TESTING


Microbiological quality of personal care products


Natalie Sendukas, David Hernandez – Eurofins


Cosmetics and personal care products rely on preservative systems to prevent the overgrowth of microorganisms introduced during manufacturing and use, and ultimately protect an end-user. These diverse product categories are not required to be sterile upon release, and it is the manufacturer’s responsibility to identify permissible limits for release and to confirm the effectiveness of preservative systems. The Personal Care Products Council (PCPC)


states that every personal care product manufacturer “has a dual responsibility relative to the microbiological quality of its products. The first is to ensure that the product, as purchased, is free from the numbers and types of microorganisms that could affect product quality and consumer health. “The second is to ensure that


microorganisms introduced during normal product use will not adversely affect the quality or safety of the product”.1


This is the


principle and impetus behind establishing a microbiological quality regimen – it is a mission statement for manufacturers, production managers, and quality control personnel. Microbial contamination is one of the


leading causes for cosmetic and personal use product recalls.2


Cosmetic products are at risk


of problematic contamination due to their chemical composition, where basic emulsions often provide microorganisms with growth factors and water content necessary – ideal, even – for exponential proliferation, combined with the repetitive consumer use that is typical of these products.3 During normal use, cosmetics may be


exposed to transient and normal flora on the hands, face, and/or body of the consumer as well as nearby environmental surfaces. Once microorganisms are introduced to these nutritional sources, their growth may be further encouraged by the atmospheric conditions in which cosmetics and personal care products are often stored – in hot and humid bathrooms, or altogether outside of climate control (such as in a car or personal bag). Excessive microbial contamination and/


or the presence of potentially pathogenic microorganisms like Staphylococcus aureus, Burkholderia cepacia, or Pseudomonas aeruginosa, can lead to undesired changes to the composition of products. These may be recognizable to consumers as indicative


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of spoilage, impacting a brand’s reputation. Importantly, contamination may present serious consequences like skin infections that pose health risks to consumers.4


Current guidelines While the United States Food & Drug Administration (FDA) does not at the time of this publication have stated requirements for microbiological quality, internationally, practices have come to align behind guidance issued by the European Union’s Scientific Committee on Consumer Safety (SCCS) and the Association of South East Asian Nations (ASEAN).5,6 These are harmonized in the International


Standards Organization (ISO) informational chapter 17516, Cosmetics – Microbiology – Microbiological Limits.7


In the United


States, recommendations informed by such regulations are offered in the FDA Bacteriological Analytical Manual Chapter 23 for Cosmetics.8 There is little variation across these


publications, and all cover two complementary sides of microbiology quality: preservative efficacy and microbial limits. Many regulatory resources also provide guidance on conducting a microbiological risk assessment – a necessary first step in determining applicable limits and efficacy criteria.


Hurdle effects The ultimate goal of any risk assessment affecting manufacture or distribution of cosmetic and personal care product categories is to prevent an adverse effect on health of the consumer. Professional judgement should be exercised to define parameters such as scope and stringency, and these may vary on a product-to-product basis. The following factors should be considered: ‘self-preserving’ qualities known as hurdle effects, route of administration, and intended recipient (the consumer as end-user). The concept of hurdle technology dates to


safety assessments in the food industry from the 1970s.9


In this arena, the prevention of


microbial spoilage is paramount to product quality but opportunities for introduction of synthetic preservatives are limited. In the present state of the cosmetic and personal care industry, popular distrust of synthetic preservatives contributes to increasing demand for ‘preservative-free’ formulations, which may be perceived as gentler and/or more harmonious with natural skin flora. The concept encompasses product


development from manufacture to packaging, and is predicated on the basis that proper handling in combination with a formulation’s intrinsic qualities will prevent the proliferation of any organisms introduced during the


May 2024 PERSONAL CARE


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