NGT deregulation proposal – GMO-free food production at risk


On the 5th July the Commission presented its legislative proposal on “plants obtained by certain new genomic techniques and their food and feed.” It will water down or even abolish the current safety and transparency standards and puts the European Union’s GMO-free agriculture and food production at risk. ENGA calls on the European Parliament and Ministers from member states to reject this proposal.


According to the proposal, New GMOs, or new genomic techniques (NGTs), are GMOs that do not carry material from other non-crossable species. NGTs are to be subject to their own legislation (“lex specialis”). NGTs comprise targeted mutagenesis (techniques like CRISPR/Cas) and cisgenesis (a procedure that produces plants into which only genes specific to the species have been introduced using genetic engineering techniques). 

Old GMOs - GMOs that carry material from other non-crossable species - remain regulated as before, with a thorough risk assessment and labelling and traceability. 
Should member states and the European Parliament agree on a new legislation for NGTs, GMOs will be regulated in two different legal regimes in the future.

Category 1 NGTs and category 2 NGTs

The Commission’s legislative proposal creates two different categories of NGTs with two different levels of regulation or deregulation, respectively.

With category 1 NGTs a new class of NGTs has been invented. Category 1 NGTs are considered to be equivalent to conventional breeding if they meet certain criteria. They may contain up to 20 genetic modifications of 5 different types, among them “substitution or insertion of no more than 20 nucleotides” (the basic building blocks of DNA and RNA), “deletion of any number of nucleotides”, “targeted inversion of a sequence of any number of nucleotides” (this provision allows for any section of DNA, be it 20 nucleotides or 2000 nucleotides, to be turned around), and in especially vague terms: “any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (…) in a species from the breeders’ gene pool”. For these ‘considered to be equivalent to conventional breeding plants’ any risk assessment is to be dropped and the precautionary principle overruled. 

ENSSER, the European Network of Scientists for Social and Environmental Responsibility, has criticised the criteria as arbitrary and not backed by science. The up to 20 modifications “could result in a very complex and deeply altered organism, for example with altered metabolic pathways and modulated by their respective genomic and environmental context”. As ENSSER points out, these modifications explicitly only include changes at intended target sites or at highly similar off-target sites – unintended effects are not to be assessed. Most NGTs are likely to belong to category 1.

Category 1 NGTs shall be subject to a verification procedure to assess whether they meet the criteria for being equivalent to conventional breeding. If a field trial is required, it has to be carried out by member states. Afterwards the Commission decides, on the basis of a European Food Safety Authority (EFSA) consultation, about the NGT1 status of a plant. If the decision is about placing on the market, for example for food and feed imports, EFSA is responsible for the verification, and it is the Commission that decides about category 1 classification.

Category 1 NGTs are subject to the Novel Food Regulation if a foodstuff shows a “significantly changed composition or structure that effects the nutritional value, metabolism or level of undesirable substances of the food.” The Novel Food Regulation deals with food that does not have a significant history of consumption. It covers new foods, food from new sources, new substances used in food as well as new ways and technologies for producing food. Seeds of category 1 NGTs have to be labelled as “new genomic technique category 1”, accompanied by an identification number. Information on all authorised category 1 NGTs including the technology and the trait used is entered in a publicly accessible database. Traceability has been abolished as well as the need for detection methods and coexistence requirements. Category 1 NGTs remain banned in organic production.

Food and feed using category 1 NGTs will not be labelled, transparency on the NGT origin for category 1 plants applies only to farmers and breeders, not to other business operators or consumers.

Category 2 NGTs are all NGTs which do not fall into category 1. They are to be subject to a risk assessment according to Directive 2001/18/EC and Regulation 1829/2003/EC but with less data requirements. Regulatory incentives shall apply to them, namely accelerated risk assessment procedures. Category 2 NGTs remain subject to labelling and traceability. A GMO label is mandatory for them. Marketers can use a second label on a voluntary basis that indicates the purpose of the genetic modification or a sustainable trait, respectively. Member states are responsible for coexistence measures. Category 2 NGTs are banned in organic farming.

For category 2 NGTs the precautionary principle has been restricted. Category 2 NGTs can carry two labels, a GMO label and a kind of sustainability label. In doing so, sustainability is not seen as a holistic approach or an agricultural system but as a genetically engineered trait. Few NGTs are likely to fall under category 2 (NGTs without foreign DNA).

All power to the Commission

The legislative proposal severely restricts states' options for action. According to the proposal member states are not allowed to impose cultivation bans for NGTs on their territory. However, where things get complicated, in the case of coexistence between agriculture and food production with and without genetic engineering, the Commission shifts all responsibility to the member states.

In addition, the Commission grants itself the right to issue so-called delegated acts. It wants to define the criteria for ‘equivalent to conventional breeding’, adapt risk assessment requirements for category 2 NGTs and broaden the list of sustainable traits without the involvement of member states and the European Parliament. This would give the Commission the possibility to further deregulate NGTs at any time.

The EU’s GMO-free agriculture and food production at risk

This proposal puts the EU’s GMO-free agriculture and food production at risk. Those who want to or have to produce Non-GMO (the organic sector!) lack the necessary means. To reliably exclude NGTs from value chains, all business operators - not only breeders and farmers - need knowledge of which plants and products have been made with category 1 and category 2 NGTs. They need traceability, labelling and testing methods. Secondly, breeders, farmers, beekeepers, food and feed processors and retailers need EU-wide legally binding coexistence measures for category 1 and category 2 NGTs, for cultivation, storage, transport and processing. They need a site register for field trials and cultivation (not only a database which lists NGT authorisations), liability in case of NGT contamination, the application of the polluter also pays principle – those who use NGTs have to keep their NGTs out of other operators' supply chains. 

The way the proposal is designed, all the advantages are with those who want use NGTs and all burden and costs lie with those who do not want use GMOs. It is a proposal made for the biotech seed sector, commodity traders and NGT exporting countries. And it goes against the interests of the EU food sector and EU citizens. The latter would lose their right to know what is in their food, the former would be faced with critical questions and the anger of consumers.

Concealing NGTs is the wrong road to go down. It undermines trust in political institutions and in the food industry. Now it is up to member states and the European Parliament to act on behalf of their citizens and a highly relevant business sector.