PhilGeis
Forum Replies Created
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Data offers no support for EHG beyond phenoxyethanol.
What is the product?
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The primary risk for cosmetics is microbiological, not chemical. Hobbyists, flea marketers and the like will always do as they wish and FDA will never have resources to address their issues even if they knew what to do.
Significant/magnitude risk (as recall) is realized in small to midsized operations as a function of poor, politically-correct preservation and half-assed manufacturing hygiene. There is no mechanism to assess in use contamination but that is even greater with poor preservation.
Virtually every recalled product has passing preservative testing data and “GMP’s”
Legislators know nothing of the industry (witness classic PAO idiocy). EU (and proposed US legislation) merely establishes a paperwork confirmation, addiung no effective value. Big cosmetic writes most of the text at the fed level and little guys are usually exempted or greatly limited/delayed for enforcement. Some states (e.g. California) are more influenced by the chemophobes and their crazy stuff is typically very focused (bans of micro plastics, PFAS, formaldehyde releasers, parabens, whatever).
FDA regulations and enforcement based on legislation is the reality - not legislation per se. The Agency is focused on drugs and vaccines (CDER), Cosmetics are regulated as secondary priority by the foods guys (CFSAN).I represented P&G for over a decade at state and fed level for cosmetics and other issues. In the big legislation/regulation picture, cosmetics are a secondary if not tertiary concern. Folks might look at the original FD&C act history to understand dynamics involved in such regulation - https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1937&context=lcp
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There certainly are barriers for import of cosmetics. e.g. https://www.accessdata.fda.gov/cms_ia/industry_53.html
Some ports of entry are known to be more demanding than others.
I’ve successfully argued with FDA such cases for clients.
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Ask for the CTFA test and pursue elimination.
Chlorphenesin is largely an antifungal. It may help your system. -
Clearly your product sucks vs fungi and you’ve seen the good suggestions above — but increasing the phenoxy is not likely to help.
USP 51 is a very poor challenge test - any reasonable system should be eliminating/greatly reducing fungal counts.
Mold aspect of the test is real stupid. Inoculate with spores and fungal growth does not necessarily increase CFU. Likely the “small increase” is a result of mixing not growth, but that’s a technical detail . You should be killing not holding steady. -
Diols generally can cause irritation - and some users experience this in context of deodorants. Generally takes a fairly high level and is transient. Disappears with continued use.
As grapefruit observed, very doubtful in apparent context of your question. -
Think 9010 is prob not a good system in this app. Think I’d check with FDa on this - it may require GRAS status.
The Aw is likely pretty high - bet >0.9. A pH 8 rinse is not going to enjoy much protection from benzoic acid.
Think about benzalkonium Cl. It has its gaps so need good manufacturing hygiene. -
Yes, Zemea is a good addition. One major upscale cosmetic marketer routinely uses it in their systems.
The marketing literature is real stupid. -
Zemea has some efficacy but don’t get carried away with marketing literature. Showing efficacy at 50% recommended level when they did not test at 100% is hardly compelling
To your question - doubtfully effective with just DHA. Geogard 221 includes DHA and benzyl alcohol.
Why would you titrate down to the just effective level? Cost savings are not that great and the test, tho’ better than USP 51, is still not validated. -
But to the question - legislation proposed largely demands big companies do what they’re doing now. and it’s largely paperwork. It lets small guys largely off the hook. The rub - the extents that small guys will comply and FDA has resources to enforce for small operations.
For EU folks that comply with the directive, they run their stuff by a qualified person. There aren’t many folks of any degree with enough expertise in judging preservative or manufacturing systems and you’d be very hard pressed to find one among those in field of “pharmacy, toxicology, dermatology, medicine or a similar discipline” even adding chemist , biochemist and veterinarian.
US regulation would pick up some guys at the margin - getting them to pass USP and write down their GMP’s - at best, marginally limiting contamination from operations and projected in use.
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@grapefruit22
I understand EU reg’s quite well and know not all in EU follow them by engaging with inspectors who know little about cosmetic quality any more than US folks using garbage “clean” systems and blowing off GMP’s.
EU also has the technical fantasy of PAO that clearly gives license to garbage systems. I’ve encountered folks using PAO down to 6 month - one at 3. We know consumers do not respect ex dates.
Let’s not discuss “clean” further - we all know it’s a marketing claim that sadly offers garbage preservation and unfortunately has traction in US and EU.Bottom line (rather than opinion )- what are the data?
