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Cosmetic Colorants question
I have a question regarding FDA Certified colorants. Even after spending hours and hours on the fda website combing through sections and articles, I am still a bit confused on what and where I can purchase my colorants for my bath products.
Specifically FD&C Dyes, D&C Dyes, and also Lakes. If someone can help me sort out the following:
If I want to use straight dyes or lakes my understanding is that they must be purchased from a company that offers Batch Certified lots.
Assuming the above is true, what about supply companies that take these same dyes and lakes that they purchase in certified batches, then add to a liquid such as castor oil or glycerin. Is it legal for me to use these pre-dispersed dyes in products that I would resell?
We make bath bombs to be clear on what the colorants will be used for.
I prefer to purchase my own powdered Dyes and Lakes in Certified Batches, however I would have to purchase 11 pounds of each Color minimum. I don’t know if it is appropriate to ask, but does anyone know of a colorant company that sells Certified Batches in a much smaller scale? say maybe 2 kilos or so? We are in the USA.
I appreciate any advice and clarity.
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10 Replies
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Is it legal for me to use these pre-dispersed dyes in products that I would resell? Yes, that’s not a problem. As long as the certified color is not changed chemically, the certification remains valid.
It is very seriously illegal in the US to sell anything labelled FD&C or D&C that is not “Batch Certified” - I’m talking jail-time level illegal, not a fine or a slap on the wrist. The amount of material you purchase makes no difference - if you buy 10 grams of dye or 10 tons, it still has to be certified, and the seller has to provide the certificate to you on request. It’s perfectly OK to buy from a distributor 3, 4, or 5 levels down from the manufacturer who had the material certified, and whoever sells you the colorant HAS to provide you with the paperwork if/when you ask for it.
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Bobz,
Thank you so much for replying.Just to clarify. There is so much controversy going on about this subject on a few groups that I belong to.
Let’s say I want to purchase from someone like tkb trading a powdered dye such as FD&C Blue 1 Al Lake. They sell it in a small quantity but does not come with a batch certification, because they are breaking down large batches of certified dye into smaller portions. I am assuming this now makes the powder illegal for me to use if I use it in products that I sell to the public?
On the other hand they also sell that same Blue Lake Dye in a liquid form that is in a castor oil base. But I can buy that liquid dye, make my products with it and sell the products to the public legally?
If this is true I hope that you can understand why it is confusing. I just want to do the right thing and the legal and safe thing.
By the way just in case you go to tkb to check them out for what ever reason, they are now selling a 1 pound bag of Red 40, Blue 1, and Yellow 5 Lakes as batch certified. I know that it is a lengthy and probably expensive procedure to have things recertified after repackaging, so I am wondering if this can even be for real.
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To clarify - as far as I know, re-packaging in smaller quantities never requires re-certification. Last I heard, certification cost about $200,000 so you can see why that would be a problem.
The manufacturer of the pigment/dye is required to certify each batch of pigment that will be used for food, drugs, or cosmetics. To do this, they send samples of each batch to the FDA, where they are analyzed chemically. As long as there are no contaminants, and the colorant is what it’s supposed to be, the FDA certifies that lot of pigment.
Again, as far as I know, that certification follows every single gram of color made from that lot.
I did some checking, so here’s how this works, I think. When the certified batch of colorant is divided up by distributors, if the colorant is going to be used commercially, the distributor needs to keep track of what batch is sold to who. So, each of the packages sold to you must have a product name, the distributor name, at least one lot number, and the batch certification number. You should also get a CofA and a SDS. The distributor is required to keep records of what you buy, as are you. The idea being that the FDA requires commercial cosmetic manufacturers to be able to track back what batch of colorant was used in any given individual product, if there’s a problem. This is why you will see lot numbers on all the cosmetic products you buy - it’s a FDA requirement.
