Genetic Engineering Act (Germany)

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Basic data
Title: Law regulating genetic engineering
Short title: Genetic Engineering Act
Abbreviation: GenTG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Administrative law , environmental law
References : 2121-60-1
Original version from: June 20, 1990
( BGBl. I p. 1080 )
Entry into force on: June 24, 1990
and July 1, 1990
New announcement from: December 16, 1993
( BGBl. I p. 2066 )
Last change by: Art. 95 VO of June 19, 2020
( Federal Law Gazette I p. 1328, 1339 )
Effective date of the
last change:
June 27, 2020
(Art. 361 of June 19, 2020)
Please note the note on the applicable legal version.

The German law on the regulation of genetic engineering (GenTG) was enacted in 1990 to regulate the use of genetic engineering and the prevention of dangers. The Genetic Engineering Safety Ordinance as a subordinate set of rules to the GenTG regulates the safety requirements for genetic engineering work in genetic engineering facilities and the release of genetically modified organisms .

Purpose of the law and scope

The purpose of the law is to protect the life and health of people, the environment, animals, plants and property from the harmful effects of genetic engineering processes and products and to take precautions against the emergence of such dangers. At the same time, the law is intended to provide a legal and ethical framework for research, development and testing of genetic engineering (Section 1).

The law applies to all genetic engineering systems and work, the release of genetically modified organisms and the placing on the market of products with genetically modified organisms.

The use of genetically modified organisms on humans is not covered by the law.

I.a. The GenTG specifies the following points:

  • Security levels and security measures
  • Approval and registration of genetic engineering facilities
  • first-time genetic engineering work
  • Approval requirements
  • Liability (see below)

Terms and definitions of the GenTG

Genetically Modified Organism (GMO)
A GMO is an organism, with the exception of humans, whose genetic material has been modified in a way that does not occur under natural conditions through crossing or natural recombination.
Genetic engineering facility
A genetic engineering facility is a facility in which genetic engineering work is carried out in a closed system and in which specific containment measures are applied in order to limit the contact of the organisms used with humans and the environment and to guarantee a level of safety appropriate to the hazard potential.
release
Targeted release of GMOs into the environment, as far as no authorization has been granted for marketing for the purpose of later release into the environment.

Liability, criminal law

Due to the hazards of genetic engineering that is civil liability as strict liability designed ( § 32 ). A fault is not necessary. The liability itself is limited to 85 million euros ( § 33 ). A simplification of the evidence applies to the causation through rebuttable presumption that the causality is given by the genetically modified organisms ( Section 34 ).

The Genetic Engineering Act requires biotechnology companies to exercise a higher standard of care, which is also reflected in the provisions on fines and penalties in Sections 38 and 39 of the GenTG. The Genetic Engineering Act is therefore part of ancillary criminal law .

On November 24, 2010, the Federal Constitutional Court ruled that the law is compatible with the Basic Law. Farmers must therefore be fully liable for damage if genetically modified material is found in conventional crops from neighboring fields and this can no longer be used or can only be used to a limited extent.

See also

literature

  • Volker Steinborn: Genetic Engineering Act - with Genetic Engineering Safety Ordinance, Genetic Engineering Recording Ordinance, Genetic Engineering Procedure Ordinance, Genetic Engineering Participation Ordinance, Genetic Engineering Hearing Ordinance, ZKBS Ordinance, Federal Costs Ordinance for the Genetic Engineering Act, Genetic Engineering Emergency Ordinance, Genetic Engineering Plant Production Ordinance and Infection Protection Act . Verlag W. Kohlhammer, Stuttgart 2009, ISBN 978-3-17-020451-5

Web links

Individual evidence

  1. ^ Text of the Genetic Engineering Safety Ordinance