Download Admin Book: Memo, Agenda, Minutes, Report Strategies, PEGs Cocamine

352 Pages·2014·7.07 MB·English

by  Bart Heldreth

ADMIN
Agenda
Memo
Minutes
Report Strategies
Report Strategies Unified Memo
Boric Acid Strategy
Glyceryl Esters Strategy
Botanical Ingredient Strategy: Citrus
Fruit-derived Ingredients
PEGs Cocamine

CIR EXPERT PANEL MEETING
DECEMBER 8-9, 2014
Agenda
rd
133 Cosmetic Ingredient Review Expert Panel Meeting
December 8-9, 2014
Washington Court Hotel
525 New Jersey Avenue, N.W.
Washington, D.C. 20001

Monday, December 8
8:00 am CONTINENTAL BREAKFAST
8:30 am WELCOME TO THE 133rd EXPERT PANEL TEAM MEETINGS Drs. Bergfeld/Gill
8:40 am TEAM MEETINGS Drs. Marks/Belsito
Dr. Marks’ Team* Dr. Belsito’s Team
Admin (IB) PEGs cocamine TR (WJ) polysaccharide gums
FR (LB) Avena sativa DR (WJ) Centella asiatica
FR (LB) glycerin DR (WJ) phosphoglycerides
FAR (LB) hydroquinone FAR (MF) PCA
FAR (LB) hydroxyanisole FR (MF) PEG glycerides
FAR (LB) PGesters FAR (MF) sorbitan esters
FR (LB) polysiloxanes Admin (BH) Report strategies
DR (LB) benzotriazolyl TR (IB/CB) ceramides
RR (LB) PEG diesters Admin (IB) PEGs cocamine
FAR (MF) PCA FR (LB) Avena sativa
FR (MF) PEG glycerides FR (LB) glycerin
FAR (MF) sorbitan esters FAR (LB) hydroquinone
TR (WJ) polysaccharide gums FAR (LB) hydroxyanisole
DR (WJ) Centella asiatica FAR (LB) PGesters
DR (WJ) phosphoglycerides FR (LB) polysiloxanes
TR (IB/CB) ceramides DR (LB) benzotriazolyl
Admin (BH) report strategies RR (LB) PEG diesters

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

FR: Final report
FAR: Final 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Distributed for comment only -- do not cite or quote

Tuesday, December 9
8:00 am CONTINENTAL BREAKFAST
8:30 am WELCOME TO THE 133rd FULL CIR EXPERT PANEL MEETING
8:45 am Admin MINUTES OF THE SEPTEMBER 2014 EXPERT PANEL MEETING Dr. Bergfeld
9:00 am DIRECTOR’S REPORT Dr. Gill
9:15 am FINAL REPORTS, REPORTS ADVANCING TO THE NEXT LEVEL, RE-REVIEWS, and OTHER DISCUSSION ITEMS
Final Reports
FR (LB) Avena sativa -Dr. Marks reports
FR (LB) Glycerin - Dr. Belsito reports
FAR (LB) Hydroquinone - Dr. Marks reports
FAR (LB) Hydroxyanisole – Dr. Belsito reports
FAR (LB) PGesters - Dr. Marks reports
FR (LB) Polysiloxanes - Dr. Belsito reports
FAR (MF) PCA – Dr. Marks reports
FR (MF) PEG glycerides - Dr. Belsito reports
FAR (MF) Sorbitan esters – Dr. Marks reports

Reports Advancing

TR (IB/CB) Ceramides – Dr. Belsito reports
TR (WJ) Polysaccharide gums – Dr. Marks reports
DR (LB) Benzotriazolyl – Dr. Belsito reports
DR (WJ) Centella asiatica – Dr. Marks reports
DR (WJ) Phosphoglycerides – Dr. Belsito reports

Re-reviews

RR (LB) PEG diesters – Dr. Marks reports

New Information
Admin (BH) Report Strategies – Dr. Belsito reports
Admin (IB) PEGs cocamine – Dr. Marks reports

