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Recommended Microbial Limits for Botanical Ingredients (in ...

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.

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

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Transcription of Recommended Microbial Limits for Botanical Ingredients (in ...

1 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.

2 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.

3 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.

4 There is a zero tolerance for the presence of EEC. -1- 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.

5 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.

6 #918, Silver Spring, MD 20910; 301-588-1171. EHIA European Herbal Infusions Association EP European Pharmacopoeia Edition , Chapter 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.

7 **Other types of organisms ( 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. -2.


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