Memo/Agenda Minutes 2014 Draft Priority List New Data Formaldehyde/Methylene Glycol Re-Review Summaries HC Yellow No. 4 HC Orange No.

Memo/Agenda Minutes 2014 Draft Priority List New Data Formaldehyde/Methylene Glycol Re-Review Summaries HC Yellow No. 4 HC Orange No. 1 BUFF CIR EXPERT PANEL MEETING JUNE 10-11, 2013

MEMORANDUM To: CIR Expert Panel Members and Liaisons From: Director, CIR Subject: 127th Meeting of the CIR Expert Panel Monday and Tuesday, June 10-11, 2013 Date: May 17, 2013 Enclosed are the agenda and accompanying materials for the 127 th CIR Expert Panel Meeting to be held June 10-11, 2013. The location again is the Madison Hotel, 1177 Fifteenth Street, NW, Washington, DC 20005. Phone: (202) 862-1600. Fax: (202) 785-1255. The meeting agenda includes consideration of 15 ingredient groups advancing in the process, 2 re-reviews, 2 re-review summaries, and a review of the 2014 Priorities. The Professional Keratin Smoothing Council (PKSC) will make a presentation at the meeting. They have submitted a request for a Panel review of their information including a proposal for a maximum safe concentration of methylene glycol in keratin smoothing products, recommended safe use practices, new test data on methylene glycol. Schedule and hotel accommodations We have reserved rooms for the nights of Sunday, June 9 and Monday, June 10 at the Madison. If you encounter any travel problems, please contact me on my cell phone at 301-512-7846. Paperless meeting round 2 We ve built on the experience at the March meeting and made some changes that we think you will appreciate. For example, we have used the same term to identify a report on the agenda and on the flash drive. Also, we will not try to project reports on a screen at the meeting (you were all looking at your laptops anyway). Please continue to provide feedback on aspects of the paperless approach that are working for you and which ones are problematic! Team meetings New data - formaldehyde and methylene glycol (agenda and flash drive name formaldehyde) - the PKSC requested time on the first meeting day to present their new information related to safe concentrations of methylene glycol in keratin smoothing products. As of this date, we do not have the package of material from the PKSC, but we will provide that as soon as we receive it. Re-reviews - there are 2 safety assessments to re-review and make a determination on the need to reopen to revise the conclusion. Both provide an opportunity to reopen to expand the scope. 1. Polyvinylpyrrolidone (agenda and flash drive name -PVP) was reviewed previously (published in 1998) with a conclusion of safe as used in cosmetics. Uses have nearly doubled and the reported maximum use concentration has increased from 35% to 94%. Reported case studies related to allergic reactions are included for your review. 1101 17 th Street, NW, Suite 412, Washington, DC 20036 Ph 202.331.0651 Fax 202.331.0088 Internet www.cir-safety.org Email info@cir-safety.org 1

Page 2-127th Meeting of the CIR Expert Panel Monday and Tuesday, June 10-11, 2013 Additionally PVP-iodine (data used in the original report) can be added to this report although currently there are no reported uses in cosmetics. The Panel should decide whether to reaffirm the current conclusion or to re-open and issue an amendment and add PVP-iodine. 2. Alkyl Sulfosuccinate Salts (agenda and flash drive name - sulfosuccinates) Diethylhexyl sodium sulfosuccinate reviewed previously (published in 1994) with the conclusion of safe as used up to 0.42%. The report was amended (1998) with a conclusion of safe predicated on the formulation being non-irritating, especially in products intended for prolonged contact with the skin. Uses have increased from 35 to 62, but the reported use concentration remains unchanged at <5%. The Panel should review and confirm the conclusion and determine if the similarity to chemical structure and use concentration supports expanding the scope to include 19 alkyl sulfosuccinate salts, diesters and monoesters of 2-sulfosuccinic acid. Draft reports - there are 7 draft reports for review. 1. Alkyl PEG-PPG Ethers (agenda and flash drive name PEG-PPG ethers) - This is the first time that the Panel is seeing this document. Alkyl PEG ethers and the polypropylene glycols (PPG) previously were reviewed and found safe when formulated to be non-irritating. The data profiles for these reviews and several pieces of unpublished data were added. Do we need more data or can we proceed to issue a tentative report? 2. Amino Acid Alkyl Amides (agenda and flash drive name alkyl amides) - This is the first time that the Panel is seeing this report addressing 115 ingredients. The Panel previously reviewed the safety of α-amino acids and several related fatty acid constituents with a conclusion that these ingredients are safe for use in cosmetic products. Do we need more data or can we proceed to issue a tentative report? 3. Alumina and Aluminum Hydroxide (agenda and flash drive name alumina) - This is the first time that the Panel is seeing this report addressing two ingredients. FDA safety data on alumina used in medical devices and for aluminum hydroxide used in OTC antacids are included to support the safety of these ingredients as used in cosmetics. Are the data on these ingredients as used in medical products acceptable for determining the safety for use in cosmetics? Do we need more data or can we proceed to issue a tentative report? 4. Chamomile Ingredients (agenda and flash drive name chamomile)- This is the first time that the Panel is seeing this report addressing 15 ingredients. Technical comments from the Council have been addressed and unpublished data were added. Do we need more data or can we proceed to issue a tentative report? 5. Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCl (agenda and flash drive name hair dye) This is the first time that the Panel is seeing this report on this hair dye. The reported maximum use concentration is 0.28% which is below the current SCCP position that this hair dye is safe at a maximum concentration on head of 0.4%. Do we need more data or can we proceed to issue a tentative report? 6. Polyquaternium-22 and Polyquaternium-39 (agenda and flash drive name polyquats) At the December 2011 meeting, the Panel tabled the draft report on polyquaternium-22 and polyquaternium-39, to consider expanding report to include other polyquaternium ingredients. Since the crux of the matter for expanding this report would be the potential presence of unreacted monomers and not the polymers - and different monomers for each different polyquaternium ingredient, we requested information from industry. The Council responded in early 2013 indicating that the data on monomers needed to expand this group to 108 ingredients would probably not be available. We think that the best course of action is to move forward with a report on the original two ingredients. Do we need more data or can we proceed to issue a tentative report? 2

Page 3-127th Meeting of the CIR Expert Panel Monday and Tuesday, June 10-11, 2013 7. Retinol, Retinoic Acid, and Retinyl Esters (agenda and flash drive name retinol) At the September 2012, meeting, the Panel reopened the safety assessment of retinol and retinyl palmitate to consider new data from the NTP photocarcinogenicity study and to consider adding 7 seven new ingredients. This report includes a review of the available photo co-mutagenicity and photo co-carcinogenicity data as well as data received from the Council. Do we need more data or can we proceed to issue as tentative report? Tentative report there are 3 draft tentative reports. 1. Achillea Millefolium-Derived Ingredients (agenda and flash drive name achillea) At the December 2012 meeting, the Panel tabled this reopened insufficient data report (2012) to allow for the submission of sensitization data at or above the highest reported use concentration. We did not receive those data. Without such data, the Panel had suggested that a limit on the safe use concentration might be established at the highest level that was tested. The draft abstract and discussion also incorporates the new botanical language framework that addresses the Panel concerns about safety when using multiple botanical ingredients. If the information is still insufficient, then a tentative conclusion of insufficient data should be issued. If the information now available is sufficient, the Panel should issue a Tentative Report with an appropriate discussion/conclusion. 2. Isethionate Salts (agenda and flash drive name isethionates) this report has slipped through a crack. The Panel agreed to reopen this safety assessment back in 2009 to add ingredients. Industry indicated that additional reproductive and developmental data that would be available by the end of 2009, so the Panel tabled the report to await those data. We ve been waiting for that new data but none have been forthcoming. It now appears that those data are part of data submitted to REACH and it appears that we have access to those REACH data. Those data and updated data on reported uses are incorporated in this report. The Panel should review the tentative amended report and confirm that it is appropriate to add the additional isethionate salts. As a procedural matter, CIR elected not to return the Panel s previously reviewed reports on Sodium Cocoyl Isethionate as there were no comments noted in the books for you to check and those materials can be found in the original report or in the updated data. 3. Tromethamine, Aminomethyl Propanediol, and Aminoethyl Propanediol (agenda and flash drive name tromethamine) At the March, 2013 meeting, the Panel tabled this assessment for the submission of irritation and sensitization data at the maximum reported use concentration. New irritation and sensitization data were provided. The Panel should confirm that the new data satisfy (or don t satisfy) the needs of the Panel. The Panel should review the draft tentative conclusion, and the discussion section which presents the rational for the conclusion. Final reports - there are 5 final reports for consideration. After reviewing these drafts, especially the rationale in the discussion section, the Panel should issue them as final reports. 1. Animal and Plant Derived Amino Acids (agenda and flash drive name derived amino acids) At the March meeting, the Panel issued a tentative report for the animal- and plant-derived amino acid ingredients and concluded that these ingredients are safe in the present practices of use and concentration in cosmetics. Separated for future review were the hydrolyzed proteins of similar sources. Technical comments received from the Council were considered. The only new data are updated VCRP data. 3

Page 4-127th Meeting of the CIR Expert Panel Monday and Tuesday, June 10-11, 2013 2. Boron Nitride (agenda and flash drive name boron nitride) At the March meeting, the Panel issued a tentative report with a conclusion of safe in cosmetics in the present practices of use and concentration. The Panel encouraged the submission of additional HRIPT data at the maximum use concentration using a greater number of subjects. That information is captured in the report. Additional information updating the toxicity data for the nanotube form of boron nitride has also been added to the report. 3. Hypericum Perforatum-Derived Ingredients (agenda and flash drive name hypericum) At the March meeting, the Panel concluded that these ingredients were safe in cosmetics in the present practices of use and concentration, but tabled the issuance of a final report until a new boilerplate addressing the concern about the additive effects of constituents when multiple botanical ingredients are used in a single cosmetic product is developed. The boilerplate language developed to address this potential was broadened to include pesticides/heavy metals and aflatoxins where appropriate. That document is attached for review and the appropriate language incorporated into the report abstract and discussion. Technical comments from the Council were considered. Updated use concentration data have been added. 4. Methyl Glucose Polyethers and Esters (agenda and flash drive name methyl glucose) In March, the Panel issued a revised tentative report with a safe in cosmetics in the present practices of use and concentration conclusion, except for the use of methyl glucose sesquistearate, PEG-20 methyl glucose sesquistearate, and PEG-20 methyl glucose distearate in lipstick products. For those insufficient data ingredients, you asked for adequate repeated-dose oral toxicity data and other appropropriate systems toxicity data. Use concentration data for PEG- 20 methyl glucose sesquistearate in lipstick were requested. Oral dose toxicity data from the ECHA website and systemic toxicity data from the Council are incorporated in this report. Updated use concentration data have been added. Information from the Council indicates that PEG-20 methyl glucose sesquistearate is not being used in lipstick. 5. Nitrocellulose (agenda and flash drive name nitrocellulose) In March, the Panel issued a tentative report with the conclusion that nitrocellulose is safe in cosmetics in the present practices of use and concentration. The Panel concluded that collodion, a solution of nitrocellulose, ethanol and ether, is also safe. No data were received to indicate that collodion is manufactured de novo. The Council provided technical comments on the report, which have been considered. Full Panel Meeting Remember, the breakfast buffet will open at 8:00 am and the meeting starts at 8:30 am on day 2. The Panel will consider the 5 reports to be issued as final safety assessments, followed by the rest of the reports advancing in the process, and finish with a discussion of formaldehyde and the 2014 Priorities. The bulk of the agenda is the draft reports, but there are a number of final reports that don t appear to be too controversial (I know, be careful what you say ). It is still likely that the full Panel session will conclude before lunch on day 2, so plan your travel accordingly. Have a safe journey. 4

