Guest guest Posted March 6, 2003 Report Share Posted March 6, 2003 >Can anybody shed some light on this? CTFA petition regarding harmonization of ingredient labeling names and recognition of the International Cosmetic Ingredient Dictionary Sixth Edition: September 20, 1996 http://www.cfsan.fda.gov/~acrobat/cosltr06.pdf FDA response to petition: July 7, 1997 http://www.cfsan.fda.gov/~acrobat/cosltr07.pdf However, the FDA also states that the " CTFA Cosmetic Ingredient Dictionary, Ninth Edition, (2002) " " [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. " http://www.cfsan.fda.gov/~dms/industry.html Maurice -------------------------------------------------------- Maurice O. Hevey Convergent Cosmetics, Inc. http://www.ConvergentCosmetics.com ------------------------------------------------------- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 6, 2003 Report Share Posted March 6, 2003 > > >Can anybody shed some light on this? > > CTFA petition regarding harmonization of ingredient labeling names > and recognition of the International Cosmetic Ingredient Dictionary > Sixth Edition: September 20, 1996 > http://www.cfsan.fda.gov/~acrobat/cosltr06.pdf > > FDA response to petition: July 7, 1997 > http://www.cfsan.fda.gov/~acrobat/cosltr07.pdf > > However, the FDA also states that the " CTFA Cosmetic Ingredient > Dictionary, Ninth Edition, (2002) " " [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. " > http://www.cfsan.fda.gov/~dms/industry.html > > Maurice > The first link is the CFTA petitioning to use common names before the Latin names after they were subsequently denied use of the Latin name only and the Latin name before the common name. (see the FDA link) http://www.cfsan.fda.gov/~acrobat/cosltr03.pdf The second link is the Response of the FDA telling the CFTA that no decision will be made at this time. The last link is a webpage with the text maintained by web people and not the FDA. The ninth edition does indeed contain many appropriate names for labeling, but it also contains names that are not allowed for labeling by the FDA. Here are Halper (Head of Cosmetic Enforcement of the FDA) and Jeannie Ertter-Prego relating the FDA's current stance on the use of Latin names on ingredient labels. September 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 ********************* " Ertter-Prego, Jeannie " Although there are clearly no more than perhaps 20% of the ca. 12,500 ingredients monographed in ICID-9(2000)that are monographed in CID-2 (1977), it is equally clear that the use of Latin names and CI Numbers for ingredient declarations on cosmetic product package labels is not acceptable from the perspective of either the spirit or the letter of the 1966 FPLA and fails to serve the informational needs of U.S. consumers and their physicians. Jeannie Ertter-Prego ******************** T. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 6, 2003 Report Share Posted March 6, 2003 > >>The rule of thumb is to use the most recent version of the CTFA Dictionary. > >I've never heard it expressed quite that way and I'm sure that is the rule of thumb or standard operating procedure in many companies. > >But I subscribe to the belief that you should stay within the rule and intent of FDA's lebeling regulations, I also believe that many times you can communicate more >effectively using 5th or 6th edition names. > >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. > >I see the ingredient list as a marketing tool as well as compliance requirement. > >> For domestic products there is no real difference in the >>past three volumes for the most part. The greatest changes have occurred >>with the harmonization of the labeling of products that will be marketed >>in both the US and the EU. > >I agree. Here is good FDA website that deals with the " harmonization " process as it relates to cosmetics: >http://vm.cfsan.fda.gov/~dms/cos-intl.html > >>Therefore if you have the 7th ed then feel free to use it but if you >>have access to the 9th ed then that is the version to use. > >Your not suggesting that using labeling names from the 5th or 6th editions is wrong? Because as far as I know they are still " legal " . > >Maurice Maurice Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 7, 2003 Report Share Posted March 7, 2003 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. 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. 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? Rose The London Soap Company > 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 > ------------------------------------------------------- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 7, 2003 Report Share Posted March 7, 2003 > 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. > > 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. > > Would this be a correct assessment or am I missing something here? > Rose > The London Soap Company > Rose, Through endless telephone conversations, 6 months of email exchanges, and being directed by the FDA to read all the CFTA petitions and FDA responses, this is what I have been told repeatedly and have read regarding the listing of oils and botanicals: (provided in example form) 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 OTW Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 7, 2003 Report Share Posted March 7, 2003 Maurice, You keep referring to the CTFA. But isn't it the FDA who regulates labeling in this country? For the small homecrafter, isn't it what the FDA says that matters? csnelg > > >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. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 8, 2003 Report Share Posted March 8, 2003 ---Thanks for posting those written opnions Maurice. It irks me that the FDA just doesn't partner more openly with the CTFA anyway - this shouldn't be a guessing game as to how to label! At least, the FDA is very nice to deal with on the phone. Willow Quote Link to comment Share on other sites More sharing options...
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