PhilGeis
Forum Replies Created
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@Microformulation
They received > 200 questions. hope they’ll answer those they can -
@MarkBroussard
Sorry Mark - you would have found it interesting.
Nope. That’s on FDA’s list of development items. They emphasized product in place of ingredient but suggested ingredient news could screw up a product assessment. -
Don’t know if you guys sat in - some points cam across to me that folks here should understand
- safety that all must substantiate is for product, not ingredients per se
- adverse event reporting can be by website - assume company’s website as in
“none reported”
- FDA recall authority is for Class I recalls, the most serious - almost all
cosmetic recalls are the less serious classes II or III.
- A lot of stuff is hanging fired until FDA sets up the regs - GMP’s big sand small business, fragrance allergen labeling (but might go to school on EU) -
Today!
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It’s used in cosmetics soaps typically as tallowate - FDA does not have authority over pure soap.
if your concern is for BSE - see: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=700.27 -
your water phase pH?
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What presrvative do you propose?
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Adding to ngarayeva001’s good comment, be aware you may have trouble passing a preservative test whatever preservative you use as inoculum droplets may not encounter water droplets with preservative. That should not be considered a show stopper.
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@BUNSEN87
Sure - “trend” means exploitation of consumer ignorance that sells ingredients with little safety information and rejects those whose safety is well established. -
Aw tells you the risk in use. Your primary risk is humidity and fungi. Packaging must protect vs. direct water addition.
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There is no challenge test that’s appropriate and applying aq. product standards is not appropriate.
Your worry is growth of fungi - if its wet enough for bacteria, you haven’t a chance. Get the lab to run AW (water activity) on product held at humidified conditions.
What is the pres system you’ve tried? -
The final product is an anhydrous powder? How are you testing it for preservation, and what is bioburden of the rice starch?
Think you need to generate some in-use data - not only direct water contamination but taking up water from humid shower environment.Please drop the “too much food’ context - bacteria can grow in distilled water and fungi on basement walls.
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Micro testing: content to spec and, if you’ve not conducted it, stability testing.
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Thanks Mark
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Meant that a claim of “quality ingredients” is meaningless - no one should use poor quality ingredient.?
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@Ghita37
It just more meaningless advertising. Every one (definitely better) use quality ingredients. -
@Ghita - that one is a weak chelator that can inhibit fungi.
Leave-on versus rinse off products typically have different preservative systems.
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@blueberry
I’d not count on rinse-off products offering much benefit in that regard. -
@Graillotion
I think you’re ok without an attempt at head space protection. Open pots have been around for around a century. My experience - we didn’t worry about growth on inner package surface. -
considered - as regarded, thought of as
Less than consensus - there is no objective definition.
Safe - clearly clean products as a group are LESS safe - with their limited, sometimes ridiculous preservative systems. We are charged to market safe products - Clean ingredients, esp. relevant preservatives, typically have profoundly less safety data than the priority materials they replace - materials specifically addressed by the FDA as safe in use.
Eco-friendly is a technically garbage term.
I understand/know Clean as an advertising claim without technical significance. -
@Graillotion
Consumer touches? Can you explain?
Have you seen contamination on inner package surfaces? -
@MarkBroussard
LOL - you are a marketing devil! -
@RobboAU
“…considered safe, non-toxic, and environmentally friendly.
Bull - the functional term is “considered” as in marketed under these meaningless terms.I’m impressed they put so much BS behind it.
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Life cycle analysis - ask Dupont.
Think you’ll get lost in the weeds in comparison. -
O-Cymen-5-ol vapor pressure is a bit < PEA’s. Don’t know if either would be effective for headspace from cosmetic matrix
Are you sure you need headspace preservation?