Vietnam’s Ministry of Health introduced the “National technical regulation on the limits of contaminants for health supplements / dietary supplements” last month, having released a draft version last June.
The document listed limits on heavy metals, microorganisms, as well as sampling and testing methods for health supplements based on the ASEAN Guidelines on Limits of Contaminants for Health Supplements.
Prior to this, Vietnam regulated the levels of contaminants permitted in food supplements together with general foods under the "National technical regulation on the limits of heavy metals contamination in food."
In the new regulation, Vietnam is following the ASEAN guidelines by keeping the maximum level of arsenic at 5mg/kg, while adding a maximum limit of 1.5mg/kg for inorganic arsenic at the same time.
The country is also limiting cadmium at 3mg/kg in ingredients derived from seaweed or bivalve molluscs. Cadmium in ingredients derived from all other sources is limited at 1mg/kg.
The above however, is higher than the ASEAN guidelines, where cadmium is limited at 0.3mg/kg.
Two other heavy metals, namely mercury and lead are kept at 0.5mg/kg and 10mg/kg respectively, which is the same for both Vietnam and the ASEAN guidelines.
These levels, however, are higher than the existing amounts permitted by Vietnam. Currently, mercury is kept at a maximum limit of 0.1mg/kg and lead at 3mg/kg.
Tonic wine products would not be affected by the new contaminant limits, the Vietnamese health ministry added.
The notice also included maximum microbial limits permitted in health supplements containing ingredients from plants.
For example, the total aerobic microorganisms are limited at 50k CFU/g or CFU/mL. Total yeast and mould count is to be kept at 500 CFU/g or CFU/mL.
These are similar to ASEAN guidelines, except that Vietnam has added maximum limits for Enterobacteriaceae – a bile-tolerant gram-negative bacteria, with limits at 100 CFU/g or CFU/mL.
The Vietnamese health authorities added that if the plant-derived health supplements contained probiotics, the limits on 1) total aerobic microorganisms or 2) total yeast and mould count would not be required – depending on whether the probiotics is spore or non-spore forming.
In this case, spore-forming probiotics are required to keep their total yeast and mould count at a maximum limit of 100 CFU/g or CFU/mL.
Non-spore-forming probiotics need to follow the same rule, as well as limiting its non-lactic acid bacteria count to 500 CFU/g or CFU/mL.
The notice also listed maximum microbial limits for probiotics belonging to the yeast group.
“Organisations and individuals producing and trading health protection foods are responsible for the products, ensuring that the health protection food products they produce and trade comply with the requirements of this technical regulation and relevant legal provisions,” the authorities said in the notice.