Plants derived from genome editing technologies have to be considered as genetically engineered

Today a legal dossier on the legal status of new methods for the production of genetically engineering plants is published. The dossier, drawn up by Professor Ludwig Kraemer, is being presented ahead of a decision due to be announced by the EU Commission within the next few weeks. Industry is demanding that new methods of changing genetic conditions in plants and animals should not be regulated in the same way as genetically engineered plants, and should be allowed onto the market without registration, risk assessment or labelling. Contrary to industry, many civil society organisations are of the opinion that EU regulation has to be applied to these plants and animals in same way as to other genetically engineered plants.

The position of the civil society organisations is now set to gain support from the new legal dossier drawn up by Professor Dr Ludwig Kraemer, who is widely regarded to be one of the top experts in environmental law and EU policy. He argues that the new technologies fulfil all criteria for EU regulation under EU Directive 2001/18. This is because they are based on technical processes that are new and different from those that were regarded as “conventional breeding” at the time when the Directive was adopted. The new methods make use of short sequences of synthetic DNA (oligonucleotids) and so-called nucleases that can be used to introduce specific changes in DNA. They are often summarised as “genome editing” or “synthetic genetic engineering”. The EU Commission is expected to publish its opinion till the end of the year.

“We are at a crossroads. The new methods known as genome editing have huge potential for radical changes of the genome. We do not have the experience to declare these products safe. If these new techniques are not regulated, there will be no transparency, no choice for farmers and consumers as well as no possibility of safeguarding human health or protecting the environment as required by EU regulation,” says Christoph Then for Testbiotech. “So we are urging the Commission to make a clear position statement that these new technologies will not escape EU regulation.”

The dossier was commissioned by Arbeitsgemeinschaft bäuerliche Landwirtschaft (AbL), Bund für Umwelt und Naturschutz Deutschland (BUND), Bund Ökologische Lebensmittelwirtschaft (BÖLW), Gen-ethisches Netzwerk, Greenpeace, Interessengemeinschaft für gentechnikfreie Saatgutarbeit (IG Saatgut), Testbiotech and Zukunftsstiftung Landwirtschaft (ZSL).