Page
1
of
8
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
August
29,
2003
MEMORANDUM
SUBJECT:
Tolerance
Reassessment
Decisions
Completed
by
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
FROM:
Peter
Caulkins,
Associate
Director
Registration
Division
TO:
Richard
Keigwin,
Acting
Associate
Director
Special
Review
and
Reregistration
Division
Please
find
attached
the
Focus
Group
Decision
Documents
for
(
1)
beeswax
and
(
2)
carnauba
wax.
The
two
tolerance
exemptions
for
these
chemicals
in
40
CFR
180.1001
are
reassessed.

If
you
have
any
comments
or
questions,
please
contact
Kathryn
Boyle
at
703­
305­
6304.

Attachments
(
2)
Page
2
of
8
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
27,
2003
MEMORANDUM
FROM:
Kathryn
Boyle,
Chair
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Registration
Division
TO:
Susan
Lewis,
Acting
Chief
Minor
Use,
Inerts,
and
Emergency
Response
Branch
Registration
Division
SUBJECT:
Recommendation
for
Tolerance
Reassessment
The
attached
science
assessment
discusses
the
toxicity
of
carnauba
wax.
Based
on
its
long
history
of
use
as
a
food
additive
and
its
extensive
uses
in
cosmetics,
and
given
the
existing
assessments,
a
qualitative
assessment
was
performed.

Based
on
its
review
and
evaluation
of
the
available
information,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
residues
of
carnauba
wax
from
their
uses
as
inert
ingredients
in
pesticide
products.
The
carnauba
wax
exemption
from
the
requirement
of
a
tolerance
as
established
in
40
CFR
180.1001
(
c)
is
reassessed.
Carnauba
wax
is
reclassified
as
List
4A
based
on
it
overall
low
toxicity.
Page
3
of
8
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
25,
2003
Memorandum
Subject:
Carnauba
Wax:
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Document
for
Tolerance
Reassessment.

CAS
No.:
8015­
86­
9
PC
Code:
900258
From:
Mark
Perry
Special
Review
and
Reregistration
Division
(
7508C)

To:
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Kathryn
Boyle,
Chair
Registration
Division
(
7505C)

Background:

Attached
is
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group's
science
assessment
to
support
the
reassessment
of
the
tolerance
exemption
for
carnauba
wax.
The
purpose
of
this
review
is
a
reassessment
of
the
exemption
from
the
requirement
of
a
tolerance.
This
assessment
summarizes
the
available
information
on
use
patterns,
physical/
chemical
properties,
toxicological
effects
and
the
exposure
potential
of
carnauba
wax.
In
performing
this
assessment,
EPA
has
relied
on
peer­
reviewed
evaluations
performed
by
the
Food
and
Agriculture
Organization
of
the
World
Health
Organization
(
FAO/
WHO),
and
the
Cosmetic
Ingredient
Review
expert
panel.

I.
Executive
Summary:

Carnauba
wax
is
derived
from
the
leaves,
berries
and
stalks
of
the
Brazilian
palm
tree,
Copernica
cerifera.
It
is
a
hard,
brittle
wax
composed
primarily
of
fatty
esters
(
80­
85%)
in
addition
to
free
alcohols,
hydrocarbons
and
acids.
Page
4
of
8
Carnauba
wax
has
a
high
melting
point
and
is
used
in
various
cosmetics,
as
a
surface
polish
and
as
a
coating
agent
for
certain
paper
products.
The
U.
S.
Food
and
Drug
Administration
(
FDA)
has
classified
carnauba
wax
as
a
Generally
Recognized
As
Safe
(
GRAS)
direct
food
additive
(
21
CFR
184.1978)
to
be
used
as
an
anticaking
agent,
formulation
aid,
lubricant
and
release
agent
and
as
a
surface­
finishing
agent.
Carnauba
wax
is
also
used
in
cosmetics
at
concentrations
up
to
50%.
No
toxicologically­
significant
effects
were
found
in
the
available
data.

Based
on
available
information
on
carnauba
wax,
its
safe
history
of
use
as
a
food
additive,
its
extensive
use
in
cosmetics,
and
its
low
toxicity,
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
has
determined
that
a
screening­
level
quantitative
risk
assessment
is
not
required
for
this
compound.

II.
Use
Information:

The
pesticidal
and
non­
pesticidal
uses
of
carnauba
wax
are
summarized
briefly
below.

