Download Safety Assessment of Source Amino Acids as Used in Cosmetics

62 Pages·2012·2.06 MB·English

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Safety Assessment of
Source Amino Acids
as Used in Cosmetics

CIR EXPERT PANEL MEETING
DECEMBER 10-11, 2012
Memorandum
To: CIR Expert Panel Members and Liaisons
From: Christina L. Burnett
Scientific Writer/Analyst
Date: November 16, 2012
Subject: Draft Report on Source Amino Acids

In May 2012, CIR issued the Scientific Literature Review (SLR) for source amino acids. These ingredients each are
mixtures of amino acids derived from specific plant and animal sources. Accordingly, the group is given the name:
source amino acids – indicating that they come from specific sources.
The research strategy followed the approach taken with the safety assessment of α-amino acids, which was to rely
heavily on the GRAS direct food additive status of the common amino acids and to demonstrate the absence of
significant oral toxicity. That is the approach we have taken; however, very little information was found in the
published literature, especially information on dermal exposures. In the SLR, data were requested on method of
manufacturing, impurities and approximate composition for cosmetic grade ingredients, physical properties, and
dermal irritation and sensitization data.
Since the May announcement, the Personal Care Products Council (Council) has provided comments on the report,
which have been considered, method of manufacturing and composition data on lyceum barbrum (wolfberry) amino
acids, and concentration of use data. These data have been incorporated into the report. No further data that had
been requested has been received. The comments and the data are in the panel book so that you can see what was
provided.
According to the FDA’s VCRP database, silk amino acids has the most reported uses in cosmetic and personal care
products, with a total of 324; 151 of those uses are in leave-on formulations. Wheat amino acids has the second
greatest number of overall uses reported, with a total of 257; 89 of those uses are in leave-on formulations. No uses
were reported to the VCRP for apricot kernel amino acids, corn gluten amino acids, elastin amino acids, garcinia
mangostana amino acids, jojoba amino acids, keratin amino acids, lycium barbarum amino acids, sesame amino
acids, spirulina amino acids, sweet almond amino acids, and yeast amino acids.

In the Council’s use concentration survey, collagen amino acids had a wide maximum use concentration range of 3.0
x 10-4 to 6%, with the 6% reported hair tonics, dressings, and other hair grooming aids. Hair keratin amino acids
had a reported use concentration of 3% in hair tonics, dressings, and other hair grooming aids. All other use
concentrations that were reported were below 1%. No use concentrations were reported for apricot kernel amino
acids, corn gluten amino acids, elastin amino acids, garcinia mangostana amino acids, jojoba amino acids, keratin
amino acids, lycium barbarum amino acids, milk amino acids, sesame amino acids, spirulina amino acids, sweet
almond amino acids, vegetable amino acids, and yeast amino acids.

If no further data are needed, the Panel should issue a Tentative Report.
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*TheCIRStaffnotifiesofthepublicofthedecision nottore-openthereportandpreparesa draftstatementforreview bythePanel. After
Panel review,thestatementisissuedtothePublic.
*41fDraftAmendedReport(DAR) isavailable,thePanelmaychoosetoreview;ifnot,dRstaffpreparesDARforPanel Review.
ExpertPanel Decision
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OptionforRe-review

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Source Amino Acids History

May 2012 – Scientific Literature Review announced.

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Source Amino Acids Data Profile* – December 2012 – Writer, Christina Burnett
Reported Use Composition Chemical Properties Irritation/ Sensitization - Animal Irritation/ Sensitization - Clinical Ocular/ Mucousal
Apricot Kernel Amino Acids
Collagen Amino Acids X X
Corn Gluten Amino Acids
Elastin Amino Acids
Garcinia Mangostana Amino Acids
Hair Keratin Amino Acids X
Jojoba Amino Acids
Keratin Amino Acids X X
Lupine Amino Acids X
Lycium Barbarum Amino Acids X
Milk Amino Acids X
Oat Amino Acids X
Rice Amino Acids X
Sesame Amino Acids
Silk Amino Acids X X
Soy Amino Acids X X
Spirulina Amino Acids
Sweet Almond Amino Acids
Vegetable Amino Acids X
Wheat Amino Acids X
Yeast Amino Acids

*“X” indicates that data were available in a category for the ingredient

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SEARCH STRATEGY FOR SOURCE AMINO ACIDS
(Performed by Christina Burnett and Ivan Boyer)

February-April: SCIFINDER search for Source Amino Acids (21 substances, searched under INCI names and
CAS No.):
Apricot Kernel Amino Acids Oat Amino Acids
Collagen Amino Acids Rice Amino Acids
Corn Gluten Amino Acids Sesame Amino Acids
Elastin Amino Acids Silk Amino Acids
Garcinia Mangostana Amino Acids Soy Amino Acids
Hair Keratin Amino Acids Spirulina Amino Acids
Jojoba Amino Acids Sweet Almond Amino Acids
Keratin Amino Acids Vegetable Amino Acids
Lupine Amino Acids Wheat Amino Acids
Lycium Barbarum Amino Acids Yeast Amino Acids
Milk Amino Acids

- Initial search for “adverse effect, including toxicity” yielded 0 references.
- Revised search for “Amino Acids in Cosmetics” yielded 59 references, but 0 were ingredient
specific

Searches for individual ingredients in TOXLINE (excluding PUBMED, English only) and PUBMED yielded 1
reference by De Groot.