Agenda 127 th Cosmetic Ingredient Review Expert Panel Meeting June 10-11, 2013 Monday, June 10 8:00 am CONTINENTAL BREAKFAST 8:30 am WELCOME TO THE 127 th EXPERT PANEL TEAM MEETINGS Drs. Bergfeld/Andersen 8:45 am Professional Keratin Smoothing Council presentation Dr. Robert Golden 8:45 am TEAM MEETINGS Drs. Marks/Belsito Dr. Marks Team* Dr. Belsito s Team FR (CB) derived amino acids FAR (LB/IB) hypericum TAR (CB) isethionate TAR (LB) achillea DR (CB) alkyl amides TR (LB) tromethamine RR (CB) PVP DR (LB) hair dye FR (WJ) methyl glucose DR (LB) alumina DAR (WJ) retinol FR (MF) boron nitride DR (WJ) polyquats FR (MF) nitrocellulose DR (WJ) chamomile DR (MF) PEG-PPG ethers RRsum (FAA) re-review summaries (2) RR (MF) sulfosuccinates (re-review) Admin (FAA) formaldehyde (new data) FR (CB) derived amino acids Admin (BH) 2014 priorities TAR (CB) isethionate FAR (LB/IB) hypericum DR (CB) alkyl amides TAR (LB) achillea RR (CB) PVP (re-review) TR (LB) tromethamine FR (WJ) methyl glucose DR (LB) hair dye DAR (WJ) retinol DR (LB) alumina DR (WJ) polyquats FR (MF) boron nitride DR (WJ) chamomile FR (MF) nitrocellulose RRsum (FAA) re-review summaries (2) DR (MF) PEG-PPG ethers Admin (FAA) formaldehyde (new data) RR (MF) sulfosuccinates (re-review) Admin (BH) 2014 Priorities Noon Lunch for Panel, liaisons, and staff 1:00 pm Team meetings - continue as needed 5:00 pm ADJOURN DAY 1 SESSION FR: Final report FAR: Final amended report TR: Tentative report TAR: Tentative amended report DR: Draft report RR: Re-review NOTE: The order of presentation and discussion of each topic will be maintained. However, the scheduled times may be accelerated or delayed depending upon the time required for the Expert Panel to complete its review of each subject. * Team moves to breakout room.

Tuesday, June 11 8:00 am CONTINENTAL BREAKFAST 8:30 am WELCOME TO THE 127 th FULL CIR EXPERT PANEL MEETING 8:45 am Admin MINUTES OF THE March 2013 EXPERT PANEL MEETING Dr. Bergfeld 9:00 am DIRECTOR S REPORT Dr. Andersen 9:30 am FINAL REPORTS, REPORTS ADVANCING TO THE NEXT LEVEL, RE-REVIEWS, and OTHER DISCUSSION ITEMS Final Reports FR (CB) FAR (LB) FR (MF) FR (MF) FR (WJ) TAR (LB) TR (LB) DR (LB) DR (LB) TAR (CB) DR (CB) DR (MF) DR (WJ) DAR (WJ) DR (WJ) Admin (CB) Admin (MF) Admin (FAA) Admin (FAA) Admin (BH) Derived amino acids - Dr. Marks reports Hypericum - Dr. Belsito reports Nitrocellulose - Dr. Marks reports Boron nitride - Dr. Belsito reports Methyl glucose - Dr. Marks reports Reports Advancing Achillea Dr. Belsito reports Tromethamine - Dr. Marks reports Hair dye - Dr. Belsito reports Alumina - Dr. Marks reports Isethionate - Dr. Belsito reports Alkyl amides Dr. Marks reports PEG-PPG ethers Dr. Belsito reports Chamomile Dr. Marks reports Retinol Dr. Belsito reports Polyquats Dr. Marks reports Re-reviews PVP - Dr. Belsito reports Sulfosuccinates Dr. Marks reports re-review summaries (2) - Dr. Andersen reports New Data Formaldehyde - Dr. Belsito reports 2014 Priorities - Dr. Marks reports ADJOURN - Next meeting Monday and Tuesday, September 9-10, 2013 FR: Final report FAR: Final amended report TR: Tentative report TAR: Tentative amended report DR: Draft report RR: Re-review NOTE: The order of presentation and discussion of each topic will be maintained. However, the scheduled times may be accelerated or delayed depending upon the time required for the Expert Panel to complete its review of each subject.

Commitment & Credibility since 1976 ONE HUNDRED TWENTY-SIXTH MEETING OF THE EXPERT PANEL March 18-19, 2013 The Madison Hotel Washington, D.C. Expert Panel Members Wilma F. Bergfeld, M.D., Chair Donald V. Belsito, M.D. Liaison Representatives Consumer Rachel Weintraub, Esq. Ronald A. Hill, Ph.D. Curtis D. Klaassen, Ph.D. Daniel C. Liebler, Ph.D. Industry Halyna Breslawec, Ph.D. James G. Marks, Jr., M.D. Ronald C. Shank, Ph.D. Thomas J. Slaga, Ph.D. Paul W. Snyder, D.V.M., Ph.D. Government Linda Katz, MD., M.P.H. Adopted (Date) Wilma F. Bergfeld, M.D. 1101 17th Street, NW Suite 412, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) cirinfo@cir-safety.org (Website) www.cir-safety.org

Others Present at Meeting Distrubted for Comment Only -- Do Not Cite or Quote F. Alan Andersen CIR Yutaka Aoki Kanebo Cosmetics Lillian Becker CIR Don Bjerke Procter & Gamble Ivan Boyer CIR Christina Burnett CIR Jon Busch ACC Natalie Cook Avon Kapal Dewan FDA Carol Eisenmann PCPC Mark Ellis IMA-NA Hervé Ficheux Thor PC Monice Fiume CIR Kevin Fries CIR Lillian Gill CIR Tara Gottschalck Steinberg Associates Chris Greissing IMA-NA Bart Heldreth CIR Brian Hughes Dow Chemical Carla Jackson CIR Wilbur Johnson, Jr. CIR William G. Kelly, Jr. Ctr. For Reg. Effectiveness Akiho Kinoshita Shiseido Dennis Laba Presperse Linda Loretz PCPC Damant Parrar Akzu Nohol Julie Pier Derys Thomas Re L Oreal Diego Rua FDA Shripal Sharma Imerys Delores Shaw Dow Noriko Shibuya Shiseido Lynn P. Tordo Thor Sp. 1

CHAIRMAN S OPENING REMARKS MINUTES FROM THE 126 th CIR EXPERT PANEL MEETING The 126 th meeting of the CIR Expert Panel was called to order by Dr. Bergfeld at 8:30 a.m. on Tuesday, March 19, 2013, and all attendees were welcomed. She stated that 15 ingredient reports are scheduled for review at this meeting, and that a few other ingredients are subject to the Panel s comments. Dr. Bergfeld noted that the Panel had expressed concern over botanical mixtures and their toxic components, particularly the possibility of an additive effect of a toxic component in multiple botanical ingredients in a single formulation. Based on yesterday s Team discussions, a boilerplate to address this particular issue will be generated. APPROVAL OF MINUTES The minutes of the December10-11, 2012 CIR Expert Panel meeting were unanimously approved. DIRECTOR S REPORT Dr. Andersen congratulated the Panel on their handling of the review material presented to them solely as PDF and Microsoft Word files. While the move to going paperless has been discussed over the past year, he explained that the equipment needed to produce the paper copies was no longer going to be available, and the cost of printing the books using an outside vendor was prohibitive. So, CIR just did it. In addition to making safety assessment decisions, this meeting was a learning experience on the new paperless approach. Projecting the reports on a screen turned out to be unnecessary, because everyone focused on using their laptops instead! Feedback from the audience and the Panel members still will be needed, so that we may improve how we do this in the future. Dr. Andersen also officially announced that he will retire from CIR effective at the end of June, 2013. Dr. Gill will take over the program and work to develop a plan to address CIR s ongoing staffing needs. Dr. Andersen indicated that he will continue to be available on a consultant basis after he retires. Final Safety Assessments Alkyl Esters Distrubted for Comment Only -- Do Not Cite or Quote The 237 alkyl esters listed below are safe as cosmetic ingredients in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating. arachidyl behenate arachidyl erucate* arachidyl propionate batyl isostearate* batyl stearate* behenyl beeswax behenyl behenate behenyl erucate behenyl isostearate* behenyl olivate behenyl/isostearyl beeswax* butyl avocadate butyl babassuate* butyl isostearate* butyl myristate butyl oleate* butyl stearate butyloctyl beeswax* butyloctyl behenate* butyloctyl candelillate* butyloctyl cetearate* butyloctyl oleate* butyloctyl palmitate* C10-40 isoalkyl acid octyldodecanol esters* C14-30 alkyl beeswax* C16-36 alkyl stearate* C18-38 alkyl beeswax* C18-38 alkyl c24-54 acid ester* C20-40 alkyl behenate* C20-40 alkyl stearate C30-50 alkyl beeswax* C30-50 alkyl stearate* c32-36 isoalkyl stearate* C40-60 alkyl stearate* C4-5 isoalkyl cocoate* caprylyl butyrate* caprylyl caprylate caprylyl eicosenoate cetearyl behenate cetearyl candelillate cetearyl isononanoate cetearyl nonanoate* cetearyl olivate cetearyl palmate* cetearyl palmitate* cetearyl rice branate* cetearyl stearate cetyl babassuate cetyl behenate* cetyl caprate cetyl caprylate cetyl dimethyloctanoate* cetyl esters cetyl isononanoate* cetyl laurate cetyl myristate 2 cetyl myristoleate* cetyl oleate* cetyl palmitate cetyl ricinoleate cetyl stearate cetyl tallowate chimyl isostearate* chimyl stearate* coco-caprylate coco-caprylate/caprate coco-rapeseedate* decyl castorate* decyl cocoate decyl isostearate* decyl jojobate* decyl laurate* decyl myristate* decyl oleate decyl olivate decyl palmitate* decyltetradecyl cetearate* erucyl arachidate* erucyl erucate* erucyl oleate* ethylhexyl adipate/palmitate/stearate* ethylhexyl C10-40 isoalkyl acidate* ethylhexyl cocoate ethylhexyl hydroxystearate

