PhilGeis
Forum Replies Created
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Advanced Testing Laboratory in Cincinnati. The do all Procter & Gamble’s work.
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MarkBroussard said:@Pharma
The EU regulations contain the list of ingredients, percentages, restrictions, etc. of ingredients classified as preservatives that may be used in personal care cosmetic products. But, it does not specify that any preservative ingredient on the list must be used in personal care cosmetic products.
Bayer clearly wanted to market a “preservative-free” product and found ingredients not on the preservative annex that yielded acceptable preservation results to pass the safety assessment and get the products on the market. It would appear that they are relying on 1,2-Hexanediol, low pH (Citric Acid) and perhaps airless packaging to achieve this. The odd thing to me is if they cannot use “Preservative Free” claims in their advertising and packaging, what is the benefit?
Presumably, their market research indicated a decent market demand for a product line that did not contain any of the preservatives on the annex.
The directive prohibits use of preservatives not on the list. Largely drive by SCCS consideration, there is a pathway to add new stuff.
Citric acid may adjust pH but is unlikely to offer preservative effect , and I’d not give them the benefit of a doubt for airless. Think Pharma observed they do use free claim but caution others - are they selling the formula for others to package and sell under their brand?
Assume marketing drives the claim with Bayers cynical decision that they’ll not be challenged - with “emollient” BS but wonder at response to “what’s the preservative then” the “expert” premarket approver might offer.
To my perspective, it’s no different than using Ecocert cover for “natural” claim re. synthetic chemical ingredients. Enforcement is very unlikely, others are doing it and I have a good story for cover. -
Prob not - on what data does he claim 3 year stability?
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9010 is ok - if it works. Some shampoos screw it up.
The primary micro issue for shampoos is due to Gram negative bacteria and those are the target of phenoxy and its EHG booster. Don’t buy its “broad spectrum” marketing BS.
Think a chelator (EDTA or phytate) Na benzoate would be good additions. -
Sure - I’m ignorant of your policy or pursuit of alternatives or “naturals” but the best is chloromethyl isothiazolinone/benzoate/EDTA. Do you have preservative testing capacity or budget?
Is this product intended for commercial sale or for personal use?
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Suspect microbial contamination. Just parabens are not that great for shampoos.
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HrH said:Is there any protection from the ‘do a patch test on a small area before smearing the product all over your body’ statement that I will now be adding to my label?
No. You are responsible for the product, not the consumer in their normal cosmetic use.
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What is pH? Why both benzoate and benzoic acid? Think I’d check on in-use contamination risk - this will be inoculated at every use.
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Try them - they’ve been around for a long time and there’s a reason you see little use - they don’t work well. Watch the pH - their pKa’s are around 4.5. Please don’t engage with Cosphatec’s dishonest “multifunctional” dodge.
Toothpaste is irrelevant to other cosmetics - formulation is generally hostile with flavoring agents, Aw and some with benzoate or parabens. Packaging is protective.
USP is a poor determinant of micro safety and the others not much better. None of these is validated to protection in consumer use - the primary purpose of preservation - and you’re clearly playing at the edge of efficacy even for those.
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True Bill - alcohol with quats can be effective combination.
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Multifunctionals? Those are (weak) preservatives, and multifunctional here is a head fake to the Directive.
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A formaldehyde releaser with 2/1 Methyl/Propyl was the classic preservative combination for emulsions for 30 years. Combine with a solvent like prop glycol or in heated water phase - not in oil phase. Partitioning can be an issue and should be addressed.
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I’ve used 2/1 and 3/1. Propyl has comparatively limited solubility and considered more effective vs. fungi.
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DaveStone said:
Good points. Although I would think a big company might not use an ingredient simply to cut costs.
I assure that a big company would use an ingredient simply to cut costs. Consider millions of units sold globally for years - a couple of pennies per unit is worth pursuing.
To the paper - please understand reports of “significant” differences versus controls in controlled protocol may not - often do not - amount to benefit in product application and there was no comparison to ingredients currently used. Don’t forget that academics often exaggerate impact of their work.
Further, use as sunscreen would require new drug approval.
Above doesn’t mean folks wouldn’t use a n ingredient just for the “story”. Most of cosmetics are sold on hype. -
ethanol at 20%
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I like any of the three to the left
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For fungi, parabens or IPBC are best - you could try Caprylhydroxamic acid.
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Parabens or IPBC are best - you could try Caprylhydroxamic acid.
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You should design a system for broad spectrum efficacy and test to confirm. Phenoxy has little effect vs fungi and ok but not great vs Gram positive bacteria.
Phytate is pretty good as is EDTA.
Open jars are risky but if it’s for personal use - it’s your risk only. -
Oatmeal products are difficult to preserve. Can absorb oils so important to understand stability even if preservation initially effective.
9010 by itself is not enough - suggest chelator addition, and you’ll need addition with antifungal efficacy.What package design do you anticipate using?
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will you use parabens or IPBC?
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As Abdullah noted - you should establish antifungal efficacy in your preservative system. “Broad spectrum” claim for 9010 is the usual marketing BS.
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Have you ruled out microbial contamination?
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Please look at the specific monograph - some do require specific testing - e.g. spf determination for sunscreen products.
see monographs at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfmI gather you’re concerned with the skin protectant monograph - that does not specify testing.
https://www.accessdata.fda.gov/drugsatfda_docs/omuf/OTCMonograph_M016SkinProtectantDrugProductsforOTCHumanUse09242021.pdfFurther - please understand these are drugs products and must comply with relevant regulations under 21CFR for registration, GMP’s etc.. A product can also be both a cosmetic and a drug and comply to both sets of regs.
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap