UK FSA Seeks to Plough Its Own Furrow and Set Itself Apart from Its European Counterparts

UK FSA SEEKS TO PLOUGH ITS OWN FURROW AND SET ITSELF APART FROM ITS EUROPEAN COUNTERPARTS AND CREATE A MORE DYNANIC AND SWIFTER ROUTE TO MARKET FOR NOVEL FOODS

THE AIM, THE DELIVERY AND THE OUTCOME

At an FSA Board meeting in Leeds on 20th March 2024 the UK FSA adopted the proposals which had been advanced by a Working Group into Novel Foods. In this document we explain how the UK FSA intends to regulate the assessment of Novel Foods now that it is free of the shackles of the European Commission and the European Food Safety Agency (EFSA).

The intentions of the UK FSA are certainly progressive and, if they can pull off their intentions in a workable structure based on the EU model, but which is not dragged down by the bureaucracy of the Continent, then they will place the UK at the vanguard of food advancement, without any compromise on safety.

A more efficient regulatory system will bring benefits to consumers through an enhanced choice of safe food whilst providing greater value for the taxpayer. The FSA Board has been clear that reform will be necessary to achieve a high-quality service: in the short-term, to make the current service work better, and in the longer-term to put in place an effective, proportionate and sustainable service that will be able to keep pace with innovation in the sector.

PRINCIPLES FOR THE REFORM OF THE REGULATED PRODUCTS SERVICE

The reforms focus on seven fundamental Pillars:

1. The protection of public health

There will be no reduction in food safety or standards as a result of our reforms.

2. The protection of consumer interests

The UK FSA’s new regulatory service will improve our ability to take consumer needs and preferences into account when making regulatory decisions.

3. Decisions will be based on science and evidence

They will continue to set high standards for evidence, working collaboratively with others on issues of mutual interest in order to maximise efficiency.

4. Openness and transparency

The FSA will continue to publish their risk assessments and the basis for their regulatory decisions, maintaining their focus on excellent risk communication for consumers and we will improve communication with applicants at all stages of the process.

5. Streamlining the regulatory process

They will design an agile, responsive and future-proofed service that allows them to be flexible, proportionate and proactive in their regulatory approach. Market access for safe products, processes and food technologies will be efficient, easy to navigate for businesses, and work for a UK context.

6. The facilitation of innovation and enterprise

The intention is that the regulatory environment will be able to evolve with the developing food system, responding to emerging technologies, and will make the UK a preferred destination for approvals for safe, innovative products.

7. Striving for four-country working

The FSA will minimise divergence within the UK and aim to have a common approach to regulatory reform with a framework that operates across the four nations.

THE CASE FOR CHANGE

The UK officially opened for applications at the end of the Transition Period, on 1st January 2021. The inherited EU legislation was demonstrably not designed to operate in a Great Britain context and was transferred into GB legislation with only minor amendments for operability. The legislative requirements are prescriptive and, in some cases, not proportionate to the risk; this, along with resource limitations, prevents the FSA from being able to operate flexibly to address the growing number of applications efficiently.

The current caseload in the Regulated Product Service is 450. The FSA have completed 63 applications to date, taking on average around 2.5 years from the submission of an application to completion.

Based on current inflows, resources, and processes, they expect their caseload to continue to grow from 450 in March 2024 to more than 570 by March 2026. Therefore, without urgent action, the FSA would have been unable to keep pace with its growing caseload, affecting consumers’ choice and access to new and potentially beneficial products – the proposed reforms are aimed at addressing the dual needs of capacity and safety.

RENEWALS OF AUTHORISATIONS

For the majority of food and feed products regulated by the FSA, once a product is authorised, the company that makes that product does not need to apply again for their authorisation to be renewed. The FSA – through its risk analysis process and risk assessment – reviews any new information that emerges. If there is new evidence about safety, it will independently assess this evidence, and retains the ability to review existing authorisations and powers to take action to protect public health.

However, in line with EU legislation, authorisations for smoke flavourings, feed additives and genetically modified food and feed must be renewed every ten years. Since taking over the administration of approvals in 2021, the FSA has yet to reject any of the renewal applications received. At the same time, through its risk analysis process, when new evidence about the safety of a product emerges, the FSA can review existing authorisations. For example, such a review is underway for titanium dioxide as a food additive with the FSA considering updated evidence using its risk analysis process.

It is estimated that currently 22% of the Regulated Products Service caseload consists of applications solely for renewal of an existing authorisation (111 of 513 applications received up to end of February 2024).

