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. 2022 Jan 9;31(2):167–199. doi: 10.1007/s11248-021-00294-3

Table 1.

Approaches to oversight of food safety of products of animal biotechnology in selected countries and supranational groups

Country/Union Regulatory agency Regulatory policy for GM animals? Consistent with Codex Alimentarius? GM animal product approved for food? Regulatory policy for GnEd animals? Supporting presentation or reference
Argentina SENASAa Yes Yes No Yesb Maggi (2020) and Whelan (2020)
Australia/New Zealand Food Standards Australia New Zealand Yes, Food Standards Australia New Zealand Act 1991 Yes No No; Code under review Kelly (2020)
Brazil CTNBioc Yes, Biosafety Law 11,105, 2005; also see 28 Normative Resolutions Yes Yes Yes Finardi (2020)
Canada Canadian Food Inspection Agency, Health Canada, othersd Yes Yes Yes NAe Cianciarelli (2020)
Japan Ministry of Health, Labor, and Welfare Yes Yes No Yes Tsuda and Ohsawa (2020)
Philippines Department of Agriculture, Bureau of Animal Industry No Yes No No Mingala (2020)
South Africa Department of Science and Innovation Yes Yes No No Groenewald (2020)
United States Department of Health and Human Services, Food and Drug Administration; othersf,g Yes Yes Yes Yes Kanelakis (2020)
African Unionh NA NA NA NA Nengomasha (2020)
European Union European Food Safety Authority Yes Yes No No EFSA (2012)

aServicio Nacional de Sanidad y Calidad Agroalimentaria

bUpdated policy under consideration

cNational Biosafety Technical Commission

dOthers as appropriate to application, may include Environment and Climate Change Canada, Department of Fisheries and Oceans, Agriculture and Agri-Food Canada, Global Affairs Canada, and Innovation, Science and Economic Development Canada

eCanada’s regulations are product-based. The method of genetic modification does not determine whether a safety assessment is required; 'novelty' of product is regulatory trigger for pre-market assessment. Canada has a Proposed new guidance for Novel Food Regulations focused on plant breeding

fU.S. Department of Agriculture (USDA), Animal and Plant Health Inspection and Food Safety and Inspection Service released an Advanced Notice of Proposed Rulemaking in December 2020 that may result in a shift of regulatory jurisdiction for some products

gUSDA, Food Safety and Inspection Service is responsible for the final safety determination and labeling for certain products, such as meat

hA union of 55 African member states aimed at promoting economic and political integration. Strategy and advisory role, rather than regulatory