PhilGeis
Forum Replies Created
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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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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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Love to see the ‘concrete reason.”
To your question - the relevant OTC drug monographs establish data requirements needed you need to market.
https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
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Pretty sure that would not be a drug claim - but give me break. That’s BS.
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Agree - the solution is at risk for contamination. You could get a rough idea by comparing ZOI - before and after autclaving.
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Makes to difference - it’s a poor preservative system at an y concentration.
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At best “broad spectrum” is based on an existing MIC (at any concentration) for each of the bugs representing the groups: Gram + and -, yeast and molds. While in-formula efficacy data establish practical the definition, we know the mythical creature does not exist - as seen on labels with major brands.
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Why would you autoclave?
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Inactivation? Test it.
COSMOS/Ecocert confines your efforts to options limited in efficacy. Your package may limit consumer contamination but magnifies risk (via inhalation) if there is contamination. What is the quality of your production - water, raw materials, sanitization, etc.? Major manufacturers work on a 3 year product life.
To ketchito’s question - efficacy (hair growth and anti dandruff) - add safety, esp. via inhalation. How do you answer these?
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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?
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Good point Mike - as a scientific question -safety in any aspect is and will always be open for discovery. Parabens have been the most investigated of preservatives and SCCS is reportedly in process of addressing additional data that offered in support of methyl paraben safety.
It’s also worth noting that many of the replacement preservatives are not approved and the subjects of limited to no safety testing.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://health.ec.europa.eu/system/files/2022-02/sccs2022_q_001.pdf
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Mike, whereas the scare mongering may have made the question academic, what do you see as the open question re. parabens that current risks assessments have not addressed?
https://www.sciencedirect.com/science/article/abs/pii/S027323002100146X
https://www.cir-safety.org/sites/default/files/paraben_web.pdf
https://journals.sagepub.com/doi/full/10.1177/1091581820925001
https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics
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Analogous - one can find >750,000 citations for combined search terms formaldehyde and cancer. Yet the same sources CIR, FDA, SCCS have determined and confirmed safety in use for formaldehyde releasing preservatives in cosmetics. As correctly noted by J&J researchers when they grudgingly removed Dowicil from their baby shampoo - there’s more formaldehyde in a plum than their product.
Be aware- CIR, SCCS, FDA work on risk assessment rather than an attempt at risk elimination - consistent with Paracelsus caution - the poison is in the dose.
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That two terms are associated in a publication does not mean they report or confirm cause and effect. You might also research to meaning of endocrine disruption. The working definition (binding to estrogen receptors) would find many phytoestrogens such as are commonly found in diets profoundly more effective. Lastly - take anything authored by Darbre with caution - tho’ as a scientist you might enjoy her profoundly flawed methodologies.
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Amber doesn’t control evaporation - perhaps oxidation. and leaching.
For sprays, you should have a stronger system as, if present, contamination will be inhaled. Mere presence of a nonionic line Tween in formula does not mean it will neutralize but 221 is a weak preservative in any context. Perhaps phenoxyethanol?
What is pH?
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“Saponified oils” - it’s simply soap. “Hurdle ” here is pretentious.