Novel Foods and the Food Standards Agency – a vision for the future of Market Authorisations?

As we've discussed previously (see our blog Novel Food Compliance in the UK – Finally, a Brexit Benefit? | Fieldfisher), in 2022 the UK Government confirmed its intention to make novel food authorisation a priority as one of the 'Benefits of Brexit'.  The stated goal is for the FSA to:

"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".

Following the election of the new Labour government in July 2024, industry players will be eager to see whether regulated product reform continues to be a priority.   

The FSA's latest Board Meeting

On 19 June 2024, the FSA held its most recent quarterly Board Meeting.  Although the meeting was closed to the public due to the then upcoming General Election, the FSA has subsequently made available the materials from the meeting: FSA Board Meeting - June 2024: Agenda and Papers | Food Standards Agency.  The papers include a report from the sub-group that handles market authorisations for regulated products (the Market Authorisations Group). The report is available here: Market Authorisations | Food Standards Agency.[1] 

Reforming the approval process for regulated products

At the June Board Meeting, the Market Authorisations Group reported on the progress that has been made in reforming how regulated products are approved, in an effort to increase the FSA's efficiency.  The Market Authorisations Group touched on two reforms that were previously raised at the FSA's March 2024 Board Meeting, namely:

1. Removal of 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 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 will also retain its ability to take action to protect public health if new information comes to light.   

2. Removal of the need for a statutory instrument

Under the current system, after the FSA completes its risk assessment, it makes a recommendation to GB Government ministers and a statutory instrument (SI) must be laid before Parliament to implement the decision. The use of SIs 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 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.  This would no doubt be a welcome change for all manufacturers of regulated products: it would be a relief for manufacturers to not have to wait the additional three to six months for this administrative step after a product has already gone through the lengthy approval process. 

Together these proposed reforms demonstrate the FSA's commitment to freeing up capacity for reviewing new applications and increasing efficiency across the board. The reforms were put to public consultation between April and June 2024 and are expected to be progressed in the legislative process soon. Fortunately, we have also learned that a previous cap on FSA headcount will no longer apply, and so additional personnel can also be hired to help build up review capacity within the FSA. 

Problems to be solved

In addition to its efforts to push through the two proposed reforms, the Market Authorisations Group's report also set out the problems that it is trying to solve:

1. Pre-application

It was reiterated that there is not enough pre-application support for the industry and for manufacturers wishing to submit applications for regulatory approval.  Indeed, support is currently limited to online guidance, which businesses have said is difficult to navigate.  The report stated:

"We have engaged extensively with industry stakeholders and have received consistent feedback that a shortcoming of the GB system is the limited pre-application support with an expressed need for meetings and workshops.”

2. Authorisation process

As has been discussed before, the actual authorisation process for regulated products is complicated and lacks transparency.  It is inflexible, and each type of product is prescribed in different legislation.  The process needs to be reformed and adjusted to account for different product risk levels. 

3. Post-authorisation process

The report also discusses the post-marketing surveillance of products.  As it stands, authorisation holders are already required to inform the FSA of any new evidence that may influence a decision on safety.  However, more can be done to align post-authorisation review, as post-market surveillance is not consistently defined in current legislation.

A vision for the future

The report concludes with the Marketing Authorisations Group's vision for the future:

“We envisage a system which upholds standards, while modernising the system to be effective, proportionate, and transparent where products are safe by design.”

We expect additional reforms to be proposed and discussed at the next FSA Board Meeting on 18 September 2024.

Of course, even without reforms, the FSA has been busy getting products through the pipeline under the current system.  In July of this year, dog food manufacturer Meatly received approval for the marketing of its cultivated chicken as an ingredient in pet food.  The authorisation process was done by the Animal and Plant Health Agency (APHA), Defra and the FSA, and was completed in 18 months.  The speed of the approval is reflective of the fact that, as animal feed, the cultivated animal cells are classified and regulated as an animal byproduct, rather than as a novel food.  The UK's approval of Meatly puts the UK as the fourth country to approve the sale of cultivated meat, after Singapore, the US, and Israel.

Manufacturers of novel foods and, indeed, the many other categories of regulated food and feed products will eagerly wait to see what additional reforms the FSA may be implementing in the short and long term.  We will continue to watch this space. 

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

You can also find further insights from Taly and Robert in the following presentation which they prepared for members of the novel food industry in August 2024: Novel Food Regulatory Reforms.

The content of this blog and its related materials does not constitute legal advice and is provided for general information purposes only. Specific legal advice should be sought before taking any actions based on the content of this blog.