Download Admin Book: Memo, Agenda, Minutes, Aerosols, Format, Priorities

145 Pages·2016·12.31 MB·English

by  Julia Linthicum

ADMIN
Memo
Agenda
Minutes
Aerosols BP
Format
Priorities
Gingko
PHMB
2017 Priorities

CIR EXPERT PANEL MEETING
MARCH 31 – APRIL 1, 2016
Distributed for Comment Only -- Do Not Cite or Quote

Commitment & Credibility since 1976
MEMORANDUM

To: CIR Expert Panel Members and Liaisons
From: Director, CIR
Subject: 138th Meeting of the CIR Expert Panel — Thursday and Friday, March 31- April1, 2016
Date: March 7, 2016

Welcome to the first meeting of the year! Enclosed are the agenda and accompanying materials for the
138th CIR Expert Panel Meeting to be held on March 31-April 1, 2016. We have a new location for our
2016 Panel meetings. This year, all meetings will be held at the Melrose Georgetown Hotel which is
located at 2430 Pennsylvania Ave., Washington, DC. Phone: [phone]; Fax: [phone]. The
hotel is located close to the Foggy Bottom Metro Station.

The meeting agenda includes consideration of 15 ingredient groups advancing in the review process. In
addition to these reports, the agenda also includes a review of the final draft of the CIR format for safety
assessments as well as CIR responses to Industry’s comments on the proposed revisions. At the
December 2015 meeting, the Panel discussed a response from the CIR Science and Support Committee
(CIR SSC) regarding incidental inhalation exposures to ingredients in cosmetic products. The revised
Aerosols Precedents Document and Framework, which incorporates information from the CIR SSC, is
available for your review. A number of reports on the agenda contain the revised language.

There are 3 agenda issues related to CIR priorities: Gingko biloba, Polyaminopropyl Biguanide (PHMB)
and the 2017 CIR Priorities. CIR is evaluating the use of the CIR SSC botanicals assessment framework
and decision tree to assess the safety of Gingko Biloba Leaf Extract, a 2016 priority list ingredient, and is
asking for the Panel’s guidance on using this approach. Although PHMB does not meet the criteria for
the CIR priority list (low frequency of use and no submission for cause), there is a recent opinion on the
safe use of this preservative by the European Commission’s Scientific Committee on Consumer Safety
(SCCS). CIR is requesting the Panel’s guidance on the review of this ingredient. Lastly, the draft 2017
CIR Priority List of ingredients is included for the Panel’s review and discussion. This list will be published
for public comment and finalized at the June 2016 meeting.

Schedule and hotel accommodations

We have reserved rooms for the nights of Wednesday March 30 and Thursday March 31, at the Melrose
Georgetown Hotel. If you encounter travel problems, please contact me on my cell phone at 410-299-
0777.

Team meetings

Re-reviews – there are 2 safety assessments to re-review and decide not reopen, or, determine the need
to re-open to revise the conclusion.

1. Sarcosines and Sarcosinate Amides (agenda and flash drive name – sarcosine) – Sarcosines
and Sarcosinate Amides were reviewed previously (published in 2001) with the conclusion that 5
acyl sarcosines and 5 fatty acid sarcosinate amides are safe as used in rinse-off products, safe
for use in leave-on products at concentrations ≤5%, and the data are insufficient to determine the
Distributed for Comment Only -- Do Not Cite or Quote
safety for use in products where the sarcosines and sarcosinates are likely to be inhaled. These
ingredients should not be used in cosmetic products in which N -nitroso compounds may be
formed. Much of the new toxicity data were found on the ECHA website. Four ingredients are
proposed for addition to this family. If the Panel agrees that the data in the existing reports and
the new data presented in this re-review document, support the safety of these proposed
ingredients, the Panel should re-open this assessment and add these ingredients.

2. Sodium Sulfate (agenda and flash drive name – sodium sulfate) – Anhydrous and decahydrate
forms of Sodium Sulfate were previously reviewed (published in 2000) with the conclusion that
Sodium Sulfate is safe as used in rinse-off formulations and safe for use up to a concentration of
1% in leave-on formulations. Information from the published literature and unpublished data from
the European Chemicals Agency (ECHA) website were added to this report. Frequency of use
has increased considerably (777 uses up from 28). However concentrations of use, where
reported in the original assessment have slightly increased.

