A NEW NOVEL FOODS FRAMEWORK FOR THE UK?
In late 2022 Deloitte LLP was awarded the £130,000 ($160k) contract to evaluate the potential of a new regulatory model for the assessment of novel foods (Food with no history of significant consumption pre-May 1997) in the United Kingdom (UK). On the 7th June 2023 an executive summary of the project was published by the Food Standards Agency (FSA) and in the following article we discuss its main findings and implications for the future of the UK novel foods market.
5-KEY MODELS – Are one of these the future of UK Novel foods?
Despite the concerns of Deloitte’s links to the medical cannabis market, the UKs competent authority for novel foods (the FSA) awarded the project. The need for such a report was on the back of the overwhelming number of cannabidiol (CBD) submissions to the FSA post BREXIT, resulting in any timely assessment of novel foods close to a grinding holt.
To address such issues such as the FSA not meeting its legally mandated assessment deadlines and inter aliathe likely developing market for alternative protein a new approach that would be divergent to the inherited medicalised assessment from EFSA had to be considered.
The report looks to carry out, “Extensive external engagement with Food Business Operators (FBOs); interest groups; food regulators in other jurisdictions and UK regulators”. However, we don’t believe many of the true stokeholds where fully engaged in the process as suggested within the report when it speaks of, “Any future proposals for reform would be subject to public consultation and give full consideration to the interests of consumers, as well as those of other stakeholders including Ministers, Parliament and the devolved administrations.”
Despite these limitations in possible scope, the review centres around 5-key models for the assessment of novel foods. We provide a brief of each and some questions the model(s) or perhaps concepts raise:
· MODEL 1: No regrets opportunities – Strip the current model of features that result in additional costs and delay of gaining novel food approval.
o What will be stripped other than processes outlined in legislation? Could such removal result in less protection for business who want legal deadlines to ensure the FSA meet its obligations of a timely assessment?
o Additional features are considered as possibilities including accessibility, transparency, and information over the novel food framework. How will these be achieved?
· MODEL 2: Triaging – The take home here is a retention of current framework but with possible grouping of similar applications based on risk-based analysis (low, medium, high) (Does this mean a cohort approach?). In addition, frameworks could be developed to offer a clear route for new technologies (e.g., Recombinant proteins) including prioritisation.
o The concern here is possible push towards cohort assessments where IP must be shared. There could also be a situation that grouped applications are fast-tracked vs. a small business being placed at the back of the assessment queue.
· MODEL 3: Conditional authorisations (Supervision models) – This so-called lifecycle approach takes its lead from perhaps what we have seen in the UK regarding CBD (tolerated until approved). It may also lean on the current additives assessments where historic approval was granted based on available data, but a re-evaluation of safety is required.
o In this approach any adverse effects are monitored such as with the yellow card medicines scheme in the UK. At present post market monitoring of novel foods is by case-by-case (Article 24 of the novel foods regs)
· MODEL 4: Global collaboration – This model may be the most likely to be implemented (at least in part) and uses insights from other national level authorities to form the basis of a novel foods approval e.g., Health Canada and/or the FDA in the US.
o The question is what would be accepted as assuring safety? Would it need to be a GRAS notification, or would a GRAS Self-Affirmation submission suffice? What about Canada would a view from Health Canada be enough or would it need to be a positive opinion from the Canadian Science Advisory Committee?
· MODEL 5: Innovation-centric regulation - It is unclear what this model may mean but it could be a complete move from current approach to novel foods to a ‘direct-to-consumer’ information only model. Such a model could consider the risks a food presents and then helping consumers make an informed choice through knowledge sharing rather than an approval or non-approved regime.
o Again, it is not clear what level of ‘risk’ an ingredient would need to present to exclude the possibility of an information campaign. Also, how would such information be delivered to the consumer? Perhaps an app or a website similar to novel foods catalogue could hold such data. Will there be an obligation for industry to communicate such information at the point of purchase on on-pack? We know smocking is dangerous but permitted with label warnings, would that work for foods.?
