To “Keep Pace with Innovation,” FSA Considers Possible Future Changes to UK Novel Food Regulatory Framework, Commissions Report

The UK Food Standards Agency (FSA) recently published the findings of a report that was conducted to inform possible future changes to the Novel Foods Regulatory Framework. FSA commissioned Deloitte to assess the existing framework and provide feedback.

The report was conducted in light of the rapid development of novel foods and technologies in the present day, and FSA says that trying to keep up with the pace of innovation using the current Novel Foods Regulatory Framework may cause future challenges. Specifically, the purpose of the project was to understand the efficacy of the current Novel Foods Regulatory Framework and where there are pain points and opportunities for change; understand broader international and sectoral approaches to the authorization of new products (both food and non-food); demonstrate how the Novel Foods Regulatory Framework could be improved; and ensure relevant stakeholders across FSA understand the implications, risks, and opportunities of potential new models. The report is not intended to be implemented without further policy development and appropriate legal advice.

To inform the development of future models, two main activities were conducted:

1. Extensive external engagement with Food Business Operators (FBOs), interest groups, food regulators in other jurisdictions, and UK regulators.
2. Critical evaluation of the current framework, based around five evaluation criteria: evidence-led and safety-based, collaborative and transparent, user-centered, efficient, and future proofed.

Feedback from External Stakeholders

External engagement revealed key suggestions for alternative authorization models, such as conditional authorization, early engagement with FBOs, and robust application guidance. Some of the key learning points from engagements with external groups include:

Learnings from Engagements with International Food Regulators in Other Jurisdictions

• Horizon scanning, insight, and pre-authorization activities should include regular outreach efforts with industry, encourage early engagement, and provide clear application guidelines
• Policy and standards should include product-based regulation, be aligned with food safety standards of peer nations, enable FBOs to conduct taste testing for novel foods within clear frameworks, and have the regulator hold the registry of approved products
• The authorization process should include clear timelines and performance standards, use a weighted evidence approach for outcome-based food safety regulation, and require the publication of regulators’ assessments to help inform industry and educate the public.

Learnings from Engagements with FBOs and Interest Groups

• Horizon scanning, insight, and pre-authorization activities should specifically consider nascent industries for which clear guidance and robust information-sharing is crucial, and make an effort to publish, consult on, and regularly update industry guidance in response to feedback to lower the risk of regulatory capture
• Policy and standards must take a novel approach to handle changing industry circumstances and foods without precedents, could benefit from a review of the UK’s regulatory definition of and position on “food safety,” leverage risk-benefit assessments as opposed to only risk assessments, and take more of a focus on educating the public about novel foods
• The authorization process should emphasize safety and efficiency, consider a method of prioritizing applications, and be as transparent and communicative with applicants as possible.

Criteria-Based Evaluation

The criteria-based evaluation identified a number of opportunities for improvement to refocus around the added value to consumers and FBOs, including reducing additional burden in the way processes are currently delivered and repositioning FSA’s current framework to better align with emerging technologies through revisions to novel foods definitions. Key learnings regarding each of the five criteria include:

1. Evidence-led and safety based: The current risk assessment process is thorough, involves a wide range of experts, and is generally perceived as robust by consumers and FBOs. However, the outcomes of risk assessment and evidence requirements are not always clear to applicants, and opportunities for synergy through grouping applications for similar products and drawing on evidence and conclusions in other jurisdictions are not always fully maximized. The risk management process as currently laid out in regulations does not allow for sufficient weighing of potential benefits to wider society, demonstrating a need to review the process in a refreshed food industry context.
2. Collaborative and transparent: There is strong collaboration across the four UK nations in authorizing safe, novel foods, and the risk of divergence is managed through collaboration. A priority for applicants is for the publication of detailed risk assessment outcomes and more regularly updated application guidance.
3. User-Centered: FBOs would prefer guidance to be updated more frequently and dynamically, with advance guidance on emerging product classes, and there is demand for more information and engagement across all stages of the authorization process. Resources are constrained within the limits of agreed government funding, and is limited capacity to build resources in anticipation of future demand. Consumers are protected through the current framework and it is essential to maintain their trust in the FSA’s processes, but they are likely to demand access to a wider range of novel products in the future.  
4. Efficient: There are inefficiencies in the current framework such as poor quality applications that may be rejected or require multiple rounds of processing, additional administrative effort around ministerial sign-offs, and statutory instruments for approved novel foods. The high number of applications in the current pipeline compared to the number of applications that have been approved to date indicate a need for ongoing focus on efficiency and measures to speed up the authorization process where possible.
5. Future-Proofed: There are perceived complexities and ambiguity in the way some innovative products and processes are dealt with in the current framework, including the definition of “novel foods” and the interdependencies between different regimes across FSA. A review of the Novel Foods Regulatory Framework poses an opportunity to better align the framework, and potentially its legislation, to emerging food technologies. FSA could benefit from more resources being invested into foresight and horizon scanning functions to better anticipate future food innovations.

The Potential Future of UK Novel Food Regulation

A list of potential regulatory features for the Novel Foods Regulatory Framework was developed, from which a series of models were formulated to present strategic choices around the framework. The models are not mutually exclusive and FSA could consider combining regulatory elements from each model when reviewing the existing Novel Food Regulatory Framework. The models include:

1. “No regrets” opportunities, which do not have evident downsides and are likely to benefit all FBOs, consumers, and those administering the regulations
2. Triaging applications based on the level of risk arising from the product/process, recognizing that novel foods is a broad category and a one-size-fits-all approach may not be appropriate
3. Lifecycle-based regulation underlined by the principle that a single point of authorization for novel foods is not sustainable long-term given the pace of innovation and that evidence about safety may develop over time, leading to a conditional authorization and supervision model, similar to that used in other sectors
4. Collaborative regulation, recognizing that food innovation is global and FSA could leverage opportunities to more formally collaborate with other regulators, academia, and other organizations
5. Innovation-centric regulation, representative of a reimagining of the Novel Foods Regulatory Framework and based on greater consumer awareness of novel foods and a single entry point for all FSA food safety assessments

The report also mentions considerations for implementing changes to the Novel Foods Regulatory Framework. Specifically, factors relating to the level of complexity involved—FSA would have to consider whether the model might require legislative change to be implemented, the scale of change involved in comparison to the current framework, dependencies on internal or external factors, and any known risks and issues relating to implementation. Additionally, FDA must consider its resources, for example, capacity within FSA and administration teams responsible for design, oversight, and implementation of the current process; capability and skills required to design and implement the alternative models; and additional cost requirements such as third party spend on systems or other resources. Depending on the nature of any reforms, requirement for additional resources is likely to be permanent.

Finally, the report highlights key enablers for regulatory reform that are critical to the successful implementation of new regulatory features and models. These key enablers are: clear drivers, consistent risk appetite, and leadership alignment; organization-wide cultural change; appropriate skills and capabilities; and funding and capacity.