Re: Re: Labeling - INCI Names

[Guest guest]

From: Maurice Hevey

>One of my favorite examples is Comfrey Extract:

>

>5th edition = Comfrey Extract

>6th edition = Comfrey (Symphytum Officinale) Extract

>7th edition = Symphytum Officinale Extract

>9th edition = Symphytum Officinale Extract

>

>Compared to " Symphytum Officinale Extract " , I think that " Comfrey

Extract " is more meaningful to the typical consumer.

Maurice, I believe there is a lot of confusion out there. I think the main

question that Janice wanted answered was do we always have to use INCI

Nomeclature on our labels. As far as I recall, we do.

Many people on the various lists use Sherri's INCI names that she has on her

Oshun site as it probably is the most complete one on the net. So the

assumption is that this is the only correct way to list ingredients. Up

until recently none of the chemists even suggested that we could use earlier

versions of the CTFA dictionaries to label our products. You started giving

examples several months back, but I don't recall anything prior to that. Of

course I live in my own world now and then, so you may have:-)

So the short answer for Janice is that yes, we do have to use INCI

nomenclature, but we can choose a CTFA dictionary where the nomenclature is

closer to the common name that is recognized by most people. I know that if

I am not understanding this correctly, you will let me know.

Pat.

Peace, Joy, Serenity

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

pat@...

http://www.houseofscents.com/

[Guest guest]

As of today, this is all the information regarding this INCI labeling

issue/concern that was raised by T. (aka OTW) on In-Toiletries.

I have taken the liberty

capitalize the portions that I thought were important.

According to current FDA regs (21 CFR 701.3©(2))

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=701.3

" (2) In the absence of the name specified in Sec. 701.30, the name adopted for

that ingredient in the following editions and supplements of the following

compendia, listed in

order as the source to be utilized:

(i) CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.) Cosmetic

Ingredient Dictionary, Second Ed., 1977 (available from the Cosmetic, Toiletry

and Fragrance

Association, Inc. 1110 Vermont Ave. NW., Suite 800, Washington, DC 20005, or

available for inspection at the Office of the Federal Register, 800 North

Capitol Street, NW.,

suite 700, Washington, DC 20408) "

The FDA Cosmetic Labeling Guide says:

http://vm.cfsan.fda.gov/~dms/cos-lab3.html

" The currently recognized edition of the CTFA (Cosmetic, Toiletry and Fragrance

Association, Inc.) Cosmetic Ingredient Dictionary is the second edition

published in 1977.

This edition is recognized only in part, i.e., not all names listed in the

second edition have been adopted.

The third edition of the CTFA Cosmetic Ingredient Dictionary published in 1982

and the Supplement published in 1985 [this must've been the fourth edition] have

not yet been

recognized. However, FDA HAS INFORMED THE CTFA THAT THE AGENCY WILL NOT TAKE

REGULATORY ACTION AGAINST PRODUCTS LABELED IN

ACCORDANCE WITH THESE EDITIONS WHILE THEIR REVIEW IS IN PROGRESS. "

Quoting from the introduction of the 9th Edition of the International Cosmetic

Ingredient Dictionary (ICID-9)

" In the Fifth Edition (1993), some alternate INCI labeling names for the United

States and the EU were first identified, as national regulations required

different names for their

approved colorants, and certain new conventions were being developed to address

some U.S. parochial nomenclature.

Based on the nomenclature in the Sixth Edition (1995), Colipa prepared an

inventory of cosmetic ingredients, assigning different names to color additives,

botanicals, and

certain " trivial " names. The European Commission published this inventory on

June 1, 1996 (Commission Decision 96/335/EEC). "

The CTFA started placing the Latin name first with the more common name in

pararenthesis begining with ICID-8. Here are some examples:

