How are new food products authorised at the moment?

Various kinds of foods and animal feed are subject to regulatory safety assessment and market authorisation before they can lawfully be sold in the UK. These include genetically modified (GM) foods, novel foods (food not previously eaten in the UK), and food additives (such as colours and flavours). The range of foods subject to safety assessment and market authorisation has grown over time and in response to scientific and technical innovations of various kinds.

Decisions as to whether a food required regulatory approval was once the sole province of the EU. And the process by which a food was risk assessed and authorised for sale in the UK was a matter of EU law. That all changed in 2021 when the transition period for Brexit came to an end. After that time, the UK was able to decide on its own approach to the safety of particular foods, and what the process of market authorisation for foods should involve. Northern Ireland was an exception. Under the Windsor Framework, regulatory safety assessment for food and feed in Northern Ireland remains subject to EU law.

Despite these Brexit freedoms, for the time being at least, the UK operates a process of regulatory safety assessment and market authorisation inherited from EU law. Put simply, the process involves a food safety authority (the FSA or FSS) carrying out a scientific risk assessment and providing safety advice to ministers. If ministers are content to do so, they then grant a market authorisation for the food in the form of a statutory instrument. The system effectively mirrors that of the EU, where the European Food Safety Authority provides advice to the European Commission, who then, if thought fit, grant market authorisations for the food in the form of EU legislation.

Why is change in the authorisation process needed?

The process takes time. Statutory instruments have to be drafted and laid before the Westminster Parliament, the Scottish Parliament and the Welsh Assembly. The process and timings have to be coordinated so that the statutory instruments come into force across Great Britain at the same time. None of this is straightforward. And each separate regime, GM, novel food, additives, etc has its own, slightly different, process of assessment and market authorisation set out in law. This makes the process difficult to navigate for food producers, particularly industry newcomers, and its administration by the FSA and FSS is slower and more expensive than it needs to be. The time to market for innovative food and feed products is much longer than it needs to be. This means that return on investment by food businesses is delayed, and innovation may be discouraged.

What changes might be made?

The FSA and FSS recently consulted on proposed reforms to the market authorisation process for particular foods and feed. Subject to ministers’ agreement, and to the passing of amending legislation, the FSA and FSS propose to streamline the market authorisation process in two main ways.

No more statutory instruments

The consultation suggests that the market authorisation of regulated food and feed need no longer be made in the form of statutory instrument. Instead, ministers would decide whether to authorise the food or feed in the normal way and then the authorisation itself would take the form of publication and inclusion in an online official register. The FSA and FSS comment that scientific and technical details contained in an authorisation do not intrinsically need to be set out in legislation and that not doing is likely to save at least three months in the market authorisation process.

No more renewals

Certain food and feed products are subject to time-limited market authorisations. These are feed additives, GM foods and feeds, and smoke flavourings. The time limit is ten years, after which the authorisation holder has to apply for a renewed authorisation. This involves an assessment of any new safety data and identification of any new testing technologies not available when the product was first authorised, followed by an application for a renewed market authorisation. There is no particular reason why these particular regulated foods and feeds should be treated differently from other types of regulated foods and feed. The FSA and FSS point out that post-market monitoring arrangements can be carried out for all regulated foods and feeds, and that food businesses must report any concerns about safety to their enforcement authorities regardless of the circumstances of a market authorisation.

Our thoughts

Provided safety is maintained, we think that the proposed changes to the market authorisation process have much to commend them. We have the ability, now, to design a new system – one which is more agile in responding to scientific and technical advances. Reducing the time to market for safe, nutritious and innovative food and feed products will benefit everyone. Consumers will have more choice, businesses will be better placed to invest, and the UK will remain at the forefront of food innovation, globally.

We will be keeping a close eye on the progress of these proposed changes and are always happy to assist any food business who needs advice. Please contact Chris McGarvey if you have any questions about the market authorisation process, or food law generally.