I found out that it’s not illegal for a distributor to sell a colorant for hobbyist/non-commercial use, without tracking lots or customers. Of course, it’s cheaper to sell colorants this way. While these colorants are from batch certified lots, and you can ask the distributor to prove that what was sold to you is certified, the distributor does not have to be able to tell you which of the batch certified lots he bought is the one you received. Because of this, you can’t show the FDA a batch record showing that you used a specific batch of certified colorant. And that means that it is effectively illegal for anyone who intends to sell their cosmetics to use materials sold by TKB or anyone else that is not lot-tracked and associated with a specific certified batch of colorant.
This is all true whether you buy dry colorants or colorants dispersed in a carrier liquid.
Hope this clears things up. Let me know if you hear differently - its certainly possible I got something wrong.
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Today I got lucky enough to speak with a gentlemen that is a Cosmetic Color Consultant with IFC-Solutions. His back ground is 30 years as a Color Consultant for L’oreal. He is also a professor at the University in New Jersey, where he teaches Cosmetic Coloring. Don’t ask me how I was transferred to him.
I am not saying that he is the tell all know all of cosmetic colorants, but damn close to it. His guidance was this:
Us being the end user of the colorant, being that I am using the colorants in my products, not redistributing or selling colorants, I can purchase the powder or liquid form of any of the single colorants (on the FDA approved list and of course for it’s intended purpose) as long as the seller of the colorant can provide me with the original Batch Certification Number from the original batch.
They must not be altered or mixed in any way at the distributing end of course or that would change the scenario. Once the barrel, truck load or whatever has been certified and issued a batch number, that batch number is carried throughout the life of the colorant whether they portion it into pounds, grams, etc.. it doesn’t matter.
I can then purchase those colorants and mix to make my colors and legally use them in products that I sell to the public.
I cannot speak for most of the small companies that sell these colorants (no one responds to my emails) but for TKB in particular receive their colorants in certified barrels, and they themselves break the colorants into smaller portions for resale. They can provide me with the certification numbers, lot numbers and COA upon request, so they said. I am not affiliated with them in any way or trying to give them a plug, it is just that they are the only small company that has even considered corresponding with me on this subject.
I do have two inquiries (emails) to the FDA but the auto-responder email does claim it can take a while to hear back from them. I can only hope that they will confirm the Prof and your feedback.
If I have something to add later or if you also happen to come across more info on this subject (there are tons of folks out there in my boat) and we would all love to hear what you find.
Thank you
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Just wanted to update this discussion in case someone here is researching the legality of using color additives in their cosmetic products.
The final ruling from the FDA:
Dear Teresa,
Answers to your questions are below…
Question: 1. Can we purchase FD&C, D&C, and Lake powdered colorants from smaller suppliers, that purchase batch certified lots and then repackage into smaller lots and use them in our products that we sell to the public? Does the re-portioning void the certification making them illegal to use?
Answer: The company that repackages lots of certified color additives, should obtain “repack” certification for those smaller lots. Repack certification is a fast process and usually only takes 1 or 2 days, as opposed to the more thorough testing for regular certification (5 day turnaround time). There are companies that specialize in selling smaller quantities of certified color additives. I cannot recommend companies to you, but you should be able to find them on our list of “Companies Requesting Certification Within the Last Two Years”
Question 2. Can we purchase FD&C, D&C, and Lake colorants that are pre-dispersed in a liquid such as Castor Oil or glycerin and use them in our products that we sell to the public?
Answer: Yes, such a product would be a Mixture as defined in 21 CFR part 80.35(b):
§80.35 Color additive mixtures; certification and exemption from certification.
Question: If the answer to question 1 is no and the answer to question 2 is yes, why is one legal and not the other?
