 
   
  
Association of South East Asian Nations (ASEAN)  
  
ANNEX  III 
ASEAN  GUIDELINES  ON LIMITS  OF 
CONTAMINA NTS FOR  HEALTH  
SUPPLEMENTS   
 
Disclaimer:  
This document is provided for inform ation purpose only and subject to changes, pending the finalisation of 
the ASEAN Agreement on Regulatory Framework for Health Supplements. Official references to this 
document can only be made once the said Agreement has been finalised.  
Version 2.0  ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 DOCUMENT INFORMATION  
 
This version is adopted at the 27th ACCSQ TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS 
SCIENTIFIC COMMITTEE MEETING (ATSC) 1 -2 June 2015, Kuala Lumpur, Malaysia and endorsed at 
the 23rd  ACCSQ TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING 
GROUP (TMHSPWG) MEETING 4-5 June  2015, Kuala Lumpur, Malaysia.  
  
  
  
  
  
  
  
  
 
  
 
 
 
 
 
 
Version 
No. History of adoption and endorsement  Reasons for revision  ATSC adoption date  TMHSPWG endorsement date  
1 18th ATSC Meeting  
11– 14 March 2013  19th TMHSPWG Meeting  
28-29 June 2013  - 
2 27th ATSC Meeting  
1-2 June 2015  23rd TMHSPWG Meeting  
4-5 June  2015   
 To include a table of  “History of Changes” under 
“Document Information”  
 To replace “litre” to “L” and “ml” to “mL”  
 To amend the first paragraph under “Section 3.Pesticide 
Residues”  
 To remove “Task Force’s “  for examples of International 
guidelines/standards on pesticide residue  
 
  ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 CONTENTS  
Introduction  ................................ ................................ ................................ ................................ ........................  3 
Objective  ................................ ................................ ................................ ................................ ............................  3 
ASEAN Limits of Contaminants for HS  ................................ ................................ ................................ ............  3 
1.     Limit on heavy metals:  ................................ ................................ ................................ .............................  3 
2.     Limit for Microbial Contaminations  ................................ ................................ ................................ ....... 4 
3.     Pesticide Residues  ................................ ................................ ................................ ................................ .... 6  ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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Introduction  
The ASEAN Guidelines on Limits of Contaminants for Health Supplements (HS) is developed by 
taking into consideration the safety and quality requirements of HS.  
Other limits  of contaminants may be reviewed and included into the guideline as deemed 
necessary.  
In determining the limits of microbial contamina tion, the following was taken into consideration:  
     The nature of the product whether it is a pure compound, an extrac t, raw 
material or its combination.  
     The route of administration.  
     The method of preparation, e.g boiling.  
Objective  
The objective of these guidelines is to provide specifications on the limits of heavy metals and 
microbial contaminants of the v arious dosage forms to ensure their quality and safety. These 
guidelines also provide guidance notes on the control of pesticides in HS.  
ASEAN Limits of Contaminants for HS  
 
1.     Limit on heavy metals:  
Maximum limit for heavy metals:  
1.1.     Lead: NMT 10.0 mg/kg or 10.0 mg/ L (10.0ppm)  
1.2.     Arsenic: NMT 5.0 mg/kg or 5.0 mg/ L (5.0ppm)*  
1.3.     Mercury: NMT 0.5 mg/kg or 0.5 mg/ L (0.5ppm)  
1.4.     Cadmium: NMT 0.3 mg/kg or 0.3 mg/ L (0.3ppm)   ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 Note:  *Due to special circumstances such as national regulator y requirement, the limits of 
arsenic in the Philippines is 0.3 mg/kg or 0.3 mg/ L (0.3 ppm)  
2.     Limit for Microbial Contaminations  
The limit used is based on British Pharmacopoeia (2013). Hence, the specifications may change 
as required according to the compendium requirements from time to time.  
The list is not necessarily exhaustive and for a given preparation, it may be necessary to test for 
other micro -organisms depending on the nature of the starting materials and in the 
manufacturing process.  
Test fo r Microbial Contamination  
  
Table I Microbiological Quality of Health Supplement (not applicable to products containing 
viable microorganisms as active ingredients)  
  
Route of Administration  Acceptable criteria for microbiological quality  
TAMC  
(CFU/g or  CFU/ 
mL) TYMC 
(CFU/g or CFU/ 
mL) Specified 
Microorganisms  
For Oral Use  
A.     Health supplement 
products 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)  NMT 5 x 107 NMT 5 x 105 -     NMT 103 CFU of 
Escherichia coli  in 1g 
or 1m L 
  
-     Absence of 
Salmonella  in 25g or 
25mL 
B.     Health supplement 
products 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 NMT 5 x 104 NMT 5  x 102 -     NMT 102 CFU of bile -
tolerant gram -
negative bacteria in 
1g or 1m L 
  
