Document zQbkZ78bGGrbBB8d6XaGNkV5R

together with their requested classification. The German Dyestuff Commission already has our safety data for these colors and, ) feel that in the interest of International coop eration, and if the toxicological data supports It, we can expect early listing of such colors as FD&C Green 3, D&C Red 17, D&C Red 31, D&C Red 33, D&C Red 6, D&C Blue 6, D&C Orange 17 and External D&C Violet 2. Further more, the Commission can be requested to broaden allowed uses of such colors as FD &C Blue 1. The meeting closed with a call for continued Interna-, tional exchange of scientific information. The success of this meeting was made possible by a large number of people, too many to name here. However, three men deserve special thanks. Dr. Opdyke's contribution was enormous in magnitude. His many months of work In studying data and In develop ing strategy for the meeting, as well as his fantastic per formance throughout the meeting doubtlessly had a great effect on its outcome. Dr. Goswin Van Ham of Margaret Astor Cosmetics In Germany, and Dr. Otto Jacobi of Koimar Laboratories, came to the U.S. for the express purpose of painstakenly examining our data and translating it into tables In German for consideration by the Commission. The cosmetic Industry owes these men and our friends in Germany a debt of gratitude for their efforts on its behalf. CTFA-FDA -- Scientific Liaison Report Dr. Harold Schwartz* Since the last Scientific Conference, three meetings of the CTFA-FDA Scientific Liaison Committee were held. It has been most interesting and certainly gratifying In many ways; interesting because each meeting brought forth new questions, problems, and occasionally even resolutions of some of those problems; gratifying because I believe for the first time, sound scientific discussion represented the atmosphere at our meetings. I t Is my recollection that approximately thirty different subjects were thoroughly discussed. From our ingredient survey to such widely diverse subjects as chloroform use in toiletries, bubble baths, color petitions, mercury in cosmet- *The Menncn Company, M orrklown, N.J,, 07960 10 CTFA COSMETIC JOURNAL, VOL. 3, NO. 4 les, microbiology, etc., were discussed. When requj problems were studied in separate sessions, Very often subject matter became so deep and so important to evij one, that a special committee of scientists was required, i we brought In people from outside In order to assist necessary. ! For example, when the question of asbestos In talc cai up, people who were interested in talc and who were j perts In the field of analysis of talc were brought In so (| the subject could be thoroughly handled on a sclent; basis. Dr. George Wolcott mentioned how a group formed In order to study chloroform In toiletries, especj; in dentrifices. Hexachlorophene and other subjects w, discussed at these joint meetings held by scientists and j by compliance people. I really have to emphasize this cause t think our biggest hang-up when we first started^ to determine that this committee would meet and di< only on a scientific basis and certainly not on a legal or compliance basis. 1 bolieve, certainly in the (ast year, we have been conducting our business in that manner. Much of the success of our committee is due to participants. Through the leadership o f Commissioner Edwards his staff, Dr. Wodlcka, Dr. Schaffner, and all other I participants, a willingness to deal with scientific prohj on a scientific basis has been demonstrated. Additionally, accolades must go out to all the me.1(v of the CTFA participating In this joint venture. They ii worked diligently, controlled their tempers for the tn part, and I believe have performed a noteworthy service.- Certainly much of the uneasiness about discussing pr, lems with FDA has noticeably decreased and, I say this the face of what i believe are the most trying times. Not only our industry, but FDA Is feeling great pro__ from such sources as consumer groups, Congress, and so and yet, the discussions have been kept on a rather.' keel. The best way to describe the kinds of activities that group has participated in would be to just read the ag of our last meeting which was held in Washington August 18th. It represents a far cry from the sparring took place some two-and-a-haff years ago at the first sion. This Agenda reads as follows: -- 1. CTFA Petitions 2. Color Additives 3. Hair Coloring Research 4. Chronic Eye Studies 5. Hexachlorophene 6. Feminine Deodorant Sprays 7. Aerosols 8. Asbestos In Talc ' : 9. Chloroform 10. Shampoos 11. Microbiology 12. Mercurials 13. Hypoallergenic Cosmetics ..14. Organic or Natural Cosmetics This agenda certainly covers a wide gamut that affects all us. ' " I hope that we continue to approach scientific probli affecting our industry with forthrightness, without vl WCD-357 QE-CPC00001182 requli Jess, and with an openness dedicated to resolving prob- often tp f the present and avoiding problems of the future. to O' $>e1l :ve the FDA-CTFA Scientific Liaison Committee uired. a, fl|.w>runue to approach problem solving with those crl- isist wh^ ? hn mind. talc >were in soil scientiTu roup ' especially DisCUSSBOBI O f sets WfJ s and ft'ij Voluntary Petitions e this I arted s| id discua al O' ona /e. , the >e 8HUBJ*PV James H. Merritt, Moderator Dr. Murray Berdick Dr. Harold Schwartz John C. Warley, Jr. to the /ards and es H. Merritt her FDK .he subject of our discussion this morning, our Peti- problems, ugs. really has Its genesis a couple decados ago when there p, first Introduced in Congress legislation to require pre- members; jrnce of cosmetics before they were marketed. That "hey ha, Shjtlon has been Introduced ropeatedly. Congress, In Its the tn<* om, has not enacted It. It has felt, and I think rlght- rvlce. j so, there are more pressing problems for the Food and ing prob jp g Administration. iy this in| W ith the knowledge that pre-clearance legislation had Sn Introduced several times and with the knowledge too pressures: ' In the color additives suit there were efforts made to nd so on;"' irpret the regulations as Including pre-clearance, this As- ;ber