EFSA updates novel foods guidance: streamlined safety assessments and industry insights

The European Food Safety Authority (EFSA) has updated its guidance on novel foods, marking an important step for companies aiming to bring new products to the European market. The updated guidelines, published recently, are designed to streamline the process for safety assessments and ensure the highest standards for consumer protection. Novel foods, defined as any food that was not significantly consumed by humans in the EU before May 1997, encompass a wide range of items, including innovative foods, food derived from new production processes, and foods produced using new technologies.

EFSA’s latest update is built upon its commitment to refine the evaluation process for novel foods while maintaining consumer safety. The updated guidelines offer a more transparent and comprehensive approach to assessing novel foods, especially in the face of evolving food technology and increasing consumer demand for innovative and sustainable food products.

One of the central changes in the updated guidance is the clarification of the types of data required for a safety assessment. EFSA emphasizes that applicants must provide thorough evidence to demonstrate the safety of their novel food products, which includes detailed compositional data, manufacturing process information, and nutritional profiles. EFSA has also emphasized the importance of considering vulnerable population groups in safety assessments, such as infants, the elderly, and those with specific dietary requirements.

For companies preparing novel food applications, the guidance offers a clearer roadmap of what information needs to be included. By providing a more detailed breakdown of data requirements, EFSA aims to reduce the number of back-and-forth requests for additional information during the review process. This should lead to a more efficient pathway to approval, potentially speeding up market entry for innovative products.

EFSA is also introducing a more comprehensive approach to data collection, where applicants are expected to provide not only traditional toxicological data but also data on allergenicity, potential contaminants, and nutritional impact. The authority's objective is to ensure that all possible risks are thoroughly evaluated before a product can be introduced to consumers.

As food production technologies evolve, the regulatory environment must adapt. EFSA’s new guidance acknowledges the growing importance of food produced through techniques such as precision fermentation, cellular agriculture, and novel protein extraction methods. These innovations, often hailed as solutions to global food security and sustainability challenges, bring their own set of safety questions. EFSA’s updated guidance takes these into account by providing more specific instructions for assessing foods produced by these cutting-edge technologies.

For example, when assessing food products derived from genetically modified microorganisms or cell culture techniques, EFSA requires applicants to clearly outline how these processes affect the safety and nutritional content of the food. This is crucial for building consumer trust and ensuring that novel foods meet the same safety standards as traditional products.

This update to the novel foods guidance comes at a time when the food industry is increasingly focused on sustainability and innovation. Many novel foods, such as alternative proteins and plant-based products, are developed with sustainability in mind, addressing concerns about environmental impact, food security, and animal welfare. The updated guidance ensures that these products can be evaluated efficiently and thoroughly, without compromising safety.

The clearer framework also benefits smaller companies and startups that may be entering the novel foods space for the first time. By providing a more transparent and predictable assessment process, EFSA is making it easier for these companies to navigate the regulatory landscape, encouraging innovation in the European food sector.

EFSA’s updated guidance on novel foods reflects the organization’s proactive approach to ensuring the safety of the European food supply while fostering innovation. By refining the safety assessment process, EFSA is helping to create a more transparent, efficient, and predictable regulatory environment. This is especially important as novel foods become increasingly common on supermarket shelves, driven by consumer demand for healthier, more sustainable, and ethically produced products.

As part of the ongoing dialogue between industry and regulatory bodies, Wolfgang Gelbmann, a senior expert from EFSA, will be speaking at the Future of Protein Production conference in Amsterdam on October 23-24. He will discuss How to engage with EFSA to speed the regulatory application process, providing valuable insights for companies looking to bring novel food products to market faster. This event highlights the importance of collaboration between food producers and regulatory agencies to meet the growing demand for safe and innovative food products.

For companies in the novel foods space, these updates provide an essential tool for navigating the complex approval process, ensuring that new products are both safe and compliant with European regulations. As the food industry continues to evolve, EFSA’s role in safeguarding public health remains more critical than ever, balancing the need for innovation with the responsibility of protecting consumers.