PhilGeis
Forum Replies Created
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PhilGeis
MemberMarch 7, 2024 at 7:16 am in reply to: Define “sulfate” and are there sulfur-free surfactants?Search Google images for ingredient names and look for “Sulfate” as SO4
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What testing and standards do they reco at “retest”?
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Mike - re.” Importantly, we must make a distinction between synthetic and essential oil fragrances. Safety assessments have not been conducted for many of the synthetic fragrances.”
I dispute this statement. Extensive safety assessment IS conducted by major manufacturers for their perfumes and perfume ingredients - synthetic or otherwise. These data are not made public as they represent substantial investment by perfume suppliers. I’ll offer that natural ingredients including essential oils in general have much less (some no) analytical and safety data support - both as expected and as supplied.
Further, we should avoid casual, unjustified scare mongering.. re. “Avoid any product that uses the words fragrance, parfum, phthalate, DEP, DBP, or DEHP in its ingredient list.”
Consider phthalates. Citing its own findings and conclusions of CIR, CDC and NIEHS, FDA comments “… the FDA does not have evidence that phthalates as used in cosmetics pose a safety risk.”
https://www.fda.gov/cosmetics/cosmetic-ingredients/phthalates-cosmetics
fda.gov
Overview of safety and regulatory issues related to the use of phthalates in cosmetics.
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Good idea - but do not “blend”. Formulate as individual ingredients and, if pH allows, use Na benzoate rather than sorbate. Doubt you really need the tocopherol.
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Prob should check micro
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No reason to. What is your geography?
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PCPC test - can you be more specific?
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Adding tap water will add Pseudomonas aeruginosa - a typical water bug and one of the worst for cosmetic contamination. Using the same bottle with the added water will give it a chance to adapt and grow in your product.
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Regulators/bureaucrats are as uninformed as you, Mike. Hopefully their safety decisions re. ingredients and products decisions are based on appropriate review and risk assessments by toxicologists. That is precisely the basis for FDA’s position on phthalates.
To repeat. Citing its own findings and conclusions of CIR, CDC and NIEHS, FDA comments “… the FDA does not have evidence that phthalates as used in cosmetics pose a safety risk.”
I’m not familiar with Malaysian regulator authorities or their scientific support. For P&G I reviewed and offered comment for ASEAN micro standards and protocols some years back - and was not impressed. What is their position on phthalates?
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Please explain the experience as the co-founder and Master Formulator of a skincare manufacturing factory in Viet Nam and Malaysia since 2006 that qualifies one as a toxicologist - esp. one with superior technical insight vs. those of CIR, FDA, CDC, SCCP. etc.
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Let’s also remember the limited relevance of “endocrine disruptor”. In its basic form - it means binding to estrogen receptors - esp. membrane receptors - to start a cascade for gene activation including those of sexual maturity. Parabens e.g. do indeed bind - with an affinity orders of many magnitude less than estrogen and in an a noncompetitive manner so readily displaced by estrogen. That it activates is unsure. but estrogen itself is listed as a carcinogen in this regard.
“Endocrine disruptor” is bandied about by activists with ignorant horror of a zombie invasion while researchers conduct experiments irrelevant to application but eagerly extrapolate data to were all going to die.
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Mike you are not a toxicologist (nor am I) and it is not agreeing to disagree - it is risk assessment vs risk elimination (aka scare mongering). As with parabens and some of chemical targets of endocrine disrupting scare mongering, there are data of some effect (tho parabens data are often crap). Science addresses those data by estimating the risk in use - and that is the practice of toxicologists at FDA, CIR SCCP, IFRA, P&G, Unilever etc. Presence of data/potential risk/publishes articles means nothing practical until placed into a use context.
The only totally safe material/chemical is the one that hasn’t been tested. Risk assessment considers exposure, effect, NOEL, product context, etc. by standardized and validated protocols and specified safety factors.
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PhilGeis
MemberMarch 4, 2024 at 5:56 am in reply to: Preservative-Free Eye Drops Linked to Bacterial Infection and DeathCynical posturing from a criminally-incompetent Indian company. “Abundance of caution” with a body count and FDA Enforcement Report noting “Non-Sterility: FDA analysis found unopened products to have bacterial contamination.” and includes recall from the same folks of eye ointment for the same problem. Marketers were EzriCare and Delsam.
Dave’s right- tough to see a scenario by which a consumer contaminates eye drops with aeruginosa but obviously a manufacturing risk.
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Add Sodium benzoate to ~ 2500ppm
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What is your preservative policy? do you use formaldehyde releasers? parabens? And what is your pH?
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May or may not be important to your problem but that is a useless preservative system
Nancide (assume Naticide) is a sham. If by “Grapefruit extract” you mean the seed extract, you’ve fallen for more BS.
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Great! You should expect no recovery -even one is a concern as you hopefully will be selling the product for years exposing lots of folks. If you find bugs, check product for chemical and physical adulteration. Some folks like to combine products or dilute. Chemical adulteration unless frequent, is not something preservative risk assessment needs to address. Dilution is common for shampoos and less so hand soaps. For that, establish the level whose risk you accept. We used 50% as it was common globally and about the limit of what consumers would see as functional.
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PhilGeis
MemberFebruary 29, 2024 at 7:17 am in reply to: Preservatives: Do Consumers Actually Care?Sure Mike, and risk is driven by application and culture. Hand soap product in pump less so than shampoo in a bottle. Culture - e.g. customers intentionally diluting product - some Chinese customers use sachets for months for family washing.
This is the best one in public access https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
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PhilGeis
MemberFebruary 28, 2024 at 6:44 pm in reply to: Preservatives: Do Consumers Actually Care?Mike - I do not know if consumer safety is compromised by your products. Based on our previous exchanges, I understand have no data that preservative function - protecting the consumer in use - is fulfilled with your products. So you too do not know.
There are no “toughest standards” for functional preservation anywhere but with the major companies who preserve to address in-use risk. And that in general would not be just passing a USP/ISO/EP/BP test.
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Sounds good. Just be sure to understand and control
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Imagine companies doing it know (perhaps care) nothing of the risk.
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Thanks for clarification - I understand the test and a member of the committee responsible for it.
Do NOT go off happy it passed “unpreserved” - it is preserved but how?. There is a reason and you need to confirm the WHY and confirm that the WHY will be in every product you make through stability. It might be a preservative or impurity in a raw material that the supplier may not maintain, some unique combination of ingredients and process that is not controlled.
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PhilGeis
MemberFebruary 27, 2024 at 8:56 am in reply to: Preservatives: Do Consumers Actually Care?My point is this - one would expect any alkaline true soap product to “Pass” as USP/ISO/ASTM/EP protocol. The bugs are weak sisters - pH alone knocks down and add fatty acids esp. C12 - the product passes..
But the purpose of preservation is to protect in-use. With good GMP’s and manuf hygiene, one can make poorly preserved products clean. IN[-use - a pump product may protect but in a typical shampoo bottle, you will get water ingress and poorly preserved products fail. We’ve spoken before on this and i understand you have noIin-use data to this risk.
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Let’s see where MoCRA comes out. Mike may indeed be right that preservative testing is required, and I’m sure 3rd parties (good and the EWG types) will offer their services as intermediaries. Haven’t heard that FDA will make that part official.
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PhilGeis
MemberFebruary 25, 2024 at 10:25 am in reply to: Preservatives: Do Consumers Actually Care?Come on Mike -it doesn’t take a scientist to make and sell soap.