even) jlation, then known asTGA, met and decided to develop d promulgate, if possible, a system of self-regulation on a thatDUf'jj Jpftary basis, e agenda |;We contend that self-regulation will be just as effective, igton on; ijjj-be much more economical than mandatory regulation, ring d*l'i "diSvUl provide the consumer an adequate level of protecfirst s1 Jf.so that the consumer will be protected against those juries or that harm which might come from unsafe prod i: Ip first two steps in the program of self-regulation filed with the Food and Drug Administration several tjts ago. They involved two petitions, to be proroul- ji under the Food, Drug and Cosmetic Act as voluntary Options. They have since been published in the Federal ajsrer for comment. p w , first on our office staff team, I am going to call on " fi Warley, a lawyer, who will discuss tha concept lrv jed in the two petitions filed; the first, or voluntary jtration of manufacturers; the second, for the voluntary ire of ingredients. X . Warley, Jr. cts all roblem5? t vln^Q |'m going to be discussing some of the legal and regulaJj? overtones to these petitions; and, I won't get very Mititle for obvious reasons. Two items --where cosmetics p h a d c and what is in them - have been a top priority on FDA's list for some while; and, they are now a top priority on the CTFA and the cosmetic industry's list, as well. In considering the steps by which Information could be submitted to FDA on the location of manufacturers and the Ingredients in cosmetics, there were basically two paths open to the industry; One was mandatory regulation. The other was voluntary regulation. The mandatory regulation seemed at first, I suppose, to be the most obvious way to go because voluntary regulation In this context had never really been attempted by an In dustry before. Therefore, the petitions which we submitted, and the steps which we are taking In submitting this information to the government is, I think unprecedented in the field of statutory regulation, For that reason perhaps there are few precedents for us to follow and the regulatory road might be a Wt rocky for a while, but we are sold on the concept. For a number of reasons we chose the voluntary regula tion route. First and foremost was our conviction that this Industry would cooperate In supplying the Information to the government; that It did not have to be coerced into submitting the Information and that it would be something of a grand gesture on Industry's part to comply fully and to show the government and the consumer that there Is a con scientious soul in Industry which is going to cooperate where cooperation is needed. We submitted two petitions. Most of you, I feel sure, have seen them by now. If you haven't had a chance to scrutinize them, you a t least know of their existence. The first calls for the registration of manufacturers and packagers of cosmetic products. You will be asked to file with the Food and Drug Ad ministration a registration for all o f your plants, factories, etc. In return, you will receive from them a plant registration number which you will use with future correspondence with the agency. The second petition is for the filing of cosmetic Ingred ients In classes. By classes I mean between fifty and a hun dred per cent, twenty-five and fifty percent, etc. on down. So, it Is not a completely quantitative formulation but It Is completely qualitative, with the exception of flavors and fragrances, whose composition, due to their complexity and the great number of ingredients involved, is not requested. The information will be submitted In order of decreasing predominance and there is a very strict legally binding con fidentiality provision by which the FDA will bo precluded from revealing this information submitted on the product Ingredients statement to anyone, except under very certain spelled out and defined conditions. In our grounds for submission to the Food and Drug Administration we stated that in our belief the Information we were providing was necessary for FDA to do its job under the Food, Drug, and Cosmetic Act and to carry out the responsibility that the public has charged that agoncy with, and since we have acknowledged the fact that the information Is necessary for FDA to do Its job, it puts us in a very paradoxical position not to give them the Informa tion that we have spoken of. We are encouraging support for these. We think support will be forthcoming and if for some reason It is not, then It QE-CPC00001183 Pharmacology & Toxicology Robert Giovacchini, Ph.D.* 1972 COMMITTEE REPORT l should like to begin by first discussing the Inter-Indus try aerosol testing program, which was formed as a subcom mittee under the pharmacology and toxicology committee, This program involves the safety evaluation of propellants and several contracts have been let In this area. The first one is to Dr. Richard Stewart of the Medical College of Wisconsin. This is an evaluation of the absorp tion, excretion, and physiological effects, both under acute and subacute exposure In humans using a wide range of propellant concentrations and exposure times. ''' There Is an associated study going along with this which is being funded completely by the du Pont Company, which Is an evaluation of propellant levels Under conditions of use. This study is being done to insure that the concen trations utilized in the Stewart study will be more than that seen under normal use conditions. The second study has been funded and is In progress at the University of Maryland College of Pharmacy under Dr, David Blake. This study examines the biotransformation and metabolic fate of propellants, the study beginning first In rats moving onto dogs and later to humans. The third study has been funded at the Medical College of Georgia with Dr. Nancy Flowers. It's a study which Is examining the early changes In the electroconduction system of the heart following exposure to propellants; dogs are utilized In this study. On Wednesday the Inter-Industry Aerosol Subcommit tee will meet to discuss three additional areas where protocols have been made available. One deals