Companies seeking approval to sell novel foods in the European Union are being told to engage with regulators long before they submit an application, as the bloc’s food safety body works to make the process faster and more predictable.
The European Food Safety Authority (EFSA) assesses products such as cultivated meat, alternative proteins and reformulated ingredients before they can be placed on the market. The system is deliberately rigorous, but the length and uncertainty of the process have discouraged investors, particularly in newer sectors such as cultivated meat.
Oceane Albert, a policy officer at EFSA, says the most successful applications are those that demonstrate safety under the conditions proposed for use. “I would encourage applicants to engage with EFSA as early as possible and request pre-submission guidance,” she told FoodNavigator.
The authority examines factors including the identity of the new food, its production process, composition, nutrition, toxicity and allergenicity, and the dossier must be detailed enough for an expert to complete a full risk assessment. Pre-submission talks are already becoming more common: EFSA executive director Dr Nikolaus Kris says the number of such discussions has risen by 47 per cent.
Submitting too early is one of the most frequent mistakes. Incomplete data, products still in laboratory development and missing toxicological information all slow the assessment, with questions bouncing back to the applicant during the risk assessment itself.
Stability data are also often absent, even though applicants must prove a product remains safe for its stated shelf life. The same applies to nanoparticles, which can enter foods through processing aids; EFSA says applicants must demonstrate their absence before an application can progress.
EFSA is working to simplify the process, and a forthcoming EU Biotech Act could give the authority more time to interact with applicants and improve pre-submission guidance. For now, the message is straightforward: complete, thorough and detailed dossiers are the fastest route through the system.
The decisions will shape how quickly new ingredients reach supermarket shelves, at a time when big food brands are racing to reformulate familiar products.