World’s Largest Food Companies Call on EU to Include Novel Foods in Regulatory Sandboxes

The EU’s decision to exclude novel foods from regulatory sandboxes under the Biotech Act is facing pushback from the food industry, including a trade group representing the sector’s largest companies.

Novel foods are the only category left out of the new food and feed regulatory sandboxes announced by the EU’s first Biotech Act in December, but the food industry argues this exclusion is “not justified on legal, scientific or innovation grounds”.

“Experience has shown that certain types of novel foods trigger ethical or cultural concerns among various consumer segments regarding their acceptability,” the act states.

In a joint statement, eight food and biotech groups have urged the EU to ensure that novel foods like cultivated meat and precision-fermented proteins benefit from its sandboxes, which are controlled environments that let businesses and researchers design standards and guidance for new products with regulators.

One of these associations is FoodDrinkEurope, the largest trade group for the food industry in Europe, which represents companies like Nestlé, Coca-Cola, ADM, Mars, Danone, Ferrero, Kraft Heinz, and many other giants.

Other co-signees include Food Fermentation Europe, EuropaBio, the European Federation of Associations of Health Products Manufacturers, Food Supplements Europe, the European Agrifood Biotech Alliance and EIT Food – the latter two are co-funded by the EU itself.

“The justification for excluding novel foods based on ‘ethical or cultural concerns’. does not align with the legal framework of EU food law, where authorisation is based on scientific safety assessment,” the organisations say, suggesting that it creates an “internal inconsistency within the Biotech Act framework”.

Food groups highlight ‘incoherence’ of EU Biotech Act

Part of the life sciences strategy announced in July, the Biotech Act was designed to speed up the regulatory pathway for such novel foods, which has become a sticking point for the alternative protein space.

The final proposal only achieved this partially. It’s set to enhance pre-submission interactions between regulators and applicants by expanding the advice available to the latter, paving the way for improved dossiers and faster approvals from the European Food Safety Authority (EFSA). However, these products are explicitly precluded from the regulatory sandboxes.

The industry letter notes that the novel food framework is the primary regulatory pathway for the approval of innovative food ingredients, so excluding this sector from the sandboxes “removes the possibility for the EU food sector to test and refine many of the very innovations that the Biotech Act seeks to promote”.

The organizations point out that the proposed act allows sandboxes to apply to components like food enzymes, additives, flavorings, production processes, and AI methodologies (among others), so long as they don’t qualify as novel foods. This, they say, is a “deliberate introduction of incoherence” in the proposal.

“The same biotechnological process, data generation method or AI-supported testing strategy may benefit from a sandbox when applied to enzymes, additives or processing aids, yet be excluded when leading to a product classified as a novel food,” the letter states.

“This distinction is not based on scientific risk, nor on the nature or complexity of the technology involved, but solely on the regulatory classification of the final product,” it adds. “This exclusion weakens the coherence of the regulatory framework and introduces avoidable fragmentation in the treatment of biotechnology-derived innovations.”

Novel food exclusion ‘sits uneasily’ with Biotech Act’s goals

Outlining why sandboxes are important, the groups note that these have the potential to provide a structured and transparent framework for early dialogue between applicants and authorities, support clarity on data requirements, facilitate high-quality risk assessments before formal procedures begin, reduce uncertainty, avoid unnecessary costs, and prevent avoidable failures.

The EU’s former member, the UK, is a golden example of how sandboxes can drive the novel food industry forward. The country launched a cultivated meat sandbox in February 2025 with eight companies, which has resulted in the publication of the first set of safety guidance for novel food approval in the country. It aims to hand out its green light by next year.

The statement’s signatories argue that the EU’s exclusion of novel foods based on “ethical and cultural concerns” in some countries is “disproportionate”, suggesting that a vast majority of authorised products don’t trigger such considerations.

“Even where broader societal questions arise, regulatory sandboxes could provide a structured setting in which such aspects are discussed early in the development process, without affecting the science-based safety assessment carried out by EFSA,” they write.

They add that the introduction of regulatory sandboxes concerns the scientific and technical preparation of risk assessment, not market authorisation and not broader societal debates, so including novel foods would not modify the legal basis for authorisation, bypass the required safety assessments, or risk consumer safety.

The exclusion also “sits uneasily” with the Biotech Act’s broader objectives, which emphasise the need to strengthen biomanufacturing and digitalisation, and broaden the scope of the EFSA’s pre-submission advice. “Yet the category of foods most directly resulting from these biotechnological advances is excluded from the very instrument designed to support regulatory adaptation to them,” the groups say.

“Including novel foods within this framework would strengthen the quality of safety assessments, improve EFSA pre-submission dialogue, support the validation of innovative methodologies, and ensure that the regulatory system evolves in step with scientific and technological progress in the EU food sector,” they add.