Prop 65 Information

Dietary supplement cGMPs (Good Manufacturing Production) require that manufacturers take steps to ensure their products are free of contamination with objectionable microorganisms. As a result, manufacturers must be prepared to test raw materials and finished products for relevant microorganisms. The United States Pharmacopeial (USP) is a scientific nonprofit association that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, circulated and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration. By testing with QC Test Lab you can show your products are safe, reliable, and USP compliant.

Here at QC Test Lab we primarily want to help other manufacturing companies avoid the severe fines that come from not complying with California’s Prop 65 and the standards set by the United States Pharmacopeial. The lawyers of Proposition 65 are searching out manufacturing companies who sell their products in California to fine them an average of $48,000 per settlement, if you are taken to court for not complying. Prop 65 can impose a fine of $2,500 per exposure per day. We here at QC Test Lab make it easy for manufacturers to test their samples to determine if they meet the terms set by Prop 65.

“Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment. By providing this information, Proposition 65 enables Californians to make informed decisions about protecting themselves from exposure to these chemicals. Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water.”-

http://oehha.ca.gov/prop65/background/p65plain.html

Daily Limits for THE BIG 4 Heavy-Metals

USP <2023>
MICROBIAL ATTRIBUTES OF NON-STERILE NUTRITIONAL AND DIETARY SUPPLEMENTS
Recommended Microbial Limits for Botanical Ingredients and Products

                 Material

Recommended Microbial Limit Requirements (cfu/g or mL)

Dried or Powdered Botanicals

Total Aerobic Microbial Count NMT 105
Total Combined Yeast & Mold Count NMT 103
Bile-tolerant Gram-negative Bacteria NMT 103
Absence of Salmonella spp. & E.coli in 10 g

Powdered Botanical Extracts

Total Aerobic Microbial Count NMT 104
Total Combined Yeast & Mold Count NMT 103
Absence of Salmonella spp. & E.coli in 10 g

Tinctures

Total Aerobic Microbial Count NMT 104
Total Combined Yeast & Mold Count NMT 103

Fluidextracts

Total Aerobic Microbial Count NMT 104
Total Combined Yeast & Mold Count NMT 103

Infusions/Decoctions

Total Aerobic Microbial Count NMT 102
Total Combined Yeast & Mold Count NMT 10

Nutritional Supplements with Botanicals

Total Aerobic Microbial Count NMT 104
Total Combined Yeast & Mold Count NMT 103
Absence of Salmonella spp. & E.coli in 10 g

Botanicals to be treated with boiling water before use

Total Aerobic Microbial Count NMT 105
Total Combined Yeast & Mold Count NMT 103
Absence of E.coli in 10 g

Recommended Microbial Limits for Dietary Supplement Ingredients and Products

                 Material

Recommended Microbial Limit Requirements (cfu/g or mL)

Other Raw Materials and Dietary Supplement Ingredients

Total Aerobic Microbial Count NMT 103
Total Combined Yeast & Mold Count NMT 102
Absence of E.coli in 10 g

Nutritional Supplements with synthetic or highly refined Ingredients

Total Aerobic Microbial Count NMT 103
Total Combined Yeast & Mold Count NMT 102
Absence of E.coli in 10 g

NSF International Standard for Dietary Supplements
Acceptable limits for microbiological contaminants in raw materials

Ingredient

Aerobic

Yeast/Mold

Enterobacteriaceae

Vitamin and/or mineral ingredient

1 x 103 CFU/g

1 x 102 CFU/g

1 x 102 CFU/g

Botanical ingredient – extract / Other dietary supplement ingredient

1 x 104 CFU/g

1 x 103 CFU/g g

1 x 102 CFU/g

Botanical ingredient – non-extract

1 x 107 CFU/g

1 x 105 CFU/

1 x 104 CFU/g

Acceptable limits for pathogenic microbiological contaminants in raw materials

Ingredient

Salmonella
sp.

Escherichia
coli1

Staphylococcus aureus

Vitamin and/or mineral ingredient

ND(2)

ND(2)

ND(2)

Botanical ingredient – extract / Other dietary supplement ingredient

ND(2)

ND(2)

ND(2)

Botanical ingredient – non-extract(1)

ND(2)

1 x 102 CFU/g

ND(2)

(1) Upon the presence of Escherichia coli, 7.3.6.2 is to be followed to determine whether the colonies are enterovirulent. There is a zero tolerance for the presence of enterovirulent Escherichia coli.
(2) ND = Not Detected. Not Detected requires that no colonies shall be present in 10 g of sample when tested under the conditions of the USP method cited in 7.3. The detection level for this testing is 10 CFU/g for the period of time tested.

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