Volume 13 Issue 3
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The Emerging Role of MicroRNAs: As Minimally Invasive Biomarkers in Animal Health Novel Clinical Syndrome in Pigs : And its Association with Fox Parvovirus Introduction Protecting Feed Value: Through Better Silage Management From Voluntary to Mandatory: What FDA’s Proposed GRAS Overhaul Means for Animal Feed
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CONTENTS 04 EDITORS LETTER RESEARCH/ INNOVATION/ DEVELOPMENT 06 The Emerging Role of MicroRNAs as Minimally Invasive Biomarkers in Animal Health MicroRNAs (miRNAs) have emerged as one of the most promising classes of minimally invasive biomarkers in animal health. Their potential as biomarkers therefore lies not only in their accessibility, but in their fundamental role in regulating the molecular mechanisms underlying disease. Dr. Vicky Strong of Synapse Animal Health Consultancy discusses these approaches could ultimately allow testing to move beyond centralised laboratories and into veterinary practice, contributing to more accessible, earlier disease detection and monitoring and, ultimately, supporting more informed clinical decision-making across veterinary medicine.
MANAGING DIRECTOR Mark A. Barker MANAGING EDITOR Alice Phillips alice@senglobalcoms.com EDITOR Melissa Cavner melissa@senglobalcoms.com RESEARCH AND CIRCULATION Carla Devine carla@senglobalcoms.com
10 The Missing Half of Nutrition: Why Delivery Matters as Much as Formulation For decades, nutrition research focused on what went into the feed. Far less attention was given to what happens after feed is consumed, where digestive processes, interactions among nutrients and biological variability all influence how much of a nutrient is ultimately used by the animal. Aidan Connolly of ArgiTech discusses how certain changes are shifting attention from formulation alone toward nutrient delivery: whether nutrients reach the right place, at the right time and in a form the animal can effectively use. Encapsulation has emerged as one of the more established responses, attracting investment across the industry rather than from any single company.
DESIGNER Jana Sukenikova www.fanahshapeless.com BUSINESS DEVELOPMENT Jerome D’Souza info@senglobalcoms.com FRONT COVER © istockphoto PUBLISHED BY Senglobal Ltd. 46 Plover Way, London, SE16 7TT, UK Tel: +44 (0) 2045417569 Email: info@senglobalcoms.com www.international-animalhealth.com International Animal Health Journal – ISSN 2752-7697 is published quarterly by Senglobal Ltd.
LIVESTOCK 14
Novel Clinical Syndrome in Pigs and its Association with Fox Parvovirus In 2024 there was an outbreak of ocular disease in weaned piglets on a farm. Initial diagnostic investigations were inconclusive. Increasing evidence points towards a causal relationship between presence of fox parvovirus in pigs and the observed clinical signs, despite the fact that not all postulates of Koch have yet been studied as well as many aspects of virus pathogeneses and routes of transmission. Tijs Tobias of Royal GD discusses that given the extensive spread in the Netherlands and into neighboring countries, it can be expected that the outbreak will continue and spread further into other European countries. COMPANION ANIMALS
The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.
16 Re-evaluating the Role of Amoxicillin Clavulanate Vs Narrow-Spectrum Agents
Volume 13 Issue 3 Autumn 2026 Senglobal Ltd.
The veterinary profession faces an urgent imperative to preserve antibiotic effectiveness for future generations. Akhter Rasool an Independent Veterinary Researcher discusses that while amoxicillin-clavulanate is an effective and important antimicrobial, its routine use for acute, uncomplicated infections in otherwise healthy animals is difficult to justify on pharmacological, ecological, or stewardship grounds. In this article Akhter outlines the five recommended changes needed in practice.
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CONTENTS 20 Why Veterinary Instrument Care Starts Before Sterilisation For veterinary practices and wider animal health facilities, this first step has both clinical and operational value. Prompt and consistent pre-cleaning helps reduce bioburden, protect instrument surfaces, support staff safety and improve the reliability of the full decontamination process. Juan De Paz-Lavalle of Chemist at MicroCare Medical discusses how precleaning helps reduce this risk by keeping contamination from drying onto the instrument surface before full cleaning begins. For many veterinary practices, this is particularly important because instrument reprocessing is managed as part of the daily clinical workflow rather than through a separate sterile services department. 24 Street-Cat Welfare: Urban Redevelopment Triage, Veterinary Coordination and Limits of Smell-Scale Rescue Urban redevelopment changes animal health through the loss of continuity. Food, shelter, observation and familiar movement routes can disappear before any injury is visible. Julie Choi of YongsanCats discusses how Humane response depends on connecting the stages that are often treated separately: field knowledge, triage, capture, veterinary assessment, recovery and a safe destination. Clinics need honest histories and workable discharge plans. Rescuers need clear medical guidance and realistic capacity. Municipalities need to count the labour and infrastructure that exist outside the procedure itself. FOOD AND FEED 28 From Voluntary to Mandatory: What FDA’s Proposed GRAS Overhaul Means for Animal Feed FDA is proposing the biggest change to the GRAS framework in decades. Under a proposed rule published
2 International Animal Health Journal
on 11 August 2026, companies would generally be required to notify the agency of new GRAS conclusions rather than deciding whether to do so voluntarily. Laura Payo of Agenta discusses that if the rule is finalised, this would bring greater transparency, enabling FDA to identify uses that may require food additive approval, detect potentially unsafe substances more quickly, confirm that GRAS conclusions are based on adequate scientific documentation and strengthen public confidence in its oversight of the food supply. 32 Protecting Feed Value Through Better Silage Management Corn silage, known as maize silage across Europe, is typically the largest component of the ration for dairy farms throughout the world. It’s also one of the largest investments, carrying the full cost of seed, fertiliser, fuel and labour. John Winchell of Alltech discusses that the better solution is to boost corn silage efficiency. Improving silage efficiency means protecting corn silage quality and reducing problems such as silage dry matter losses. Better corn silage efficiency doesn’t start with producing more maize — it starts with reducing silage dry matter losses and protecting corn silage quality. 36 Bringing Novel Foods to Market: A Guide to the EU, UK and US Regulatory Pathways Innovation in the food sector is accelerating rapidly. New protein sources, precision fermentation, algaebased ingredients, cultured meat, cell cultures, fungal mycelium, new plant-based foods and other innovative products are creating opportunities to bring new products to market and address sustainability challenges. Mari Eskola and Mari Lyyra of Medfiles discusses how companies that understand regulatory requirements and incorporate them into their development strategy from the outset will be better positioned to bring safe and innovative products to market successfully.
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EDITORS LETTER As the leaves begin to change, we welcome you to our third edition of IAHJ in 2026. We hope you enjoy reading all the hard work and research conducted by the great minds of the animal health industry. In this Autum issue it tackles the growing challenges the veterinary world is facing and how this sector of health generates greater visibility. Vicky Strong of Synapse Animal Health Consultancy explores how miRNAs participate directly in the regulatory networks that drive disease processes. As such, changes in their expression can precede clinical signs, offering the possibility of earlier disease detection. Moreover, because many miRNAs are tissue-specific and exhibit distinct expression patterns in different diseases, they can help pinpoint both the organ affected and the underlying pathological process. Vicky goes further to assert that the approaches outlined in the article could ultimately allow testing to move beyond centralised laboratories and into veterinary practice, contributing to more accessible, earlier disease detection and monitoring and, ultimately, supporting more informed clinical decision-making across veterinary medicine.
investigations were inconclusive. However, as veterinary practitioners reported similar observations during the spring of 2025, attention increasingly shifted toward an infectious causative pathogen. Tijs Tobias of Royal GD asserts that increasing evidence points towards a causal relationship between presence of fox parvovirus in pigs and the observed clinical signs, despite the fact that not all postulates of Koch have yet been studied as well as many aspects of virus pathogeneses and routes of transmission. Tijs states that Given the extensive spread in the Netherlands and into neighbouring countries, it can be expected that the outbreak will continue and spread further into other European countries. Laura Payo of Argenta examines how the FDA is not proposing to change what it takes to establish that a substance is Generally Recognised as Safe. The science remains the same. What would change is who needs to see that information and when. The proposal includes several exemptions that could limit its impact on ingredients already recognised through existing regulatory pathways. Even so, companies with self-affirmed GRAS ingredients will benefit from reviewing their portfolios and preparing supporting documentation well before a final rule is issued.
In late 2024, Royal GD was notified of an outbreak of ocular disease in weaned piglets on a farm. Initial diagnostic
Melissa Cavner, Editor
EDITORIAL ADVISORY BOARD Amanda Burkardt, MSc, MBA – CEO of Nutripeutics Consulting Germán W. Graff – Principal, Graff Global Ltd Fereshteh Barei – Health Economist & Strategy Advisor, Founder of BioNowin Santé Avenue Association Carel du Marchie Sarvaas Executive Director Health For Animals Kimberly H. Chappell – Senior Research Scientist & Companion Animal Product Development Elanco Animal Health Dr. Sam Al-Murrani – Chief Executive Officer Babylon Bioconsulting & Managing Director at Bimini LLC Sven Buckingham – Buckingham QA Consultancy Ltd. Dawn Howard – Chief Executive of the National Office of Animal Health (NOAH) Jean Szkotnicki – President of the Canadian Animal Health Institute (CAHI) Dr. Kevin Woodward – Managing Director KNW Animal Health Consulting 4 International Animal Health Journal
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The Emerging Potential of MicroRNAs as Minimally Invasive Biomarkers in Veterinary Medicine MicroRNAs (miRNAs) have emerged as one of the most promising classes of minimally invasive biomarkers in animal health. Over the past two decades, research has shown that these small regulatory RNAs are not only remarkably stable in blood and other biofluids, but also closely linked to disease processes. Their potential as biomarkers therefore lies not only in their accessibility, but in their fundamental role in regulating the molecular mechanisms underlying disease. Traditional biomarkers often reflect downstream consequences of disease, such as protein leakage, tissue damage, or metabolic disturbance. By contrast, miRNAs participate directly in the regulatory networks that drive disease processes. As such, changes in their expression can precede clinical signs, offering the possibility of earlier disease detection. Moreover, because many miRNAs are tissue-specific and exhibit distinct expression patterns in different diseases, they can help pinpoint both the organ affected and the underlying pathological process. MicroRNAs (miRNAs) are small (typically 20–24 nucleotide), non-coding RNA molecules, that play a critical role in posttranscription regulation of gene expression.1 MiRNAs were first discovered in 1993, when Victor Ambros and colleagues identified lin-4 in as encoding a small RNA capable of regulating developmental timing in the nematode, Caenorhabditis elegans by base pairing to the 3' untranslated region of lin 14 mRNA.2 Initially regarded as a nematode specific oddity, their broader significance became clear with the subsequent discovery of microRNA let 7 by Gary Ruvkun and colleagues, followed by the discovery that this miRNA was conserved across diverse animal species, including mammals.3 This finding established miRNAs as a fundamental, evolutionarily conserved component of gene regulation. As sequencing technologies advanced through the early 2000s, miRNAs were increasingly recognised as abundant, stable and deeply integrated into the fine-tuning of several biological processes including development, immunity, metabolism and disease pathogenesis. A pivotal turning point came in 2008, when Mitchell and colleagues demonstrated that circulating miRNAs are present and stable in human serum and plasma, despite exposure to conditions that would normally degrade RNA.4 This discovery established their potential as non-invasive biomarkers of disease and accelerated interest across biomedical fields. In human medicine, the feasibility and potential value of miRNA based diagnostics have been demonstrated across multiple disease areas. Circulating miRNA signatures are being actively explored for the early detection of cancer, with studies reporting promising diagnostic performance across case– control and validation cohorts.5,7 In cardiovascular disease, certain miRNAs have been shown to rise rapidly in plasma following myocardial injury and have been proposed as sensitive early markers of acute myocardial infarction. Several studies have reported that cardiac-associated miRNAs can be detected within hours 6 International Animal Health Journal
of symptom onset and may provide diagnostic information comparable with, or in some cases preceding, conventional cardiac biomarkers such as cardiac troponins.6–8 Distinct miRNA profiles have also been associated with autoimmune conditions and chronic inflammatory diseases, such as rheumatoid arthritis, systemic lupus erythematosus and inflammatory bowel disease, as well as exposure to environmental toxins such as tobacco smoke and air pollution. Collectively, these findings illustrate the diagnostic versatility of into miRNAs and provide a strong translational foundation for veterinary applications. Veterinary research in this area is expanding rapidly and already demonstrates clear potential across species. In canine myxomatous mitral valve disease (MMVD), stage-dependent changes in circulating miRNAs have been documented across cross pre-clinical disease and congestive heart failure with several miRNAs showing potential diagnostic and prognostic value.10–12 Distinct miRNA signatures have also been described in other companion animal conditions, including dilated cardiomyopathy, lymphoma, osteosarcoma and mammary carcinoma, with studies reporting disease-associated expression patterns and potential diagnostic or prognostic applications.13–16 Beyond companion animal medicine, early studies in horses have identified circulating and synovial microRNA profiles associated with osteoarthritis and laminitis,17–19 while work in livestock has explored miRNA profiles and their potential as biomarkers of infectious disease, mastitis and mycotoxin exposure.20–22 Collectively, these findings indicate that miRNA-based biomarkers are biologically plausible and analytically feasible across multiple veterinary species. Until recently, however, veterinary studies have focused predominantly on miRNA discovery and characterisation, identifying diseaseassociated changes in the expression of individual miRNAs or miRNA profiles. Data have largely been generated from single centre studies from small cohorts and focused on specific breeds. Furthermore, challenges such as the need for standardised sample handling and analytical workflows, adequately powered and well phenotyped validation cohorts and demonstration of clear clinical utility alongside existing diagnostics have, to date, limited scope for these findings to be translated into clinical use. Furthermore, the inherent complexity of miRNA biology adds an additional layer of difficulty to the development of clinically useful diagnostic tests. Individual miRNAs can regulate multiple genes within interconnected regulatory networks, while many are involved in pathways shared across inflammatory, metabolic and neoplastic diseases. Circulating miRNAs may also originate from multiple tissues and occur in different molecular forms and carriers, complicating interpretation of their biological source.23–24 Together with inter-individual variation and the limited disease specificity of many individual miRNAs, these factors suggest that diagnostic information may be more reliably captured by multimiRNA signatures or ‘fingerprints,’ than by individual miRNAs.23 The field is now moving into a new phase, in which the use of miRNA signatures as biomarkers of disease is becoming a potentially clinically feasible prospect. The integration Volume 13 Issue 3
