Status of probiotic regulations in Southeast Asia countries

Abstract

This review summarises the key components of the available probiotic regulations in six Southeast Asia countries (Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam). Diverse approaches have been undertaken by the countries in regulating the marketing and sale of probiotics in foods and health supplements. Only Indonesia, Malaysia, Philippines and Thailand have enacted specific regulations which include their respective legal definition of probiotics. Only Malaysia, Philippines and Thailand publish a list of microorganisms permitted to be used as probiotics in foods or health supplements; the approved microorganisms are not harmonised among these countries. All six countries allow the application for new microorganisms to be used, but have adopted differing requirements and approaches. A common requirement is that all applications must be accompanied by scientific data to demonstrate clinically that the microorganisms are safe and provide health benefits. All the countries, except Indonesia and Vietnam permit the use of a small number of pre-approved generic function claims. It is noted that the countries have different specific labelling requirement for products containing probiotics. The divergent probiotic regulations in the region, either for foods or health supplements, creates inconsistencies and difficulties for all stakeholders including regulators, academia, industries and consumers, as well as impacting trade among countries. This review highlights the importance of having regulatory control to ensure consumers have access to safe, genuine and efficacious probiotic products. We propose working towards a harmonised probiotics regulation in the region to enable further development and progress of probiotics in the region.