ADJOURN - Next meeting Monday and Tuesday, March 16-17, 2015 at The Mayflower Renaissance Hotel, 1127
Connecticut Avenue, NW, Washington, DC 20036
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: 133rd Meeting of the CIR Expert Panel — Monday and Tuesday, December 8-9, 2014
Date: November 14, 2014

Enclosed are the agenda and accompanying materials for the 133rd CIR Expert Panel Meeting to be held
on December 8-9, 2014. The meeting will be held at the Washington Court Hotel, 525 New Jersey
Avenue, NW, Washington, DC 20001. Phone: [phone]. Fax: [phone]. This will be our
final meeting at this location. The meeting agenda includes consideration of 14 ingredient groups
advancing in the process and 1 re-review.

In addition to the reports, the agenda includes a discussion of PEGs cocamine and related ingredients.
The original safety assessment of the PEGs cocamine was published in 1999. At the December 2012
meeting, the Panel agreed to reopen the original assessment based on several submissions to the Panel
over the past 5 years, and information presented to the Panel at the Structure Activity Relationship (SAR)
Workshop during the March 2012 meeting. For the December 2014 meeting, CIR is presenting this
information in a memorandum titled Strategy for the Safety Assessment of PEGs Cocamine and Related
Ingredients, to facilitate the Panel’s review. The information is not submitted as a report (the current
report status would be a tentative amended report), although it is organized to facilitate the incorporation
of the information into a report. A tentative amended report will be prepared for review at the March 2015
meeting if the Panel decides to move forward with a safety assessment of the PEGs cocamine and
related ingredients.

The Panel is also asked to provide direction on proposed strategies for reopening the boric acid report,
and determining ingredients to be included in the glyceryl esters report and the follow-up report on citrus
fruit-derived ingredients.

Schedule and hotel accommodations

We have reserved rooms for the nights of Sunday December 7 and Monday December 8, at the
Washington Court Hotel. If you encounter any travel problems, please contact me on my cell phone at
410-299-0777.

Team meetings

Re-review – there is one safety assessment to re-review and re-open to revise the conclusion, re-open to
add additional ingredients, or reaffirm the original conclusion and not reopen.

1. PEG Diesters (agenda and flash drive name – PEG diesters). PEG diesters were previously
reviewed in several safety assessments (1999, 2000, 2011) with the conclusion that these
ingredients that mostly function as surfactants are safe for use in cosmetics (1999, 2011) and that
the PEG dilaurates are safe for use at concentrations up to 25%. Both frequency of use and
Distributed for comment only -- do not cite or quote

concentration of use have increased. Thirty additional PEG diesters are being suggested for
addition to this family. If the Panel agrees that the data in the existing report and the new data
support the safety of these ingredients, the Panel should re-open this assessment to add these
ingredients.

Draft reports - there are 3 draft reports for review.

1. Centella asiatica-derived Ingredients (agenda and flash drive name – Centella asiatica) – This is
the first time that the Panel is seeing this report on 9 ingredients. The Scientific Literature Review
was announced for public comment on September 14, 2014. Centella asiatica-derived
ingredients are reported to function in cosmetics as skin conditioning agents, and are used in
leave-on cosmetic products at maximum use concentrations up to 0.5%. Unpublished data and
concentration of use data received from the Council have been incorporated into the report. Are
these data sufficient or are more data needed to issue a tentative report?

2. Lecithin and Other Phosphoglycerides (agenda and flash drive name – phosphoglycerides) – This
is the first time that the Panel is seeing this report on 17 ingredients. The Scientific Literature
Review was announced for public comment on September 14, 2014. Lecithin and other
phosphoglycerides are reported to function mainly as skin and hair conditioning agents,
emulsifying agents and surfactants in cosmetic products. The highest maximum concentration is
50% for lecithin in a leave-on product. Unpublished data and concentration of use data have
been incorporated into the report. Do we need more data or can we proceed to issue a tentative
report?