RESEARCH/INNOVATION/DEVELOPMENT of machine learning and advanced predictive modelling represents an important development in addressing the complexity of miRNA biology. Recent veterinary studies have begun to apply these approaches to a range of companion and production animal diseases. In a multicentre, prospective study of 97 dogs, Palarea-Albaladejo et al. used a 15-miRNA serum panel combined with penalised logistic regression to discriminate dogs with MMVD from healthy controls (AUC 0.93; sensitivity 0.85; specificity 0.82).24 Preliminary data also indicate that miRNA profiles can distinguish cats affected by hypertrophic cardiomyopathy (HCM) from healthy controls (sensitivity 0.89; specificity 0.77; AUC 0.88).25 Further preliminary data indicate that miRNA profiles can distinguish dogs with dilated cardiomyopathy (DCM; n=34) from healthy controls (n=42) (AUC 0.96; sensitivity 0.94; specificity 0.86), and earlystage (stage B) cardiac disease, comprising DCM and MMVD, from healthy controls (AUC 0.98; sensitivity 0.97; specificity 0.79)26 Notably, the panel also differentiated DCM from MMVD despite shared pathological pathways between the two diseases. This suggests that multi-miRNA signatures may capture disease-specific biological differences and could potentially provide information beyond disease detection alone. Beyond cardiac disease, miRNA expression has also been investigated as a diagnostic biomarker for canine urothelial (transitional cell) carcinoma. When combined with detection of the BRAF mutation, miRNA profiling improved diagnostic performance, achieving an AUC of 0.88, with 0.88 sensitivity and 0.78 specificity.27 Looking ahead, advances in multi-omics integration are likely to broaden the application of miRNAbased diagnostics in veterinary medicine. Combining miRNA profiles with genomic, proteomic and metabolomic data may provide a more comprehensive understanding of disease processes and improve the discriminatory power of biomarker models. These developments may ultimately support precision medicine approaches in veterinary practice, with applications in areas across a variety of diseases, species and contexts. Much of the emerging veterinary evidence has been generated through work by MI:RNA, a spin-out from Scotland’s Rural College (SRUC), alongside collaborations with academic and clinical groups. Further preliminary studies have explored the potential application of miRNA profiling to canine heartworm disease,28 while ongoing work is investigating the application of miRNA profiling to companion animal chronic kidney disease, anxiety, osteoarthritis and haemangiosarcoma in companion animals. This work also extends to production animal health, where earlier detection may have implications for animal welfare, productivity and disease control. In a preliminary study of Johne's disease, a chronic and economically significant enteritis of cattle caused by Mycobacterium avium subspecies paratuberculosis (MAP), Capewell et al. measured 24 circulating miRNAs in serum from MAP positive (n=66) and MAP negative (n=65) cattle and applied machine learning to identify an optimal diagnostic classifier.29 These findings provide an early indication that miRNA profiles may have value in diseases where existing diagnostic approaches are constrained by limited sensitivity, while also demonstrating the applicability of the approach beyond companion animal medicine. Much of this progress has been made possible by advances in the laboratory methods needed to make miRNA testing reliable and reproducible. MI:RNA’s development and evaluation of workflows for miRNA extraction and detection across multiple sample types, including blood, milk and urine, has provided a foundation for applying these approaches across different species and clinical settings. This cross-matrix www.international-animalhealth.com
flexibility is particularly important in veterinary practice, where the choice of sample is often determined by species, context and practicality rather than an ideal analytical preference. Establishing this level of assay robustness and reproducibility has been a critical prerequisite for translating the discoveryphase findings described above into commercially viable diagnostics. It also provides a framework that other groups in the field are likely to adopt as the sector continues to mature. Furthermore, by combining standardised sample-handling and extraction protocols with a proprietary machine learning interpretation model, this work also demonstrates progression beyond single-analyte detection towards a scalable diagnostic platform capable of supporting multiplexed testing. The recent development of robust platforms capable of measuring multiple miRNAs, alongside machine learning and advanced predictive modelling, has brought their use as disease biomarkers closer to clinical application. The ability to translate this multiplexed approach into rapid, near-patient testing using minimally invasive samples would represent an important milestone in the development of miRNAbased diagnostics, marking a shift from biomarker discovery towards real-world clinical application. These approaches could ultimately allow testing to move beyond centralised laboratories and into veterinary practice, contributing to more accessible, earlier disease detection and monitoring and, ultimately, supporting more informed clinical decision-making across veterinary medicine. REFERENCES 1.
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O’Brien J, Hayder H, Zayed Y, Peng C. Overview of MicroRNA Biogenesis, Mechanisms of Actions, and Circulation. Front Endocrinol 2018;9:402. https://doi.org/10.3389/ fendo.2018.00402. Lee RC, Feinbaum RL, Ambros V. The C. elegans heterochronic gene lin-4 encodes small RNAs with antisense complementarity to lin-14. Cell 1993;75:843–854. https://doi. org/10.1016/0092-8674(93)90529-Y. Reinhart BJ, Slack FJ, Basson M, Pasquinelli AE, Bettinger JC, Rougvie AE, Horvitz HR, Ruvkun G. The 21-nucleotide let-7 RNA regulates developmental timing in Caenorhabditis elegans. Nature 2000;403:901–906. https://doi.org/10.1038/35002607. Mitchell PS, Parkin RK, Kroh EM, Fritz BR, Wyman SK, PogosovaAgadjanyan EL, Peterson KP, Noteboom J, O'Briant KC, Allen A, Lin DW, Urban N, Drescher CW, Knudsen BS, Stirewalt DL, Gentleman R, Vessella RL, Tewari M. Circulating microRNAs as stable blood-based markers for cancer detection. Proc Natl Acad Sci USA 2008;105:10513–10518. https://doi.org/10.1073/ pnas.0804549105. Nguyen THN, Nguyen TTN, Nguyen TTM, Nguyen LHM, Huynh LH, Phan HN, Nguyen HT. Panels of circulating microRNAs as potential diagnostic biomarkers for breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat 2022;196:1– 15. https://doi.org/10.1007/s10549-022-06728-8. D’Alessandra Y, Devanna P, Limana F, Straino S, Di Carlo A, Brambilla PG, Rubino M, Carena MC, Spazzafumo L, De Simone M, Micheli B, Biglioli P, Achilli F, Martelli F, Maggiolini S, Marenzi G, Pompilio G, Capogrossi MC. Circulating microRNAs are new and sensitive biomarkers of myocardial infarction. Eur Heart J 2010;31:2765–2773. https://doi.org/10.1093/eurheartj/ehq167. Witwer KW. Circulating microRNA biomarker studies: pitfalls and potential solutions. Clin Chem 2015;61:56–63. https://doi. org/10.1373/clinchem.2014.221341. Wu Y, Li Q, Zhang R, Dai X, Chen W, Xing D. Circulating microRNAs: biomarkers of disease. Clin Chim Acta 2021;516:46–54. https:// doi.org/10.1016/j.cca.2021.01.008. Kimura M, Kothari S, Gohir W, Camargo JF, Husain S. MicroRNAs in infectious diseases: potential diagnostic biomarkers and therapeutic targets. Clin Microbiol Rev 2023;36:e00015-23. International Animal Health Journal 7
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F, Stucke D, Minero M. Circulating miR-23b-3p, miR-145-5p and miR-200b-3p are potential biomarkers to monitor acute pain associated with laminitis in horses. Animal 2018;12:366–375. https://doi.org/10.1017/S1751731117001525. Kappari L, Dasireddy JR, Applegate TJ, Selvaraj RK, Shanmugasundaram R. MicroRNAs: exploring their role in farm animal disease and mycotoxin challenges. Front Vet Sci 2024;11:1372961. https://doi.org/10.3389/fvets.2024.1372961. Tzelos T, Ho W, Charmana VI, Lee S, Donadeu FX. MiRNAs in milk can be used towards early prediction of mammary gland inflammation in cattle. Sci Rep 2022;12:5131. https://doi. org/10.1038/s41598-022-09214-9. Lai YC, Fujikawa T, Maemura T, Ando T, Kitahara G, Endo Y, Yamato O, Koiwa M, Kubota C, Miura N. Inflammation-related microRNA expression level in the bovine milk is affected by mastitis. PLoS One 2017;12:e0177182. https://doi.org/10.1371/ journal.pone.0177182. Backes C, Meese E, Keller A. Specific miRNA disease biomarkers in blood, serum and plasma: challenges and prospects. Mol Diagn Ther 2016;20:509–518. https://doi.org/10.1007/s40291016-0221-4. Palarea-Albaladejo J, Bode EF, Partington C, Basili M, Mederska E, Hodgkiss-Geere H, Capewell P, Chauché C, Coultous RM, Hanks E, Dukes-McEwan J. Assessing the use of blood microRNA expression patterns for predictive diagnosis of myxomatous mitral valve disease in dogs. Front Vet Sci 2024;11:1443847. https://doi.org/10.3389/fvets.2024.1443847. Hanks E, Coultous R, Capewell P, Palarea-Albaladejo J, DukesMcEwan J. Application of a novel microRNA platform to cardiac disease diagnoses in companion animals. Poster presented at American College of Veterinary Internal Medicine (ACVIM) Forum; June 19-21,2025; Louisville, Kentucky. Dukes-McEwan J, Palarea-Albaladejo J, Bode EF, Partington C, Basili M, Mederska E, Hodgkiss-Geere H, Capewell P, Coultous RM, Hanks E. Novel microRNA profiling for the detection of canine dilated cardiomyopathy. Poster presented at Veterinary Cardiovascular Society Autumn Meeting; November 6-8 2025; United Kingdom. Hanks E, Capewell P, Singh A, Coultous R. Diagnostic performance of combined microRNA and cell-free DNA biomarkers in canine urothelial carcinoma. Presentation at American College of Veterinary Internal Medicine (ACVIM) Forum; June 11–13, 2026; Seattle, Washington. Coultous R, Soca A, Turnbull F, Capewell P, Albanese F, Hanks E. MicroRNA biomarkers as a potential novel diagnostic tool for canine heartworm disease. Poster presented at American College of Veterinary Internal Medicine (ACVIM) Forum; June 11–13, 2026; Seattle, Washington. Capewell P, Lowe A, Athanasiadou S, Wilson D, Hanks E, Coultous R, et al. Towards a microRNA-based Johne's disease diagnostic predictive system: preliminary results. Vet Rec 2024:e4798. https://doi.org/10.1002/vetr.4798.
Dr. Vicky Strong Dr. Vicky Strong MRCVS is a Clinical Associate Professor at the University of Nottingham School of Veterinary Medicine and Science. She holds a BSc (Hons) in Veterinary Pathology and a Doctorate in Veterinary Medicine (DVetMed). Dr Strong is co-founder of Synapse Animal Health Consultancy, which brings together veterinary and scientific expertise, strategic communication and education, to support organisations working across animal health. Dr Strong works with MI:RNA as a Consultant in Clinical Education and Engagement in the Business Development team.
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International Animal Health Journal 9
RESEARCH/INNOVATION/DEVELOPMENT
The Missing Half of Nutrition: Why Delivery Matters as Much as Formulation The livestock industry has become exceptionally good at formulating diets. Better ingredients, improved genetics and more precise formulation have transformed animal nutrition over the past half-century. Yet two animals consuming the same diet can still perform very differently. The challenge has expanded beyond formulation. Nutrients still need to survive manufacturing and digestion before reaching the site where they can be effectively absorbed and utilised. For decades, nutrition research focused on what went into the feed. Far less attention was given to what happens after feed is consumed, where digestive processes, interactions among nutrients and biological variability all influence how much of a nutrient is ultimately used by the animal. The importance of that process is becoming harder to ignore. Ingredient costs remain volatile (Morciani, 2026), sustainability expectations are tightening (Place, 2024), heat stress is becoming a more persistent production challenge (Mangan & Siwek, 2024) and antibiotics are steadily being withdrawn from feed (European Medicines Agency, 2021). At the same time, sensors, biological monitoring and AI-driven analytics provide a much clearer picture of what happens inside the animal (Michelena et al., 2025). Together, these changes are shifting attention from formulation alone toward nutrient delivery: whether nutrients reach the right place, at the right time and in a form the animal can effectively use. Encapsulation has emerged as one of the more established responses, attracting investment across the industry rather than from any single company. A growing body of published research suggests that nutrient delivery is becoming an important part of precision nutrition. Why 'More' Stopped Working The traditional response to unpredictable nutrient losses has been to over-formulate: adding more vitamins or minerals than the animal needs as a hedge against pelleting losses, storage instability and gastric degradation. That insurance is not free. Every percentage point of surplus adds cost without guaranteeing a return, and margins designed solely to offset degradation accumulate quickly across the volumes handled by a commercial feed mill. The pattern is not specific to any one company's technology: reviews of trace mineral bioavailability more broadly note that cheaper inorganic sources are also less bioavailable, which has historically encouraged higher inclusion rates simply to compensate (Byrne & Murphy, 2022). Over-formulation also carries biological and environmental trade-offs. Less bioavailable nutrient sources can increase mineral excretion without a corresponding improvement in animal performance, while excess nutrients that are not absorbed simply represent additional cost and environmental burden (van Rensburg, 2025). In addition, excess nutrients can result in bacterial blooms, particularly among pathogenic bacteria. None of this implies that vitamins and minerals were oversupplied out of carelessness; it reflects a genuine engineering challenge. For many years, over-formulation was 10 International Animal Health Journal
the most practical way to compensate because more precise delivery systems did not exist. The Delivery Problem A better solution is to address two challenges simultaneously. Vitamins vary considerably in stability and pelleting and extrusion add further losses through heat and pressure (Wedegaertner et al., 2020). Manufacturing is half of the problem. The second half starts once the feed is eaten: a nutrient that survives milling intact still must get past stomach acid, then be released at the point in the intestine where it can be absorbed rather than consumed by competing microflora further down the gut. In weaned pigs, lipid matrix microencapsulation delivered close to 42% of an encapsulated compound specifically to the mid-jejunum (Choi et al., 2020) and in broilers, a separate research group found more than 60% of an encapsulated marker compound reached the lower intestine using a different encapsulation approach entirely (Abdelli et al., 2021). Surviving manufacturing and being released in the right place are two different engineering problems and technology must solve both to be useful in practice. A Broader Industry Response Encapsulation is not a single technique but a family of approaches applied to very different nutrients. Vitamins, trace minerals, amino acids, organic acids, essential oils, enzymes and even live probiotics have all been protected for targeted release, although the objective varies by nutrient and species. Rumen-protected amino acids, for example, solve a different problem than delayed-release trace minerals in monogastrics, even though both rely on the same principle: protecting nutrients until they reach the point where they can be used most effectively. As pharmacological zinc oxide is phased out across the EU and medically important antibiotics face growing restrictions elsewhere, feed formulators are being asked to achieve more, through biological efficiency rather than simply higher inclusion rates (All About Feed, 2026). That challenge has accelerated investment across the industry. Companies including Adisseo, Alltech, Balchem, Kemin, Jefo and Novus (alphabetically listed) are all developing encapsulation or protected-delivery technologies, each using different technical approaches to improve nutrient stability, targeted release and utilisation, with Jefo reported in Canada as making exceptional investments. The growing industry interest is supported by published research. Across pigs and poultry, encapsulated minerals, organic acids, botanicals and essential oils have maintained or improved performance while supporting gut health or reducing reliance on medicated feed under both research and commercial conditions (All About Feed, 2026; Blair et al., 2025; Johnson et al., 2023; Pham et al., 2020; Samuels, 2024). Although the technologies differ, the overall direction is consistent: improving nutrient utilisation through protected, targeted delivery. One well-documented example is Jefo Matrix Technology (JMT), which uses a patented lipid matrix to protect vitamins and trace minerals during feed manufacture and digestion before releasing them progressively in the intestine through Volume 13 Issue 3
RESEARCH/INNOVATION/DEVELOPMENT lipase activity. Across several independent poultry studies, JMT has maintained or improved performance under reduced inclusion levels, although responses have varied depending on the production system and outcome measured (Ferket et al., 2018; Dewez, 2024; Malheiros et al., 2025a; Malheiros et al., 2026). Using substantially lower levels of vitamins, minerals and amino acids has the potential to revolutionise current practices around premix and animal feeding.