ethylhexyl isononanoate ethylhexyl isopalmitate ethylhexyl isostearate ethylhexyl laurate ethylhexyl myristate ethylhexyl neopentanoate* ethylhexyl oleate* ethylhexyl olivate ethylhexyl palmitate ethylhexyl pelargonate ethylhexyl stearate heptyl undecylenate heptylundecyl hydroxystearate hexyl isostearate hexyl laurate hexyldecyl hexyldecanoate* hexyldecyl isostearate hexyldecyl laurate hexyldecyl oleate* hexyldecyl palmitate* hexyldecyl stearate hexyldodecyl/octyldecyl hydroxystearate* hydrogenated castor oil behenyl esters* hydrogenated castor oil cetyl esters * hydrogenated castor oil stearyl esters* hydrogenated ethylhexyl olivate hydrogenated ethylhexyl sesamate* hydrogenated isocetyl olivate* hydrogenated isopropyl jojobate* hydroxycetyl isostearate* hydroxyoctacosanyl hydroxystearate isoamyl laurate isobutyl myristate* isobutyl palmitate* isobutyl perlargonate* isobutyl stearate* isobutyl tallowate* isocetyl behenate* isocetyl isodecanoate* isocetyl isostearate* isocetyl laurate* isocetyl myristate isocetyl palmitate isocetyl stearate isodecyl cocoate isodecyl hydroxystearate* isodecyl isononanoate isodecyl laurate isodecyl myristate isodecyl neopentanoate isodecyl oleate isodecyl palmitate* isodecyl stearate* isohexyl caprate isohexyl laurate* isohexyl neopentanoate* isohexyl palmitate* isolauryl behenate* isononyl isononanoate isooctyl caprylate/caprate* Distrubted for Comment Only -- Do Not Cite or Quote isooctyl tallate* isopropyl isostearate isopropyl arachidate* isopropyl avocadate* isopropyl babassuate* isopropyl behenate* isopropyl hydroxystearate isopropyl isostearate isopropyl jojobate isopropyl laurate* isopropyl linoleate isopropyl myristate isopropyl oleate* isopropyl palmitate isopropyl ricinoleate isopropyl stearate isopropyl tallowate* isostearyl avocadate isostearyl behenate isostearyl erucate* isostearyl hydroxystearate isostearyl isononanoate isostearyl isostearate isostearyl laurate isostearyl linoleate isostearyl myristate isostearyl neopentanoate isostearyl palmitate isotridecyl isononanoate isotridecyl laurate* isotridecyl myristate* isotridecyl stearate lauryl behenate* lauryl cocoate* lauryl isostearate* lauryl laurate lauryl myristate* lauryl oleate/ lauryl palmitate lauryl stearate/ lignoceryl erucate* myristyl isostearate* myristyl laurate myristyl myristate myristyl neopentanoate myristyl stearate octyldecyl oleate* octyldodecyl avocadoate* octyldodecyl beeswax* octyldodecyl behenate* octyldodecyl cocoate* octyldodecyl erucate octyldodecyl hydroxystearate* octyldodecyl isostearate octyldodecyl meadowfoamate* octyldodecyl myristate octyldodecyl neodecanoate* octyldodecyl neopentanoate octyldodecyl octyldodecanoate octyldodecyl oleate* octyldodecyl olivate octyldodecyl ricinoleate 3 octyldodecyl safflowerate* octyldodecyl stearate oleyl arachidate* oleyl erucate oleyl linoleate oleyl myristate* oleyl oleate oleyl stearate* propylheptyl caprylate stearyl beeswax stearyl behenate* stearyl caprylate stearyl erucate* stearyl heptanoate stearyl linoleate* stearyl olivate stearyl palmitate stearyl stearate tetradecyleicosyl stearate* tetradecyloctadecyl behenate* tetradecyloctadecyl hexyldecanoate* tetradecyloctadecyl myristate* tetradecyloctadecyl stearate tetradecylpropionates* tridecyl behenate* tridecyl cocoate* tridecyl erucate* tridecyl isononanoate tridecyl laurate* tridecyl myristate* tridecyl neopentanoate tridecyl stearate

*Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. Alkyl esters is the name that CIR devised to describe this large group of cosmetic ingredients, which are reaction products of fatty acids and alcohols. Although there are data gaps in this report, the relatedness of molecular structures, physicochemical properties, and functions and concentrations in cosmetics allow grouping these ingredients together and extrapolating the toxicological data to support the safety of the entire group. The data on many of the ingredients, especially the previously reviewed ingredients and on some of the constituent alcohols and acids, are sufficient, and similar structure-property relationships, biologic characteristics, and cosmetic product usage suggest that the data may be extrapolated to support the safety of the entire group. One ingredient originally included in this safety assessment, isopropyl sorbate, was removed because it differs in function and chemical structure from the other ingredients in this group. The Panel recognized that some of these ingredients can enhance the penetration of other ingredients through the skin and cautioned that care should be taken in formulating cosmetic products that contain these ingredients in combination with any ingredients the safety of which was based on their lack of dermal absorption, or when dermal absorption was a concern. The Panel also recognized that the potential exists for dermal irritation with the use of products formulated with some of the alkyl esters. Therefore, the Panel specified that products using these ingredients must be formulated to be non-irritating. Alkyl Ethylhexanoates Distrubted for Comment Only -- Do Not Cite or Quote The 16 alkyl ethylhexanoates listed below are safe as cosmetic ingredients in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating. C12-13 alkyl ethylhexanoate C12-15 alkyl ethylhexanoate C14-18 alkyl ethylhexanoate* cetearyl ethylhexanoate cetyl ethylhexanoate decyltetradecyl ethylhexanoate* ethylhexyl ethylhexanoate hexyldecyl ethylhexanoate* isocetyl ethylhexanoate isodecyl ethylhexanoate* isostearyl ethylhexanoate* lauryl ethylhexanoate* myristyl ethylhexanoate* octyldodecyl ethylhexanoate* stearyl ethylhexanoate tridecyl ethylhexanoate *Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. A common concern addressed in the review of the safety of alkyl ethylhexanoates was that 2-ethylhexanoic acid, a possible metabolite, is a liver and developmental toxicant in animal studies at high doses. The mechanism is attributed to a cascade of effects that includes metallothionein (MT) induction followed by zinc accumulation in the liver due to MT binding, and a consequent zinc deficiency in the developing embryo. The Panel determined that results of testing with di-2-ethylhexyl terephthalate (a 2- ethylhexanoic acid precursor used as a model for ethylhexanoic acid exposures that do not induce MT in the liver) suggested that the low rate of metabolic conversion of di-2-ethylhexyl terephthalate follows a time course that allows clearance of the 2-ethylhexanoic acid metabolite before sufficient levels can arise to produce zinc deficiency. The Panel concluded that the low rate of metabolism of alkyl ethylhexanoate compounds that could be absorbed through the skin would not generate 2-ethylhexanoic acid at levels sufficient to trigger the MT-induction-dependent effects observed in animal studies. The Panel considered that the rationale described above applied to the entire group of alkyl ethylhexanoates. Additionally, the similar chemical structures, physicochemical properties, functions, and concentrations in cosmetics allow interpolation of the available toxicological data to support the safety of the entire group. 6-Hydroxyindole 6-Hydroxyindole is safe as a hair dye ingredient in the present practices of use and concentration. The Panel expressed concern that 6-hydroxyindole appears to be a photosensitizer at a concentration of 5%. Data, however, did not indicate photosensitization at 2%. The Panel noted that this ingredient has 104 uses in hair dye products at concentrations up to 0.5%. The Panel recognized that 6-hydroxyindole is considered a coal tar hair dye. Accordingly, products containing this ingredient are exempt from certain adulteration and color additive provisions of the Federal Food, Drug, and Cosmetic Act, when the product label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Panel considered concerns about such self-testing, but agreed that following this procedure enables consumers to determine, prospectively, whether they will have an irritation/sensitization reaction, and allow them to avoid subsequent significant exposures. In the future, the Panel will consider the results of ongoing studies by the industry to evaluate the risks and benefits of consumer self-testing. 4

Modified terephthalate polymers Distrubted for Comment Only -- Do Not Cite or Quote The 6 modified terephthalate polymers listed below are safe for use in cosmetics in the present practices of use and concentration. adipic acid/1,4 butanediol/terephthalate copolymer* polybutylene terephthalate polyethylene isoterephthalate polyethylene terephthalate polypentaerythrityl terephthalate* polypropylene terephthalate *Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100%. The Panel considered the presence of a phthalate moiety in these ingredients. Terephthalates incorporate a para-phthalate isomer. This is different from the ortho-phthalate esters (common plasticizers such as di(2-ethylhexyl)phthalate (DEHP)) that have been considered as potential endocrine disruptors. Given the nature of the terephthalates used in cosmetics, there would not be any significant orthophthalate impurities in these terephthalate plastics, and no reason that ortho-phthalate esters would be added to them as softeners during manufacturing. The data indicate the absence of endocrine disruption associated with modified terephthalate polymers as used in cosmetics. The lack of case reports, along with several use tests of eye products containing modified terephthalate polymers up to 46%, led the Panel to conclude that ocular injury from these products is unlikely. Nylon Polymers The 8 nylon polymers listed below are safe in the present practices of use and concentration in cosmetics. nylon-6 nylon-11 nylon-10/10* nylon-12 nylon 6/12 nylon-66 nylon-611* nylon-12/6/66* *Not reported to be in current use. Were ingredients in this group not reported to be in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. The Panel considered that unpublished data submitted by the Council supported the conclusion that nylon ingredients in cosmetics would not cause irritation or sensitization. The Panel reviewed human repeat insult patch test data on nylon-12 at its maximum use concentration of 35%. No sensitization or irritation was observed in this study. Likewise, in vitro studies of nylon, as used in cosmetics, found no evidence of genotoxicity. From these data, the Panel determined that residual monomers in nylon-12 were not present, or not released, at concentrations sufficient to cause dermal reactions in subjects tested at the maximum use concentration. Talc Talc is safe in the present practices of use and concentration in cosmetics. The Panel warned that talc should not to be used on skin where the epidermal barrier is removed or on skin that has greater than 1st degree burns, because case reports indicate that granulomas formed when talc was applied to skin where the epidermal barrier was not intact. The Panel received documentation from industry of the analytical methods used to confirm the purity of talc, particularly the absence of asbestos, quartz and other inorganic substances. The Panel also reviewed representative certificates of analysis of talc from two suppliers. Taken together, the information provided sufficient evidence of compliance with the 1976 cosmetics industry specification that talc used in cosmetic products is free of asbestiform fibers. Tentative Safety Assessments Animal- and plant-derived amino acids The Panel issued a tentative safety assessment for public comment for the 21 animal- and plant-derived amino acids ingredients listed below with the conclusion that they are safe in the present practices of use and concentration as described in the safety assessment. 5

