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Re: Alkanet

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please say it ain't so........

Patti in PA.

even in soap coloring???? Oh come on I just bought 2 lbs of the stuff.....

Alkanet

Although I am in England, and it is still a permitted ingredient here, I

understand that alkanet use has been banned recently by the FDA in cosmetics.

(Thanks Jules!) In theory I should include this information somewhere in the

piles of paperwork I have to keep.

Can someone direct me to the relevant bit of legislation? Is there anywhere

that I can find the basis for this decision?

Thanks

Rose

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In a message dated 2/12/01 4:41:55 PM Pacific Standard Time,

Cosmeticinfo writes:

<< If you are making soap, and using alkanet to color your soap with, and are

not making cosmetic or drug claims on your label, then you are okay. Soap

is not regulated by the FDA unless you make claims. Soap is regulated by

the CPSC. If you want to make claims or cosmetics, then you need to be

using colorants approved for use by the FDA. >>

Yes, Ellen, but if the alkanet is deemed not safe for cosmetics, I personally

would hesitate to put it in my soap product without additional information on

it.

To me it is not an issue of who regulates it, it is an overall safety issue.

I guess my question would be is, why the FDA chose not to approve it and

then go from there as a deciding factor.

Dee ·´¯`·.. ><((((º>``·.¸:.¸:.¸.·´¯`·.><((((º> .¸:.¸.·´¯`·...¸><((((º>

·´¯`·:

me >^;;^< >^;;^< >^;;^< >^;;^< >^;;^<

ow

·´¯`·.. ><((((º>``·.¸:.¸:.¸.·´¯`·.><((((º> .¸:.¸.·´¯`·...¸><((((º>·´¯`·:

·´¯`·.. ><((((º>``·.¸

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>Although I am in England, and it is still a permitted ingredient here, I

>understand that alkanet use has been banned recently by the FDA in cosmetics.

> (Thanks Jules!) In theory I should include this information somewhere in the

>piles of paperwork I have to keep.

I'm not sure what you exactly mean when you say " recently banned " , but I don't

recall Alkanet ever being approved as a colorant for

cosmetics. I did do a search of the US Federal Register from 1995 through 2001

for " alkanet " and " Alkanna tinctoria " and couldn't find

any reference. I also searched the Code of Federal Regulations and could find

any reference.

According to the 8th Edition of the CTFA's International Cosmetic Ingredient

Dictionary, Alkanet (INCI: Alkanna Tinctoria Root Extract)

is also called Alkanna Tinctoria in the EU.

I understand that the UK is not part of the EU, but as far as I can tell from

searching the EU's Pharmaceutical and Cosmetic website

http://pharmacos.eudra.org/

Alkanna Tinctoria is not an approved colourant in the EU.

If you have a literature reference that says that Alkanet is an approved

colourant for cosmetics, I'd like to know for my personal files.

>Can someone direct me to the relevant bit of legislation? Is there anywhere

>that I can find the basis for this decision?

The approved colors for use in cosmetics on the US can be found at:

http://vm.cfsan.fda.gov/~dms/opa-col2.html

Maurice

---------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.convergentcosmetics.comÿ

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Apparently Aklanet is not innocuous. I did a MEDLINE search

http://igm.nlm.nih.gov/ for Alkanet

or Alkanna tinctoria and found the following citation:

------------

TITLE: Studies on the relationship of structure to antimicrobial properties of

naphthaquinones

and other constituents of Alkanna tinctoria.

AUTHORS: Papageorgiou VP, Winkler A, Sagredos AN, Digenis GA

SOURCE: Planta Med. 1979 Jan;35(1):56-60. No abstract available.

------------

TITLE: Wound healing properties of naphthaquinone pigments from Alkanna

tinctoria.

AUTHORS: Papageorgiou VP

SOURCE: Experientia. 1978 Nov 15;34(11):1499-501.

