The Brussels-based think tank launched the New Foods RegLab today (Oct. 15), alongside a paper setting out its proposals. The platform builds on former Prime Minister of Italy Mario Draghi’s call for greater EU investment in innovation, simpler regulation and stronger collaboration between Member States to improve Europe’s competitiveness and economic resilience.
While pre-submission advice supports individual applicants, the proposed platforms would help Member States, European Food Safety Authority (EFSA) and the European Commission share knowledge, identify recurring challenges and improve regulatory guidance.
The initiative aims to identify where companies struggle to interpret regulatory guidance and prepare applications, Anna Handschuh, founder and managing director of the Ministry of Future Affairs, explained.
“The urgency is real,” Handschuh told NutraIngredients. “Companies that developed their ingredients in Europe are scaling up in the United States and elsewhere now, not in three to five years.”
The issue of unpredictability
Handschuh explained that unpredictability, rather than the rules themselves, is the biggest regulatory challenge facing nutraceutical companies.
EU novel food authorisation is supposed to take 18–24 months, but according to the Ministry, the process takes an average of two and a half years in practice, and some applications take more than five years. Delays often stem from administrative steps and requests for additional data, creating uncertainty for businesses investing in new ingredients.
“A nutraceutical company has to pay for toxicology studies, specifications and production data years before it sees any return, and it cannot know in advance what EFSA will ask for,” Handschuh said. “UK companies face the same uncertainty when they turn to the EU market, on top of their own domestic process.”
She noted that the issue is that applicants, consultants and national authorities currently learn the same lessons separately, rather than sharing insights to improve guidance, pre-submission advice and applications across the sector.
Working with the European Commission
As advances in biotechnology create new opportunities for food production, the EU faces growing pressure to ensure that its regulatory framework supports innovation while maintaining high food-safety standards.
The European Commission therefore recently proposed a two-phase legislative package to strengthen the EU’s biotechnology sector.
Biotech Act I focuses on health biotechnology and aims to boost innovation, investment and regulatory efficiency, and Biotech Act II, which is still in the developmental stage, will focus on industrial biotechnology and biomanufacturing with the aim of strengthening the EU’s competitiveness, resilience and transition to more sustainable production.
The Ministry of Future Affairs proposes that cross-border regulatory learning platforms could complement the Biotech Acts by strengthening knowledge-sharing between Member States, applicants, the EFSA and the European Commission.
“If embedded in EU legislation, Biotech Act I and II could provide a space to enable regulatory learning, without changing a single safety requirement,” Handschuh said.
She noted that while the European Commission’s Biotech Acts would expand pre-submission advice for individual applicants, the RegLab would then be able to share insights across companies to help shape clearer guidance and more effective advice without compromising consumer safety or scientific standards.
“Better prepared dossiers mean fewer clock stops and shorter assessments, with the same rigor applied to the same evidence,” Handschuh said. “The same logic serves every regulator, the FSA included.”
How will it work?
The New Foods RegLab will help companies navigate the EU novel-food authorisation process more efficiently and bring innovative ingredients to market sooner by improving their preparation before submitting an application, Handschuh explained.
Companies preparing to bring novel foods to the EU market can apply within the deadline of Nov 30, 2026, including businesses based outside the bloc. The RegLab will bring together up to 10 non-competing companies for a two-day Brussels workshop in January 2027, where experienced regulatory experts will review their interpretation of EFSA guidance and provide feedback to help strengthen their novel-food applications before submission.
“In a next step, we publish a framework with recommendations for the future EU novel foods pre-submission advice, based on what we learn from working with applicants at this early stage,” Handschuh told NI.
The RegLab does not grant authorisations, she noted, but by addressing EFSA’s questions upfront, applicants could avoid additional data requests that take almost a year on average to answer.
Encouraging the UK
UK nutraceutical companies planning to enter the EU market are encouraged to apply to the RegLab.
“The EU remains the largest export market for UK food and drink, and a company that can plan its EU route from the start can scale up at home rather than relocate,” Handschuh said.
She explained that the RegLab would also help EU regulators learn from the UK’s experience with its cultivated meat regulatory sandbox. The platform would provide a route to share anonymised findings with EFSA and the European Commission, helping regulators keep pace with scientific advances.
“A cross-border regulatory learning platform such as the New Foods RegLab needs no treaty,” she explained. “Companies and regulators can learn together.
“For the UK, the gain is a predictable EU route to market for its companies and a formal channel for its own regulatory experience. Approvals on time would keep the next generation of ingredients, and the companies behind them, in Europe.”
