A Comprehensive Guide to Lakes & Dyes – Body Bonbon DIY

So I’ve noticed that there seems to be a lot of confusion surrounding what can and can’t be used in bath bombs and what the different colourants actually are. I think this is partly because when we talk about colourants we throw around words like “dye” and “food colouring” in a really general fashion so things can get really confusing. I had originally planned to make a video on colourants, just one outlining all the information I had found on them while researching, and I still may do that, but I thought I would make a post on the topic for now.

I should say first that I am not some kind of colour scientist (do those even exist? I’m sure they must). I do love colours though, who doesn’t, and I enjoy researching them. This is purely information I have found online during that research, i’m not pulling it out of my head or out of a nifty colour encyclopaedia, it’s all online and I’ve included a few links at the bottom if you want to do more reading. Most of this stuff can be found with a quick google search or wiki search or by checking out your relevant government pages regarding the use of colourants in cosmetics…

Also some of this information is FDA (USA) specific, but most is generic information.

1. What is a Colourant?
Colourants are used in pretty much everything from clothing to toys and cosmetics to food. There are two main types of colourants:

  • Natural Colourants – Those that come from natural sources such as plants and minerals and even bugs n stuff.
  • Artificial Colourants – These are the ones that aren’t natural, they are chemically synthesized colourants. Most of the ones we use fall into this category.

(I’m not going to talk about Natural Colourants in this post, i’ll be referring to Artificial Colourants from this point onward because that’s really all I’ve been researching for my own bath bombs so far.)

2. What is the difference between a dye, a pigment and a lake?
A dye is  a chemical powder that is water soluble. When it’s dissolved it produces colour. Dyes are highly concentrated – this is basically the top of the concentration ladder, for lack of a better way to describe it. I have some Blue No 1 (C.I. 42090) in a “true” dye powder. It’s so concentrated the stuff looks like a shiny black/red. When I received it I actually thought they’d sent me a sample of the wrong colour lol. My dyes are all 80% + pure dye content.

An Aluminium Lake is basically a dye combined with a metallic salt or some other compound in order to make it insoluble – so basically they turn a dye into a pigment. Lakes are not water-soluble. If you have a powder at home that totally dissolves in water and instantly gives you colour, it ain’t a lake. Lakes are also not oil soluble, they are oil dispersible. This means that the oils will disperse the lake colourant through the water but it won’t actually dissolve in the stuff.
Lakes come in different concentrations. Low Dye (generally 15-17% pure dye) and High Dye (generally 36-42% pure dye). Therefore lakes are generally a lot less concentrated than a true dye. This is why when you purchase a lake colourant for your bath bombs, the powder looks really nice and bright – like the colour you are expecting. Whereas when you purchase a true dye powder you might be like me and end up thinking they’ve sent you the wrong colour because some of them look very strange before they’ve been added to water. 😉

A pigment is a water insoluble and oil insoluble colourant. They will not dissolve but they will disperse. An example of pigments are Oxides and Ultramarines.

Here are some photos showing you the differences between Lakes and True Dyes.

On the left is a LAKE, on the right is a DYE. These are both Brilliant Blue aka Blue no 1 aka CI 42090

On the left is a LAKE, on the right is a DYE. These are both Brilliant Blue aka Blue no 1 aka CI 42090. Notice how colourful the Lake is because it’s less concentrated than the Dye, which is VERY dark.

Here I have poured a little water on each sample. Notice how the water beads on top of the LAKE, only revealing a little colour whereas with the DYE, the dye instantly dissolves into the water and is so concentrated it still looks very dark.

Here I have poured a little water on each sample. Notice how the water beads on top of the LAKE, only revealing a little colour whereas with the DYE, the dye instantly dissolves into the water and is so concentrated it still looks very dark.

Here I have smeared the water across the Lake and Dye. Notice how the LAKE still has granules of powder that haven't dissolved whereas the DYE on the right dissolved fully.

Here I have smeared the water across the Lake and Dye.
Notice how the LAKE still has granules of powder that haven’t dissolved whereas the DYE on the right dissolved fully.

