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Hi there! 

Welcome to the Spring 2026 edition of Argenta Regulatory Insights.
In this issue, we bring you a concise overview of the most important regulatory developments shaping the food and feed sector across the UK, EU, and US, along with key scientific and technical insights to support your strategic decisions.

Matthew Stober_small

Hi!
I’m pleased to welcome you to the Spring 2026 edition of Argenta Regulatory Insights. As the regulatory landscape continues to evolve across the UK, EU and US, staying ahead of emerging expectations is more important than ever.
In this issue, we share key developments and insights to support your strategic decision-making in an increasingly complex and fast-moving environment.

Best regards,
Matthew Stober
CEO, Argenta


Newsletter Section - Regulatory Signals (6)

Key Regulatory Signals 

Several developments this month may affect companies preparing regulatory submissions or managing authorised products:

    • The UK will align most of its food chain assessments with EU, and will no longer require independent UK applications
    • Botanical and flavouring substances are receiving increased safety scrutiny
    • EFSA continues to expand its digital regulatory tools and scientific methodologies
    • Discussions in the United States could lead to greater oversight of self-affirmed GRAS ingredients

Understanding these shifts early can help companies anticipate regulatory expectations and avoid delays in authorisation processes.  



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Key regulatory developments in UK, EU and US - affecting food and feed regulatory strategy 

Regulatory frameworks across the food and feed sectors continue to evolve rapidly. From tightening scientific expectations in feed additive dossiers to emerging regulatory pathways for microbial products and growing discussions around GRAS oversight in the United States, companies operating in this space face an increasingly complex landscape.
In this edition, we highlight key developments shaping regulatory strategy across the UK, EU and US, and explore the role of short-term toxicology studies in feed additive safety assessment.

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United Kingdom Regulatory Developments


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UK–EU SPS Alignment: Implications for GB Authorisations

The proposed UK–EU Sanitary and Phytosanitary (SPS) Agreement marks a significant step in aligning UK food and feed regulation with EU standards. Beyond trade facilitation, this alignment will reshape how companies approach authorisations in Great Britain.
Since Brexit, UK legislation has diverged from EU rules only minimally. The agreement signals a move toward dynamic alignment, covering food and feed safety, food supplements, fortified foods, novel foods, nutrition claims, and broader agrifood standards including organics, marketing standards, and pesticide/biocide regulation.

Implications for industry:

    • Reduced need for parallel GB submissions: EU-authorised products will automatically gain access to GB once agreement is in place (expected mid-2027)
    • EFSA-standard dossiers as baseline: EU-compliant data packages may increasingly satisfy GB regulatory expectations.
    • Post-authorisation obligations: EU-style reporting and compliance measures may extend to GB.

Strategic considerations:

    • Ensure EU dossiers are aligned with EFSA guidance.
    • GB will accept EU outcomes
    • Identify products that could face disruption if GB–EU alignment accelerates.

While alignment promises smoother trade and reduced duplication, short-term uncertainty remains, particularly for ongoing applications and category-specific requirements.
Companies investing in robust EU dossiers may benefit from a dual-market advantage as the UK framework converges with EU SPS legislation.
Official source: UK–EU SPS Agreement: Legislation in Scope

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Botanicals and flavouring substances under review 

Botanical preparations and flavouring compounds are also attracting increased regulatory attention. A recent entry in the UK Risk Analysis Issues Register concerning preparations containing eugenol and related substances illustrates the growing focus on these categories.
Regulators are paying closer attention to issues such as:

    • User exposure through inhalation
    • Impurity profiles
    • Toxicological justification for complex botanical mixtures

Why it matters
Companies marketing botanical-derived feed additives should ensure that their dossiers clearly address user safety and compositional characterisation, particularly where natural extracts contain multiple bioactive compounds.

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Advisory Committee and Toxicology Oversight  

Recent and upcoming meetings of theAdvisory Committee on Animal Feeding stuffs and the Committee on Toxicology continue to shape scientific evaluation approaches in the UK. 

In parallel, the FSA and FSS have evaluated and incorporated several EFSA technical guidance documents published since 2021 into the domestic assessment framework. Discussions reflect increased scrutiny of exposure scenarios, user safety and methodological alignment with EU standards, reinforcing the need for robust and well-structured technical justifications in new and renewal applications.