Maurice

---------------------------

MauriceÿO.ÿHeveyÿ

ConvergentÿCosmetics,ÿInc.

http://www.convergentcosmetics.comÿ

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> If you are making soap, and using alkanet to color your soap with, and are

> not making cosmetic or drug claims on your label, then you are okay. Soap

> is not regulated by the FDA unless you make claims. Soap is regulated by

> the CPSC. If you want to make claims or cosmetics, then you need to be

> using colorants approved for use by the FDA.

Yes and No. Labeling and cosmetic claims are not one and the same. When you

label-even if you don't make cosmetic claims-you still need to follow the

only law that is in effect for labeling, and that means using INCI

nomenclature. When it comes to listing your Alkanet, if you list it as a

colorant, it is not approved. If you don't list it as a colorant, and list

it just as another herb, you are ok.

Pat.

Peace, Joy, Serenity.

www.houseofscents.com

/group/Cosmeticinfo

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Thank you for your reply Maurice.

The UK *is* part of the EU, and all regulations apply...

The point you raise about alkanet not being listed as a colourant here is

correct; it is in neither the permitted or prohibited listings. However it

is listed as a cosmetic ingredient in the EU INCI listings, (Einecs No

286-469-4, CAS No 85251-58-7) and can therefore be used as an ingredient.

If it is listed in the CTFA directory, then presumably the case is similar in

the US.

As a soapmaker, my recipes have to be certified by a cosmetic chemist or

toxicologist, and one or both of us should provide as much information as

possible about such an ingredient, although at the end of the day the

decision regarding it's safety rests with him. I have certified recipes

containing infusions of Alkanna tinctoria, but it is my responsibility to

keep the information up to date...

To answer your question Maurice, I don't have any literature that states that

it is an approved colourant; only some references to papers recommending it

not be used during pregnancy etc. My chemist assessed it's activity in the

product as 0%, (presumably because it is a strained infusion?) and noted that

it is considered by the AHPA to be suitable only for use in a rinse off

product. He also notes that it is being used as a colouring agent.

I would be very curious to know what your opinion on it's use would be.

There are any number of permitted ingredients that whilst not listed as

permitted colourants, have the effect of colouring the finished product. It

is interesting to note that here in the UK, many commercial soap

manufacturers are now producing soaps designed to look as if they are

handmade, complete with rough edges and various dried botanicals sprinkled

through them. I am aware that these probably don't contain pyrrolilizidine

alkaloids, but I suspect that at some point the regulatory bodies might have

to catch up with this.

Rose

In a message dated 12/2/01 11:55:19 pm, maurice@...

writes:

<<I'm not sure what you exactly mean when you say " recently banned " , but I

don't recall Alkanet ever being approved as a colorant for

cosmetics. I did do a search of the US Federal Register from 1995 through

2001 for " alkanet " and " Alkanna tinctoria " and couldn't find

any reference. I also searched the Code of Federal Regulations and could

find any reference.

According to the 8th Edition of the CTFA's International Cosmetic Ingredient

Dictionary, Alkanet (INCI: Alkanna Tinctoria Root Extract)

is also called Alkanna Tinctoria in the EU.

I understand that the UK is not part of the EU, but as far as I can tell from

seaching the EU's Pharmaceutical and Cosmetic website

http://pharmacos.eudra.org/

Alkanna Tinctoria is not an approved colourant in the EU.

If you have a literature reference that says that Alkanet is an approved

colourant for cosmetics, I'd like to know for my persoanl files.

>Can someone direct me to the relevant bit of legislation? Is there anywhere

>that I can find the basis for this decision?

The approved colors for use in cosmetics on the US can be found at:

http://vm.cfsan.fda.gov/~dms/opa-col2.html

Maurice

>>

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As a soapmaker, the number 1 reason for using Alkanet is for coloring. I am

more than sure that coloring soap was the reason behind the original

question about alkanet. Alkanet is not " deemed unsafe " .. it has not been

" banned " it simply " isn't approved " . It equates to about the same thing as

adding dillweed for a green color or paprika for a peach color (among

several other herbal items) to soap.

Ellen

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>The UK *is* part of the EU, and all regulations apply...

I stand corrected. I was under the impreesion that Ireland and the UK decided

to hold out for awhile.

