PhilGeis
Forum Replies Created
-
Please stop. The first isn’t natural and poor - the last two are fantasy.
-
Can’t technical safety - but the EU directive doesn’t give any wriggle room.
-
Can’t say why someone would use now but the term has been used in ref to EDTA around a century.
-
You need to describe the product
-
and water activity is not based on water % short of anhydrous. 4% has to be controlled.
-
Should i assume this is a water in oil emulsion?
-
Probably a better preservative capacity.
-
Maybe it’s not a great problem - if only a little nontransparent at 5C that resolves when warmer. What will be the chances of consumers using/seeing it at 5C and will they be put off?
-
Mike
For any preservative system, the marketer should have a reasonable assurance that it will not become contaminated in use - in the hands of the consumer - a function of formula, package and consumer practices. “GMP compliance”, most of which is tangential to micro risks, is not relevant as making it clean and passing the classic test fail the question. Further, bugs can grow after release in an apparently clean product. I think that is the biggest miss for most of the folks posting here. For classic preservative combinations, there’s a lot of data - most of which is in the hands of large companies, For an alternative system - and dilute soap with its vulnerabilities - that’s significant as washing products are the most susceptible in consumer use compromise.
The EU Cosmetics Regulation governs how cosmetics and personal care products are made and placed on the market. It is the most comprehensive set of laws for our industry in the world, requiring cosmetics to be safe for human health when applied under normal or reasonably foreseeable conditions of use.
.
-
Your risk - but please be careful.
-
Consumer data? Can you share it?
-
Sure would be more cautious about “self preservation” unless you have in-use data. - packaged product.
-
Even at the right pH, that is not enough for this kind of product. You need something for Gram negative bacteria.
-
You need preservation.
-
Good point. I don’t see anything that would discourage any relevant bug.
-
You could look at similar marketed products but, to Perry’s point, you don’t know their risk assessment. If this is just for you - you can be arbitrary. If you plan to sell, (micro) safety is on you and a food grade preservative like parabens might give you a technically-defensible position.
-
That’s the only water in your product. If you water quality is good, you will have a small weakness vs fungi.
Do you control its pH?
Assume you’ll not try to challenge test.
-
No - the composition of the aqueous addition - 4 parts water to 3 parts glycerine?
-
What is composition of aq. mixture?
-
Not to be argumentative - but do you have that in depth understanding? Can you say what hormone do you have in mind and to what purpose. I’m certainly not much help in risk but think pharma can provide perspective..
-
Thanks and good points. There is no lab test that replicates with validity in-use challenge - the paper merely observed the efficacy of preservative in context of package and offered in vitro challenge data that apparently identified that level of preservative efficacy. What isn’t shown is that all the preserved products would have passed USP 51.
I’m not aware of any in vitro test that considers preservation risk in context of package or, for formulas, manufacturing risk. That so many are happy with a “pass” in compendial tests is a major flaw in the industry - every recalled product passed a compendial test.
In-use risk is what keeps most of the big companies in classic systems. The EO’s, organic acids, esters, glycols, eyes of newt/toe of frog and “naturals”ecocerts in general do not give that level of assurance. You’ll see a few rare excursions from those guys - specific formulations carefully constructed to meet their criteria and satisfy marketing but nothing that can work financially or effectively across the lines.
-
Thanks for your comments. Please recall the discussion was about consumer testing in effort to determine in-use protection of consumers as is the practice of industry scientists from larger companies . Brannan et al. was offered as an example of a protocol. The wide ranges of consumer practices, esp. in a global context are hard to replicate with validity in the lab.
Do I understand you’ve not conducted such a study on your system? I do suggest you consider such a protocol. In my experience, dilute soap esp. in shampoo context could be at risk.
-
sorry - P&G - meant Procter & Gamble as in global Pantene, Head & Shoulder , Olay, Clairol, Old Spice, etc,
-
Thanks Mike
The assurance is yours - here’s an example of how P&G condiucted consumer testing and caimed method and preservative validation. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
This is not a question answered with preservative testing, GMP compliance or absence of consumer complaints. Consumer are unlikely to recognize contamination or attribute relevant infection to their cosmetics.
Yes - I managed P&G global microbiology for decades. These same practices I describe can be found at Estee, Unilever, Avon etc.