PhilGeis
Forum Replies Created
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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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Parabens to Molokai !!! Or maybe Dreyfus to Devil’s Island.
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So just “unclean” ingredients?
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Regulatory Affairs Professionals Association https://www.raps.org/
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@healthybooth
I did not see ingredient listed on your website so can’t comment to your application of “clean beauty.”
However, please understand safety is an affirmative process - you must have data that shows safety for all your “clean beauty ingredients and products re. appropriate endpoints - carcinogenicity, sensitization, irritation, eye safety, teratogenicity, preservative efficacy, etc.? Without such appropriate data - your product are not safe and in US would be labelled.
“<strong style=”font-family: inherit; font-size: inherit; color: var(-bb-body-text-color);”>Warning-The safety of this product has not been determined.”
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@healthybooth
Clean beauty is a technically meaningless marketing claim - there is no technical synonomity with safety or “non-toxic” ingredients. Ironically, many of the “clean beauty” ingredients (esp. preservatives) have very little human safety data in context while those rejected are a among the best qualified in terms of safety in use as document by the FDA and SCCP (e.g. https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics).
Please, if you insist on a technical basis for this makrei8ng claim - please provide the technical support. Repeating the marking BS does not establish its validity.
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To the previous comment, I’ll add that you must consider how you will validate your in vitro protocol to consumer use.
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As he said, terminology “pH” - “p” means the negative log value, here concentration, and “H” refers to hydrogen ion.
and pH balanced is largely BS.
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Soap is certainly not immune from contamination - esp. with bugs that are not readily picked up with routine testing - e.g. https://onlinelibrary.wiley.com/doi/abs/10.1111/ics.12401
Are the body wash/shampoo/etc. products in question all of the classic soap, alkaline pH-based composition? This is generally ok as made clean - BUT - common consumer practice is dilution - by intent or unintended exposure in shower.
Most of the cosmetic recalls are of the “clean beauty” preservative type. All no doubt passed their version of <51>, probably +/-total “kill” at early time points. Not only does the test fail to address fairly minor manuf. issues (“minor” as I’ve consulted on some) , it’s not relevant to the primary objective of consumer protection. Major companies qualify their preservative systems and to some extent their own challenge test with in-use experience (e.g. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987).
Think any novel approach to preservation should be qualified vs consumer use. Not aware Dr. Bronner has so qualified their systems and wouldn’t take just their word for it anyway. Their systems don;t impress.
I know you are a veteran of the cosmetic industry science and sure have learned a lot from your posts. On this matter, I don’t understand the justification or science.
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Please explain the data set - not that no one challenged. That said, the purpose of preservation is consumer protection - and none of the compendial challenge tests are validated for that purpose. What data do you have in that context.
btw - you have a totally incompetent and negligent assessor.
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Ketchito may be addressing soap fatty acids av. synthetics as in Ivory v. Dove. I recall of the FA’s, laurate C12 had the greatest irritation and antimicrobial potential.
Not familiar with pipes but we all know soap scum.
Could you address the microbiology - preservative-free - aspect please.
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Self-preserving? The products? Please elaborate.
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Appreciate your professionalism and concern for safety. In that regard, please drop the Ecocert charade and forget the GDL/Leucidal - in any application.
Suggest . parabens and organic acid(s).
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Please be aware that anhydrous products can be contaminated. Note recall of an anhydrous eye ointment due to Bacillus cereus contamination.
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#1 is a good better system with pH control.
The organic acids alone or in combination are poor - at any pH. At acidic pH, they mainly target fungi and Gram positive bacteria and are very weak vs. Gram negatives - the most common contaminants. they can also form poorly soluble salts with divalent cations like Mg and Ca - that you might find with kaolin. Phenoxy is best for Gram negatives . Here too. kaolin may screw you up - might absorb the phenoxy. A chelator would help but that too could be screwed up with divalent cations from kaolin
#1 combination should give you a good start.
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The no-no lists are marketers’ and retailers’ - telling consumers what they should want - not a compelling % of `consumers.
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Content testing is important but preservative testing by typivcl protocol is pretty meaningless for such products. You should get a risk assessment for product and production.
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3 and. as Abdullah suggested, with a chelator.
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Think recent fed legislation (MoCRA) should preempt moronic state BS like this.