>The point you raise about alkanet not being listed as a colourant here is

>correct; it is in neither the permitted or prohibited listings. However it

>is listed as a cosmetic ingredient in the EU INCI listings, (Einecs No

>286-469-4, CAS No 85251-58-7) and can therefore be used as an ingredient.

>If it is listed in the CTFA directory, then presumably the case is similar in

>the US.

True. It can be used as a botanical additive.

Maurice

---------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.convergentcosmetics.com

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> I stand corrected. I was under the impreesion that Ireland and the UK

decided to hold out for awhile.

Maurice, Ireland (The Republic) is part of the EU. As a matter of fact it

has the fastest growing economy in the EU as a result of them cutting taxes

to attract business. Looks like they were paying attention to

Regan:-)

Pat.

Peace, Joy, Serenity

House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap, Etc.

achil@...

www.houseofscents.com/

www.yourhealthandbody.com

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Hi Sara

I read this through a few times before I realized that I completely agree...

It is a problem though with ingredients that ARE listed as approved, but that

have very little research done or published about them. Or that, as in the

case of eos, have new research coming out all the time.

There are no MSDSs for alkanet, or for cinnamon or dill or parsley for that

matter. I use some of them to enhance the appearance of my product; much the

same as any cosmetic manufacturer would try to enhance the appearence of

their product. In my own case I would prefer to use these sorts of items

because it happens to fit in with my particular market. It is however,

absolutely up to me to make sure that in doing so, I make a product that is

provably just as safe as one that uses approved colourants. In fact (and

this is a particular bugbear of mine!) this whole area of using botanicals in

this fashion to improve appearance and perceptible value is virtually

confined to handmade soap, the one area of cosmetics that doesn't have any

input into the deliberations of legislative bodies, or the ability to fund

research.

Did you know there are no EU INCI listings for saponified cocoa butter? Or

sunflower, corn, canola, shea, grapeseed, neem, sesame, jojoba... The list

goes on. They can be used in soap perfectly legally, since the oil listings

include the physically modified extractives and fatty acids, but it means

that soaps have to be labelled with just the oil names. It is perfectly

possible to sell a bar of soap that according to the label has no soap in it

at all! I can only assume that since no major commercial soap manufacturer

uses these oils, they were 'forgotten' when the lists of sodium fatty acids

were drawn up.

So with regard to approved ingredients such as alkanet, parsley etc, isn't it

possible that they are not on the list of approved colourants because no-one

informed the committees that drew them up that there are cosmetics makers who

use them for this purpose?

Rose

<<, I can't thank you enough for posting this. If I can't come up

with a reasonable explanation for using cinnamon in my soap, other

than it makes neat brown specks, why am I using it? Just like why

would I use woad dye which is poisonous, artists' pigments which may

contain lead, textile dyes, etc, etc.

It just makes sense that the ingredients which haven't been

established as safe for use in topicals or aren't listed as

acceptable by the FDA are going to be the ones we are found liable

for if there's a problem, even if they aren't the cause of the

problem, I would add.

sara

>>

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> Did you know there are no EU INCI listings for saponified cocoa butter?

Or > sunflower, corn, canola, shea, grapeseed, neem, sesame, jojoba... The

list > goes on.

Probably a good reason to list the ingredients that you put into your soap

rather than the saponified oils. If you are looking for a fairly extensive

list of INCI names there is a link to Sherri's web page in the " bookmarks "

section of our home page. Browse the rest of her site while you are there as

she stocks many ingredients.

> So with regard to approved ingredients such as alkanet, parsley etc, isn't

it

> possible that they are not on the list of approved colourants because

no-one

> informed the committees that drew them up that there are cosmetics makers

who

> use them for this purpose?

I think the only manufacturers you will find using those are the

home-crafters in the soap making industry. Moreso with people that want to

keep their product as close to natural as possible. By natural I mean

originating from a live or dried plant.

Pat.

Peace, Joy, Serenity

House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap, Etc.

achil@...

www.houseofscents.com/

www.yourhealthandbody.com

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