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Biodiesel and SVO Forums Home Forums Biodiesel Making Soap from the Glycerine by-product Safety of BDG soap, FDA information, Therapeutic Claims and LabelingGo | New | Find | Notify | Tools | Reply | |
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I thought I would start a place to post what we as a community find out from authorities about our soaps and regulations around selling them. Please post information as you find out, supporting links will be helpful. -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | ||
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I have recently opened a dialog with the FDA and the Consumer Product Safety Commission concerning our soaps. This is what I have found out so far. If you make any claim about your soap it falls into the drug category. However that does not necessarily mean pharmaceutical drug. In most cases it would be an over the counter drug. There are several monographs in place for items such as "anti-bacterial". If you use the ingredient in a way that is outlined in the monograph you can make that claim on your soap. I am getting more information as to if we have to register the product with the FDA for those claims. Here is a link that speaks of the above in more detail. http://www.fda.gov/Cosmetics/P...mation/ucm115449.htm Because of the confusion about what defines a product as soap the FDA has created a definition of soap. The following is a quote from the FDA whitepaper.
If your product meets the above definition then we are in the realm of the Consumer Product Safety Commission. I will post new information on this as it comes in. After speaking with the FDA rep about methanol in soap she indicated to me that methanol is not listed as prohibited by the FDA in soap products. This does not mean that it is safe to have large concentrations of methanol in our products. Here is a link to the FDA prohibited ingredients. http://www.fda.gov/Cosmetics/P...dients/ucm127406.htm There is a concept of incidental ingredients. Basically if the ratio of an ingredient is low enough it does not have to be listed. Many transparent soaps are made with alcohols but because they evaporate out and become incidental ingredients they do not have to be listed. Methanol at the levels left in our soaps after proper methanol removal along with additional ingredients and dilution should fit the bill for that. Again I will post more about that as I find out more info. Here is an FDA Quote for incidental ingredient found here.
Before you sell your product it would be a good idea to have it tested by a lab for the methanol content. I am working to find out at what PPM methanol becomes an incidental ingredient. Many of us have just assumed this in the past and do not list methanol as an ingredient but I think it's wise that we get something in writing from someone that has the authority to do so. I'm hoping that after talking with the Consumer Product Safety Commission we can get that. -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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Very good idea to get all this information in one place. Might motivate me to actually get back to Health Canada again. Especially if there are some hard numbers from the FDA that I can reference. Here is the e-mail I recieved from health canada when I inquired
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Because bureaucratic as they may or may not be, they and Consumer Product Safety are the ones that will be knocking at your door if there is a customer complaint. I get tons of questions about methanol safety, personally I want an answer from someone official. The two questions I would like answered by this are
freesoul, What did the lab tests show for PPM of methanol in your soaps? Are you listing methanol as an ingredient? -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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http://biodiesel.infopop.cc/ev...1087632?r=2281081072 we take ours to 260F+, at that point there is barely any methanol coming out. This is also covered in The Guide. I think most on this forum are as equally distrustful of authorities. Being a bureaucrat does not make one an expert on subject matter. Is methanol listed as an ingredient in aspartame and diet soda? One would think the FDA would be on top of that as well, well apparently they are they approved aspartame. make sure you also call the IRS and get their approval on the proper filing of your taxes as well  | |||
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So what you are basically saying is that you have no idea of the methanol content of your soaps, and you have no idea what the 'acceptable' health limits are. This is exactly what we are trying to find out. You reference the guide whatever that is. If you know the limits post them, at least contribute to the discussion. Even according the the theoretical graph in that link you posted you will still be well above 1% methanol, and at best 'taking it to 260F+ until barely any methanol comes out' will only work for you. At worst it's useless. Methanol in aspartame might be a good starting point actually if anyone knows a company that is still using the old method. If there is a lower reporting limit for food there might also be a lower reporting limit for topical usage in the same document. | |||
