cosmecs dose forms - capsig · “the food and drug administration has announced that arbonne ......

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Cosme(csDoseForms

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PersonalCareDoseForms

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“LowRisk”Cosme(csISO 29621:2017

ISO 29621:2017 Cosmetics -- Microbiology -- Guidelines for the risk assessment and identification of microbiologically low-risk products

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WaterAc(vity>0.75a

“HighRisk”Cosme(cs:Emulsions

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“The Food and Drug Administration has announced that Arbonne recalled 14,837 units of ‘It’s a Fine Line Liquid Eyeliner’ in black and 3,818 units of the same formula in brown.”

“HighRisk”Cosme(cs:EyelinerpH

Womens Wear Daily 30th Aug 2016

Typically: Iron Oxides Carbon BlackNeutral pH

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High pH is a big challenge for solid soap Very few preservatives are active above about pH 9 Organo-metals eg copper – tin!

Ac(vepHRange

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Grapefruit Seed Extract - myth debunkedRosemary Extract - oxidisedVitamin E Oil - antioxidantGermaben II – pH limit 7.5Germall Plus – pH limit 8.0Optiphen Plus – pH limit 6.0ALLINAPPROPRIATE!

SolidSoapRecommenda(ons?

http://www.soap-making-essentials.com

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Protein+Formaldehydeliberatorse.g. Quaternium-15: Diazolidinyl Urea: Imidazolidinyl Urea:

Dmdm Hydantoin: 2-bromo-2-nitropropane-1,3 Diol.

Preserva(veCompa(bility

Sequence-specific capture of protein-DNA complexes for mass spectrometric protein identification. Wu CH, Chen S et al PLoS ONE (2011)

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Elas(nEyeCream

Identification of Contaminating OrganismsFacial TreatmentStaphylococcus saprophyticus Enterococcus faecium Eye CreamBacillus species – low discriminationEnterococcus faecium

Preserva(veCompa(bility

Product Recall ex Retail Sept 2012 : Unpublished Internal Data

Another example ofProtein complex formation

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FDARecallJan2018 Enterobacter cloacae

Preserva(veCompa(bility–Protein?

Hydrolyzed Wheat Protein Polysorbate 20Methychloroisothiazolinone Methylisothiazolinone

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ISO11930

Neutralisation chart = guidance on incompatibility

Preserva(veCompa(bility

Annex C (informative)

 Examples of neutralizers for the antimicrobial activity  

of preservatives and washing liquids

Table C.1 — Examples of neutralizers for the antimicrobial activity  of preservatives and washing liquids

Preservative Chemical compounds able to neutralize the antimicrobial activity of preservatives

Suitable neutralizers and washing liquids (for membrane filtration methods)

Phenolic substances:

Parabens, phenoxyethanol, phenylethanol, etc.

Anilides

Lecithin

Polysorbate 80

Fatty alcohol ethylene oxide condensate

Non­ionic surfactants

Polysorbate 80, 30 g/l + lecithin, 3 g/l.

Fatty alcohol ethylene oxide condensate, 7 g/l + lecithin, 20 g/l + polysorbate 80, 4 g/l.

D/E neutralizing brotha; SDCLP brothb

Washing liquid: distilled water; tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.

Quaternary ammonium salts

Cationic surfactants

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, 3 g/l.

D/E neutralizing brotha; SDCLP brothb.

Washing liquid: distilled water; tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.

Aldehydes

Formaldehyde­generating agents

Glycine, histidine Lecithin, 3 g/l + polysorbate 80, 30 g/l + L­histidine, 1 g/l.

Polysorbate 80, 30 g/l + saponin, 30 g/l + L­histidine, 1 g/l + L­cysteine, 1 g/l.

D/E neutralizing brotha; SDCLP brothb

Washing liquid: polysorbate 80, 3 g/l + L­histidine 0,5 g/l.

Oxidizing agents Sodium thiosulphate Sodium thiosulphate, 5 g/l.

Washing liquid: sodium thiosulphate, 3 g/l.

