NOVEL FOOD:
OVERCOMING THE BARRIERS TO INDUSTRIAL SCALING
ALTERNATIVE PROTEIN FRONTIERS: THE NOVEL FOOD CHALLENGE
The search for sustainable, nutrient-dense ingredients—ranging from microalgae and alternative proteins to traditional foods from non-EU regions—has become a central pillar of the future food system. However, these innovations frequently encounter a significant “regulatory ceiling” within the European market. The EU Novel Food Regulation (2015/2283) remains one of the most complex and resource-intensive barriers in the global food sector, often preventing promising scientific breakthroughs from reaching the commercial shelf.
In response to these challenges, the industry is moving toward collaborative authorization models. This shift enables diverse partners to share the financial and evidentiary burdens of safety dossiers, creating a collective pathway for industrial scaling. For international consortia, the priority has shifted from simple technical discovery to the strategic management of safety data and the navigation of the rigorous institutional requirements necessary to unlock the European market.
OUR FOCUS: THE TECHNICAL-LEGAL PATH TO MARKET ENTRY
Our focus is directed toward the pragmatic management of the Novel Food authorization process, where we prioritize the transformation of alternative proteins into legally recognized food assets. We focus on identifying the specific toxicological and nutritional data requirements set by EFSA, ensuring that research into microalgae, insects, or side-stream-derived bioactives is informed by the rigorous standards of the EU regulatory framework. By mapping these requirements early in the innovation lifecycle, we help consortia evaluate the feasibility of their results and avoid the “regulatory dead-ends” that often hinder high-tech nutrition.
A central pillar of this focus is the facilitation of collaborative authorization roadmaps. We examine how diverse partners can synchronize their efforts to share the burden of safety dossiers, moving away from fragmented submissions toward a unified, institutional approach. This focus allows us to act as a technical-legal bridge, ensuring that the evidentiary foundation for a new ingredient—from its production process to its nutritional profile—is presented with the level of precision required to withstand institutional scrutiny.
Finally, we place a high priority on the protection of innovation through data exclusivity. Our focus extends to the strategic use of the Novel Food regulation’s provisions to secure competitive advantages for partners who invest in high-quality safety data. By pinpointing the intersection between scientific excellence and intellectual property, we ensure that the transition toward a more sustainable food system is built on a foundation that is not only scientifically sound but also legally and commercially resilient.
PROVEN IMPACT: FROM LAB TO SHELF READINESS
Our contribution to flagship European projects demonstrates our focus on transforming scientific discovery into legally recognized nutritional assets through specific operational benchmarks:
Mapping Market Entry Requirements:
We provided the technical-legal framework for four target microalgae species within the ProFuture consortium, assisting industrial partners in identifying the path to legal certainty for product reformulation across the EU.
Investigating Simplified Authorization Procedures:
We focused on the requirements for traditional foods from third countries during the CAMELMILK project, establishing the framework necessary for Mediterranean smallholders to access the European market.
Contributing to Evidence-Based Policy Briefs:
As a technical contributor to the Horizon4Proteins cluster, we assisted in identifying the regulatory hurdles facing alternative proteins to inform the strategic dialogue on the European dietary shift.
ESTABLISHING A FOUNDATION FOR MARKET ENTRYS
By collaborating with WIISE, a consortium integrates a perspective dedicated to ensuring that scientific excellence results in a legally viable nutritional product. We provide the technical-legal assessment necessary to address the complexities of introducing innovative ingredients into a highly regulated market. Our role is to ensure that the evidentiary foundation of a project is aligned with institutional expectations, allowing for a transparent and credible transition from the laboratory to the public market.
How can your consortium leverage collaborative regulatory strategies to translate scientific breakthroughs into legally authorized food assets?
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