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Safety Assessment of Source Amino Acids as Used in
Cosmetics

Status: Draft Report for CIR Expert Panel Review
Release Date: November 16, 2012
Panel Meeting Date: December 10-11, 2012

The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.;
Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G.
Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR
Director is F. Alan Andersen, Ph.D. This report was prepared by Christina Burnett, Scientific Analyst/Writer, and
Bart Heldreth, Ph.D., Chemist CIR.

Cosmetic Ingredient Review
1101 17th Street, NW, Suite 412 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax [phone] ♢
[email protected]

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Table of Contents 
Introduction .................................................................................................................................................. 1 
Chemistry ...................................................................................................................................................... 1 
Impurities .................................................................................................................................................. 1 
Use ................................................................................................................................................................ 1 
Cosmetic .................................................................................................................................................... 1 
Toxicological Studies ..................................................................................................................................... 1 
Irritation and Sensitization ............................................................................................................................ 1 
Data Needs .................................................................................................................................................... 2 
Tables and Figures ........................................................................................................................................ 3 

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INTRODUCTION
This safety assessment covers 21 ingredients, which are each mixtures of amino acids, derived from
specific plant and animal sources. Accordingly, the group is given the name: source amino acids – indicating that
they come from specific sources. These ingredients function as skin and hair conditioning agents in personal care
products. The full list of ingredients in this report is found in Table 1.
A concurrent review of the safety of hydrolyzed proteins from plant and animal sources is being performed
by the Cosmetic Ingredient Review (CIR) Expert Panel. The Expert Panel previously has reviewed the safety of α-
amino acids and concluded that α-amino acids are safe for use in cosmetic ingredients.1

CHEMISTRY
The ingredients in this group are related because they each are prepared from proteins by complete
hydrolysis to yield cosmetic grade amino acid mixtures. The most frequently used method for hydrolyzing proteins
to amino acids appears to be heating to at least 110°C with concentrated hydrochloric acid.2,3 However, some amino
acids, including tryptophan, are readily destroyed or are only partially hydrolyzed by hydrochloric acid oxidation,
so alternate hydrolysis agents, like sulfonic acid, are used in place of hydrochloric acid, or alkaline hydrolysis is
performed.3-5 It is important to note that although these amino acids are produced from proteins, the hydrolysis
process commonly racemizes the amino acids and the end product is not primarily in the L- form of the
stereoisomers, but is a mixture of L- and D-.
The composition of amino acids may be analyzed by chromatographic separation and detection of the
residues, such as liquid-liquid chromatography on ion-exchange columns, after adequate hydrolysis of the
substrate.2,3 Table 2a presents composition data for commercial protein derivative from collagen keratin, silk, and
soy hydrolysates.
Method of Manufacturing
A supplier has reported that lycium barbarum (wolfberry) amino acids are derived from the lycium
barbarum fruit.6 The fruit is autolysated in water to free the cytoplasmic proteins. The proteins are then hydrolyzed
with proprietary protease enzymes. The hydrolysis breaks down the fruit proteins into basic amino acid constituents
that are water soluble. The product is then purified by filtration and spray-dried to obtain a powdered mixture.
Impurities
No data were found in the published literature on the impurities of source amino acids. Unconfirmed
composition analyses were found for collagen, keratin, silk, and soy hydrolysate. A supplier has provided the
composition data on lycium barbarum amino acids (see Table 2b).6 No composition data were discovered for the
remaining source amino acid ingredients.

USE
Cosmetic
The source amino acids in this safety assessment function primarily as hair conditioning and skin
conditioning agents in cosmetic formulations.7
Table 3 presents the current product formulation data for source amino acids. According to information
supplied to the Food and Drug Administration (FDA) by industry as part of the Voluntary Cosmetic Registration
Program (VCRP), silk amino acids have the most reported uses in cosmetic and personal care products, with a total
of 324; approximately half of those uses are in non-coloring hair products.8 Wheat amino acids have the second
greatest number of overall uses reported, with a total of 257; again, approximately half of those uses are in non-
coloring hair products. In a recent survey of use concentrations by the Personal Care Products Council, silk amino
acids had a maximum use concentration range of 8.0 x 10-5% to 0.2%, with the 0.2% reported in shampoos and other
personal cleanliness products.9 Wheat amino acids had a maximum use concentration range of 1.0 x 10-4% to 0.3%,
with the 0.3% reported in hair dyes. No use concentrations were reported for apricot kernel amino acids, corn
gluten amino acids, elastin amino acids, garcinia mangostana amino acids, jojoba amino acids, keratin amino acids,
lycium barbarum amino acids, milk amino acids, sesame amino acids, spirulina amino acids, sweet almond amino
acids, vegetable amino acids, and yeast amino acids.
The European Commission’s Scientific Committee on Consumer Products (SCCP) concluded that the risk
of exposure to viruses, such as avian influenza virus or papillomavirus, is negligible through topical application of
cosmetic products containing amino acids from the hydrolysis of human hair or chicken feathers.10

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