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Fakultät für Rechtswissenschaft
Genetic engineering in the light of European Law Marcel Raschke
Hoş geldiniz- Herzlich Willkommen!
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Fakultät für Rechtswissenschaft
Genetic engineering are those methods and
procedures of bio technology, which are based on
the knowledge of molecular biology and genetics
and allow targeted modifications of the genetic
constitution of creatures or viral genoms.
What is genetic engineering?
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Fakultät für Rechtswissenschaft
Different applications of genetic engineering
Green genetic engineering [Agriculture]
Red genetic engineering
[application to organisms / medicine]
White genetic engineering
. [Industrial processes]
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Fakultät für Rechtswissenschaft
Especially controversial: Green genetic engineering – chances?
Fighting hunger
Reduction of pest control
Faster growth
Higher resistance against heat or cold
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Fakultät für Rechtswissenschaft
Especially controversial: Green genetic engineering - risks!
Unclarity about long-term effects
Contamination of normal plants through crossing or pollen
Dependency on big business
Consumers oppose green genetic engineering
„Normal“ farmers fear worse marketing because of contamination
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Fakultät für Rechtswissenschaft
Rules in Europe
System directive - DIRECTİVE 2009/41/ECabout the application of genetically modified microorganisms in closed systems
Release directive - Richtlinie 2001/18/EG about the intentional release of genetically modified organisms into the environment
The release directive regulates the release for scientific purposes, (PART B), but also the marketing (PART C)
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Fakultät für Rechtswissenschaft
Rules in Europe
Regulation about genetically modified consumer goods and animal feed (VO 1829/2003/EC)
„Regulation about the retraceability and identification of genetically modified organisms(VO 1830/2003/EC).
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Fakultät für Rechtswissenschaft
Rules in Germany
Law on genetic engineering (since 1990)
EC-genetic engineering implementation law
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Release
„Experiment on the field“
Request in the state cultivation - informational participation of the Member States in the process
§§ 14 ff. GenTG in connection with part B of the directive
2001/18/EG
Administrative assessment of risk
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Fakultät für Rechtswissenschaft
Marketing
Art. 2 Nr. 4 of the release directive definesmarketing as “the commercial or gratitous supplyfor third parties“.
The GenTG defines in § 3 Nr. 8 marketing
basically as „the disposal of products, whichcontain the genetically modified organisms orwhich consist of such, to third parties“.
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Fakultät für Rechtswissenschaft
Marketing
because of the common market: not only participation of theMember States is required, but also their consent
assessment of risks / inspection of the environment by aEuropean administration
Qualified majority required for a decision[complicated majority: Member States + votes cast]
businesses complain about the long procedure example: Amflora-potato (BASF) 1996-2010
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Location registry for transparency
§ 16a GentG
high transparency for the public
publicly accessible
precise denomination of the genetically modifiedorganism
exact description of the location
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Fakultät für Rechtswissenschaft
Dispute over cultivation restrictions
Despite approval of products Member States have enactedrestrictions on cultivation
On the basis of the precautionary principle there is a so-called protection clause in art. 23 of the release directive
In Germany there is the corresponding § 20 para. 2 GentG
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Fakultät für Rechtswissenschaft
Dispute over cultivation restrictions
new scientific knowledge or new information with effect onthe assessment of risks
Danger for people and / or the environment
Restriction or ban, in Germany: MON 810 corn
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Fakultät für Rechtswissenschaft
Dispute over cultivation restriction –New proposition
At the moment: many states use the protection clause
New proposition: states should be able to decidethemselves, without scientific reasoning
Problematic wording of the proposition
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Fakultät für Rechtswissenschaft
Co-existence – possible ?
Co-existence of green genetic engineering and conventionalplants / organic agriculture – possible?
Contamination by crossing / pollen
National regulations - release directive leaves the regulationin Art. 26a to the Member States
In Germany strict regulations about liability apply
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Fakultät für Rechtswissenschaft
Coexistence – liability in Germany
§§ 906 BGB / 36a GentG are of special importance
liability independent of fault
Joint and several liablitiy of more than one possibleoriginators
Not discussed liability fonds
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Fakultät für Rechtswissenschaft
Labelling
„Positive labelling“ – a higher part than 0,9% of any individualingredient – information obligation
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Fakultät für Rechtswissenschaft
Labelling
BUT:No labelling, if indirectly genetically modified
Result: If a cow is fed with genetically modified feed,meat and milk need not be labelled
Often use of foreign genetically modifiedsoy for feed
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Fakultät für Rechtswissenschaft
Labelling
EU does not regulate negative labelling, but allows for it
Reasoning 10 of the Novel Food-regulation Nr. 258/97
„nothing can… hinder the supplier, to inform the consumer on
the labels of the good or of an ingredient, that the concerned
product is no new consumer good in the sense of this
regulation.”
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Fakultät für Rechtswissenschaft
Labelling
Germany made regulations: „Without genetic engineering“
§ 3a and § 3b of the EC-genetic engineering-implementation
law
No genetically modified ingredients
Appendix regulates, that no genetically modified feed may havebeen given
For pork: four months before slaughter, for milk 3 months beforemilking => genetically modified feed need not be disclaimedduring the whole life span
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Conclusion
Green genetic engineering is still not wanted
Cultivation in Europe should be given up
Lately problems in Sweden (illegal cultivation by BASF) themistrust in the industry
Genetically modified products are imported as feed – lead tomonocultures in those countries
Labelling was improved, but has gaps
Can the consumers stop green genetic engineering?