Isothiazolinones

Imidazoles

Lecithin, saponin

Amines, sulphates, mercaptans, sodium bisulphite, sodium thioglycolate

Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, 3 g/l.

Washing liquid: tryptone, 1 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, 3 g/l.

Washing liquid: tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.

Metal salts (Cu, Zn, Hg)

Organo­mercurials

Sodium bisulphite, L­cysteine

Sulphydryl compounds, thioglycolic acid

Sodium thioglycolate, 0,5 g/l or 5 g/l.

L­cysteine, 0,8 g/l or 1,5 g/l.

D/E neutralizing brotha; SDCLP brothb

Washing liquid: sodium thioglycolate, 0,5 g/l.a Dey/Engley neutralizing broth.b Soybean­casein digest broth with lecithin and polysorbate 80.

ISO/FDIS 11930:2012(E)

 18  © ISO 2012 – All rights reserved

ISO 11930 Cosmetics – Microbiology – Evaluation of the antimicrobial protection of a cosmetic product

Preservative SuitableNeutraliser

Previous Example

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Essen(alOilasaPreserva(veMelaleucaalternifoliainwater/CCTG(oil)mixSurfactantwaspolyoxyl35CastorOil

Par((oningintheProductItself

Melaleuca Oil - a Healthy Natural alternative. James S Rowe John A StatonCosmetics, Aerosols & Toiletries in Australia 1999; 11: (5) 12-15.

Phase WithoutSurfactant WithSurfactant

Oil 100% 20%

Water 0% 80%

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Par((oningintheProduct“substrate”

Chromatography Effect!

Product Recall ex Retail 2001 : Unpublished Internal Data

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Overcome by package design change

Par((oningintheProduct“substrate”

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Dry Herbal extracts

Earth Minerals

Seed Husks

All have potential for high bioburden

“Natural”Ingredients:Spores

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R&DorManufacturingFault?

Exampleof“Headspace”Failure

Damages Claim $A585,357+

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Adsorption

ExamplesofFailures

“The issue was discovered during routine re-testing. The preservative

system in several lots had been compromised.”

CBC News Sep 25th 2013

"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.

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Historical:TalcContamina(on

Sydney Morning Herald May 1st 1946

1946

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Five per percent of the talcum powders were contaminated with 104 C.F.U. /gm and none of the body lotions were contaminated to that extent.

Recent:TalcContamina(on

A Study of Microbiological Contamination in Cosmetics and Toiletries in Iraq. Contamination of Talcum Powder and Body Lotion Raghad A. Razooki AJPS, 2010, Vol. 8, No.2

2009

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60 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.

Present:TalcContamina(on

Microbiological quality assessment of some brands of cosmetics powders…Dashen M. et al J. Microbiol. Biotech. Res., 2011, 1 (2): 101-106

2011

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The ACCC’s survey involved 115 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.

AustralianRecalls:Survey2013

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Internet=24%>1000org/g

MarketplaceSurvey

Comar D. Science of Beauty Journal Vol 6 No 1 : 2016

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LargestgroupcontaminatedwasMineralpowders

MarketplaceSurvey

Comar D. Science of Beauty Journal Vol 6 No 1 : 2016

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ACCCRecall:Eyeliner

ACCC 23rd Nov 2017

“If the product comes in contact with eyes it could cause an eye irritation.”

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MIC versus P.E. !

“Natural”Preserva(ves

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Natural Preservative inSunscreen - Zinc Oxide dispersion

RecentExamplesinourlab

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Separation after mold growth

RecentExamplesinourlab

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Ifwehadtheperfectpreserva(ve,wewouldalluseit!

Preservatives for Cosmetics, 3rd Edition Third Edition 2012Dr David Steinberg

ChoosingaPreserva(veCocktail

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ChoosingaPreserva(veCocktail

Industrial Microbiology: An Introduction: Waites M et al

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ChallengingthePreserva(veCocktail

In house stability protocol Eurofins TecConsult

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An(microbialsUsedinPersonalCareProducts•  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.

AustralianSocietyofCosme(cChemists

Position Paper: Antimicrobials Used in Personal Care Products ASCC.com.au