Cosmetic microbiology

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. CosmeticMicrobiology
•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
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5. Preservation-Efficacy-Testing (PET)
•USP51/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)
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Source: 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
•USP51 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.USP51/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