apricot kernel amino acids* collagen amino acids corn gluten amino acids* elastin amino acids* garcinia mangostana amino acids* hair keratin amino acids jojoba amino acids* Distrubted for Comment Only -- Do Not Cite or Quote keratin amino acids lupine amino acids lycium barbarum amino acids* milk amino acids oat amino acids rice amino acids sesame amino acids* silk amino acids soy amino acids spirulina amino acids* sweet almond amino acids* vegetable amino acids wheat amino acids yeast amino acids* *Not reported to be in current use. Were ingredients in this group not reported to be in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. The above ingredients had been included in a safety assessment that also included plant- and animal-derived hydrolyzed proteins, but the Panel segregated the amino-acid group and tabled the hydrolyzed-protein group (see 126 th meeting notes). The Panel expressed concern about the lack of information regarding method of manufacturing and impurities that may be present in these amino acids derived from plant and animal sources. The Panel considered that vigorous acid hydrolysis would yield amino acids with little or no residual peptides, because such acid hydrolysis attacks all of the peptide bonds in a protein in a non-preferential manner. The Panel was concerned that enzymatic hydrolysis of proteins can disrupt the peptide bonds in a protein in a site-specific manner, and may produce di-, tri- or other peptides, as well as amino acids. Such residual impurities may have the potential to cause allergic reactions in sensitive individuals. Input was sought on the usual methods used to produce amino acids from animal and plant proteins. If the methodology involves rigorous acid hydrolysis, there is less concern that residual small peptides will be present. In any case, the Panel would emphasize that industry should manufacture plant- and animal-derived amino acids in a way that ensures that residual peptides could not cause allergic reactions in sensitive individuals. Boron Nitride The Panel issued a tentative safety assessment for public comment with the conclusion that boron nitride is safe in the present practices of use and concentration. The Panel remarked, however, that irritation and sensitization data were not provided from tests of the maximum reported use concentration (25%) in eye formulations. Because human repeat insult patch test (HRIPT) data were available for 18.7% in formulation, the Panel determined that the data could be considered adequate, although HRIPT data from tests using up to the 25% maximum would be preferable. Further, the available HRIPT study tested only 55 subjects. Thus, additional HRIPT data would greatly improve the basis for the Panel s conclusion. The Panel also noted that, although there are data gaps, this ingredient is an insoluble polymer that is not expected to penetrate the skin and, even if it did, it would not be expected to cause adverse effects. Although nanoparticles of boron nitride are not reported to be used in cosmetic formulations, the lack of toxicity observed in a single-dose intravenous study of boron nitride nanotubes supports the safety of the other forms of boron nitride that are used in cosmetics. The discussion of the physical/chemical form(s) of boron nitride that are used in cosmetics indicated that further chemical characterization data could clarify their chemical structures and strengthen the safety assessment. Methyl Glucose Polyethers and Esters The Panel issued a revised tentative safety assessment for public comment with a conclusion that the 25 methyl glucose polyethers and esters listed below are safe as used in cosmetics in the present practices of use and concentration, except that the available data are insufficient for evaluating the safety of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate in lipsticks. Ethers: Polyethers Esters and polyethers: methyl glucose caprylate/caprate* PPG-10 methyl glucose ether PEG-120 methyl glucose dioleate methyl glucose dioleate PPG-20 methyl glucose ether PEG-20 methyl glucose distearate methyl glucose isostearate* PPG-25 methyl glucose ether* PEG-80 methyl glucose laurate* methyl glucose laurate* methyl glucose sesquicaprylate/ sesquicaprate* PPG-20 methyl glucose ether acetate* PPG-20 methyl glucose ether distearate PEG-20 methyl glucose sesquicaprylate/ sesquicaprate* PEG-20 methyl glucose sesquilaurate* methyl glucose sesquicocoate* methyl gluceth-10 PEG-20 methyl glucose sesquistearate methyl glucose sesquiisostearate methyl gluceth-20 PEG-120 methyl glucose triisostearate* methyl glucose sesquilaurate* PEG-120 methyl glucose trioleate methyl glucose sesquioleate methyl glucose sesquistearate 6

*Not reported to be in current use. Were ingredients in this group not reported to be in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. As previously issued, the tentative report on these ingredients indicated that the polyether form of these methyl glucose ingredients reportedly function as skin and hair conditioning agents, whereas the methyl glucose esters and the ester/polyether forms function only as skin conditioning agents in cosmetic products. Uses of three ingredients in lipsticks raised the concern about repeated ingestion as a route of exposure that Panel had not previously considered. There was, however, some confusion regarding use of these ingredients in lipsticks. Information from FDA s 2013 VCRP database indicated uses of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate in lipsticks. Use concentration data were supplied by the Personal Care Products Council for methyl glucose sesquistearate and PEG-20 methyl glucose distearate (not reported in the VCRP) in lipsticks, but no use concentration data were available for PEG-20 methyl glucose sesquistearate. The absence of use concentration data for PEG-20 methyl glucose sesquistearate in lipsticks was particularly concerning because no systemic toxicity data sufficient to support the safety of uses in lipsticks were available. Until such information is available, the Panel determined that the data are insufficient for evaluating the safety of these methyl glucose polyethers and esters in lipsticks. Use concentration data are needed for PEG-20 methyl glucose sesquistearate in lipsticks (or a determination that this ingredient is not actually used in lipsticks). Regardless, two ingredients clearly are used in lipsticks and, so that the Panel can assess the risks of ingestion, adequate repeated-dose oral toxicity data or other appropriate systemic toxicity data are needed. Nitrocellulose The CIR Expert Panel issued a tentative safety assessment for public comment with the conclusion that nitrocellulose and collodion are safe in the present practices of use and concentration. The Panel debated the need to include collodion in this report. While nitrocellulose is widely used in nail polish and nail enamel, basecoat, and undercoat formulations, no uses of collodion appeared in the VCRP data. It is presumed, however, that there is at least one use of collodion, because a maximum concentration of use in a nail product was reported in response to a survey conducted by the Personal Care Products Council. The Panel considered, therefore, that the tentative report can address collodion as well as nitrocellulose. Collodion is listed in the International Cosmetic Ingredient Dictionary and Handbook as a cosmetic ingredient. Based on its definition, however, it appeared to the Panel that collodion is a solution of nitrocellulose, ethanol, and ether, which could be termed a trade name mixture rather than a distinct ingredient. Accordingly, the Panel removed the word collodion from the report title. If the Panel is correct that collodion is simply nitrocellulose in a volatile vehicle, then data supporting the stability of nitrocellulose in that matrix would be useful. If collodion is the de novo product of a manufacturing process, rather than the product of simply dissolving nitrocellulose in ethanol and ether, then data on that method of manufacture would be essential; Otherwise, collodion could be omitted from the conclusion, or require an insufficient data announcement. The Expert Panel did note that sensitization testing was conducted using a concentration that was less than the maximum reported use concentration. Because most use is in nail care products, significant exposure to the skin would be minimized, so that these data likely are adequate. Also, the high molecular weight and chemical properties preclude significant absorption of this nail formulation ingredient. Re-review and New Data HC orange no. 1 not reopened Distrubted for Comment Only -- Do Not Cite or Quote The Panel reaffirmed the original conclusion that HC orange no. 1 is safe as a hair dye ingredient at concentrations 3%. The Panel reviewed the evaluation of this hair color ingredient in Europe and noted no new safety issues. The concentration of use for this hair dye has increased from 0.15% to 0.55%, but the use concentration is still well below the maximum concentration of 3% supported by the available data. The Panel recognized that HC orange no.1 can be considered a coal tar hair dye. Accordingly, products containing this ingredient are exempt from certain adulteration and color additive provisions of the Federal Food, Drug, and Cosmetic Act, when the product label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Panel has considered concerns about such self-testing, but agreed that following this procedure enables consumers to determine, prospectively, whether they will have an irritation/sensitization reaction, and allow them to avoid subsequent significant exposures. In the future, the Panel will consider the results of ongoing studies by the industry to evaluate the risks and benefits of consumer self-testing. 7

HC yellow no. 4 not reopened Distrubted for Comment Only -- Do Not Cite or Quote The Panel reaffirmed the original conclusion that HC yellow no.4 is safe for use in hair dyes in the present practices of use and concentration. The Panel reviewed the evaluation of this hair color ingredient in Europe and noted that this color could be subject to n-nitrosation to form potentially carcinogenic reaction products. Accordingly, the Panel cautioned formulators that HC yellow no. 4 should not be used in formulations where N-nitroso compounds may be formed. The Panel also considered new studies examining reproductive outcomes in rats dosed with HC yellow no.4. While there was some evidence of reproductive toxicity in these studies using rats, all were oral toxicity studies using high concentrations, and the findings are not relevant to cosmetics uses. HC yellow no.4 is not expected to penetrate the skin in hair coloring usage, so no systemic exposure would occur, and reported use concentration for cosmetics are only 0.75%. These new reproductive toxicity data, therefore, do not suggest a concern for use of HC yellow no.4 in hair coloring. New data showing an absence of sensitization potential at concentrations up to 10% added support that the original safety conclusion was correct. The Panel recognized that HC yellow no. 4 can be considered a coal tar hair dye. Accordingly, products containing this ingredient are exempt from certain adulteration and color additive provisions of the Federal Food, Drug, and Cosmetic Act, when the product label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Panel has considered concerns about such self-testing, but agreed that following this procedure enables consumers to determine, prospectively, whether they will have an irritation/sensitization reaction, and allow them to avoid subsequent significant exposures. In the future, the Panel will consider the results of ongoing studies by the industry to evaluate the risks and benefits of consumer self-testing. Hydroquinone and p-hydroxyanisole - reopened These ingredients were previously reviewed by the Panel in separate reports. A new use of these ingredients, alone or in combination, has been reported in UV-cured nail polish gels, and this use is not addressed in either of the previous safety assessments. The Panel agreed to reopen these safety assessments to address the new usage. Interested parties are encouraged to provide all available data relevant to this new use. Methylisothiazolinone reopened The Panel reviewed newly provided clinical data indicating a higher than expected frequency of individuals who have allergic reactions to the preservative methylisothiazolinone. In some cases, comparative data are available indicating a higher frequency of positive reactions than currently seen with the combination preservative, methylisothiazolinone/methychloroisothiazolinone. The Panel reopened this safety assessment to gather and evaluate further clinical data. Interested parties are encouraged to provide all available data relevant to this concern about allergic reactions. Reports Tabled Animal- and plant-derived hydrolyzed proteins The Panel tabled further discussion on animal- and plant-derived hydrolyzed proteins to allow CIR staff to reorganize the report and to analyze further data from Japan regarding Type I allergic reactions to hydrolyzed wheat protein in a soap product. These ingredients had been presented in a single report package with animal- and plant-derived amino acids, but the Panel split the amino acid ingredients into their own report (see Tentative Reports). Among the approaches that have been proposed as alternatives to grouping all hydrolyzed proteins together is to organize the ingredients by plant/animal source. In that scheme, proteins derived from wheat, for example, would be the focus of a group that could include hydrolyzed wheat proteins and hydrolyzed wheat protein derivatives. Ideally, such an approach would facilitate consideration of the concern about hydrolyzed wheat protein in Japan and not dilute the evaluation with other unrelated ingredients. The other perspective is that, while the parent proteins are from different animal and plant sources, the protein hydrolysates are unlikely to represent novel protein sequences with unique toxicities. In this view, hydrolyzed wheat protein and the Type I allergic reactions reported in Japan are unique to hydrolyzed wheat protein, and are not associated with exposures to hydrolyzed proteins from other sources. At the time the report was tabled, the 54 ingredients included in this safety assessment were: ammonium hydrolyzed collagen* calcium hydrolyzed collagen* hydrolyzed actin hydrolyzed albumen hydrolyzed amaranth protein hydrolyzed avocado protein* 8 hydrolyzed barley protein hydrolyzed brazil nut protein hydrolyzed casein

