Novel Foods update

The Food Standards Agency sets out to increase efficiency.

On 20 March 2024, the Food Standards Agency (FSA) had its quarterly Board Meeting in which it discussed a number of topics, including reforms to the Regulated Products Services (RPS).  In advance of the meeting, the FSA published a paper summarising the suggested reforms: Regulated Products Reform Update | Food Standards Agency.

A key issue for Novel Food businesses has been and continues to be how the FSA will improve the process by which Novel Foods receive regulatory approval and can be brought to market. 

Novel Foods include alternative proteins, such as lab grown meat, animal-free dairy products derived from precision fermentation, certain insect-based foods, and other foods that are developed through new processes. 

While more and more companies are investing in Novel Food development, the regulatory approval process in the UK has been criticised for being cumbersome, lengthy, and lacking in transparency. To improve the process, in October 2022, the FSA commissioned an investigation by Deloitte, which published its report in June 2023. 

The report recommended that:

• the Novel Food application process should be made more streamlined;
• there should be more open and frequent communication with applicants;
• information should be shared among agencies; and
• reliance on other countries' health agencies' scientific reviews and approvals should be explored. 

The March 2024 Board Meeting touched on some of these topics and noted reforms that can take place in the short term to increase efficiency for the RPS, as well as reforms that can be implemented in the medium and long term.

Short term reforms

The FSA proposed two reforms in the short term, that can be taken forward using powers under the Retained EU Law (Revocation and Reform) Act 2023.  These suggested reforms will be subject to public consultation and were arrived at through working closely with the devolved administrations in Scotland and Wales. The suggested reforms are:

1. Remove the need for renewal authorisations

Most food products that the FSA reviews and approves do not need to be re-authorised.  However, in line with EU legislation, FSA authorisations for smoke flavourings, feed additives, and genetically modified food and feed must be renewed every ten years. The RPS caseload for these renewals is estimated to be 22%, and is likely to grow to 50% of the caseload in the next few years. The FSA proposes to do away with these required 10-year renewals. As with any product, the FSA will retain the power to consider any product authorisation at any time, and can always take action to protect public health if new information comes to light. 

2. Remove the need for a statutory instrument (SI)

Under the current system, after the FSA completes its risk assessment it makes a recommendation to GB ministers and statutory instruments (SIs) must be laid to confirm the decision. The use of statutory instruments came about as a result of the transposition of EU legislation post-Brexit, although there is no direct equivalence between EU and UK national authorities. This step adds an unnecessary three to six months to the approval process. The proposal is to remove the need for an SI and instead create a publicly available official register, following ministerial approval. 

Impact

Manufacturers of Novel Foods may regard these short term changes as not impacting them. Indeed, if you are not a manufacturer of e.g. feed or smoke flavouring, you may not see the removal of the renewal requirement as having any impact whatsoever on your business or your Novel Food application.

However, what these suggested reforms demonstrate is the FSA's overwhelming commitment to free up capacity for reviewing new applications and to increase speed and efficiency across the board. 

The FSA intends to launch a public consultation on these reforms shortly and implement changes by July 2024.

Medium and long-term proposed reforms

During the March Board Meeting, the FSA also discussed additional reforms suggested by the sub-group on regulated products, a group specifically set up to scrutinise the RPS and make recommendations about further actions to improve performance. The following recommendations came from the sub-group:

1. The FSA and FSS (Food Standards Scotland) should actively manage the regulated products caseload so that resources are focused on achieving the best outcomes in the interests of consumers. Active management means making active choices about where to put resources so that the performance of the service as a whole is improved.
2. The FSA and FSS should review the approach to public consultation and engagement to ensure that it is proportionate and tailored to the needs of consumers and stakeholders.
3. At all stages of the process, firm deadlines must be set and adhered to when seeking information and input from stakeholders and applicants. Periods of time allowed for further information to be provided must be as short as is reasonable to meet the requirements.
4. Decisions at each stage of the process should be taken by a lead responsible official, limiting review and sign-off to the minimum required to meet quality standards and to achieve three- and four-country working.
5. The FSA and FSS must continue to make a strong case to Ministers that, without adequate resources and/or further changes to the process, performance of the current service will fail to deliver timely outcomes for the benefit of consumers and food businesses.

With respect to consultations, one proposal raised at the Board Meeting was that when the consultation relates to a reduction in burden to the consumer or manufacturer, the consultation period can be relatively short (4-6 weeks). In contrast, if a proposed reform would result in additional tasks or burden on the consumer or manufacturer, it would be appropriate to provide a longer consultation period. 

Lastly, the Board discussed working with food and feed regulators internationally to ensure that the process of authorising regulated products is proportionate and efficient. The goal would be to allow for greater data-sharing and/or partnership approaches to risk assessment through formal agreements. More on this plan of using other regulators' opinions and decisions will be presented at the June Board Meeting. 

At the meeting, it was acknowledged that more robust reform which entails legislative change may have to wait until the next General Election.  For that reason, many of the proposals in the Deloitte report may have to wait.  It will be interesting to see what additional reforms the FSA can implement in the near term. 

In the meantime, you can find our discussion of Deloitte's report, and possible improvements to the regulatory approval process, here: Novel Food Compliance in the UK – Finally, a Brexit Benefit? | Fieldfisher.

If you would like to discuss any of the issues in this blog, please contact Robert Jappie and Taly Dvorkis.