New draft regulations provide further clarity on bringing gene edited crops to market as foods

Draft regulations on how to bring a precision bred organism (‘PBO’) crop to market as a food have now been published. There has also been draft guidance published by the Department of Environment, Food and Rural Affairs (‘Defra’). The Food Standards Agency (‘FSA’) have updated their draft guidance for applicants requiring a food/feed marketing authorisation for a PBO. The publication of the draft regulations and guidance has provided further clarity on what the route to market looks like for PBOs.  

In line with the FSA’s proposals, there will be two possible routes to market under the legislation. In either case, before organisations can apply for marketing authorisation, they would need to submit a marketing notice to Defra for precision bred confirmation.  

The next step is to then to run an internal assessment to see if the PBO crop concerned met the criteria for the lighter touch route to market, or if a full application needs to be made for an FSA safety assessment. To qualify for the lighter touch regime, there must be evidence to demonstrate the below. Importantly, this evidence will need to be shared with the FSA to review. While we would not anticipate the evidence required would be as stringent as a novel food application or GMO application, it will likely nonetheless require some scientific testing.

The requirements are as follows:

• The PBO must belong to species that has a history of safe consumption by a significant number of people in the UK or EU before 15 May 1997.
• The changes made must not change the nutrient quality in a detrimental way, elevate the toxicity, create risks related to allergens or otherwise affect the safety of the PBO as a food.

Assuming these points are demonstrated to the satisfaction of the FSA, the application will be validated, and the organisation will have the marketing authorisation to bring the product to market as a food. It is then possible to start commercialising it immediately, in relation to sales in England and Wales, where it will not be necessary to label products as coming from PBOs when they are sold to consumers. Additional complexity will nonetheless remain in relation to Scotland, due to the fact that the underlying Act does not apply in Scotland, so any sales in Scotland will be by virtue of the complex interactions with the Internal Markets Act.

The alternative, if the criteria above are not met, is an application to the FSA for a second-tier safety assessment process. This will involve a more detailed investigation into the PBO’s characteristics which we anticipate will be somewhat akin to a novel foods application.  

Our food regulatory lawyers Katrina Anderson and Jessica Burt have been following developments very closely. Please do get in touch if you would like to speak about what the new draft regulations would mean for you in practice.