• TPC in products

    Posted by Stanley on December 13, 2021 at 11:17 pm

    What is generally acceptable total plate count for cosmetics?  having issues with a RM that is hard to replace that is causing high counts.

    PhilGeis replied 2 years, 11 months ago 2 Members · 7 Replies
  • 7 Replies
  • PhilGeis

    Member
    December 14, 2021 at 3:03 pm

    Most major manufactuers use 100 cfu/g for all produicts.  
    FDA offers “Since there are no widely acceptable standards for numbers, temporary guidelines are used instead. For eye-area products, counts should not be greater than 500 colony forming units (CFU)/g; for non-eye-area products, counts should not be greater than 1000 CFU/g. “

  • Stanley

    Member
    December 15, 2021 at 11:14 pm

    @PhilGeis
    thank you for this information! 

  • Stanley

    Member
    December 27, 2021 at 4:40 pm

    @PhilGeis
    FDA offers “Since there are no widely acceptable standards for numbers, temporary guidelines are used instead. For eye-area products, counts should not be greater than 500 colony forming units (CFU)/g; for non-eye-area products, counts should not be greater than 1000 CFU/g. “

    May I trouble you to ask exactly where is that written? In my own searches I have seen this but nothing leading back to the source.

  • PhilGeis

    Member
    December 27, 2021 at 5:10 pm

    Sure - it was in an older version of https://www.fda.gov/food/laboratory-methods-food/bam-chapter-23-methods-cosmetics.

    Current wording (revised this month) and thanks for asking - this changed just this last week!

    Current, widely accepted standards for microbiological limits in cosmetics specify that the total number of microorganisms per gram or milliliter generally should not exceed:

    • 1×102 colony forming units (CFU)/g or mL for cosmetics intended topically (i.e., applied to the surface of the body) for the eye area, mucous membranes, and children < 3 years old; and
    • 1×103 CFU/g or mL for all other topical cosmetics.
  • PhilGeis

    Member
    December 27, 2021 at 5:22 pm

    the heart above reads “<3”  in text.

    the section goes on to say
    The presence of pathogens would also be important in evaluating the microbial contents of a cosmetic. Pathogens or opportunistic pathogens whose incidence would be of particular concern include Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. Additionally, microbes normally regarded as nonpathogenic when introduced in certain ways (e.g., topically) may become opportunistic pathogenic and virulent when introduced in other ways (e.g., in wounds, or via cosmetics introduced into or through the skin).

  • Stanley

    Member
    December 27, 2021 at 8:12 pm

    Okay found it… wow, thank you very much!  Just to make sure I understand the exponentials….1×102 is 100 and the 1×103 is 1000   cfu… I am assuming the 2 and 3 are exponentials.

  • PhilGeis

    Member
    December 28, 2021 at 11:54 am

    Stanley said:

    Okay found it… wow, thank you very much!  Just to make sure I understand the exponentials….1×102 is 100 and the 1×103 is 1000   cfu… I am assuming the 2 and 3 are exponentials.

    Yup

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