Around the World - A comprehensive review of probiotic claim regulations: updates from the Asia-Pacific regions, the United States, and Europe
USA
Dec 06, 2024
Probiotics are defined, classified, and regulated differently across countries, which affects consumer protection and market access for manufacturers. This review examined the regulatory similarities and differences for probiotics in the APAC region, the U.S., and Europe to address these challenges.
Probiotics are categorized in the U.S., Europe, Japan, Thailand, Malaysia, Singapore, and Indonesia, with Malaysia, Singapore, and Indonesia also classifying them as "health supplements." Other terms like “functional food," "novel food," and "health functional food" are used in various countries. Claims for probiotics also vary internationally. Countries such as China, the Philippines, and Singapore have pre-approved claims, while the U.S., South Korea, Australia & New Zealand, and India require scientific evidence before approval. Europe enforces the strictest rules and does not approve any probiotic health claims, whereas the U.S. and APAC regions are more flexible. In Japan and Australia & New Zealand, the claim of “reducing disease risk” is permitted.
Harmonizing these regulations could benefit consumers and manufacturers by ensuring consistent standards and facilitating market entry. This would help industry stakeholders navigate the complex regulatory landscape and aid consumers in understanding probiotic claims.
Author(s): Garg, V., Velumani, D., Lin, Yu-C & Haye, A.
Published in: PharmaNutrition.
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