Draft reports - there are 5 draft reports for review.

1. Acryloyldimethyltaurate Polymers (agenda and flash drive name – dimethyltaurate polymers) –
This is the first time that the Panel is seeing a report on this group of 22 ingredients, which
function as dispersing agents – nonsurfactant, emulsion stabilizers, opacifying agents, and
viscosity increasing agents – aqueous. The Scientific Literature Review (SLR) was announced
for public comment on January 14, 2016. Are the data sufficient to proceed with a tentative report,
or should an insufficient data announcement be issued?

2. Keratin and Keratin-Derived Ingredients (agenda and flash drive name – keratin) – This is the first
time that the Panel is seeing this report on 8 ingredients derived from the keratin family of
proteins. The Scientific Literature Review (SLR) was announced for public comment on
December 10, 2015. These ingredients, which may be derived from many different sources, such
as human hair, bird feathers, and sheep wool, mainly function as skin and hair conditioning
agents. Is the information sufficient to proceed with a tentative report of safety, or should an
insufficient data announcement be issued?

3. Phosphoric Acid and Simple Salts (agenda and flash drive name – phosphoric acid) – This is the
first time that the Panel is seeing this report on 31 ingredients that are reported to function as
buffering agents, corrosion inhibitors, chelating agents, and pH adjusters. The Scientific
Literature Review (SLR) was announced for public comment on November 17, 2015. These
ingredients are reported to be used at maximum use concentrations up to 58% in leave-on skin
preparations. Are the available data sufficient for issuing a tentative report with a safe as used or,
safe with qualifications conclusion, or should an insufficient conclusion be issued?

4. Polyglyceryl Fatty Acid Esters (agenda and flash drive name – polyglyceryl fatty acid) – This is
the first time the Panel is seeing this report on 275 ingredients that are structurally constituted of
the esterification products of polyglycerin chains and fatty acids. The Scientific Literature Review
was issued on January 19, 2016. Most of these ingredients are reported to function as skin-
conditioning agents and/or surfactants. Are the available data sufficient for issuing a tentative
report with a safe as used or, safe with qualifications conclusion, or should an insufficient
conclusion be issued?

5. Rosa canina-derived Ingredients (agenda and flash drive name – Rosa canina) – This is the first
time that the Panel is seeing this report on 11 ingredients which are reported to function as skin
conditioning agents, fragrance ingredients, cosmetic astringents, anti-acne agents, abrasives,
humectants, and exfoliants. The Scientific Literature Review was issued on January 14, 2016.
Do we need more data or can we proceed to issue a tentative report?
Distributed for Comment Only -- Do Not Cite or Quote
Tentative reports – there are 2 draft tentative reports.

1. Chamomilla Recutita-Derived Ingredients (agenda and flash drive name – Chamomilla recutita) –
At the September 2015 CIR Panel meeting, the Panel reopened the final report on Chamomilla
recutita-derived ingredients issued at the December 2013 Panel meeting. Additional data were
submitted in response to the Panel’s December 2013 determination that the available data are
insufficient for determining the safety of 7 (of 12) ingredients derived from chamomilla recutita.
The Panel should consider the new information and decide whether to change or to reaffirm the
existing conclusion.

2. Helianthus annuus (Sunflower)-Derived Ingredients (agenda and flash drive name – Helianthus
annuus) – At the December 2015 meeting, the Panel issued an insufficient data announcement
for the 13 ingredients in this report. Data requested on HRIPT, method of manufacture and
composition data were received. The Panel also requested more information on the 2S-albumin
fraction of sunflower seeds, and its potential to cause allergenicity. A summary of the published
research on the 2S-albumin fractions of seeds and nuts is attached to memo to the Panel for the
sunflower-derived ingredients. If the information is still insufficient, then a tentative report with a
conclusion of insufficient data should be issued. If the information is sufficient, the Panel should
issue a tentative report with an appropriate discussion and conclusion.

Final reports - there are 6 draft final reports for consideration. After reviewing these drafts, especially the
rationales provided in the Discussion sections, the Panel should issue them as final reports, as
appropriate.