3. Sodium Benzotriazolyl Butylphenol Sulfonate (agenda and flash drive name – benzotriazolyl) –
This is the first time that the Panel is seeing a report on this ingredient. The Scientific Literature
Review was announced for public comment on May 29, 2014. Sodium benzotriazolyl butylphenol
sulfonate, a hydrophobic UV absorber, is reported to function as a light stabilizer in cosmetics.
This ingredient is used at concentrations up to 0.64% in leave-on products. Most of the data in
this report are summary information from the ECHA website. Are these data sufficient or are
more data needed to issue a tentative report?

Tentative reports – there are 2 draft tentative reports.

1. Ceramides (agenda and flash drive name – ceramides) – At the June 2014 meeting, the Panel
requested additional data to support the safety of 23 ceramide ingredients. The data needs
included methods of manufacture, impurities, and dermal absorption data. If appreciable dermal
absorption was indicated, the additional data needs included reproductive and developmental
toxicity, genotoxicity, and dermal irritation and sensitization at the highest maximum reported use
concentration. In addition, Industry was expected to provide safety test data and concentration of
use data on the 8 structurally similar ingredients added to this report. Substantial unpublished
data have been received and incorporated into the report. Are these data sufficient to issue a
tentative report with a safe or safe with qualifications conclusion? Or, are there remaining unmet
critical data needs?

2. Polysaccharide Gums (agenda and flash drive name – polysaccharide gums) – At the September
meeting, the Panel issued an insufficient data announcement for polysaccharide gums. The 102
ingredients in this report are from plant and algal sources. The data needs included methods of
manufacture and impurities data on each of the ingredients, particularly the hydrolyzed
polysaccharides and other modified polysaccharide gums. The Panel requested that the
ingredients be organized to reflect 4 types of chemical structures: linear, branched, cyclic, and
unknown structure. Polysaccharide gums are used in rinse-off cosmetic products at maximum
use concentrations up to 50%, and in leave-on cosmetic products at maximum use
concentrations up to 45.7%. Data submitted, including method of manufacture and composition
data, have been included in the report. Are the data sufficient to issue a tentative report with a
safe or safe with qualifications conclusion? Or, are there remaining unmet critical data needs?
Distributed for comment only -- do not cite or quote

Final reports - there are 9 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.

1. Avena sativa -Derived Ingredients (agenda and flash drive name – Avena sativa) – At the
September meeting, the Panel issued a tentative report for Avena sativa (oat)-derived
ingredients. The Panel concluded that 20 ingredients in this group were safe for use as cosmetic
ingredients in the present practices of use and concentration when formulated to be non-
sensitizing. Data were insufficient to address the safety of avena sativa (oat) meristem cell
extract. No new data have been submitted. Concentrations of use data for the hydrolyzed
ingredients have been added to the report. Comments from the Council have been addressed.

2. Glycerin (agenda and flash drive name – glycerin) – At the September meeting, the Panel issued
a tentative report for this ingredient with a conclusion of safe as used in the present practices of
use and concentration. No new data were submitted. Comments from the Council have been
addressed.

3. Hydroquinone (agenda and flash drive name – hydroquinone) – At the September meeting, the
Panel concluded that hydroquinone is safe at concentrations ≤ 1% for cosmetic formulations
designed for discontinuous, brief use followed by rinsing from the skin and hair. Hydroquinone is
safe for use in nail adhesives and as a polymerization inhibitor in artificial nail coatings that are
cured by LED (light emitting diode) light. Hydroquinone is unsafe for use in other leave-on
cosmetic products. Additionally, the Panel concluded that only nail lamp devices that use LED
bulbs, and not fluorescent bulbs, are safe for use with artificial nail coatings that require curing by
light, in both professional and home settings. The Panel cautioned that, if UV-light sources with
fluorescent bulbs are used, photo protective materials for the skin (e.g., gloves, sunscreen)
should also be used. No new data were received. Comments from industry have been
addressed.
4. p-Hydroxyanisole (agenda and flash drive name – hydroxyanisole) – At the September meeting,
the Panel concluded that p-hydroxyanisole is safe for use in nail adhesives and in artificial nail
coatings that are cured by LED light as a polymerization inhibitor; and unsafe for use in all other
cosmetics because of the potential for dermal depigmentation. This conclusion supersedes the
earlier conclusion issued by the Expert Panel in 1985, which stated that it was unsafe for use in
all cosmetic products. No new data on this ingredient or UV nail lamps have been received.
Comments from industry were addressed.

