THE CHALLENGE: THE “REGULATORY CEILING” OF INNOVATION

In the fields of biotechnology, circular economy, and functional foods, the greatest risk to innovation is not scientific failure, but regulatory obsolescence. Many research teams spend years developing a “breakthrough” only to discover that the resulting product cannot be legally sold in the EU because it lacks regulatory authorization (e.g. Novel Food food additive), fails to meet harmonised safety standards, or falls into a legal “grey zone” (such as the transition from waste to ingredient, including by-products and animal by-products). Without integrating legal constraints into the earliest stages of the R&D process, scientific results often lack the “policy-readiness” required for industrial scaling.

OUR APPROACH: VALIDATING INNOVATION IN REAL-TIME

By working in close synergy with research teams, we validate that scientific breakthroughs are grounded in the latest regulatory realities. We deliver the essential compliance frameworks and legal constraints that guide the innovation process, securing results that are “policy-ready,” commercially viable, and strategically positioned for industrial scaling from the very beginning.

We perform “Regulatory Scouting” alongside technical development, ensuring that every iteration of a product—from extraction method to final formulation—is optimized for future EFSA approval.

INNOVATION IN ACTION: LESSONS FROM OUR PROJECT PORTFOLIO

Our track record in multi-partner research initiatives proves that a “compliance-first” approach to innovation accelerates market entry:

Dismantling the “Regulatory Ceiling”

In the microalgae sector, scientific innovation in cultivation was insufficient. In the ProFuture project, we provided the legal architecture to transition breakthroughs from the lab to the shelf. By identifying gaps between research data and Qualified Presumption of Safety (QPS) requirements, we ensured that the consortium’s R&D efforts produced the exact toxicological evidence needed for Novel Food and other regulated products (e.g. food additives, food enzymes, food flavours) applications or notifications.

Defining Circular Architecture

In the EcoeFISHent project,our contribution turned biological “liabilities” into certified raw materials. Within this circular innovation cluster, we managed the interface between green extraction technologies (like skin protein recovery) and institutional validation. This ensured that the extraction process was designed from day one to comply with the dual requirements of ABP (Animal By-Products) legislation and cosmetic/food safety standards.

Establishing the Basis for Exportation

In the CAMELMILK project, we integrated R&D with specialized legal services to bridge the two Mediterranean shores. By applying the simplified procedure for traditional products from third countries under Reg. (EU) 2015/2283, we saved the research partners years of potential delays, transforming a “superfood” into a legally tradable asset in the EU.

Validating Digital Innovation

In the realm of digital innovation for the WASTELESS Project, we ensured that blockchain and AI monitoring systems were not just technically functional but met the stringent data integrity standards of JRC and Eurostat. This allowed the “innovation” to be immediately recognized as a trusted tool for official EU waste quantification.