The Genetic Technology (Precision Breeding) Act 2023 (the Precision Breeding Act) opens the door to gene-edited foods being placed on the UK market in the near future. As a result, questions around the regulatory framework for such products have recently become a hot topic, but what does this new legislation mean for innovators and supermarket shelves across the UK?
What is precision breeding?
Precision breeding involves altering the DNA of plants or animals through sophisticated techniques such as such as CRISPR/Cas 9 gene-editing. In this way it is possible to achieve a result equivalent to what might be achieved using traditional breeding methods, although much more quickly. In contrast, genetically modified organisms (GMOs) have been altered in a way that would not occur naturally.
Drivers for the development of PBOs include improving nutritional value, making crops resilient to climate change and tackling plant or animal diseases.
How will precision bred organisms come to be sold as food?
The Precision Breeding Act applies to precision bred plants and animals, and is limited to England only. The Government has tasked the Food Standards Agency with creating a new regulatory regime to allow precision bred crops and other plants to be brought to market as a food. The FSA is proposing to create a two-tier system whereby PBOs from species that have a history of consumption in the UK or EU and have no safety concerns can be brought to market without further safety review. All other PBOs will likely need to go through a process somewhat akin to the existing novel foods authorisation process.
In practice, this means companies developing PBOs will want to give some thought upfront to whether they can establish history is safe consumption of the species.
How does this law apply in the wider UK?
At present, the Precision Breeding Act only applies to activity in England as the regulation of genetic technologies for food is a devolved matter. However, the United Kingdom Internal Market Act 2020 potentially means that precision bred products that have been legally marketed in one nation may also be marketed in the other UK nations. There is some legal uncertainty around this, particularly if a food containing PBOs is subject to further processing. For example, where precision-bred wheat is made into flour, and then that flour is baked into a cake, this rule may no longer apply .
What is happening elsewhere in the world?
The EU is developing a broadly similar legislative programme, although it is directed to plants only. In July 2023, the European Commission proposed a new regulation on plants produced by New Genomic Techniques (NGTs). The EU Parliament response is broadly positively, although with calls for greater transparency through mandatory labelling and stricter controls. The EU Council of Ministers has yet to reach agreement, and highly divergent member state positions on farming practices are likely to make this challenging.
Beyond Europe, certain other countries with less regulation surrounding gene-editing are pioneering innovation for new foods. For example, in Japan a gene-edited variety of tomato has been released to the market. The tomato contains high levels of gamma-aminobutyric acid (GABA), an amino acid believed to aid relaxation and help lower blood pressure, and has been determined not to be subject to genetically modified product regulation. Two gene-edited fish varieties that grow larger than conventional counterparts have also been approved for sale. Japan is particularly focused on reducing its reliance on imported foods, seeing technologies like gene-editing as an important opportunity.
Similarly, in the US, products have reached the market. For example, several companies have used gene-editing to create healthier foods, such as soybean oil with less saturated fats.
Comment
Different regulatory approaches around the world make development of new products in this area particularly difficult. Those countries taking a low-regulation stance are likely to see greater levels of investment, with more cautious countries less attractive for innovators.
The UK Precision Breeding Act promises to be more permissive than the previous UK regime. However, implementing regulations are still needed to see if it is ultimately easier to bring PBO to market as a food. The discrepancies between England and other parts of the UK are creating unwelcome uncertainty.
The EU proposals are likely to be somewhat more restrictive than the Precision Breeding Act once they are finalised, but have the potential to provide new opportunities for gene modified plants compared with the strict approach of treating gene editing as a form of gene modification that now applies.
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