treating nutrient delivery as an integral part of nutrition rather than an afterthought. Important questions remain about how consistently these responses translate across species and commercial production systems, particularly under antibiotic-free conditions and when better delivery produces measurable changes in gut biology. Answering them will help identify where encapsulation creates the greatest biological and economic value.
Gut Health and Antibiotic Stewardship One explanation is that encapsulated nutrients reduce the amount of unabsorbed substrate reaching the hindgut, potentially limiting opportunities for less desirable bacteria to proliferate. Independent studies using encapsulated organic acids, essential oils and protected vitamin and mineral programmes have reported improved gut-barrier function and favourable shifts in the gut microbiota (Johnson et al., 2023; Pham et al., 2020; Wedegaertner, 2020).
Even so, waiting for perfect certainty is rarely how industries move forward. Other areas of animal health have already rewarded companies willing to invest early in emerging technologies; artificial intelligence provides a recent example (Connolly & Ulloa, 2026). Precision nutrient delivery appears to be following a similar trajectory. For decades, competitive advantage came from deciding what belonged in the ration. The next opportunity may lie in ensuring those nutrients complete the journey.
Improving nutrient utilisation may help support intestinal health and complement antimicrobial stewardship, alongside the biosecurity, vaccination and management practices that remain the primary tools for antibiotic-free production (Shannon & Hill, 2019). This is a role that encapsulated nutrient delivery systems can play.
REFERENCES
Beyond Feed Formulation The implications of nutrient delivery extend beyond feed efficiency. Improved trace mineral bioavailability has been associated with better egg production, antioxidant status and reproductive performance in broiler breeders compared with conventional inorganic mineral sources (Wang et al., 2019; Malheiros, 2021; Malheiros et al., 2025b). At the same time, maintaining performance at lower inclusion rates may reduce mineral excretion, an increasingly important consideration as environmental regulations tighten in many livestockproducing regions (Alltech, 2025). Precision nutrient delivery does not eliminate biological variability; it changes where that variability appears. Nutrient release still depends on digestive physiology, including lipase activity, which varies among animals and even between breeds (Liu et al., 2021). Research evaluating lipid-matrix encapsulation illustrates how these biological differences can influence nutrient release and animal responses, reinforcing that nutrition remains an interaction between the feed and the animal rather than the formulation alone (Wedegaertner, 2020). A recent presentation at the Poultry Science Meeting in Toronto, Canada, by Dr Ferket described the biological and economic inefficiencies of over-supplementation, what he calls the ‘hidden cost of asynchronous nutrition’, specifically the timing and kinetics of nutrient absorption. This is the future of feeding, beyond precision nutrition. What Does this Mean for Industry? That variability is why the practical takeaway is not that every premix should be switched overnight inclusion rate and delivery form are now two separate levers rather than one. Encapsulation technologies can improve feed mill handling by reducing moisture uptake and improving flowability during storage (Wedegaertner et al., 2020), but improvements in animal performance remain dependent on species, genetics, production system and diet. The practical approach is to validate results under an operation's own conditions rather than assume published findings will transfer directly. Stepping back, the pattern is bigger than any one technology. Encapsulation illustrates a broader shift toward www.international-animalhealth.com
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Abdelli, N., Pérez, J. F., Vilarrasa, E., Melo-Duran, D., Cabeza Luna, I., Karimirad, R., & Solà-Oriol, D. (2021). Microencapsulation improved fumaric acid and thymol effects on broiler chickens challenged with a short-term fasting period. Frontiers in Veterinary Science, 8, Article 686143. https://doi.org/10.3389/ fvets.2021.686143 All About Feed. (2026, June 3). Less in, more out: The rise of precision gut nutrition. https://www.allaboutfeed.net/animalfeed/feed-additives/less-in-more-out-the-rise-of-precisiongut-nutrition/ Alltech. (2025). Advancing animal performance and welfare for a sustainable future. International Animal Health Journal. https://international-animalhealth.com/advancing-animalperformance-and-welfare-for-a-sustainable-future/ Balchem. (2025). Microencapsulation [Company technology page]. https://balchem.com/innovation/microencapsulation/ Blair, J. A., Samuels, J., Samuels, W., & Persia, M. (2025). Effects of microencapsulated copper sulfate on the performance of 0 to 35 d old broiler chickens raised on used litter [Conference abstract]. Poultry Science Association 2025 Annual Meeting Scientific Program. Byrne, L., & Murphy, R. A. (2022). Relative bioavailability of trace minerals in production animal nutrition: A review. Animals, 12(15), Article 1981. https://doi.org/10.3390/ani12151981 Choi, J., Wang, L., Ammeter, E., Lahaye, L., Liu, S., Nyachoti, M., & Yang, C. (2020). Evaluation of lipid matrix microencapsulation for intestinal delivery of thymol in weaned pigs. Translational Animal Science, 4(1), 411–422. https://doi.org/10.1093/tas/txz176 Connolly, A., & Ulloa, C. (2026). Artificial intelligence is the new competitive advantage in animal health. International Animal Health Journal, 13(2), 14–16. Dewez, M. (2024, October 25). Tecnología Jefo Matrix. nutriNews. https://nutrinews.com/jefo-matrix-tecnologia/ European Medicines Agency. (2021). Sales of veterinary antimicrobial agents in 31 European countries in 2019 and 2020 – Trends from 2010 to 2020 (Eleventh ESVAC report). https://www.ema.europa.eu/en/news/2011-2020-more-40decrease-sales-antimicrobials-use-animals Ferket, P. R., Fontaine, J., & Bunod, J.-D. (2018). Encapsulation of nutritional and/or compounds for controlled release and enhancing their bioavailability by limiting chemical or microbial exposure (Patent No. CA3043176A1). Canadian Intellectual Property Office. Ferket, P., Malheiros, D., Lahaye, L., Tactacan, G., Moore, D., & Fontaine, J. (2026). Microencapsulated vitamins and trace minerals maintain broiler growth performance under reduced inclusion levels [Conference abstract]. Poultry Science Association 115th Annual Meeting Abstracts, Abstract #281, p. 108. Johnson, C. N., Arsenault, R. J., Piva, A., Grilli, E., & Swaggerty, C. L. International Animal Health Journal 11
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(2023). A microencapsulated feed additive containing organic acids and botanicals has a distinct effect on proliferative and metabolic related signaling in the jejunum and ileum of broiler chickens. Frontiers in Physiology, 14, Article 1147483. https://doi. org/10.3389/fphys.2023.1147483 Kemin. (n.d.). Kemin encapsulation technology [Company technology page]. Kemin Animal Nutrition & Health. https:// www.kemin.com/na/en-us/markets/animal/encapsulationtechnology Liu, X., Lyu, W., Liu, L., Lv, K., Zheng, F., Wang, Y., Chen, J., Dai, B., Yang, H., & Xiao, Y. (2021). Comparison of digestive enzyme activities and expression of small intestinal transporter genes in Jinhua and Landrace pigs. Frontiers in Physiology, 12, Article 669238. https://doi.org/10.3389/fphys.2021.669238 Malheiros, D. (2021). Effect of microencapsulated trace minerals and dietary supplementation level on broiler breeder egg production, egg quality, and progeny performance [master’s thesis, North Carolina State University]. NC State University Repository. Malheiros, D. M., Malheiros, R. D., Anderson, K. E., & Ferket, P. R. (2025a). Broiler breeders fed diets supplemented with conventional or lipid matrix microencapsulated trace minerals at standard or high levels: Part I. Influence on production, skeletal integrity, and intestinal histomorphology of broiler breeders. Poultry, 4(2), Article 17. https://doi.org/10.3390/ poultry4020017 Malheiros, D. M., Malheiros, R. D., Anderson, K. E., & Ferket, P. R. (2025b). Broiler breeders fed diets supplemented with conventional or lipid matrix microencapsulated trace minerals at standard or high levels: Part II—Influence on hatching egg quality. Poultry, 4(2), Article 18. https://doi.org/10.3390/ poultry4020018 Malheiros, D., Lahaye, L., Moraes, M. L., Babatunde, O., Ferket, P. R., & Fontaine, J. (2026). Achieving Gut Harmony through Jefo Matrix Technology: Optimizing nutrient utilization and performance in poultry [Conference abstract]. World's Poultry Congress 2026 Abstract Book, Abstract #4081, p. 187. Mangan, M., & Siwek, M. (2024). Strategies to combat heat stress in poultry production—A review. Journal of Animal Physiology and Animal Nutrition, 108, 576–595. https://doi. org/10.1111/jpn.13916 Michelena, Á., Fontenla-Romero, Ó., & Calvo-Rolle, J. L. (2025). A review and future trends of precision livestock over dairy and beef cow cattle with artificial intelligence. Logic Journal of the IGPL, 33(4), jzae111. https://doi.org/10.1093/jigpal/jzae111 Morciani, J. (2026, February 10). Navigating the storm: A strategic procurement playbook for pet food and feed markets in 2026. Fastmarkets. https://www.fastmarkets.com/ insights/a-strategic-procurement-playbook-for-pet-foodand-feed-markets-in-2026/ Pham, V. H., Kan, L., Huang, J., Geng, Y., Zhen, W., Guo, Y., Abbas, W., & Wang, Z. (2020). Dietary encapsulated essential oils and organic acids mixture improves gut health in broiler chickens challenged with necrotic enteritis. Journal of Animal Science and Biotechnology, 11, Article 18. https://doi.org/10.1186/s40104019-0421-y Place, S. E. (2024). Environmental sustainability of livestock systems. Meat and Muscle Biology, 8(1), Article 18117. https:// doi.org/10.22175/mmb.18117 Samuels, W. A. (2024, November 27). Improving gut health with microencapsulation. Poultry World. https://www.poultryworld. net/health-nutrition/health/improving-gut-health-withmicro-encapsulation/ Shannon, M. C., & Hill, G. M. (2019). Trace mineral supplementation for the intestinal health of young monogastric animals. Frontiers in Veterinary Science, 6, Article 73. https://doi.org/10.3389/fvets.2019.00073 van Rensburg, L. (2025, April 7). Benefits of organic trace mineral supplementation in poultry. All About Feed. https:// www.allaboutfeed.net/animal-feed/feed-additives/thebenefits-of-organic-trace-mineral-supplementation-inpoultry/
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28. Wang, G., Liu, L. J., Tao, W. J., Xiao, Z. P., Pei, X., Liu, B. J., Wang, M. Q., Lin, G., & Ao, T. Y. (2019). Effects of replacing inorganic trace minerals with organic trace minerals on the production performance, blood profiles, and antioxidant status of broiler breeders. Poultry Science, 98(7), 2888–2895. https://doi. org/10.3382/ps/pez035 29. Wedegaertner, O. (2020). Handling and broiler growth performance of lipid matrix encapsulated vitamin and mineral premixes [master’s thesis, North Carolina State University]. NC State University Repository. 30. Wedegaertner, O., Fahrenholz, A., Bunod, J.-D., Fontaine, J., & Ferket, P. (2020). Handling characteristic evaluation of free, standard and lipid microencapsulated vitamin and mineral premixes. Journal of Agricultural Science and Technology A, 10, 247–256. https://doi.org/10.17265/2161-6256/2020.05.002
Aidan Connolly Aidan Connolly is an advisor, investor, author, speaker and coach focused on the future of agriculture, food and technology. Described by Forbes as ‘a food/feed/farm futurologist,’ he is the author of The Future of Agriculture, now published in four languages, and a recent white paper on AI in agri-food systems.
Camila Ulloa Camila Ulloa is a Market Research Analyst in agricultural economics. Her work combines industry analysis and applied research on innovation, sustainability and emerging trends across agriculture and food systems.
