Recommendations for reforming the UK's Novel Foods approval process are eagerly awaited by industry
The Novel Foods industry is exploding. Innovative companies operating in the sustainable protein sector are growing at a rapid pace all over the world, and accordingly significant investment is being directed towards this space.
In the UK, recognition of this trend coupled with the strength of the domestic Food & Beverage and Life Science industries may lead to significant changes in UK regulation, which could elevate Britain to the forefront of the Novel Food industry.
The UK government is under pressure to deliver the so-called 'Brexit benefits' which were promised as justification for leaving the EU. The Novel Food compliance regime has been identified as an area where the government feels its ability to diverge from the EU can be put to good use.
In January 2022, the government confirmed the intention to make Novel Food authorisation a priority in a 'Benefits of Brexit', publication, stating that the Food Standards Agency will:
"update the process for approving novel foods, to create a transparent and effective system that is the best in the world for innovators, investors and consumers and encourages safe innovation in the sustainable protein sector."
Reform in this area would substantially increase the UK's attractiveness as a jurisdiction for innovative food businesses.
Review and reform
Pursuant to these goals, in October 2022 the Food Standards Agency (FSA) commissioned Deloitte to conduct the Novel Foods Regulatory Framework Review.
Based on discussions with Food Business Operators (FBOs), interest groups, food regulators in other jurisdictions, and UK regulators operating in adjacent sectors, the FSA published the executive summary of the report in June 2023.
The report evaluates the current Novel Foods Regulatory Framework (which is based on the retained EU Legislation) and identifies opportunities for reform.
The overarching theme of the report is the need to provide more regulatory engagement and support to innovative companies seeking to engage in the Novel Food process.
This demonstrates what many in the UK Novel Food industry feel is long-overdue awareness of the criticisms levelled at the European Food Safety Authority (EFSA) regime, which is difficult to wade through and lacks open communication and clear time frames.
Suggested reforms of the UK regime include:
- Bi-monthly virtual information sessions with the industry, in which the FSA provides FBOs with greater clarity for when they prepare Novel Food applications;
- Early engagement – encouraging companies to contact regulators early in the product development process, which would provide FBOs with a clearer understanding of the regulator’s requirements at an early stage, allowing FBOs to prioritise resources towards productive research directions and minimise compliance costs and time. Food regulators could then benefit from a more efficient authorisation process; and
- More communication with applicants generally.
There is also a stated need for greater transparency on the application process, and for the provision of clear application guidelines and regular updates to these guidelines.
The report also focuses on aligning food safety standards with those of other nations to reduce safety evaluations and regulator workloads, and notes the need to allow companies to conduct taste testing under strict conditions, setting clear frameworks for food tasting while applications are pending.
As regards product safety, the report suggests that rather than prescribe specific tests for safety, the FSA can rely on the industries to act responsibly within primary safety regulations and take an holistic approach to safety assessments, looking at the balance of evidence.
These recommendations demonstrate a clarity of purpose, which reflect the deficiencies in the EFSA regime.
The report also notes that:
• The current risk assessment process is thorough, but outcomes of risk assessment and evidence requirements are not always clear to applicants;
• One option for streamlining safety review is to group applications for similar products;
• The FSA can draw on evidence and conclusions from other jurisdictions; and
• Looking at risk-benefit assessments, not just risk and safety of food, but other potential benefits e.g. sustainability and carbon footprint, can potentially allow the FSA to prioritise applications accordingly.
Finally, the report outlines five potential regulatory models for consideration, as an overhaul of the incumbent Novel Food regulatory approval process conducted by the FSA:
In summary, these models involve:
- "No regrets" opportunities – i.e. retaining key features of the current model but removing some of the main pain points for companies and consumers.
- Triage-based regulation – the FSA could reform the pipeline processing of Novel Food applications by grouping similar applications into high/medium/low risk categories, and prioritising applications based on specific criteria.
- Lifecycle based regulation – a staged approach to regulation, with conditional authorisation of Novel Foods and ongoing monitoring.
- Collaborative regulation – the FSA could authorise Novel Foods using knowledge and insights from other organisations (in other jurisdictions), or place more responsibility on industry to assure safety.
- Innovation-centric regulation – providing one front door for all products deemed high risk but removing the Novel Foods Regulatory Framework and focusing more on consumer awareness of Novel Food safety.
Time for a new approach
In the context of political and economic disquiet, the UK's newly sovereign regulators are under pressure to utilise these new freedoms to create a favourable environment for companies seeking to do business in the UK – with the Novel Foods industry positioned as one of the frontrunners for positive reforms.
While implementation of some of the more radical reforms proposed by the Deloitte report will require primary legislation, there are a number of clear near-term opportunities that Novel Food producers will be hoping the FSA will seize.
There is no doubt that there is significant motivation on the part of the FSA to act, and companies seeking assistance from UK regulators will be hopeful that a more progressive Novel Food regime is not far away.
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