As far as I am aware Lakes only come in small variety colours. Blue 1, Yellow 5, Yellow 6 (orange), Red 40 are the ones you tend to see for Bath Bombs. There are some other reds available and I believe blue 2, though that’s not approved for cosmetic use in some places. I’ve never come across an actual purple Lake colourant. There is a Violet no 2 in a dye, which is beautiful, but it’s expensive. There is Manganese Violet, which is a pigment. It’s quite bright and pretty but as it’s a pigment, it’s water insoluble so you need to disperse it.  I find it easiest to just mix my purples using one either Red 33 or Red 28 (or both) with Blue 1. I also mix my own greens.

You can also get Dyes and Lakes as liquids. These are just the powders added to a solvent, whether that be glycerin or an alcohol or oil. They are probably easier to use for some and less messy than their powder counterparts.

3. If the colour I am using says “FD&C” does that mean I can use it in bath bombs and other cosmetics?
Usually but not always. While FD&C does mean that it falls under the Food, Drug & Cosmetic act which generally means it’s safe for those things, think about all those colourants you can buy that say “Not safe for Lip use” or “Not safe for the eye area”. Now, most of those tend to be Pigments or FD&C colours so obviously just because it’s been deemed safe for “Cosmetic use” doesn’t mean it’s been deemed safe for general cosmetic use. You should always double-check the colour you want to use just to be sure. Another thing to note is that just because something is safe for use in Food doesn’t necessarily mean it’s okay for use in Cosmetics. It’s weird, I know, but I know of at least two colours that are in foods that aren’t actually on the approved US FDA list for cosmetic use. I spoke to the FDA about it and was told: “In order for a color additive to be approved for use in FDA regulated products, someone has to submit a petition to FDA asking for approval. Part of the petition process includes asking for specific uses and restrictions for that color. In the case of FD&C Blue No. 2 (FB2), no one has ever asked for it to be used in cosmetics or externally applied drugs. It is generally believed that there was never any interest in using FB2 in cosmetics  because the color fades quite rapidly. The story behind FD&C Red No. 3(FR3) is more complicated and has to do with various regulatory decisions that were made in the 1970s. Here is a link to an article, although old, discusses the history of color additive regulations.
http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm ”

There are also some colours that are Ext. D&C colourants. This means they are for External Use only. Initially I wasn’t sure if this meant they would be okay for use in the bath so I contacted the FDA about it and was told: “Unless the regulation specifically prohibits or restricts the use of a color additive from being used for bathing or on the skin, external application of colors are permitted on the body.”

4. Can I use Wilton’s Gels or Americolor Gels in my bath products?
If you are making your bath bombs and products for personal use, sure, go ahead. You can colour them with a tomato if you like, though I wouldn’t recommend it, lol. If you are creating products for sale then I would look to your cosmetic regulations. This is probably the only question I haven’t asked the FDA because I was never bothered enough as there are plenty of dyes/lakes available for cosmetic use so why even use a diluted version?
I’m not sure if the FDA allows things like Wilton Gels to be used in cosmetics. I mean if you break the ingredients down and the dyes being used are safe for use on the body and there is nothing else in the gel that isn’t approved for cosmetics then I don’t see why it would be an issue (skip to q17 for more on this). However batch certification could be an issue if you are using food dye powders. If you are in Canada, your colour regs are different, I believe there is a hotlist of banned ingredients and I am not sure what their stance is on premade food colourings. In Australia you can pretty much use whatever you want in your cosmetics as long as it’s on the AICS and there are no restrictions placed upon it.

I will, however, ask: why would you bother? Those food gels contain preservatives, sugar and other ingredients that you would be required by law to list on your labels. Why do that when you can just check the box, find the dye they are using and go buy that instead?

Another issue with the food colouring gels is that they actually contain colourants that, despite being referred to as “FD&C”, aren’t actually on the FDA approved list for cosmetic use anymore. The ones I know of are FD&C Red No. 3 and FD&C Blue No. 2. They are only approved for Foods and Drugs.  So when you use those food gels in your bath bombs you could be using dye colours that aren’t approved.

