REGULATORY READINESS IN AQUAFEED INNOVATION: BRIDGING NUTRITION, POLICY AND PRACTICE

Introduction:

Aquafeed innovation is increasingly shaped by sustainability goals and the search for alternatives to traditional protein sources such as fishmeal. New ingredients — including agro-industrial by-products, insect meals, microalgae, single cell proteins (SCPs), and fermentation-derived biomass — offer promising nutritional and environmental advantages. However, their integration into commercial aquafeeds is often constrained by regulatory bottlenecks and unclear legal classifications under the European Union feed legislation.

One key barrier lies in the classification of feed ingredients within the EU regulatory framework. While placing a new feed material on the market may not require EFSA evaluation, this changes when the product is either considered a feed additive — subject to mandatory EFSA authorisation — or may be interpreted as a “novel” feed material under current regulatory practice, due to lack of historical use or innovative processing. Although no formal EU definition of “Novel Feed” exists, such cases will trigger an EFSA authorisation process. In both cases, authorisation processes can be complex and time-consuming, delaying innovation in feed formulation.

This presentation draws on internal formulation work conducted at SPAROS during the CIPROMED project, sharing lessons learned from the screening and evaluation of novel ingredients under real-world regulatory and nutritional constraints. The approach aligns with CIPROMED’s mission to valorise local biomass and develop circular, sustainable protein sources within Mediterranean food systems.

Internal approach

 To contextualize regulatory constraints, it is important to distinguish two common bottlenecks: (1) ingredients not listed in the EU Catalogue of Feed Materials (Reg. (EU) 68/2013) for aquaculture species — which may be permitted for terrestrial animals but not for fish — and (2) ingredients without documented history of use in aquafeed, or which involve new production processes, thus triggering additional legal scrutiny.

A structured, practice-oriented screening process was implemented to support internal ingredient triage and early-stage formulation planning, aiming to reduce regulatory and technical risk. Although scientific assessment typically begins with nutritional suitability, regulatory feasibility was screened early in this case to avoid investment in ingredients unlikely to reach market approval. The process included five sequential filters:

 (1) Regulatory status (Catalogue listing, Registration process (if new ingredient), species and substrate restrictions); (2) Nutritional suitability (composition, literature-based digestibility, anti-nutritional factors); (3) Feed safety (compliance with legal undesirable substances thresholds); (4) Technical feasibility (process compatibility, ingredient stability); (5) Strategic relevance (alignment with sustainability and product innovation goals).

Ingredient performance modelling was supported by FEEDNETICS™, a nutritional simulation tool that estimates growth and nutrient retention using user-defined inputs such as feed intake, digestibility coefficients, proximate composition, fatty acid, and amino acid composition. This supported decision-making when in vivo data were limited or unavailable.

Results and Discussion
This framework enabled risk-based  screening in early formulation stages:

• Oriental fruit fly larvae (Bactrocera dorsalis) reared on mixed vegetal waste:
  This ingredient shows promising nutritional value but is currently not authorised under Regulation (EU) 2017/893, which limits insect feed use to specific species and approved substrates. Both the insect species and the vegetal substrate fall outside current regulatory allowances. However, this case underscores the importance of aligning insect rearing practices with existing approvals or supporting novel applications through EFSA dossiers.
  (Filters 1 and 5 – Regulatory status, Strategic relevance)
• Mediterranean fruit fly (Ceratitis capitata) larvae reared on olive pomace:
  Olive pomace is a sustainable agro-industrial by-product, widely studied and legally acceptable as a substrate. However, this insect species is not among the seven approved for feed use in aquaculture. Historical data on its safe use is lacking, which would necessitate a full EFSA safety assessment under Regulation (EC) 767/2009 before commercial inclusion. This highlights an opportunity for further research and regulatory engagement. (Filters 1, 2, and 3 – Regulatory status, Nutritional suitability, Feed safety)
• Schizochytrium sp., dried biomass:
  Both dried and fermented biomass forms are listed as feed materials in the EU Catalogue (e.g. 13.1.5) and can be used in aquafeeds under general feed law. Oil extracts — such as those commercialised in the aquafeed market — are treated as feed materials, not feed additives, and thus do not require pre-market EFSA authorisation. Their inclusion depends on meeting safety criteria (e.g. contaminant limits) and being properly labeled. These products represent successful examples of regulatory-compatible innovation in DHA supplementation. (Filter 1 – Regulatory status; Filter 2 – Nutritional suitability)
• Spirulina (Arthrospira platensis):
  A well-established microalga in aquafeeds, Spirulina is listed in the EU Feed Catalogue and supported by extensive research confirming its nutritional and antioxidant properties. As aquafeed innovation evolves, claims beyond nutrition (e.g., immune modulation) or use of novel strains or extraction techniques may require further validation.  (Filters 1, 2, and 4 – Regulatory status, Nutritional suitability, Technical feasibility)
• Yeast-based SCP (Cyberlindnera jadinii):
  A non-GMO protein-rich biomass already present in the EU Feed Catalogue (sections 13.8.1 and 13.8.3), and widely used in commercial aquafeeds. Its established safety, nutritional value, and processing consistency position it as a low-risk ingredient for inclusion in formulation pipelines.  (Filters 1, 2, and 4 – Regulatory status, Nutritional suitability, Technical feasibility)

This approach helped avoid investment in ingredients with low regulatory feasibility and supported early alignment between legal, nutritional, and technical considerations.

Conclusion
A paradox emerges: ingredients with the highest sustainability and circularity potential — such as insect meals on alternative substrates or agro-industrial residues — are often the most constrained by regulatory frameworks. By integrating legal feasibility into early-stage formulation, this framework improves internal decision-making and enhances support for clients developing experimental feeds. These insights directly support CIPROMED’s mission to foster responsible innovation and valorise underused biomass in Mediterranean aquaculture systems.