PhilGeis
Forum Replies Created
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Forgot to wash (clean) and assume forgot to sanitize and black dots (suggest black fungi).
the product would be reasonably considered adulterated - “If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.”suggest you scrap the product and focus on a production system not in control.
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Don’t recall tottle caps I’ve used have carried those distinctions. Filled and inverted, it may not make much difference.
Pressure differentials can play a trick. Product made and packaged in midwest US, sold in high altitude markets can squirt a little product at 1st customer opening.
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Don’t see anything in that formula that would preserve. Think the brand is blowing you off. If nothing else, they haven’t qualified stability.
Suggest you contact the FDA at: https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/how-report-cosmetic-related-complaint
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Dipslides from anyone are a poor for anything but water.
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Thanks - and they still suck.
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No mystery - the medium includes Rose Bengal that inhibits bacterial growth. It’s intended to culture only fungi - yeast and mold. You’ll likely find no growth unless you have thrush.
Please do not use dip slides for cosmetics. They do not provide valid data either way - growth or not.
If they manufacturer recommended these for cosmetics - they are clearly ignorant and irresponsible. -
Think you might want a bit more preservation than just G. Ultra
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Be aware - don’t see it listed in Annex V - Cosmetic Directive
https://ec.europa.eu/growth/tools-databases/cosing/pdf/COSING_Annex%20V_v2.pdf -
The CIR Expert Panel concluded that formaldehyde and
methylene glycol are safe for use in cosmetics when formulated
to ensure use at the minimal effective concentration, but in no
case should the formalin (note 1) concentration exceed 0.2%
(w/w), which would be 0.074% (w/w) calculated as formaldehyde or 0.118% (w/w) calculated as methylene glycol.
https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PRNS547.pdf -
I don’t think you understand the industry. Detergents in household products or cosmetics do not build up over time. Those that did - esp. with branched chain alkyl groups - were banned back in the 70’s.
Phosphate bans were and are regulatory requirements to which industry complied. It was/is not a matter of ingredient statementsUnlike cosmetics, every ingredient used in household US products has to be specifically approved by EPA in years long PMN process that considers environmental fate and human and environmental safety, and high volume materials (HPV’s) are specifically followed in regard to environmental fate and accumulation. Major manufacturers, as with cosmetics guys, market effectively the same product everywhere.
Please understand - the science drives a risk assessment approach here as it does in cosmetics and drugs. I understand folks’ feelings, and your sentiment is closer to that of EWG than science.
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Presume the bacteria found no water in which to grow - just the silicone continuous phase. Some might survive but not enough to recover.
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@ketchito
phosphates in detergents, plastic bags and straws, cosmetic preservatives, propellants and ethanol in hair spray, trigger words, and other cartoon villains -
@zetein
What was the seaweed disaster?
Banning of phosphates in US household products was political posturing by ignorant politicians. The amount discharged is tiny compared to other sources such as phosphate in urine and feces. Lake Erie algae bloom is attributed in part to poor farm practices - esp. re. N and PO4 from manure.
https://www.sciencedirect.com/science/article/abs/pii/S0045653511001925 -
Please recall - FDA enforcement only addresses manufacturing contamination and recalls are voluntary. Many - perhaps most - contaminations are not reported.
Consumer contamination is much more common and obscure. -
@Herbnerd - reasonable thought butnone of the compendial methods meet what most major manuf’s expect either in protocol, efficacy or both.
@grapefruit22
Take a look at these for closure perspective
https://journals.asm.org/doi/abs/10.1128/aem.56.5.1476-1479.1990
https://www.sciencedirect.com/science/article/abs/pii/S0002939414708323
https://www.aptar.com/wp-content/uploads/2022/04/Overview-of-microbial-integrity-tests-for-preservative-free-nasal-spray-pumps-and-multidose-eyedroppers.pdfSome folks have offered protocols, but with the objective of protecting consumers through millions of units over years, prob the best for major guys is large(geographic)-based in-use evaluation.
Wish I could access the Schnittger (Este Lauder ) paper for you. The product failed challenge but in-use found no contamination. The dynamic was its water-in-oil formula. Inoculum in challenge droplets never found the formula water droplets with preservative so very little efficacy. Similarly, in-use bugs never found any water where they might grow.
Water in oil emulsions are generally more hostile for that.You prob shouldn’t have asked, I get carried away.
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@Pharma
My (just a ) guess was that pseudomonad siderophores have a greater affinity for Fe, Mg than hydoxamates - cap, ZPT, NaPT.
ZPT is used in Head & Shoulders - as a raw material, it’s supplied as a ~26% saturated slurry that comes contaminated with pseudomonads unless preserved. -
There is no gold technical standard - in a regulatory sense these tests are validated in their respective authority.
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@grapefruit22
Each company has it’s own protocol and returns from consumer (rather than clinical testing are a typical part. Global countries have to consider different cultural practices - e.g. a single use (in US) sachet of shampoo may be used for months in other countries.
The test itself may also calibrated - e.g. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987Others rely as heavily on in use testing as challenge. Don’t have a link to the paper cited but these guys showed failing challenge results were irrelevant to the micro quality through consumer use
Schnittger, S., J. Sabourin, and D. King. “Preservation of water-in-silicone emulsions.” JOURNAL OF COSMETIC SCIENCE 53.1 (2002): 78-80. -
It is possible - the issue in addition to efficacy is the effort needed to qualify each product preservative application separately as opposed to a system that carries over from product to product.
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the largest companies are not “adapting to the new standards”. To the extent they’re using other preservatives - they are still using the standard of consumer use and not USP 51. I’m familiar with some of the seemingly “lesser” systems and those are the product of a lot of effort and carefully controlled to meet the corp standards. That doesn’t mean some corp (advertsing or marketing) VP didn’t decide to take a risk for specific sku’s.
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Every formula in FDA enforcement reports passed PET - USP 51. Passing the test means little and garbage systems - esp. “natural” and the contrivance of “hurdle” - readily pass.
As ketchito said, those working to the purpose of preservation - protecting the consumer in use, - maintain the traditional systems despite the market pressures driven by EWG BS, “clean beauty”, priority lists, Ecocert head fakes, etc.
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@Pharma
I’ve had some luck with phytate.
Hydroxamates are good for fungi - not for pseudomonads. The best known are pyrithiones - Zn (ZPT) and Na. -
Phytic acid