Melbec Microbiology’s team of scientists has extensive expertise in the field of claim support and product release for the cosmetic and personal care industry. Testing is carried out to assist in compliance with the Cosmetic Regulation (EC) 1223/2009 (which includes Preservative Efficacy, Stability and Batch Release testing) and also with various stages of the product development process.

To market a cosmetic product in the UK (and Europe), products must be registered on the Cosmetic Product Notification Portal (CPNP). In order to register, your product must have a Cosmetic Product Safety Report (CPSR), which requires a Preservative Efficacy Test and a Stability Assessment.

Preservative Efficacy Test (PET) – ISO 11930 & Pharmacopoeia

This test, often referred to as a challenge test, assesses the ability of the product to reduce and prevent growth of micro-organisms present in, or that may enter the product when in use. Samples of the product are inoculated with known numbers of micro-organisms and tested for up to 28 days to assess the reduction of microbial growth. Testing can be carried out according to ISO 11930 or to the European Pharmacopoeia (harmonised).

Stability assessment

The stability of a product is assessed at different temperature conditions over a 12 week period. Many clients opt for a minimum assessment of 45oC versus freeze-thaw (in comparison to a 20oC in the dark control), however additional parameters, e.g. 5oC, 32oC, ambient daylight) can be added according to your requirements or the type of product. Testing at 45oC, sometimes referred to as accelerated shelf life, provides an indication of a products performance of a long period at extreme temperatures. Freeze-thaw cycling is a controlled way of replicating the extreme cold night-time temperatures through to daylight temperatures often experienced when shipping products by air or sea freight.

Batch release testing – BS EN ISO 21149 & BS EN ISO 16212

After registration and ongoing throughout manufacture, it is Good Manufacturing Practice to subject products to batch release testing (also referred to as sterility checks, quality control tests, QC tests, TVC/total viable count). For cosmetics and personal care products this testing requires enumeration (counting) of Aerobic Mesophilic Bacteria (AMB) and Yeasts & Moulds (Y&M). This test reports the number of organisms (as AMB and Y&M) in 1 gram of product.

Alternatively, tests can be carried out in accordance with USP 61 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 62 Microbiological Examination of Non-Sterile Products: Tests for Specified Organisms. Furthermore, batch release testing can be extended to include presence/absence of specified micro-organisms such as:

  • E. coli BS EN ISO 21150
  • Staphylococcus aureus BS EN ISO 22718
  • Pseudomonas aeruginosa BS EN ISO 22717
  • Candida albicans. BS EN ISO 18416
  • Detection of specified & non-specified microorganisms BS EN 18415