with the effects of propellants on the mucocllllary system, a second area deals with the effects of propellants on pulmonary cytology, and the third deals with health status surveys of people exposed to propellants. The Pharmacology and Toxicology Committee has had task forces working in basically 17 other areas, and 1won't cover all 17. Quickly I'd lust like to summarize a couple of them. One Is a task force under Dr. Guido Battista (Warner Lambert) which Is dealing with ways and means of handling poison control information. In addition we've been working with the committee that Dr. Berdlck referred to which Is looking for methodol ogy for the safety evaluation of eye-are colors. We're look ing into the area of antimicrobials as well as --a program for dermatologists, and additional guidelines for the safety evaluation of cosmetic products. "Gillette Medical Evaluation Laboratories, Rockville, Md. 20850 10 CTFA COSMETIC JOURNAL, VOL. 5, NO. 2 One thing that has come up and I've been directly In volved with is the OTC-FDA Antimicrobial Review. I need not say what this review panel has done up to now, I think everyone who reads the newspapers Is aware of what's happening. We are scheduled to meet again this week to deal with the safety and efficacy of TBS, TCC, and DP 300. 1973 COMMITTEE REPORT This year has been a busy and progressive year for the members of the Pharmacology and Toxicology Committee. 1think there have been times when we felt like we were like the last group to leave Dunkirk or members of the Charge of the Light Brigade. In spite o f all this, we've worked In several very definitive areas. I'd like to cover them In the order that I've got them on my list - which is not neces sarily the order in which they were handled. One of the major problems that we concentrated on this year was the Poison Control Center Program. This was a pro-am that was developed with the - then the poison control center within the Food and Drug Administration. This unit at this moment is part of the Consumer Product Safety Agency. The thrust of the program was (1) how does one handle Poison Control calls for cosmetic type products, and (2) how can such a program be placed In the CPSC Poison Center computer in an all-encompassing procedure for the members of the industry. Dr. Guido Battista, headed this task force of Pharmacology and Toxicology and with his task force group put together a list of, If you will, generic type formulations, and the types of antidote proce dures that might or might not be required. This document, at the present time, has gone to the Scientific Advisory Committee and will be moving Its way up through CTFA before being sent out to the Industry for comment and review. The second program that we're working on Is en titled the Program for Dermatologists. If a physiciandermatologist were to contact you with respect to patch testing, or a consumer with respect to an alleged, allergic reaction, how should one handle it? This program will shortly be reviewed by the Pharmacology and Toxicology Committee and then will also begin working Its way up through CTFA for review. It describes various ways In which the Industry can handle these types of situations prudently and scientifically. The third major program we have been working on for the year have been guidelines for Prognostic Safety Evalua tion of Cosmetic and Toiletries Products. We are trying to develop the safety guidelines based on product categories. Thus, you will have a checklist, not a litany of tests. As you develop a product within a certain product category, you can use the checklist to see the areas of possible concern. The table can be used as a review. As you examine your product vs. the checklist do you believe there may or may not be a problem with respect to, for example, ophthalmic irritancy, dermal Irritancy, etc. Then you can decide if addi tional studies are needed. Also, you may conclude that no .studies are required. We want to be very clear on the fact that in going through this checklist, you might conclude that you have sufficient evidence in your files that you don't have to do a specific test There may be sufficient evidence from the medical literature that lets you conclude that you don't have to do a test. It's the sort of review to go through to ascertain whether or not you have sufficient QE-CPC00001184 - JI C! sI > 1 s 1 I. t s ! e . d I, >* t, y a d i v h c H y p a is jr a.o iu U 1. jr *y ic lilO cl le tu it le to it information for the safety of that particular product before you go to market Other areas that the Pharmacology and Toxicology committee task forces have been involved In --Include ophthalmic pigmentation; Dr. Costello and his group are working on a review of saccharin for use in oral products; a chloroform safety review; eye anesthesia and shampoos; asbestos and talc; support to the color additives committee; and, a review of the EEC lists with respect to Ingredients. An area that we're going to be moving into, with Dr. Lanman, in charge of this task force, and now that Dr. Estrin has the funds to hire staff, will be a review of the medical literature with respect to antimicrobial Ingredients. We shall be requesting from companies any Internal infor mation they may have on the safety of antimicrobial in gredients. Microbiology Committee C h a rle s Goldman, P h.D .