ICID-6

Olive (Olea Europaea) Extract

Olive (Olea Europaea) Husk Oil

Olive (Olea Europaea) Extract

Olive (Olea Europaea) Husk Oil

Olive (Olea Europaea) Leaf Extract

Olive (Olea Europaea) Oil

Olive (Olea Europaea) Oil Unsaponifiables

ICID-7

Olive (Olea Europaea) Extract

Olive (Olea Europaea) Husk Oil

Olive (Olea Europaea) Leaf Extract

Olive (Olea Europaea) Oil

Olive (Olea Europaea) Oil Unsaponifiables

ICID-8

Olea Europaea (Olive) Fruit Extract

Olea Europaea (Olive) Fruit Oil

Olea Europaea (Olive) Husk Oil

Olea Europaea (Olive) Oil Unsaponifiables

Olea Europaea (Olive) Leaf Extract

ICID-9

Olea Europaea (Olive) Fruit

Olea Europaea (Olive) Fruit Extract

Olea Europaea (Olive) Fruit Oil

Olea Europaea (Olive) Husk Oil

Olea Europaea (Olive) Oil Unsaponifiables

Olea Europaea (Olive) Leaf Extract

Olea Europaea (Olive) Seed Powder

On September 6, 1996, CTFA petitioned the FDA to change some regulatory

language. Among the regulaory changes requested by the CTFA, was a change in 21

CFR

701.3©(2)(i) to recognize the sixth edition of the International Cosmetic

Ingredient Dictionary (ICID-6).

http://www.cfsan.fda.gov/~acrobat/cosltr06.pdf

On July 7, 1997, the FDA responded by saying that in accordance with 21 CFR

10.30(e), " we have not been able to reach a decision within the first 180 days

of the filing of

the petition, because of the limited availability of resources and other agency

priorities.

PLEASE BE ASSURED THAT YOUR PETITION IS UNDER ACTIVE REVIEW AT THE PRESENT TIME,

AND A MORE SUBSTANTIAL RESPONSE REFLECTING THE

AGENCY'S DETERMINATION OF THE MERITS OF SEVERAL ELEMENTS OF THE PETITION WILL BE

FORTHCOMING AS SOON AS POSSIBLE "

Two interesting observations.

1) The person that wrote this letter, Dr. , now works for the CTFA.

2) Although the FDA did not approve the ICID-6, Dr. made a point to say

" YOUR PETITION IS UNDER ACTIVE REVIEW " . But we know that the " FDA HAS

INFORMED THE CTFA THAT THE AGENCY WILL NOT TAKE REGULATORY ACTION AGAINST

PRODUCTS LABELED IN ACCORDANCE WITH THESE EDITIONS

WHILE THEIR REVIEW IS IN PROGRESS " .

In a online document titled " International Activities at FDA's Office of

Cosmetics and Colors " and dated April 28 2000,

http://www.cfsan.fda.gov/~dms/cosintov.html

the FDA's Center for Food Safety and Applied Nutrition, Office of Cosmetics and

Colors (OCAC) identified harmonization of ingredient nomenclature is one of the

" key

international issues under consideration at OCAC " .

And then the FDA published their summary of the Cosmetics Harmonization and

International ation (CHIC) Meeting which was held on May 8th and 9th,

2000.

http://www.cfsan.fda.gov/~dms/cos-ch00.html

In this summary of the meeting, the FDA states:

" A round-table discussion addressed the differing nomenclature needs in the

various administrations. ACCORDING TO THE U.S. OFFICIAL, DUAL DECLARATION IS

GENERALLY ACCEPTED IN THE U.S., WITH THE INTERNATIONAL NAME OF THE INGREDIENT IN

PARENTHESES, INCLUDING COLOUR INDEX (CI) DESIGNATIONS

FOR COLOR ADDITIVES. "

Remember, the CTFA stopped putting the " international name " and Latin names with

the 8th edition.

In the forward of the ICID-6, the CTFA say that the parenthetical information is

optional.

And a FDA, CFSAN webpage titled " Information Materials for the Food and

Cosmetics Industries " ,

http://www.cfsan.fda.gov/~dms/industry.html

the FDA says that the Ninth Edition of the International Cosmetic Ingredient

Dictionary (ICID-9) " [p]rovides a common nomenclature for use in preparing

ingredient labels and

in disclosing product trade and chemical names are cross-referenced to CTFA

adopted names. "

And then T. posted this message on In-Toiletries :

[in-Toiletries] Re: INCI labeling...ugh !!

