EU Novel food submissions: strategy for success


7 September 2023


With regulators struggling to keep up with novel food technologies, understanding what is required to secure approval is more challenging than ever. In the absence of a clearly defined framework, it’s a question of learning from the latest developments and being prepared to pivot when necessary.

Future of food


Novel food technologies look set to play an important role in the future of our food production system. For populations without access to good nutrition, they offer significant potential for more effective food fortification. While elsewhere, there’s scope to create healthier foods and better choice for those with specific dietary restrictions such as allergies and intolerances. Given these benefits, it’s not surprising that developments are advancing at pace.


However, a fundamental step in bringing novel foods onto the market is regulatory approval and this is a strictly governed process with highly complex guidelines. Without a clear product strategy and the right supporting scientific data, presented in the correct format, applications are likely to fail – leading to longer lead times, increased costs and no guarantee of a positive outcome.

There’s also the fact that these technologies are outpacing regulations. Which means the only current option is to use existing frameworks to generate scientific data that demonstrates new concepts meet safety thresholds. But this is far from straightforward. Identifying what regulators are looking for is only part of the challenge. Without specific guidelines in place, you also need the experience to recognise when certain safety assessments are not applicable and find new ways of proving materials are safe.


To understand why this matters, it’s important to look at two leading novel food technologies in the context of the current regulatory landscape.



Precision fermentation


Precision fermentation has already successfully been used to create a range of novel food ingredients including oligosaccharides, proteins, dietary fibres, lipids, food pigments and colours. Although the basic principle of feeding raw materials to a specific microorganism or enzyme to yield the finished product is familiar, this technology has advanced to such an extent that it offers game-changing possibilities.


A growing number of novel food ingredients produced in this way have already secured approval and moved to industrial scale-up. These products are available on the market and present in certain commercial foods, such as plant-based proteins in milk alternatives. From a regulatory perspective, however, this is just the beginning.


Rather than signal a clear framework for every future submission, these developments are helping to build a solid point of reference. As more players enter the market and more data becomes available, this knowledge bank will continue to expand and inform future novel food applications. In the meantime, there remains the very real need to understand the detailed nuances within the regulatory approvals process in each target market.



Emerging technology


Cellular agriculture on the other hand, is a comparatively new and evolving technology. Although application can be plant based, in our experience the current focus is very much on ‘lab grown’ meat which also – somewhat confusingly - goes by the name of ‘cellular’ and ‘cultivated’ meat.


How quickly the resulting novel foods become a commercial reality remains to be seen. As a cutting-edge technology, it’s largely without precedent and many decisions relating to crucial issues, such as optimum yield and stable growth, are yet to be finalised. This uncertainty means that while many countries plan to apply existing frameworks for novel foods to cell-cultivated meat, others are still deciding whether this is the right approach or a specific pathway is needed.


There are also wider issues to consider. For example, a small number of approvals have already been issued in Singapore and the US, but what happens when these small-scale operations transition to larger volumes? Will the same regulatory framework be appropriate?


And what about product labelling? With many different terms already in use, a unified approach seems unlikely. Which means consumer perception, cultural trends and political dynamics will play into regulatory developments, particularly around key issues such as GMO status and preferred on pack labelling.

Strategic science-based approach


Submitting a compliant novel foods submission is without doubt a complex process. It demands an integrated approach, where a strategic understanding of current regulatory guidelines informs the process and strong scientific capabilities deliver the correct data. So what might this look like in practice?


Working with RSSL to carry out a gap assessment in the early concept stage can prove crucial. It provides opportunity to ask fundamental questions around labelling, product status and potential outcomes. Ultimately, this evaluation helps to define the regulatory pathway and associated data that needs to be presented for the territories of interest from the outset.

When it comes to providing analytical data, there are several critical aspects that need to be considered when seeking approval. In the EU, UK and US, for instance, this includes:


  • Method development: Developing and validating reliable analytical methods suitable for the novel ingredient and study matrices.
  • Nutritional intakes: It’s important to understand whether there is a potential risk of the material taking overall nutritional intake of the general population above regulated levels.
  • Material characterisation: It is essential that the novel food is fully characterised. The precise suite of tests required will depend upon the nature of the novel material.
  • Protein profiling: DNA sequencing should be used to identify whether the material is similar to any known allergens on the market. 
  • Chemical properties: These include amino acid levels, impurities and anti-nutrients, with most requiring validated analytical methods.
  • Stability assessment (as-is and in-use): To confirm that the new novel food is stable as supplied as well as in the selected finished food product formats.

Faced with such a challenging regulatory environment, it can be easy to lose sight of its ultimate purpose which is to ensure novel foods are safe for human consumption. To take this judgement, regulatory authorities need to be presented with relevant, accurate and complete scientific evidence.
That’s why we tailor our approach to ensure both the analytical methods and data are correct for your product. This level of sophistication is only possible due to the depth of scientific expertise and regulatory knowledge within the RSSL team.


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