* 1972 COMMITTEE REPORT The Microbiology Committee has been very active during this past year. All o f you in this room have been caught up in the various pressing problems which beset our industry today. The fact that there are virtually no pressing, microbiological crises which are facing our industry is the best measure of our committee accomplishments. The members of this committee, and the various sub committees, deserve recognition for their contribution to the cosmetic and tolletry industry,This has only been possi ble because of the support and the committment of the various member companies of the CTFA. Our Preservation Subcommittee, which is under the chairmanship of Dr. John Smith of Chesebrough-Pond's, has completed a col laborative study Involving microbial challenge of cosmetic formulations, with pure and mixed cultures and using both qualitative and quantitative methods for assessment This paper will be published In the near future. This subcommit tee also has compiled a list o f microbial cultures In order to facilitate the exchange among various CTFA member com panies. James Rodgers (Mennen) who Is a member of this sub committee, Is currently investigating a standardization pro cedure using dioxin as the reference. If this approach proves feasible, a larger collaborative study will be done. Currently member laboratories are starting another collaborative study to evaluate the rechallenge method demonstrating the efficacy of a preservative in a test cosmetic formulation. Avon Products, Inc., Suffer, N .Y. 10901 The Microbial Content Subcommittee under the chair manship of Dr. S. Mark Henry (Bristol-Myers) has prepared a document entitled The Microbial Limit Guidelines for cosmetics and toiletries. This document was recently ap proved by the board for distribution to CTFA member companies. This subcommittee also has sent out forms for the completion of a CTFA study on the microbiological status of products produced by CTFA member companies. The study will encompass a total of 4,000 products. A preliminary pilot study covering 100 products has been conducted by cooperating laboratories. The subcommittee Is continuing to study methodology with regard to the classification and Isolation of various types of microorganisms. Mr. John Yablonski (Avon) of this subcommittee is coordinating the work on a simplified methodology for classifying microorganisms. This Is in tended for use by quality control microbiologists. This subcommittee Is also functioning in the area of maintaining the file of microbiological cultures which can be used for preservation tests and other testing procedures. The list of cultures will be made available to those member companies who submit a list of cultures in their own cul ture collections. Our Education and Information Subcommittee has completed a slide presentation which can be seen in the exhibit area. The professional quality of this presentation Is the best tribute which can be given to the efforts of this committee. This slide presentation will be made available to member companies. This subcommittee also played a most vital role In plan ning and coordinating a Raw Materials Seminar which was held in Saddlebrook, New Jersey last June. This was the first meeting of its kind covering this most important area in the microbiology of cosmetic products. The Microbiological Aspects of Quality Assurance Sub committee during the past year has completed a document entitled Quality Assurance Procedures for the Management of Process Water. The CTFA Board of Directors has recently approved this document for distribution to the CTFA membership. The entire subcommittee participated in the discussion and participation on the management of demineralized water systems at the Raw Materials Seminar held at Saddlebrook last Juno. The subcommittee has also completed pre liminary drafts of a document entitled Cleaning and Sanitizing Equipment. This was submitted to the Quality Assurance Committee whose chairman Is Mr. William Fead, A draft of a document entitled a Check List for Inplant Inspections was prepared and submitted to the Micro biology Committee. The Raw Materials Subcommittee consists of two branches, one is located on the West Coast and is under the direction of Dr. David Anderson of Max Factor, The other Is located on the East Coast and is headed by James Rodgers of the Mennen Company.- During the past year, this subcommittee participated in the symposium on the microbial content of raw materials. Various raw material categories for round robin testing were selected and technical conferences were held with invited suppliers on the particular raw materials which were under study. This group is to be congratulated for the work that was done, and a very fine conference in which they participated CTFA COSMETIC JOURNAL, VOL. 5, NO. 2 . J.1 QE-CPC00001185 d inforught to at. Obnd will Jcatlon ly been thodollited to , have nalytiver the ble for es that menta ) appli ' years, )hyslcs ereticai practlmeans ty and nt very chemi- ingreuslvely i techlalsdo pectrod In the greater ilted to way is signlflfor the joe the oscopy analyrumen1which ition to ed that t aid in cation, remely Iversity /orkers was of t Impeonably nt of a inet for duced. \; and now NMR equipment is available In the same In all areas of analysis the tendency has been * price range as Infrared equipment, to be increasingly concerned with the minor The particular significance of NMR for Identifi trace components of the materials. We have been cation is that the structure of an organic mole testing for arsenic and lead for many years, using cule could readily be deciphered from its NMR the classical laborious wet chemical procedures. spectrum. This cannot be done easily by Infrared As the need for testing trace metals became f and this is what makes NMR very attractice for more apparent, the technique for accomplishing Identification purposes. this was also developing. This last decade saw ! We are using NMR primarily for Identification the Introduction of atomic absorption spectro of those compbunds which are quite indlstln- photometry and made It possible to analyze for . , ,guishable by !R such as a homologous series, most trace metalB in the parts per million range. which differ only by a methylene or an oxi- What was once a horrendous analytical prob methylene group. lem can now be performed qn a routine basis. The polyoxyethylene sorbitanes all give a very This new method has already been incorporated similar IR spectra, while the NMR spectra can in one of our standard methods of metal analysis, readily distinguish these closely related com and In the future many more trace metals will be pounds. tested In this way. ` As simple identifications have become more With the application of computers to analytical and more instrumental, the assay procedures chemistry, It Is now possible to combine all the have also followed the same path. The Introduc data