-     Absence of 
Escherichia coli  in 1g 
or 1mL   ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 category    
-     Absence of 
Salmonella  in 25g or 
25mL 
C.     Health supplement 
products 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 s ufficiently to 
reach the criteria required 
under B  NMT 5 x 105 NMT 5 x 104 -     NMT 104 CFU of bile -
tolerant gra m-
negative bacteria in 
1g or 1mL  
  
-     Absence of 
Escherichia coli  in 1g 
or 1m L 
  
-     Absence of 
Salmonella  in 25g or 
25mL 
D.     Health supplement 
products 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/m L NMT 2 x 104 NMT 2 x 102 -     NMT 102 CFU of bile -
tolerant gram -
negative bacteria in 
1g or 1m L 
  
-     Absence of 
Salmonella  in 10g or 
10mL 
  
-     Absence of 
Escherichia coli  in 1g 
or 1m L 
  
-     Absence of 
Staphylococcus 
aureus  in 1g or 1m L 
E.     Aqueous preparations 
which does not fall under 
category A, B, C or D  NMT 2 x 102 NMT 2 x 10  -     Absence of 
Escherichia coli  in 1g 
or 1m L  ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 F.     Non-aqueous 
preparations which does 
not fall under category A, 
B, C or D  NMT 2 x 103 NMT 2 x 102 -     Absence of 
Escherichia coli  in 1g 
or 1mL  
  
Not all member states will allow all the route of  administration mentioned above  
The limits for microbial contamination for  Health Supplements with routes of administration not 
specified above shall be determined by the regulatory authority of each Member State.  
3.     Pesticide Residues  
The safety and quality of plant materials and finished products  containing materials of plant 
origin  have become a major concern for health authorities, pharmaceutical industries and the 
public. Undesirable and/or undeclared substances have been present or have been purported 
to be present in plant materials or products containing materials of plant origi n in many parts of 
the world. These substances have included pesticides, radioactive particles , microbes including 
pathogens, mycotoxins and heavy metals.  
The control on pesticides will not be on finished products as:  
-     the risk is very low due to the  small unit size and also the dilution effect from 
other non -pesticide containing ingredients and excipients.  
-    pesticides are internationally regulated and there are global 
harmonizations on regulations currently in process.  
-     currently no other ec onomic bloc has regulations on pesticide residues in  
health supplements  
The onus is on the suppliers of raw materials and manufacturers of HS products to ensure that the 
raw materials supplied and used comply with the law.  
The control of pesticide residue s in raw materials should be covered under Good Agriculture 
Practice (GAP).   ASEAN Guidelines on Limits of Contaminants for Health Supplements   
 
 
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 Emphasis is on the raw material supply and reliance is thus placed on horizontal legislation rather 
than vertical legislation.  
Recommendations  
Pesticide Residue limits should remai n under review and if conditions change in the future, for 
example, from post marketing surveillance data, a new assessment for the need of the limits for 
the finished product can be conducted, taking into consideration international 
guidelines/standards.1 
Steps to be taken by each member country on pesticide control:  
1.     To promote closer cooperation and liaison between Ministry of Health and 
the ministries responsible for co ntrol of pesticides and GAP in agricultural 
products (in most countries it will be the Ministry of Agriculture).  
2.     To reinforce, during GMP training on the need for manufacturers to be 
responsible and not to accept raw materials that do not comply wit h 
applicable pesticide residue limits.  
  
  
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GLOSSARY  
NMT  Not More Than  
TAMC  Total Aerobic Microbial Count  
TYMC  Total Combined Yeasts/Moulds Count  
CFU  Colony Forming Unit  
  
 
1 Below are examples of International guidelines/standards on pesticide residues for reference:  
A.     WHO has suggested that the limits for pesticide residues to be established 
following the recommendations of the Food and Agriculture Organization 
of Unite d Nations and WHO for food and animal feed. Analytical 
methodology for the assessment of specific pesticides residues for 
medicinal plant materials are described in the WHO guidelines on QC 
methods for medicinal plants.  
B.     EMEA guideline on specificati ons; test procedures and acceptance 
criteria for herbal substances, herbal preparations and herbal medicinal 
products/traditional herbal medicinal products (CPMP/QWP/2820/00 Rev 
1). The guideline states that where possible, the limit of pesticide residues 
should be controlled at the herbal substance and/or herbal preparations 
(e.g. extraction) level.  
C.     BP has established limits for pesticide residues in herbal drug (i.e. whole, 
fragmented, or cut plants parts of plants, algae, fungi or lichen, in an 
unprocessed state, usually in dried form but sometimes fresh). USP also has 
established analytical methods and limits for pesticide residues in articles 
of botanical origin.  
 
 