EU Votes to Deregulate Gene Editing

February 7, 2024 by Staff Reporter

A lengthy series of votes in the European Parliament today has resulted in a proposal for significant deregulation of gene edited organisms in agriculture under new European legislation.

The proposed new regulation for what is called New Genomic Techniques (NGTs) in the EU, marks a sea change in the EUs regulatory approach to agricultural genetic modification.

In many cases the votes, which covered multiple amendments to the draft legislation, proposed in the summer of 2023, as well as the final version of the legislation, were close; the final proposal passed by just 44 votes. The narrow margins suggest ongoing concern amongst Member States about the impacts of the new liberalised regime.

There were some important wins, however. As the proposal currently stands, for example, there will be:

  • Mandatory labelling of category 1 organisms (those with so-called simple alterations) in food, feed and seed. In the EU these will be labelled as “New Genomic Techniques”. Category 2 organisms (those with complex alterations and/or foreign genetic material) will also be labelled.
  • Exclusion of herbicide tolerant plants (but not pesticide producing plants) from category 1
  • Mandatory (document based) audit trails that will allow traceability of gene edited organisms throughout the food system
  • Clear pathways to withdraw the authorisation of a gene edited organism if ongoing monitoring reveals problems
  • Clearer reporting rules on effects on biodiversity and the environment
  • Strengthened risk assessment for category 2 gene edited organisms (including looking at impacts on organic farming).
  • Requirements for the EU reference laboratory to affirm developers’ claims that there are no detection methods for their genetic creations.

The new EU regulations also address the issue of patenting, albeit in an incomplete way. Plants which are truly indistinguishable from nature or conventional plants will be excluded from patenting, which will come as some relief to conventional breeders. However, the larger issues around patenting remain largely unaddressed and still leaves farmers and breeders vulnerable to lawsuits for patent infringement. We can expect this to be a much bigger conversation in the future.

The new EU regime (in common with the UK) also fails to protect the products of organic and non-GMO farmers and businesses from contamination with gene edited organisms – something which could cost them their livelihoods.

Better than the UK – but not much

As devastating as they are, the new EU regulations still do not go as far as the UK’s deregulation agenda.

This may prove to be a complicating factor for the UK government which has been hoping that the EU regulations will mirror those of the UK and therefore open up uncomplicated trade routes into the EU market for gene edited crops (which we are calling precision bred organisms or PBOs).

The UK, for instance, has rejected any labelling and traceability of gene edited organisms as well as monitoring for environmental and biodiversity effects, but farmers and food businesses will need to provide this paperwork if they wish to access the EU market.

The exclusion of herbicide tolerant plants from category 1 classification in the EU raises some trade barriers for any UK farmers looking for an easy route to market in the EU. It may also cause problems for supermarkets if they are not proactive about excluding ingredients made from such plants in their own brand products in both markets. The UK government has also continuously refused to discuss the complex issue of patents, though it may be forced to do so now.

Says Pat Thomas, Director of Beyond GM, “This isn’t the end of the story of GMOs in Europe; it is the beginning of a new chapter. The EU has always been a regulatory powerhouse, setting global benchmarks in rational precautionary regulations. Today it has rejected the Precautionary Principle – a cornerstone of its own values and the values of its citizens – in favour of empty rhetoric around food security and sustainability based on an inadequate, incomplete and uncertain science. Inevitably there will be consequences for businesses and farmers and for consumer trust.”

Thomas notes that “The biggest complicating factor in the EU, as well as the UK, is that GMOs are a clear red line for consumers. Polls continually show that citizens don’t want to buy or eat new or old GMOs and they don’t want to see them growing in their fields. Farmers aren’t going to grow anything they can’t sell and food manufacturers don’t want to use ingredients that their customers reject. The deregulation agenda will, in the end, fail because it fails to respect public views and the needs of farmers and food businesses.”

But…things can still change

As with the UK legislation, several steps still remain to finalise the new EU legislation – including approval by the Council of the EU’s Committee of Permanent Representatives, or COREPER. At time of writing, the proposal has been blocked by the COREPER. This means the legislative proposals will likely be subject to further interinstitutional negotiations between representatives of the European Parliament, the Council and the Commission. This process, known as a trilogue, aims to reach agreement on a text that is acceptable to both the Council and the Parliament, but it is unlikely to start until after the European Election in June 2024, giving those with concerns more time to make their case for further changes.