obtained from the new Instrumentation and tion of ultraviolet spectrophotometry about 25 to automate many of these procedures. years ago completely altered analytical proce The next decade will show even more growth dures and made possible many accurate ana as the available technology Is absorbed and lyses where before then only semi-quantitative becomes common practice. We no longer can determinations were possible. resist the Influx of this developing methodology. The great change In our day was the expan The only rational approach is to accept the sion of the use of all forms of chromatography. inevitable changes that are almost upon us and Gas chromatography has been of particular Im take advantage of the new opportunities that are . portance to our Industry. The instrumentation Is . now available. relatively inexpensive, simple, and is capable of analytical separations unheard of previously. It Is * ^ now possible for the first time to determine In detail the composition of many raw materials. <> --'Fatty acid analysis has become a routine procedure and enables us to have a greater control over our products. Gas chromatography has been applied to all types of raw materials and finished products, and its use Is growing at a very rapid rate. We have been Introducing GC methods Into our standards ~j T h e CTFA Talo Subcommittee was es< tablished In September 1973. Its first assignment f was to evaluate the optical microscope method for the detection and estimation of asbestos minerals in talc used for foods and drugs, which , was published In the Federal Register of Sep tember 28,1973, as an FDA proposal. The miner als were identified by the use of retractive index mounting liquids. and quite a number are to be found In the latest v - edition of the CTFA manuals. A very recent development in chromatography Talc < been the introduction of high speed liquid George W . Sandland chromatography. The manual column procedure In use for many years has been revitalized, and Bristol-Myers Company with the application of high pressure pumps, the speed of separation has been greatly acceler Based on the application of the published ated. Separations that previously took hours or method to the analysis of seven different talc days can now be accomplished in a matter of samples, ten scientists presented data which minutes. Heat sensitive blo-materials which can indicated lack of reliability and reproducibility In not be handled by gas chromatography can readily be separated by high pressure liquid the method. Four of the investigators disqualified themselves due to uncertainty and lack of confi chromatography at room temperature. The * ^grow th of this technique parallels that ot GC In die '60's, and there Is no doubt that we will be > '-publishing methods using this technique in fu ture editions of the CTFA manuals. dence In their Interpretations. A report describing the round robin was filed with the Hearing Clerk in December 1973, along with a recommendation to delay finalizing the proposed regulation until further work could be is 21 CTFA COSMETIC JOURNAL, VOLUME 8. NUMBER 1, JANUARY/MARCH 1976 QE-CPC00001186 done either to modify the optical microscopic method or to develop more satisfactory metho dology. The subcommittee agreed to form an Ad Hoc Methodology Committee to be headed by Dr. Robert Rolle of Johnson & Johnson. Scientists from government and Industry were Invited to participate on this committee. Every Known me thod was considered by the committee, Including refinement of the optical microscopic method to Include the use of dispersion staining. The mi croscopic method was finally abandoned as a general procedure due to the lack of confidence In the sample size, and the Inability to resolve particles which are submicron In size. The mi croscopic method was found to have some value, however, when used with dispersion staining, for the confirmation of fibrous amphlbole. The work of the Ad Hoc Methodology Com mittee eventually led to the selection of differen tial thermal analysis (DTA) for the detection of . chrysotlle, but this method has the disadvantage of tack of specificity for chrysotlle since It detects other serpentine minerals as well. The only known backup method for a positive Identifica tion in this event. Is transmission electron mi croscopy with selected area diffraction. This equipment is very expensive and Is not readily available. It was also agreed, though, that despite many efforts, the committee had been unable to find a sample of cosmetic talc containing natu rally occurring chrysotlle, and that Indeed there may not be such an entity; therefore, a backup method would not be necessary anyway. If this be true then, it was asked, "Why should we test for chrysotile If there Isn't any?" This resulted in a survey of the Industry wherein data were accumulated for a total of 3397 analyses of cosmetic talc. Incidentally, the manufacturers and suppliers of cosmetic talc have been monitoring for chrysotlle since 1971 and some have done so since 1968. Not one single sample analyzed In this total, showed a positive detection of chrysotile. Based on these data, the Talc Subcommittee has recommended that it should not be necessary to monitor cosmetic talc for chrysotlle. The Ad Hoc Methodology Committee has developed a method for the detection of fibrous amphibole using continuous scanning X-ray dif fraction plus optical microscopy with dispersion staining. The latter procedure Is necessary In the case of a positive result by X-ray, The method has a detection limit of about 0.5 percent and offers the advantage of a more statistically valid sample size, at two grams compared with the optical microscopic method which examines a portion of a one milligram sample, The Talc Subcommittee has recommended to the CTFA Standards Committee that a revised standard for cosmetic talc be Issued, with updat ing to Include specifications for Fibrous Amphl bole at "none detected," Free Crystalline Quartz at "As specified by buyer," and X-ray as an alter nate to IR for identification. Since some perfectly good cosmetic talcs contain dolomite or calclte, which are