Document 5qZbRy7zkv1JMVLgN9Mm7MBJ

together with their requested classification. The German Dyestuff Commission already has our safety data for these colors and, I feel that in the interest o f international coop eration, and if the toxicological data supports it, we can expect early listing o f 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 V io le t 2. Further more, the Commission can be requested to broaden allowed uses o f such colors as FD & C Blue 1. The meeting closed with a call for continued Interna tional exchange o f scientific information. The success o f this meeting was made possible by a large number o f people, too many to name here. However, three men deserve special thanks. Dr. O pdyke's contribution was enormous in magnitude. His many months o f 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. O tto Jacobi o f Kolmar 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 o f gratitude for their efforts on its behalf. CTFA-FD -- Scientific Liaison Report Dr. Harold Schwartz* Since the last Scientific Conference, three meetings of the C T F A -F D A Scientific Liaison Comm ittee 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 o f some o f 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 Mennen Company, Morristown, N .J. 07960 10 C T F A COSMETIC JOURNAL, VO L. 3, NO. 4 1 1 ics, microbiology, etc., were discussed. When requit problems were studied in separate sessions. Very often m 1 subject matter became so deep and so important to eveS ' one, that a special committee o f scientists was required,^ we brought in people from outside in order to assist necessary. %1 For example, when the question of asbestos in talc up, people who were interested in talc and who were perts in the field o f analysis o f talc were brought in so the subject could be thoroughly handled on a scientj] basis. Dr. George W olcott mentioned how a group formed in order to study chloroform in toiletries, espeei in dentrifices. Hexachlorophene and other subjects discussed at these joint meetings held by scientists and by compliance people. I really have to emphasize this cause I think our biggest hang-up when we first started to determine that this committee would meet and d only on a scientific basis and certainly not on a legal or compliance basis. I believe, certainly in the last year, til we have been conducting our business in that manner. Much o f the success o f our committee is due to participants. Through the leadership o f Commissioner Edwards his staff, Dr. Wodicka, Dr. Schaffner, and all other participants, a willingness to deal with scientific pn on a scientific basis has been demonstrated. Additionally, accolades must go out to all the mei of the C T F A participating in this joint venture. They worked diligently, controlled their tempers for the part, and I believe have performed a noteworthy services Certainly much o f the uneasiness about discussing lems with F D A has noticeably decreased and, I say thi the face o f what I believe are the most trying times. N o t only our industry, but F D A is feeling great prei from such sources as consumer groups, Congress, and so and yet, the discussions have been kept on a rather ej keel. The best way to describe the kinds o f activities t group has participated in would be to just read the of our last meeting which was held in Washington August 18th. I t represents a far cry from the sparring took place some two-and-a-half years ago at the first sion. This Agenda reads as follows: -- 1. C T F A Petitions 2. Color Additives ; 3. Hair Coloring Research | 4. Chronic Eye Studies j 5. Hexachlorophene I 6. Feminine Deodorant Sprays j 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 prob affecting our industry with forthrightness, without vi QE-CPC00001182 require ' ^ nCsSj and with an openness dedicated to resolving prob- 0 en ^ p f the present and avoiding problems o f the future. 0 eevvemn,,% !;.'| beli ve the F D A -C T F A Scientific Liaison Comm ittee uired, ai*j Ipcjborcinue to approach problem solving with those cri- Ssist Whit ]|ln mind. F D A 's list for some while; and, they are now a top priority on the C T F A and the cosmetic industry's list, as well. In considering the steps by which information could be submitted to F D A on the location o f manufacturers and the ingredients in cosmetics, there were basically two paths talc cai^ > were t in so that scientific I roup was especially Discussion of SCtS W C';1 :s and h-h e this ^ Voluntary Petitions arted was id discuss al o- on /e. , that ie . to the James H. Merritt, Moderator Dr. Murray Berdick Dr. Harold Schwartz John C. Warley, Jr. Nimes H. Merritt /ards art :her FDA |P ie subject o f our discussion this morning, our Petiproblems jjs, really has its genesis a couple decades ago when there 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, 1 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 bit rocky for a while, but we are sold on the concept. For a number o f 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 o f a grand gesture on industry's part to comply fully and to show the government and the consumer that there Is a con first Introduced in Congress legislation to require pre members!! ntice' o f cosmetics before they were marketed. That hey have illa tio n has been introduced repeatedly. Congress, In its the most mtri, has not enacted It. I t has felt, and I think right- rvice. so, there