German Federal Agency for Nature Conservation (BfN)


Legal opinion: Insufficient control of New Technologies outside of European genetic engineering law

Problem formulation and conclusion

  • Food and agricultural law not suitable for regulating new genome editing techniques and unsuitable for nature and environment protection
  • BfN President is against removing New Technologies from European genetic engineering law

Can all plants developed by gene editing technologies, such as CRISPR/Cas, be regarded as genetically modified organisms? Are they covered by European genetic engineering law? The European Court of Justice will rule on these legal issues in 2018. A legal opinion commissioned by the Federal Agency for Nature Conservation (BfN) now shows for the first time that various specialised European laws outside of genetic engineering law – such as the seed legislation - do not provide adequate control and testing standards for so-called new technologies.

The President of the German Federal Agency for Nature Conservation (BfN), Prof. Beate Jessel, warns: "Exclusion of new technologies from genetic engineering law would lead to considerable gaps in the regulations and fragmentation of responsibilities. Given the enormous potential of new technologies, risk assessment based on the precautionary principle and environmental protection issues is indispensable. However this can currently only be achieved in the frame of the genetic engineering law. There is no suitable substitute in the current legal framework."


New techniques such as CRISPR/Cas and other methods of genome editing enable genetic modifications of organisms in a far-reaching and targeted biotechnological manner. These techniques are being developed at a rapid pace, and there is huge potential - both in terms of potential applications and risks to consumers, nature and the environment. At present, it is legally controversial whether the use of these new technologies is covered by the genetic engineering definition of the EU Directive 2001/18/EC and thus by the regulations of European genetic engineering law.

Details of the legal opinion

On behalf of the BfN, Tade M. Spranger, law professor at the University of Bonn, systematically examined for the first time whether and to what extent other regulatory regimes besides genetic engineering law are suitable for controlling the possible environmental risks of organisms developed by new technologies. The author analyses - among other – the European seed legislation, food and feed law as well as the plant protection law and plant variety protection law. He discovered blatant loopholes in their regulatory capabilities for new technologies. They are neither individually nor collectively able to ensure an assessment and control of possible negative environmental impacts. This is already clear by the fact that the legal norms examined serve completely different purposes - for example, to ensure sufficient and efficient plant varieties for agriculture in seed legislation. Wild plants, for example, would not be included in seed legislation and would therefore not be subject to approval testing. In addition, the legislation on seeds is not designed to assess specific risks that could arise from the use of such high-tech processes. The same applies to plant protection law which is limited to active substances of plant protection products.

In addition to these massive regulatory deficits, regulation outside genetic engineering law would cause considerable practical implementation problems that could not solely be solved in administrative organisational terms. The laws examined involve a large number of federal and state authorities that would have to act alongside each other within their respective areas of competence. Besides the fact that most of them would first have to gain comprehensive expertise in the field of biotechnology, uncertainty would arise on the level of mixed competent authorities in different cases.

On the basis of the legal report, BfN President Prof. Beate Jessel points out that the specialised legislation examined covers only parts of the possible applications of new technologies, if at all, and therefore cannot replace genetic engineering law, as has sometimes been stated.


Legal opinion, Spranger, T.M. (2017): "In-depth analysis of various European directives and regulations with regard to their potential to regulate environmental effects of New Technologies be-sides Genetic Engineering Law".

Summary of the key findings resulting from the legal opinion prepared by Professor Dr. Dr. Tade M. Spranger (2017). 

Last Change: 27/11/2017