hydrolyzed conalbumin* hydrolyzed conchiolin protein hydrolyzed cottonseed protein hydrolyzed egg protein* hydrolyzed elastin hydrolyzed extensin hydrolyzed fibroin hydrolyzed fibronectin hydrolyzed gadidae protein hydrolyzed gelatin* hydrolyzed hair keratin hydrolyzed hazelnut protein hydrolyzed hemoglobin* hydrolyzed hemp seed protein* hydrolyzed honey protein hydrolyzed jojoba protein *Not reported to be in current use. Distrubted for Comment Only -- Do Not Cite or Quote hydrolyzed keratin hydrolyzed lactalbumin* hydrolyzed lupine protein hydrolyzed maple sycamore protein* hydrolyzed milk protein hydrolyzed oat protein hydrolyzed pea protein hydrolyzed potato protein hydrolyzed reticulin* hydrolyzed royal jelly protein* hydrolyzed sericin hydrolyzed serum protein* hydrolyzed sesame protein* hydrolyzed silk hydrolyzed soy protein hydrolyzed soymilk protein hydrolyzed spongin* hydrolyzed sweet almond protein hydrolyzed vegetable protein hydrolyzed wheat gluten hydrolyzed wheat protein hydrolyzed whey protein hydrolyzed yeast protein hydrolyzed yogurt protein hydrolyzed zein* MEA hydrolyzed collagen MEA hydrolyzed silk* sodium hydrolyzed casein* zinc hydrolyzed collagen* Hypericum perforatum- derived ingredients The Panel tabled further discussion of hypericum perforatum-derived ingredients to develop language for the discussion to reflect a growing concern about constituents that may be present in multiple botanical ingredients in cosmetic formulations, resulting in greater than expected exposures to said constituents. For these ingredients, hypericin, a known photosensitizer, might be a good example of such constituents of concern. The seven ingredients in this amended safety assessment are: hypericum perforatum extract, hypericum perforatum flower extract, hypericum perforatum flower/leaf extract, hypericum perforatum flower/leaf/stem extract, hypericum perforatum flower/twig extract, hypericum perforatum leaf extract, and hypericum perforatum oil. Palmitoyl oligopeptides The report was tabled pending reorganization of this document. These ingredients were preliminarily grouped together, as they are related structurally by an identical fatty, hydrophobic tail connected to a variable sequence of peptides. The Panel noted, however, that the terminology used for these ingredients does not enable adequate evaluation. Further information is sought to better understand the extent and manner in which solid-phase peptide synthesis is used to create the peptide portion of such fatty acid peptide ingredients. If additional information enables a better understanding of the amino acid sequences of the peptides of these ingredients than afforded by their definitions in the dictionary, then grouping them together in some fashion may be reasonable. If there is a substantial degree of randomness associated with the peptides of these ingredients, then it would be important for the Panel to consider how that might influence the safety evaluation. For example, some small peptides are potent stimulators of angiogenesis. The potential for such an activity to promote tumor growth and metastasis in people with undiagnosed skin cancer might then be an issue. Given the present uncertainties, grouping a large number of these ingredients together might be inappropriate. At the time the report was tabled, the following ingredients were included: palmitoyl oligopeptide palmitoyl dipeptide-7 palmitoyl dipeptide-10 palmitoyl dipeptide-13 palmitoyl dipeptide-17 palmitoyl dipeptide-18 palmitoyl tripeptide-1 palmitoyl tripeptide-4 palmitoyl tripeptide-5 palmitoyl tripeptide-8 9 palmitoyl tripeptide-28 palmitoyl tripeptide-29 palmitoyl tripeptide-31 palmitoyl tripeptide-36 palmitoyl tripeptide-37 palmitoyl tripeptide-38 palmitoyl tripeptide-40 palmitoyl tripeptide-42 palmitoyl tetrapeptide-7 palmitoyl tetrapeptide-10

palmitoyl tetrapeptide-20 palmitoyl pentapeptide-4 palmitoyl pentapeptide-5 palmitoyl hexapeptide-12 palmitoyl hexapeptide-14 palmitoyl hexapeptide-15 palmitoyl hexapeptide-19 palmitoyl hexapeptide-26 palmitoyl hexapeptide-32 palmitoyl hexapeptide-36 palmitoyl hexapeptide-27 acetate palmitoyl heptapeptide-5 palmitoyl nonapeptide-6 Distrubted for Comment Only -- Do Not Cite or Quote palmitoyl decapeptide-21 palmitoyl oligopeptide-70 palmitoyl hydrolyzed collagen palmitoyl hydrolyzed milk protein palmitoyl hydrolyzed wheat protein potassium palmitoyl hydrolyzed corn protein potassium palmitoyl hydrolyzed oat protein potassium palmitoyl hydrolyzed rice protein potassium palmitoyl hydrolyzed sweet almond protein potassium palmitoyl hydrolyzed wheat protein sodium palmitoyl hydrolyzed collagen sodium palmitoyl hydrolyzed wheat protein Tromethamine The Panel tabled the safety assessment of tromethamine so that aminomethyl propanediol (AMPD) and aminoethyl propandiol (AEPD) may be incorporated into the report. The Panel noted that there were no sensitization data for tromethamine and that it is used up to 4% in both leave-on and rinse-off products. The only available sensitization data is for AEPD up to 0.5%. It was also noted that impurity data were lacking. The Panel invites additional sensitization data at the maximum use concentration and data on impurities. If such data are not submitted, the CIR Expert Panel may issue an insufficient data announcement or a maximum concentration of use may be specified in the conclusion of a tentative report posted for public comment in the future. Draft 2014 Ingredient Review Priorities Interested parties are invited to comment on the inclusion of the ingredients listed below as 2014 CIR priorities based on those unreviewed ingredients with the largest number of 2013 VCRP uses. Comment also is sought on the additional ingredients that might be included in each ingredient family. Note that the first three are grouped together in anticipation that they would be evaluated as a group. It is likely that not all of those listed will be chosen for work in 2014. Ingredient and Number of formulations containing ingredient sodium hydroxide (3961) potassium hydroxide (1032) ammonium hydroxide (946) algae extract (805) ginkgo biloba leaf extract (530) phospholipids (527) sodium benzotriazolyl butylphenol sulfonate (473) sodium methylparaben (466) ethylene/propylene/styrene copolymer (449) avena sativa (oat) kernel extract (444) polysilicone-2 (442) butylene/ethylene/styrene copolymer (435) centella asiatica extract (420) buteth-3 (409) PEG-150 pentaerythrityl tetrastearate (408) cetyl PEG/PPG-10/1 dimethicone (387) malus domestica (apple) fruit extract (382) potassium cetyl phosphate (377) butyrospermum parkii (shea) butter extract (363) hydrofluorocarbon 152a (360) triethoxycaprylylsilane (354) tridecyl trimellitate (353) panthenyl ethyl ether (351) to be determined hair dye (na) 10

Date: June 10, 2013 From: Bart Heldreth, Ph.D., Chemist CIR To: CIR Expert Panel Members, Liaisons and the general public Re: 2014 Priority List The CIR Procedures require that we prepare the Draft 2014 Priority List for public comment by June 1, 2013. The Draft 2014 Priority list was issued for public comment earlier in the hope of giving more time for the acquisition of data. The list was based on frequency of use data (FOU) from FDA s Voluntary Cosmetic Registration Program (VCRP), received from FDA in March, 2013. The list includes only the lead ingredients. Potential groupings have been provided for comment (attachment 1). We received comments from the industry (attachment 2). The Expert Panel now has the opportunity to review this list and finalize the 2014 Priority List at this meeting. Ingredients on the 2014 Draft Annual Priority List are summarized below: Draft CIR 2014 Priority List (6/10/2013) LEAD INGREDIENT FOU (2013) GLYCERIN 14799 SODIUM HYDROXIDE 3961 POTASSIUM HYDROXIDE 1032 AMMONIUM HYDROXIDE 946 ALGAE EXTRACT 805 GINKGO BILOBA LEAF EXTRACT 530 PHOSPHOLIPIDS 527 SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE 473 ETHYLENE/PROPYLENE/STYRENE COPOLYMER 449 BUTYLENE/ETHYLENE/STYRENE COPOLYMER 435 PEG-6 CAPRYLIC/CAPRIC GLYCERIDES 448 AVENA SATIVA (OAT) KERNEL EXTRACT 444 CENTELLA ASIATICA EXTRACT 420 PEG-150 PENTAERYTHRITYL TETRASTEARATE 408 CETYL PEG/PPG-10/1 DIMETHICONE 387 MALUS DOMESTICA (APPLE) FRUIT EXTRACT 382 POTASSIUM CETYL PHOSPHATE 377

2014 Re-reviews While there is no requirement for CIR to publish an annual list of scheduled re-reviews, below is the list of the potential re-reviews planned for 2014. This list is based on those safety assessments completed in 1999, or earlier, and not yet re-reviewed. Potential expansions to include additional ingredients are also being provided (attachment 3). 2014 RE-REVIEWS GLYCERYL STEARATE 4744 GLYCERYL STEARATE SE 1131 POLYSORBATE 20 2706 POLYSORBATE 60 1434 POLYSORBATE 80 871 & Polysorbates -21, 40, 61, 65, 81, and 85 ASCORBYL PALMITATE 2095 ERYTHORBIC ACID 866 & Ascorbyl Dipalmitate, Ascorbyl Stearate, and Sodium Erythorbate SODIUM PCA 1256 & PCA BISABOLOL 995 SORBITAN STEARATE 931 & Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate PEG-7 GLYCERYL COCOATE 827 PEG-150 DISTEARATE 583 PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE 531 HYDROXYSTEARIC ACID 118 ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE 289 NONOXYNOL-4 126 PPG-9 DIETHYLMONIUM CHLORIDE 9

Distrubted for Comment Only -- Do Not Cite or Quote Draft 2014 CIR Priority List with Ingredient Groupings June, 2013 Group/INGREDIENT NAME GLYCERIN Uses 2013 14799 Inorganic Hydroxides SODIUM HYDROXIDE POTASSIUM HYDROXIDE AMMONIUM HYDROXIDE 3961 1031 946 Alga 1 ALGAE EXTRACT 805 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) None (1) 1. Calcium Hydroxide 2. Lithium Hydroxide 3. Magnesium Hydroxide (6) 1. Agarum Cribrosum Extract 2. Ahnfeltia Concinna Extract 3. Alaria Esculenta Extract 4. Algae 5. Aphanizomenon Flos-Aquae Powder 6. Ascophyllum Nodosum Extract 7. Ascophyllum Nodosum Powder 8. Asparagopsis Armata Extract 9. Betaphycus Gelatinum Extract 10. Botryocladia Occidentalis Extract 11. Calliblepharis Ciliata Extract 12. Capsosiphon Fulvescens Extract 13. Caulerpa Lentillifera Extract 14. Caulerpa Okamurai Extract 15. Caulerpa Racemosa Extract 16. Caulerpa Taxifolia Extract 17. Ceramium Kondoi Extract 18. Ceramium Rubrum Extract 19. Chlamydocapsa Extract 20. Chlamydomonas Extract

