Cosmetic Microbiology

1

Ana Carolina M. de Almeida

Agenda

• Cosmetic Microbiology

• Legislation

• Preservation Efficacy Testing

• Trends

• Challenges

• Conclusion

• Q&A

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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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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 119304

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 5

Preservation-Efficacy-Testing (PET)

6Source: http://www.microbiol.org/wp-content/uploads/2011/06/Antimicrobial-Efficacy-Test.jpg

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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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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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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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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Thank you

11

Ana Carolina M. de Almeida

Questions?

12

Ana Carolina M. de Almeida