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Cobalt(II) Compounds – Provisional Authorisation Consultation 

Food Standards Scotland consulted on a two-year provisional authorisation for four cobalt(II) compounds used in feed.

This development follows EFSA’s identification of consumer safety data gaps in its assessment of cobalt at EU level, indicating coordinated scientific attention across jurisdictions and suggesting that trace element additives may face enhanced data requirements, particularly regarding consumer exposure modelling and long-term safety.

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Updated Guidance on Advertising Non-Medicinal Veterinary Products

Veterinary Medicines Directorate updated its guidance clarifying advertising rules for non-medicinal veterinary products.

Given the sensitivity of claims at the boundary between feed additives and veterinary medicines, companies should review product positioning and marketing language to reduce classification risk.

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Precision Breeding - New Marketing Authorisation Route

The Genetic Technology (Precision Breeding) Regulations 2025 entered into force in November 2025, enabling businesses in England to apply for marketing authorisation of Precision Bred Organisms (PBOs) for food and feed use.

Applicants must first obtain confirmation and a marketing notice from Defra before submitting an application to the FSA.

Although the regulations apply to England, the UK Internal Market Act 2020 permits authorised products to circulate in Wales and Scotland. The introduction of this new pathway represents a structural development in the UK regulatory landscape and provides a defined route for gene-edited food and feed products, while maintaining case-by-case safety assessment requirements.

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Cell-Cultivated Products - Safety Guidance Published  

In December 2025, the FSA published the UK’s first industry guidance for cell-cultivated products under the Novel Foods framework. The guidance addresses regulatory considerations for taste trials conducted during development, confirms that cell-cultivated products are classified as products of animal origin, and outlines expectations relating to allergenicity and nutritional assessment.

This publication provides greater clarity for developers operating within the FSA’s CCP Sandbox programme, which remains active until 2027, and signals increasing regulatory maturity in the oversight of alternative protein technologies. 

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European Union Regulatory Developments


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A busy pipeline for feed additives and renewal activity

The EU continues to process a large number of feed additive authorisations and renewals, reflecting both the maturity of the regulatory system and the increasing complexity of dossiers.
For many companies, the most immediate challenge is the preparation of renewal applications, which must demonstrate compliance with current scientific standards, even where the original authorisation dates back many years.

Why it matters
Renewal dossiers are no longer simple updates. Companies should expect to provide new scientific data, updated safety assessments, and modern characterisation methods.

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SCoPAFF Discussions and Regulatory Pipeline

Standing Committee on Plants, Animals Food and Feed discussions during this period covered draft feed additive regulations, feed labelling terminology and disease-related Implementing Decisions. 

Monitoring SCoPAFF agendas remains one of the most effective ways to anticipate upcoming regulatory changes before formal adoption. 

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Chemicals Policy Interface  

European Chemicals Agencyactivity included committee updates, workshops and ongoing discussions related to CMR classifications. 

Developments in chemicals policy increasingly intersect with feed additive risk assessment, particularly in relation to user safety classification and occupational exposure considerations.

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EFSA Stakeholder Community Updates

EFSA has recently shared several initiatives aimed at improving its digital tools, data submission processes and statistical methodologies. These updates were discussed within the EFSA Stakeholder Community and may be relevant for companies preparing regulatory applications.

Key topics include consultations on EFSA’s digital platforms (Open.EFSA and Connect.EFSA), feedback on new data submission templates used by laboratories, and proposed stakeholder support actions for 2026 such as e-learning resources and guidance on common application shortcomings.
EFSA has also launched a consultation on improvements to its Benchmark Dose (BMD) statistical tool, which is widely used in toxicological risk assessments.

Why it matters:
Although these initiatives are still at the consultation stage, they may influence how applicants prepare dossiers, submit data, and interact with EFSA’s digital systems in the future.

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Animal Health and Trade Measures  

Recent animal disease outbreaks have triggered emergency measures affecting the movement of animals and certain animal products across Europe. Such measures can have knock-on effects for feed supply chains and the availability of animal-derived ingredients.

At the same time, regulatory discussions continue around international trade agreements and sanitary measures, including negotiations related to EU–Mercosur trade and the evolving regulatory relationship between the EU and the UK.

These developments underline the importance of monitoring both scientific and policy-driven regulatory changes in the sector.