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 21. Chlorella Ellipsoidea Extract 22. Chlorella Emersonii Extract 23. Chlorella Minutissima Extract 24. Chlorella Pyrenoidosa Extract 25. Chlorella Pyrenoidosa Powder 26. Chlorella Variabilis Extract 27. Chlorella Vulgaris Extract 28. Chlorella Vulgaris Powder 29. Chondracanthus Teedii Powder 30. Chondrus Crispus 31. Chondrus Crispus Extract 32. Chondrus Crispus Powder 33. Cistus Monspeliensis Extract 34. Cladosiphon Novae-Caledoniae Extract 35. Cladosiphon Okamuranus Extract 36. Codium Fragile Extract 37. Codium Tomentosum Extract 38. Codium Tomentosum Powder 39. Corallina Officinalis Extract 40. Corallina Officinalis Powder 41. Cyanidium Caldarium Extract 42. Cystoseira Amentacea/Caespitosa Branchycarpa Extract 43. Cystoseira Baccata Extract 44. Cystoseira Compressa Extract 45. Cystoseira Compressa Powder 46. Cystoseira Tamariscifolia Extract 47. Delesseria Sanguinea Extract 48. Dictyopteris Membranacea Extract 49. Dictyota Coriacea Extract 50. Digenea Simplex Extract 51. Dilsea Carnosa Extract 52. Dunaliella Bardawil Extract 53. Dunaliella Bardawil Powder 54. Dunaliella Salina Extract 55. Durvillea Antartica Extract 56. Ecklonia Cava Extract 2

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 57. Ecklonia Kurome Extract 58. Ecklonia Kurome Powder 59. Ecklonia Laminaria Extract 60. Ecklonia Maxima Extract 61. Ecklonia Maxima Powder 62. Ecklonia Radiata Extract 63. Eisenia Arborea Extract 64. Emiliania Huxleyi Extract 65. Enteromorpha Compressa Extract 66. Enteromorpha Compressa Powder 67. Enteromorpha Flexuosa Extract 68. Euglena Gracilis Extract 69. Fucoxanthin 70. Fucus Serratus Extract 71. Fucus Vesiculosus Extract 72. Fucus Vesiculosus Powder 73. Furcellaria Lumbricalis Extract 74. Gelidium Amansii Extract 75. Gelidium Cartilagineum Extract 76. Gelidium Pulchrum Protein 77. Gelidium Sesquipedale Extract 78. Gellidiela Acerosa Extract 79. Gigartina Skottsbergii Extract 80. Gigartina Stellata Extract 81. Gloiopeltis Aenax Powder 82. Gracilaria Verrucosa Extract 83. Gracilariopsis Chorda Extract 84. Grateloupia Livida Powder 85. Haematococcus Pluvialis Extract 86. Haematococcus Pluvialis Powder 87. Halimeda Opuntia Extract 88. Halopteris Scoparia Extract 89. Haslea Ostrearia Extract 90. Himanthalia Elongata Extract 91. Himanthalia Elongata Powder 92. Hizikia Fusiforme Extract 93. Hydrolyzed Algae Extract 3

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 94. Hydrolyzed Asparagopsis Armata Extract 95. Hydrolyzed Chlorella Vulgaris Extract 96. Hydrolyzed Chlorella Vulgaris Protein 97. Hydrolyzed Chondrus Crispus Extract 98. Hydrolyzed Corallina Officinalis Extract 99. Hydrolyzed Ecklonia Cava Extract 100. Hydrolyzed Enteromorpha Compressa 101. Hydrolyzed Euglena Gracilis Extract 102. Hydrolyzed Fucus Vesiculosus Extract 103. Hydrolyzed Fucus Vesiculosus Protein 104. Hydrolyzed Porphyra Yezoensis 105. Hydrolyzed Rhodophycea Extract 106. Hypnea Musciformis Extract 107. Kappaphycus Alvarezii Extract 108. Kassou 109. Kousou 110. Kousou Ekisu 111. Laminaria Angustata Extract 112. Laminaria Cloustoni Extract 113. Laminaria Digitata Extract 114. Laminaria Hyperborea Extract 115. Laminaria Japonica Extract 116. Laminaria Longissima Extract 117. Laminaria Ochotensis Extract 118. Laminaria Ochroleuca Extract 119. Laminaria Saccharina Extract 120. Lessonia Nigrescens Extract 121. Lessonia Nigrescens Powder 122. Lithothamnium Calcarum Extract 123. Lithothamnium Calcarum Powder 124. Lithothamnium Corallioides Powder 125. Macrocystis Pyrifera (Kelp) 126. Mesophyllum Lichenoides Extract 127. Monostroma Obscurum Extract 128. Nereocystis Leutkeana Extract 4

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 129. Nostoc Flagelliforme Extract 130. Odontella Aurita Oil 131. Palmaria Palmata Extract 132. Palmaria Palmata Powder 133. Pelvetia Canaliculata Extract 134. Pelvetia Siliquosa Extract 135. Phaeodactylum Tricornutum Extract 136. Phormidium Persicinum Extract 137. Phormidium Uncinatum Extract 138. Phyllacantha Fibrosa Extract 139. Phymatolithon Calcareum Extract 140. Pikea Robusta Extract 141. Pleurochrysis Carterae Extract 142. Polysiphonia Lanosa Extract 143. Porphyra Linearis Powder 144. Porphyra Tenera Extract 145. Porphyra Umbilicalis Extract 146. Porphyra Umbilicalis Powder 147. Porphyra Yezoensis Extract 148. Porphyra Yezoensis Powder 149. Porphyridium Cruentum Extract 150. Porphyridium Purpureum Extract 151. Pyrocystis Noctiluca Extract 152. Pytocystis Noctiluca Lysate 153. Ransou Ekisu 154. Rhodymenia Palmata Extract 155. Rissoella Verruculosa Extract 156. Sahel Scenedesmus Extract 157. Sarcodiotheca Gaudichaudii Extract 158. Sargachromanol D 159. Sargachromanol E 160. Sargachromanol F 161. Sargassum Filipendula Extract 162. Sargassum Fulvellum Extract 163. Sargassum Fusiforme Extract 164. Sargassum Horneri Extract 165. Sargassum Muticum Extract 5

Group/INGREDIENT NAME Ginkgo GINKGO BILOBA LEAF EXTRACT Uses 2013 530 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 166. Sargassum Vulgare Extract 167. Sphacelaria Scoparia Extract 168. Spirulina Maxima Powder 169. Spirulina Platensis Extract 170. Spirulina Platensis Powder 171. Spirulina Subsalsa Extract 172. Thalassiosira Pseudonana Extract 173. Ulva Lactuca Extract 174. Ulva Lactuca Powder 175. Ulva Pertusa Extract 176. Undaria Pinnatifida Extract (177) 1. Ginkgo Biflavones 2. Ginkgo Biloba Leaf 3. Ginkgo Biloba Leaf Powder 4. Ginkgo Biloba Leaf Water 5. Ginkgo Biloba Meristem Cell 6. Ginkgo Biloba Nut Extract 7. Ginkgo Biloba Root Extract 8. Ginkgo Leaf Terpenoids (9) Phosphoglycerides PHOSPHOLIPIDS 527 R O 1. Hydrolyzed Phospholipids O 2. Phosphatidic Acid 3. Phosphatidylglycerol 4. Phosphatidylserine (5) O O R O O P O OH R' 6

Group/INGREDIENT NAME SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE Uses Structure/Formula/Description Ingredient Group Potential Add-ons 2013 (Total # in Ingredient Group) 473 None (1) 7 Styrene and Vinyl-type Styrene Copolymers ETHYLENE/PROPYLENE/ STYRENE COPOLYMER BUTYLENE/ETHYLENE/ STYRENE COPOLYMER 449 435 1. Acrylates/Ethylhexyl Acrylate/Styrene Copolymer 2. Butyl Acrylate/Styrene Copolymer 3. C4-6 Olefin/Styrene Copolymer 4. C5-6 Olefin/Styrene Copolymer 5. Hydrogenated Butadiene/Isoprene/Styrene Copolymer 6. Hydrogenated Butylene/Ethylene/Styrene Copolymer 7. Hydrogenated Ethylene/Propylene/Styrene Copolymer 8. Hydrogenated Styrene/Butadiene Copolymer 9. Hydrogenated Styrene/Isoprene Copolymer 10. Isobutylene/Styrene Copolymer 11. Methacrylic Acid/Styrene/VP Copolymer 12. Methylstyrene/Vinyltoluene Copolymer 13. Polystyrene 14. Polystyrene/Hydrogenated Polyisopentene Copolymer 15. Sodium Methacrylate/Styrene Copolymer

8 Group/INGREDIENT NAME Uses 2013 PEGylated Alkyl Glycerides PEG-6 CAPRYLIC/CAPRIC GLYCERIDES 448 Structure/Formula/Description Sub-components of the ingredients in the PEGylated Oils report. Ingredient Group Potential Add-ons (Total# in Ingredient Group) 16. Sodium Styrene/Acrylates Copolymer 17. Sodium Styrene/Acrylates/Ethylhexyl Acrylate/Lauryl Acrylate Copolymer 18. Styrene/Acrylates Copolymer 19. Styrene/Acrylates/Ethylhexyl Acrylate/Lauryl Acrylate Copolymer 20. Styrene/Butadiene Copolymer 21. Styrene/Isoprene Copolymer 22. Styrene/Methylstyrene Copolymer 23. Styrene/Stearyl Methacrylate Crosspolymer 24. Styrene/VA Copolymer 25. Styrene/VP Copolymer (27) 1. PEG-6 Almond Glycerides 2. PEG-20 Almond Glycerides 3. PEG-35 Almond Glycerides 4. PEG-60 Almond Glycerides 5. PEG-192 Apricot Kernel Glycerides 6. PEG-11 Avocado Glycerides 7. PEG-14 Avocado Glycerides 8. PEG-11 Babassu Glycerides 9. PEG-42 Babassu Glycerides 10. PEG-4 Caprylic/Capric Glycerides 11. PEG-7 Caprylic/Capric Glycerides 12. PEG-8 Caprylic/Capric Glycerides 13. PEG-11 Cocoa Butter Glycerides 14. PEG-75 Cocoa Butter Glycerides 15. PEG-7 Cocoglycerides 16. PEG-9 Cocoglycerides 17. PEG-20 Corn Glycerides 18. PEG-60 Corn Glycerides 19. PEG-20 Evening Primrose Glycerides 20. PEG-60 Evening Primrose Glycerides 21. PEG-5 Hydrogenated Corn Glycerides 22. PEG-8 Hydrogenated Fish Glycerides 23. PEG-20 Hydrogenated Palm Glycerides 24. PEG-16 Macadamia Glycerides

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 25. PEG-70 Mango Glycerides 26. PEG-13 Mink Glycerides 27. PEG-25 Moringa Glycerides 28. PEG-42 Mushroom Glycerides 29. PEG-2 Olive Glycerides 30. PEG-6 Olive Glycerides 31. PEG-7 Olive Glycerides 32. PEG-10 Olive Glycerides 33. PEG-40 Olive Glycerides 34. PEG-18 Palm Glycerides 35. PEG-12 Palm Kernel Glycerides 36. PEG-45 Palm Kernel Glycerides 37. PEG-60 Passiflora Edulis Seed Glycerides 38. PEG-60 Passiflora Incarnata Seed Glycerides 39. PEG-45 Safflower Glycerides 40. PEG-60 Shea Butter Glycerides 41. PEG-75 Shea Butter Glycerides 42. PEG-75 Shorea Butter Glycerides 43. PEG-35 Soy Glycerides 44. PEG-75 Soy Glycerides 45. PEG-2 Sunflower Glycerides 46. PEG-7 Sunflower Glycerides 47. PEG-10 Sunflower Glycerides 48. PEG-13 Sunflower Glycerides 49. PEG-5 Tsubakiate Glycerides 50. PEG-10 Tsubakiate Glycerides 51. PEG-20 Tsubakiate Glycerides 52. PEG-60 Tsubakiate Glycerides (53) 9

