A letter sent by the EU Commission in mid-June to the relevant authorities of EU Member States clearly confirms that a decision made by the German Federal Office of Consumer Protection and Food Safety (BVL) on the release of a genetically engineered oilseed rape produced by the US company Cibus, cannot be implemented. The letter strongly contradicts the decision made by the German authority in February 2015, which would have allowed the release of Cibus oilseed rape without it being subject to regulation required for genetically engineered organisms. This particular oilseed rape is produced using so-called oligonucleotids, short synthetic DNA sequences.
The letter sent by the EU Commission now advises Member States not to allow the release of plants produced using oligonucleotides. The Commission further reminds Member States that the deliberate release of genetically engineered plants without appropriate prior authorisation is illegal.
There was strong support in the letter for the organisations that have been demanding the immediate revocation of the decision made by the German authority. The Commission will now make a final decision on the legal status of the plants by the end of the year, and advises Member States not to allow any uncontrolled release until such time as a decision has been made.
“Evidently the German authority was rather premature in taking a biased position to serve the interests of industry. Now it has to make it very clear that this national decision on Cibus has been withdrawn. Any uncontrolled release or cultivation has to be considered illegal”, says Annemarie Volling from a small farmers union in Germany (AbL), “Otherwise these plants can spread into the environment and put GMO-free food production at risk.”
The German authority argues that the method used to produce Cibus oilseed rape should be classed as mutagenesis, which – according to EU regulation – is not subject to regulation. Mutagenesis has been used for many years in plant breeding and is to some extent controversial since it makes use of chemicals and sometimes even radioactive substances. However, the method is not as yet subject to regulation. In contrast, the use of oligonucleotids is a technique used in 'genome editing' or 'synthetic genetic engineering' and is covered by EU regulation 2001/18: It involves the insertion of nucleic acid molecules produced in the laboratory into an organism. The nucleic acid molecules are inserted into the cells to change the DNA at targeted sites. The intended changes are made at specific sites, but these can be carried out repeatedly leading to a extensive alteration of genome. The mechanisms of the genetic alteration are currently not fully understood and off-target effects have been reported. A new study from Norway emphasis more biosafety research needs to be performed.
“The EU Commission should not exempt new methods of genetic engineering such as genome editing from regulation”, says Christoph Then for Testbiotech, “Otherwise the oilseed rape produced by Cibus will open the door to many more products derived from these new methods, and allow them to enter the market without any registration or systematic risk assessment.”
Christoph Then, Tel 0049 (0) 15154638040, email@example.com
(The letter of the Commission is available upon request.)