> The use of Latin names only or the use of Latin names before the

> common name are not allowed by the FDA.

>

> This is from Halper of the FDA, Sept 2002:

>

> **************************************************

> R. Halper, HFS-105

> Office of Cosmetics and Colors

> Division of Programs and Enforcement Policy

>

> " Second, with respect to the use of " harmonized " nomenclature, we

> direct you to the cosmetic web site [ http://www.fda.gov ], scroll

> into " Cosmetics " and then into " International Activities " . The

> letters under " Requests Regarding the Harmonization of Ingredient

> Nomenclature " will provide you with information concerning the proper

> declaration for ingredients. For example, while we would not object

> to the parenthetical Latin term after the common or usual name of

> the ingredient (e.g., " Olive (Olea Europaea) Oil " , the listing of the

> Latin term first would not comply with the common or usual name

> requirement for ingredients. In addition, the term " essential

> oil " should be declared as " fragrance " .

>

> We trust that you will find this information helpful.

>

> Sincerely,

>

> R. Halper, HFS-105

> Office of Cosmetics and Colors

> Division of Programs and Enforcement Policy "

>

> **************************************************

I do not see any reason why OTW would create images that aren't supported by

reality. I have sent email to the CTFA to see what their position is on this

subject. As soon

as I hear back, I'll let you know.

Personally, I always provide ingredient labeling options to my clients. Most

choose names from the 6th edition names without the Latin names.

Maurice

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

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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

[Guest guest]

> As a totally disinterested party in this discussion, but having a

> Black Belt in wading through eye-glazing legislation, I have to say I

> am unclear about what is being said here.

Welcome to the crowd.

> The essential difference between what you are stating and citing, and

> what OTW is saying and citing boils down to one thing only as far as I

> can see. This is that one of you is saying it is allowable and

> acceptable to use latin names in the INCI name before a common name,

> and the other is saying that it is not allowed at all.

Basically that is it for that part. Anybody that lists their essential oils

would definitely want to use the Latin. In some cases plants can have the

same common name and completely different Latin Names for different species.

The example of

> using the latin name only is irrelevant. Having no knowledge of the

> earlier editions, I can only assume that these were listings of the

> common names only, or else none of this makes sense, especially the

> use of the '6th edition names without the latin names'...

>

> Would this be a correct assessment or am I missing something here?

As I pointed out yesterday, we always had the choice of which edition to use

for our labels. We could even mix and match editions. Maurice has stated

today that he always gives his clients a choice of the edition they want to

use for their labeling. Most choose the older version because you can list

your oils like Olive Oil instead of Olive (Olea Europaea) Oil or Olea

Europaea (Olive) Fruit Oil.

I am not going to give a lot of time to this topic because it has the

potential to confuse people, and people have a difficult enough time with

labeling as it is. There is nothing new in what is saying, but he

seems to have missed a lot of the correspondence between the FDA and the

CTFA.

Pat.

Peace, Joy, Serenity

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

pat@...

http://www.houseofscents.com/

----- Original Message -----

[Guest guest]

>The essential difference between what you are stating and citing, and

>what OTW is saying and citing boils down to one thing only as far as I

>can see.ÿ This is that one of you is saying it is allowable and

>acceptable to use latin names in the INCI name before a common name,

>and the other is saying that it is not allowed at all.

Based on information provided by the CTFA and what I had read on the web, I was

always under the impression that you could used any edition of the Cosmetic

Ingredient

Dictionary (CID) or International Cosmetic Ingredient Dictionary (ICID).

Now, based on the email messages from the people that work for the FDA's Center

for Food Safety and Nutrition, it appears that the use Latin names with the

common

name in parenthesis is unacceptable to these representives of the FDA.

I have posted these FDA messages to the CTFA for their response. I'm looking

forward to the CTFA's response.

>The example of

>using the latin name only is irrelevant.ÿ Having no knowledge of the

>earlier editions, I can only assume that these were listings of the

>common names only, or else none of this makes sense, especially the

>use of the '6th edition names without the latin names'...