Group/INGREDIENT NAME Avena Sativa AVENA SATIVA (OAT) KERNEL EXTRACT Centella Asiatica Uses 2013 444 CENTELLA ASIATICA EXTRACT 420 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 53. Avena Sativa (Oat) Bran 54. Avena Sativa (Oat) Bran Extract 55. Avena Sativa (Oat) Flower/Leaf/Stem Juice 56. Avena Sativa (Oat) Kernel Flour 57. Avena Sativa (Oat) Kernel Meal 58. Avena Sativa (Oat) Kernel Oil 59. Avena Sativa (Oat) Kernel Protein 60. Avena Sativa (Oat) Leaf Extract 61. Avena Sativa (Oat) Leaf/Stalk Extract 62. Avena Sativa (Oat) Leaf/Stem Extract 63. Avena Sativa (Oat) Meal Extract 64. Avena Sativa (Oat) Meristem Cell Extract 65. Avena Sativa (Oat) Peptide 66. Avena Sativa (Oat) Protein Extract 67. Avena Sativa (Oat) Seed Water 68. Avena Sativa (Oat) Sprout Oil 69. Avena Sativa (Oat) Starch 70. Avena Sativa (Oat) Straw Extract (19) 1. Centella Asiatica Callus Culture 2. Centella Asiatica Flower/Leaf/Stem Extract 3. Centella Asiatica Leaf Cell Culture Extract 4. Centella Asiatica Leaf Extract 5. Centella Asiatica Leaf Water 6. Centella Asiatica Meristem Cell Culture 7. Centella Asiatica Meristem Cell Culture Extract 8. Centella Asiatica Root Extract (9) 10

Group/INGREDIENT NAME PEG-150 PENTAERYTHRITYL TETRASTEARATE Uses Structure/Formula/Description Ingredient Group Potential Add-ons 2013 (Total# in Ingredient Group) 408 None (1) Alkoxy Polysiloxanes CETYL PEG/PPG-10/1 DIMETHICONE 11 387 1. Behenoxy Dimethicone 2. Bis-Cetyl/PEG-8 Cetyl PEG-8 Dimethicone 3. Bis-Hydroxyethoxypropyl Dimethicone 4. Bis-PEG/PPG-14/14 Dimethicone 5. Bis-PEG/PPG-15/5 Dimethicone 6. Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone 7. Bis-PEG/PPG-18/6 Dimethicone 8. Bis-PEG/PPG-20/20 Dimethicone 9. Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone 10. Bis-PEG-1 Dimethicone 11. Bis-PEG-12 Dimethicone 12. Bis-PEG-12 Dimethicone Beeswax 13. Bis-PEG-12 Dimethicone Candelillate 14. Bis-PEG-15 Methyl Ether Dimethicone 15. Bis-PEG-20 Dimethicone 16. Bis-PEG-4 Dimethicone 17. Bis-PEG-8 Dimethicone 18. Bis-Stearoxyethyl Dimethicone 19. Cetyl PEG/PPG-10/1 Dimethicone 20. Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone 21. Cetyl PEG/PPG-7/3 Dimethicone 22. Cetyl PEG-8 Dimethicone 23. Dimethicone Copolyol 24. Dimethicone/PPG-20 Crosspolymer 25. Lauryl Dimethicone PEG-15

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) Crosspolymer 26. Lauryl Dimethicone/Polyglycerin-3 Crosspolymer 27. Lauryl PEG/PPG-18/18 Methicone 28. Lauryl PEG-10 Methyl Ether Dimethicone 29. Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone 30. Lauryl PEG-8 Dimethicone 31. Lauryl PEG-8 PPG-8 Dimethicone 32. Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone 33. Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone 34. Methoxy PEG/PPG-25/4 Dimethicone 35. Methoxy PEG-13 Ethyl Polysilsesquioxane 36. PEG/PPG-10/2 Dimethicone 37. PEG/PPG-10/3 Oleyl Ether Dimethicone 38. PEG/PPG-12/16 Dimethicone 39. PEG/PPG-12/18 Dimethicone 40. PEG/PPG-14/4 Dimethicone 41. PEG/PPG-15/15 Dimethicone 42. PEG/PPG-15/5 Dimethicone 43. PEG/PPG-16/2 Dimethicone 44. PEG/PPG-16/8 Dimethicone 45. PEG/PPG-17/18 Dimethicone 46. PEG/PPG-18/12 Dimethicone 47. PEG/PPG-18/18 Dimethicone 48. PEG/PPG-18/6 Dimethicone 49. PEG/PPG-19/19 Dimethicone 50. PEG/PPG-20/15 Dimethicone 51. PEG/PPG-20/20 Dimethicone 52. PEG/PPG-20/22 Butyl Ether Dimethicone 53. PEG/PPG-20/22 Methyl Ether 12

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) Dimethicone 54. PEG/PPG-20/23 Dimethicone 55. PEG/PPG-20/29 Dimethicone 56. PEG/PPG-20/6 Dimethicone 57. PEG/PPG-22/22 Butyl Ether Dimethicone 58. PEG/PPG-22/23 Dimethicone 59. PEG/PPG-22/24 Dimethicone 60. PEG/PPG-23/23 Butyl Ether Dimethicone 61. PEG/PPG-23/6 Dimethicone 62. PEG/PPG-24/18 Butyl Ether Dimethicone 63. PEG/PPG-25/25 Dimethicone 64. PEG/PPG-27/27 Dimethicone 65. PEG/PPG-27/9 Butyl Ether Dimethicone 66. PEG/PPG-3/10 Dimethicone 67. PEG/PPG-30/10 Dimethicone 68. PEG/PPG-4/12 Dimethicone 69. PEG/PPG-6/11 Dimethicone 70. PEG/PPG-8/14 Dimethicone 71. PEG/PPG-8/26 Dimethicone 72. PEG-10 Dimethicone 73. PEG-10 Dimethicone Crosspolymer 74. PEG-10 Dimethicone/Vinyl Dimethicone Crosspolymer 75. PEG-10 Methyl Ether Dimethicone 76. PEG-10/Lauryl Dimethicone Crosspolymer 77. PEG-11 Methyl Ether Dimethicone 78. PEG-12 Dimethicone 79. PEG-12 Dimethicone Crosspolymer 80. PEG-12 Dimethicone/Bis-Isobutyl PPG- 20 Crosspolymer 81. PEG-14 Dimethicone 82. PEG-15/Lauryl Dimethicone 13

Group/INGREDIENT NAME Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) Crosspolymer 83. PEG-15/Lauryl Polydimethylsiloxyethyl Dimethicone Crosspolymer 84. PEG-17 Dimethicone 85. PEG-3 Dimethicone 86. PEG-32 Methyl Ether Dimethicone 87. PEG-4 PEG-12 Dimethicone 88. PEG-6 Dimethicone 89. PEG-6 Methyl Ether Dimethicone 90. PEG-7 Dimethicone 91. PEG-7 Methyl Ether Dimethicone 92. PEG-8 Cetyl Dimethicone 93. PEG-8 Dimethicone 94. PEG-8 Dimethicone Dimer Dilinoleate 95. PEG-8 Dimethicone/Dimer Dilinoleic Acid Copolymer 96. PEG-8 Methicone 97. PEG-8 Methyl Ether Dimethicone 98. PEG-8 Methyl Ether Triethoxysilane 99. PEG-8 PEG-4 Dimethicone 100. PEG-8 PPG-8 Dimethicone 101. PEG-9 Dimethicone 102. PEG-9 Methyl Ether Dimethicone 103. PEG-9 Polydimethylsiloxyethyl Dimethicone 104. Polysilicone-13 105. PPG-12 Butyl Ether Dimethicone 106. PPG-12 Dimethicone 107. PPG-2 Dimethicone 108. PPG-25 Dimethicone 109. PPG-27 Dimethicone 110. PPG-4 Oleth-10 Dimethicone 111. Stearoxy Dimethicone (112) 14

Group/INGREDIENT NAME Pyrus Malus PYRUS MALUS (APPLE) FRUIT EXTRACT Potassium Alkyl Phosphates Uses 2013 382 POTASSIUM CETYL PHOSPHATE 377 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 1. Pyrus Malus (Apple) Bark Extract 2. Pyrus Malus (Apple) Carpel Powder 3. Pyrus Malus (Apple) Fiber 4. Pyrus Malus (Apple) Flower Extract 5. Pyrus Malus (Apple) Fruit 6. Pyrus Malus (Apple) Fruit Water 7. Pyrus Malus (Apple) Juice 8. Pyrus Malus (Apple) Leaf Extract 9. Pyrus Malus (Apple) Pectin Extract 10. Pyrus Malus (Apple) Peel Extract 11. Pyrus Malus (Apple) Peel Powder 12. Pyrus Malus (Apple) Peel Wax 13. Pyrus Malus (Apple) Pulp Extract 14. Pyrus Malus (Apple) Root Bark Powder 15. Pyrus Malus (Apple) Root Extract 16. Pyrus Malus (Apple) Seed Extract 17. Pyrus Malus (Apple) Seed Oil 18. Pyrus Malus (Apple) Stem Extract (19) 1. Potassium C9-15 Alkyl Phosphate 2. Potassium C11-15 Alkyl Phosphate 3. Potassium C12-13 Alkyl Phosphate 4. Potassium C12-14 Alkyl Phosphate 5. Potassium Lauryl Phosphate (6) (Potential # of Ingredients: 445) 15

2014 CIR Re-Review Priority List June 2013 Group/INGREDIENT NAME Function (1982) Glyceryl Mono-Esters GLYCERYL STEARATE GLYCERYL STEARATE SE Uses 2013 4744 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 1. Glyceryl Abietate 2. Glyceryl Abietate/Maleate 3. Glyceryl Acetate 4. Glyceryl Adipate 5. Glyceryl Alginate 6. Glyceryl Arachidate 7. Glyceryl Arachidonate 8. Glyceryl Behenate 9. Glyceryl Behenate/Eicosadioate 10. Glyceryl Caprate 11. Glyceryl Caprylate 12. Glyceryl Caprylate/Caprate 13. Glyceryl Citrate/Lactate/Linoleate/Oleate 14. Glyceryl Cocoate 15. Glyceryl Cocoate/Citrate/Lactate 16. Glyceryl Collagenate 17. Glyceryl Erucate 18. Glyceryl Ethylhexanoate 19. Glyceryl Ethylhexanoate Dimethoxycinnamate 20. Glyceryl Ethylhexanoate/Stearate/Adipate 21. Glyceryl Glycyrrhetinate 22. Glyceryl Heptanoate 23. Glyceryl Hydrogenated Rapeseedate 24. Glyceryl Hydrogenated Rosinate 25. Glyceryl Hydrogenated Soyate 26. Glyceryl Hydroxystearate 27. Glyceryl Hydroxystearate/Oleate Esters 28. Glyceryl Isopalmitate 29. Glyceryl Isostearate 30. Glyceryl Isostearate/Myristate 31. Glyceryl Isostearates 1

