Feed additives for methane mitigation: Regulatory frameworks and scientific evidence requirements for the authorization of feed additives to mitigate ruminant methane emissions

This article describes the regulatory and evidence requirements necessary for the authorization of antimethanogenic feed additives (AMFA) aimed at mitigating enteric methane (CH ) emissions from ruminants. It outlines the legislation and legal procedures in Australia, Canada, the European Union, New Zealand, South Korea, the United Kingdom, and the United States as illustrative examples, offering insights for applicants seeking authorization. Additionals objectives are to highlight consequential similarities and differences in regulations and evidence requirements and offer recommendations for scientists and applicants. The pivotal role that scientific evidence plays in the evaluation and approval processes is emphasized, along with the need for applicants and researchers to understand and adhere to the specific regulations of each jurisdiction. Feed additives are regulated to ensure their safety for animals, humans, and the environment, and to verify their effectiveness for the intended use of enteric CH mitigation. Regulations cover various aspects, including ingredient safety, manufacturing practices, product labeling, and the establishment of permissible limits for certain substances to ensure their safe use in animal feed. Compliance with these regulations is mandatory, and they are enforced by regulatory agencies within each jurisdiction, aiming to protect animal health, promote food safety, and prevent misleading claims and unsafe practices. The assessment processes involve evaluating scientific evidence submitted by applicants, along with evaluations of quality control procedures, and record-keeping practices. The major difference in regulations is that each jurisdiction developed unique criteria to legally classify AMFA, making it challenging to satisfy all legal classifications with a single set of criteria for scientific evidence. However, numerous similarities and a universal reliance on the concept of intended use indicate consistency across all jurisdictions on the need for robust evidence for efficacy, safety, and product quality and documentation even if the type, size, duration, and location of the studies they require differ. Recommendations are made for both scientists and applicants, emphasizing the importance of designing, conducting, and reporting scientific evaluations transparently, using validated standards and methods, and communicating with regulatory bodies to ensure compliance with regulations and evidence requirements. [Abstract copyright: The Authors. Published by Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).]