Cosme(cs Dose Forms 1

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2 Cosme(cs Dose Forms

3 Personal Care Dose Forms

4 Low Risk Cosme(cs ISO 2962:207 ISO 2962:207 Cosmetics -- Microbiology -- Guidelines for the risk assessment and identification of microbiologically low-risk products

5 High Risk Cosme(cs:Emulsions Water Ac(vity > 0.75 a

6 High Risk Cosme(cs:Eyeliner ph The Food and Drug Administration has announced that Arbonne recalled 4,837 units of It s a Fine Line Liquid Eyeliner in black and 3,88 units of the same formula in brown. Typically: Iron Oxides Carbon Black Neutral ph Womens Wear Daily 30 th Aug 206

7 Ac(ve ph Range High ph is a big challenge for solid soap Very few preservatives are active above about ph 9 Organo-metals eg copper tin!

8 Solid Soap Recommenda(ons? Grapefruit Seed Extract - myth debunked Rosemary Extract - oxidised Vitamin E Oil - antioxidant Germaben II ph limit 7.5 Germall Plus ph limit 8.0 Optiphen Plus ph limit 6.0 ALL INAPPROPRIATE!

9 Preserva(ve Compa(bility Protein + Formaldehyde liberators e.g. Quaternium-5: Diazolidinyl Urea: Imidazolidinyl Urea: Dmdm Hydantoin: 2-bromo-2-nitropropane-,3 Diol. Sequence-specific capture of protein-dna complexes for mass spectrometric protein identification. Wu CH, Chen S et al PLoS ONE (20)

10 Preserva(ve Compa(bility Elas(n Eye Cream Identification of Contaminating Organisms Facial Treatment Staphylococcus saprophyticus Enterococcus faecium Eye Cream Bacillus species low discrimination Enterococcus faecium Another example of Protein complex formation Product Recall ex Retail Sept 202 : Unpublished Internal Data

11 Preserva(ve Compa(bility Protein? FDA Recall Jan 208 Enterobacter cloacae Hydrolyzed Wheat Protein Polysorbate 20 Methychloroisothiazolinone Methylisothiazolinone

12 Preserva(ve Compa(bility Anilides ISO 930 Neutralisation chart = guidance on incompatibility Previous Example Quaternary ammonium salts Cationic surfactants Aldehydes Formaldehyde generating agents Non ionic surfactants Washing liquid: distilled water; tryptone, g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l. Lecithin, saponin, polysorbate 80, sodium dodecylsulphate Fatty alcohol ethylene oxide condensate Polysorbate 80, 30 g/l + sodium dodecylsulphate, 4 g/l + lecithin, 3 g/l. Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, D/E neutralizing broth a ; SDCLP broth b. Washing liquid: distilled water; tryptone, g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l. Glycine, histidine Lecithin, 3 g/l + polysorbate 80, 30 g/l + L histidine, g/l. Polysorbate 80, 30 g/l + saponin, 30 g/l + L histidine, g/l + L cysteine, g/l. D/E neutralizing broth a ; SDCLP broth b Washing liquid: polysorbate 80, 3 g/l + L histidine 0,5 g/l. Oxidizing agents Sodium thiosulphate Sodium thiosulphate, 5 g/l. Isothiazolinones Imidazoles Lecithin, saponin Amines, sulphates, mercaptans, sodium bisulphite, sodium thioglycolate Washing liquid: sodium thiosulphate, 3 g/l. Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, Washing liquid: tryptone, g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l. Biguanides Lecithin, saponin, polysorbate 80 Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, Metal salts (Cu, Zn, Hg) Organo mercurials a Preservative Dey/Engley neutralizing broth. Sodium bisulphite, L cysteine Sulphydryl compounds, thioglycolic acid b Soybean casein digest broth with lecithin and polysorbate 80. Suitable Neutraliser Washing liquid: tryptone, g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l. Sodium thioglycolate, 0,5 g/l or 5 g/l. L cysteine, 0,8 g/l or,5 g/l. D/E neutralizing broth a ; SDCLP broth b Washing liquid: sodium thioglycolate, 0,5 g/l. ISO 930 Cosmetics Microbiology Evaluation of the 8 ISO 202 All rights r antimicrobial protection of a cosmetic product

13 Par((oning in the Product Itself Essen(al Oil as a Preserva(ve Melaleuca alternifolia in water/ CCTG (oil) mix Phase Without Surfactant With Surfactant Oil 00% 20% Water 0% 80% Surfactant was polyoxyl 35 Castor Oil Melaleuca Oil - a Healthy Natural alternative. James S Rowe John A Staton Cosmetics, Aerosols & Toiletries in Australia 999; : (5) 2-5.

14 Par((oning in the Product substrate Chromatography Effect! Product Recall ex Retail 200 : Unpublished Internal Data

15 Par((oning in the Product substrate Overcome by package design change

16 Natural Ingredients:Spores Dry Herbal extracts Earth Minerals Seed Husks All have potential for high bioburden

17 Example of Headspace Failure R&D or Manufacturing Fault? Damages Claim $A585,357+

18 Examples of Failures Adsorption The issue was discovered during routine re-testing. The preservative system in several lots had been compromised. "The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi," the U.S. Food and Drug Administration said. CBC News Sep 25 th 203

19 Historical : Talc Contamina(on 946 Sydney Morning Herald May st 946

20 Recent : Talc Contamina(on 2009 Five per percent of the talcum powders were contaminated with 0 4 C.F.U. /gm and none of the body lotions were contaminated to that extent. A Study of Microbiological Contamination in Cosmetics and Toiletries in Iraq. Contamination of Talcum Powder and Body Lotion Raghad A. Razooki AJPS, 200, Vol. 8, No.2

21 Present : Talc Contamina(on Samples from the market in Nigeria 50 % were contaminated with Staphylococcus aureus, 20 % were contaminated with Clostridium tetani and 7 % were contaminated with Candida albicans. Microbiological quality assessment of some brands of cosmetics powders Dashen M. et al J. Microbiol. Biotech. Res., 20, (2): 0-06

22 Australian Recalls: Survey 203 The ACCC s survey involved 5 cosmetic products found in shops and online retailers, which were sent for microbiological testing against internationally-set recommended limits. The ACCC negotiated recalls with suppliers after finding that three products contained unacceptable levels microbial contamination.

23 Marketplace Survey Internet = 24% > 000 org/g Comar D. Science of Beauty Journal Vol 6 No : 206

24 Marketplace Survey Largest group contaminated was Mineral powders Comar D. Science of Beauty Journal Vol 6 No : 206

25 ACCC Recall:Eyeliner If the product comes in contact with eyes it could cause an eye irritation. ACCC 23 rd Nov 207

26 Natural Preserva(ves MIC versus P.E.!

27 Recent Examples in our lab Natural Preservative in Sunscreen Zinc Oxide dispersion

28 Recent Examples in our lab Separation after mold growth

29 Choosing a Preserva(ve Cocktail If we had the perfect preserva(ve, we would all use it! Preservatives for Cosmetics, 3rd Edition Third Edition 202 Dr David Steinberg

30 Choosing a Preserva(ve Cocktail Industrial Microbiology: An Introduction: Waites M et al

31 Challenging the Preserva(ve Cocktail In house stability protocol Eurofins TecConsult

32 Australian Society of Cosme(c Chemists An(microbials Used in Personal Care Products Preservatives can provide benefits in relation to providing practical shelf life. Must never be used to mask poor manufacturing practices. Judicious choice at appropriate content levels does not impact on the safety of cosmetics. Position Paper: Antimicrobials Used in Personal Care Products ASCC.com.au

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