As food innovation pushes boundaries, with an increasing number of companies turning to unconventional ingredients and methods to address sustainability, health, and ethical concerns, the world of food production is evolving rapidly.
Novel foods represent one of the fastest-growing segments in the food industry. But while the potential for these products is immense, the path to market is far from straightforward. Navigating the novel food landscape isn’t just about innovation—it’s about understanding and overcoming the numerous regulatory and quality control challenges that come with bringing these new products to market.
But first, what is a Novel Food exactly?
As defined by the European Food Safety Authority (EFSA), a novel food refers to any food that wasn’t consumed significantly in the European Union before 15 May 1997. This includes newly developed, innovative food products, food produced using new technologies, or those derived from traditional ingredients or sources that haven’t been used in the EU previously. While examples like plant-based meat alternatives, edible insects, and mycelium-based foods may come to mind, it is important to remember that a wide range of innovative foods fall into this category, each facing their own regulatory hurdles.
Regulatory Hurdles: Authorization of Novel Foods
One of the most significant hurdles for new companies is obtaining the necessary authorization to market their product as a Novel Food. Mary-Liis Kütt, Chief Innovation Officer at ÄIO, an Estonian startup created in 2022 that has been developing alternative fat and oil with a non-conventional yeast, shares her experience navigating this lengthy and costly process.
For a startup like ÄIO, obtaining novel food approval is not just about proving the safety and quality of the product. It’s a lengthy process that requires an in-depth application, including scientific evidence and assessments, which can be daunting for a small company. The complexity of the regulatory guidelines adds an extra layer of difficulty: rather than a single, straightforward document, companies face a complex system of interrelated regulations. Navigating these requires both time and a deep understanding, often pushing companies to rely on external consultants or established industry players to help them interpret and comply with the regulatory landscape.
With the recent publication of the EFSA’s new "Guidance on the scientific requirements for an application for authorisation of a novel food" in September 2024, there is some hope that the process will become clearer for applicants. However, Mary-Liis emphasized the importance of talking to other experts and professionals in the field to truly navigate the system.
"I have been sitting too long and trying to figure out on my own" Mary-Liis Kütt
Defining Quality Control Post-Authorization
Once a Novel Food product receives authorization, the challenge isn’t over. Establishing and maintaining a robust quality control process is essential to ensure product consistency, safety, and compliance with regulations throughout its lifecycle. Quality control typically involves monitoring production processes, testing final products for contaminants, and ensuring adherence to set standards. It can be challenging, as there's no 'one-size-fits-all' guideline available, and it's likely impossible to create one — though fortunately, the new EFSA dossier shows some improvement already. But how, then, can companies maintain the safety of their products?"
One strategy often adopted by companies is to base their quality control processes on the regulations of similar, more established food products. Drawing parallels with related categories can provide a useful framework and narrows down the number of guidelines and parameters for company’s needs. For instance, Mathilde Guichet, a quality manager with extensive experience in the novel food sector, shared how mycelium-based products, which are becoming popular as meat alternatives, often rely on the stringent safety standards used for meat products.
While this approach offers a starting point, its relevance can be debated. In the case of mycelium, which is grown in controlled environments, the likelihood of contamination by microorganisms such as E. coli—a common concern in meat production—is minimal. Applying meat regulations might therefore appear overly cautious, given the differing risk profiles between these two food sources.
Collaboration and Strong Partnerships: A Key to Navigating Novel Food Challenges
In both the authorization and quality control processes, one thing is clear: collaboration and knowledge sharing are essential. Companies navigating the Novel Food space are often pioneering entirely new territories, meaning there are few precedents to follow. By connecting with other innovators, regulatory bodies, and industry experts, companies can share their experiences, learn from one another, and build more robust frameworks for success.
Both Mathilde Guichet and Mary-Liis emphasized the importance of these connections. However, beyond collaboration, having strong, experienced partners who can guide and advise during the more uncertain stages of development is crucial.
Mary-Liis pointed out that while every novel product has its specificities, there are also common elements like proteins, lipids, and carbohydrates that often face similar regulatory hurdles. Without input from knowledgeable partners, some companies might not even realize certain regulatory requirements until much later in their process, potentially jeopardizing their product’s market entry. In fact, through discussions with others in the field, Mary-Liis was able to identify carotenoid assessment as a key point of vigilance early in her product development, enabling her team to monitor and address it proactively before it could become a potential challenge.
Strong partnerships, built on trust and shared expertise, not only help companies anticipate these challenges but also provide a path forward when navigating the uncertainties of novel food regulation.
Conclusion: From Novel to Mainstream
Despite the challenges, success stories in the Novel Food industry are becoming more common. Products that once seemed niche or experimental are now staples in many households. For instance, chia seeds, which were only authorized as a Novel Food by the EU in 2009, and cocoa extract, approved as a Novel Food in 2013, are now integral to the wellness and food industries.
This growing acceptance signals a positive future for innovators. As the industry continues to evolve and collaboration between companies and regulators strengthens, many of the current hurdles will likely become smoother paths, paving the way for even more groundbreaking food innovations.
What advice would you give to a company that is just starting to launch ?
"Tried to get as much help as possible, talk to other companies and don't forget to double check !" Mary-Liis Kütt
And you, what’s been your biggest challenge in getting a novel food product to market? Let’s chat about it in our WhatsApp group – we’d love to hear your thoughts!
Picture from Freepik