If you really like the Wilton’s or Americolor Gel colours, do what I mentioned above. Check the ingredients on the box and look for the actual colourants. They will all be listed. Then find yourself a dye supplier and buy some of those colours that are certified for cosmetic use. Yes they will be harder to source. Yes they will be more expensive initially but they will also last you a very long time because you will be getting a highly concentrated non-diluted version of what you were using when you were using those gels because the gels get their colour from the dyes.

5. I have heard you shouldn’t use food colouring because people are allergic to it or it can cause health issues. Is this true?
Well, yes. Sort of. This question is confusing because “food colouring” can mean different things. If you are talking about those little bottles of watered down colours people buy for colouring icing, well those things get their colour from dye. If you are talking about Food Colouring in general, as in FD&C colours then you are talking about dye, again. Thing is, even the Lakes people rave about being “specifically designed for bath bombs” get their colour from dye as I explained above in Q2. Food Colouring, Food Gels, “Bath Bomb” Lake Colourants all get their colouring from the same place: dye. So you can probably see why it’s difficult to answer the question about “food colouring” causing health issues when pretty much all the colourants – apart from the Natural ones – get their colour from the exact same place.

Yes. Some dyes are controversial. Some people are sensitive to certain synthetic colours. This is why there has always been that movement toward using natural colours instead of the synthetic dyes. But it doesn’t matter where that colour comes from, be it a food colouring gel or a “bath bomb colorant”. You need to look at the actual colour name or the Colour Index identifier and google it. Then you can find out all the nasty details of every single colour you want to use in your products.

So, to answer the question – yes food colouring can cause health issues in some people. But if you are concerned about the health issues behind food colourants, then you really need to be concerned about ALL synthetic colourants and not just “food” ones.

This brings me to another point:
6. What are “Bath Bomb Colourants”?
Aaah Bath Bomb Colourants. That’s not really a thing. Well it is a thing but it’s not an actual thing. If you know what I mean ;)
It’s marketing. Nothing else. When you buy “bath bomb colourant” you aren’t buying some special colourant that was specifically formulated for bath bombs. You are buying Lake Dye. That’s all they are. Lake Dyes. Look at the ingredients. Look at the MSDS.

7. What about Bath Bomb colourants with Cornstarch added?
Okay here’s the thing, I have a few issues with this stuff. When you buy bath bomb colourant with cornstarch added, you are buying Lake Dye that’s been cut with cornstarch. It might seem like you are getting a bargain because you are getting a lot, but you will also have to use a lot more than if you were to just spend the extra cash and buy actual Lake Dye Powder.
Now if you already use cornstarch in your bath bombs, this isn’t really an issue. If you don’t then you are just adding an extra ingredient for no reason.

The main issue with Dyes or Lake Dyes that have been cut with cornstarch (or whatever) is Batch Certification. Batch Certification is required by the fda if you intend on selling products made with a specific set of colourants within the US. I am not 100% sure that dye and lake powders cut with cornstarch are okay in regards to batch certification, I suspect they wouldn’t be considered batch certified as they have been opened, cut and split, but to be perfectly honest with you the batch certification regulations are kind of confusing and contradictory in parts so if you want to be 100% sure I would contact the fda and ask about whatever specific brand you want to use and make sure they are aware you wish to sell your product.
Scroll to 14 for more info on Batch Certification.

8. I’ve heard that Food Colouring shouldn’t be used as it will stain the bath. Is this true?
Again, sort of. Maybe. It depends. See above for the “food colouring” issue.
True Dyes WILL stain – if you don’t use them properly. If, for example, I was to shake a tiny little bit of Blue no 1 and Red no 33 onto my palm, then add water to make a lovely purple, it would be fabulous but, yes my hand would end up stained temporarily.

dyehandThat, right there, that stained my hand for a day. Some dyes are more potent and more likely to stain. I find Red 28 is a good one for staining, but god I love it.

