PhilGeis
Forum Replies Created
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Membrane to some extent but EDTA does not kill. More important the impact on bacterial slime and biofilm. Gram negative bacteria - esp. pseudomonads and enterics - produce an alginic acid slime/biofilm that protects the cells vs preservatives. Alginic acid is stabilized by calcium ions and EDTA by sequestering Calcium ion disaggregates the slime facilitating preservative access.
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Here’s what FDA says regarding testing - “Formerly, there were no validated tests for cosmetic preservative efficacy (9), although the test for pharmaceutical preservative efficacy in the U.S. Pharmacopeia (2) or the cosmetic test in the technical guidelines of the Cosmetic, Toiletry, and Fragrance Association (CTFA) (1) were used. Recently, the CTFA test has been AOAC validated (2b) for use with liquid cosmetics.”
https://www.fda.gov/food/laboratory-methods-food/bam-chapter-23-methods-cosmetics
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If in US - believe the Bureau Veritas lab in Buffalo NY does this testing.
https://www.cps.bureauveritas.com/bureau-veritas-buffalo-consumer-product-test-lab
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Broad spectrum but ECT is ok? No one with depth of experience would see that.
Sounds like boiler plate. Any elaboration of the cautions - synergism etc.?
BP is marginally better than USP but allows the BS exemption of B criteria and neither includes any bugs representing contamination risk like CTFA. Is there any comment to cepacia?
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What are other preservatives and pH ?
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Where are you?
Here’s FDA position. with recent legislative changes, perhaps they’ll ask for data from ma
https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics
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For cosmetics, chose a system/combination at concentrations that technically should be effective as broad spectrum and then confirm it has efficacy with a challenge test. The test (USP, EP, ISO, whatever) is not validated. “Pass” merely show some efficacy but not enough to protect consumers - passing criteria are too tolerant and isolates too feeble. What does IPCS instruct in this regard?
I’m aware of a few remarkably “synergistic” combinations - not aware any are marketed as combinations.
ECT is technically not be expected to work by itself.
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You’re right - what efficacy ECT has is at the lower pH, but it is a poor combination even in acidic context as it has a gap vs Gram negative bacteria, the primary contaminants of cosmetics. The pH range and “broad spectrum” are marketing hype. The response you received is silly - preservatives are in Annex and have favorable risk assessments from CIR. The supplier is not going to run more safety studies on the combination. I’m aware of no data and supplier offers none showing the combination is magic.
If IPSC endorsed this combination - I do wonder at their preservative training. As for FB, think it’s a waste of time in any context.
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David - to your original post - do you have micro contamination and if so with what bugs?
You have a decent preservative system (tho EDTA would help). If a micro problem - it’s likely in your manufacturing hygiene, not your formula.
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It is generally considered that +/- 0.5 logs is no change and this rule is included in USP <51> AET.
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I appeal to you - if your preservative system is so impotent it has no impact on mold inoculum - please please find a more effective system.
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You might also consider phenylethyl alcohol. At low concentration, it’s used in media to selectively isolate staph from a Gram negative mixed culture. It’s not that great vs. pseudomonads and doubt you’ll find much antifungal efficacy.
https://microbeonline.com/phenylethyl-alcohol-agar-pea-principle-composition-and-preparation/
I gather you’re looking at a Gram positive probiotic - is this your “change the microbiome” deodorant?
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To your question re. education or conversion - for most major brands - neither, yet.
Companies and the cosm industry are not equipped and not willing to attempt education Don’t view companies as monoliths - they exist in internal conflict with marketing as the driver that can/will only sell.
Micro is part of the efficiency drives global formulas - with global preservative systems 1) legal in all regions incl EU and 2) effective in high speed manufacturing and in-use. Conventional preservatives satisfy these - alternatives do not.
“Yet”- industry lost out on recent fed legislation. The bill they supported would prevent states from banning preservatives - the bill that passed does not. States will ban - Washington st. just banned formaldehyde releasers. For alternatives - there’s not much safety data for most and no one is trying to get the new ones into the EU directive. So there’s going to be a squeeze.
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Formaldehyde releasers and isothiazolinones are not that great vs fungi. In any case, we can’t use isothiazolinones in leave on products like creams due to sensitization,
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Good idea - and David’s Germall Plus includes IPBC. I’m not sure he confirmed contamination and if so what it was. But Germall Plus should generally be ok unless manufacturing issues or formula incompatibility.
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For perspective - the 2020 CIR assessment for methyl parabens included 197 citations - the great majority of which were published after its 2008 assessment.
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The alternative to reading “100” papers you know to be flawed and reaching a conclusion regarding subject not in your expertise? Reminds of the EIC for Dabre’s infamous breast cancer hit piece admitted her work was “flawed” but published it anyway.
Not an alternative but the best assessment exists in the SCCS, CIR and FDA by which expert toxicologists review all the data. Not the f lawed 100 effectively anonymous folks who carry no responsibility for the work but individuals whose careers and reputations rest on their rigor nd the resulting safety impact of their conclusions.
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Why do you say that? It is extremely hard to study the microbiome of the axilla. Culture methods are useless and molecular methods are complicated by the 3 dimensional elements skin and hair follicles and the spatial and microbial aspects of odor production..
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I’ve not called you old fashioned, and suggest we avoid ad hominem including re. authorship of publications. In fact, you’ll see little from industry in the literature. That they hire experts in the field to execute assessments is to their credit, and I take your comment as a personal insult. I’ve worked in this industry for four decades never once saw the cynicism you suggest.
I’m not aware you have toxicologic expertise having seen nothing to that effect in your publications. I do not have that expertise. However, I know many of the folks at CIR having provided data and perspective regarding preservatives they have rejected. I greatly respect their expertise and conclusions.
Again, read the assessments better to understand their conclusion of safety in use.
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Mike please - I doubt you’ve read these papers or have the expertise to develop an informed risk assessment.
Please read the CIR, SCCS, etc. assessments whose authors have both the toxicologic expertise and have considered all the literature in arriving at a conclusion of safety in use.
In use is the context - not absolute safety - the process is risk assessment not the impossibility of risk elimination. You might also consider the absence of data for most of the compounds folks use in place of parabens.
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Is this for a probiotic?
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Please share the data - the specific consumer health data that these scientists directly responsible for consumer health have apparently not seen.
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Endocrine disruption from preservatives is real in consumer context? Don’t think this is consistent with CIR, SCCS and FDA opinion. Can you elaborate?