Industry coalition presses EU to include novel foods in Biotech Act sandboxes

A coalition of food and biotech industry groups has called on EU policymakers to include novel foods within the scope of proposed regulatory sandboxes under the European Biotech Act, arguing that their exclusion could hinder innovation and delay market access for new products.

• FoodDrinkEurope and seven partner organizations have urged the EU to allow novel foods into regulatory sandboxes under the Biotech Act.
• The groups said current approval timelines for innovative foods can take years, slowing development and commercialization in Europe.
• They argued that including novel foods would improve risk assessment, regulatory clarity, and innovation without changing existing safety standards.

The joint statement, backed by organizations including FoodDrinkEurope, EuropaBio, Food Fermentation Europe, the EU Agri-Food Biotech Alliance, EHPM, Food Supplements Europe, and EIT Food, focused on the role of regulatory sandboxes as a tool to support emerging food technologies.

Under the European Commission’s proposal, sandboxes would provide controlled environments where companies and regulators can test new products, processes, and methodologies before formal approval. However, the current framework excludes novel foods, a category that includes many of the most advanced innovations in food and biotechnology.

The coalition argued that this exclusion creates an inconsistency within the Biotech Act, particularly as other categories such as enzymes, additives, and production processes would be eligible for sandbox participation.

The groups said that regulatory sandboxes could help address one of the key challenges facing food innovation in Europe, lengthy and complex approval timelines. By enabling earlier dialogue between developers and regulators, sandboxes are intended to improve study design, clarify data requirements, and reduce uncertainty before formal submissions.

In their statement, the associations said that excluding novel foods is not justified on legal, scientific, or innovation grounds, and risks undermining the objectives of the Biotech Act.

“The undersigned associations consider that the exclusion of any innovative sector, like novel foods from regulatory sandboxes is not justified on legal, scientific or innovation grounds and creates an internal inconsistency within the Biotech Act framework,” the statement said.

They emphasized that including novel foods would not alter existing safety requirements under EU law, but would instead improve how safety assessments are prepared and conducted.

“[Including novel foods] would instead enhance the quality, predictability and efficiency of scientific risk assessment for the most innovative and technologically advanced food products,” the groups said.

The statement highlighted that many novel foods, particularly those developed through fermentation, cell-based production, and other biotechnological methods, are first-of-their-kind products. These innovations often require new types of data, testing strategies, and regulatory approaches, making early engagement with authorities especially valuable.

The coalition also pointed to the role of the European Food Safety Authority in evaluating novel foods, noting that assessments are based strictly on scientific evidence. They argued that broader ethical or cultural considerations cited as a reason for exclusion do not form part of the formal safety evaluation process.

The groups said that including novel foods in regulatory sandboxes would strengthen pre-submission dialogue with EFSA, support validation of new methodologies, and ensure that regulatory frameworks evolve alongside scientific progress.

“We therefore invite the Commission and co-legislators to ensure that novel foods can benefit from regulatory sandboxes under the same science-based conditions applicable to other regulated food categories,” the statement concluded.

The intervention reflected growing concern among industry stakeholders that Europe risks falling behind other regions in bringing innovative food technologies to market if regulatory processes are not adapted to support faster and more predictable pathways.