Now, don’t let this turn you off using dyes. Dyes are fantastic. You just can’t overuse them. I only need a pinch of dye in a batch of bath bombs to make a nice colour. A little more and I get a vibrant colour. The only time I want a  really strong colour is when I am making colour embeds.
If your children or customers are the type to grab a bath bomb and literally play with it while it’s fizzing away, then yep they may end up temporarily colouring their hands. Especially if the bath bomb contains colour embeds.

As for the bath tub, well I haven’t had any issues at all with using dyes in my bath bombs and I like vibrant colours. My son enjoys putting his half disintegrated bath bombs right on the edge of the bath tub and leaving them there overnight. See Exhibit A:

edgeoftub

This still doesn’t stain my tub. Any colourant that is on the tub usually washes down the drain with some hot water. If it’s caked on then I just wipe it down with a wash cloth. The only time I would think dyes would stain your bath tub is if the enamel of your tub is damaged or badly scratched. OR if you have used way too much dye in your bath bombs, in which case you need to use a lighter hand. Calm yo bad self.

Since Lakes are made with dyes you will likely find that they too will stain if overused or used incorrectly. However seeing as Lakes are generally a lot less concentrated than a true dye most people probably believe ‘lakes don’t stain but dyes do’ when really it’s just that lakes aren’t as powerful.

9. I used Dyes/Lakes and ended up with a ring stain around my tub! What happened?
Okay here’s the thing. If you throw a heap of Dye or Lake Powder into a bath generally speaking it won’t stain. I mean there’s a lot of water in a bath so it would take a very large amount of dye to stain the entire bath. If your entire tub is stained where the water was, then yes, you’ve used way too much or you’ve left it in the tub for a week.
If you are getting stains only around the water edge, that means something is carrying your colourant over to the edge and plonking it there. That something is probably the oils and butters in your recipe. You may have heard of this with Mica, though mica can just float on over there by itself sometimes, it’s why people use Polysorbate 80 to disperse the oils so they can’t carry the mica over like little slick boats and stick it to the edge. This is annoying enough with something like Mica but now imagine it with Dye and Lake powder. Imagine them floating to the edge atop their slick little boat and depositing themselves at the side of your tub as the water cools and the butters and oils harden. They are Dyes. What is the job of a Dye? To colour things. Usually permanently. So those dyes and lakes will sit there at the edge of your tub in those oils and get to work staining your tub. Generally speaking you would need an awful lot of powder in order to get a perma-stain and most stains can be scrubbed off with some detergent.

Catch that? Detergent. This is why we include something like SLSa – a surfactant in our bath bombs. Surfactants will break down those oils and butters and disperse them in the water. Therefore you have no little slick boats to carry your dyes to the edge. You can also use Polysorbate 80 (which is also a surfactant) to do the same job but I like to save that for really buttery bath bombs.

Bottom line is, if you are making very basic bath bombs with oils, don’t overdo the Lake or Dye use or you may end up with stained or temporarily coloured tubs. If you want really vivid colour, make sure you include something like SLSa or Polysorbate80 and always test your products in your own bath.

10. Is there a list of colourants that are FDA approved?
Yep, there sure is. If you are in the UK, EU, anywhere else or Australia like me you will have to check for any other restrictions that apply to certain colours in your country.

You can find some generic info on FDA colourants here.
There is also a really useful summary of color additives here. If you skip to the table labeled “Color Additives Approved for Use in Cosmetics” you can find a handy list of the FD&C and D&C colours that are approved and what they are approved for.  You’ll notice that Blue 2 and Red 3 are on the approved list for food but not cosmetics. That’s what I was talking about earlier in the question about icing gels.

11. How do I know what I am buying when they all look like powders?
I’ve seen lakes and dyes described kinda vaguely on some pages so it can be confusing.
The easiest way to tell is to look at the INCI for the product you want to buy. Say, for example, you are purchasing Brilliant Blue. Ignore the description and go straight to the inci information and see what it says.
If it says “FD&C Blue No. 1”  then you are buying a DYE.
If it says “FD&C Blue No. 1 Al Lake” then you are buying a LAKE.
If it says “C.I. 42090” then you are buying a DYE.
If it says “C.I. 42090:2” then you are buying a LAKE.

