Opinion issued upon request of health ministry regarding ECJ ruling on mutagenesis techniques

Similar to a request of the Federal Office of Consumer Protection and Food Safety (BVL) (see here), the Federal Ministry of Health (BMG) asked BIO Deutschland in late January 2019 to deliver an opinion. This again concerned whether the recent judgment of the European Court of Justice (ECJ) – stipulating that organisms whose genome was edited using new molecular genome-modifying techniques are to be classified as genetically modified organisms (GMOs) for the purposes of the EU Directive 2001/18/EC – is also applicable to the use of GMOs in closed systems. The specific question asked was: “Would the application of the ECJ judgment to genome-edited organisms in closed systems have negative consequences for BIO Deutschland’s members?”

BIO Deutschland believes that the application of the ECJ’s decision under the System Directive would lead to two genetically identical microorganisms being regulated differently, microorganisms which in cases of doubt could even be developed by natural means. If microorganisms in which point mutations were introduced by genome editing techniques are considered GMOs, this has consequences for labelling. Applying the labelling rules – EU regulation (EC) No 1830/2003 and the “GM-free label” – to these GMOs has a negative impact on product acceptance and thus on the adoption of innovations.

BIO Deutschland therefore recommends that the German government advocates for updating GMO legislation at the European level and revises German GMO legislation accordingly. Such updated legislation should replace the current legislation, which dates back to the 1980s, and also should:

•    be brought up to date to reflect the current state of science and technology, especially revising the definition of a genetically modified organism/microorganism based on current scientific knowledge;
•    put the result of genetic modification at the centre of the approval assessment process and not the path leading to this result; and
•    be reviewed for scientific topicality and practical applicability at regular intervals.

The full text of the opinion can be found here (in German only).