PhilGeis
Forum Replies Created
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Trade scret is possible but very, very rarely granted (reportedly once in last 20 years)
https://www.fda.gov/cosmetics/cosmetics-labeling/trade-secret-ingredients -
sure
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~100 ppm. Benzoate prob better for shampoos.
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As Mike observed, rapid aging data are almost always confirmed with products in real time BUT decide now (not when the data has you in a panic) what you’ll do if NOT confirmed.
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Appreciate your effort to take responsibility.
Think about all the critcisms companies face - carcinogenicity, sensitization, the BS of endocrine disruption, etc. I do NOT recommend EWG, but look at the safety considerations it uses in its (BS) safety assessments. -
Pictures/plant decriptions implying drug effect are the same as the textual claim. Boiler plate denial does not neutralize.
As cosmetic - recall regulatory demands including ingredient labeling - what will be the appropriate name for this “extract”?
Please also be aware of your affirmative safety responsibility - toxicology and microbiology.I’m sure this would go under FDA’s radar. But be aware, in this discussion you established product as drug - the FD&C Act addresses “intent.”
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Consider 1 and 3 months at 45C as relevant to 1 and 2 year exp. dates. Wouldn’t presume anything in rapid aging predicts 3 years.
Get 1,2 and 3 year real time data. 1 and 2 confirm rapid aging and 3 is instructive to preservative systems even if product no longer on market.Also see how US FDA sees stability testing of OTC drugs.
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It’s largely irrelevant. The product is diluted and rinsed off in use.
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Good luck - > 20 “Designated lists” and > 3000 ingredients.
Lists linked at https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/CSCP/Pages/SB312.aspx#
Prob concern would be fragrance allergens of EU directive.Legislation
https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB312 -
It is a really poor preservastive at any concentration and pH.
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Bacteria can grow in distilled water and filtration is unlikely to help.
As with any ingredient, quality is the responsibility of the maker and should be data based. -
What’s Germall III?
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Crazy George Deckner - great formulator
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Think it’s only a recommendation at this time. I understand, if implemented, it would require for formaldenyde releasers labeling - contains formaldehyde.
Think thye’ve recommended formaldehyde as an ingredient be placed on prohibited list.
That’s just my iunderstanding/
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From EU directive
Formaldehyde paraformaldehyde ►M51 (*) ◄ 0,2 % (except for products for
oral hygiene)
0,1 % (products for oral hygiene)
expressed as free formaldehydeI’m not sure the status of formaldehyde ongoing but above is current language.
Can’t address safety of a combination.
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Not aware it’s advanced beyond SCCS reco. Unfortunate that they considered only one side of the risk assessment.
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That is certianly one. Also offers competition for other trace elements - Fe, Mg, CU.
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Stanley said:Okay found it… wow, thank you very much! Just to make sure I understand the exponentials….1×102 is 100 and the 1×103 is 1000 cfu… I am assuming the 2 and 3 are exponentials.
Yup
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Without obvious mold - could be the usual suspects - cepacia or aeruginosa.
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the heart above reads “<3” in text.
the section goes on to say
The presence of pathogens would also be important in evaluating the microbial contents of a cosmetic. Pathogens or opportunistic pathogens whose incidence would be of particular concern include Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. Additionally, microbes normally regarded as nonpathogenic when introduced in certain ways (e.g., topically) may become opportunistic pathogenic and virulent when introduced in other ways (e.g., in wounds, or via cosmetics introduced into or through the skin). -
Sure - it was in an older version of https://www.fda.gov/food/laboratory-methods-food/bam-chapter-23-methods-cosmetics.
Current wording (revised this month) and thanks for asking - this changed just this last week!
Current, widely accepted standards for microbiological limits in cosmetics specify that the total number of microorganisms per gram or milliliter generally should not exceed:
- 1×102 colony forming units (CFU)/g or mL for cosmetics intended topically (i.e., applied to the surface of the body) for the eye area, mucous membranes, and children < 3 years old; and
- 1×103 CFU/g or mL for all other topical cosmetics.
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microbial contamination seems reasonable -
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Subsequently elaborated - they’re targeting small producers who can’t control the quality of their water. Think most of us understand the position of the EU and FDA - “preservatives” should not be used to correct for failed GMP’s. Those with experience know they are not effective in that context.