PhilGeis
Forum Replies Created
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Mike
For any preservative system, the marketer should have a reasonable assurance that it will not become contaminated in use - in the hands of the consumer - a function of formula, package and consumer practices. “GMP compliance”, most of which is tangential to micro risks, is not relevant as making it clean and passing the classic test fail the question. Further, bugs can grow after release in an apparently clean product. I think that is the biggest miss for most of the folks posting here. For classic preservative combinations, there’s a lot of data - most of which is in the hands of large companies, For an alternative system - and dilute soap with its vulnerabilities - that’s significant as washing products are the most susceptible in consumer use compromise.
The EU Cosmetics Regulation governs how cosmetics and personal care products are made and placed on the market. It is the most comprehensive set of laws for our industry in the world, requiring cosmetics to be safe for human health when applied under normal or reasonably foreseeable conditions of use.
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Your risk - but please be careful.
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Consumer data? Can you share it?
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Sure would be more cautious about “self preservation” unless you have in-use data. - packaged product.
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Even at the right pH, that is not enough for this kind of product. You need something for Gram negative bacteria.
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You need preservation.
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Good point. I don’t see anything that would discourage any relevant bug.
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How do you propose to address safety and, if in us, regulatory compliance?
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That is a pretty poor preservative system
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Rr fatty acids you mentioned, I’d not worry that much about chemical oxidation. They can be metabolized by microorganisms via “beta oxidation” - that would require gross contamination.
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Mark is right. The nonionic Polysorbate (Tween) 80 is used as preservative neutralizer in finished product micro testing. It may or may not have the same effect as ingredient in finished product formulation,
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Thanks. Do they ever ask questions re. the data?
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I’ve not heard anything about Leucidal and methylisothiazolinone. I hope it’s not true - I’ve met the Leucidal folks. They didn’t seem the type to salt the mine - just folks selling an ineffective product.
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And remember the enviro-angst-ers wringing their hands over parabens in sunscreen killing coral reefs? Of course the data supporting the claim were Darbre-caliber irrelevant and meaningless.
BUT a coral reef-isolated marine bacterium was shown to produce parabens. No data offered that it produced parabens while on an actual reef but it is natural reef flora.
Discovery of a Marine Bacterium Producing 4-Hydroxybenzoate and Its Alkyl Esters, Parabens
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Please pay attention to KMRCSMiami’s comment re/ preservation. You can do better.
Not so sure “all natural” is defensible
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What is “everything” GMP data? Finished product and raw material testing? monitoring data? water testing? batch sheets? yield? training records?
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Hair spray? Can you please explain formulation. That much water and Ethoxydiglycol at rel low VP - wonder if it’ll ever dry, and ethoxydiglycol is an eye irritant. “Active” as Diphenyl diselenide - for hold or orange hair?
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What “GMP data” are you sharing?
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Both links should be accessible - maybe I screwed up the cut and paste.
The 1st was from FDA’s GRAS (Generally Recognized As Safe) notice for foods and it said there was no limitation - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1923
The second was from CIR (Cosmetic Ingredient Review) and they concluded was safe as used in cosmetics but the max they saw used was 10% so that’s the limit of what they said was safe. They didn’t say greater was unsafe and talked about results for some exposures up to 60%. You can also find the info below on Google Scholar. Let me know if it still won’t open - I’ll down load andemail to you.
https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PRS310.pdf
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You might point out which ingredients condemn the 2nd formula to the depths of the unclean.
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Urea is GRAS - re. foods https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1923
“In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.”
Found nothing from FDA re cosmetic application. Here’s CIR https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PRS310.pdf. Looks likke they considered up to 10%.
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Right - this is garbage waiting for a bug to drop in. Suppose it’s feasible it might have met the nominal criteria of 51 but no GMP’s will save that mess and in-use contamination is certain.
Granted this is obvious but a lot of the Ecocert and other “clean” systems I’ve seen here are not much better.
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Thanks for the explanation.
Attempts with various lab bugs to generate growing contaminating in products seemingly “self-preserving” like soap aren’t effective. Recall similar attempts with unpreserved high pH products (e.g. Mr. Clean and L:iq Tide) - both of which suffered contamination with bugs that only grow at high pH.
But the primary issue for cosmetics is micro risk in use. A liq. soap failed P&G’s challenge test only with dilution to the extent observed with consumer in-use testing.
Risks in making can be controlled but In-use risk is apparently not controlled per discussion- not unusual as it looks like only the big guys (can) address it. It is boiler plate but assessors are ignorant to call the question.
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sorry - P&G - meant Procter & Gamble as in global Pantene, Head & Shoulder , Olay, Clairol, Old Spice, etc,
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Thanks Mike
The assurance is yours - here’s an example of how P&G condiucted consumer testing and caimed method and preservative validation. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
This is not a question answered with preservative testing, GMP compliance or absence of consumer complaints. Consumer are unlikely to recognize contamination or attribute relevant infection to their cosmetics.
Yes - I managed P&G global microbiology for decades. These same practices I describe can be found at Estee, Unilever, Avon etc.