Introduction
The opening of the Paris Olympics on 26 July 2024 coincided with a potentially significant development in one of France’s most renowned gastronomic traditions. The French cultivated meat startup, Gourmey, applied for a novel food authorization for its cultivated foie gras in the EU, as well as in Singapore, Switzerland, the United Kingdom, and the United States. This first-ever authorization procedure for a cultivated meat product in the EU represents a potential “legal disruption” and warrants close attention from both policy and research communities.
Cultivated meat, produced from animal cells grown in controlled environments outside of animals, is hailed as a potential solution to the numerous environmental and ethical challenges posed by conventional meat production. At the same time, scientific, sustainability and regulatory challenges are well regarded. Notwithstanding, the first commercial cultivated meat product was introduced in Singapore in 2020, following regulatory approval granted to the American company “Eat Just” for chicken nuggets partially composed of cultivated cells. As of May 2024, these nuggets are also available in Singaporean retail stores. Meanwhile, several other cultivated meat products have received approval in Singapore, the United States, and Israel. Regulators in various jurisdictions are actively collaborating with innovators to establish pathways to market for these products.
The EU has not yet taken a leading role in the regulation of cultivated meat. Most food innovations are governed by the EU’s novel food framework, defined by Regulation (EU) No 2015/2283, and cultured meat is no exception. The novel food framework is praised for its robustness but criticized for hindering innovation due to lengthy and demanding procedures. Innovators also fear political interference in the authorization process, as cultivated meat faces intense political backlash in several EU Member States. Since 2020, for example, the French legislature has repeatedly attempted to prohibit the use of meat-related terms for alternative protein products. In November 2023, the Italian government adopted Law No. 172/2023 prohibiting the production and commercialization of cultivated meat. Article 1 provides that the ban is necessary to:
“ensure the protection of human health and citizens’ interests as well as preserve the agri-food heritage, as a set of products that are an expression of the socio-economic and cultural evolution process of Italy, of strategic importance for the national interest”.
Policymakers in Poland and Romania have expressed similar intentions, and the governments of these sceptical countries are proposing revisions to the novel food framework at the EU level.
Disruptive Potential for Novel Food Framework and Animal Welfare
Legal disruption occurs when new technologies challenge the applicability and suitability of existing regulatory frameworks. In our view, the authorization procedure for cultivated foie gras could trigger such disruption concerning the novel food framework, food labelling regulations, and animal welfare laws.
First and foremost, the authorization procedure at the EU level will test the Commission’s claim, that the existing novel food framework is adequate for handling such applications. The European Food Safety Authority (EFSA) has recently taken several steps to engage with stakeholders in the field of cellular agriculture through a Scientific Colloquium on cell culture-derived foods and food ingredients. It has promised specific guidelines for submitting dossiers on cultivated meat products, which are expected to be included in the new general guidance for novel food applications to be published in September 2024. This application will illustrate whether these steps effectively address the concerns of the cellular agriculture industry.
The parallel filing of applications in Singapore, Switzerland, the UK and the United States will also enable a comparative assessment of regulatory regimes and potentially expedite regulatory cooperation. While all countries share the fundamental objective of ensuring food safety, their specific authorization procedures, approval times and transparency requirements vary significantly. Different countries exhibit varying levels of risk acceptance when it comes to food innovations. For instance, Singapore aims to position itself as a regulatory pioneer to attract innovators because it views cultivated meat and novel foods as essential to achieve the objectives of the national food security strategy ‘30 by 30’, aiming to produce locally 30% of the country’s nutritional needs by 2030.
In this context, the foie gras application may influence the EU’s stance on radical food innovation more broadly. Whilst the EU’s novel food framework primarily focuses on food safety, the political discourse on cultivated meat encompasses additional aspects. Legislative efforts in France and Italy reflect concerns about agriculture and, rural development, the right to informed consumer choices. An EU novel food authorization would challenge the effectiveness of such national legislation and compel stakeholders to defend the (perceived) interests of conventional animal production at the EU level.
Unlike most dairy and meat products, foie gras is a “luxury” product that is already highly controversial. It has been the subject of heated political debate and regulatory action. The process of force-feeding geese to enlarge their livers has been banned in several countries, including more than half of the EU Member States, and some countries have started banning foie gras imports. Protecting its conventional producers is unlikely to garner broad public support.
Au contraire, the authorization of cultivated foie gras could even spur advancements in animal welfare regulation. Animal welfare is enshrined as a principle of EU primary law in Article 13 TFEU. For animals kept for farming purposes, this translates into Article 3 of Directive 98/58/EC, according to which ‘Member States shall […] ensure that the owners or keepers take all reasonable steps to ensure the welfare of animals under their care and to ensure that those animals are not caused any unnecessary pain, suffering or injury’. The availability of cultivated alternatives to animal products alters the trade-offs implied by this rule. The authorization of cultivated foie gras could thus reshape the regulatory debate on biotechnological food innovation in general. Until now, opponents have argued for consideration of the broader socio-economic implications of innovative products during the authorization process, assuming this would justify limitations and prohibitions. However, considerations of animal welfare (or other aspects such as working conditions, one health, or ecological impacts) could support the urgent approval of such products.
Conclusion
The first novel food application concerning cultivated meat in Europe is now a reality. Gourmey’s focus on foie gras, as a controversial and high-value luxury item, appears to be a smart strategy given the polarized political debate on cultivated meat in Europe. This move should prompt French and other European policymakers to reconsider their positions and potentially reinvent one of their most recognizable food delicacies. The timing of the application’s publication on the opening day of the Paris Olympics 2024 may have limited broader public scrutiny, but this should not deter food innovation scholars from carefully monitoring its development.