 

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United States Regulatory Developments


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Ongoing Discussions on Animal Food Ingredient Oversight 

Regulatory discussions in the United States continue to focus on the pathways used to evaluate and authorise animal food ingredients.

At the latest meeting of the Association of American Feed Control Officials (AAFCO), regulators and industry stakeholders discussed several initiatives that may influence future regulatory processes, including:

    • Updates and guidance related to the Scientific Review of Ingredient Submissions (SRIS) pathway. Materials from the recent SRIS workshop are available online https://www.youtube.com/watch?v=Enff1CYUk3Q&t=2s
    • Proposed updates and checklist development for the Comprehensive Feed Labelling Guide, which is currently undergoing revision.
    • Discussions on a strategic plan to strengthen and retain animal feed regulators, including the development of training resources.
    • A Medicated Feed Labelling Workshop, planned for 25 August 2026 during the AAFCO Annual Meeting.
    • Continued development of the Animal Food Ingredient Consultation (AFIC) program.
    • Expansion of the Animal Food GRAS Notification Inventory.
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Developments Concerning the GRAS Pathway 

Policy discussions are also continuing regarding the future of the Generally Recognized as Safe (GRAS) framework, which currently allows companies to determine the safety of certain food and feed ingredients without mandatory pre-market review by the U.S. Food and Drug Administration (FDA).

Following a directive issued in March 2025 by the U.S. Secretary of Health and Human Services, Robert F. Kennedy Jr., the FDA has been tasked with developing a proposed rule aimed at eliminating the self-affirmed GRAS pathway. Under the anticipated proposal, companies would be required to notify the FDA of GRAS determinations prior to marketing new ingredients.

Although the proposed rule has not yet been released publicly, a draft was submitted in late 2025 to the White House Office of Management and Budget (OMB) for review. Until the proposal is formally published, uncertainty remains regarding the potential scope of the changes and whether transition periods or other implementation provisions will be included.

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Animal Food Ingredient Consultations (AFIC)

The Animal Food Ingredient Consultation (AFIC) program, launched in October 2024, is now recognised by AAFCO as a pathway for introducing new ingredient definitions or modifications into Chapter 6 of the AAFCO Official Publication through the Ingredient Definition Committee (IDC) review process.

As of the latest update, no new AFIC submissions have been filed or completed since November 2025, according to the AFIC inventory.

Why it matters

These discussions signal potential changes to how animal food ingredients are evaluated and authorised in the United States. Companies developing new ingredients should monitor developments closely, particularly those related to GRAS determinations and evolving regulatory review pathways.


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Technical Insight
The role of 14-day toxicology studies in feed additive safety evaluation

Why 14-Day Toxicology Studies Matter?
The 14-day repeat-dose toxicity study is a cornerstone in ensuring the safety of feed additives. This early-stage study is essential for supporting dossier submissions, guiding dose selection and maintaining high standards of animal welfare. 



Newsletter section - IPIFF partnership

Industry and Company updates

IPIFF and Argenta join forces to accelerate innovation in insect-based animal health and nutrition products and human nutrition products

Argenta and IPIFF have formed a strategic partnership to advance insect-based solutions for animal and human nutrition.
By combining regulatory, scientific, and sector expertise, the collaboration supports efficient approval pathways, including EFSA and EMA. The goal is to bring safe, sustainable, and validated innovations to market faster.



Upcoming Argenta-Hosted Events
Discover our upcoming conferences and workshops designed and hosted by Argenta experts.


Where to meet us this spring

 This spring,  Argenta will be present at key industry events across Europe. Our team will be delighted to connect, exchange insights, and explore opportunities to collaborate.
You can meet us at: 

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IFW 2026 - Insects to feed the world

9 - 12 June 2026
Turin, Italy 

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The 19th Annual International Scientific Conference on Probiotics, Prebiotics, Gut Microbiota and Health - IPC2026

22 - 24 June 2026
Krakow, Poland

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The 16th EAVPT Congress 2026 - International Congress of the European Association for Veterinary Pharmacology and Toxicology

28 June - 1 July 2026
 Thessaloniki, Greece

This Newsletter reflects the collective efforts of Argenta's Regulatory Team including Laura Payo, Rocío Duchén Bocángel, Agapi Lazaridi, Ana Martin, and Laia Espinas, whose input is gratefully acknowledged. 

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For further information or regulatory support, feel free to contact our regulatory affairs team.