Navigating regulatory frameworks and meeting compliance demands in the animal feed industry can be complex, especially with the recent updates that have emerged. To help you stay informed and prepared, we have compiled a comprehensive recap of the most significant regulatory changes. Our goal is to ensure you are equipped with the latest knowledge to effectively manage these developments and maintain compliance in this evolving landscape.

New efficacy guidance for feed additives

The European Food Safety Authority (EFSA) has released new guidance on assessing the efficacy of feed additives. This document is crucial for anyone involved in a feed additive authorisation process following Article 7.6 of Regulation (EC) No 1831/2003. Some of the changes in this guidance are:

• In vivo trials now need a certificate from a competent authority or an independent ethical committee declaring compliance with animal welfare directives.
• The number of efficacy trials required was reduced.
• For enzymes as zootechnical additives, in vitro data can partially replace the required in vivo trials.

If you are interested to gain more insights on this guidance, we encourage you to join our free webinar 'Overview of the key updates in the 2024 EFSA Feed Additive Efficacy Guidance' on the 3 October, 2024. In this webinar we will provide an in-depth overview of the new EFSA guidance on the efficacy of feed additives, focusing on the significant changes and updates in the 2024 guidelines. Attendees will gain critical insights into the implications of these updates for feed additive registrations, including the number of studies required, compliance with animal welfare criteria, and other essential considerations to ensure EFSA compliance for new trials. Register for the webinar here.

Click here to access the guidance.

‍Food enzyme intake model (FEIM) webtool

EFSA’s new webtool, to calculate dietary exposure to food enzymes, was released to the public. The food enzyme intake model (FEIM) is EFSA’s open-source platform to calculate the exposure to the food enzyme - total organic solids when a specific food enzyme is used in one or more food manufacturing processes. This tool simplifies the process of assessing consumer exposure to food enzymes by providing a user-friendly platform to calculate potential intake based on specific consumption data and enzyme use levels.

Key benefits of the tool include:

• Enhanced accuracy: It allows for more precise estimations of dietary exposure, which is crucial for risk assessments and ensuring compliance with safety standards.
• Time efficiency: The tool streamlines what would typically be a time-consuming process, allowing users to quickly obtain reliable data for decision-making.
• Regulatory compliance: By facilitating accurate exposure assessments, the tool helps companies ensure their products meet regulatory requirements, thereby supporting the approval process for food enzymes.
• User-friendly interface: Designed for ease of use, the tool makes it accessible to a wide range of users, from scientists to regulatory professionals, without the need for extensive training.

Overall, this tool is essential for anyone involved in the evaluation of food enzymes, providing a streamlined and accurate method to assess dietary exposure and support safety assessments. It is freely accessible to anyone through the R4EU platform upon registration.

Catalogue of antimicrobial resistance genes in species of Bacillus used to produce food enzymes and feed additives

This report is part of EFSA's efforts to standardise and enhance the quality of data used in scientific assessments. It provides an overview and inventory of current practices within EFSA and across national food safety authorities in Europe for assessing the quality of existing and new scientific evidence and explores the methodologies and criteria used to evaluate the reliability, relevance, and adequacy of data that inform risk assessments and regulatory decisions. It is intended for professionals involved in food safety, risk assessment, and regulatory affairs, particularly those working within EFSA, national food safety authorities, and related scientific institutions. It is also relevant for researchers, policymakers, and stakeholders interested in understanding how data quality is assessed, and the best practices employed across Europe to ensure the integrity and reliability of scientific evidence used in food safety evaluations.

You can access the full report here.

New developments in biotechnology applied to microorganisms

EFSA issued an opinion which identifies a variety of products containing microorganisms obtained with new genomic techniques (NGTs), falling within the remit of EFSA, that are expected to be placed on the European Union (EU) market in the next 10 years. No novel potential hazards/risks from NGT-Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity, and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT-Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA's guidance is ‘partially applicable', therefore on a case-by-case basis for specific NGT-Ms, fewer requirements may be needed.

Access the link here.

Updated qualified presumption of safety (QPS) microorganisms list

For applications based on microorganisms: qualified presumption of safety (QPS) status provides a harmonised safety assessment approach used by EFSA that covers safety concerns for humans, target animals, and the environment. Strains belonging to QPS taxonomic units (TUs) still require a safety assessment based on a specific data package to be conducted by EFSA’s scientific Panels; however, QPS status facilitates a simplified evaluation. Always check if your strain(s) are in the current list.

This document is updated twice a year and is particularly useful for professionals in the animal nutrition and feed industry, regulatory affairs, and poultry farming sectors. It is also relevant for scientists and researchers working in veterinary science, microbiology, and animal health, as well as policymakers and regulatory bodies involved in the approval and monitoring of feed additives in the EU.

To access the document, click here.

US Food and Drug Administration (FDA)’s longstanding memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024

The MOU between the FDA and AAFCO, which has been in place for a considerable time, is set to expire on October 1, 2024. This MOU has facilitated cooperation between the FDA and AAFCO in regulating animal feed and ensuring consistency in feed standards across the US. The expiration will affect how animal feed and feed additives are regulated. Access the MOU here.

Therefore, the existing AAFCO definition process will be discontinued and the FDA announced they would implement a new definition process: Animal Feed Ingredient Consultation (AFIC). AAFCO will review ingredients recommended by the FDA’s Animal Food Ingredient Consultation Program for acceptance in the Official Publication. Also, AAFCO may recognise an alternate expert panel for the scientific review of new feed ingredients, may review ingredients for acceptance such as those approved by the Canadian Food Inspection Agency and/or EFSA.

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