Tricarico Juan M, Garcia Florencia, Bannink André, Lee Sang-Suk, Miguel Michelle A, Newbold John R, Rosenstein Peri K, Van der Saag Matthew R, Yáñez-Ruiz David R
Dairy Management Inc., Rosemont, IL 60018.
Universidad Nacional de Córdoba, Facultad de Ciencias Agropecuarias, 5000 Córdoba, Argentina.
J Dairy Sci. 2025 Jan;108(1):395-410. doi: 10.3168/jds.2024-25051.
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.
本文介绍了旨在减少反刍动物肠道甲烷（CH）排放的抗产甲烷饲料添加剂（AMFA）授权所需的监管和证据要求。文章概述了澳大利亚、加拿大、欧盟、新西兰、韩国、英国和美国的立法及法律程序，作为示例，为寻求授权的申请人提供见解。其他目标是突出法规和证据要求方面的相应异同，并为科学家和申请人提供建议。强调了科学证据在评估和批准过程中所起的关键作用，以及申请人和研究人员了解并遵守各司法管辖区具体法规的必要性。对饲料添加剂进行监管，以确保其对动物、人类和环境的安全性，并验证其在减少肠道CH排放预期用途方面的有效性。法规涵盖多个方面，包括成分安全性、生产规范、产品标签以及确定某些物质的允许限量，以确保其在动物饲料中的安全使用。遵守这些法规是强制性的，由各司法管辖区内的监管机构执行，旨在保护动物健康、促进食品安全并防止误导性声明和不安全做法。评估过程包括评估申请人提交的科学证据，以及对质量控制程序和记录保存做法的评估。法规的主要差异在于，每个司法管辖区都制定了独特的标准来对AMFA进行法律分类，这使得用一套单一的科学证据标准来满足所有法律分类具有挑战性。然而，众多的相似之处以及对预期用途概念的普遍依赖表明，即使各司法管辖区要求的研究类型、规模、持续时间和地点不同，但在对有效性、安全性、产品质量和文件的有力证据需求方面，所有司法管辖区都是一致的。针对科学家和申请人都提出了建议，强调透明地设计、开展和报告科学评估的重要性，使用经过验证的标准和方法，并与监管机构沟通以确保符合法规和证据要求。
