PhilGeis
Forum Replies Created
-
ketchito said:In my experience visiting some plants here in Latin America, I found that both the person who weights the ingredients and the manufacturer were constantly exposed to some amounts of formaldehyde gas when manipulating large amounts of formalin (not that the ingredient itself is to blame for this), and since we have well performing and safer alternatives (formaldehyde-releasers), and especially in places where there’s low survailance over manufacturing sites and practices, wouldn’t the decission from Europe especifically about formaldehyde make some sense?I am aware of the broader use of formaldehyde (formalin) in Latin America - not sure some could even make clean products without it. But ‘m not with you on this. Manufacturing risks are established by many ingredients and practices - caustics, HCl, heat, ozone, unprotected belts, pinch points, inappropriate tank entry, failed lock out, etc. Failure in worker safety should be addressed by PPE, safety procedures, etc.
Banning formaldehyde Europe fixes none of that. We sure do not have “safer alternatives” than releasers as preservatives. -
You can’t expect the preservative to resolve a contaminated raw material - esp. water. Water quality is probably the biggest risk for cosmetic manufacturing.
-
Folk should be confident their water meets at least finished product specification. The worst contaminants P. aeruginosa and B. cepacia can grow in distilled water to millions per ml - more than enough to overwhelm any preservative - esp. the alternative/naturals
-
Banning formaldehyde and lower free formaldehyde in preservation is typical EU bureaucratic excess. This misguided ban merely increases micro risk by eliminating some of the few generally effective preservatives.
FDA typically doesn’t chase useless efforts in this context. Covid is prob irrelevant - cosmetics are under CFSAN not CDER,
It does address the higher levels in some products -https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated . AND
https://www.fda.gov/cosmetics/cosmetic-products/nail-care-products -
and perhaps that it’s expensive and not very effective
-
Formaldehyde reactivity may limited its stability. Formaldehyde releasers can maintain an effective level through consumer use.
To your question - 100-500 ppm should be effective for bacteria, fungi can be more challenging. -
unstable emulsion
-
Thanks Graillotion. +/- multifunctional system - couple of glycols (one prob the solvent) and an obscure alcohol. Suppose one of Streatmans Dermosofts. Doubtful there’s much safety data or efficacy experience and unapproved for most of the world. Synthetic - so why when there are options with substantial safety, efficacy and stability data/experience with reg blessing.
-
See:https://cosmeticseurope.eu/files/5914/6407/8121/Guidelines_on_Stability_Testing_of_Cosmetics_CE-CTFA_-_2004.pdf
You need to test the product as the consumer sees it - as well as the projecting its safety in rapid aging. Confirm with real time aged product the data you see with rapid aged product.PET (presume USP) is a pretty poor test - so all tested products must pass as bare minimum to justify consumer exposure. Suggest you show it passes as made and after 1 month both ambient and rapid aged before you put it on the shelf for consumers. And all ageing studies must be with product in final packaged.
-
KimberlyLars said:PhilGeis said:How will you address stability?
Typical stability with light, dark, 25°C, 40°C, 4°C, Freeze/Thaw
Curoxyl 42 as Benzoyl peroxide - I assume you’re including this as an anti-acne active. How do propose its determine its stability. Be aware - if you’re in US -this will be a drug product.
Also - don’t understand the apparent comparison tio Sepimax. -
Like phyate. Suggest 2500 Na Benzoate and 5000 phenoxy. and
would adjust pH to 4-5. -
Pharma!!! Got it!
-
What is the relevance of this method for measuring pH?
-
In addition to manipulation in production, extract will be repeatedly dispensed in production of multiple product batches until exhausted.
Suggest preservation as if finished product. Suggest sodium benzoate with pH adjusted appropriately and phenoxyethanol. Are you willing to use EDTA? -
doesn’t offer a lot of confidence on that supplier.
-
As Ilse pointed out - the CoA is confusing. Eugenol is both 75% and 7%. Ask the supplier for clarification.
Eugenol is among the Fragrance allergens that require cosmetic/detergent labeling.
-
Some water must be present but the % doesn’t necessarily control. Water condensing, taken up from the air (anhydrous powders in a humid bathroom) or isolated in droplets can support growth.
The limiting factor for water if present is water activity (Aw) as Syl noted - and for cosmetic preservation purposes that’s about 0.7 (70% relative humidity). Aw is a function of dissolved solids in water - don’t know ghee. For perspective - 67% sugar (sucrose) would offer an Aw ~.86.
-
“Natural“ (emphasis on the quotation marks) preservatives are often neither natural nor effective preservatives. It is surprising that so many ethical folks are happy to accept the Ecocert/COSMOS head fake and supplier BS for the natural claim. In my mind - the equivalent - “made in USA” for a China-sourced material that also happens to be made in US.
Some of these are frauds - grapefruit seed extract and allegedly Leucidal.
Extracts, essential oils, eye of newt, etc. are weak, vary profoundly batch to batch (typically without any idea as to the active component(s), can include pesticides, UN observed their production in 3rd world can disrup subsistence agriculture and worse https://www.cdc.gov/media/releases/2021/p1022-aromatherapy-bacteria.html.
Most here likely use USP 51, a test that poorly represents the micro risk - it’s validated to nothing.
It’s certainly possible to effectively preserve a product with a natural (without quotation marks) preservative system. Most attempting that will not know what’s in the natural material and will never know if they were actually successful in protecting the user.
-
@ Pharma -thanks, think the “preservative -free” marketing hype shows Bayer in this case is unethical. As you point out, it’s just hexanediol - a synthetic compound that finds common use as a preservative.
-
Those can work in challenge but 2 organic acids have little technical support. As you noted, benzoate/benzoic pKA is facilitated with some surfactants.
The combination is not that great in use so packaging has to considered.
-
How will you address stability?
-
is that ethanol?
-
Phenethyl alcohol can migrate in to packaging and implements so be sure to get stability data with complete packaged product.