Cultured foie gras submitted for regulatory approval in EU and UK
October 1, 2024
French start-up, Gourmey, has submitted the first premarket application for a cultured meat product intended for human consumption in the EU and the UK. Cultured meat has been in development for decades, but it’s currently only available for human consumption in Singapore and the US. With this new step towards EU and UK approval, it could be appearing on shelves sooner than expected.
What is cultured meat?
Cultured meat is grown from animal cells in a nutrient-rich culture medium, which causes the cells to multiply and develop, mirroring the growth of cells inside of an animal. Cultured meat has been gaining traction, with Gourmey’s submission coming just a month after pet food company, Meatly, received regulatory clearance to sell cultured chicken to the UK pet food market.
A major drive for cultured meat is its reduced environmental impact, with 78-96% less greenhouse gas emissions, 99% less land use, and 82-96% less water use than conventional European meat (1). As the global populace is projected to reach 9.7 billion by 2050, finding ways to feed the growing population sustainably is essential.
However, with innovation comes opposition. Italy was the first country to ban cultured meat in December 2023, restricting both its production and marketing. Italian agribusinesses expressed concerns over the consequences that focusing on environmental issues may have on their profits. Farming associations campaigned for the ban, calling cultured meat a risk to Italian agriculture. Florida followed in May 2024 for the same reason, making it a misdemeanour to manufacture, sell or distribute cultivated meat; companies that do so risk having their licenses suspended.
Public opinion could also impede the growth of cultured meat. In a global study commissioned by Leatherhead Food Research in 2023, 22% of participants said they would be willing to try cultured meat and only 17% said they’d feel safe eating cultured meat even if they knew it was heavily regulated. People’s reluctance to try it may be behind Gourmey’s decision to target the premium segment with its flagship duck product. Gourmey’s CEO explains: ‘The premium segment has always been at the forefront of food trends, where the most exciting innovations occur… Starting with haute cuisine acts as a catalyst for our future product launches, with chefs serving as the best ambassadors to introduce new product categories to consumers and drive sustainability’ (2).
Regulatory concerns
A significant challenge for companies is navigating the complex regulatory landscape. Cultured meat’s infancy places it in a regulatory grey area in Europe, requiring it to be categorised as a novel food unless produced using GMOs.
In the EU, companies submitting novel foods to be approved for human consumption face a complex three-stage process:
- Submit an application to the European Commission via a national competent authority for a member state.
- The European Food Safety Authority (EFSA) conducts a risk assessment of the substance and issues an opinion within nine months regarding its safety for human consumption
- The Commission then has seven months to determine whether the product should be approved and made commercially available (3)
Due to the lack of information surrounding cultured meat, approval is not simple. Though EFSA has a fixed legal deadline of nine months, the agency can extend its deadline if further data or clarification is necessary (4) and with an uncharted topic like this, the extension could be justified. Moreover, due to the novelty of cultured meat there are research gaps which could hinder EFSA’s ability to conduct a risk assessment.
According to the UK’s Food Standards Agency (FSA), there are ‘considerable gaps in the type of knowledge that is required by other regimes within UK novel foods regulations available in the public domain.’ (5) The FSA was concerned with the lack of ‘empirical data found on the final analytical composition of products, key toxicology data, nutrition profiles, product stability, allergy risk, and any recorded adverse effects when consumed by animals or humans’ (5). As more products get approved and the market for cultured meat grows, the knowledge gap should close and the regulatory process ease; this could be a slow process due to the complex regulations. Indeed, the Advisory Committee on Novel Foods and Processes are meeting in September to discuss ‘A proposal for a new Subcommittee to consider the scientific issues and assessments of alternative and cell cultivated proteins” (6). This suggests that ‘scientific issues’ surrounding cultured meat are being considered by the FSA, and that the knowledge and regulations surrounding it may change.
Moreover, the FSA identified hazards unique to cultured meat, from nutritional hazards to contamination from components used in cell culturing to a variety of cell culture infections and cell line associated risks (5), all of these present unique and novel challenges for the regulatory process. Considerable research needs to be undertaken to define and consolidate the hazards and protocols for cell-cultured meat; in the meantime, the current under-researched hazards could extend the time needed by the FSA to approve such products.
The future of cultured meat regulation
Whilst Gourmey’s submission for authorisation is an exciting step for getting cultured meat into supermarkets, the regulatory process is still long and complex. However, by observing Gourmey’s regulatory process and the outcome produced by this submission, it could act as a template for what to do or what to avoid when submitting cultured meat applications for approval to the EU and UK.
Regulatory support
As cultured meat continues to advance, the regulations surrounding it will evolve. Leatherhead’s experts can provide insight into the regulatory landscape across the globe. We provide a novel food dossier service to help your company achieve the best possible outcome for your submission. Contact us at [email protected] to discuss how we can assist you. We can also provide you with more information about Leatherhead Food Research’s study on cultured meat.
(1) Cultured Meat: Promises and Challenges - PMC (nih.gov)
(2) Lab-grown foie gras application submitted in UK and EU | News | The Grocer
(3) The Regulatory Minefield of Novel Foods | FoodUnfolded
(5) Hazard identification: identification of hazards in cultured animal cells (food.gov.uk)
