Replacement of the Acceptance Criteria for Microbiological Quality of Herbal Medicinal Products for Oral Use according to Ph. Eur. 6th Edition, Supplement 6.7, chapter 5.1.8 valid from April 01st, 2010

 

Category A: Herbal medicinal products containing herbal drugs, with or without excipients, intended fort he preparation of infusions and decoctions using boiling water (for example herbal teas, with or without added flavourings)

 

TAMC (2.6.12)

Acceptance criterion:
 ≤ 107CFU/g
Maximum acceptable count:
50.000.000 CFU/g
TYMC (2.6.12) Acceptance criterion:
 ≤ 105 CFU/g
Maximum acceptable count:
500.000 CFU/g
Escherichia coli (2.6.31)                                    Acceptance criterion:
 ≤ 103 CFU/g
Salmonella (2.6.31)     Absence (25 g)        

 

 

Category B: Herbal medicinal products containing, for example, extracts and/or herbal drugs, with or without excipients, where it can be demonstrated that the method of processing (for example, extraction) or, where appropriate, in the case of herbal drugs, of pre-treatment reduces the level of organisms to below those stated for this category

 

TAMC (2.6.12)

Acceptance criterion:
 ≤ 104 CFU/g or CFU/ml
Maximum acceptable count:
50.000 CFU/g or CFU/ml
TYMC (2.6.12)

Acceptance criterion:
 ≤ 102 CFU/g or CFU/ml
Maximum acceptable count:
500 CFU/g or CFU/ml
Bile-tolerant gram-negative bacteria (2.6.31) Acceptance criterion:
 ≤ 102 CFU/g or CFU/ml
Salmonella (2.6.31)     Absence (25 g or 25 ml)             

 

 

Category C: Herbal medicinal products containing, for example, extracts and/or herbal drugs, 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, in the case of herbal drugs, of pre-treatment, would not reduce the level of organisms sufficiently to reach the criteria required under B

 

TAMC (2.6.12)

Acceptance criterion:
 ≤ 105 CFU/g or CFU/ml
Maximum acceptable count:
500.000 CFU/g or CFU/ml
TYMC (2.6.12) Acceptance criterion:
 ≤ 104 CFU/g or CFU/ml
Maximum acceptable count:
50.000 CFU/g or CFU/ml
Bile-tolerant gram-negative bacteria (2.6.31) Acceptance criterion: 
 ≤ 104 CFU/g or CFU/ml
Escherichia coli (2.6.31) Absence (1 g or 1 ml)
Salmonella (2.6.31) Absence (25 g or 25 ml)

 

If you need help, we'll find the solution!
We would be glad to answer any questions you may have.

 

Dr. Wolfgang Leis
Head of Microbiology


Tel: +49-721-9737-113

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Ria Sporn
Head of the Microbiological Laboratory

 

Tel: +49-721-9737-150

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