PhilGeis
Forum Replies Created
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You’ll always have those. I was in a legal suit as an expert. The opposition to the attorney that hired my had an “expert” consultant whose testimony about micro contamination was crazy - +/-cepacia has never been an issue for cosmetics and thre FDA doesn’t care if its present.
Pissed me off - but the attorney that brought me in told me to calm down and “watch this”. He asked - “isn’t it true” that the state of Texas has determined you’re trstimony is unreliable and will are permitted to testify as an expert in state court? -
Dave Steinberg’s books are excellent but I’m not aware he addresses the organic acid combination. I’d worry less about synergism than, as Mark said, efficacy of comnbinations. I know it takes a lot of resources but once you’ve established a good combination you can prob reapply with confidence. P&G did this with isothiazolinone/benzoate/EDTA in all its shampoos through all versions for over a decade. Benzoate/Benzyl alcohol/EDTA was another combination that carried over well. - in shampoos atd up to neutral pH.
Alternative systems can work but aren’t so versatile. -
Please do not belei.ve supplier literature. almost all claim broad spectrum through wide pH range.
Think you’re ok with Benozate/Phenoxy/EHG in a emulsion context - but add EDTA. -
Thanks - Think you should read these carefully - they do not support “synergism” of the combination.
By design, they’re not that relevant to cosmetic preservation - metric was MIC in various broths without pH control. “Synergism” defintion was arbitrarty.The first two concluded no synergism and the last didn’t address the phenomenon.
1st. Tho difficult to follow - concluded twice no synergism e.g. “The sodium benzoate + potassium sorbate combination exhibited no synergistic effect; ..”
2nd looked only at a Bacillus isolate - not relevant to cosmetic preservation - but concluded “The combined treatment of the two preservatives did not show any synergistic effect of the growth inhibition of B. subtilis.”
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This is not my claim - it is yours. Please do not send unsolicited samp,es.
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Why not share the link here?
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I’m not aware there is effective synergy. The conclusion is often poorly supported in such papers - largely an opinion rather than meeting a predetermined justifiable performance level. Can you share the ones you find compelling?
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Why does she think its misbranding?
Please consider Olay Regenerist Micro-Sculpting Cream
https://www.olay.com/en-us/skin-care-products/regenerist-micro-sculpting-cream-moisturizer-
INGREDIENTS LIST
WATER, GLYCERIN, ISOHEXADECANE, NIACINAMIDE*, DISTARCH PHOSPHATE, ISOPROPYL ISOSTEARATE, DIMETHICONE, PANTHENOL**, PALMITOYL PENTAPEPTIDE-4***, SODIUM HYALURONATE^, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYLGLYCERIN, HYDROXYACETOPHENONE, DIMETHICONOL, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, STEARIC ACID, PALMITIC ACID, STEARYL ALCOHOL, CETYL ALCOHOL, BEHENYL ALCOHOL, DISODIUM EDTA, SODIUM ACRYLATES COPOLYMER, PEG-100 STEARATE, TITANIUM DIOXIDE, MICA, PHENOXYETHANOL, FRAGRANCE
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Labeling is responsibility of name on the bottle.
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There should be no effective difference.
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There is a 3rd ed (2020) that includes more info - natural and multifunctional preservatives/preservation, detailed manufacturing etc. but it’s kinda pricey.
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Most major manufactuers use 100 cfu/g for all produicts.
FDA offers “Since there are no widely acceptable standards for numbers, temporary guidelines are used instead. For eye-area products, counts should not be greater than 500 colony forming units (CFU)/g; for non-eye-area products, counts should not be greater than 1000 CFU/g. “ -
I’m not familiar with efficacy of hydroxyacetophenone as preservative or booster or its chelating capability. One (I think Japanese) report concluded it might limit phenoxy migration into oil phase. I recall little else but supplier words on this stuff in context.
Note CIR (Cosmetic Ingredient Review) 2021 summary failed to render an opinion pending data needed to address its (dermal) safety.
Think this is a bad idea. You’ll just have phenoxy leaving at least a gap in fungal protection. You’re responsvbiel for the safety of your product - so on what basis do you think it’s safe?
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I’m with ketchito . Neither comnbination or supplier is exciting.
Hexane or Octane diol is ok vs, bacteria in testing - at substantial and expensive levels. Not sure why you need both. Tropolone is anther chelator for whiuch you’d have a tough time gettin risk assessment in this context. The related compound Hinokitol has some reported preservative function
The combination is not “hurdle”- it’s just another marketing-driven combination you generally can’t use outside US. -
some information chapter 7 - https://www.anme.com.mx/libros/Cosmetic%20Microbiology%20-%20A%20Practical%20Approach.pdf
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Rather than pursuing a simple add, why not use an effective system in the 1st place? Not aware Levulinate and Anisate are no more natural than the “natural” Benzoate and Sorbate. Aren’t these synthesized?
Graph A failed EP due to Candida albicans curve, not A. brasiliensis. Data from 1st and 2nd would justify “pass” by USP 15 topical critieria. -
Amen Matt - and something likely effective vs wild-type cepacia and aeruginosa - bugs that would happily eat these “preservatives”.
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The top graph appears to report efficacy of 1388 - Sodium Levulinate; Sodium Anisate - and the bottom adds GCMB glyceryl caprylate. Think performance of this very weak system shows the limited significance of preservative tests - whether USP 51, EP, ISO, ASTM. None of these is validated to anything - but regulatory compliance.
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Every preservative has this kind of claim and tese are nopt very compelling results.
They’re using the Euro Pharma test 5.1.3. http://uspbpep.com/ep60/5.1.%203.%20efficacy%20of%20antimicrobial%20preservation%2050103e.pdf
A bit more challenging than USP 51 but like it as n eother is validated. Offers 2 crtieria - A - normal pass and B acceptable if you can make up a good story to justify.
Top does not pass - A requires 2 log kill at day 14 for fungi and B one log - Candida fails both. Aspergillus brasiliensis meets B.
Bottom graph nominally meets criteria for all. -
At risk of pedantry - the dip slide such as Schuelke’s is not “validated” by external labs showing the same result. If it were - you wouldn’t need the external lab asnd it is clearly not.
The industry standard test (that would meet FDA expectations) includes growth promotion and neutralization controls for every product and internal lab controls maing is costly e.g. -https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter61.pdfPretty sure a company reporting contamination of one product would find the FDA unsatisfied that dip slide was adequate for addressing micro quality of any product.
Dip slides might give you a heads up but shouldn’t replace accepted testing. If you can’t afford quality, perhaps don;t sell/distribute your product
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I’d not count on dip slides beyind water testing for anything beyond hygiene monitoring, hobby and presumptive testing.
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Analytically. This was needed to stay under EU cosmetic directive labeling re. contains formaledehyde.
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Do not have that information. Experience - at use levels of ~2500 ppm - 100-200 ppm “free” formaldehyde.
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Very poor preservation