Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May, the U.S. Food and Drug Administration (FDA) published a revision of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".

It is well known that cosmetic products can be contaminated by microorganisms and that these MO often can grow and reproduce in cosmetic products. This causes the risk of spoilage or chemical changes in cosmetic products and injury to the user. Therefore, a microbiological quality control of cosmetic products is essential. Moreover, due to a decreasing use of potential allergenic preservatives, it is of increasing importance.

Chapter 23 of the Bacteriological Analytical Manual says : "Methods for isolation of microorganisms from cosmetic products are direct colony counts and enrichment culturing. Products that are not soluble in water are initially treated to render them miscible before isolation procedures are conducted. Dilution and plating media that partially inactivate preservative systems commonly found in cosmetic products are used. The isolated microorganisms are identified by routine microbiological methods or by commercial identification kits."

To provide information and guidance for the selection and use of such methods, the document comprises information about:

  • Equipment and materials
  • Media for enumeration and identification of Gram-positive bacteria and fungi
  • Media for identification of Enterobacteriaceae
  • Media and reagents for identification of Gram-negative non fermentative (NF) bacilli
  • Other media and reagents
  • Handling of cosmetic samples for microbiological analysis
  • Preliminary sample preparation
  • Microbiological evaluations - incl. aerobic plate count, fungii, yeasts and mold plate count, anaerobic plate count, identification methods and examination of biochemical results

The current revisions of the chapter are the following:

  • Section H.1. Changed dilution range from 10-1 - 10-6 to 10-1 - 10-3.
  • Section H.4. Deleted the entire section: Screening test for total numbers of microorganisms.
  • Section: Identification of Microbes updated: A.1. Gram-positive rods. Identify Bacillus-like rods if isolated from aerobic plates.

To get more detailed information please see the complete Chapter 23 Microbiological Methods for Cosmetics including the current changes.

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