Volume 13 Issue 3
www.international-animalhealth.com
International Animal Health Journal 13
LIVESTOCK
Novel Clinical Syndrome in Pigs and Its Association with Fox Parvovirus Introduction In late 2024, Royal GD was notified of an outbreak of ocular disease in weaned piglets on a farm. Initial diagnostic investigations were inconclusive. However, as veterinary practitioners reported similar observations during the spring of 2025, attention increasingly shifted toward an infectious causative pathogen. In search of such a pathogen, a non-targeted Oxford Nanopore Technology (ONT) sequencing and virus metagenomics approach was undertaken leading to the identification of a protoparvovirus. This virus was previously discovered in feces of a fox in 2012.1 In the pigs, this virus was subsequently found in organ material of 18 affected pigs from 5 different farms, but not in similar organs from unaffected control pigs. Afterwards, near-complete parvovirus genomes were obtained with more than 98% nucleotide sequence identity to the Fox parvovirus. Subsequent investigations have now strengthened the hypothesis that this virus is indeed responsible for the ongoing outbreak of ocular and dermal disease in pigs in the Netherlands.2 Epidemiology Royal GD plays a key role in the Netherlands by facilitating a national animal health surveillance programme aimed at monitoring, detecting and controlling animal diseases.3 Within this framework, pig veterinarians contribute actively by reporting their observations of unusual clinical signs,
sending in clinical samples for diagnostics, or submitting carcasses for post-mortem examinations. Based on notifications and ongoing communication with farmers and veterinarians between 2024 and 2026, it is estimated that by mid-2026 approximately 80–90% of Dutch sow farms have experienced outbreaks associated with this virus. Comparable observations have been reported in neighbouring countries, including Belgium, Germany and Denmark,4 suggesting that the virus is spreading across several parts of Europe. In multiple cases across these countries, the presence of Fox parvovirus has been confirmed. A Fox parvo RT-PCR assay has been published elsewhere and is available at Royal GD.2 Clinical Signs and Farm Impact To date, clinical signs are most notable in suckling and weaned pigs, but can also be observed in replacement gilts, sows and finishing pigs. Clinical signs have not been observed in newborn piglets but can appear in pigs as young as one week old. Within a litter, the number of affected piglets may range from one to almost all. Affected piglets exhibit one or more of the following signs (Figure 1); bilateral exophthalmos (bulging eyes), bilateral strabismus (laterally rotating eyes), generalised erythema (red skin), hair loss and sometimes mild thoracic skin wrinkling. Pigs may show a swelling in the neck and an apparently shortened lower jaw. Animals do not appear to experience fever. Clinical signs in individual pigs can last up to four weeks or more. Only in very fresh cadavers evidence of exophthalmos was observed macroscopically. No microscopic lesions were found in any of the affected pigs submitted for routine post-mortem examination. To date, no studies have been performed to estimate the economic burden of the disease. However, farmers have anecdotally reported that affected pigs do not tend to take up creep feed during the suckling period. Therefore, the animals may suffer from anorexia post-weaning and are prone to develop diarrhea. In addition, it takes farmers several hours daily to provide additional feed and care in such periods. Finally, farmers report a concurrent increased incidence of umbilical hernias and exudative epidermatitis (greasy pig disease) during peaks of the outbreaks and as such additional use of antimicrobials. Although direct mortality is usually not reported, affected pigs have lower weaning weights (approx. -1 kg) and lower weight at 10 weeks (approx. -2kg). Farmers report inferior pig quality and higher numbers of piglets for slaughter for several months. Initial outbreaks last around four months, but some reports indicate outbreaks lasting up to eight months and increased mortality in weaned pigs due to concomitant disease, up to 6%.
Figure 1. Two affected suckling pigs showing mild exophthalmos and strabismus. The skin of the front pig seems not affected, but the other pig shows mild erythema and it has less hair. In addition, the second pig shows a swelling in the neck and stands with an open beak and shows few skin scratches that can often be observed in affected pigs. © Royal GD 14 International Animal Health Journal
The Virus The protoparvovirus in pigs is a carnivore parvovirus (Genbank accession number PX496757). This is nearly identical to fox parvovirus found in fox feces across Europe.1,5 In pigs, eight other parvovirus infections are known, such as porcine parvovirus type 1 (PPV1), which causes reproductive disease. Given that vaccination against PPV1 is common in the Netherlands and that there is considerable genetic Volume 13 Issue 3
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Healthy (non-affected) pigs © Royal GD
distance between PPV1 and fox parvovirus, cross-immunity is not expected. Infections with PPV2 to PPV8 have never been associated with the clinical signs described for the new PPV virus. Although spill-over from carnivores to pigs is rare, crossspecies transmission of parvovirus has been documented before. For instance, canine parvovirus originating from coyotes was found in pig tissues in the US,6 but no clinical signs were associated with this parvovirus. It is also important to note that while initial findings of the parvovirus were made in fox feces, the original host of the virus could potentially be a prey animal of the fox.7 Laboratory Diagnostics Following the discovery of fox parvovirus as the causal pathogen through metagenomics, Royal GD has successfully isolated the virus by cell culture and developed a real-time quantitative PCR test for rapid and more affordable screening of various sample types. This PCR test is now available for routine diagnostic investigations. Additionally, Royal GD developed an in-situ hybridisation test to detect viral mRNA in tissue samples or virus culture flasks. Using this technique, we were able to demonstrate virus replication in cells of different tissues of affected pigs. The above methods are being utilised to further study parvovirus pathogenesis in collaboration with partners. Conclusion and Acknowledgements Increasing evidence points towards a causal relationship between presence of fox parvovirus in pigs and the observed clinical signs, despite the fact that not all postulates of Koch have yet been studied as well as many aspects of viral pathogenesis and routes of transmission. Given the extensive spread in the Netherlands and into neighbouring countries, it can be expected that the outbreak will continue and spread further into other European countries. We acknowledge all collaborators, farmers and veterinarians that contributed to this work. Contact us if you would like to collaborate with us on further research into this new virus. www.international-animalhealth.com
About Royal GD – Pig Research At Royal GD, we combine decades of expertise with advanced facilities to support innovation in pig health. Our scientists specialise in major swine pathogens, including PRRS virus, swine influenza virus, Escherichia coli and Streptococcus suis. As an independent Contract Research Organisation (CRO), we provide end‑to‑end support, from early research to regulatory approval. Our multidisciplinary teams conduct clinical field studies through a strong network of farmers and veterinarians, alongside controlled on‑site trials in modern BSL‑2 swine facilities. Royal GD is internationally recognised for the validated challenge models, designed to assess vaccine efficacy, disease progression and treatment impact under controlled conditions. With integrated diagnostics, research capabilities and industry collaboration, support is provided in the development of effective and sustainable pig health solutions worldwide. More information: www.gdanimalhealth.com
Tijs Tobias Tijs Tobias (PhD, DVM, MSc, Dipl ECPHM) is a senior veterinarian and European veterinary specialist of porcine health management at Royal GD, Deventer, the Netherlands. Dr. Tobias holds a PhD and MSc in Veterinary epidemiology from Utrecht University, the Netherlands. Dr. Tobias is also an associate researcher at Utrecht University.
International Animal Health Journal 15
COMPANION ANIMALS
Re-evaluating the Role of AmoxicillinClavulanate Vs Narrow-Spectrum Agents •
Amoxicillin-clavulanate is frequently overused for acute, uncomplicated infections in dogs and cats, even though narrow‑spectrum alternatives (amoxicillin alone or first‑generation cephalosporins) are often equally effective.
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Narrow-spectrum agents impose less selective pressure for antimicrobial resistance, preserve the clinical utility of clavulanate combinations and align with contemporary antimicrobial stewardship principles.
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Pharmacological distinctions between amoxicillin and amoxicillin-clavulanate matter clinically: the addition of clavulanate extends activity against β‑lactamase‑producing bacteria but also carries ecological costs, including selection for ESBL and AmpC producers.
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Current evidence supports a ‘narrow first,’ approach for conditions such as superficial pyoderma, uncomplicated urinary tract infections and mild respiratory infection in immunocompetent patients.
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Adopting such an evidence-based algorithm helps mitigate antimicrobial resistance while maintaining high standards of patient care in small animal practice.
Antimicrobial resistance has been designated a global health emergency, with veterinary medicine recognised as both a contributor to and a victim of this crisis. In small animal practice, antibiotics remain among the most frequently prescribed medications, yet significant variability exists in selection patterns. Amoxicillin-clavulanate is the most frequently prescribed antibiotic in small animal practice, accounting for more than 45% of prescriptions.1 A common clinical scenario involves the veterinarian confronting an acute infection, a superficial pyoderma, uncomplicated urinary tract infection, or mild respiratory presentation and needing to choose between amoxicillin, a cephalosporin such as cephalexin or cefadroxil, or the combination amoxicillin-clavulanate. The instinct to ‘cover all bases,’ is understandable. However, accumulating evidence suggests that this precautionary approach may be counterproductive, driving resistance without conferring meaningful clinical benefit in many common situations. This manuscript examines the scientific foundation for preferring narrow-spectrum agents as initial therapy for acute infections in immunocompetent dogs and cats. Pharmacological Distinctions: Amoxicillin versus Amoxicillin‑Clavulanate Understanding the mechanistic difference between these agents is essential for rational prescribing. Amoxicillin is a time-dependent, bactericidal aminopenicillin that inhibits bacterial cell wall synthesis by binding to penicillin‑binding proteins (PBPs). It is well absorbed orally, with good tissue penetration and a relatively long half‑life. Its spectrum includes 16 International Animal Health Journal
many Gram-positive aerobes (non‑β‑lactamase‑producing Staphylococcus pseudintermedius, Streptococcus spp.), select Gram‑negative organisms (Pasteurella spp., some Escherichia coli isolates) and anaerobes. Critically, amoxicillin is inactivated by β-lactamase enzymes, bacterial-derived proteins that hydrolyse the β-lactam ring. Consequently, amoxicillin exhibits no activity against β-lactamase‑producing staphylococci, many Bacteroides species and a substantial proportion of enteric Gram‑negative rods.2 Amoxicillin-clavulanate combines amoxicillin with clavulanic acid, an irreversible β-lactamase inhibitor. Clavulanic acid forms a stable, inactive complex with β-lactamases, ‘protecting,’ the co-administered amoxicillin from enzymatic degradation. This extends the spectrum to include β-lactamase‑producing S. pseudintermedius, Bacteroides fragilis, Klebsiella spp., and many E. coli strains that would otherwise be resistant.3 However, this extended spectrum comes with ecological costs. The clavulanate component exerts its own selective pressure, favouring bacteria that possess or can acquire alternative resistance mechanisms such as extended-spectrum β-lactamases (ESBLs) or AmpC cephalosporinases. Evidence Base for Narrow‑Spectrum First‑Line Therapy Superficial Pyoderma Canine superficial pyoderma is predominantly caused by S. pseudintermedius. While some strains produce β-lactamase, first-generation cephalosporins (cephalexin, cefadroxil) remain reliably effective. Cephalexin demonstrates excellent activity against methicillin‑susceptible S. pseudintermedius, achieving therapeutic concentrations in skin and soft tissues. Standard dose of 15-30 mg/kg PO q12h in dog and cat for 14–21 days achieves clinical cure rates exceeding 85% for first-time or infrequent recurrences.4 The BSAVA PROTECT ME guidelines explicitly recommend employing narrow-spectrum agents when culture and susceptibility testing confirm susceptibility, reserving broader agents for refractory or recurrent cases. A reasonable approach for first-time pyoderma in a systemically healthy dog is cephalexin monotherapy, reserving amoxicillin-clavulanate for suspected β-lactamase producing strains or cases failing initial narrow-spectrum therapy.5 Uncomplicated Urinary Tract Infections Acute, uncomplicated lower urinary tract infections (UTIs) in dogs are most commonly caused by E. coli (approximately 50–60% of isolates), followed by Proteus, Enterococcus, Staphylococcus and Streptococcus species.6 For immunocompetent patients with no history of prior antibiotic exposure or recurrent infections, amoxicillin alone (22 mg/kg PO q8–12h) is often sufficient. Many E. coli isolates remain susceptible to amoxicillin in community-acquired settings, and the narrow spectrum spares the commensal gut microbiota. Clinical trials and expert consensus documents support this approach. The dvm360 empirical therapy proceedings list amoxicillin-clavulanate as a first choice for UTIs but note that in ‘uncomplicated, never before treated, lower urinary tract infections in immunocompetent animals, amoxicillin Volume 13 Issue 3
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+ clavulanate is very effective,’ importantly, this does not preclude amoxicillin alone, which may be equally effective for susceptible isolates.7 Where resistance is suspected or confirmed, culture and susceptibility testing should guide therapy rather than automatic escalation to clavulanate combinations. Respiratory Tract Infections For acute tracheobronchitis (kennel cough), primary pathogens include Bordetella bronchiseptica, Mycoplasma spp., and various viral agents. Antibiotics are not always indicated; however, when bacterial infection is suspected, doxycycline (which covers both Bordetella and Mycoplasma) is preferred over amoxicillin-clavulanate. For secondary bacterial pneumonia in dogs, amoxicillin-clavulanate is a first‑line option, but amoxicillin alone may suffice for susceptible Pasteurella and Streptococcus species.8 Evidence Against Routine Amoxicillin‑Clavulanate Use Concerns regarding amoxicillin-clavulanate overuse are not merely theoretical. Surveillance data reveal rising resistance rates among canine E. coli isolates. One study reported that 51.22% of canine clinical E. coli isolates (n=82) were nonwild‑type (i.e., resistant or intermediate) to amoxicillinclavulanate, with an MIC90 of 1/0.5 μg/mL – approaching the upper limit of the susceptible category in some interpretive criteria.9 While these data require cautious interpretation (the population included referral and recurrent cases), they signal concerning trends. Furthermore, the pharmacokinetic challenges of oral amoxicillin-clavulanate formulations warrant attention. A www.international-animalhealth.com
bioavailability study documented that two commercial oral products were not bioequivalent and non‑interchangeable, with relative bioavailabilities of 76.50% (amoxicillin) and 72.70% (clavulanic acid) compared to reference formulations.10 Suboptimal clavulanic acid exposure risks therapeutic failure and resistance selection. In contrast, amoxicillin alone and cephalexin have more predictable pharmacokinetic profiles. Antimicrobial Stewardship: The ‘Narrow First,’ Principle The BSAVA/SAMSoc PROTECT ME framework provides explicit guidance for responsible antibiotic use. The guideline instructs clinicians to prescribe only when necessary, employ narrow spectrum, conduct cytology and culture and tailor their practice policy.5 It emphasises that antibiotic use, both appropriate and inappropriate imposes a powerful selection pressure on bacteria and is the primary driver of antibiotic resistance. Thus, eliminating unnecessary use, including unnecessary breadth of spectrum, is essential. When Is Amoxicillin-Clavulanate Appropriate? Amoxicillin-clavulanate remains valuable for specific indications. These include polymicrobial infections involving mixed aerobes and anaerobes (e.g., bite wounds, deep pyoderma, aspiration pneumonia); empirical therapy for suspected β‑lactamase-producing pathogens when culture results are pending in moderate-to-severe infections; infections in immunocompromised patients in which delayed appropriate therapy carries higher risk; and cases failing narrow‑spectrum therapy with documented susceptibility to the combination. International Animal Health Journal 17
COMPANION ANIMALS Conclusions The veterinary profession faces an urgent imperative to preserve antibiotic effectiveness for future generations. While amoxicillin-clavulanate is an effective and important antimicrobial, its routine use for acute, uncomplicated infections in otherwise healthy animals is difficult to justify on pharmacological, ecological, or stewardship grounds. The following practice changes are recommended. First, adopt ‘narrow first,’ as default prescribing for acute infections in immunocompetent patients, reserving clavulanate combinations for confirmed or strongly suspected β-lactamase‑producing pathogens. Second, utilise first-generation cephalosporins (cephalexin, cefadroxil) for suspected staphylococcal pyoderma rather than automatically reaching for amoxicillin-clavulanate. Third, consider amoxicillin alone for uncomplicated UTIs, recognising that many community‑acquired E. coli remain susceptible. Fourth, perform culture and susceptibility testing before prescribing amoxicillin-clavulanate for recurrent, refractory, or severe infections. Fifth, educate clients and colleagues that ‘broader,’ is not synonymous with ‘better,’ narrow‑spectrum therapy is a marker of clinical sophistication, not therapeutic inadequacy. REFERENCES 1.