5. PCA (2-pyrrolidone-5-carboxylic acid) and It’s Salts (agenda and flash drive name – PCA) – At
the September meeting, the Panel concluded that 5 PCA ingredients and its salts are safe as
used in cosmetics, and these ingredients should not be used in cosmetic products in which
N-nitroso compounds can be formed. The Panel requested clarification of the stereochemistry of
PCA, particularly the identity of the stereoisomer that was evaluated in the studies described in
the original report (1999). No additional information was received and no clarification was
provided. Comments from industry were addressed.

6. PEGylated Alkyl Glycerides (agenda and flash drive name – PEG glycerides) – At the September
meeting, the Panel concluded that 60 PEGylated alkyl glycerides that function mostly as skin
conditioning agents or surfactants, are safe in the present practices of use and concentration in
cosmetics when formulated to be non-irritating. This report includes the PEG glyceryl cocoates
that were found safe in rinse-off products and safe at up to 10% in leave-on products (published
in 1999). Data submitted from a developmental toxicity study are included in the report.
Comments from industry were addressed.

7. Polyoxalkylene Siloxane Copolymers, Alkyl-Polyoxyalkylene Siloxane Copolymers, and Related
Ingredients (agenda and flash drive name – polysiloxanes) – At the September meeting, the
Panel concluded that 111 polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane
copolymers, and related ingredients are safe as used in cosmetics. Information that the Panel
requested on the rationale for the presence of residual polyethers found in all siloxane polymers
was received. Comments from industry were addressed.
Distributed for comment only -- do not cite or quote

8. Propylene Glycol Esters (agenda and flash drive name – PGesters) – At the September meeting,
the Panel concluded that these 32 ingredients that function mostly as skin-conditioning agents –
emollients and surfactants – emulsifying agents, are safe as used in cosmetics. The Council
suggested adding propylene glycol soyate to this report, and it is now included. Although this
ingredient is similar to the ingredients in this group, there are no reported uses in the VCRP and
the Council does not anticipate the receipt of concentration of use information. No additional data
were received. Comments from industry were addressed.

9. Sorbitan Esters (agenda and flash drive name – sorbitan esters) – At the September meeting, the
Panel concluded that 21 sorbitan esters are safe in the present practices of use and
concentration in cosmetics. One reported function of sorbitan theobroma grandiflorum seedate
is skin bleaching agent; this not a cosmetic use in the United States, and use as a skin bleaching
agent is not reviewed in this safety assessment. Updated data on concentration of use are
included in the report. Comments from the Council 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 9 reports to be issued as final safety assessments, followed by the remaining
reports advancing in the process, and finish by providing guidance on the proposed report strategies for
boric acid, glyceryl esters, citrus fruit-derived ingredients, and PEGs cocamine.

The majority of the agenda involves reviewing the final reports. I anticipate a lively discussion on PEGs
cocamine. 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

ONE HUNDRED THIRTY-SECOND MEETING

OF THE

EXPERT PANEL

September 8-9, 2014

Washington Court Hotel

Washington, D.C.

Expert Panel Members Liaison Representatives
Wilma F. Bergfeld, M.D., Chair Consumer
Donald V. Belsito, M.D. Rachel Weintraub, Esq.
Ronald A. Hill, Ph.D.
Curtis D. Klaassen, Ph.D. Industry
Daniel C. Liebler, Ph.D. Jay Ansell, 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