are more pressing problems for the Food and scientious soul In industry which Is going to cooperate where cooperation is needed. We submitted two petitions. Most o f you, I feel sure, have seen them by now. I f you haven't had a chance to scrutinize them, you at least know ing prob- ug Administration. o f their existence. The first calls for the registration of ty this in I p ^ i t h the knowledge that pre-clearance legislation had manufacturers and packagers o f cosmetic products. Ipen introduced several times and with the knowledge too You will be asked to file with the Food and Drug A d pressures in the color additives suit there were efforts made to ministration a registration for all o f your plants, factories, nd so on; gtjierpret the regulations as including pre-clearance, this As- etc. :her even fibciatlon, then known as T G A , met and decided to develop In return, you will receive from them a plant registration Ii promulgate, if possible, a system o f self-regulation on a untary basis. number which you will use with future correspondence with the agency. The second petition is for the filing o f cosmetic ingred v ^We contend that self-regulation will be just as effective, ients in classes. By classes I mean between fifty and a hun igton on M$J|t be much more economical than mandatory regulation, dred per cent, twenty-five and fifty percent, etc. on down. ring that will provide the consumer an adequate level o f protec- So, it is not a completely quantitative formulation but it first ses Igioo so that the consumer will be protected against those is completely qualitative, with the exception o f flavors and B u rie s or th at harm which might come from unsafe prod- m first tw o steps in the program of self-regulation fragrances, whose composition, due to their complexity and the great number o f ingredients involved, is not requested. filed w ith the Food and Drug Administration several The information will be submitted in order o f decreasing s ago. T hey involved tw o petitions, to be promul- predominance and there is a very strict legally binding con fidentiality provision by which the F D A will be precluded PPfjfl under the Food, Drug and Cosmetic Act as voluntary " 'plfions. They have since been published in the Federal from revealing this information submitted on the product H r for comment. ingredients statement to anyone, except under very certain first on our office staff team, I am going to call on spelled out and defined conditions. In our grounds for submission to the Food and Drug ft Warley, a lawyer, who will discuss the concept in- in the tw o petitions filed; the first, or voluntary Administration we stated that in our belief the information we were providing was necessary for FD A to do its job l lifetfation o f manufacturers; the second, for the voluntary under the Food, Drug, and Cosmetic A c t and to carry out B ijosure o f ingredients. the responsibility that the public has charged that agency cts all of |l C. Warley, Jr. ||ni going to be discussing some o f the legal and regula- with, and since we have acknowledged the fact that the information is necessary for F D A to do its job, it puts us in a very paradoxical position not to give them the informa roblen15; t vindic- ^ ,-V overtones to these petitions; and, I won't get very B o fie for obvious reasons. T w o items -- where cosmetics made and w hat is in them have been a top priority on 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 ............ C TFA .CO.SMEI.IC T O U R N A L , V O L . 3, NO. 4 11.......... QE-CPC00001183 Pharmacology & Toxicology Robert Giovacchini, Ph.D.* 1972 C O M M ITTEE REPORT I should like to begin by first discussing the Inter-indus try aerosol testing program, which was formed as a subcom m ittee under the pharmacology and toxicology committee. This program involves the safety evaluation o f propellants and several contracts have been let in this area. The first one is to Dr. Richard Stewart o f the Medical College o f Wisconsin. This is an evaluation o f the absorp tion, excretion, and physiological effects, both under acute and subacute exposure in humans using a wide range o f 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 o f propellant levels under conditions o f use. This study is being done to insure that the concen trations utilized in the Stewart study w ill be more than that seen under normal use conditions. The second study has been funded and is in progress at the University o f Maryland College of Pharmacy under Dr. David Biake. This study examines the biotransformation and metabolic fate o f propellants, the study beginning first in rats moving onto dogs and later to humans. The third study has been funded at the Medical College o f Georgia w ith Dr. Nancy Flowers. I t 's a study which is examining the early changes in the electroconduction system o f 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 o f propellants on the mucocilliary system, a second area deals w ith the effects o f 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 I w on't cover all 17. Q uickly I 'd just like to summarize a couple of them. One is a task force under Dr. Guido Battista (WarnerLambert) which is dealing w ith ways and means of handling poison control information. In addition w e've been working with the committee that Dr. Berdick referred to which is looking fo r methodol ogy for the safety evaluation o f eye-are colors. W e're look ing into the area o f antimicrobials as well as -- a program for dermatologists, and additional guidelines for the safety evaluation o f cosmetic products. ^Gillette Medical Evaluation Laboratories, Rockville, Md. 208S0 One thing that has come up and I've been directly in volved with is the O TC -FD A Antimicrobial Review. I need not say what this review panel has done up to now, I think everyone who reads the newspapers is aware o f w hat's happening. We are scheduled to meet again this week to deal with the safety and efficacy o f TBS, TCC, and DP 300. 