2.
3.
4.
5. 6.
7. 8.
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Radford AD, Noble PJ, Coyne KP, et al. Antibacterial prescribing patterns in small animal veterinary practice identified via SAVSNET: the small animal veterinary surveillance network. Vet Rec. 2011;169(12):310. doi:10.1136/vr.d5062 Kushwaha A, Gupta P. Amoxicillin: mechanism of action, pharmacokinetics, and therapeutic implications in bacterial infections. PEXACY International Journal of Pharmaceutical Science. 2023;2(6):42-64. Weber DJ, Tolkoff-Rubin NE, Rubin RH. Amoxicillin and potassium clavulanate: an antibiotic combination. Mechanism of action, pharmacokinetics, antimicrobial spectrum, clinical efficacy and adverse effects. Pharmacotherapy. 1984;4(3):122-136. doi:10.1002/j.1875-9114.1984.tb03333.x Toma S, Colombo S, Cornegliani L, et al. Efficacy and tolerability of once-daily cephalexin in canine superficial pyoderma: an open controlled study. J Small Anim Pract. 2008;49(8):384-391. doi:10.1111/j.1748-5827.2008.00585.x BSAVA/SAMSoc Guide to Responsible Use of Antibiotics: PROTECT ME. British Small Animal Veterinary Association, 2024. Rampacci E, Bottinelli M, Stefanetti V, et al. Antimicrobial susceptibility survey on bacterial agents of canine and feline urinary tract infections: Weight of the empirical treatment. J Glob Antimicrob Resist. 2018;13:192-196. doi:10.1016/j. jgar.2018.01.011 Empiric antibiotic therapy (Proceedings). dvm360. 2008 (Updated 2020). Lappin MR, Blondeau J, Boothe D, et al. Antimicrobial use Guidelines for Treatment of Respiratory Tract Disease in Dogs and Cats: Antimicrobial Guidelines Working Group of the International Society for Companion Animal Infectious Diseases. J Vet Intern Med. 2017;31(2):279-294. doi:10.1111/ jvim.14627 Clinical and Laboratory Standards Institute (CLSI) Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals. 7th ed. CLSI Supplement Vet 01S. Available online: https://clsi. org/standards/products/veterinary-medicine/documents/ vet01s/ Vasuntrarak K, Patthanachai K, Charoenlertkul P, Nuanualsuwan S, Cheng H, Suanpairintr N. Comparative bioavailability study of two oral formulations of amoxicillinclavulanic acid in healthy dogs. BMC Vet Res. 2025;21(1):173. Published 2025 Mar 17. doi:10.1186/s12917-025-04649-4
18 International Animal Health Journal
Dr. Akhter Rasool Dr. Akhter Rasool (BVSc, MVSc) is a veterinary clinician and independent researcher. He holds an MVSc degree from Madras Veterinary College, Chennai, India and has contributed to numerous scientific papers, book chapters and peer-reviewed articles. His primary research and clinical interests encompass clinical and molecular diagnostics, veterinary ultrasonography and emergency veterinary care.
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International Animal Health Journal 19
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Why Veterinary Instrument Care Starts Before Sterilisation In veterinary practice, infection prevention does not begin when instruments are placed in the steriliser. It starts much earlier, as soon as an instrument has been used and before blood, tissue or other biological material has time to dry on the surface. Whether used during routine surgery, dental procedures, wound care, orthopaedics or emergency treatment, reusable veterinary instruments are exposed to a wide range of biological soils. If these residues are allowed to dry, they become harder to remove and may compromise the effectiveness of the cleaning, disinfection and sterilisation steps that follow. Pre-cleaning, sometimes referred to as point-ofuse cleaning, is therefore an important part of veterinary instrument care. Its role is not to sterilise the instrument, but to prevent contamination from becoming fixed to the surface before the item reaches the main cleaning and reprocessing stage. For veterinary practices and wider animal health facilities, this first step has both clinical and operational value. Prompt and consistent pre-cleaning helps reduce bioburden, protect instrument surfaces, support staff safety and improve the reliability of the full decontamination process. Why Pre-Cleaning Matters Veterinary teams work in fast-moving environments where procedures can vary significantly from one animal to the next. A practice may move from routine neutering to dentistry, wound management or emergency surgery within
the same day. Instruments may be used on different species, in different clinical conditions and with varying levels of contamination. This creates a particular challenge for instrument reprocessing. Organic material can begin to dry soon after use, adhering to joints, hinges, serrations, textured surfaces and other hard-to-clean areas. Once this happens, residues become more difficult to remove and may interfere with the cleaning, disinfection and sterilisation steps that follow. The issue is not simply visible cleanliness. Residual organic matter can shield microorganisms from later decontamination stages and prevent detergents or disinfectants from making full contact with the instrument surface. Even the most effective washer-disinfector or steriliser relies on instruments being properly cleaned first. Pre-cleaning helps reduce this risk by keeping contamination from drying onto the instrument surface before full cleaning begins. For many veterinary practices, this is particularly important because instrument reprocessing is managed as part of the daily clinical workflow rather than through a separate sterile services department. A clear, practical pre-cleaning process can help reduce variation and support a more consistent standard of infection control. Protecting Instruments, Patients and Staff Veterinary instruments represent a significant investment for practices and animal health facilities. Surgical packs, dental sets, orthopaedic instruments and specialty devices must remain sharp, smooth, aligned and functional if they are to perform reliably in clinical use. Poor cleaning habits can shorten their service life. Dried blood, tissue and saline can contribute to staining, corrosion and pitting. Vigorous scrubbing to remove hardened debris may scratch surfaces or damage fine edges. Over time, even small surface defects can create areas where contamination is more difficult to remove. Hinges may become stiff, cutting edges may dull and precision instruments may lose performance. Pre-cleaning helps limit the time that corrosive or adhesive soils remain on the instrument surface. When debris is softened or removed early, staff can use gentler cleaning methods during the main reprocessing stage, helping instruments remain in better condition longer. Keeping instruments in good condition has clear implications for both clinical performance and practice costs. Instruments that are well maintained are easier to clean, safer to use and less likely to need premature repair or replacement. For practices managing cost pressures, effective pre-cleaning offers a practical way to protect existing equipment while supporting infection control.
Prompt pre-treatment helps prevent blood, tissue, and other biological soils from drying onto instrument surfaces before sterilisation. 20 International Animal Health Journal
There is also an important occupational safety consideration. Instrument reprocessing can expose veterinary nurses and other clinical staff to contaminated sharps, scalpels, instruments and other items with cutting or piercing edges. If biological material has dried, staff may need to scrub Volume 13 Issue 3
COMPANION ANIMALS more forcefully, increasing the risk of slips, puncture injuries, splashing and exposure to contaminants. A workflow that reduces the need for aggressive manual cleaning can also support better ergonomics. Repetitive scrubbing, particularly in high-volume surgical settings, can contribute to hand fatigue and discomfort. By making instruments easier to clean at the main reprocessing stage, pre-cleaning can help reduce unnecessary strain on the staff responsible for instrument care. Enzymatic Cleaning Enzymatic cleaning has an important role in the early stages of instrument reprocessing because it helps break down the organic soils that can remain on instruments after use. Enzyme-based formulations are designed to act on materials such as proteins, fats and carbohydrates, reducing larger residues into smaller, more water-soluble fragments that can be removed more easily during the main cleaning stage. This is particularly relevant in veterinary practice, where the type and level of contamination can vary widely depending on the procedure, species and clinical setting. Enzymatic pre-cleaning helps start the breakdown of these residues before the main cleaning stage, supporting a more consistent process. Enzymatic pre-cleaning should not be viewed as a replacement for the main cleaning stage, nor does it remove the need for careful inspection before sterilisation. Its value lies in preparing the instrument so that the following stages can work more effectively. By preventing soils from becoming fixed to the surface, it helps support a more reliable reprocessing pathway. Tools and Techniques Pre-cleaning needs to be practical enough to fit into the daily routine of veterinary work. The exact approach will depend on the practice setting, the type of procedure and the instruments being used, but the aim is to prevent contamination from drying and to prepare instruments for effective cleaning. Enzymatic spray foams can be applied directly to used instruments soon after a procedure. These solutions help begin the breakdown of biological material and keep instruments moist during transfer to the cleaning area. They can be useful where instruments cannot be cleaned immediately but need to be protected before full reprocessing begins. Pre-saturated wipes may be used for smaller items, or instruments that cannot be submerged. They provide a practical way to remove visible soil at the point of use and can be particularly useful where quick handling is needed between procedure areas and the reprocessing space.
Consistent instrument pre-cleaning protocols help protect veterinary staff from exposure risks associated with biological materials
Enzymatic sponges and soaking pads can also support pre-cleaning by providing gentle mechanical action on delicate or more complex surfaces. This can help loosen residue without relying on harsh scrubbing that may damage the instrument finish. Because timing has a direct effect on how easily instruments can be cleaned, pre-cleaning should take place as soon as practical after use, before contamination has time to dry and adhere to the instrument surface. Even relatively short delays can make later cleaning more difficult, particularly around hinges, serrations, joints and other areas where residues can become trapped. Material compatibility should also be considered. Veterinary instruments may include stainless steel, aluminium, plastics, rubber components and specialty coatings, all of which can respond differently to cleaning chemistry and repeated reprocessing. Products and processes should therefore be selected to avoid corrosion, pitting, dulling or degradation, with practice protocols reflecting the manufacturer’s instructions for each instrument, particularly for complex or delicate devices. Daily Workflows For pre-cleaning to be effective, it has to fit naturally into the way a veterinary practice operates. Teams are often moving between consultations, procedures, recovery, theatre preparation and stock control, so any process that is unclear or too difficult to follow is unlikely to be applied consistently. Used instruments can then be left untreated while staff move on to the next animal or task. A practical protocol should make clear what happens to instruments immediately after use, how they are contained during transfer, and who is responsible at each stage. This is particularly important in practices where reprocessing is managed by the same team responsible for wider clinical duties, rather than by a separate department. Labelling, tray systems and written procedures can all help reduce uncertainty and support a more consistent approach. Training should cover both the purpose of pre-cleaning and the practical steps needed to carry it out safely. Veterinary nurses, clinical staff and support teams need to understand when instruments should be treated, how they should be handled and what precautions are required during transfer to the cleaning area. This includes safe segregation of sharps, appropriate personal protective equipment, suitable containment and adherence to written procedures.
Organic debris can become trapped in hinges, serrations, and box locks. Early pre-cleaning helps prevent contamination from drying in hard-toclean areas. www.international-animalhealth.com
The workflow should also include inspection before sterilisation. Instruments need to be checked after cleaning International Animal Health Journal 21
COMPANION ANIMALS Pre-cleaning should be viewed as part of this wider governance structure. It is not an optional extra, but a practical step that supports the reliability of the full reprocessing cycle. Good instrument care can also contribute to more sustainable practice. Reusable veterinary instruments are designed to withstand repeated cleaning and sterilisation, but their lifespan depends on how they are handled. Preventing corrosion, pitting and avoidable damage helps reduce waste and limits the need for unnecessary replacement.
Enzymatic cleaners help break down proteins, fats, and carbohydrates commonly found on veterinary instruments, supporting more effective cleaning and reprocessing
to confirm that visible contamination has been removed and that the item remains in good condition. If residues are found, the instrument should be re-cleaned before it is sterilised, as sterilising an instrument that has not been properly cleaned undermines the reliability of the whole process. Supporting Compliance and Instrument Management Veterinary practices are expected to maintain robust infection control procedures, even though the regulatory framework may differ from human healthcare. Professional guidance, health and safety requirements, manufacturer instructions and local protocols all influence how reusable instruments should be managed. In practice, effective reprocessing depends on a consistent approach in which instruments are cleaned as soon as possible after use, visible contamination is removed before sterilisation, and staff are protected from avoidable exposure. Manufacturer instructions for cleaning, disinfection and sterilization should also be followed, particularly for complex or delicate instruments.