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I couldnt locate the thread where Matt (farmer) had posted the results from the PA DEP on his glycerin that showed that 260F was a temp that got the glycerin to a point low enough where it was below 5% methanol. We've been using the soap for several years and are confident in that number, and our soap. I posted a link to a discussion thread from several years ago that Rick participated in himself, not sure why the need for a new one when the old one could be continued and built upon. | |||
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http://www.fda.gov/cosmetics/p...mation/ucm115449.htm "Today there are very few true soaps in the traditional sense on the market. You might recognize these soaps as products marketed with characteristics such as "pure." "True" soaps are regulated by the Consumer Product Safety Commission, not FDA, and do not require ingredient labeling." So with a little reading I am confused on why anyone would "open a dialog" with the FDA when it clearly states they do not regulate soaps. Unless you are making claims that it helps with any sort of health issue. We do not do that. Continue please, interested to see where this goes.  | |||
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I'll wager there is stuff just as nasty in most 'soaps' or 'hand cleaners' today. Not to mention food and beverage industry. | |||
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Yep, in the USA it is legal to put anything you want in in the soap you sell without considering whether it is safe for human use. In fact the onus of proof is for someone to show what you are selling is NOT safe. I bet a small amount of Agent Orange in your soap would provide a real invigorating wake-up tingle for your morning shower. | |||
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Yep, the FDA performs an absolutely meaningless service. We should make the whole food, drugs and cosmetics industry "Open Slather" just like the soap industry is now. A bit of methanol in your soap is a meer piffle. And why did they ever require arsenic be removed from face powder? | |||
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The intention of this post is for those of us concerned with the safety and proper labeling of our products to have some "real" regulatory answers. Maybe a debate over the legitimacy of the organizations that could fine us, put us out of business or put us in jail can be started on another post. Methanol at higher than 4% is considered toxic and requires special labeling and packaging per 16CFR1500. See 16CFR1500.14. I learned this after my discussions with the FDA today. ***Edited to add another section of 16CFR1500.14
In a beverage the percentage of acceptable methanol is exponentially less. if you choose to label your product there are rules about proper labeling -- it has to be accurate and only incidental ingredients are exempt from being listed. Myself and many others would like to know officially when methanol becomes incidental and no longer is required to be listed as an ingredient, not just when it is no longer toxic. Again, that is under 4% methanol, I don't think you can determine that for yourself. If you are serious about selling your soap, be responsible and get it lab tested to be sure it's at least under the 4% and no longer toxic. Personally if my soaps contained 4% methanol that would not acceptable to me. My goal is to lower the PPM of methanol as far as I possibly can regardless of what we find out what is acceptable. Hopefully there are enough of us that really care about the methanol in our BDG soaps and responsible enough to do our best to find the official answers.This message has been edited. Last edited by: Rick K, -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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In addition I spoke with the Consumer Products Safety Commission, They indicated that because of the glycerin content in our BDG soaps our soaps possibly fall under the FDA. I am awaiting a final answer from both the FDA and the Consumer Products Safety Commission on this. http://www.fda.gov/Cosmetics/G...mation/ucm074201.htm
In addition, there is not a debate as to whether or not a label is required, it is not required. But if you do chose to label it must be accurate. With that said, just because you do not label it does not mean it can contain something toxic, like over 4% methanol content. People have smoked for years with no negative effects to find out 30 years later they are dying from one of a number of ailments... I don't think I want to use BDG soaps with greater than 4% methanol for 30 years and find out I'm sick or one of my customers are sick. Bottom line for Knice-N-Clean is we will label our products accurately. If it is found that the methanol PPM in our products in not considered incidental it will be listed. And we will participate in continued lab testing of our products to always know the methanol content and to keep it as low as possible. How other BDG soapers decide what is safe and acceptable is up to them. -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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I asked myself this methanol question a year ago, how to prove my distillation and final soap product contained "safe" meth levels. Since I add no other ingredients other than lye and water in my liquid soap, meth ppm, ph, and saponification were my concerns. I can verify the last two. By the nature of my coworkers