Answer: we agree that this is a confusing issue. FDA’s regulations regarding certified color additives are quite strict. Once a batch of color is certified, it is up to the owner of the certificate to make sure that the material does not change in composition until the package of color is opened and used in FDA regulated products (or used as components of mixtures). That is why only the owner of the certificate can package and label the material. If FDA allowed the owner of the certificate to sell the color to a repacking facility, there would be no control over the composition of the color additive. We allow for “repack” certification because that requires FDA to test the material again to ensure that it hasn’t changed in composition.
If you have any other questions, please do not hesitate to contact me.
Regards,Naomi
Naomi Richfield-Fratz
Director, Color Certification & Technology Division
Office of Cosmetics and Colors
CFSAN/FDA HFS-105
5001 Campus Drive
College Park, MD 20740
240-402-1136 -
Wow, that’s really interesting, and different from what I’d heard, but coming from the FDA, it’s definitive.
This letter has a number of startling implications. For one thing, anyone selling a repacked colorant without a repack certificate, and still calling it a D&C or FD&C colorant is violating FDA regulations. For another, anyone using those repacked colorants and then offering their products for sale in the US is violating FDA regulations big-time, as in “selling an adulterated product” and “using unapproved colorants”.
Coming on top of the FDA’s impending stricter regulation/monitoring of small cosmetic manufacturers, this is going to make a lot of people very worried (or at least, it should).
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Yes and it wasn’t the answer I wanted I guess so I asked her to clarify. Then she gave her response to make it even more vague in regards to suppliers.
Hi Naomi,Thank you for responding so quickly. I just want to clarify please. I apologize for creating extra work for you, but I really need to be clear.Our company is the end user of the colorants. I prefer to purchase the powder lakes and dyes so I just want to make sure that I am correctly understanding.We would be purchasing a powdered colorant (dye or lake) from a company that obtains large unopened batches of certified colorant, re-portions the certified batch themselves at the facility into smaller portions (without changing the composition of the dye) and then sells the smaller portions to us, the end user, to use in our products that we sell to the public. We are making cosmetics, not reselling the colorants.So from your answer I am understanding that I cannot purchase smaller portions of a large certified batch of dyes or lakes from this company, even if they can supply us with their original batch certification number that the smaller portion came from, even though they are the owners of the original certified batch.Thank you for clarifying.Her response:
Dear Teresa,
It appears you have a reasonably clear understanding of what is required. The company from whom you purchase the repackaged color additives is supposed to obtain “repack” certification from FDA. As the end user, you would know that the certified color was tested and had not changed in composition since the original certification. We understand that this does not always occur. Some repackaging companies have distribution agreements with the color certifiers that allow for the certified color to be repackaged and still use the original FDA certification lot number. Since you haven’t provided me with any other details about the suppliers you use, I cannot tell you not to purchase color additives from them.
Also, I want to point out that FDA considers the term ”colorant” a dye or pigment that comes in contact with FDA regulated products, such as dyes used in packaging. “Color additives” are colors that are added directly to FDA regulated products.
Regards,
Naomi
Naomi Richfield-Fratz
Director, Color Certification & Technology Division
Office of Cosmetics and Colors
CFSAN/FDA HFS-105
5001 Campus Drive
College Park, MD 20740
240-402-1136 -
Thank you for all this GREAT info!
I will add something that I found:
The fee for certifing color addtives is 0.35$ per pound, with a minimum of 224$
http://fda-news.registrarcorp.com/2014/12/fda-color-batch-certification/
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=80.10I found this company that sells batch certified colors in 4 oz …so they say, to be verified!
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One of my companies does sell small quantities of batch certified D&C and FD&C Dyes. We can do this because we have the actual manufacturer who holds the certificate pack and label all the bags for us and they supply a copy of the matching compliance form. It takes ages to get them though as we are not on top of their priority list when it comes to filling orders. There is also a pricey packing fee which is fine with me as they are incredibly messy to pack. Thanks both Bob and Naomi for all the clarification. Rebecca
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I see you have posted our link, http://www.justpigments.com.
Yes they are truly batch certified in small quantities.
Rebecca
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