Jay Ansell PCPC
Lillian Becker CIR
Don Bjerke Procter & Gamble
Ivan Boyer CIR
Roshil Budhram PCPC
Christina Burnett CIR
Lynn Cordo Thor
Kapal Dewa FDA
Michael Fenola Johnson and Johnson
Monice Fiume CIR
Kevin Fries CIR
Lillian Gill CIR
Ashley Gilman Keystone Research & Pharma
Tracy Guerrero SEHSC
Bart Heldreth CIR
Carla Jackson CIR
Paul Jean Dow Corning
Wilbur Johnson, Jr. CIR
Wendy Koch SEHSC
Lois Kotkoskie Croda
Dennis Laba Presperse
Julia Linthicum CIR
Linda Loretz PCPC
Russell Mait Evonik
Lauren Nardella The Rose Sheet
Nick Palmer Keystone Research & Pharma
Abel Pereira Croda
Damani Parran Akzo Nobel
Aziz Robera
Diego Rua FDA
Noriko Shibuya Shiseido
David Steinberg Steinberg & Associates
Victoria Tu Revlon
Claudia Valenzuela FDA
Distributed for comment only -- do not cite or quote

MINUTES FROM THE 132nd CIR EXPERT PANEL MEETING
CHAIRMAN’S OPENING REMARKS
The 132nd meeting of the Cosmetic Ingredient Review (CIR) Expert Panel was called to order by Dr. Wilma Bergfeld at 8:30 a.m. She
welcomed the attendees and also extended a very hearty welcome to Dr. Beth Lange, the new Industry Liaison to the CIR Expert
Panel. Dr. Bergfeld stated that a robust discussion of the 16 ingredient reports scheduled for review took place during yesterday’s
Team meetings, and that the Panel also heard an excellent presentation by Dr. Ivan Boyer on CIR’s infant skin document, which will
be subject to additional reviews by the Panel. Other discussion items included: the 2015 strategy for ingredient re-review, CIR
boilerplate updates and their incorporation into safety assessments, and the handling of data received after meeting materials have
been submitted to the Panel.
APPROVAL OF MINUTES

The minutes of the June 9-10, 2014 CIR Expert Panel meeting were unanimously approved, with editorial changes.

DIRECTOR’S REPORT

Dr. Beth Lange, the new Executive Vice President and Chief Scientist of the Personal Care Products Council, was officially welcomed
as the Industry Liaison to the CIR Expert Panel.

Dr. Gill discussed the increase in administrative issues that CIR has presented to the Panel to consider over the past few meetings,
related to implementing some of CIR’s 2014 strategic objectives. Beginning with the June 2014 meeting, the Panel reviewed 6 of the
15 boilerplate and guidance language documents. A presentation by an expert on infant-skin-related issues provided additional
information for revising the infant skin resource document and drafting boilerplate language for review at this (September 2014)
meeting. In addition, CIR proposed approaches to grouping ingredients in safety assessments for the apple and algae families of
ingredients, and requested Panel input on strategies for re-reviewing 11 ingredient groups that are scheduled for review in 2015.

Dr. Gill was encouraged by the positive response from the Panel and the Industry to CIR’s proposed approaches to ensuring the
scientific credibility and defensibility of CIR safety assessments, increasing the efficiency of developing safety assessment reports,
and improving communication throughout the safety-assessment process. She emphasized that she is committed to providing more
opportunities for proactive discussions at future Panel meetings.

Final Safety Assessments

Alkyl Phosphates

The Panel issued a final safety assessment with the conclusion that the following 28 alkyl phosphates are safe as used in cosmetics
when formulated to be non-irritating:

potassium cetyl phosphate oleyl phosphate*
potassium C9-15 alkyl phosphate C9-15 alkyl phosphate
potassium C11-15 alkyl phosphate* C20-22 alkyl phosphate
potassium C12-13 alkyl phosphate potassium C12-14 alkyl phosphate*
C8-10 alkyl ethyl phosphate* potassium lauryl phosphate
castor oil phosphate sodium lauryl phosphate*
cetearyl phosphate* stearyl phosphate
cetyl phosphate dicetyl phosphate
disodium lauryl phosphate* dimyristyl phosphate*
disodium oleyl phosphate* dioleyl phosphate
lauryl phosphate tricetyl phosphate*
myristyl phosphate* trilauryl phosphate*
octyldecyl phosphate* trioleyl phosphate
oleyl ethyl phosphate* tristearyl phosphate*

*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.