A SIXTH OPTION?
A final option could be one that combines some of the aspects of the models above but any obligations and enforcement to be basic on basic principles of all foods. Under The General Food Regulations 2004 a food shall not be injurious to health and thus there is a general prohibition and obligation already placed on business. What is missing is an ability for consumer collective redress mechanisms where said foods are found to be injurious and which could be brought about in a similar manner to US style class action.
In addition, we don’t have a direct personal injury claim that is defined in food law that results from a novel ingredient. Of course, we have the product liability directive, but this is much more difficult to enforce compared to making some sector specific enforcement rules including perhaps penalties that a based on strict liability. Such rules could ensure that business gets in place adequate science to protect itself and indeed to be able to be insured as food business.
At present the novel foods regime is not fit for purpose with fixed monetary penalties of £200 (reduced to £100 if paid within 28days of notice) of no incentive for business to comply.
WHO AND WHAT ARE THE ENABLERS?
For any new model to be a success the summary of the report talks about ‘Enablers’. These are changes that will need to occur within the FSA (and its stakeholders) to ensure successful reform. If the FSA move away from a precautionary model to a reasonable certainty of no harm (US model) then if harm occurs will the FSA and its leadership be in the media firing line? The report suggests a cultural shift will be needed to align to the change in risk based on any new model. In addition to FSA management and staff the organisation will need to consider if it has enough expertise to put in place the proposed models and if it can adopt to a new way of working with stakeholders.
CONCLUSIONS
At present we need to see the summary for what it is, a snapshot of a larger report but what it does not include is a legal or regulatory analysis. There are a few interesting comments within the text of the summary that at first sight may not stand out and are not discussed above.
The text of the report highlights “enabling innovation is a UK government priority” and “a complex political landscape and continued pressure on resources within the FSA”. As such the FSA may have no choice but to consider the move to an alternate model or the industry will continue to be frustrated by the FSA missing its legal obligations to issue a novel food opinion within 9 months of validation of an application. In addition, the pace of new technologies and the many novel foods already on the market without adequate and consistent enforcement practices points to a broken system.
There are also further discussions in relation to an Innovation-centric type model which may provide a registry of approved products perhaps in a similar manner to that of the CBD register. This site may include in the case on supervised approvals additional information for consumers on level of risk. What will such a register mean to the public and will they really be able to understand it?
A very simple approach to any database or register may be a colour coding system or similar so the average consumer can easily recognise a low, medium or high-risk food based on the presence of a novel food. Given the headache traffic light labelling has resulted in for nutrient profiling then we need to take some lessons before proposing a new one.
Finally, there is discussion of transparency issues such as the publication of regulatory assessments (with removal of commercially sensitive info). This is already in place in the most part but may now consider addition requirements that are implemented at EU level under the Transparency regulation (EU) 2019/1381.
It is our view the repeal and re-imagining of the UK novel foods system (just likes the health claims system) needs a total overhaul. The market has already spoken, and vast numbers of novel foods exist on the market due to either lack of understanding or simply giving consumers what they demand. Increasing the financial burden and complexity of novel foods submissions are not an effective way to support business but we do agree a balance between consumer safety, innovation, and freedom for business needs to be considered.
The key will be to ensure the right stakeholders are involved in any future changes and the FSA does not get captured by trade associations or big pharma that wish to block the entry of new products onto the market.
SOURCE MATERIAL
The Novel Foods (England) Regulations 2018
https://www.legislation.gov.uk/uksi/2018/154/made
Novel foods Regulation (EU)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32015R2283
Tender accepted. FS431145 Novel foods regulatory framework review. https://www.find-tender.service.gov.uk/Notice/035871-2022
Novel Foods Regulatory Framework Review: Executive Summary
Deloitte - A look at those about to redefine Novel Food Regulations. https://www.hemphound.co.uk/post/deloitte-a-look-at-those-about-to-redefine-novel-food-regulations
Transparency regulation. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32019R1381