Recommended Microbial Limits for Botanical Ingredients (in colony-forming units (cfu)/g)
© AHPA 2014
[Current as of July 2012]
Organization AHPA NSF/ANSI USP WHO EHIA EP AHPA USP
Dried,
unprocessed Powdered
Botanical Dried or Untreated crude Powdered
herbs for use as botanical
Plant material ingredient, powdered intended for further NA NA botanical
ingredients in extracts
non-extract botanicals processing extracts
dietary and soft
supplements extracts
NA or 105-107 as per
7 7 5
Total aerobic microbial count 10 10 10 specific NA NA 104 104
monographs
105 (mold
Total combined yeast & mold propagules);
105 105 103 NA NA 103 103
count Occasionally 104 for
specific monographs
Enterobacteria count (bile- 104 (Total 102 (Total
104 103 103 NA NA NA
tolerant Gram-negative bacteria) coliforms) coliforms)
Not
Not detected in Absence Absence
Escherichia coli 102** 104 NA NA detected
10 g* in 10 g in 10 g
in 10 g*
Not
Not detected in Not detected in Absence Absence
Salmonella spp. NA or absent NA NA detected
25 g* 10 g in 10 g in 10 g
in 25 g*
Not detected in
Staphylococcus aureus NA NA NA or absent NA NA NA NA
10 g
AHPA – American Herbal Products Association, Guidance, 8630 Fenton St. #918, Silver Spring, MD 20910; 301-588-1171.
EHIA – European Herbal Infusions Association
EP – European Pharmacopoeia
NSF/ANSI – NSF International Standard/American National Standard for Dietary Supplements 173 – 2006
USP – United States Pharmacopeial Convention, USP-NF 35-30, 2012
WHO – World Health Organization, Quality control methods for medicinal plant materials, Geneva, 1998
NA – Not Assigned
*Sample size may vary depending on the method used.
**If the presence of Escherichia coli is confirmed, then testing shall be performed based on the USFDA Bacteriological Analytical Manual in Chapter 4A to
determine whether the colonies are pathogenic enterovirulent Escherichia coli (EEC), not limited to 0157:H7. There is a zero tolerance for the presence of
EEC.
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Recommended Microbial Limits for ‘Finished’ Botanical Products (in colony-forming units (cfu)/g)
© AHPA 2014
[Current as of July 2012]
Organization AHPA EP EP NSF/ANSI USP WHO AHPA NSF/ANSI
Herbal Herbal
Antimicrobial pre-
supplements in supplements
treatment and/or If pretreatment Containing Containing Plant
solid form in solid form Containing
microbial or process fail botanical botanical materials
Product consisting of
reduction in to achieve ingredients, ingredients for internal
consisting of botanical
dried, powdered extract
production compliance non-extract use
unprocessed extracts or soft
process
herbs extracts
Total aerobic
107 104** 105** 107 104 105 104 104
microbial count
Total combined
105 102** 104** 105 103 103 103 103
yeast & mold count
Enterobacteria
103 (inc.
count 104 (total 2 102
10 certain 104 NA 103 102
(bile-tolerant Gram- coliforms) (coliforms)
others)***
negative bacteria)
Not
Not detected in Absence Not detected
Escherichia coli Absent in 1 g Absent in 1 g 102**** 10 detected
10 g* in 10 g in 10 g*
in 10 g
Not Not
Not detected in Absent in absence Not detected
Salmonella spp. Absent in 25 g detected in none detected
25 g* 10 g in 10 g in 25 g*
10 g in 10 g
Not Not
Staphylococcus
NA NA NA detected in NA NA NA detected
aureus
10 g in 10 g
AHPA – American Herbal Products Association, Guidance, 8630 Fenton St. #918, Silver Spring, MD 20910; 301-588-1171.
EHIA – European Herbal Infusions Association
EP – European Pharmacopoeia Edition 6.8, Chapter 5.8.1 – Category B and C
NSF/ANSI – NSF International Standard/American National Standard for Dietary Supplements 173 – 2006
USP – United States Pharmacopeial Convention, USP-NF 35-30, 2012
WHO – World Health Organization, Quality control methods for medicinal plant materials, Geneva, 1998
NA – Not Assigned
*Sample size may vary depending on the method used.
** Acceptance criterion. Maximum acceptable count is five times this value.
***Other types of organisms (e.g. Aeromonas, Pseudomonas) may be recovered.
****If the presence of Escherichia coli is confirmed, then testing shall be performed based on the USFDA Bacteriological Analytical Manual in Chapter 4A to
determine whether the colonies are pathogenic enterovirulent Escherichia coli (EEC), not limited to 0157:H7. There is a zero tolerance for the presence of EEC.
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