1. Alkonium Clays (agenda and flash drive name – alkonium clays) – At the December 2015
meeting, the Panel issued a revised tentative report for public comment with the conclusion that 8
alkonium clays are safe when formulated to be non-irritating. No additional data have been
submitted. Technical comments have been addressed.

2. Apple-derived Ingredients (agenda and flash drive name – apple). At the December 2015
meeting, the Panel issued a tentative report for public comment with the conclusion that 21 apple-
derived ingredients are safe when formulated to be non-irritating and non-sensitizing. The Panel
further concluded that the available data are not sufficient to evaluate the safety of 5 other apple-
derived ingredients. Pyrus malus (apple) seed oil and malus domestica (apple) seed oil, which
are names for the same ingredient, were removed from the safety assessment because pyrus
malus (apple) seed oil was previously evaluated in the CIR safety assessment on plant-derived
fatty acid oils. No new data have been received. Technical comments have been addressed.

3. Hexamethylene Diisocyanate (HDI) Polymers (agenda and flash drive name – HDI). At the
December 2015 meeting, the Panel issued (1) a tentative report with the conclusion that 7 HDI
polymers are safe as used, and (2) an insufficient data conclusion for 12 HDI polymers reviewed.
Additional data on molecular weight and residual monomers were submitted. Industry suggests
that existing data are sufficient to support the safety of 9 polymers currently determined by the
Panel to have insufficient data. Technical comments have been addressed.

4. 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate (agenda and flash drive name – pyrazole hair dye)
– At the December 2015 meeting, the Panel issued a tentative report with the conclusion that this
ingredient is safe as an oxidative hair dye ingredient in the present practices of use and
concentration. Updated frequency of use data were added. Technical comments have been
addressed.

5. Polymerized Tetramethylcyclotetrasiloxanes (agenda and flash drive name cyclotetrasiloxanes) –
At the December 2015 meeting, the Panel issued a tentative report with the conclusion that these
3 ingredients are safe in cosmetics when used as surface modifiers. Additionally, the available
data are insufficient to determine the safety when these ingredients are used independently for
other reported functions (e.g., antifoaming agents, hair conditioning agents, and viscosity
increasing agents – nonaqueous). Updated concentration of use data have been received.
Technical comments have been addressed.
Distributed for Comment Only -- Do Not Cite or Quote

6. Trimellitic Anhydride Copolymers (agenda and flash drive name – trimellitic copolymers) – At the
December 2015 meeting, the Panel issued a Tentative Report with the conclusion that 6 trimellitic
anhydride copolymers are safe for use in nail products, but the data are insufficient to determine
safety for use in all other types of cosmetic formulations. No additional unpublished data have
been received. The updated VCRP data that were received on the use of these ingredients
continue to include non-nail product uses. Technical comments have been addressed.

Full Panel Meeting

Remember, the breakfast buffet will open at 8:00 am and the meeting starts at 8:30 am on day 1 and on
day 2.

The Panel will consider the 6 reports to be issued as final safety assessments, followed by the remaining
reports advancing in the process, and finish by providing comments on report format and CIR priority
items.

The majority of the agenda involves reviewing the draft and final reports. It is likely that the full Panel
session will conclude before lunch on day 2, so plan your travel accordingly.

Have a safe journey.
Distributed for Comment Only -- Do Not Cite or Quote

Agenda
th
138 Cosmetic Ingredient Review Expert Panel Meeting
March 31- April 1, 2016
The Melrose Georgetown Hotel
2430 Pennsylvania Avenue, N.W.
Washington, D.C. 20037

Thursday, March 31
8:00 am CONTINENTAL BREAKFAST
8:30 am WELCOME TO THE 138th EXPERT PANEL TEAM MEETINGS Drs. Bergfeld/Gill
8:40 am TEAM MEETINGS Drs. Marks/Belsito

