Microformulation
Forum Replies Created
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If you look in the “Anouncement Need Formulating Services? Here are some contacts” formulators post their contact info. Several Color Cosmetic Specialists have posted in the last few months.
I see three who have posted since April.
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I think this is a case where you will need to retain a Cosmetic Chemist with Color experience. There are many listed in the resources section. Many of us do this to pay the bills and I think this goes a bit beyond free advice. Just my opinion.
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Tetrasodium EDTA as a preservative? Especially in a typical pH environment of 5 or so? (rough guess). Then Vitamin E as a preservative? He was way off!
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Except for nonsense from Mr. Bekas (crap across the board) it was mostly a pretty fair article.
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I have to agree. I see these ambitious ingredient lists all the time in Product Development. They almost always get revisited once the pricing occurs.
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If it doesn’t require such a harsh environment as a saponified soap, Schulke also has an option.
http://microsites.schuelke.com/wet-wipe-preservation/en/preservation/antimicrobial-stabiliser.phpI think Bob Zonis can weigh in also but I believe many Pet Odor eliminators use enzyme systems as well.
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http://www.carrubba.com/deoplex-natural-deodorant.php
Deoplex has been used in bar soaps as a purported deodorant active.
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Odor is an organoleptic test or measurement in my stability testing which follows the PCPC protocol in as much as they define it. Hence I smell the odor of my finished product. There really is no reason to taste raw materials especially as they are not intended for oral ingestion. In fact when they quantify the safety of Cosmetic materials they base the safety assessment on topical application. The LD50 really addresses the toxicity further.
Do you taste your SD40B denatured alcohol also?
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Why are you tasting your raw materials?
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Zinc oxide is usually incorporated in a paste-like (Water in Oil, Water in Silicone) base when used as a skin protectant. I have also seen it used in some scar products. Generally it is combined with a higher viscosity dimethicone as well. Diligent research will find numerous starting formulations. HOWEVER in the US at least these are all Over the Counter applications covered under an FDA Monograpgh. You would have to comply with these regulations if selling at any level in the US at least.
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Try Natural Sourcing (http://www.naturalsourcing.com/). They have a good selection of quality essential oils and will quote wholesale pricing. In my region they are represented by McCullough.
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I would contact Douglas Schoon at Schoon Scientific in Orange County, California. He is very firmly positioned int hat market sector and could make some great recommendations.
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PE9010 does have yeast/mold coverage. It is recommended to always use it with a chelant. Many do not know, but if you use the Schulke products, Schulke will perform testing for you. You just have to ship it to them. You can contact Schulke’s rep (McCullough in our region). I did ask the Schulke representative about using PE9010 with small amounts of polysorbates. They did recommend using it at the highest level (depends if it is leave onor rinse off) and they had testing to support it. This was with polysorbates <3%.
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These tests would need to be sent out. There are microbial stick tests for the Hobbyist BUT these will not be acceptable for outside testing. PET also needs to be sent out. Cosmetic Test Labs (a member of this forum) is pretty affordable.
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Phenoxyethanol is approved in Europe. It is limited to 1% by the French.
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I am still here. Just trying to budget my online time since it can get away from you and be a big distraction.
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Many lines are using outside distribution/fulfillment services. Amazon has really taken off in this area in the last year or so.
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@Bill_Toge PE9010 is my hands down favorite if the product is not a surfactant system. Although I have never gotten a clear answer from Schulke, many microbiologists don’t recommend it with surfactants and polysorbates as these could inactivate the preservative. Never saw the concern in Schulkes literature.
Also evey once in awhile I will get push back against Phenoxyethanol. Usually this issue with Phenoxyethanol arises from Markerters and Mommy blogger formulators.
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Here is the link to an absolutely brilliant presentation David Steinberg has given on numerous occasions. It covers preservation in an easily understandable manner; http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB8QFjAA&url=http%3A%2F%2Fwww.midwestscc.org%2Fblog2%2Fwp-content%2Fuploads%2Fpresentations%2FJan2012CurrentTrendsinCosmeticPreservation.pdf&ei=oLwWVeTHGoe5ggToi4DABg&usg=AFQjCNHojfoTT6uVRhFlXz3kFgAu8AHWjg&sig2=QUhmKcayqexdNFSMwa483Q&bvm=bv.89381419,d.eXY
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To properly suggest a preservative one would need to see the Formula. There is no “one size fits all” preservative, even if you are just making “cream-like products.”
Also, remember preservation isn’t just a matter of adding a preservative and then blissfully being done. Proper cGMP, packaging, pH, etc. must be considered. This is what we refer to as hurdle technology.
Preservation is not horribly hard if you select the right preservative for the Formulation and follow the hurdle approach. However it is an error to overly simplify the issue.
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I agree that there needs to be a more streamlined OTC approval process, similar to what we are seeing with Sunscreen Innovation Act. HOWEVER, with some of the accounts I see it is the only censure they believe in and hence the only reason to comply. Without the FDA we would see egregious and disingenuous marketing. What I see is bad enough.
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Having some experience with the FDA I think you are all wrong about it being protectionism. Firstly, there are legions of smaller companies that fly under the radar and are wildly noncompliant so if it was intended to protect Big Business it is an abject failure.
Secondly most of the FDA Inspectors I have met had no ulterior motives. They were focused on ensuring compliance and in fact were great resources if you treated it as a learning experience rather than being adversarial.
Lastly, the whole “Big bad FDA is killing people and protecting Big Pharma” is generally what I hear almost daily when a clients project is noncompliant. I have seen ingested Essential oils (without trained advice) and other pseudoscience defended solely on the big bad FDA argument. I have seen smaller lines misuse testimonials and take the “I can’t control what people say about my product” to excess. I for one was happy to see the FDA adress this issue.
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Perry makes a great point. I reread the article to see if they used a qualifier for what is “natural.” Again unless they endorse and cite a credible natural standard they really have a difficult time proving what is natural and not natural.
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You can preserve with a glycol but you really need to do testing such as Micro and Water activity (Aw). Every text is quite adamant that you can not extrapolate the Aw. A few years ago I was sat at an SCC Dinner with several chemists from a company where they preserve with Aw. It was difficult and they measure Aw not just in the lab but also as a QC Check on the floor. All this for a “preservative free” claim. For me it is way more than one needs to do. Just use the correct preservative and do the micro. No shortcuts there.