using my soap to clean with in my high school, I now find that my school is interested in using my soap on a bigger scale. Since one of my potential markets is a public school with 1,000 young people who can't read the label if my soap is put in bathroom dispensers or they use it to clean the ag shop, art counter tops, chem lab, they would essentially be trusting me. Clearly, if I want to sell it to my school system, I have to be prepared to prove my once-toxic BDG is "safe." And finding out the safe level has been a quest. And, as mentioned in my earlier post, a person who contemplated using it on her horse and around her farm researched BDG and asked HOW I was refining my BDG and could I prove it was demethed appropriately. As mentioned before on a previous post, our chem students make bio in small batches and wondered about making the soap. It was a logical question by AP chem students to ask how do we safely remove methanol and to what level. My search for this info is no reflection on anyone's soap company or process. Hey, I've used my soap for 3 years, my sister cleans houses with it, 200 gallons have been used by local people, trooper garage, car garage, restaurants. And, I agree that my soap is a lot safer than many other products that the FDA or any other govt agency has approved. However, I don't plan on basing my response to my supt with that comment. I have to know I am making the safest product and be able to answer for its safety. My ppm test is around .5%,on a thinly diluted recipe, and I believe it can be lower. Next test should validate that. All parties that I have spoken with--CDC, FDA, USDA lab, Biofuels Producer and BDG seller to Proctor and Gamble--all have agreed that I should try to prove my product is safe and meth is the biggest issue for me. I agree. And if I don't, then my supt and a few local farm suppliers are not willing to buy it or continue to use it. Not everyone here has this market, I understand. I wanted to post my lab tests and ask everyone a few questions, thinking it might be of help to anyone else. This forum has aided me tremendously. | |||
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Freesoul does bring up a point though. What if there is no biodiesel soap methanol guideline because there isn't one? The definition he listed for soap by the FDA hasn't been updated since 1979 by the look of it. What are the chances biodiesel soaps weren't large enough to warrant FDA attention back then? This could explain why information has been so hard to find. So maybe we shouldn't be looking for something biodiesel soap related. Maybe it's just methanol content period. On a side note 4% for the U.S eh. Wonder what the reasoning behind the Canada/US differences there are then since I was told 1% when I spoke with Health Canada. | |||
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I'm not sure about the 4% vs 1% difference I just received the information about 16CFR1500.14 today. It states that special labeling and packaging is required. There may be another regulation that states that 1% is toxic. But the that is the whole point of this research and dialog with the regulatory organizations. BWilder you are correct there is no consideration for BDG soaps, however our soaps are the same as other natural soaps except that ours contains a higher ratio of glycerin and also contain some PPM of methanol. The acceptable PPM of methanol and when it becomes an incidental ingredient is my primary concern. That information may not be there for BDG soap, however it may be there for other products already. One that comes to mind is anti-bacterial gels. The main ingredient in anti-bacterial gel is alcohol, that alcohol may have been denatured with methanol. I will keep sharing the information I find, if anyone else finds anything out please let us know. -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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Here it is: http://biodiesel.infopop.cc/ev...281081072#2281081072 Cheers, Jon ___________________________ Simple schematic for a pump and heater control with a high limit Sensor for the biodiesel/glycerin layer | |||
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yeah that was the link I posted, I thought I recall there being another thread as well... | |||
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Glycerol / Methanol Solution % MeOH --- Boiling Point, F 45.00 --------- 172 40.00 --------- 177 35.00 --------- 182 30.00 --------- 189 25.00 --------- 197 20.00 --------- 207 15.00 --------- 222 10.00 --------- 244 5.00 ---------- 288 1.00 ---------- 416 0.00 ---------- 550 Methanol at higher than 4% is considered toxic and requires special labeling and packaging per 16CFR1500. See 16CFR1500.14. ***Edited to add another section of 16CFR1500.14
Personally I will be taking it to higher temps under vacuum and having my BDG soap lab tested for PPM of methanol to be sure it's safe for my customers.This message has been edited. Last edited by: Rick K, -Rick http://www.knicenclean.com your single-most largest free BDG soaping content on the internet. SAP Testing, Ingredient Properties, Soap Glossary and Recipes just to name a few. Making Biodiesel Byproduct Soap Learn how to use your biodiesel byproducts to make great bar and liquid soap!!! "Closing the loop on biodiesel production one bar at a time!" Beware of the Dunning–Kruger effect. | |||
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