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16.06.2017 - Microbiology

Requirements of DIN EN ISO 17516 (Cosmetic products – Microbiological limits)

Requirements and Implementation

A fundamental change is coming in the presentation and evaluation of microbiological results (colony count determinations) of cosmetic samples. 
In this process, we aim to implement the requirements of DIN EN ISO 17516 (Cosmetic products – Microbiological limits) and thereby replace the previous evaluation according to SCCS recommendations, ensuring that we remain at the technical forefront for you. 
The foundations for evaluation according to DIN EN ISO 17516 can be found in Table 1. 

Table 1: Microbiological limits for cosmetics according to ISO 17516

* CFU = Colony Forming Units 

Due to unavoidable measurement uncertainties of the testing method, there is a limit exceedance of the results as also found in the American Pharmacopeia (Chapter 61) or the European Pharmacopeia (Chapter 2.6.12), at 

a > 200 CFU/g or ml, 
b > 2,000 CFU/g or ml 

This results in two major changes to the previous procedure: 

• The evaluation of the total number of aerobic mesophilic microorganisms is carried out after forming a sum of the two parameters:    
  • Aerobic mesophilic bacteria
  • Yeasts and molds
• The limit values of ISO 17516 for the total number of aerobic mesophilic microorganisms take measurement uncertainties into account and are thus somewhat more lenient than with SCCS recommendations (a factor of 2 is typically considered in the evaluation)

Examples of result presentation: