The FSA has mooted a number of new ideas in its regime review
When the FSA called a review on its novel food regime in February, it followed several years in which many of the businesses most affected by the rules had endured a bruising experience trying to follow them.
The novel foods process for legitimising the UK’s CBD market for example, was fraught, to put it mildly. Suppliers complained of poor communication from the FSA, with deadlines missed and a lingering uncertainty over when any products would be fully authorised as safe for human consumption.
“I don’t think anyone would suggest the way the FSA approached CBD was the best way forward,” says Dominic Watkins, head of consumer sector at DWF. “It might be kindly described as learning on the job.”
“The way the FSA approached CBD might be kindly described as learning on the job”
Dominic Watkins, head of consumer sector at DWF
CBD suppliers will have taken a special interest in the initial findings of the review, which were published earlier this month. But its implications go wider. Insect-based protein, lab-grown or ‘cultivated’ meat and other alternative proteins will all be affected by the outcome of the review.
Some of its conclusions are so obvious as to be banal. Clearer guidance on the rules, more engagement with food businesses and stronger commitments from the regulator to hit deadlines are the kind of measures that would improve regulation in any industry.
That isn’t to say they’ve not been welcomed. “If any organisation of this magnitude says they need to look at the way they do things and make it more fair and efficient, that can only be a good thing,” says Paul Duffy, a toxicology associate who works with the Association for the Cannabinoids Industry.
New models
More striking is the mooting of new models that could radically alter the UK’s novel foods regime. As it stands, most new foodstuffs must show they are safe before they make it to market. In the case of CBD, the FSA allowed existing products to remain on sale, pending analysis of toxicity data.
The simplest option for the FSA would be to largely retain this way of doing things, but remove pain points. Information could be more available and better communicated, while the agency could remove the need for statutory instruments for novel foods that don’t provide clear benefits.
But more radical options have also been raised. These include a triage approach to applications based on risk levels, conditional authorisation with ongoing monitoring, recognising decisions from other jurisdictions, and introducing a single authorisation for high-risk products.
“Demonstrating a product is ‘safe’ might be more aligned to the US standard of ‘reasonably certain of no harm’ rather than the legacy EU precautionary principle”
Katrina Anderson, associate director at Osborne Clarke
Osborne Clarke associate director Katrina Anderson says the triage approach could mean a “priority lane” for certain applications, “most likely based on the government’s policy agenda around bringing sustainable plant-based alternatives to market”, among other objectives.
A “more radical” step would be to take the US definition of safety, weighing risks more finely against benefits. “This would mean the threshold for what a company needs to demonstrate to establish their product is ‘safe’ might be more aligned to the US standard of ‘reasonably certain of no harm’ rather than the legacy EU precautionary principle which is a higher standard,” Anderson adds.
Conditional authorisation followed by monitoring looks similar to the approach the FSA has taken with CBD. This has “significant commercial benefits as it would allow companies to sell during at least some of the authorisation period”, Anderson says.
While some of these ideas hold promise, the industry will need to see specifics before it forms a judgement. “I think if you described the current model in a paragraph it would sound fine,” says DWF’s Watkins. “The devil is in the detail with these things.”
And he notes the FSA is still suffering from a lack of adequate staffing in the wake of the UK’s exit from the EU. “The FSA used to have a lot of subject matter experts, but then it didn’t need them because it relied on other people in Europe,” he adds.
Rebuilding that will take time and budgets. And the task may prove just as decisive in making the UK a hospitable place for novel foods innovation as the regulatory model.
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