The colon and number following the colour index number usually just means you are looking at a Lake because there has been a chemical change indicated by the colon number. You can find some very interesting information about the Color Indexing system and what the colons and numbers mean here.

Now, this isn’t foolproof as ingredients can be listed incorrectly or may not even have the inci details listed at all – in which case you will have to contact the supplier. If you do buy a powder and aren’t sure if it’s a dye or a lake, the easiest way to tell is to throw it in water. You will know straight away because the dye will instantly bloom into a very concentrated colour and dissolve fully whereas the lake will give a little colour but the powder will settle on the bottom. I have a video showing this here.

This also goes for liquid dyes and lakes, btw. If you aren’t sure what is in a liquid colour you are buying, check the inci. If it has the word “Lake” in it then it’s a Lake added to a solvent. If it doesn’t, then it’s a Dye that’s been added to a solvent. If it’s just the CI number then it’s a dye and solvent. If it’s got that colon in there and another number then it’s a lake and solvent.

For example: Brambleberry’s LaBomb colours are Dye mixed with a solvent. We know this because they actually tell you in the description, but if they didn’t all you’d have to do is check the INCI which will say something like this: “Glycerin, Isopropyl Alcohol, FD&C Yellow No. 5 (CI 19140)”
So we have our colour right there, Yellow No 5. Notice it doesn’t say lake and there are no colons in the CI info so it’s a DYE. The yellow dye powder has been mixed with Glycerin and Alcohol to give you your liquid dyes.

12. What do you like to use in your bath bombs?
I prefer Dyes. Lakes are great as well but I just love dyes. When it comes to stuff like bubble dough or bar dough or icing, I tend to prefer using a liquid because I find it’s easier to incorporate. If I don’t have a liquid dye or lake on hand I will just use one of my water-based liquid ingredients as a solvent with some of my dye powder and create a liquid dye myself.

13. Do you have any tips for using Lakes and Dyes?
Well the one thing you need to keep in mind when using either Dyes or Lakes in powder form is their solubility.

Dye powders are water soluble so they won’t “bloom” colour until some kind of water based product is added to them. What that means for bath bombs is that if you aren’t using water or something water based in your bath bomb mix, your bath bombs aren’t going to look especially vibrant until they hit the water. Don’t make the mistake of adding a metric shit ton of dye powder to your mix if you only use oils to bind – your mix is only pale because there is no water in there and when you pop that baby into the tub you are going to colour bomb the thing. If you spritz the mix with water you will see instant colour. You can use this information to your advantage and create some interesting effects with your bath bombs.
If you do use some water or a water-based ingredient to bind your bath bomb mix, you will get a vibrant looking bath bomb that also colours the bath well.

As for Lakes, well those will show up in a bomb mix regardless of what you use to bind. Generally you will get a bright coloured bath bomb when using Lake powder which will then colour the water nicely. You will need more powder than you would a Dye, however, and remember the lake won’t dissolve in the water it will just disperse thanks to the oils so you will never get as vibrant a bath colour with a lake as you would a dye. Unless you use a lot of that powder.

Another thing to keep in mind is concentration. If you are using the water soluble dye powders make sure you protect your hands and work space. Don’t spill the powder, seriously, you don’t wanna do that. Take my word for it. If you are a beginner working with the dye powders remember LESS IS MORE. Start small until you get a good idea of the potency of the dyes and always test in your own bath and not someone else’s.

I have some videos I made a while ago showing the differences between Lakes and Dyes:
There is my Quick Look at Colourants and then my followup Lakes vs Dye Powders where I show how they behave in actual bomb mix. These are really quick and dirty videos so don’t expect anything spectacularly scientific lol.
You can also watch my Embed Creation video to see just how little dye powder is required for a vibrant colour. I also have an old embed video (I don’t use this recipe anymore) that will also show you how some colours react to the pH of the mix and change slightly until added to water.