1973 COM M ITTEE REPORT This year has been a busy and progressive year for the members o f the Pharmacology and Toxicology Committee. I think there have been times when we felt like we were like the last group to leave Dunkirk or members of the Charge o f 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 o f the major problems that we concentrated on this year was the Poison Control Center Program. This was a program that was developed w ith the - then the poison control center within the Food and Drug Administration. This unit at this moment is part o f the Consumer Product Safety Agency. The thrust o f the program was (1) how does one handle Poison Control calls fo r 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 o f the industry. Dr. Guido Battista, headed this task force o f Pharmacology and Toxicology and with his task force group put together a list of, If you will, generic type formulations, and the types o f 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 C T F A 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. I f a physiciandermatologist were to contact you w ith 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 C T F A 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 fo r Prognostic Safety Evalua tion o f 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 o f tests. As you develop a product within a certain product category, you can use the checklist to see the areas o f 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 w ant to be very clear on the fact that in going through this checklist, you mij^it 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. I t 's the sort of review to go through to ascertain whether or not you have sufficient QE-CPC00001184 i sQ ) a information for the safety o f that particular product before you go to m arket 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 o f saccharin for use in oral products; a 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 w e're going to be moving into, with Dr. Lanman, in charge o f this task force, and now that Dr. e Estrin has the funds to hire staff, will be a review o f the e medical literature with respect to antimicrobial ingredients. n We shall be requesting from companies any internal infor e mation they may have on the safety o f antimicrobial in gredients. i s n i, t s >> Microbiology e t, Committee d I, t, y \ Charles Goldman, Ph.D.* d 1972 C O M M ITTEE REPORT 1- 1- The Microbiology Committee has been very active h during this past year. A ll o f you in this room have been c caught up in the various pressing problems which beset our II industry today. The fact that there are virtually no pressing, y microbiological crises which are facing our industry is the p best measure of our committee accomplishments. n The members o f this committee, and the various sub is committees, deserve recognition for their contribution to the cosmetic and toiletry industry.This has only been possi >r ble because o f the support and the comm ittm ent o f the a- various member companies o f the C T F A . Our Preservation .0 Subcommittee, which is under the chairmanship of Dr. s. John Sm ith o f Chesebrough-Pond's, has completed a col u laborative study involving microbial challenge o f cosmetic u formulations, w ith pure and mixed cultures and using both 1. qualitative and quantitative methods for assessment This ir paper w ill be published in the near future. This subcommit *y tee also has compiled a list o f microbial cultures in order to ic facilitate the exchange among various C T F A member com i- panies. 10 James Rodgers (Mennen) who is a member o f this sub ; t committee, is currently investigating a standardization pro Je cedure using dioxin as the reference. I f this approach proves IU feasible, a larger collaborative study will be done. Currently i t member laboratories are starting another collaborative Je study to evaluate the rechallenge method demonstrating the to efficacy o f a preservative in a test cosmetic formulation. i t *Avon Products, Inc., Suffern, N .Y . 10901 ' 6&Ms. ,.