When instruments are damaged or unavailable, the impact is felt beyond the cost of repair or replacement. Procedures may be delayed, specialty devices may need to be taken out of service, and staff may spend additional time managing avoidable equipment issues. A well-managed pre-cleaning process helps reduce these risks by keeping instruments in better condition and supporting a more predictable turnaround between procedures. Safer Care In a busy veterinary setting, the way instruments are handled immediately after use can have a lasting effect on the rest of the reprocessing cycle. Once biological material has dried onto a surface, cleaning becomes more difficult and the reliability of the following stages can be reduced. Pre-cleaning should therefore be treated as part of routine clinical practice, rather than a task that can be delayed until instruments reach the cleaning area. By preventing residues from becoming fixed to the surface, veterinary teams can make cleaning, inspection and sterilisation more dependable. For veterinary practices and animal health facilities, this first step supports safer care, protects valuable instruments and helps staff maintain a more reliable approach to reprocessing.
Documentation can also support good practice. Written procedures, training records, equipment maintenance logs and sterilisation records help demonstrate that infection control is being managed systematically. In larger veterinary groups, consistent protocols across sites can support quality assurance and reduce variation.
Juan De Paz-Lavalle
Every instrument should be inspected after cleaning to verify that visible contamination has been removed before sterilisation. 22 International Animal Health Journal
Juan De Paz-Lavalle, Chemist at MicroCare Medical, specialises in product development and advanced cleaning chemistries for the medical, dental and veterinary industries. For over half a decade, Juan has been developing innovative instrument care solutions that support effective reprocessing and regulatory compliance. Juan holds a Bachelor of Science degree in Chemical and Biological Engineering from Colorado State University.
Volume 13 Issue 3
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International Animal Health Journal 23
COMPANION ANIMALS
Street-Cat Welfare: Urban Redevelopment Triage, Veterinary Coordination and Limits of Smell-Scale Rescue Urban redevelopment can turn a stable street-cat territory into an animal-welfare emergency before demolition begins. Residents move, feeding points disappear, gates close and familiar routes are cut off. A cat may still occupy the same coordinates while losing the resources that made survival there possible. For a small independent rescuer, the resulting cases require more than capture and a clinic appointment. They demand rapid field assessment, veterinary coordination, recovery space and a defensible decision about whether return remains safe. Drawing on practical rescue work in Seoul, this paper proposes a continuity-of-care framework that connects pre-capture observation, humane trapping, clinical assessment, foster monitoring and long-term placement. It also identifies the limits that rescuers, clinics and municipalities must acknowledge if redevelopment-related interventions are to be humane and sustainable. Redevelopment is an Animal-Health Event The first visible sign of redevelopment is often not demolition but vacancy. Doors stay closed, rubbish accumulates differently and the people who once noticed a limping cat or refilled a water bowl leave the neighbourhood. Fencing may follow. To a person, the fence marks a legal boundary. To a street cat, it can sever a route to food, water, shelter or a familiar escape point. These changes have clinical consequences. Interrupted feeding can worsen existing disease and make medication impossible. Noise and machinery alter movement patterns. Cats may retreat into unstable structures or remain inside restricted areas because the territory on the other side of the fence is the only one they know. A nursing mother may move her kittens repeatedly. An older cat that appeared self-sufficient while residents were present may become vulnerable when those informal supports vanish. I run an independent street-cat rescue effort in Seoul's Yongsan district. The most important lesson from redevelopment cases is that rescue cannot be divided
neatly into fieldwork, veterinary treatment and placement. Each decision changes the next one. Capturing a cat without a safe discharge plan can exchange one danger for another. Booking a clinic without reliable transport can waste a narrow opportunity. Treating a cat and returning it to a territory that no longer functions can undo the benefit of care. The practical unit of work is therefore not the appointment. It is the entire path from observation to a safe, realistic outcome. Begin With a Field Baseline Useful clinical information often begins before a cat enters a carrier. A regular caregiver may know the cat's usual arrival time, posture, appetite, gait and relationship with other cats. That baseline makes change visible. A cat that normally approaches quickly but remains hidden may be in pain. A cat that eats on one side only may have an oral problem. A mother who appears alone at unusual hours may have moved her litter or lost access to it. In redevelopment areas, observation should also record the territory itself. Is the usual entrance still open? Is water available? Has heavy equipment begun moving? Are workers present at the times the cat normally appears? Is there a secondary route, and will it remain accessible after capture or treatment? These are not peripheral details. They affect trap placement, stress, release safety and the likelihood of finding the same cat again. A concise field record can include: 1. 2. 3. 4. 5. 6.
The cat's identifying features and recent photographs. The last confirmed sighting, usual schedule and feeding response. Observable health changes, including breathing, movement, discharge, wounds and body condition. Reproductive or caregiving status, especially evidence of nursing. Current access conditions, hazards and a safe trapping window. The proposed destination after the veterinary visit.
A street cat remains in a Yongsan alley as nearby homes are emptied for redevelopment. Photograph courtesy of YongsanCats 24 International Animal Health Journal
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Humane capture must be planned together with transport, veterinary assessment and recovery space. Photograph courtesy of YongsanCats
Thinking through all four parts reduces improvisation at the clinic door. It also allows the veterinarian to advise within the actual constraints of the case. Veterinary Coordination with an Incomplete History Street-cat cases rarely arrive with a full age, vaccination or treatment record. The cat may be stressed, poorly socialised or difficult to examine without sedation. The rescuer may know the animal only through photographs and repeated sightings. Good coordination depends on stating these limits plainly. Regular observation establishes a baseline for appetite, movement and access before capture. Photograph courtesy of YongsanCats
This information does not replace examination by a veterinarian. It makes the examination more useful when the patient's history is otherwise incomplete. A Four-Part Triage Before Capture Small rescuers rarely have enough traps, foster rooms, transport or funds to respond to every cat at once. Triage is unavoidable. The aim is not to rank lives by worth, but to identify which intervention is both urgent and executable.
Before arrival, the clinic should receive the reason for capture, key field observations, likely socialisation level and any time-sensitive site conditions. If a nursing cat is involved, the possibility of dependent kittens must be raised before sedation or prolonged separation. If the cat may return outdoors, the veterinarian needs to know what follow-up is realistically possible. If return is doubtful, the likely duration and conditions of foster care matter to treatment planning. After examination, instructions should distinguish between what is essential immediately and what can be monitored. Foster carers need concrete thresholds: what appetite change
Immediate Danger Is demolition, sealing or heavy machinery imminent? Is the cat visibly injured, trapped, unable to move normally or showing respiratory distress? A site-access deadline may make a case urgent even when the cat appears clinically stable. Medical Urgency Can the cat eat and drink? Is there active bleeding, severe ocular disease, neurological change, marked lethargy or rapid deterioration? Remote observations should be communicated to a clinic so that the rescuer understands whether emergency care is required and what transport precautions to take. Territory Viability If the cat is treated and sterilised, is there a functioning place to return to? A viable territory requires more than an address. It requires safe access, food and water, shelter, monitoring and enough continuity that the cat is not released into an unfamiliar or actively hazardous environment. Recovery Capacity What will happen after discharge? Is there a quiet, secure place for anaesthetic recovery, medication and observation? Can the person providing care safely handle a frightened cat? Is isolation available if infectious disease is suspected? If not, the capture plan may need to change before the trap is set. www.international-animalhealth.com
Returning to the same coordinates is not a safe return when access, shelter and monitoring have disappeared. Photograph courtesy of YongsanCats International Animal Health Journal 25
COMPANION ANIMALS is concerning, when swelling is expected, how long sedation effects may last and which signs require an urgent call. Written instructions are especially useful because the person who transports the cat may not be the person who provides recovery care. Rescuers also owe clinics accurate communication. We should avoid presenting an estimate as a confirmed history and disclose when medication cannot be given safely. A sustainable relationship is built through preparation, follow-through and honest reporting, not only during emergencies. The Return Decision After Territory Loss Trap-neuter-return is an important tool when a stable outdoor territory and continuing care are available. The difficulty in a redevelopment zone is the final word: return. Releasing a cat at the same point on a map does not mean returning the animal to the same environment. A responsible return assessment should ask whether the cat can reach familiar shelter, whether regular food and water will continue, whether construction access is controlled, whether a caregiver can monitor recovery and whether another sudden closure is likely. If several of those conditions have disappeared, sterilisation alone does not resolve the welfare problem. Alternative placement is not automatically simple or humane. Some adult street cats need considerable time to adjust indoors; some may be better suited to a carefully managed outdoor setting if one exists. Foster capacity is finite, and long stays can prevent other urgent admissions. The decision should therefore be individual: health, temperament, age, dependence on a specific territory, available care and the pace of redevelopment all matter. In Yongsan, a local trap-neuter-adopt (TNA) collaboration has explored a pathway that connects health checks, vaccination and microchipping with adoption for cats who cannot safely return. The approach is useful precisely because it recognises that medical treatment and destination planning are inseparable. It also demands more capacity than standard TNR, so it should not be described as an effortless substitute. Recovery Is Part of Assessment A frightened cat in a trap or examination room offers only a narrow view of its behaviour. Pain, confinement and unfamiliar smells can make a social cat withdraw or a fearful cat defend itself. A stable foster period may reveal information that changes the long-term plan. One older cat in our care, Coco, had lived outdoors for more than seven years. In the neighbourhood he appeared calm and self-contained. After rescue, he was initially reserved, which seemed to confirm that impression. In foster care, however, he began exploring furniture, running through the room, relaxing near other cats and accepting treats by hand. Safety did not create a new personality; it allowed behaviour that survival had concealed to become visible. Foster observation can also identify persistent pain, appetite problems, elimination changes, medication difficulties and
social preferences. Daily notes and short videos can help a veterinary team distinguish improvement from a new concern. For adoption planning, this period clarifies whether a cat needs a quiet home, feline companionship, experienced handling or more time before placement. The clinic is therefore the middle of the care pathway, not its conclusion. Capacity Is Clinical and Ethical Constraint Independent rescue is often described through successful outcomes, but capacity limits shape every decision. A single complex case can require repeated trapping attempts, transport, diagnostics, medication, isolation and weeks or months of foster care. During that time, another animal may need the same room or carrier. Overextension creates predictable risks: rushed recovery, missed medication, poor infection control, inadequate behavioural assessment and burnout. Saying that a case cannot be taken immediately can feel morally uncomfortable, yet accepting a cat without the ability to provide minimum care is not a neutral choice. Practical safeguards include setting a maximum recovery census, confirming a discharge destination before capture, maintaining separate supplies for isolation, recording medication and follow-up dates and identifying which clinic can receive an urgent case outside normal plans. Municipal programmes should recognise these limits. Funding only sterilisation or the clinical procedure leaves transport, foster care, isolation, monitoring and placement as invisible labour. A Minimum Continuity-of-Care Standard Redevelopment-related street-cat interventions can be improved without requiring every city to build a large new programme. A minimum standard would include:
A minimum continuity-of-care pathway for redevelopment-related street-cat cases. 26 International Animal Health Journal
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Case Closure. Record whether the cat was returned, transferred, adopted, remained in care or was lost to follow-up. Outcomes should be visible, including difficult ones.
The most effective interventions begin before an emergency. Once a neighbourhood has emptied and access is blocked, every part of rescue becomes slower, riskier and more expensive. Conclusion Urban redevelopment changes animal health through the loss of continuity. Food, shelter, observation and familiar movement routes can disappear before any injury is visible. For the cat, a fence can be both a territorial rupture and the beginning of a medical crisis. Humane response depends on connecting the stages that are often treated separately: field knowledge, triage, capture, veterinary assessment, recovery and a safe destination. Clinics need honest histories and workable discharge plans. Rescuers need clear medical guidance and realistic capacity. Municipalities need to count the labour and infrastructure that exist outside the procedure itself. 1. 2. 3. 4. 5. 6.
Early Notice and Access. Engage known caregivers before fencing and provide a defined period for monitoring and humane trapping. Individual Identification. Use photographs and simple records so cats are not counted twice or overlooked after routes change. A Veterinary Pathway. Establish clinics or contacts able to advise on urgent triage, sterilisation, vaccination, injury and discharge needs. Return-Safety Review. Treat territory viability as a real criterion, not an assumption based on coordinates. Recovery Planning. Include transport, short-term housing, medication and monitoring in budgets and timelines. Placement Options. Create foster and adoption routes for cats who cannot safely return, while recognising that not every cat will adapt at the same pace.
No framework removes the difficult choices. It can, however, prevent the most avoidable one: treating a cat successfully and then returning the animal to a place that no longer exists in any meaningful sense.
Julie Choi Julie Choi runs YongsanCats, an independent street-cat rescue effort in Seoul. She works with local caregivers, veterinary clinics, volunteers, foster homes and adopters to help cats affected by redevelopment move from immediate danger toward treatment, recovery and a safe long-term outcome.
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International Animal Health Journal 27
FOOD & FEED
From Voluntary to Mandatory:
What FDA's Proposed GRAS Overhaul Means for Animal Feed
FDA is proposing the biggest change to the GRAS framework in decades. Under a proposed rule published on 11 August 2026, companies would generally be required to notify the agency of new GRAS conclusions rather than deciding whether to do so voluntarily. If finalised, the proposal would significantly reshape the regulatory pathway for new food and feed ingredients in the US market. If the rule is finalised, this would bring greater transparency, enabling FDA to identify uses that may require food additive approval, detect potentially unsafe substances more quickly, confirm that GRAS conclusions are based on adequate scientific documentation and strengthen public confidence in its oversight of the food supply. The trade-off would be additional compliance cost for industry: preparing and submitting notices and maintaining ongoing notification for new GRAS determinations. On FDA's side, resource planning will be key as there would be a wave of new mandatory notices to absorb. Background – Feed Today, a company can conclude that a substance is Generally Recognised as Safe (GRAS) based on publicly available safety data without notifying FDA. Submitting a GRAS Notice (GRN) to FDA's Centre for Veterinary Medicine (CVM) is optional. In addition to FDA's GRAS and Food Additive Petition (FAP) pathways, several other mechanisms can support the market entry of feed ingredients. The Association of American Feed Control Officials (AAFCO) launched its Scientific Review of Ingredient Submissions (SRIS) programme in late 2025 in partnership with Kansas State University's Olathe Innovation Campus. FDA also established the Animal Food Ingredient Consultation (AFIC) programme through Guidance for
Industry #294, which opened in January 2025. Companies that complete the process receive a 'consultation completed,' letter, indicating that CVM does not currently intend to take enforcement action regarding the ingredient's use. On the legislative side, the Innovative FEED Act, reintroduced as S.1906 and H.R.2203, would create a new category of ‘zootechnical animal food substances.’ These products would be reviewed through FDA's existing Food Additive Petition process rather than being regulated as new animal drugs. The legislation remains under consideration. Separately, FDA may exercise enforcement discretion on a case-by-case basis for products that meet the statutory definition of an animal drug, such as for certain enteric methane-reduction additives. The proposed rule would change only one part of this landscape, but it is a significant one: the ability to reach a self-GRAS conclusion without notifying FDA. Proposed Rule for Animal Feed: Exemptions, Transition Provisions and Timelines The proposed rule would require companies that intend to market an animal food substance based on a GRAS conclusion to notify FDA and provide the basis for that conclusion, unless an exemption applies. Proposed exemptions include substances already listed as GRAS in 21 CFR Parts 582 or 584, as well as prior-sanctioned substances, meaning uses that were approved before 1958. FDA is also proposing an animal food-specific exemption for ingredients listed in the 2024 edition of the AAFCO Official Publication (OP), provided the agency has not publicly raised concerns about their GRAS status and for those that have undergone an AFIC consultation.