I don't have a Fifth Edition available, but based on recall, the Fifth Edition

was the last edition to use ONLY " common names " . It was with the Sixth Edition

did the CTFA

begin to add the Linne system genus/species name in parenthesis.

In the introduction of ICID-6, the CTFA states that for labeling products for

sale in the US, the use of the genus/species name in parenthesis is optional.

It was in the ICID-8, that the CTFA started to use the Latin genus/species name

with the " common name " in parenthesis.

>Would this be a correct assessment or am I missing something here?

I don't think you are missing anything.

Maurice

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

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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

[Guest guest]

I am thinking the thing would be is which agency supersedes the other. THEN

you go by that agency. Which one has direct oversight to what we do? The FDA

or the CTFA.

Yoki

I cried unto the Lord with my voice,

and he heard me out of his holy hill.

Selah

Re: Re: Labeling - INCI Names

>The essential difference between what you are stating and citing, and

>what OTW is saying and citing boils down to one thing only as far as I

>can see.ÿ This is that one of you is saying it is allowable and

>acceptable to use latin names in the INCI name before a common name,

>and the other is saying that it is not allowed at all.

Based on information provided by the CTFA and what I had read on the web, I

was always under the impression that you could used any edition of the

Cosmetic Ingredient

Dictionary (CID) or International Cosmetic Ingredient Dictionary (ICID).

Now, based on the email messages from the people that work for the FDA's

Center for Food Safety and Nutrition, it appears that the use Latin names

with the common

name in parenthesis is unacceptable to these representives of the FDA.

I have posted these FDA messages to the CTFA for their response. I'm

looking forward to the CTFA's response.

>The example of

>using the latin name only is irrelevant.ÿ Having no knowledge of the

>earlier editions, I can only assume that these were listings of the

>common names only, or else none of this makes sense, especially the

>use of the '6th edition names without the latin names'...

I don't have a Fifth Edition available, but based on recall, the Fifth

Edition was the last edition to use ONLY " common names " . It was with the

Sixth Edition did the CTFA

begin to add the Linne system genus/species name in parenthesis.

In the introduction of ICID-6, the CTFA states that for labeling products

for sale in the US, the use of the genus/species name in parenthesis is

optional.

It was in the ICID-8, that the CTFA started to use the Latin genus/species

name with the " common name " in parenthesis.

>Would this be a correct assessment or am I missing something here?

I don't think you are missing anything.

Maurice

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

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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

Post message: Cosmeticinfo

Subscribe: http://groups.yahoo.com/group/Cosmeticinfo

Unsubscribe: Cosmeticinfo-unsubscribe

List owner: Cosmeticinfo-owner

URL to this page: http://groups.yahoo.com/group/Cosmeticinfo

[Guest guest]

>The FDA does NOT allow the following form:

>

>* Olea Europaea Oil

>* Olea Europaea (Olive) Oil

>

>The FDA generally accepts the following from:

>

>* Olive (Olea Europaea) Oil

>

>The fully accepted method by the FDA is:

>

>* Olive Oil

I guess I'll call you OTW because it irks me to call you T.

.

Quite frankly, I think it's fair to say that Alan Harper or Jeannie

Ertter-Prego represent a public face for the FDA but I don't believe

that either speak for the FDA, nor do they make policy or create

regulations.

As you probably know, Alan Harper is a Consumer Safety Officer working

for CFSAN's Office of Cosmetics and Colors/Division of Programs and

Enforcement Policy and Jeannie Ertter-Prego is a Consumer Affairs

Specialist working for CFSAN's Office of Constituent

Operations/Consumer Education Staff.

I wonder how much authority has been delegated to them in the FDA

bureaucracy. I can only imagine.

It will be interesting to see what the CTFA has to say.

Maurice

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

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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

[Guest guest]

>You keep referring to the CTFA.ÿ But isn't it the FDA who regulates

>labeling in this country?

Yes.

> For the small homecrafter, isn't it what

>the FDA says that matters?

Yes.

Maurice

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

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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

[Guest guest]

> the FDA says that matters?

>

> csnelg

Please use your real name when you post to this list. It is a list

requirement.

Pat. List owner.

Peace, Joy, Serenity

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

pat@...

http://www.houseofscents.com/