<v-XA'r` ......... The Microbial Content Subcommittee under the chair manship o f Dr. S. Mark Henry (Bristol-Myers) has prepared a document entitled The Microbial Lim it Guidelines for cosmetics and toiletries. This document was recently ap proved by the board for distribution to C T F A member companies. This subcommittee also has sent out forms for the completion o f a C T F A study on the microbiological status o f products produced by C T F A member companies. The study will encompass a total o f 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 o f 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 o f microbiological cultures which can be used for preservation tests and other testing procedures. The list o f cultures will be made available to those member companies who submit a list o f cultures in their own cul ture collections. Our Education and Inform ation Subcommittee has completed a slide presentation which can be seen in the exhibit area. The professional quality o f this presentation is the best tribute which can be given to the efforts o f 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 o f its kind covering this most important area in the microbiology of cosmetic products. The Microbiological Aspects o f Q uality Assurance Sub committee during the past year has completed a document entitled Q uality Assurance Procedures for the Management o f Process Water. The C T F A Board of Directors has recently approved this document for distribution to the C T F A membership. The entire subcommittee participated in the discussion and participation on the management o f demineralized water systems at the Raw Materials Seminar held at Saddlebrook last June. The subcommittee has also completed pre liminary drafts o f a document entitled Cleaning and Sanitizing Equipm ent This was submitted to the Quality Assurance Committee whose chairman is Mr. William Fead. A draft o f a document entitled a Check List for Inplant Inspections was prepared and submitted to the Micro biology Committee. The Raw Materials Subcommittee consists o f two branches, one is located on the West Coast and is under the direction o f Dr. David Anderson o f Max Factor. The other is located on the East Coast and is headed by James Rodgers o f the Mennen Company. During the past year, this subcommittee participated in the symposium on the microbial content o f raw materials. Various raw material categories fo r 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. C T F A CO SM ETIC JO U R N A L , V O L . 5, NO. 2 11 QE-CPC00001185 d infor- and now NMR equipment is available In the same In all areas of analysis the tendency has been ught to al. Obnd will :ication price range as infrared equipment. The particular significance of NMR for identifi cation is that the structure of an organic mole cule could readily be deciphered from its NMR to be increasingly concerned with the minor trace components of the materials. We have been testing for arsenic and lead for many years, using the classical laborious wet chemical procedures. spectrum. This cannot be done easily by infrared As the need for testing trace metals became ly b een ? and this is what makes NMR very attractice for more apparent, the technique for accomplishing th o d o l- identification purposes. this was also developing. This last decade saw lited to We are using NMR primarily for identification the introduction of atomic absorption spectro 5, h a v e of those compounds which are quite indistin- photometry and made it possible to analyze for jn a ly ti- I , ;:guishable by IR such as a homologous series, most trace metals in the parts per million range. ver the which differ only by a methylene or an oxi- What was once a horrendous analytical prob ble for methylene group. lem can now be performed on a routine basis. es that The polyoxyethylene sorbitanes all give a very This new method has already been incorporated m enta- 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 ) ap p li- pounds. tested in this way. r years, As simple identifications have become more With the application of computers to analytical jh y s ic s and more instrumental, the assay procedures chemistry, it is now possible to combine all the ire tic a l have also followed the same path. The introduc data obtained from the new instrumentation and p racti- tion of ultraviolet spectrophotometry about 25 to automate many of these procedures. m eans years ago completely altered analytical proce The next decade will show even more growth ty and dures and made possible many accurate ana as the available technology is absorbed and nt very lyses where before then only semi-quantitative becomes common practice. We no longer can chem i- 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 in g re - sion of the use of all forms of chromatography. inevitable changes that are almost upon us and u s iv e ly Gas chromatography has been of particular Im- take advantage of the new opportunities that are ' tech- .. portance to our industry. The instrumentation is now available. ials do relatively inexpensive, simple, and is capable of p e c tro - .^.analytical separations unheard of previously. It is d in th e ** now possible for the first time to determine in q T h e CTFA Talc Subcommittee was es- g re a te r detail the composition of many raw materials. < tablished in September 1973. Its first assignment * Fatty acid analysis has become a routine Q was to evaluate the optical microscope method lited to procedure and enables us to have a greater S for the detection and estimation of asbestos w a y is control over our products. minerals in talc used for foods and drugs, which s ig n ifi- Gas chromatography has been applied to all was published In the Federal Register of Sep for th e types of raw materials and finished products, and tember 28, 1973, as an FDA proposal. The miner its use is growing at a very rapid rate. We have als were identified by the use of refractive index jc e the been introducing GC methods into our standards mounting liquids. oscopy and quite a number are to be found in the latest a n a ly - * edition of the CTFA manuals. rum en- A very recent