Dr. Marks’ Team Dr. Belsito’s Team*
FR (LB) alkonium clays FR (MF) trimellitic copolymers
FR (LB) cyclotetrasiloxanes DR (MF) polyglyceryl fatty acid
FR (LB) HDI RR (MF) sarcosine
TR (LB/IB) Helianthus annuus Admin (MF/IB) format
DR (LB) dimethyltaurate polymers RR (LS) sodium sulfate
FR (CB) pyrazole hair dye FR (WJ) apple
DR (CB) keratin TAR (WJ) Chamomilla recutita
Admin (CB/BH) Ginkgo biloba DR (WJ) phosphoric acid
Admin (BH) priorities DR (WJ) Rosa canina
FR (MF) trimellitic copolymers FR (LB) alkonium clays
DR (MF) polyglyceryl fatty acid FR (LB) cyclotetrasiloxanes
RR (MF) sarcosine FR (LB) HDI
Admin (MF/IB) format TR (LB/IB) Helianthus annuus
RR (LS) sodium sulfate DR (LB) dimethyltaurate polymers
FR (WJ) apple FR (CB) pyrazole hair dye
TAR (WJ) Chamomilla recutita DR (CB) keratin
DR (WJ) phosphoric acid Admin (CB/BH) Ginkgo biloba
DR (WJ) Rosa canina Admin (BH) priorities

Noon Lunch for Panel, liaisons, and staff
1:00pm Team meetings - continue as needed
5:00 pm ADJOURN DAY 1 SESSION

FR: Final report
TAR: Tentative amended report
TR: Tentative 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.
Distributed for Comment Only -- Do Not Cite or Quote

Friday, April 1
8:00 am CONTINENTAL BREAKFAST
8:30 am WELCOME TO THE 138th FULL CIR EXPERT PANEL MEETING
8:45 am Admin MINUTES OF THE December 2015 EXPERT PANEL MEETING Dr. Bergfeld
9:00 am DIRECTOR’S REPORT Dr. Gill
9:10 am FINAL REPORTS, REPORTS ADVANCING TO THE NEXT LEVEL, and OTHER DISCUSSION ITEMS

Final Reports

FR (CB) Pyrazole hair dye – Dr. Belsito reports
FR (MF) Trimellitic copolymers – Dr. Marks reports
FR (WJ) Apple – Dr. Belsito reports
FR (LB) Alkonium clays – Dr. Marks reports
FR (LB) Cyclotetrasiloxanes – Dr. Belsito reports
FR (LB) HDI – Dr. Marks reports

Reports Advancing

TR (LB/IB) Helianthus annuus – Dr. Belsito reports
DR (LB) Dimethyltaurate polymers – Dr. Marks reports
TAR (WJ) Chamomilla recutita – Dr. Belsito reports
DR (WJ) Phosphoric acid – Dr. Marks reports
DR (WJ) Rosa canina – Dr. Belsito reports
DR (CB) Keratin – Dr. Marks reports
DR (MF) Polyglyceryl fatty acid – Dr. Belsito reports

Re-Reviews

RR (MF) Sarcosine – Dr. Marks reports
RR (LS) Sodium sulfate – Dr. Belsito reports

Other Discussion Items

Admin (CB/BH) Gingko biloba– Dr. Marks reports
Admin (MF/IB) Format – Dr. Belsito reports
Admin (BH) Priorities – Dr. Marks reports

ADJOURN - Next meeting Monday and Tuesday, June 6-7, 2016 at The Melrose Georgetown Hotel, 2430 Pennsylvania
Avenue, NW, Washington, DC 20037

FR: Final report
TAR: Tentative amended report
TR: Tentative report
DR: Draft report
RR: Re-review
Distributed for Comment Only -- Do Not Cite or Quote
ONE HUNDRED THIRTY-SEVENTH MEETING

OF THE

EXPERT PANEL

December 14-15, 2015

DoubleTree by Hilton Hotel

Washington, D.C.

Expert Panel Members Liaison Representatives
Wilma F. Bergfeld, M.D., Chair Consumer
Donald V. Belsito, M.D. Michael Best, Esq.
Ronald A. Hill, Ph.D.
Curtis D. Klaassen, Ph.D. Industry
Daniel C. Liebler, Ph.D. Beth A. Lange, Ph.D.
James G. Marks, Jr., M.D.
Ronald C. Shank, Ph.D.
Thomas J. Slaga, Ph.D. Government

Paul W. Snyder, D.V.M., Ph.D. Linda Katz, MD., M.P.H.

