Microbiological quality is critical in cosmetics product safety assessment. European Cosmetics Regulation (EC 1223/2009) requires to provide evidences of microbiological quality of cosmetic formula, raw materials, bulk and finished products.

Specific tests are fundamental tools for safety assessors to assess the microbiological risk in cosmetic product manufacturing.

The determination of Microbiological quality evaluation typically includes the analysis of the contamination on the product (in most cases through routine testing) taking into account quantitative and qualitative specifications as the absence of specified microorganisms) and their robustness against microbiological contamination, evaluated assessing the product preservative system (challenge testing).

Some of the microbiology analyses offered include (according to either ISO, EP, USP, JP or local/clients norms):

  • Challenge Test
  • Water Activity
  • Total Counts (TYMC and TAMC) according to COSMETICS EUROPE, ISO 21149 and ISO 16212 and Pharmacopoeia EU/ USP
  • Specified microorganisms (Escherichia Coli, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans) according to COLIPA, ISO21150, 22717,22718, 18416 and Pharmacopoeia EU/ USP