Limits of contaminants for dietary supplements in Vietnam

Draft of limits of contaminants for dietary supplements in Vietnam

Post date: 15-06-2023

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The Ministry of Health of Vietnam is drafting limits of contaminants for dietary supplements in Vietnam in accordance with international practices, specifically according to Annex III - ASEAN Guidelines on Limits of Contaminants for Health Supplements.

1. Limit on heavy metals:

Limit on heavy metals for dietary supplements in Vietnam are specified in Table 1.

Table 1. Limit on heavy metals

No	Items	Maximum limit (ML) (mg/kg or mg/L)
1	Arsenic (As)	5
2	Cadmium (Cd)	0,3
3	Chì (Pb)	10
4	Thủy ngân (Hg)	0,5

2. Limit for microbial contaminations

2.1. For dietary supplements that do not contain probiotics.

The maximum limits for microorganisms in dietary supplements that do not contain probiotics are specified in Table 2.

Table 2. Limit for microbial contaminations

No	Category	Criterias	Maximum limit (ML)
1	Dietary supplements containing material of plant origin, with or without excipients, intended for the preparation of infusions and decoctions using boiling water (for example herbal teas, with or without added flavourings)	Total aerobic microbial count	≤ 5 x 10⁷CFU/g (CFU/mL)
		Total combined yeasts/moulds count	≤ 5 x 10⁵CFU/g (CFU/mL)
		Escherichia coli	≤ 1 x 10³CFU/g (CFU/mL)
		Salmonella	Absence in 25g (mL)
2	Dietary supplements containing materials of plant origin, with or without excipients, where the method of processing (for example, extraction) or pre treatment reduces the levels of organisms to below those stated for this category	Total aerobic microbial count	≤ 5 x 10⁴CFU/g (CFU/mL)
		Total combined yeasts/moulds count	≤ 5 x 10²CFU/g (CFU/mL)
		Bile tolerant gram negative bacteria	≤ 1 x 10² CFU/g (CFU/mL)
		Escherichia coli	Absence in 1g (mL)
		Salmonella	Absence in 25g (mL)
3	Dietary supplements containing materials of plant origin, with or without excipients, where it can be demonstrated that the method of processing (for example, extraction with low strength ethanol or water that is not boiling or low temperature concentration) or, of pre treatment, would not reduce the level of organisms sufficiently to reach the criteria required under 2	Total aerobic microbial count	≤ 5 x 10⁵CFU/g (CFU/mL)
		Total combined yeasts/moulds count	≤ 5 x 10⁴CFU/g (CFU/mL)
		Bile tolerant gram negative bacteria	≤ 1 x 10⁴CFU/g (CFU/mL)
		Escherichia coli	Absence in 1g (mL)
		Salmonella	Absence in 25g (mL)
4	Dietary supplements containing materials of natural (animal, plant or mineral) origin for which antimicrobial pre treatment is not feasible and for which the competent authority accepts TAMC of the raw material exceeding 103 CFU/gram or CFU/mL	Total aerobic microbial count	≤ 2 x 10⁴CFU/g (CFU/mL)
		Total combined yeasts/moulds count	≤ 2 x 10²CFU/g (CFU/mL)
		Bile tolerant gram negative bacteria	≤ 1 x 10²CFU/g (CFU/mL)
		Escherichia coli	Absence in 1g (mL)
		Salmonella	Absence in 10 g (mL)
		Staphylococcus aureus	Absence in 1g (mL)
5	Aqueous preparations (Water is the formula ingredient of the product) which does not fall under category 1,2, 3 or 4 above	Total aerobic microbial count	≤ 2 x 10²CFU/g (CFU/mL)
		Total combined yeasts/moulds count	≤ 2 x 10 CFU/g (CFU/mL)
		Escherichia coli	Absence in 1 g (mL)
6	Non-aqueous preparations (Water is the formula ingredient of the product) which does not fall under category 1, 2, 3 or 4	Total aerobic microbial count	≤ 2 x 10³CFU/g
		Total combined yeasts/moulds count	≤ 2 x 10²CFU/g
		Escherichia coli	Absence in 1 g (mL)

2.2. For dietary supplements that contain probiotics.

For dietary supplements containing probiotics, the limit for microbial contaminations specified in Table 2 will apply, except for the microbial contaminations do not specified for each category in Table 3.

Table 3. Uncontrolled microbial contaminations

No	Category	Uncontrolled microbial contaminations
1	Dietary supplements containing probiotics with aerobic microbial (i.e Bacillus spp.,..).	Total aerobic microbial count
2	Dietary supplements containing probiotics with yeasts/moulds (i.e Saccharomyces spp etc)	Total combined yeasts/moulds count
3	Dietary supplements containing probiotics with facultative anaerobic and anaerobic microorganisms (i.e: Bifidobacterium spp., Lactobacillus spp, Streptococcus spp etc.).	Nil