Genetic engineering in the light of European Law Marcel Raschke

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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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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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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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Especially controversial: Green genetic engineering – chances?

Fighting hunger

Reduction of pest control

Faster growth

Higher resistance against heat or cold

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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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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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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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Rules in Germany

Law on genetic engineering (since 1990)

EC-genetic engineering implementation law

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Release and marketing

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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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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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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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Location registry for transparency

BUT: destruction by opposers

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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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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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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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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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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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Labelling

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Labelling

„Positive labelling“ – a higher part than 0,9% of any individualingredient – information obligation

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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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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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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?

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Genetic engineering in the light of European Law Marcel Raschke

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