Figure 1. A decision guide for feed ingredients as per the proposed rule 28 International Animal Health Journal
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FOOD & FEED
Figure 2. Proposed GRAS rule clock
For substances already marketed under a self-GRAS determination, FDA is not proposing a full GRAS notification requirement. Instead, the agency would establish a streamlined notification pathway available for one year after the rule takes effect. Companies would need to submit basic information, including their name and address, the substance name, intended conditions of use, evidence that the substance was already in interstate commerce before the effective date and, where applicable, a previous GRN number. For a standard GRAS notice, FDA's regulations set a review target of 215 or 270 days review following a 30-day filing confirmation step (timelines updated in September 2026) At the end of the review, FDA responds in one of three ways: a letter stating it has no questions about the notifier's GRAS conclusion, a letter explaining why the notice does not provide a sufficient basis for that conclusion, or a decision to cease evaluating the notice at the submitter's request. A 'no questions,' letter is not itself an approval; the underlying legal basis for marketing the substance remains the company's own GRAS determination, not FDA's response to it. In practice, review times can run longer than the target. FDA states that failure to submit a notification would not automatically make a substance unlawful if the rule is finalised. However, companies that do not notify may face increased scrutiny and the absence of a notification could be considered in future enforcement decisions. Differences with Human Food The Part 570 amendments also do not mirror the Part 170 amendments exactly. FDA is not proposing a food-contact www.international-animalhealth.com
substance notification pathway for animal food (there is no equivalent packaging-migration concern built into the feed provisions the way there is for human food) and the Threshold of Regulation exemption that lets very low-exposure substances skip full review is being updated for food and foodcontact substances, not extended to feed. Industry's Views Industry groups have broadly welcomed FDA's goal of increasing transparency around ingredient oversight, while raising questions about implementation. The American Feed Industry Association (AFIA) said it supports the agency's objectives of ensuring a safe animal food supply, maintaining consumer confidence and supporting innovation. However, AFIA has stressed that FDA will need sufficient resources to manage ingredient reviews efficiently under a mandatory notification system. While AFIA's focus is on FDA's ability to manage a larger workload, AAFCO's attention is centred on a specific exemption included in the proposal. FDA proposes to exempt ingredients listed in the 2024 AAFCO Official Publication (OP) from mandatory GRAS notification, provided the agency has not publicly raised concerns about their GRAS status. However, the exemption would not automatically apply to ingredients added after 2024, including those reviewed through AAFCO's Scientific Review of Ingredient Submissions (SRIS) programme. AAFCO has said it will ask FDA to make the exemption ongoing rather than limited to the 2024 OP and to extend it to SRISreviewed ingredients, while preserving FDA's authority to require a GRAS notification when specific safety concerns exist. During AAFCO's Annual Meeting in San Diego, held 26–28 August 2026, International Animal Health Journal 29
FOOD & FEED association representatives indicated they remain optimistic that FDA will give these requests favourable consideration. Legal Uncertainties FDA stated in the preamble to its 2016 GRAS final rule that it ‘lack[s] express statutory authority to require companies to submit GRAS notices,’ (81 Fed. Reg. 54,960, 54,981–82 (Aug. 17, 2016)). A federal court later agreed, finding the statute silent on whether GRAS notices have to be mandatory. Now FDA is reversing that near-decade-old position, leaning instead on implied authority. Whether FDA's revised interpretation survives the rulemaking process, or is ultimately tested in court, remains to be seen. Practical Actions for Industry Regardless of whether the proposal is finalised in its current form, companies will benefit from reviewing their ingredient portfolios and supporting documentation now: •
Identify Affected Ingredients. Review all ingredients and uses currently on market under a self-affirmed GRAS determination, FDA no-questions letter or other route.
•
Assess Self-GRAS Supporting Documentation. Confirm that the scientific evidence is publicly available for each use, well organised and can be assembled into a submission-ready package if needed.
•
Prepare Evidence of Interstate Commerce. Companies with ingredients already on the market may benefit from reviewing their documentation before a final rule is issued, given the proposed one-year window for streamlined notifications.
•
Engage in the Consultation. Use the comment period to raise practical implementation concerns, including potential resource, timing and administrative challenges associated with the proposal.
The Bottom Line FDA is not proposing to change what it takes to establish that a substance is Generally Recognised as Safe. The science remains the same. What would change is who needs to see that information and when. The proposal includes several exemptions that could limit its impact on ingredients already recognised through existing regulatory pathways. Even so, companies with self-affirmed GRAS ingredients will benefit from reviewing their portfolios and preparing supporting documentation well before a final rule is issued. With the comment period open until 9 December 2026, industry's most effective move is not to wait for a final rule but to use that window now: flagging resourcing and implementation concerns while there is still a chance to shape the outcome, rather than reacting to it after the fact.
Laura Payo Laura Payo is a biotechnologist by training and Regulatory Affairs Group Leader at Pen & Tec Consulting SLU (trading as Argenta), based in Barcelona. She has over 15 years of experience supporting feed and food companies with compliance across evolving global frameworks.
30 International Animal Health Journal
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FOOD & FEED
Protecting Feed Value Through Better Silage Management Corn silage, known as maize silage across Europe, is typically the largest component of the ration for dairy farms throughout the world. It’s also one of the largest investments, carrying the full cost of seed, fertiliser, fuel and labour. As input costs continue to fluctuate and margins tighten, many producers are under pressure to increase corn silage output. Yet, on many farms, the better solution is to boost corn silage efficiency. Improving silage efficiency means protecting corn silage quality and reducing problems such as silage dry matter losses. Better corn silage efficiency doesn’t start with producing more maize – it starts with reducing silage dry matter losses and protecting corn silage quality. By boosting corn silage preservation and forage efficiency on-farm, producers can maximise existing resources and avoid forage shrinking. Corn Silage Losses: A Challenge that Builds Over Time At its core, corn silage efficiency is not a complex concept. It simply means preventing losses to make sure that every metric ton harvested delivers as much feed value as possible from any given type of forage grown and harvested. In dayto-day terms, that often comes down to protecting dry matter, maintaining silage quality and ensuring that nutrients are used rather than lost along the way. What makes silage losses challenging is that they rarely occur in one obvious moment. Instead, they build gradually, from small inefficiencies during harvest timing to problems in the ensiling process and finally to waste at feed-out. This makes them easy to overlook, but costly over time. When dry matter, energy and starch are lost through poor harvest timing, inadequate preservation or aerobic spoilage, farmers are often forced to compensate with purchased feed or higher inclusion rates, thus increasing costs without increasing output. Having a robust silage protection plan in place, from harvest to ensiling to storage, is therefore one of the most practical ways for improving forage efficiency and safeguarding farm profitability.
Late Harvest Pitfalls On the other hand, if we harvest too dry, above 38% dry matter, we often see reduced packing density due to a more ‘spongy’, product that resists proper packing. This reduction in density can be catastrophic for proper fermentation and will often result in dry matter loss. Other issues with harvesting dry corn silage are a classic reduction in starch digestibility, along with an inability to properly process the kernel. Together, these factors increase the risk of hind-gut fermentation and kernel passage into the manure. The increase in fecal starch is one of the main causes for unrealised milk production in the dairy industry today. Each 3% increase in fecal starch equates to three liters of lost production (Fredin et al., 2014). Harvesting at a proper dry matter – between 33–38% whole plant dry matter, depending on the storage facility – is the key to the success of the corn silage crop. Ensiling and Storage: Where Value is Protected or Lost Once the crop is harvested, attention quickly shifts to the clamp. While the ensiling process may only last a short time, it can have long-term consequences for corn silage quality and feed efficiency, preserving the nutritional benefits of highquality forage for cows. Good corn silage preservation depends on doing the basics well: • • • •
Filling the clamp quickly. Ensuring the proper weight is used on the bunk for the volume coming into the clamp. Compacting in thin layers. Sealing immediately to exclude air.
When oxygen is left in the silage, losses increase and fermentation becomes less efficient. These issues are only fully visible months later, appearing as heating and spoilage leading to reduced feed intake. Each of these outcomes reduces silage quality and limits efficiency. Why Better Silage Efficiency Improves Farm Performance The impact of silage quality becomes visible at the feed face. Silage is the foundation of the ration and any reduction in quality affects intake, feed conversion and performance. Well-preserved silage supports the production of high-quality forage for cows and delivers:
Silage Harvest Timing: The Foundation of Corn Silage Quality Getting silage harvest timing correct is one of the most important decisions in corn silage production. Harvesting corn silage when it’s too wet can lead to slower fermentation and excess effluent. Most critically, harvesting too early sacrifices valuable tonnage, reducing the amount of silage the crop can ultimately deliver.
• • •
Early Harvest Pitfalls Harvesting corn silage below 32% dry matter will often result in less production of starch, which accounts for over 60% of the total finished plant weight. This loss in both starch content and final tonnage highlights the importance of proper harvest timing. Harvesting too early will certainly increase input cost from purchased grain.
Mycotoxin Risk and Forage Quality: What the Data Shows One of the consequences of poor storage and fermentation is the development of molds and their associated mycotoxins. Results from the latest Alltech 2025 Harvest Analysis show that feed quality risk remains a real and ongoing challenge globally. In many ways, the risk is growing. Routine testing of silages and TMRs at the Alltech 37+™ laboratory network
32 International Animal Health Journal
Higher intake. More efficient conversion into meat or milk. Reduced reliance on bought-in feed.
Improving silage efficiency is therefore not just a nutritional objective. It is a practical strategy for cost control, resilience and margin protection in volatile conditions.
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International Animal Health Journal 33
FOOD & FEED continually reveals the multi-mycotoxin challenge. Insights from this testing show that most silages and TMRs are contaminated with at least six or seven mycotoxins and these are a combination of pre- and post-harvest type mycotoxins. For forage producers and dairy farmers in particular, grass silage stood out as a higher risk area. Across countries such as the U.K. and Ireland, Penicillium-derived mycotoxins are adding pressure in forages, largely driven by storage and preservation challenges rather than field contamination alone. This ties directly back to silage efficiency on-farm. The Alltech Harvest Analysis data reinforces a key message: Protecting forage quality at harvest and during storage is one of the most effective ways to safeguard margin and performance throughout the year. Protecting Feed Value with Silage Inoculants Silage inoculants for corn silage preservation, such as Egalis™, help reduce dry matter loss and play a clear role within a wider farm resource efficiency approach. Efficient fermentation is a simple process that requires proper harvest timing at the right dry matter levels and guiding initial fermentation in the correct direction. Inoculants play a crucial role in efficient fermentation due to the unpredictable nature of the epiphytic (natural) bacteria on the crop. Inoculants provide a known amount of proven bacteria designed to assist the native bacteria in fast and efficient fermentation. Once the silage reaches an anaerobic state, a fierce competition begins between the beneficial homofermentative bacteria, which conserve nutrients and undesirable bacteria that thrive in higher-pH environments, (>5). These undesirable bacteria are responsible for inefficient fermentation, resulting in loss of those precious nutrients. The chart below represents proper fermentation of corn silage from 0 to 7 days to 90 days fermented. The initial pH is representative of typical fresh forage pH at chopping. Once the crop is brought into storage, packed and covered, reducing its exposure to oxygen, the fermentation process begins. At seven days, the pH is down to 4.1. While this is slightly above the target range of 3.7–4.0 for corn silage, it is quickly approaching the desired goal. At the same time, you can also see the rapid growth of lactic acid bacteria, which pushes the lactic acid exponentially. A cautionary note: Even though the pH approaches stability parameters at seven days, this does not mean fermentation has been completed. This is just the first step in the fermentation process. Silage is suggested to be ensiled for 30 days before opening, as a general rule, due to the sanitising effect of fermentation on molds and yeasts
in the silage. The low pH will render the molds and yeasts inactive until oxygen is again present in the clamp. Egalis is designed to support a faster, more stable fermentation, helping to protect dry matter and nutrient value, limit the growth of spoilage organisms and reduce the opportunity for molds and related mycotoxins to develop during storage and feed out. By preserving more of what is harvested, farmers are better able to convert corn silage into milk or meat without needing to compensate for losses later. Focus on What You Keep In today’s farming environment, profitability is not just about what you produce. Increasingly, it is about how much of that value you can keep. Fortunately, improving silage efficiency does not always require major change. It starts with reducing silage losses and protecting quality at every stage. Disclaimer: Product availability will vary by region. Product descriptions and any associated claims are not applicable in all markets. REFERENCES 1.
Fredin, S.M., Ferraretto, L.F., Akins, M.S., Hoffman, P.C., & Shaver, R.D. (2014). Fecal starch as an indicator of total-tract starch digestibility by lactating dairy cows. Journal of Dairy Science, 97(3), 1862–1871. https://doi.org/10.3168/jds.2013-7395
John Winchell
Figure 1: Changes in pH and fermentation products during corn silage fermentation 34 International Animal Health Journal
John Winchell provides Global Technical Support within the Technology Group at Alltech, helping dairy producers and industry professionals optimize forage quality, manage mycotoxin risk, and improve on-farm performance. With more than 25 years of industry experience, he is a respected speaker and published author known for sharing practical, science-based insights through conferences, webinars, and leading agricultural publications.
