THE EMERGING PARADIGM: THE GUT-BRAIN AXIS AND PREVENTIVE HEALTH

One of the most significant shifts in modern nutrition is the recognition of the “gut-brain axis”—the profound connection between dietary intake and psycho-physical well-being. The industry is moving beyond basic caloric value toward preventive nutrition, where food is analysed for its ability to mitigate cognitive decline, stress, and mood disorders.

Key trends include the rise of nootropics and psychobiotics, alongside a growing demand for personalized nutrition tailored to specific consumer categories, such as the elderly or those with neurodevelopmental needs. For innovators, the primary challenge is navigating the rigorous EU Health Claims Regulation (EC 1924/2006) and the Novel Food framework, which require absolute scientific certainty before any mental health benefit can be communicated to the market.

OUR FOCUS: THE TECHNICAL-LEGAL ANCHOR FOR FUNCTIONAL INNOVATION

The intersection of nutrition, cognitive health, and pharmaceutical standards requires a sophisticated focus on the normative architecture of functional innovation. We prioritize the transformation of laboratory discoveries into legally marketable health assets by navigating the specialized requirements for functional ingredients, ranging from microalgae-derived proteins to bioactive compounds sourced from upcycled side-streams. This focus ensures that the technical development of these substances accounts for the stringent safety benchmarks of both the food and feed markets from the earliest stages of research.

A central priority is the convergence of the agri-food, pharmaceutical, and medical sectors, where we examine the specific requirements for clinical trials to ensure that testing protocols are legally validated. Our focus is on ensuring that resulting data is “EFSA-ready,” providing the necessary grounding to bridge the gap between traditional medicine and the “food as medicine” paradigm. By acting as a hub for scientific substantiation, we focus on the collection and alignment of toxicological and nutritional data, which is essential for the successful completion of notification procedures and safety dossiers.

Finally, we direct our attention to the institutional validation of cognitive and mental well-being claims. Our focus is on the critical interface with regulatory bodies like EFSA, where we identify the level of evidence required to withstand institutional scrutiny. By pinpointing the specific evidentiary hurdles for health claims related to cognitive function, we help ensure that functional innovations are supported by a transparent and credible legal framework, allowing for a legally sound transition from scientific discovery to the public market.

PROVEN IMPACT: MAPPING REGULATORY FEASIBILITY

Our contribution to complex European projects focuses on the pragmatic investigation of the “frontier” of nutritional science, where we assist partners in identifying the legal hurdles associated with innovative ingredients:

Examining Regulatory Constraints

In the ProFuture project, we analyzed the legal requirements for microalgae species with high nutritional potential. By drafting “Joint Authorization” roadmaps, we helped partners understand the evidentiary path required to bring these ingredients to the European market under existing safety frameworks.

Integrating Traditional Knowledge with Modern Safety

Within the CAMELMILK initiative, we examined the legal framework for products traditionally valued for their nutritional properties. Our focus was on identifying the specific Novel Food requirements necessary to establish these benefits within the EU regulatory context.

Exploring Data Integrity for Safety Dossiers

Through the WASTELESS project, we have looked into the application of blockchain-based systems to support the integrity of technical data. This work focuses on the importance of robust documentation when presenting safety evidence for functional ingredients to regulatory authorities.