EU Novel Food Regulation: expert insights from regulatory practice

Innovation in the food sector is progressing rapidly as companies develop new ingredients and microbial solutions that aim to reshape the future of food. As this development continues, the importance of strong regulatory expertise grows, especially within the demanding framework of the European Union Novel Food Regulation.

To explore this landscape, we interviewed Anne Ukkonen, Regulatory Manager at Biosafe, whose work covers a broad range of regulatory and scientific responsibilities in the areas of novel foods, food enzymes, and food additives. Her insights highlight both the complexity and the opportunities that define this field.

From biotechnology research to EU novel food regulation strategy

Anne started her career in academic research in biotechnology, completing her doctoral degree before gaining work experience in research, project management, and quality control tasks in private biotech and pharma companies. About four years ago, she transitioned into her present role at Biosafe, where she supports companies through the entire lifecycle of regulatory submissions under the EU Novel Food Regulation framework.

She explained that her work requires the ability to understand intricate scientific details while keeping sight of the overall regulatory strategy. To succeed, one must combine analytical thinking, project planning, and strong scientific communication. The work is both demanding and rewarding, and it requires a continuous willingness to learn.

Collaboration: The foundation of successful novel food applications

Anne emphasised that successful novel food and enzyme applications are always the result of teamwork. Each submission brings together specialists in microbiology, chemistry, toxicology, and bioinformatics. Although the scope of Biosafe's involvement varies from case to case, it often covers everything from defining the requirements to preparing the scientific dossier and communicating with EFSA and other authorities.

Only production-related information remains solely in the hands of the applicant, although Biosafe helps write the necessary details in that section, too. Anne highlighted that a high-quality application reflects a precise interpretation of EFSA guidance and EU Novel Food Regulation requirements. Scientific details must be presented clearly, and all administrative requirements must be handled carefully, including the management of confidential information. Attention to detail is essential since even small inconsistencies may delay the assessment.

Navigating new products in the EU novel food market

Many of the products appearing in Anne's current projects are entirely new concepts. A large proportion are microbial or fermentation-derived and often represent technologies or food innovations that have not yet been widely evaluated in regulatory processes under the EU Novel Food Regulation.

Biosafe's team works on both European Union and United States submissions. Anne noted that while scientific elements may overlap between these regions, the administrative and procedural expectations differ considerably. Her own projects currently focus mainly on the European Union market, where understanding the nuances of EU Novel Food Regulation is critical for success.

Understanding EFSA requirements: toxicity studies and regulatory questions

Authorities frequently request clarifications on microbial characterisation, genome sequencing, production processes, and the sufficiency of analytical data. Toxicity studies are a central part of most applications under the EU Novel Food Regulation and are particularly necessary when dealing with new categories of products.

Although applicants often wish to minimise the number of studies required, Anne pointed out that certain baseline studies are essential and that more extensive studies are expected for completely new product types or sources. Applicants can seek advice from EFSA at different stages of the process. However, authorities focus primarily on the interpretation of guidance documents and do not give detailed recommendations on experimental design. Still, Anne noted that even this limited interaction can be valuable in preventing misunderstandings later in the evaluation.

Evolution of EU Novel Food Regulation guidance

The guidance for novel food applications has become more detailed over the past few years. This development brings clearer expectations but also increases the administrative workload. Anne mentioned that a new annex now requires all analytical data to be delivered in Excel format, which means more time must be allocated to preparing documentation, but also facilitates the review process.

When comparing regions, Anne observed that EU Novel Food Regulation procedures are more administratively intensive than United States processes, especially regarding confidential data and the requirement for multiple document versions. Understanding these differences is crucial for companies planning to enter the European market.

Novel EFSA guidance for Novel Foods — are you ready?

What makes regulatory work rewarding

According to Anne, the most enjoyable aspect of her role at Biosafe is the opportunity to work closely with innovative companies and to gain early insight into products that may eventually transform the market. The most challenging part arises when no comparable cases exist under the EU Novel Food Regulation and the regulatory strategy must be built entirely from scratch. These situations require careful judgement to create a realistic study plan and a feasible application pathway that does not place an unreasonable burden on the applicant.

Practical guidance for your novel food application

Anne encouraged new applicants to approach the EU Novel Food Regulation process methodically. It is important to begin with a clear understanding of the product and the regulatory requirements. She advised companies to outline the necessary studies early, to plan realistic timelines and resource needs, and to invest in collaboration among experts who bring different strengths to the process.

These elements together help streamline the preparation of a robust application and prevent avoidable delays. Working with experienced regulatory consultants like Biosafe can significantly reduce the time and resources needed to navigate the complex requirements of the EU Novel Food Regulation.

AI as a supporting tool in regulatory work

Artificial intelligence also plays a supportive role in Anne's work at Biosafe. She uses it particularly for tasks that benefit from efficiency, such as compiling tables or performing initial information searches. AI can contribute to productivity, but Anne emphasised that the information it provides must always be checked carefully. It is a tool that assists experienced professionals rather than a replacement for expertise in EU Novel Food Regulation compliance.

Your partner in EU Novel Food Regulation compliance

This conversation serves as a reminder that the field is moving swiftly and that successful navigation of the EU Novel Food Regulation depends on staying informed, collaborating across disciplines, and building strategies that are both resilient and forward-looking. If the pace of innovation continues to accelerate, the regulatory landscape will evolve right alongside it, offering fresh challenges and possibilities for those ready to engage with it.

Whether you're preparing your first application under the EU Novel Food Regulation or refining existing regulatory processes, Biosafe's team of experts will help you plan a clear and effective path to market. With deep expertise in EFSA requirements, novel food applications, and food safety regulations, we ensure your innovative products meet all regulatory standards.