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FOOD & FEED
Bringing Novel Foods to Market: A Guide to the EU, UK and US Regulatory Pathways Innovation in the food sector is accelerating rapidly. New protein sources, precision fermentation, algae-based ingredients, cultured meat, cell cultures, fungal mycelium, new plant-based foods and other innovative products are creating opportunities to bring new products to market and address sustainability challenges. Consumer preferences are also changing, although slowly and mainly among well-educated and high-income consumers. While science and innovation are key to developing new products for food markets, companies must also understand the regulatory requirements at the earliest possible stage of the development process. Regulatory frameworks determine whether a product can be lawfully placed on the market. The earlier companies know what is permitted, what is prohibited and what is required from a regulatory viewpoint, the better. This helps avoid many pitfalls and speeds up lawful market access. Whether developing a new plant extract, an ingredient produced through precision fermentation, an insect-based food or another innovative product, regulatory strategy should be considered early in product development. Decisions made during research and development may influence the type of studies required, the overall project timeline and, ultimately, how quickly a product reaches the market. This white paper provides an overview of the key regulatory steps involved in bringing novel foods to the EU market, highlights the main differences in the UK and US systems and shares practical considerations to help companies prepare for a successful authorisation process. Regulatory Landscapes of the European Union, the United Kingdom and the United States In the European Union (EU), many innovative food ingredients fall under the Novel Foods Regulation (EU) 2015/2283. Before a novel food can be marketed, it must undergo a scientific safety assessment by the European Food Safety Authority (EFSA) and receive authorisation from the European Commission (EC). Although the regulatory framework is well established, preparing a successful application requires careful planning, comprehensive scientific documentation and a clear understanding of the authorisation process. It is well known that rules and regulations are the most stringent in the EU. Therefore, once a novel food application has been prepared for the EU, companies often prefer to submit it to the United Kingdom (UK) as well. Following Brexit, the United Kingdom operates under its own food regulatory framework, although its regulations are almost the same as those in the EU. However, this is expected to change shortly. The UK and the EU are currently negotiating a Sanitary and Phytosanitary (SPS) Agreement, which aims to simplify the movement of agri-food goods between the UK and the EU. This would mean that it would no longer be necessary to apply for the registration of novel foods in the UK. Although negotiations are still ongoing, the UK authorities have already published information on the potential implications for businesses and market authorisation procedures. The UK government is aiming for the agreement to enter into force around mid-2027. 36 International Animal Health Journal
For the same reason, companies often find it easier to get their novel food innovations onto the market in the United States (US). For novel foods, the typical regulatory approach is based on the Generally Recognised as Safe (GRAS) regulatory framework or New Dietary Ingredient (NDI) framework (dietary supplements only). Both are governed by the US Food and Drug Administration (FDA). As in the UK, major changes are also taking place in the US GRAS framework. Under the 'Make America Healthy Again,' agenda, the US Department of Health and Human Services is in the process of eliminating the independent GRAS determination (selfGRAS) pathway for food ingredients. This would mean that all GRAS determinations would have to be notified to the FDA, with limited exemptions. A long wait for food business operators ended on 11 August 2026, when the FDA finally released its proposed rule for a 120-day public consultation period. However, it will take some time before the final rule comes into force. Currently, this is expected to happen no earlier than 2029/2030. Transparency and regulatory oversight are becoming increasingly important in the US, as they already are in the EU and the UK. This is largely driven by strong consumer pressure and it is widely believed that there will be no return to the current form of self-affirmed GRAS determinations without FDA oversight. While the GRAS regulatory framework has historically differed significantly from those of the EU/UK, it is gradually moving closer to the approaches adopted in those jurisdictions. It is important to realise, however, that the underlying scientific evidence supporting safety remains the same in all three jurisdictions. What differs is the level of detail, the regulatory authorisation process, which is the most demanding in the EU, and the transparency requirements. Develop a Regulatory Strategy for Product Authorisation Once the target market has been decided, a regulatory classification of product is required. Provided the product falls under novel foods (EU/UK) or GRAS substances (USA), the next step is to develop a regulatory strategy. This should begin as early as possible, ideally during product development rather than after the product has been finalised. A well-made regulatory strategy helps companies identify the data required for authorisation, estimate project timelines, allocate resources efficiently and save time. It also reduces the risk of generating studies that do not fully address the scientific and regulatory requirements or overlooking important aspects of the application. One of the first considerations is the intended use of the product. Applicants should clearly define the food categories in which the novel food or GRAS substance will be used, the proposed use levels and the target population. These factors form the basis for the exposure assessment and influence the scientific evidence required to demonstrate safety. At the same time, manufacturers should begin compiling information describing the product itself. This includes its identity, composition, manufacturing process, specifications and stability. Consistent documentation throughout product development is essential, as this data will later form a significant Volume 13 Issue 3
FOOD & FEED part of the application dossier. Identity, composition and manufacturing process are the most important parts, because these may determine the safety of the product even without toxicological evidence. Only if these aspects do not provide solid evidence of safety, will toxicological data be considered. Therefore, the identity, composition and manufacturing sections of the dossier are reviewed very carefully by the authority. Most requests for clarification also relate to these sections. Depending on the characteristics of the product and the available existing evidence, the application typically requires compositional analyses, toxicological studies, allergen determination or other supporting information. The scope of the required data varies between products, and early planning, in particular for in vivo toxicological studies, can help avoid unnecessary delays later in the authorisation process. Toxicological animal studies always consume time and resources. One of the toxicological studies commonly requested is a sub-chronic toxicity study in rats. This is very expensive and requires a high level of knowledge of toxicological aspects and study conduct, as it must be performed in accordance with Good Laboratory Practice (GLP) and Organisation for Economic Co-operation and Development (OECD) guidelines, as well as scientific risk and safety assessment principles. Each dossier contains a scientific risk/safety assessment, which must be designed to satisfy regulatory purposes. Therefore, developing a regulatory strategy at an early stage also provides an opportunity to identify potential challenges before significant investments are made. Typical steps from regulatory strategy to dossier submission for a new food ingredient are presented in Figure 1. Preparing an Application Dossier The application dossier forms the foundation of the authorisation/registration process. It provides the scientific and technical information needed by the authority to assess whether the product is safe under its proposed conditions of use. A well-structured dossier helps both the applicants and the authorities. The exact content of the dossier depends on the nature of the novel food or GRAS ingredient, but every application should present a clear and comprehensive description of the product, supported by solid scientific evidence. While the companies will inevitably need to generate new data, existing scientific literature and previous risk assessments should not be forgotten, as they can play an important role in supporting the application. Therefore, it is important to take stock of the existing data, in particular because authorities are seeking to reduce animal studies and embrace the 3R (Replacement, Reduction and Refinement) principles. In silico and read-across approaches and multiomics techniques
are becoming important. While these new approach methodologies (NAMs) cannot demonstrate regulatory safety alone, they can be very useful in overall evaluation. Preparing a novel food or a GRAS dossier is typically a multidisciplinary effort involving product developers, analytical laboratories, chemists, exposure assessors, contract toxicity research organisations, toxicologists, risk assessors and regulatory specialists. Since all data included in the dossier are ultimately combined in a weight-of-evidence data package and used for the overall safety assessment, it is highly important that qualified toxicologists and risk assessors are involved in dossier authoring. These experts should understand not only international risk assessment principles, but also how they are applied in the regulatory context. Risk and safety assessment terminology differs and the regulatory terms used can also vary between jurisdictions. Coordinating all these activities ensures that all necessary information, with correct scientific and regulatory terminology, is available when the application is submitted for review. The European Union: Novel Food Authorisation Before considering the authorisation process, it is important to determine whether a product is classified as a novel food. In the EU, a novel food is defined as a food that was not consumed to a significant degree by humans within the EU before 15 May 1997, when the first Novel Food Regulation entered into force. Today, novel foods are regulated under Regulation (EU) 2015/2283. Novel foods cover a wide range of products and production technologies. They may include new plant or algal ingredients, foods derived from microorganisms or fungi, insect-based products, ingredients produced using new manufacturing processes, chemical substances, or foods with a history of consumption outside the EU but little or no history of use within the EU. Importantly, not every innovative food is necessarily a novel food. The classification depends on factors such as the source of the ingredient, the manufacturing process and whether there is sufficient evidence of significant consumption within the EU before the cut-off date. Even relatively familiar ingredients may be considered novel if they are produced using a new process that significantly changes their composition, nutritional or undesirable substance characteristics. Therefore, determining the regulatory status of a product is one of the first and most important steps in product development. Companies can consult the EC Novel Food Catalogue, which provides guidance on the regulatory status of many ingredients. However, the catalogue is intended as a reference tool and is not legally binding. Where uncertainty remains, applicants may request a consultation with the competent authority of an EU Member State (MS) to clarify whether authorisation is required.
Figure 1. Typical steps from regulatory strategy to dossier submission www.international-animalhealth.com
International Animal Health Journal 37
FOOD & FEED EFSA Safety Assessment and Authorisation Once the novel food application has been submitted to the EC and considered valid, it is forwarded to the EFSA for scientific evaluation. EFSA's role is to assess whether the novel food is safe under the proposed conditions of use. The safety assessment considers several aspects of the novel food, depending on its characteristics. The aim is to determine whether the novel food is as safe as comparable foods already consumed by the intended population. During the evaluation, EFSA may request, and often does request, additional information where clarification is needed or the submitted data are considered insufficient. The assessment timeline is paused while the applicant prepares and submits the requested information. As a result, the overall authorisation process often takes considerably longer than the legally defined EFSA timelines. Following EFSA's scientific opinion, the EC with the EU MSs decide whether the novel food should be authorised. If approved, the novel food is added to the Union list of authorised novel foods, together with any conditions of use, labelling requirements or specifications that apply to the product. The United Kingdom: EU Novel Food Authorisation Is Expected to Be Valid in the UK Soon As discussed above, the UK is now in the process of ceasing its novel food authorisation process. At the time of writing, the UK Food Standards Agency (FSA) is finalising the authorisations for the most relevant applications and has informed many companies that their applications will not be assessed. The United States: The GRAS Framework and FDA agreement Rather than requiring pre-market authorisation for all novel ingredients, the US applies the GRAS framework for many food substances (Federal Food, Drug, and Cosmetic Act, 21 CFR 170.3). Under this approach, a substance is considered safe for its intended use if there is a consensus among qualified experts based on publicly available scientific evidence or a long history of safe use. It is important to note that the safety data on which the GRAS conclusion is based must be published in peer-reviewed journals before the GRAS conclusion is made. The GRAS framework entails that companies conduct their own GRAS determination and either voluntarily notify the FDA or not of their GRAS conclusion. Still today, both FDA-notified GRAS conclusion and self-GRAS conclusion (non-FDA notified) give lawful market access in the USA. However, as presented above, in the future, all GRAS dossiers must undergo FDA scrutiny. If a GRAS notice is submitted, the FDA reviews the information provided and may request clarifications. Unlike the EU novel food authorisation, a GRAS notice does not result in formal approval by the FDA. The FDA only agrees or disagrees with the company's GRAS conclusion. Therefore, it is important that the conclusions are made by well-qualified toxicologists and risk assessors. Concluding Remarks While the EU/UK and US operate under distinct regulatory frameworks, early planning, a clear regulatory strategy and robust scientific documentation are essential for successful market access. Regulatory planning should be embedded in product development from the outset, not treated as a final step before commercialisation. Companies planning international market access, e.g. EU/ UK and US, should consider regulatory requirements across all intended markets early in development. Almost without 38 International Animal Health Journal
exception, the same scientific studies generated can support authorisations in multiple jurisdictions. In fact, much of the same data on novel foods and ingredients can also be used for applications on feed additives or feed GRAS determinations or even for cosmetics. This can improve efficiency and help avoid unnecessary duplication of studies. Timelines should also be planned realistically. Preparing the necessary documentation, generating scientific evidence and responding to authority requests for additional information all require time. Building flexibility into the project plan can help companies manage the authorisation process more efficiently. As innovation in the food sector continues to expand, companies that understand regulatory requirements and incorporate them into their development strategy from the outset will be better positioned to bring safe and innovative products to market successfully. Companies and authorities all share a common objective: ensuring that innovative food products placed on the market are safe for consumers. References 1. 2.
3. 4. 5. 6.
https://doi.org/10.2903/j.efsa.2024.8961 https://www.fda.gov/regulatory-information/search-fdaguidance-documents/guidance-industry-regulatoryframework-substances-intended-use-human-food-oranimal-food-basis https://www.hhs.gov/press-room/revising-gras-pathway. html https://www.fda.gov/regulatory-information/search-fdaguidance-documents/draft-guidance-industry-newdietary-ingredient-notifications-and-related-issues https://www.gov.uk/government/news/uk-eu-spsagreement-information-for-businesses https://www.federalregister.gov/documents/2026/08/11/ 2026-16296/substances-generally-recognized-as-safe? utm_campaign=EAS%20-%20Foods&utm_medium=email&_ hsenc=p2ANqtz-959czDMdhvBMnWswyijT64qOX-Eej1j8rc4 7SlVIs4a7WqssZGZubOfManUWIlq3Al5geuWpW-1_T1N7IcSU CeWa2NYQ&_hsmi=432561151&utm_content=432561151& utm_source=hs_email
Mari Eskola Mari Eskola (PhD) has nearly 30 years of international experience in food and feed regulatory safety across EU institutions, national authorities and industry. She spent 10 years at EFSA, conducting risk assessments and serving in leadership roles. Her background includes the European Commission, ECHA, Teagasc (IE) and Finnish Food Authority. At Medfiles, she provides regulatory and food/ feed risk assessment expertise.
Mari Lyyra Mari Lyyra (MSc) is a licensed nutritionist with over 25 years of experience in food regulation and science. Specialising in novel foods since 1999, she has contributed to numerous successful EU dossiers. At Medfiles since 2014, she leads regulatory projects covering EU and US legislation, including GRAS and NDI. Her expertise also spans food supplements, additives and animal feed.
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Are you prepared to lose 25% of your silage?
Performance you can count on. Improved nutrient protection
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Up to 25% of silage dry matter can be lost between harvest and feeding, along with the energy, nutrients and profit you worked for. Egalis helps you keep more of what you grow by improving fermentation and reducing spoilage.
More feed in the bunk. More return on every tonne. 42 International Animal Health Journal
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