development in chromatography Talc i w h ic h ., h,as been the introduction of high speed liquid George W. Sandland ition to chromatography. The manual column procedure in use for many years has been revitalized, and Bristol-Myers Company ed that with the application of high pressure pumps, the t aid in speed of separation has been greatly acceler Based on the application of the published c a tio n , ated. Separations that previously took hours or method to the analysis of seven different talc rem ely days can now be accomplished in a matter of samples, ten scientists presented data which iversity minutes. Heat sensitive bio-materials which can indicated lack of reliability and reproducibility in rorkers not be handled by gas chromatography can the method. Four of the investigators disqualified was of readily be separated by high pressure liquid themselves due to uncertainty and lack of confi t im pe- chromatography at room temperature. The dence in their interpretations. o n a b ly Tgrowth of this technique parallels that of GC in A report describing the round robin was filed nt of a the '60's, and there is no doubt that we will be with the Hearing Clerk in December 1973, along inet for ^ publishing methods using this technique in fu with a recommendation to delay finalizing the duced, ture editions of the CTFA manuals. proposed regulation until further work could be 16 21 CTFA COSMETIC JOURNAL, VOLUME 8. NUMBER 1, JANUARY/MARCH 1976 21 . .!' `i1-' .ii'l-'f 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 amphibole. The work of the Ad Hoc Methodology Com mittee eventually led to the selection of differen tial thermal analysis (DTA) for the detection of chrysotile, but this method has the disadvantage of lack of specificity for chrysotile 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 chrysotile, 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 chrysotile 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 chrysotile. 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 Amphi 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 calcite, 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. i " roducing 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 the tica rest in tl 1 pac proi asp' V corr proi pert A plin riais proc Ir for f met disc tiom ager weig ent man usee upd 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 volumes of Cosmetic Ingredient Descriptions (C ID '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 well 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 C ID 's, since the last printing and distribution of the C ID 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 Sandland 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 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 asbestiform amphiboie 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 subcommfcfJl tees. We extend our appreciation to all members oi ^ the Standards Committee and to its subcommit% tees for their valued participation in the stand-:'!?"1 ards program. m The Microbiology Committee is. composed of the main committee and five sul> . committees: Education and Information, chaired;*^ by Frank Wertalik; Microbial Content, chaired b $ f | | Warren Muiston; Quality Assurance, chaired by. Jack Bachelor; Preservation, chaired by EmilyOwen; and Raw Materials, chaired by Margan Dolan. There are approximately 30 companies or,r their divisions represented, with 45 microbioli gists participating in the various activities, would like to update you to their accompli# ments and future objectives. Microbiology James Rodgers The Mennen Company Education and Information. You have un; doubtedly noticed our booth in the Exhibit Area! The first preview of the latest slide/tape presenta tion, entitled, "Cleaning and Sanitation of Manu facturing Equipment," is being shown. Also on display are our previously completed slide/tape presentations: "Microbes, Sanitary Practices and 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 program series, designed to help stimulate greater awareness of good sanitary practices. In. addition, the "Microbiology Forum," presented in each issue of the CTFA Cosmetic Journal, is spearheaded by this subcommittee. Microbial Content The joint papers, "Method ology for Microbial Content of Finished Pro ducts National Survey" and the "National Micro biological Survey of Cosmetics and Toiletries, 1972-1975," have been completed and made available for publication by the CTFA. 12 CTFA COSMETIC JOURNAL. VOLUME 9. NUMBER 1, JANUARY/MARCH 1977 Qualit cal guid process been coi from the and the joint effe Commitl as an in< The g of manu dustry is Prese the guid Liquid a also sub "Use of 1 tion Tes group is preserva tries. Raw I categori ing mici and the the exai tent. Rc some lie from var these st metic Ji Curre general niques i raw ma Microbi Journal rum." In De determii bacteria croorga oratorie Mlcrc Advisor propose and app 1. The i meti< tee r and aspe' multi pack opmi nel. REDACTED QE-CPC00001188 1977 Annual Meeting Reports CTFA's scientific department in 1976 again demonstrates its flexibility in meeting new challenges and responding to long-range needs of the industry. Scientific Advisory Committee Dr. Robert Giovacchinni The Gillette Company Time does not permit me to do more than list a few typical committee accomplishments for 1976: 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 production. DICTIONARY: New edition covering double the number of ingredients in the 1973 edition will be in the mails 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: 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 tract to FDA. GM P'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 GM P's. GLP's: A good laboratory practice task force has Q drafted comments for submission to FDA by the o March 21 deadline. Q Talc: A task force has just concluded a round ed robin test of methodology for detection of asbes tos with FDA and Mt. Sinai Hospital scientists. This methodology has just been published by CTFA as part of a revised Standard for Talc. The results of the study are expected to affirm the purity of current talcum products. 