acid soluble, the limit for acid soluble has been Increased to 6,0 percent. The Standards Committee has accordingly updated the standard for cosmetic talc and the recommended methods will be Included. At this moment the new standard has been edited and submitted for printing. Future plans Include further study of trace impurities In cosmetic talc and the standard will be further modified, when, and as found neces sary. Another very important phase of our work Involves the motivation of the cosmetic talc suppliers to label their containers In such a manner so as to Identify cosmetic talc as CTFA Grade and thereby signify that It has been ade quately monitored to conform with the published CTFA Standard. Considering that CTFA members buy 85 to 90 percent of the cosmetic talc used In this country, and that the major suppliers of cosmetic talc participated in the development of this standard, Its Issue should do much to provide adequate control, and ensure that a suitable grade Is furnished to the market. We are indebted to Bob Rolle of Johnson & Johnson and all the other dedicated scientists who participated in this work. P ro d u c in g quality products Is a very ob vious goal of all cosmetic manufacturers. Suc cess In achieving this goal has helped to make the cosmetic Industry one that Is dynamic and fast growing. This rapid growth, coupled with Increasing consumer pressure and legislative demands, has made the CTFA guideline program more valuable and more necessary. The work of creating these guidelines demands a meaningful technical dialogue among participating compan ies. Quality Assurance Alayne Zatulove Estee Lauder, Inc. There are 16 different firms represented on our Quality Assurance Committee, and during 22 CTFA COSMETIC JOURNAL, VOLUME 8, NUMBER 1, JANUARY/MARCH 1976 22 *r :a yy\ * 5^ m 23 QE-CPC00001187 The CTFA Standards Committee has the responsibility for establishing up-to-date chemical and physical specifications for Ingre dients used In cosmetic products. The standards, which consist of a six-volume set: Specifications, Methods, Spectra and three vo lmes of Cosmetic Ingredient Descriptions (CID's), are continu ously being added to and updated. The Stand ards Committee relies upon Its members to con tribute laboratory time to the Initial testing of raw materials and the statistical establishment of specifications for the parameters studied. Standards Monroe Messinger Chesebrough-Pond's Inc. This past year has been a particularly difficult one for our laboratory testing activity. However, in spite of external obstacles, there has been significant progress. As of May 1975 we had issued a total of 130 CTFA specifications, 123 CTFA spectra and 141 CTFA methods. Since March 1976 approximately 25 methods have been completed, as welt as a corresponding number of spectra. The Cosmetic Ingredient Description subcom mittee of the Standards Committee, under the chairmanship of Dr. Fred Lowman, has prepared and approved for publication, 90 CID's, since the last printing and distribution of the CID list. Approximately 20 CID's are being prepared by several members of the subcommittee, and an additional 25 materials have been Identified as cosmetic Ingredients currently In use from the , FDA list of ingredients of cosmetics and drugs. ; The Talc subcommittee, with George Sand , land as Its chairman, has completed a revised standard which Is designed to control the quality ' of cosmetic grade talc. It will help to assure that i talc used by our membership will meet the high standards of our industry. Among the revisions and Improvements In this standard are the inclu sion of limits for fibrous asbestlform amphlbole and quartz minerals, along with suitable method ology for quality assurance applications. An alter nate method for identification has also been added In the use of an X-ray defraction procedure. There is much work that remains, In the con tinuing activity of the Standards Committee, In reviewing the cosmetic Ingredient descriptions and converting them Into standards. The emer gence of the Cosmetic Ingredient Review pro gram will certainly Increase the participation of the Standards Committee and/or its subcommk tees. We extend our appreciation to all members the Standards Committee and to its subcommlui tees for their valued participation In the stand ards program. The Microbiology Committee composed of the main committee and five sub committees: Education and Information, chair by Frank Wertallk; Microbial Content, chaired I Warren Mulston; Quality Assurance, chaired by Jack Bachelor; Preservation, chaired by Emily Owen; and Raw Materials, chaired by Margs Dolan. There are approximately 30 companies < their divisions represented, with 45 mlcroblolft gists participating in the various activities, would like to update you to their accomplish ments and future objectives. Microbiology James Rodgers The Mennen Company Education and Information. You have un doubtedly noticed our booth In the Exhibit An The first preview of the latest sllde/tape presenta tion, entitled, "Cleaning and Sanitation of Manu-| faoturing Equipment," Is being shown. Also off5* display are our previously completed slide/tape presentations: "Microbes, Sanitary Praotlcesand You," "Determination of the Microbial Content of ^ Cosmetics and Toiletries," "Treatment and Han- ' dling of Process Water," and "Spciation of ^ Yeasts, Molds and Staphylococci." The Education and Information subcommittee} Is also preparing for the industry debut of "Wally and Wanda Whitehat." This Is a new poster 1 program series, designed to help stimulate greater awareness of good sanitary practices. In y addition, the "Microbiology Forum," presented in each issue of the CTFA Cosmetic Journal, 1st spearheaded by this subcommittee. Microbial Content The Joint papers, "Method ology for Microbial Content of Finished Pro*l ducts National Survey" and the "National Micro* biological Survey of Cosmetics and Toiletries,,a 1972-1975," have been completed and madetf| available for publication by the CTFA. 12 CTFA COSMETIC JOURNAL, VOLUME 9. NUMBER 1, JANUARY/MARCH 1977 is : Quali! cal guld process been coi from the and the joint effe Commltl as an Ini The g of manu d u s try le Prese the guld Liquid a also sut "Use of I tkm Tes group Is preserve trf3. Raw I categorl ing mici and the the exar tent. Re some lit from var these st metlc Ji I f Curre general niques t !