PhilGeis
Forum Replies Created
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Think you can develop your own technical defense re. principles established in 22716. Avoid PET defining your risk - if you must generate data - try some in-use testing..
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Hey Matt - not aware of data but prob less effective exposure if addition is after clay is in formulation. But that also leaves previous formulation protected only by GMP’s/time/temp etc. and demands late addition doesn’t run afoul other formula interactions.
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Benzoic and maybe other organic acids reportedly absorbed by clays and may have issues with EDTA as preservative adjunct.
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Accepotance criteria in what context? Might consider ISO 29621 for micro risk. https://www.iso.org/obp/ui/#iso:std:iso:29621:ed-2:v1:en
“Reasonably archaic”. Please don’t be casual re. GMP’s. Per the Drective:
To ensure their safety, cosmetic products placed on the
market should be produced according to good manufacturing practice. -
Good point from Dr. Pratt, but think 50 gram net weight may be too much for the exemption. Perhaps follow the Olay regenerist line labeling - those are ~50 grams.
“The PDP of a “boudoir-type” or decorative cosmetic container, e.g., cartridge, pill box, compact or special variety, and those containing 1/4 oz or less may be a tear-away tag or tape affixed to the container [21 CFR 701.13(e)(1)]. It may also be the display panel of a card to which the immediate container is affixed [21 CFR 701.13(e)(2)].” -
and Advanced Testing Laboratory https://www.atlscience.com/
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Back to the original inquiry - please understand major manufacturers have rarely engaged in “natural” preservation. In context of consumer protection, they’ve found the approach inadequate, and that is consistent with the fact that most of the recalls involve natural/alternative preservative systems. Few are also willing to engage in the head fake of Ecocert et al.
Unless your willing to show with efficacy testing (as limited an indicator as that is) an effectvie and stable system - and confirm appropriate compostin of every batch of “natural” preservative, stay out of the category. You’ll put your consumer at risk for a trivial claim.
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A quIck glance. I’ll pass on your insightful comments.
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Good advice from Pharma. 8% ethanol is helpful but not enough. Decide what you consider “natural” - truely unchange from nature or by commercial redefintion ala Cosmocert. Might take a look at recent chapter Dr. Amoroso (P&G) wrote on the subject.https://books.google.com/books?hl=en&lr=&id=Xq0CEAAAQBAJ&oi=fnd&pg=PT46&dq=amoroso+natural+preserve&ots=JXysHfmSwm&sig=k6pIcE2zBD9jHdis9VFXAhUnpG4#v=onepage&q&f=false
But - avoid “as little as possible”. FDA and EU note preservatives are intended to protect in -use, and challenge tests (USP 51 and it’s ISO, etc. knockoffs) are not validated, As you are unlikely to do in-use validation, work within recommended concentration parameters. Be aware, most of the recalls are “natural” or preservative free products. Also be aware the natural preservatuves as undefiune mixtures (essential oils, ferments, “parfum”, etc,.) vary from in composition and efficacy from batch to batch. Grapefruit seed extract is a scam.
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mhart123 makes a good point. Why not contact the supplier (assume Lubrizol) for their perspective.
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Methyl paraben alone is a pretty weak preservative system. Have you conducted any micro testing - challenge or content?
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Good point - back to your original question. At pH 11-12 you need no preservative.
2% EDTA is well beyond the preservative aduvant level (~0.1%). In that context, citric acid is not as effective as EDTA and, at alkaline pH, will be its sodium salt. -
Pharma - assumptions/advertising - the stuff hasn’t been shown to be “safe” or nice. Enzyme sensitization on inhalation is not uncommon. One major marketer experimented tried protease enzymes in a bar soap context and ran into significant and serious allergenic response. They’ve found even worse problems in manufacturing laundry detergents with enzymes. Folks may also respond to the lactobacilli themsleves but, unwittingly those folks may have mitigated as lactobacilli in some context mitigate immune response.
Are you aware of data fom those folks re. your imagined efficacy scenario?
Also be aware that lactobacilli can carry markers for antibiotic resistance. Unlikely to be medically signficant themselves, they could be a source for horizontal gene transfer.
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There is no such system.
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Have you looked at the safety of your other ingredients?
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Agree - ecofriendly is advertising hype in any context.
Have you sen any data for the “effective microorganisms”? I’ve seen it hyped on facebook but the marketer didn’t offer any meaningful efficacy data.
A major concern they blow off is safety - spraying bacteria, fungi and their alleged enzymes in the beathing space is risk for sensitization. -
Perry, an obscure historic regulatory problem with ethanol. Think 1989 or ’90, shortage of SD40 alcohol disrupted
the industry – we couldn’t make hair sprays and gels and alcohol
deodorants.Issue - noncompliant SD40 alcohol. Brucine (SD40 denaturant aka dimethoxy
strychnine) included impurity strychnine > ATF standard. World’s brucine supply from a few plantations
(from seeds of nux vomica tree) in India came via a single supplier, and alcohol
suppliers apparently no paid attention
until crisis. No idea why supply that
one year was off – not reported before or since. -
How about PAO? That one has always hacked me off.
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You must substantiate its safety (chemical, physical, micro) by testing or reference or warn.
21 CFR 740.10
A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:
Warning - The safety of this product has not been determined.
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ngarayeva001 said:@PhilGeis, you are right, I have chosen a bad example. I was trying to make a point that in most cases cosmetics doesn’t do anything noticeable when it comes to changing how skin actually looks (unless it’s a drug). So I think a good marketing should be focused on experience because most of claims are misleading by nature.
I sure agree. Cosmetic claims are often subjective and rarely (at least this old balding guy) significant - so my focus has been on safety and tha is what the big companies do fairly well.
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shaving “soap”
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I’m with you. Adding preservatuve individually is my preference with caution that some are a bear to get in that way (e.g. IPBC).
Certainly recommend Na benzoate over K sorbate in this context - and with EDTA. -
Some major companies work on a three year stability testing plan, knowing relevant consumer use.
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ngarayeva001 said:Marketing shouldn’t be deceptive, marketers are just lazy. It’s easier to throw unsubstantiated claims like ‘cellular’, ‘genefique’, ‘antiaging’, ‘stem cells technology’ than creating an experience. I remember commercials of camay soap in 90’s. It was all about experience and ‘luxury’ and having a fine perfume added to a bar of soap. It was a popular soap back then. Consumer happily pays for experience. Having said that unsubstantiated claims come from both sides. In case of large companies it just gets proof read by the legal department.
Consumers haven’t happily paid for the Camay experience in decades - tho’ last I heard it had some presence in Eastern Europe. P&G hasn’t suppoorted the brand in many years and sold what’s left to Unilever.
Large companies typically have all claims reviewed by legal - not “proof read” - and do generate data for many relevant claims tho’ puffery is still in practice. I disagree with the your claim of equivalency to small companies in this context. If nothing eelse, it’s much less expensive and impactful on brand to generate (even seemingly) relevant data than defend vs. challenge.