001/18/EC)
Marketing application
(Directive 2001/18/EC or
Regulation 1829/2003/EC)
Marketing approval
Variety approval
Variety listing &
seed certification
Cultivation
(coexistence)
Use
(food, feed,industry,medicine)
Presentation, The Danish Plant Directorate
24-05-2017
5
Directive 2001/18/EC:
Techniques of genetic modification are inter alia:
(1) recombinant nucleic acid techniques involving the formation
of new combinations of genetic material by the insertion of
nucleic acid molecules into a host organism in which
they do not naturally occur but in which they are capable of
continued propagation;
(2) techniques involving the direct introduction into an organism
of heritable material prepared outside the organism including
micro-injection, macro-injection and micro-encapsulation;
(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.
Presentation, The Danish Plant Directorate
24-05-2017
6
Directive 2001/18/EC:
Techniques/methods of genetic modification yielding
organisms to be excluded from the Directive, on the
condition that they do not involve the use of recombinant
nucleic acid molecules or genetically modified organisms
other than those produced by one or more of the
techniques/methods listed below are:
(1) mutagenesis,
(2) cell fusion (including protoplast fusion) of plant cells
of organisms which can exchange genetic material through
traditional breeding methods.
Presentation, The Danish Plant Directorate
24-05-2017
7
Herbicide tolerant plants
Genetic
modification
(herbicide)
Chemical
mutagenesis
(herbicide)
Maize
NK603
(glyphosate)
EXP1910IT
(imidazolinone)
Wheat
MON71800
(glyphosate)
AP205CL
(imidazolinone)
Oilseed rape
T45
(glufosinate
ammonium)
NS738
(imidazolinone)
Regulated
Not regulated
Crop
Presentation, The Danish Plant Directorate
24-05-2017
8