Hannes Malfroy, Regulatory & Novel Food & Specialist Ana Merino, Senior Regulatory Scientist
The regulatory landscape around food and nutrition is ever-evolving. This month, we catch up with two of Atova’s regulatory experts – senior regulatory scientist Ana Merino and regulatory & novel food specialist Hannes Malfroy – to learn more about their views on recent regulatory developments in the area of novel foods and alternative proteins and the challenges and opportunities these may bring.
Could you tell us about a regulatory development that has stood out to you this summer?
Hannes: “For me, that would be the first submission of a cultivated meat product to the European Commission (EC). French food-tech company Gourmey announced [in July] that it had requested novel food approval in the EU for its cultivated ‘foie gras’ product. As a result, the European Food Safety Authority (EFSA) will do a safety assessment. Many questions remain about the regulatory requirements surrounding cultivated products, so it will be fascinating to get insights on how EFSA will conduct the safety assessment on a product that to them is such a new technology.”
Ana: “It’s an exciting precedent. Moreover, because there are additional details on the characterisation of cultivated meat ingredients in the updated novel food guidance, we know EFSA is preparing to evaluate this technology and product type. This makes Gourmey’s submission very nicely timed and a step towards adapting the current regulatory framework to recent innovations.”
So, what makes this first submission such a significant development?
Hannes: “Regulatory dossiers on cultivated products have been submitted to other authorities, such as the US and Singapore. However, with 27 member states, the EU is a relatively complex region. The story does not end when EFSA finalises their regulatory assessment and publishes a favourable opinion. There’s also a risk management phase where the EU Member States will need to vote to approve the cultivated meat product. It will be interesting to see what happens at that stage. We know that some countries plan to oppose cultivated meat, which may be one of the reasons we haven’t yet seen many dossier submissions in the EU. It’s good that Gourmey’s move provides a precedent.”
What kind of challenges and opportunities does Gourmey’s request bring?
Hannes: “For novel foods in general, the evaluation time is about two to four years. However, since cultivated meat is such a novel technology for EFSA, those timelines could be extended. We’ll have to wait until this first dossier goes through the whole regulatory process in the EU.”
Ana: “We see that a lot of the industry is creating more collaborative environments to engage with risk assessors and regulators to try to streamline the process and achieve more clarity on cultivated products. From a technical point of view, for example, there is not enough specific and practical guidance on testing and the required data. Having that input and a more open conversation with EFSA would be valuable for all parties involved.”
“We’ve seen European innovators looking towards other territories to launch their products because of this complexity. So that’s something we need to act upon as an industry. Communication with the risk assessors is key and a very realistic solution.”
Hannes: “In Singapore, for example, some cultivated meat products have gained approval. Singaporean authorities tend to engage actively with the industry. Direct communication between the industry and regulators may have ensured that some of the requirements were clearer when building a dossier for cultivated meat.”
Ana: “Cultivated meat, in general, brings a lot of opportunities for supportive or adjacent companies. There are many companies developing interesting media ingredients, including growth factors, and using very innovative technologies. There is a vast ecosystem around to help bring this technology to market, scale it and make it economical and feasible from a market and consumer point of view.”
Hannes: “The submission brings another opportunity for the industry. The EU Transparency Regulations introduced in 2021 mean that once the first cultivated meat dossier is validated, a non-confidential version of the dossier will be made publicly available, allowing competitors to draw inspiration to build their own dossier.”
What do more innovators need to keep in mind when it comes to novel foods in general?
Ana: “We work with many startups, and sometimes we see that these innovators think they have finished their product and that it is ready to go through the regulatory approval process.
However, we often encounter regulatory hurdles once we start digging into the product.
For example, the company may think the whole production process is compliant but then find out that a specific ingredient or material has no legal status in a particular region where they want to register the product. As a result, they need to replace this component to get regulatory approval. Doing the research is crucial, and it’s essential to start thinking about the regulatory process early on. By seeking regulatory advice from the beginning, innovators can potentially avoid running into last-minute challenges, thus lessening a little bit of the complexity and increasing the chances of a smooth evaluation process.”
Lastly, what makes working in novel foods so exciting for you?
Ana: “It’s a fast-evolving area that seems to be picking up speed over the past years, so it’s interesting to see where change is happening. I frequently talk with innovators and food tech companies with fascinating ideas, such as more sustainable alternatives to animal-derived ingredients. It’s an exciting area where you never stop learning.”
Hannes: “We currently face many issues with food production and climate change. Novel foods could be a way to help the food industry reduce its carbon footprint. I see them as a door to the future. At Atova, we help these companies get their product onto the market by supporting them during the regulatory approval process and safety evaluations.”
Thank you to Ana and Hannes for their expert insights!
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