30 TESTING
are used as challenge organisms, although other organisms may be used depending on the microbiological risk assessment. The challenge microorganisms are introduced at known concentrations, and products are subsequently enumerated at discrete timepoints for surviving microorganisms. Enumeration is performed by first
neutralizing antimicrobial activity of the preservative system. The neutralization step is verified by pre-study controls that demonstrate the ability of the neutralization method to sufficiently quench the antimicrobial activity of the preservative system. The neutralized product is then
enumerated using standard microbiological dilution and plating techniques to determine the number of surviving CFU, or the number of viable microorganisms capable of growth remaining in the product. The enumeration of surviving
microorganisms provides a quantitative measure of the antimicrobial efficacy of preservative systems over a pre-determined period, which is typically one month. PET therefore provides not only a measure of the ability of a preservative system to reduce the concentration of contamination, but also the measure of the efficacy of such a preservative system over time.
Conclusion Microbial contamination can severely impact the safety of cosmetic and personal care products and can occur at almost all points between the manufacture of a product and its final use by the consumer. Various methodologies exist that manufacturers can employ to evaluate their products for the presence of microbial contamination, and for the efficacy of their products’ preservatives. Such methodologies ultimately ensure that manufacturers meet the fundamental responsibility of ensuring their products’ safety and provide the peace of mind to consumers that they are safe from microbial contamination and its associated risks. The Eurofins CRL laboratory in Austin, Texas offers microbiological quality testing at competitive pricing and turnaround times to integrate seamlessly into product development, manufacturing, distribution and other operational stages.
References 1. Personal Care Products Council. Microbiological Guidelines – Section 16: Microbiological Risk Factor Assessment of Atypical Personal Care Products. 2018
2. Wong S, Street D, Delgado SI, Klontz KC. (2000). Recalls of Foods and Cosmetics due to microbial contamination reported to the U.S. Food and Drug Administration. Journal of Food Protection. 2000; 63(8), 1113–1116
3. US Food and Drug Administration. Center for Food Safety and Applied Nutrition. (n.d.). Microbiological Safety and Cosmetics.
https://www.fda.gov/cosmetics/potential- contaminants-cosmetics/microbiological- safety-and-cosmetics
4. Lundov MD, Moesby L, Zachariae C, PERSONAL CARE May 2024
Johansen JD. Contamination Versus Preservation of Cosmetics: a Review on Legislation, Usage, Infections, and Contact Allergy. Contact Dermatitis. 2009; 60(2), 70–78
5. EU Scientific Committee on Consumer Safety. SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th revision. 15 May 2023, corrigendum 1 on 26 October 2023, corrigendum 2 on 21 December 2023, SCCS/1647/22
6. Association of South East Asian Nations. ASEAN Guidelines on Limits of Contaminants for Cosmetics. 2019
7. International Standards Organization. ISO 17516, Cosmetics - Microbiology – Microbiological Limits. 2014
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8. Huang J, Hitchins AD, Tran TT, McCarron JE. Bacteriological Analytical Manual (BAM) – Chapter 23: Microbiological Methods for Cosmetics. US Food and Drug Administration. 2021
9. Varvaresou A, Papageorgiou S, Tsirivas E, Protopapa E, Kintziou H, Kefala V, Demetzos C. Self-preserving cosmetics. International Journal of Cosmetic Science. 2009; 31: 163- 175
10. International Standards Organization. ISO 22716, Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices. 2007
11. Halla N, Fernandes IP, Heleno SA, Costa P, Boucherit-Otmani Z, Boucherit K, Rodrigues AE, Ferreira ICFR, Barreiro MF. Cosmetics Preservation: A Review on Present Strategies. Molecules. 2018; 23(7):1571
12. Personal Care Products Council.
Microbiological Guidelines – Section 20: A Method for Preservation Efficacy Testing of Water Miscible Personal Care Products. 2018
13. United States Pharmacopeial Convention. <51> Antimicrobial Effectiveness Testing. 2019
14. International Standards Organization. ISO 11930, Cosmetics - Microbiology - Evaluation of the Antimicrobial Protection of a Cosmetic Product. 2019
15. European Pharmacopeia. EP <5.1.3> Efficacy of Antimicrobial Preservation.
16. Cloak OM, Daane L, Ganatra M, Miller W, Rook MS, Verdonk G, Williams JA. An Overview of Rapid Microbial-Detection Methods. Pharmaceutical Technology. 2010, March 1
17. United States Pharmacopeial Convention. <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. 2019
18. United States Pharmacopeial Convention. <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. 2020
19. European Pharmacopeia. EP <2.6.12> Microbiological Examination of Non-sterile Products (Total Viable Aerobic Count)
20. European Pharmacopeia. EP <2.6.13> Microbiological Examination of Non-sterile Products: Test for Specified Micro-organisms
21. International Standards Organization. ISO 21149, Cosmetics - Microbiology – Enumeration and Detection of Aerobic Mesophilic Bacteria. 2017
22. International Standards Organization. ISO 18415, Cosmetics - Microbiology – Detection of Specified and Non-specified Microorganisms. 2017
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