* raw ma Microbii Journal rum." In De determli I bacteria croorga oratorie > Mlcrc < Advisor propose u and app $ 1, The i i meti< $ tee r LV and 13 redacted QE-CPC00001188 1977 Annual Meeting Reports CTFA's scientific department In! } drafted comments for submission to FDA by the 1976 again demonstrates its flexibility in meeting!; > March 21 deadline. new challenges and responding needs of the Industry. to long-range .< i Talc. A task force has just concluded a round| robin test of methodology for detection of asbes Scientific Advisory Committee tos with FDA and Mt. Sinai Hospital scientists. This methodology has just been published by Dr. Robert Gjovacchlnnl The Gillette Company CTFA as part of a revised Standard for Tale. The results of the study are expected to affirm the purity of current talcum products. Time does not permit me to do more than list a few typical committee accomplishments for 1978: TECHNICAL GUIDELINES: Two new ones --safety substantiation and manufacturing cod ing--were added to an already substantial number available to manufacturers to assist them in developing their own quality assurance pro grams. VISUAL AIDS: The fifth In a series of audio visuals--this one on "Cleaning and Sanitization of Plant Equipment" has been prepared to help you In your training programs, and is now In OTC Panel Reviews: CTFA has several active OTC task forces open to all Interested manufac turers and suppliers. The OTC panels have been occupied since January 1,1977 on learning how to live with "open meetings" under the new Sunshine Law. Panels of concern to our Industry ! are: antipersplrant oral cavity topical analgesic miscellaneous external dentrlflce and antimicrobial II production. DICTIONARY: New edition covering double the number of Ingredients In the 1973 edition will be in the malls In March. STANDARDS: A major supplement will be pub lished In 1977. Here's a sampling of activities of the newer task forces set up to meet specific problems: Contact Jim McNerney of CTFA staff if you have questions In any of these areas. CTFA is also active In the safety research area. Murray Berdlck will discuss color additive testing requirements in a few moments. In addition, CTFA has Initiated Phase III of its long-term studies on temporary seml-permanent and oxi dation-type hair dyes, and, through the Inter industry Aerosol Safety Committee, is complet EYE AREA SAFETY: This task force has drafted proposals aimed at minimizing potential risks to consumers through misuse of eye area cosmetic products. The task force is also initiating roundrobin testing of methodology involving FDA and Dr. Louis Wilson, an ophthalmologist under con ing design of protocols for testing particulate, ingredients as well as its exploration of possible alternative propellants. SAC Organization: Finally the Scientific Advisory Committee, the body that coordinates the activi ties of the scientific department Is undergoing a tract to FDA. GMP's: A good manufacturing practices task force has prepared comments on the proposed drug GMP's and will meet with FDA to discuss FDA plans for publishing cosmetic GMP's. GLP's: A good laboratory practice task force has further reorganization designed to ensure effi cient handling of scientific programs. You may recall that the first phase of the reorganization opened up membership on the scientific advisory committee to all chief scientists of active member companies. That change considerably strength- 22 CTFA COSMETIC JOURNAL, VOLUME 9, NUMBER 2, APRIIVJUNE 1977 w QE-CPC00001189 Microbiology has been updated, and the guidelines for clean ing and sanitization of equipment are In develop Frank Wertalik Schering-Plough mental stages, Guidelines for evaluating shelf life stability of product preservation systems are /under discussion. Determination of a panel se- jlectlon and product testing protocols for In-vltro I'd like to go through some of the activities of iand In-vivo correlation testing are being dls- the subcommittees and task forces of the Micro- j-a !cussed for performing this correlation evalua biology Committee. tion. They have a joint CTFA Mutagenicity Task :< On October 10, 1976, the present Force with the CTFA Pharmacology and Toxicol- 1i Q CTFA Standard for Cosmetic Talc was pub ogy Committee. The joint committee was formed 2 lished. It marked a notable step forward in in 1977 to review, evaluate, report on published controlling the quality of the talc used by the and unpublished testing methods and scientific CTFA membership, by guarding against the Information. presence of asbestiform Impurities in the talc The Eye Area Safety Task Force, an industry - products sold by CTFA membership, As a result t2sk force was formed In 1977 to review this area. of the efforts of the ad hoc Methodology Com T h e task fo rc e m em bership is te c h n ic a lly diversi mittee under the chairmanship of Dr. Robert fied and affords an excellen t cross-section ot Rolle, it reflects the most up-to-date technology m anagem ent for full develo pm en t of each se available In the greatest number of laboratories lected topic. available to the CTFA membership. It also util The Microbiological Methods Task Force was izes the largest and most significant sample size formed to develop more uniform microbiological methods for the evaluation of materials. We have of any method for the evaluation of a talc ship ment which may be small, or carload In size. been working on a revision of the Microbiologi cal Guidelines for Process Water, recognizing new technical Information, developments and Talc Subcommittee advancements. We have the "Microbiological Forum." I'm Chairman of the Information Education Subcom George Sandland Bristol-Myers Company mittee, and the "Forum" Is one of the things that -j- we use. It's a very Important vehicle. We'd like nore contribution from the membership. The The new Cosmetic Talc Standard Is a modifi cation of the old TGA/TFA Talc Standard with Forum" Is In the CTFA Cosmetic Journal, and Includes short articles relating to the fteld of the following major additions: 1. An Optional identification procedure using microbiology. We have produced a new slide-tape presenta X-ray diffraction. 