Assessment of the legal classification of new genetic engineering methods

As the sector association of the biotechnology industry, BIO Deutschland recommends using existing regulatory requirements to classify organisms that have been modified by genome editing.

Innovations are an investment in Germany’s future viability as a business location. Only through consistent innovation can the German economy remain strong and stand up to international competition. It is therefore important to encourage new research approaches. In biotechnology, new tailored techniques for the targeted editing of genomes have ushered in a new era of research (e.g. CRISPR/CAS9 and similar systems). In addition to physical and chemical mutagenesis, which are treated as recognised methods and exceptions in genetic engineering law and are exempt from regulation, “bio-mutagenesis” should also be allowed without additional conditions.

It is BIO Deutschland’s view that new genetic engineering methods can be legally classified on the basis of valid EU GMO legislation (i.e. Directive 2001/18/EC) and its transposition into national law of EU member states:

1. The new genetic variant in the final product should not be included in the scope of EU GMO legislation:

• if the new genetic variant is the result of spontaneous or induced mutagenesis (through non-targeted methods such as chemical treatment and radiation or targeted methods such as genome editing), or
• if there are no new combinations of genetic material (e.g. no stable insertion of one or more genes in the genome of the target organism), or
• if the final product exclusively contains stably inserted inherited genetic material from sexually compatible/crossable species.

2. Products should be included under EU GMO legislation if they clearly and verifiably contain stably inserted genetic material from sexually incompatible species.

For this, it is essential that decisions be made on a case-by-case basis and that methods not be generally subject to regulation by existing GMO law. On the basis of individual decisions, the distinction can be made between naturally genetically modified organisms (NGMOs) and genetically modified organisms (GMOs).

A science-based legal framework for decision making that does not restrict certain methods, is the only way to create an environment in which innovative products can be used in a safe and sustainable way for the benefit of European citizens.