14. What the hell is Batch Certification? Is it the same as FD&C?
No, it’s not. Synthetic colourants such as Dyes and Lakes require Batch Certification upon manufacture or distribution or somesuch. I’m not 100% sure of the ins and outs of the actual certification. This is a FDA regulation so only really applies to the USA.

What this means is that when a colourant manufacturer makes a truckload of Dye Powder or Lake Powder they will split it into, say, 1kg buckets for their distributors, those batches are Batch Certified. I’m assuming this means the entire batch is checked and approved and gets a little tick and certificate from some monocle wearing man in and official coat with a clipboard.

Anyway, Soaping suppliers will then purchase large amounts of the Dye/Lake from the distributor to place on their websites for people like you and me. These are all still batch certified at this point. However, the second the soaping supplier opens those 1kg buckets for repacking purposes, the certification is VOIDED and each of those smaller packages must now be batch certified again if they are to be used in products intended for sale – this requires a repacking license and fees to be paid. So you can understand why the majority of the dyes and lakes you purchase aren’t actually Batch Certified. TKB Trading is pretty upfront about the Batch Certification thing. It’s written all over their dye and lake pages for their customers to see. Most other places don’t even mention it.

FD&C simply means a product falls under the Food Drug and Cosmetic act for approval. If a colourant is FD&C Blue no 1 for example, it means it’s regulated and certified for use in those things. But as I mentioned above, there are a few examples of FD&C colours that have actually been removed from the Cosmetic approval list.

15. So what does Batch Certification have to do with me?
To put it simply, colourants which are subject to batch certification regulations MUST be batch certified or they ARE NOT PERMITTED TO BE USED IN PRODUCTS INTENDED FOR SALE.
Yes, you heard me correctly. If you buy dye powders and lake powders and you create and sell your products in the USA, those powders must be batch certified or you are breaching fda regulations.

The only way to be 100% sure you are getting batch certified dye or lake powder is to buy from a distributor in large amounts and make sure they actually have a batch certificate or to purchase from a reputable seller who actually knows and understands what batch certification is. If a dye is batch certified, it should come with certification papers or something proving the batch you purchased is batch certified.

I actually thought the rules were so ridiculously strict that I must be misunderstanding them, so I contacted the FDA a while back and asked point blank if splitting up a batch certified package of colourant for resale would void the certification. The reply was as below (I have no idea why my initial question was cut off in the reply):

This message is being sent in response to the following submitted inquiry:

Hello,
I
Thank you,
Irene Mihopoulos

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number 00049884.

Response:

Thank you for contacting FDA’s FCIC.

Splitting the batch into smaller batches will cause the certificate to expire and the color additive would no longer be authorized for use.

Thanks for contacting FDA.
Food and Cosmetic Information Center

So, bottom line is you should be using batch certified dyes. You might want to double check with your supplier and if they claim they are, but they are small amounts of dye, perhaps ask them to clarify that the dyes were batch certified AFTER they split them up for resale.

Note: A batch number or lot number is not necessarily batch certification. Most products have a batch number or lot number for tracing purposes. Batch certification is an entirely different beast.

16. But everyone uses lakes and dyes and they get away with it so why shouldn’t I?
Well, you can do whatever you like. I personally don’t understand why anyone trying to run a business wouldn’t purchase large lots of batch certified colourant. Yes it’s more expensive having to purchase 1kg+ of each colour in one fell swoop. However, you actually get a much better deal on the dyes that way and it will probably save you a lot of money in the long run.

I hear what you are saying though, it’s annoying having to follow regulations when you know the majority of the people around you that you have competing businesses with aren’t. Add to that the multitude of people running hobbies who are clearly not about to fork out hundreds of dollars on colourants. I feel similarly about businesses and hobbyists who use other companies intellectual property to promote their products. Minion bath bombs, Disney bath bombs, Pokemon bath bombs, Hello Kitty the list goes on. They are popular and they sell so it can be tempting to take the “if you can’t beat em, join em” approach, but the bottom line is you are breaking IP law if you do.
So why should you have to fork out hundreds of dollars on bulk colourant powders when noone else is? Well, all I can say to that is, “because it’s the right thing to do”. Whether or not you bother, though, is entirely up to you. We don’t actually have the batch certification regulations here in Australia so it’s no skin off my back, that being said I purchased my colourants in bulk from a distributor because it works out a lot cheaper in the long run and they actually are batch certified even though it means nothing in regards to my business.