2. The addition of a "none detected" limit for tion entitled, "Cleaning and Sanitation of fibrous amphiboles, using CTFA Method J Manufacturing Equipment." We have continued 4-1. In this method, the following steps are our efforts for Informing and educating industry -members by completing this fifth slide-tape pres required: (a) A primary detection of amphiboles by entation. X-ray diffraction, is employed a3 the vJWe are developing a poster series. Two of the Stars are posted at the exhibit booth, in rough first step. (b) When a positive detection of amphi jrm. The Committee has in mind a series of boles Is Indicated, a secondary proce osters for plant and personal hygiene for the dure using light microscopy along with anufacture of high-microblologlcal quality cos dispersion staining Is applied to deter es. mine whether or not any amphiboles 'e're planning a workshop on decontamina do technology and sanitization technology In prlt. We have some Information at the booth on * e have developed the Microbiological . delines for Sampling Cosmetic Raw Materials Lanolin? . contact Croaa. ?th In process and finished goods. This guide 's has been approved and should be published the near future. We have developed the micro 51 M ad ison A ven u e, N ew York, N.Y. 10010 (212) 683-3089 logical aspects of quality assurance, which CTFA COSMETIC JOURNAL, VOLUME 9, NUMBER 4, OCTOBER/DECEMBER 1977 29 QE-CPC00001190 detected by X-ray diffraction are asbestlform io nature. 3. Optional procedures are given for the esti mation of quartz or crystalline silica; (a) Method J 5-1, using DTA, is capable of detecting 0.5 to 1,0% of quartz. (b) Optional Method J 6-1, using X-ray diffraction, is capable of detecting 2.0% of quartz. A round robin was conducted early this year using Method J 4-1 on samples from seven different brands representing 90% of the sales volume of talcum products on the market. The results showed inconsistencies of data among some of the participants, particularly in the use of the Part II Optical Microscopy and Dispersion Staining Method. Because of this, a more com prehensive version of the optical method was written. It has been sent to all participants for a second round robin, along with another set of -controls plus those samples from the market which seemed to be associated with the incon sistent data. As of this writing, the testing Is incomplete. It must be emphasized that the Optical Micro scopic Method Part II section of Method J 4-1 Is not an easy procedure. It requires the expertise of a very competent mlcroscoplst, who also has experience in mineralogy. Since scientists meet ing these qualifications are not numerous, we are considering a program under the sponsorship of CTFA, designed to train microscoplsts specifi cally In the required discipline. In the meantime, we have every confidence that Method J 4-1 is practical, and can be suc cessfully used by properly trained scientists. Our future plans Include a refinement of the optical microscope procedure to make it usable by as many scientists as possible. Now for just a few points of Interest; A Workship on Asbestos was conducted on July 18 to 20, 1977, at the National Bureau of Standards. Close to 400 participants, primarily from industry,, government agencies and the research community, attended. The workship did not result In recommenda tions for the definition and measurement of asbestos, which may be correlated with biologl- Paftyalcohob? cofYVtK T v r o a a . 51 M ad ison A venu e, N ew York, N.Y 10010 ( 212) 683-3089 cal activity. There was overwhelming opinion that there is a dose-effect relationship for asbes tos and an expeoted threshold. Without doubt, If there were agreement as to a definition of asbes tos for regulatory purposes, there are techniques for detection and quantitation. However, some of these techniques are extremely sophisticated, require highly specialized training; are researchbased, and are impractical for routine control purposes. There were no allegations against the safety of cosmetic talc, however, the Food and Drug Ad ministration expects to promulgate regulations for cosmetic talc in the future, to guard against the use of Impropoer talcs for cosmetic pur poses. The history of use of cosmetic talc Indicates that it Is safe, and It has been placed In Category I for efficacy and safety by the OTC Antimicro bial II and External Products Panels. I wish to extend sincere thanks to Dr. F.R. Rolle who served as Chairman of the ad hoc Talc Methodology Committee and to Dr. J.P. Schelz, Chairman of the CTFA Talc Task Force. We are also grateful for the time and effort put forth by members of the Food and Drug Administration, of the academia, and of industry, to assist In this Important project. Last year at this time, CTFA had submitted the galley proofs of the second edition of the CTFA Cosmotlo Ingredient Dictionary to the FDA and received some recommendations from them for changes. To a large extent, we modified various CTFA Adopted Names and monographs to conform with their suggestions in March of this year, the second edition was published. The Dictionary has been well re ceived. Over 3,000 copies have been sold both here and abroad. Nomenclature Griffin Shay Avon Products, Inc. In the October Issue of Cosmetics and Toile tries Ed DeNavarre gave the Dictionary a gener ally positive review. Other reviewers have been equally complimentary. On Friday, October 28, FDA proposed to rec ognize the second edition of the Dictionary, providing 60 days for comment. There are a number of ingredients for which FDA feels the monographs in the Dictionary disclose neither the chemical configurations nor, where appro priate, the substances of origin. FDA has pro posed continued adoption of the names for some 30 CTFA COSMETIC JOURNAL, VOLUME 9. JMBER 4, OCTOBER/DECEMBER 1977 QE-CPC00001191