Group/INGREDIENT NAME Function Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 32. Glyceryl Isotridecanoate/Stearate/Adipate 33. Glyceryl Lanolate 34. Glyceryl Laurate 35. Glyceryl Laurate Diacetate 36. Glyceryl Laurate/Oleate 37. Glyceryl Laurate SE 38. Glyceryl Linoleate 39. Glyceryl Linolenate 40. Glyceryl Montanate 41. Glyceryl Myristate 42. Glyceryl Oleate 43. Glyceryl Oleate Citrate 44. Glyceryl Oleate/Elaidate 45. Glyceryl Oleate SE 46. Glyceryl Olivate 47. Glyceryl Palmitate 48. Glyceryl Palmitate Lactate 49. Glyceryl Palmitate/Stearate 50. Glyceryl Palmitoleate 51. Glyceryl Pentadecanoate 52. Glyceryl Polyacrylate 53. Glyceryl/Polyglyceryl-6 Isostearate/Behenate Esters 54. Glyceryl Polyisobutenylsuccinate 55. Glyceryl Polymethacrylate 56. Glyceryl Ricinoleate 57. Glyceryl Ricinoleate SE 58. Glyceryl Rosinate 59. Glyceryl Sesquioleate 60. Glyceryl/Sorbitol Oleate/Hydroxystearate 61. Glyceryl Stearate/Acetate 62. Glyceryl Stearate Citrate 63. Glyceryl Stearate Diacetate 64. Glyceryl Stearate Lactate 65. Glyceryl Stearate/Malate 66. Glyceryl Stearates 67. Glyceryl Stearate Succinate 2

Group/INGREDIENT NAME Function (1984) Polysorbates Polysorbate-20 Polysorbate-21 Polysorbate-40 Polysorbate-60 Polysorbate-61 Polysorbate-65 Polysorbate-80 Polysorbate-81 Polysorbate-85 Uses 2013 1434 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 68. Glyceryl Tallowate 69. Glyceryl Thioglycolate 70. Glyceryl Thiopropionate 71. Glyceryl Tribehenate/Isostearate/Eicosandioate 72. Glyceryl Tripalmate/Palm Kernelate/Olivate/Macadamiate/ Rapeseedate 73. Glyceryl Undecylenate (75) 1. PEG-20 Sorbitan Cocoate 2. PEG-40 Sorbitan Diisostearate 3. PEG-2 Sorbitan lsostearate 4. PEG-5 Sorbitan lsostearate 5. PEG-20 Sorbitan Isostearate 6. PEG-40 Sorbitan Lanolate 7. PEG-75 Sorbitan Lanolate 8. PEG-10 Sorbitan Laurate 9. PEG-40 Sorbitan Laurate 10. PEG-44 Sorbitan Laurate 11. PEG-75 Sorbitan Laurate 12. PEG-80 Sorbitan Laurate 13. PEG-3 Sorbitan Oleate 14. PEG-6 Sorbitan Oleate 15. PEG-80 Sorbitan Palmitate 16. PEG-40 Sorbitan Perisostearate 17. PEG-40 Sorbitan Peroleate 18. PEG-3 Sorbitan Stearate 19. PEG-6 Sorbitan Stearate 20. PEG-40 Sorbitan Stearate 21. PEG-60 Sorbitan Stearate 22. PEG-20 Sorbitan Tetraoleate 23. PEG-30 Sorbitan Tetraoleate 24. PEG-40 Sorbitan Tetraoleate 25. PEG-60 Sorbitan Tetraoleate 26. PEG-60 Sorbitan Tetrastearate 27. PEG-20 Sorbitan Triisostearate 28. PEG-160 Sorbitan Triisostearate 3

Group/INGREDIENT NAME Function Ascorbic Acid, Esters, and Phosphates ASCORBYL PALMITATE ASCORBYL DIPALMITATE ASCORBYL STEARATE ERYTHORBIC ACID (D-Ascorbic Acid) SODIUM ERYTHORBATE Sorbitan Esters Sorbitan Stearate Sorbitan Laurate Sorbitan Sesquioleate Sorbitan Oleate Sorbitan Tristearate Sorbitan Palmitate SorbitanTrioleate PEG-x Diesters PEG-3 Distearate PEG-4 Distearate Uses 2013 2095 931 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 29. PEG-18 Sorbitan Trioleate 30. PEG-40 Sorbitol Hexaoleate 31. PEG-50 Sorbitol Hexaoleate 32. PEG-30 Sorbitol Tetraoleate Laurate 33. PEG-60 Sorbitol Tetrastearate (42) 1. Ascorbyl Isostearate 2. Ascorbyl Linoleate 3. Linseed Oil Ascorbate Esters 4. Potassium Ascorbate 5. Trisodium Ascorbyl Isopalmitate Phosphate 6. Trisodium Ascorbyl Palmitate Phosphate 7. Zinc Ascorbate 8. L-Ascorbic Acid 9. Calcium Ascorbate 10. Magnesium Ascorbate 11. Magnesium Ascorbyl Phosphate 12. Sodium Ascorbate 13. Sodium Ascorbyl Phosphate (18) 1. Sorbitan Caprylate 2. Sorbitan Cocoate 3. Sorbitan Diisostearate 4. Sorbitan Dioleate 5. Sorbitan Distearate 6. Sorbitan Isostearate 7. Sorbitan Olivate 8. Sorbitan Palmate 9. Sorbitan Sesquicaprylate 10. Sorbitan Sesquiisostearate 11. Sorbitan Sesquistearate 12. Sorbitan Theobroma Grandiflorum Seedate 13. Sorbitan Triisostearate 14. Sorbitan Trioleate 15. Sorbitan Undecylenate (22) 1. PEG-2 Distearate 2. PEG-40 Distearate 3. PEG-190 Distearate 4. PEG-250 Distearate 4

Group/INGREDIENT NAME Function PEG-6 Distearate PEG-8 Distearate PEG-9 Distearate PEG-12 Distearate PEG-20 Distearate PEG-32 Distearate PEG-50 Distearate PEG-75 Distearate PEG-120 Distearate PEG-150 Distearate PEG-175 Distearate Uses 2013 583 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 5. PEG-150 Dibehenate 6. PEG-3 Dicaprylate/Caprate 7. PEG-4 Dicocoate 8. PEG-8 Dicocoate 9. PEG-4 Diheptanoate 10. PEG-2 Diisononanoate 11. PEG-2 Diisostearate 12. PEG-3 Diisostearate 13. PEG-4 Diisostearate 14. PEG-6 Diisostearate 15. PEG-8 Diisostearate 16. PEG-12 Diisostearate 17. PEG-90 Diisostearate 18. PEG-175 Diisostearate 19. PEG-2 Dilaurate 20. PEG-4 Dilaurate 21. PEG-6 Dilaurate 22. PEG-8 Dilaurate 23. PEG-12 Dilaurate 24. PEG-16 Dilaurate 25. PEG-20 Dilaurate 26. PEG-32 Dilaurate 27. PEG-75 Dilaurate 28. PEG-150 Dilaurate 29. PEG-2 Dioleate 30. PEG-3 Dioleate 31. PEG-4 Dioleate 32. PEG-6 Dioleate 33. PEG-8 Dioleate 34. PEG-10 Dioleate 35. PEG-12 Dioleate 36. PEG-20 Dioleate 37. PEG-32 Dioleate 38. PEG-75 Dioleate 39. PEG-150 Dioleate 40. PEG-3 Dipalmitate 41. PEG-8 Ditallate 5

Group/INGREDIENT NAME Function Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) 42. PEG-12 Ditallate (55) PG Esters Propylene Glycol (PG) Dicaprylate PG Dicaprylate/ Dicaprate PG Dicocoate PG Dipelargonate PG lsostearate PG Laurate PG Myristate PG Oleate PG Oleate SE 531 1. Propylene Glycol Behenate 2. Propylene Glycol Caprylate 3. Propylene Glycol Cocoate 4. Propylene Glycol Heptanoate 5. Propylene Glycol Linoleate 6. Propylene Glycol Linolenate 7. Propylene Glycol Stearate 8. Propylene Glycol Stearate SE 9. Soybean Oil Propylene Glycol Esters 10. Propylene Glycol Dicaprate 11. Propylene Glycol Dicaproate 12. Propylene Glycol Diethylhexanoate 13. Propylene Glycol Diisononanoate 14. Propylene Glycol Distearate 15. Propylene Glycol Diundecanoate (28) PG Dioleate PG Dicaprate PG Diisostearate PG Dilaurate 6 Nonoxynols Nonoxynol-1 Nonoxynol-2 Nonoxynol-3 Nonoxynol-4 Nonoxynol-5 Nonoxynol-6 Nonoxynol-7 Nonoxynol-8 126 1. Nonoxynol-9 2. Nonoxynol-10 3. Nonoxynol-11 4. Nonoxynol-12 5. Nonoxynol-13 6. Nonoxynol-14 7. Nonoxynol-15 8. Nonoxynol-18 9. Nonoxynol-20 10. Nonoxynol-23 11. Nonoxynol-25 12. Nonoxynol-30 13. Nonoxynol-35 14. Nonoxynol-40 15. Nonoxynol-44

Group/INGREDIENT NAME Function Polyether Glyceryl Cocoates PEG-7 GLYCERYL COCOATE PEG-30 GLYCERYL COCOATE PEG-40 GLYCERYL COCOATE PEG-78 GLYCERYL COCOATE PEG-80 GLYCERYL COCOATE Uses 2013 827 Structure/Formula/Description Ingredient Group Potential Add-ons (Total# in Ingredient Group) 16. Nonoxynol-50 17. Nonoxynol-70 18. Nonoxynol-100 19. Nonoxynol-120 (27) 1. PEG-3 Glyceryl Cocoate 2. PEG/PPG-6/2 Glyceryl Cocoate 3. PPG/PEG-2/10 Glyceryl Cocoate (8) 7 BISABOLOL 995 None (1) PCA and Alkaline Earth Metal Salts SODIUM PCA PCA 1256 HYDROXYSTEARIC ACID 118 None (1) ISOSTEARAMIDOPROPYL 289 None (1) MORPHOLINE LACTATE PPG-x Diethylmonium Chlorides PPG-9 DIETHYLMONIUM CHLORIDE 9 None (3) PPG-25 DIETHYLMONIUM 1. Calcium PCA 2. Magnesium PCA 3. Potassium PCA (5)

Group/INGREDIENT NAME Function CHLORIDE Uses 2013 Structure/Formula/Description Ingredient Group Potential Add-ons (Total # in Ingredient Group) PPG-40 DIETHYLMONIUM CHLORIDE 8

Memorandum Commitment & Credibility since 1976 To: From: CIR Expert Panel Members and Liaisons F. Alan Andersen Director Date: May 17, 2013 Subject: New Information on Formaldehyde and Methylene Glycol Attached is a letter we received from the Professional Keratin Smoothing Council announcing the group s intent to provide the Panel with: 1) proposal for a maximum safe concentration of methylene glycol in keratin smoothing products, and 2) additional recommended safe use practices. The PKSC has indicated that it would make a presentation to the Panel at the June meeting and time has been set aside on the first day of the meeting for that presentation. The Panel should consider this information along with new test data on methylene glycol and determine if the safety assessment of formaldehyde and methylene glycol should be re opened. 1101 17th Street, NW Suite 412, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) cirinfo@cir-safety.org (Website) www.cir-safety.org