If you want to avoid the issue entirely you can stick with Micas and Pigments, all of which are exempt from batch certification regulations. :)

Anyway, for those of you confused about Batch Certification, these are the actual regulations below and my understanding of them:

Batch Certification

17. Do liquid dyes and lakes need to be Batch Certified in order to be used in items intended for sale?
No. They do not.
This was incredibly confusing for me because in the pages regarding batch certification on the fda website they talk about mixtures and how you can apply for certification of a mixture by filling in a form and paying a fee. There is also a section that speaks of colorant additives being exempt from batch certification if they are mixed with certain approved diluents. So I went hunting for this approved diluents list. I was able to find an approved diluents list for both foods and drugs but there was nothing listed for cosmetics. So I went back and read the diluent exemption section again and found a little note down the bottom that stated “Note: The provisions of 80.35 with respect only to diluents for use in cosmetic color additive mixtures were stayed, until a regulation is effected listing safe diluents for cosmetic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.” Now, to me, “stayed” implies that those regulations no longer apply where cosmetics are concerned. So I took this to mean, along with the fact there was no approved cosmetic diluent list, that the liquid dye exemption didn’t apply to cosmetics and all dyes whether they be powder or liquid must be batch certified. It was niggling at me for ages though so I figured I would enquire about it specifically:

My question to the fda:
Regarding mixtures – if a supplier was to purchase batch certified colourant powder and use it to make vials of liquid colourant using a diluent, do those vials of liquid colourant still have the required batch certification from the powdered colourant used to make them or is it voided?

The response from the fda:
Please refer to the definition of mixtures exempt from certification 21CFR part 80.35(b):

  • 80.35   Color additive mixtures; certification and exemption from certification.

(a) Color additive mixtures to be certified. Any color additive mixture that contains one or more straight colors listed in part 74 of this chapter, together with any diluents listed in such subparts for use with such straight colors, shall be certified if intended for use in foods, drugs, or cosmetics, or in coloring the human body, as the case may be, subject to any restriction prescribed in parts 70 and 71 of this chapter.

(b) Color additive mixtures exempted from certification. A color additive mixture prepared from a previously certified batch of one or more straight colors, with or without any diluent that has been listed in part 73 of this chapter for use in mixtures, shall be exempt from batch certification if the straight color used has not changed in composition in any manner whatsoever since its certification and if it is simply mixed with the approved diluents for exempt mixtures. The label of such color additive mixtures shall not bear the lot number assigned by the Food and Drug Administration to the certified straight color components, but shall bear the manufacturer’s control number through which the history of the straight color can be determined.

So basically I was referred to the section I had been reading about mixtures being exempted if made with an approved diluent. I decided to ask for clarification and included a copy of the note regarding the exemption being stayed. Unfortunately I didn’t receive a reply both times I enquired. I guess they got sick of me.

So the answer would be that liquid dyes and lakes are fine to use in products intended for sale as they are exempt from batch cert thanks to a mysteriously elusive approved diluents list and despite notes on the fda website implying those regulations don’t apply to cosmetics. Lol.

So this brings us full circle back to those premade food dyes and gels you can get from the supermarket. I would assume that if dyes and lakes mixed with mysterious diluents are okay for use in products intended for sale, then the premade food colour gels and liquids would be fine as well – as long as the colours being used in them are on the approved list and there are no other ingredients in the premade colouring that aren’t bodysafe. But don’t hold me to that because these regulations are confusing as hell.

Anyway, I probably forgot to mention a lot of stuff but I hope that helped explain colourants a little. 🙂

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