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 1 are: antiperspirant oral cavity topical analgesic miscellaneous external dentrifice and antimicrobial II 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 Berdick will discuss color additive testing requirements in a few moments. In addition, CTFA has initiated Phase III of its long-term studies on temporary semi-permanent and oxi dation-type hair dyes, and, through the Inter industry Aerosol Safety Committee, is complet 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 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, APRIL/JUNE 1977 !: IHMii m ip ia QE-CPC00001189 M icro b io lo g y 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 j stability of product preservation systems are | (under discussion. Determination of a panel se lection and product testing protocols for in-vitro I'd like to go through some of the activities of ' and in-vivo correlation testing are being dis- the subcommittees and task forces of the Micro P cussed for performing this correlation evalua- biology Committee. P tion. They have a joint CTFA Mutagenicity Task < j On October 10, 1976, the present Force with the CTFA Pharmacology and Toxicol- / CTFA Standard for Cosmetic Talc was pub- ogy Committee. The joint committee was formed jlished. 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 task force was formed in 1977 to review this area. of the efforts of the ad hoc Methodology Com The task force membership is technically diversi mittee under the chairmanship of Dr. Robert fied and affords an excellent cross-section of Rolle, it reflects the most up-to-date technology management for full development 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 of any method for the evaluation of a talc ship methods for the evaluation of materials. We have 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 we use. It's a very important vehicle. We'd like more contribution from the membership. The "Forum" is in the CTFA Cosmetic Journal, and includes short articles relating to the field of microbiology. We have produced a new slide-tape presenta tion entitled, "Cleaning and Sanitation of Manufacturing Equipment." We have continued our efforts for informing and educating industry members by completing this fifth slide-tape pres entation. The new Cosmetic Talc Standard is a modifi cation of the old TGA/CTFA Talc Standard with the following major additions: 1. An Optional identification procedure using X-ray diffraction. 2. The addition of a "none detected" limit for fibrous amphiboles, using CTFA Method J 4-1. In this method, the following steps are required: (a) A primary detection of amphiboles by X-ray diffraction, is employed as the |,.,We are developing a poster series. Two of the posters are posted at the exhibit booth, in rough form. The Committee has in mind a series of posters for plant and personal hygiene for the first step. (b) When a positive detection of amphi boles is indicated, a secondary proce dure using light microscopy along with manufacture of high-microbiological quality cos metics. .gpWe're planning a workshop on decontamina dispersion staining is applied to deter mine whether or not any amphiboles tion technology and sanitization technology in ^pril. We have some information at the booth on " We have developed the Microbiological <|yidelines for Sampling Cosmetic Raw Materials .^oth in process and finished goods. This guide- has been approved and should be published m the near future. We have developed the micro- Lanolin? , contextCrocks 51 M a d is o n A v e n u e , N e w York, N Y 10010 (212) 6 8 3 -3089 -Ifplogical aspects of quality assurance, which CTFA COSMETIC JOURNAL, VOLUME 9, NUMBER 4, OCTOBER/DECEMBER 1977 29 QE-CPC00001190 detected by X-ray diffraction are asbestiform in 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 ail participants for a second round robin, along with another set of ^ c o n tro ls 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 microscopist, 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 microscopists 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 biologi- PtfHhft t f e d w l s ? v C H lV U C a % r o C K I 51 M a d is o n A v e n u e , N e w Y o rk, N Y . 10010 (212) 683 -3089 cal activity. There was overwhelming opinion that there is a dose-effect relationship for asbes tos and an expected 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 Cosmetic 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 sebond 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, ine. 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, NUMBER 4, OCTOBER/DECEMBER 1977 QE-CPC00001191