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Figure and tables: Dr. Straetmans photo: Jarun Ontakrai, Shutterstock.com Failure of preservation systems in spite of challenge testing Nevertheless, in the course of the past few years, our company has ­ observed a growing number of inci- dents in which preservation systems failed to protect final cosmetic prod- ucts sufficiently, despite having passed microbiological challenge testing. The product recall data from the EU’s Rapid Alert System for non- food consumer products (RAPEX)2 supported this observation. In many cases, other microorganisms than the standard germs employed in the challenge tests, such as Burkholderia cepacia or Enterobacteriaceae, were identified to be responsible for the reported contaminations. When confronted with a contami- nated product usually the following questions arise: • What are the potential sources of product contamination? • Which germs are causing prob- lems for our customers? • How can we protect cosmetic for- mulations against these germs? Sources of contamination Cosmetic raw materials themselves may carry a microbiological load which later can begin to proliferate in the final cosmetic formulation. A responsible supplier will take suita- ble measures to prevent all kinds of potential microbial contamination. However, contaminations can still occur, and the risk clearly depends on the type of raw material. As germs rely on the availability of wa- ter for their growth and prolifera- tion, the contamination risk in wa- ter-free oils is quite low. In contrast, in natural raw materials such as clays, pigments and extracts, it can be quite high. Nevertheless, spores from fungi and bacteria as well as VBNC (viable but non-culturable) bacteria can manage to survive with- out any water in the oil phase, where they usually stay dormant while waiting for the conditions to change. Germs in cosmetic manu­ facturing The contamination risk is even high- er during the manufacturing process and when the product is applied by the end consumer. The most rele- vant germs in cosmetic manufactur- ing belong to the Pseudomonas ­ species, because they are spread ubiquitously in nature and are capa- ble of building hard-to-remove bio- films at higher concentrations. That is why Pseudomonas species are of- ten found in process water systems and throughout the whole produc- tion chain (mixing vessel, bulk con- tainer, tubes, filling line). Other C osmetics, in contrast to most food products, are expected to remain stable and sterile with a shelf life of three years or longer. When the end consumer ap- plies the product regularly, a cosmet- ic product faces severe and repeti- tive microbial exposure. However, this microbiological challenge is not solely restricted to the end phase of the product’s lifetime, but is also a challenge at the phase of the em- ployed raw materials and through- out the manufacturing process. According to Article 3 of the Cosmet- ic Regulation 1223/2009, it is the ­ responsibility of the producer to en- sure the product’s safety for human health; since some microorganisms in cosmetic products can be patho- genic, this responsibility includes a reliable preservation system. In or- der to identify a safe preservation system, producers rely on antimicro- bial preservation challenge tests. The most common challenge test used for cosmetic products is de- scribed in the Ph. Eur. 8 5.1.3.1 The standard germs associated with the test have been selected based on a risk contamination assessment and the experience on how difficult it is to control their growth in a cosmetic product; these specific germs are, in fact, the cause of the majority of product contaminations. This is why it is assumed that a preservation sys- tem able to control these selected microorganisms will also cope well with other potential contaminations. mann ffairs ector many Fig. 1: Resistant house germs (Lactobacillus plantarum) – a case study INGREDIENTS www.cossma.com  l  35 DOWNLOADS Additional information at www.cossma.com/qr00121 Your access codes for July/August: User name: cossma8 Password: nature COS1607_34_StraetmansMicrobio.indd 35 26.07.16 16:02 scribed in the Ph. Eur. 85.1.3.1 The COS1607_34_StraetmansMicrobio.indd 3526.07.1616:02

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