Argenta Spring 2026 Newsletter

Several EFSA Guidance updates are affecting companies preparing for EU food and feed submissions.
Here is what has changed - and what you should do next.

EFSA's new Catalogue of Guidance Documents centralises all current and historical guidance in one searchable platform.
What this means: Pre-submission planning just got more efficient.
Revision of the Target Animal Safety (TAS) guidance and requirements for reporting silage efficacy studies
What this means: If you have feed additive studies in progress, review your study designs against the updated requirements now to avoid costly amendments.
EFSA published a revised guidance for food additive applications.
What this means: Applicants should re-check data requirements before submission - non-compliance triggers clock-stop requests that add months to your timeline.
The draft PARNUTs guidance signals more structured, evidence-driven applications in the EU
What this means: If you are developing a PARNUTs application, begin aligning your clinical data strategy to the new framework early.

Omnibus Simplification

A series of public consultations were opened in May 2026 on the Omnibus simplification package. The proposed changes are significant for any company managing authorisations in the EU:

Renewals become more focused: the automatic 10-year renewal cycle is proposed to be removed for most feed additives, but retained for certain categories such as coccidiostats and histomonostats.
Authorisation changes get simpler: changes to the authorisation holder shift to an administrative notification, with updates reflected directly in the Feed Additive Register.
Targeted modifications become possible: for non-holder-specific authorisations, operators can request changes to use conditions with focused supporting data, rather than a full new application.
Technical updates become easier: EURL reports and, where needed, additional EFSA data requests can support updates to existing authorisations.
Labelling gets more flexible: the proposal introduces greater flexibility in feed additive labelling rules.

Behind the Scenes: a feed / food additive application journey through EFSA

EFSA's handling of food and feed additive applications has become significantly more transparent under Regulation (EU) 2019/1381 — but that transparency cuts both ways. Companies gain greater visibility into dossier progress, while submission quality and confidentiality claims face far greater scrutiny.

In practice, the process begins with EFSA's completeness check after the European Commission forwards a dossier via e-FSCP.

Within roughly 30 days, EFSA verifies data completeness, confirms study notification compliance, and may request missing information.

Once validated, the scientific assessment begins - with confidentiality assessed in parallel. Unsupported redaction claims are increasingly challenged.

Catalogue of EFSA Guidance Documents

EFSA's new Catalogue of Guidance Documents consolidates all guidance into a single, searchable platform - covering current, transitional, and obsolete documents across food additives, feed additives, novel foods, and more.

A harmonised category classification system clarifies whether documents are cross-cutting or sector-specific.

For applicants, the practical impact is meaningful: centralised access reduces the risk of referencing outdated guidance, and clearer categorisation supports more robust dossier preparation.

The standardised development process for future guidance also improves predictability - a significant advantage for long-horizon product strategies.

US feed ingredients pathways: choosing the right route

The US regulatory landscape for animal feed ingredients is evolving, with important distinctions now emerging among AAFCO SRIS, FDA GRAS notices, AFIC, and Food Additive Petitions (FAPs).
The appropriate pathway is driven by the nature and availability of safety data, intended use, and claim type - and choosing the wrong route can cost years.

FDA is also developing an approach to zootechnical additives, which may open new opportunities for non-nutritional claims - but brings heightened regulatory risk, including environmental review.

At this time the FDA has applied animal drug classification with enforcement discretion, for example for methane reduction solutions.

Animal Nutrition

In the EU, the insect market remains tightly controlled. Processed animal protein derived from insects may only be produced from authorised species - including black soldier fly, housefly, yellow mealworm, lesser mealworm, silkworm, house cricket, banded cricket, and field cricket.

Use is also limited to specific animal categories: aquaculture, poultry, pigs, and pet food.

Substrates used to rear insects must meet EU requirements.

Innovation is expanding in feed additives for insects: EFSA has recently issued a positive opinion on a zootechnical application demonstrating improvements in honeybees.

Human Nutrition

In the EU, insect products are novel foods unless they have a recognised history of consumption. Authorisations have already been granted for specific forms and uses of yellow mealworm, lesser mealworm, migratory locust, and house cricket - with multiple additional applications in the pipeline.

These authorisations are product- and process-specific.

In our Barcelona office, we recently had the chance to try some surprisingly tasty cricket energy bars - a timely reminder that the distance from regulatory approval to consumer product is shorter than many assume.

Insect Protein in Animal Feed: Why Regulatory Strategy Matters

Insect-derived proteins are now a serious ingredient in animal nutrition - but regulatory complexity is increasingly what separates fast market entry from costly setbacks.

In the EU, commercialisation depends on species, substrates, processing conditions, and target animals - spanning feed materials authorisation, hygiene, animal by-products, and TSE regulations.

In the US, two new pathways - FDA's AFIC and AAFCO's SRIS - are reshaping market access, each with different implications for timelines, data disclosure, and regulatory certainty.

For insect producers, feed manufacturers, and investors, early regulatory feasibility assessment and a clear understanding of jurisdictional differences are no longer optional - they are a strategic advantage.

Can innovative feed additives replace antibiotics?

Reducing antimicrobial use (AMU) in livestock is a key EU priority, with a target of −50% by 2030.
New insights from the EU-funded AVANT Project suggest that while innovation is progressing, there is no single solution.

Promising - but limited impact

The project evaluated alternatives including fibre-based diets, microbiome approaches, and feed additives. Some showed positive results at farm level:

Faecal filtrate transplantation: approximately 1.9% AMU reduction
High-fibre diets (e.g. alfalfa): approximately 0.5% reduction

These gains are meaningful but fall well short of what is needed to meet EU targets.

Beyond additives

Nutrition alone will not solve the problem. The AVANT findings confirm that effective AMU reduction requires a combination of optimised feeding strategies, improved farm management, disease prevention and vaccination, and reduced weaning stress.

The regulatory reality

Some of the most promising innovations - including microbiome-based solutions - still face significant regulatory and scalability challenges, limiting their short-term adoption in the EU. Companies developing in this space should engage early with regulatory strategy to avoid late-stage obstacles.