Processing large volumes of renewal applications significantly reduces the FSA’s capacity to deal with new product authorisations to a reasonable timeline. The FSA anticipate a large number of feed additive renewal applications in the run-up to renewal deadlines in 2027, meaning that by 2027 over 50% of the applications the FSA is likely to have received into the service will have been renewal applications. Without reform this will put considerable strain on the FSA’s resources, focused on products with many years of safe use where, in the majority of cases, they do not anticipate any change in risk.

Therefore, the FSA will remove the renewals requirement for these products, essentially bringing them in line with how they regulate other food and feed products, retaining the power to reconsider any product authorisation at any time just as they do with the “non-renewal products” approaching them on a risk-based rather than time- based assessment.

The consequence will be the freeing up of resource, creating future opportunities for focusing on authorisations of new applications to the regulated product service, without any negative impact food and feed safety standards, because the products subject to the previous renewal requirements have already had their safety rigorously assessed during their initial authorisation.

REMOVAL OF THE NEED FOR A STATUTORY INSTRUMENT

Under the outgoing system, after the completion of the risk assessment, the FSA made a recommendation to respective Ministers of the GB nations, who then had to make the decision as to whether or not to approve a product. Following ministerial approval from each of the GB nations, Statutory Instruments had to be laid, which confirmed the decision in legislation, either via lists in the legislation concerning a regulated product regime or via individual Statutory Instruments that authorise products.

The use of statutory instruments to authorise approvals arose from the need to transpose EU legislation into assimilated law. There was a lack of direct equivalence between EU and UK national authorities which added steps into the process not required when the UK was a Member State.

The need for the Statutory Instruments added at least a three-month delay, and in the worst-case scenario, 6 months, between an application being formally approved and authorisation being proclaimed, as well as taking up considerable resource within the Food Standards Agency, Food Standards Scotland and across the parliaments and assemblies of England, Wales and Scotland.

Under the new structure the FSA has removed the need for a Statutory Instrument, and instead creates a publicly available official register, immediately following Ministerial approval. This simplifies the authorisation process, without compromising either Ministerial decision-making and accountability, or their duty to protect consumers.

With this reform, the role of Ministers as decision-makers will remain unchanged, and there are no changes to the technical and scientific scrutiny undertaken during the authorisation. Additionally, the FSA will explore options for non-legislative measures to ensure parliamentary oversight is achieved without the need to lay secondary legislation, for example by submitting an annual report to Parliament/Senedd.

IMPLEMENTATION

The FSA want to make these reforms across Great Britain and in consultation with Northern Ireland and so they are working rapidly with the aim of achieving legislative change ahead of a General Election, which must take place on 28th January 2025 at the latest, because any changes to assimilated legislation are decisions for Ministers and ultimately for Parliament.

The FSA has undertaken policy development and analysis to advise Ministers to lay legislation using powers in the Retained EU Law (Revocation and Reform) Act 2023 as soon as possible this year. Their proposed legislative timeline is to enter parliamentary triage in April to lay the Statutory Instrument that will enable them to make these changes in July. This is subject both to Ministerial agreement, and the outcome of the formal consultation, which they plan to launch in early April – and of course whether the Government calls a General Election in a timeline which then prohibits the passing of any new legislation.

FUNDAMENTAL REFORMS WITHIN THE EXISTING GENERAL ASSESSMENT STRUCTURE

Given the growing caseload and the delivery challenges inherent in the service, the FSA has examined areas where it can do more within the current regulatory framework and within existing limited resources, taking into account the respective risk appetites of the FSA and FSS Boards.

Its aims and intentions can be distilled into five principles:

1. The FSA and FSS will 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 will 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; and,

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.

WE MAY NOT BE IN EUROPE, BUT WE ARE NOT ALONE

The FSA are seeking opportunities to expand their work with food and feed regulators internationally to ensure that the process of authorising regulated products is proportionate and efficient.

They are aiming to identify opportunities to enable greater data-sharing and/or partnership approaches to risk assessment through formal agreements. This would enable knowledge and expertise to be shared and resource utilised effectively whilst still maintaining regulatory autonomy, to make decisions that are specific and appropriate in a GB context.

ARE THESE CHANGES THE ANSWER TO ALL OF THE FSA FAULTS?

In reality the answer is “No”, but they are steps in the right direction and demonstrate a willingness on the part of the Agency to acknowledge its faults and failings and look for ways in which it can advance itself. Many of the criticism aimed at the Agency can be directly attributed to the inheritance post Brexit.

When we left the European Union, we were told that it would allow speedier innovation and progress in the assessment of the safety of new foods. In reality it has not done so thus far, but we hope that these changes are the start of progress – they are not the beginning of the end, but they may just be the end of the beginning.