What are novel foods?

Novel foods comprise foods which are new, modified or produced using a new production process. Only a novel food which has been authorised under the specific regulatory regime can be placed on the market. 

Novel food is defined in EU Regulation 2015/2283 (implemented in the UK by the Novel Foods (England) Regulations 2018). The definition of a novel food is any food that was not used for human consumption to a significant degree within the UK or the EU before 15 May 1997 and which falls within at least one of the categories listed in the definition – 10 in total, and includes, for example “food consisting of, isolated from or produced from microorganisms, fungi or algae”. 

To fall within the definition of novel food, both conditions need to be met  and it will be necessary to show that there is no history of significant use before May 1997 and that the food falls within one of the 10 categories. Examples of novel foods include agricultural products from third countries (chia seeds, noni fruit juice) and food derived from new production processes (UV-treated food (milk, bread, mushrooms and yeast). 

Novel or not? 

When assessing whether a food is novel or not, evidence of the history of use is a key factor. If history of use to a significant degree before 15 May 1997 can be proven, then the food cannot meet the definition of novel. 

Evidencing history of use can often be a difficult and time-consuming task for food business operators. There can be challenges in obtaining sales documentation if records have not been retained from 1997. Suppliers may also be unwilling to share any data they have with their supply chain. Other helpful documents can include recipes, catalogues, and testimonials from experts, however, again there can be challenges with obtaining these to evidence that there has been significant consumption of the food. 

The parameters of “significant degree” also have to be dealt with and there is no precise meaning given to this. The Commission has produced a guidance document on matters to be considered when establishing whether a food has been used for human consumption to a significant degree. Whilst this refers to the previous novel food law, it remains available on the Commission website page on novel foods and we consider this still provides a helpful indication of the type of evidence business would need to produce, or be expected to produce, in the event it was assessing the status of a food as novel or not. This notes the following:

• The use of a food only on a regional or local basis within an EU country (or the UK) doesn’t necessarily mean that it is novel. This requires consideration of whether something was used to a “significant degree” or not, such as whether it was continuously on the market.
• The more a food has been used, the easier it is to demonstrate it has been used to a significant degree, however, this should be based on typical levels of consumption for specific categories of food (i.e. the quantity of herbs used will differ to the quantities of other types of foods). 
• The length of time a food has been consumed for – the longer the period of time, the more likely it will be considered as non-novel. 

If significant consumption cannot be proven, and the food is within the categories referred to above, then authorisation would be required before placing the food on the market. 

The authorisation process is lengthy and can be expensive. Whilst it is important that a thorough risk assessment is carried out, to ensure the safety of foods placed on the market, there are inefficiencies in the current system which can lead to delays in applications being processed. 

These administrative delays can frustrate innovation in the food sector, which has grown exponentially in recent years.

Potential change in regulatory approach?

On 3 April 2024 the Food Standards Agency (FSA) proposed reforms to regulated food products. A consultation is open and the deadline for response is 5 June 2024.

The proposals include removing the need to lay new legislation for each authorisation of a novel food before it can come into effect, thereby reducing delays in these products coming to market. 

While these reforms are a welcome move to reduce administrative delays faced by business operating in the novel food space, the application process remains the same. 

The proposals do not remove other challenges facing businesses, which were identified by the FSA in its own review in 2023 of the regulations on novel food. The FSA acknowledged that innovation in novel foods is taking place at speed. The current regulatory framework could present challenges in ensuring the system works efficiently and effectively for applicants. 

The findings of the 2023 review identified a number of models for consideration to address the concerns with the current regime. This included (i) triage-based regulation, which would change how the pipeline of novel food applications are processed and could result in prioritisation of applications based on specific criteria and (ii) collaborative regulation, whereby the FSA could authorise novel foods using knowledge and insight from other organisations, which would shift how the safety of novel foods is established. 

These approaches could reduce the burden facing industry, whilst also continuing to ensure the safety of consumers. In our experience, being able to demonstrate to the authorities that the food is safe is and will continue to be of paramount concern.  

The current application process and evidence required is already leading some companies to launch their products outside of the EU and UK in order to avoid the burdensome and often unclear application process. It is clear that further developments are needed to increase investment and innovation in the novel food sector.  

The current proposal indicates that there are planned future developments for reform and modernisation of the regulated food space, however, we do not at this stage know what these will look like. Time will tell whether further consideration will be given to the models already put forward by the FSA. We anticipate that the key aspect being weighed up in developing these proposals is seeking to find that right balance between ensuring safety and allowing for efficiency. 

It should also be noted that whilst updates to streamline the authorisation process and reduce the burden on both the regulator and applicants are a welcome development, there remains a risk to businesses in having diverging regulatory regimes between the UK and EU. An already complex novel food regime may be made further complicated, with additional administrative burdens associated with complying with both regimes.