PhilGeis
Forum Replies Created
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I’d test that one as prototype.
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Yes - but I’d not bother with mold for surfactant products.
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What are chances of freezing in your distribution system?
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Suggest at minimum you use CTFA method. In any case, preserve for complete elimination in 7 days or less, not the %’s.
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Sort of - sterile water but sending it for testing won’t work. Bugs can grow in transit.
Ask the supplier about package quality. -
Run micro of rinse water of a few lots.
Also - ask the supplier. -
No need and likely not feasible to sterilize. They should be clean - if you have the resources, check micro content on samples of a few lots.
Exception might be pumps - if preprimed or tested, may have residual water and that will have bugs. These can’t be sterilized - work with supplier to stop the practice or rinse with alcohol. -
Suggest one of Abdullah’s suggestions with EDTA and benzoate.
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You should understand water loss that can throw you into net weight noncompliance. http://www.qic-intl.com/glossary/MAV.htm
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If your name is one the product, you are responsible. A contract packer would be responsible for issues associated with manufacture - contamination, adulteration, etc. for which you would sue them.
I’d ask - if they do not have liability insurance, do not work with them. -
SDS refers risk associated with the raw material. to address risk in product application, one would need to consider dose - as Perry noted in the initial post..
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what is your pH?
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Gluconate isn’t much of a chelator - use NaEDTA
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@Graillotion
IPBC, Chlorphenesin. -
Be aware suspensions/solutions may not be stable in refrigeration - solutes may fall out of solution at reduced temperature.
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@GeorgeBenson
You need to clearly state your policy. “Very mild” is meaningless as your not looking at irritation/sensitization data.
You don’t like phenoxy because someone might read the label.
What is your policy? -
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.