Basics of cosmetic microbiology for industry.

1. Cosmetic Microbiology
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Ana Carolina M. de Almeida

2. Agenda
• Cosmetic Microbiology
• Legislation
• Preservation Efficacy Testing
• Trends
• Challenges
• Conclusion
• Q&A
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3. Cosmetic Microbiology
• Safety - contaminated cosmetics can become harmful to consumers
(FDA, 2015)
• Raw materials, water or ingredients become contaminated or
encourage growth
• Effective preservative system doesn’t work
• Manufacturing, packaging, shipping or storage
• Consumer use
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4. Legislation
• European Union (EU) Cosmetic Regulation 1223/2009
• ANNEX V - PART 1 List of preservatives which cosmetic products may contain
• Method: European Pharmacopoeia (EP) Ph. Eur. 7
• FDA: Cosmetic Act (United States Code, Title 21)
• Product must be safe to consumer
• Do not require FDA approval before going to market - Inspections, voluntary registrations,
reviews
• Method (USP <51>) and ISO 11930 4

5. Preservation-Efficacy-Testing (PET)
• USP 51/ISO 11930/European Pharmacopoeia (EP) Ph. Eur. 7
• Candida albicans
• Aspergillus brasiliensis (previous niger)
• Escherichia coli
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Microorganisms are either harvested by centrifugation from broth culture or by washing surface
growth from a solid medium into a sterile vessel.
• Inoculum size 10+8 CFU/ml adjusted using optical density and calibration-curve
• Recovery analysis (time=0) determined by Plate Count and Serial Dilution
• 10 ml of volume x 5 container (each microorganisms) @ 0.5-1.0% w=vol/vol
• Incubation @ 22.5 ± 2.5°C and sampled @ time intervals (7, 14 and/or 28 day) depending on
category
• % log reduction determines preservative effectiveness
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6. Preservation-Efficacy-Testing (PET)
6Source: http://www.microbiol.org/wp-content/uploads/2011/06/Antimicrobial-Efficacy-Test.jpg

7. Trends
• Use rapid detection methods
• Culture based: metabolism, colorimetric test
• Non-cultured based: ATP bioluminescent test
• Molecular based:PCR
• Cosmetic industry tend to use standard plate counts
• Challenge product with microorganisms isolated from manufacturing
stream process
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8. Challenges
• USP 51 baseline test however test may be tailored to challenge
product further
• Inoculum higher than 10+6 CFU/ml
• Diluted product prior to inoculation
• Inoculate with organisms isolated from manufacturing environment
• Repetitive inoculation
• Is the preservative test enough (28 days test) longer incubaion
• Establish new preservative systems which are safe
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9. Conclusions
1. Cosmetic Microbiology: safety of consumers
2. European Union (EU) Cosmetic Regulation 1223/2009 &FDA: Cosmetic Act
(United States Code, Title 21)
3. USP 51/ISO 11930/European Pharmacopoeia (EP) Ph. Eur. 7
4. Standard plate counts predominant
5. Use microorganisms selected from manufacturing environment
6. Establish new preservative systems which are safe
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10. Reference
• http://ec.europa.eu/growth/sectors/cosmetics/cosing/index_en.htm
• http://cosmetictestlabs.com/EU_cosmetic_regulation_requirements.html
• https://www.cosmeticseurope.eu/using-cosmetics-colipa-the-european-cosmetic-cosmetics-association.html
• http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm
• http://ie.oriflame.com/beautyedit/health-beauty/your-skin-care-problems-solved
• https://scholar.google.com/scholar?as_ylo=2011&q=preservative+efficacy+testing+cosmetic&hl=en&as_sdt=0,5
• http://www.cosmetictestlabs.com/USP_51_preservative_challenge_test.html
• http://www.cosmetictestlabs.com/USP_61_microbial_enumerations_test.html
• http://www.cosmetictestlabs.com/preservative_challenge_testing_article.html
• http://www.antimicrobialtestlaboratories.com/USP_51_preservative_challenge_test.htm
• http://www.slideshare.net/RWestney/characterization-of-microbial-isolates-from-the-manufacturing-process-stream
• http://www.rapidmicrobiology.com/test-method/rapid-microbiological-methods-for-the-home-and-beauty-industry/
• http://www.ncbi.nlm.nih.gov/pubmed/24881116
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066379/
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11. Thank you
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Ana Carolina M. de Almeida

12. Questions?
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Ana Carolina M. de Almeida