One might look at recalls - comparing RAPEX to FDA enforcement. Historically, there has been little to no difference -
Wrong. Retailers’ priority lists ARE responsible. In US and EU. Sephora, Target Walmart, etc - all encourage use of garbage preservative systems. I’ve consulted with contamination incidents clearly provoked by these lists.
There are EU folks who make and sell cosmetics AND participate on THIS Chemists Corner who observe they do not test and express ignorance of manufacturing hygiene. As I noted before - the “test” means little - esp. when folks know nothing off manufacturing hygiene. You might also take a look at RAPEX list of cosmetic recalls.
“Clean categories” what does that mean and why should a marketing term find technical credibility n regulation? That phenoxy is “allowed” does not mean it’s used or folks chasing that marketing claim develp effective systems or make them appropriately.
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“Clean”, esp. when combined with “natural”, typically indicates advertising hype has produced a garbage preservative system. With high Tween 80, one can expected some degree of preservative neutralization.
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Counter ions can make a difference in some applications, but it’s hard to understand why. K hypochlorite is more effective than Na hypochlorite in Tilex-type products but more expensive.
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Right, EU’s ingredient ban comparison is a ridiculous - ingredients no one would use.
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The industry has been successful to this point in terms of health risks - chemical and microbiological - as good as anywhere in the world.
Statutes proposed - before covid - ranged from EWG-like craziness banning preservatives to industry (PCPC)-supported, mildly-odd Feinstein Collins. The big guys support as its what they’re already doing. It largely lets little guys off the hook
To the extent there are risks, they’re the politically-correct priority chemical lists and small manufacturers with natural preservative and no knowledge of chemistry, microbiology or manufacturing hygiene.HBO wouldn’t air it if it wasn’t a hit piece.
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natiyo123 said:they use glycols and glycerin to lower water activity and they also have chelators… their preservation is quite good actually, at the same time avoiding “controversial” traditional preservatives.
That is incorrect. Glycols and glycerine at use concentrations do not lower Aw sufficiently to preserve and those are garbage, politically-correct systems.
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Don’t do it.
In addition to above excellent comment - you’re proposing an unapproved drug product.
https://www.fda.gov/drugs/historical-status-otc-rulemakings/rulemaking-history-otc-dandruff-seborrheic-dermatitis-and-psoriasis-drug-products -
Chelate has a preservative adjunct function. EDTA specifically has been a classic addition for >40 years.
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https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clgl
Unless 1% or less, list in order of concentration. For those >1%, you do need to separate mixtures. Don’t use suppliers who don’t share compositional data - it’s often on SDS.
The ingredients must be listed in descending order of predominance. However, there are a few exceptions to this requirement.
1. If the cosmetic is also a drug, section 502(c) of the FD&C Act requires that the active drug ingredient(s) be declared before declaration of the cosmetic ingredients. A declaration, thus, would read as follows: “Active Ingredient: … (Name of drug ingredient). Other (or Cosmetic) Ingredients: … (Names of cosmetic ingredients in descending order).” [§ 701.3(d)]
2. Ingredients present at a concentration not exceeding 1% may be listed in any order after the listing of the ingredients present at more than 1% in descending order of predominance. [§ 701.3(f)(2)]
3. Color additives of any concentration may be listed in any order after the listing of the ingredients which are not color additives [§ 701.3(f)(3)].
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Not much to add to Camel’s good points
All include synthetic compounds, none is “broad spectrum” - tho’ all claim it.
Watch stability for sorbic acid and benzyl alcohol.
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Enforcement reports do not offer ingredients or pH. It will take some effort - but as Lab said, you typically can find such data by internet search - pH will be on SDS.
This is often only useful immediately after the recall. Product search may find only “discontinued” or, if product maintained, a reformulated version. -
grapefruit22 said:@PhilGeis Looking at their preservatives in water-based products, it looks like they’re just using Phenoxyethanol and Disodium EDTA. What are your thoughts on the combination: Phenoxyethanol + Ethylhexylglycerin + Chlorphenesin + Tetrasodium Glutamate Diacetate?
Phenoxy/EDTA is weak. Poor vs Gram + (staph) and fungi.
Other combination - pretty good system esp. w/ package that prevents direct skin contact in container. Phenoxy/EHG /chelator effective vs Gram - and Chlorphenesin for fungi but a combin. a little weak for staph. -
to the title of the original post - if you want to copy a system, look at an authentic “big brand” - Olay, Estee, etc. Sephora is not a brand - it’s a retailer. .
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They should be designed to be safe - formula, package and manufacturing. Available testing is confirmatory not discriminating and only considers one element.