Adopted (Date)

Wilma F. Bergfeld, M.D.
Distributed for Comment Only -- Do Not Cite or Quote

Others Present at the Meeting

Robena Am FDA
Lillian Becker CIR
Don Bjerke P & G
Ivan Boyer CIR
Christina Burnett CIR
Kapal Dewa FDA
Carol Eisenmann PCPC
Monice Fiume CIR
Kevin Fries CIR
Fernando Garcia
Lillian Gill CIR
James V. Hagan Elementis
Bart Heldreth CIR
Carla Jackson CIR
Wilbur Johnson, Jr. CIR
Christ Kanoles Elementis
Dennis Laba Presperse
Julia Linthicum CIR
Damani Parran Akzo
Alex Perez L’Oreal
Goran Peru FDA
Laura Scott CIR
Noriko Shibuya Shiseido
Tina Sigurdson EWG
David Steinberg Steinberg & Associates
Jane Vergnes B & C
Distributed for Comment Only -- Do Not Cite or Quote
MINUTES FROM THE 137th CIR EXPERT PANEL MEETING
CHAIRMAN’S OPENING REMARKS
The 137th meeting of the Cosmetic Ingredient Review (CIR) Expert Panel was called to order by Dr. Wilma
Bergfeld at 8:30 a.m. on December15, 2015, and all attendees were welcomed. She stated that 16 ingredient reports
were reviewed in Teams on the preceding day, including 8 final reports and 8 reports at the draft stage. The Panel
also reviewed a second draft of the revised CIR report format. Additional changes suggested at this meeting and
comments on the draft from the CIR Science and Support Committee (CIR SSC) will be provided to the Panel to
review at the March 2016 meeting.

In response to the Panel’s request at the September 2015 meeting for information on cosmetic powder exposures, the
CIR SSC submitted estimates of the inhalation exposures to respirable particles from the use of loose cosmetic
powders. The Panel considered the data and asked CIR to update the CIR Aerosols Precedents document and
Framework for guiding the development of CIR safety assessments to address this issue. Dr. Bergfeld noted that
CIR’s revised Aerosols Precedents document and Framework, prepared by Dr. Ivan Boyer, was reviewed in Teams,
and that the Panel plans to continue their discussion on cosmetic powder exposure at the March 2016 Panel meeting.

Finally, Dr. Bergfeld reminded the Panel of the frequent absence (data not submitted) of method of manufacturing
and composition data from CIR safety assessments on botanical ingredients, and noted that this problem related to
several reports that were reviewed at this meeting.

APPROVAL OF MINUTES

The minutes of the September 21-22, 2015 CIR Expert Panel meeting were unanimously approved, with corrections.

DIRECTOR’S REPORT

Dr. Gill highlighted the many accomplishments achieved in 2015. The Panel assessed the safety of over 500
ingredients, reaffirmed the decision on methylisothiazolinone after considering the recent SCCS opinion on this
ingredient, provided guidance on the CIR ingredient strategies and report format, rendered a decision on the first
review of ingredients incorporating a framework for evaluating analogs for read-across assessments, and responded
to numerous consumer group concerns. Presentations given in 2015 included infant skin, Quantitative Risk
Assessment (QRA), and plant cell cultures. Regarding the status of the 14 ingredients found to be insufficient in
2013 and 2014, additional information submitted to support the safety of 6 Chamomilla recutita ingredients will be
reviewed in 2016. In accordance with CIR procedures, the 7 Camellia sinensis-derived ingredients, and the
ingredient avena sativa (oat) meristem cell extract will be categorized as Use Not Supported by Data or No Reported
Use at the end of 2016 if additional data are not submitted.
Dr. Gill discussed the 2016 Panel meeting scheduling and the challenge it presents. Because the time between some
meetings is less than usual, CIR may change the review cycle for some reports. The 2016 Panel meetings will be
held at the Melrose Georgetown Hotel, in Washington, D.C.

Finally, the 2015 Compendium is scheduled to be released before the end of January. This document presents the
Abstracts, Discussions and Conclusions of all safety assessments reviewed by the CIR Expert Panel. It also includes
a Quick Reference Table that provides the safety conclusions for all ingredients reviewed by the CIR Expert Panel.

Final Safety Assessments

Alkyl Taurate Amides and Taurate Salts

The following 20 alkyl taurate amides and taurate salts were found safe as used in cosmetics when formulated to be
non-irritating: