Europe's authorisation process hinders progress in new food development
The European Union's novel food approval process is under scrutiny, with industry experts and start-ups voicing concerns about its complexity, length, and opacity. This intricate process, they argue, could hamper Europe's competitive edge and risk missing out on the next billion-dollar market.
Ivo Rzegotta, from the think tank Good Food Institute (GFI Europe), sees Europe's competitive edge at risk. He warns that the EU could fall behind in the next promising market after solar and chip industries. Rzegotta's sentiments are echoed by Patrick Noller, who claims it is easier to approve a medication than a new food in the EU.
The Dutch example of a sandbox program is being proposed as a solution to these issues. This model allows companies to temporarily test their innovative food products on consumers while the actual novel food approval process is ongoing. Bluu Seafood, a company that produces so-called cultivated fish in bioreactors, is one of the companies affected by the lengthy and opaque EU novel food approval process.
Many companies are considering moving abroad due to the EU's novel food approval process, which could lead to a loss of innovation and jobs in Europe. The calls for reforms and sandbox programs indicate a growing demand for changes in the EU novel food approval process to support innovation and start-ups in the food sector.
The proposed sandbox program could provide a more efficient and practical approach for start-ups in the food sector to test their innovative products. The real-lab law in Germany could potentially serve as a foundation for implementing the proposed sandbox program. In Germany, companies have suggested that the federal government could follow suit with the planned real-lab law.
International best practices for novel food approval emphasize scientific rigour, transparency, stakeholder engagement, and regulatory harmonization. In Europe, efforts to address criticisms of slow, innovation-averse, and opaque novel food processes include adopting more structured scientific evaluation and transparent re-evaluation frameworks through EFSA, plus regulatory reforms to streamline approvals while maintaining safety.
The European Food Safety Authority (EFSA) operates a transparent and systematic re-evaluation program for authorized food additives under EU regulations, ensuring ongoing safety checks based on updated scientific data and stakeholder submissions. EFSA provides scientific opinions and publicly accessible assessment reports, fostering transparency and trust.
However, despite these advances, some criticism remains about the pace and complexity of EU novel food approvals compared to other jurisdictions like the US. Industry experts suggest that monitoring evolving regulatory landscapes, horizon scanning, and advocacy for streamlined approaches are essential strategies for maintaining momentum in innovation-driven markets.
The affected start-ups, such as Infinite Roots and Formo, are urging for a change in the status quo. Philip Tigges, Managing Director of Infinite Roots, has been submitting scientific dossiers to authorities for years without making progress in the EU novel food approval process. Raffael Wohlgensinger, founder and CEO of Formo, is in need of quick commercialization as every month of waiting costs valuable time and capital.
Christian Dammann, Chief Technical Officer of the company Bluu Seafood, criticized the implementation of the Novel Food Regulation. Patrick Noller, from the Berlin-based start-up investor Foodlabs, criticized the EU novel food approval process as a "nightmare." Start-ups in the food sector currently have a "clear" competitive disadvantage in the EU, according to Ivo Rzegotta.
In summary, Europe implements international best practices for novel food approvals by adhering to harmonized scientific evaluations, enhancing transparency through stakeholder engagement, and exploring innovative safety assessment methods—all aimed at addressing concerns about slow, risk-averse, and opaque procedures. However, continued reforms and proactive industry-regulator dialogues remain critical for further improving innovation efficiency within EU regulatory frameworks.
[1] European Commission. (2020). Novel Food. Retrieved from https://ec.europa.eu/food/safety/novel_food/home_en [2] European Food Safety Authority. (2020). Novel Foods. Retrieved from https://efsa.europa.eu/en/topics/topic/novel-foods [3] European Food Information Council. (2020). Novel Foods. Retrieved from https://efic.org/topics/novel-foods/
- Ivo Rzegotta, from the Good Food Institute (GFI Europe), expresses concerns about the EU's complex and lengthy novel food approval process, fearing it could hinder Europe's competitive edge in promising markets like the food sector.
- Patrick Noller, a start-up investor based in Berlin, echoes Rzegotta's sentiments, stating it is easier to approve a medication than a new food in the EU, a stumbling block that could potentially lead to a loss of innovation and jobs in Europe.
- Industry experts suggest advocacy for streamlined novel food approval processes is crucial, as the current complexities in the EU could put Europe at a disadvantage compared to other jurisdictions such as the US, especially with innovation-driven markets.
