488 JOURNAL OF COSMETIC SCIENCE Risk Factors The microbiologist may perform a microbiological risk assessment of the product. Risk assessment is based on a number of factors recognized as important in evaluating the spoilage potential of a product. It is intended to guide the microbiologist and formulator in determining what level of testing is necessary to assure the quality of the product during manufacture and use. These risk factors include: Type of Emulsifier System Physical State of the Product Area of Application Frequency of Use Type of Package and Applicator Risk of Contamination during Manufacturing A good example of a high-risk product versus low-risk product is the comparison of an aqueous based mascara to an anhydrous loose powder. The mascara would be considered high risk because it is a water - based product which is being used in the eye area and could possibly be used many times a day. The loose powder would be considered low risk because it is anhydrous and does not normally support microbial growth. If the powder were recommended to be used in both a wet/dry application, than the risk factor would increase significantly. In the wet/dry application the risk would be more with the applicator than with the product alone. Once the applicator comes in contact with moisture than it has the potential to support microbial growth. Preservation of Make-up Products Today we are faced with a multitude of regulations that impact on how we formulate. The list of available preservatives that can be used in the cosmetic industry is shrinking daily. Because of this dilemma, the formulating chemist must work smarter. Preservative systems can easily be enhanced by paying close attention to a number of key factors. Raw materials such as Butylene Glycol, Hexylene Glycol, and EDTA are strongly recommended as potentiators of preservative systems. The order and temperature in which the preservative is added to the emulsion should be closely watched. Care must be taken to ensure that hydrolysis, or deactivation of the preservative does not take place due to overheating or complexing with the surfactant system. The pH of the water- phase should be kept in the acid range, to ensure the maximum efficacy of the preservative system. Conclusion The preservation and testing of makeup products is a complex subject. The type of product and its area of application play a large role in determining the type of testing required and how much preservative is needed to ensure a safe product. Hopefully, this brief presentation will the lay the ground work for giving both the new and old chemist a better insight into cosmetic microbiology.

2004 ANNUAL SCIENTIFIC SEMINAR 489 SCALE-UP IN THE COSMETIC INDUSTRY David Yacko Estee Lauder Companies, Inc., 125 Pinelawn Road, Melville, NY Scientific scaleup in the Cosmetic Industry: fact or fiction? Over the last 30 years, the cosmetic industry has moved out of the "black magic" realm and into a far more scientific arena. The methods of scaleup have become much more scientific and predictable. In the cosmetic industry it is imperative that new products get from the bench to manufacturing as quickly as possible. This is the job of the Process Development Engineer and the process is called scaleup The talk will discuss the different aspects of scaleup: heat transfer, addition rates and energy input as it pertains to batch size and different equipment