Table
1.
Use
Pattern
(
pesticidal
­
inert
ingredient)

Chemical
Name
Inert
PC
Code
40
CFR
180.1001
Inert
Use
Pattern
(
Pesticidal)
Current
Inert
List
carnauba
wax
900258
(
c)
coating
agent
4B
Use
Pattern
(
non­
pesticidal):

The
direct
food
additive
GRAS
classification
(
21
CFR
184.1978)
allows
uses
in
chewing
gum,
baked
goods
and
baking
mixes,
confections
and
frostings,
gravies
and
sauces,
fresh/
processed
fruits
and
fruit
juices,
and
candy
at
levels
not
to
exceed
current
good
manufacturing
practice.
Cosmetic
uses
for
carnauba
wax
include
uses
in
eye
and
face
makeup,
fragrance,
hair
coloring
and
skin,
nail
and
suntan
products.
Its
use
in
such
cosmetic
preparations
ranges
from
concentrations
of
less
than
0.1
up
to
50%.
Other
uses
include
as
a
coating
on
dental
floss,
cups
and
plates
and
in
automobile,
wood
and
leather
polishes.

III.
Physical/
Chemical
Properties:

Table
2.
Physical/
Chemical
Properties.

Carnauba
wax
Melting
range
83­
86
C
Solubility
in
water
insoluble
Page
5
of
8
Specific
Gravity
0.99
Physical
state
wax
IV.
Hazard
Assessment:

As
mentioned
above,
carnauba
wax
is
classified
by
the
U.
S.
FDA
as
Generally
Recognized
as
Safe
for
use
as
a
direct
food
additive
(
21
CFR
184.1978).

Toxicological
Profile:

The
World
Health
Organization
(
WHO)
Joint
Expert
Committee
on
Food
Additives
evaluated
carnauba
wax
in
1992.
This
evaluation
considered
a
90­
day
rat
study,
a
combined
reproduction/
subchronic
rat
study,
a
28­
week
dog
study,
mutagenicity
studies
and
a
rat
teratogenicity
study.
Based
on
the
no­
effect
level
at
the
highest
dose
in
the
combined
reproduction/
subchronic
study,
the
Committee
established
an
ADI
of
0­
7
mg/
kg
bw.
Using
much
of
the
same
data,
the
European
Commission
issued
the
Reports
of
the
Scientific
Committee
for
Food
(
2001)
which
included
an
opinion
on
carnauba
wax.
This
report
recommended
acceptance
use
of
carnauba
wax
as
a
glazing
agent
at
levels
up
to
200
mg/
kg
of
food.

The
reproduction/
subchronic
oral
study
considered
in
the
WHO
assessment
involved
feeding
25
female
and
25
male
rats
0%,
0.1%,
0.3%
and
1.0%
carnauba
wax
in
the
diet
starting
four
weeks
before
mating
and
continuing
through
gestation
and
lactation.
The
pups
were
supplied
the
same
diet
for
13
weeks
beyond
weaning.
No
toxicologically
significant,
treatmentrelated
effects
were
noted
at
any
dose
level
in
this
study.
In
the
90­
day
rat
study,
15
female
and
15
male
rats
were
fed
0,
1,
5,
or
10%
carnauba
wax.
No
differences
in
body
weight,
serum
enzyme
activity,
hematological
values,
organ
weights
or
histology
were
noted
as
a
result
of
treatment.
In
the
28­
week
dog
study,
four
groups
of
6
female
and
6
male
dogs
were
dosed
at
0,
0.1,
0.3
or
1%
carnauba
wax.
No
significant
treatment­
related
effects
were
noted
for
up
to
1%
carnauba
wax
in
the
diet.
In
six
assays
with
S.
typhimurium
and
S.
cerevisiae
carnauba
wax
produced
no
microbial
mutagenic
activity
when
tested
with
and
without
activation.

The
Cosmetic
Ingredient
Review
(
CIR)
performed
a
safety
assessment
of
carnauba
wax
in
1984.
This
assessment
considered
acute
oral,
eye
and
skin
irritation
data
and
human
clinical
assessment
data,
in
addition
to
the
reproduction/
subchronic
rat
study,
the
90­
day
rat
study,
the
28­
week
dog
study
and
the
mutagenicity
data
used
in
the
WHO
assessment.
The
two
acute
oral
studies
included
doses
of
1.1
and
0.5
g/
kg
administered
to
10
and
5
rats,
respectively,
resulted
in
no
mortality.
Two
eye
studies
performed
with
cosmetic
products
containing
5.6
and
10%
carnauba
wax
demonstrated
no
irritation
to
rabbit
eyes,
and
three
closed
patch
skin
irritation
studies
with
100%
and
one
with
10%
carnauba
wax
resulted
in
no
dermal
irritation
in
any
of
the
33
animals
tested.

Human
clinical
studies
summarized
in
the
CIR
assessment
included
single
and
repeated
Page
6
of
8
insult
patch
tests
and
a
photosensitivity
patch
test.
No
irritation,
sensitization
or
photosensitization
was
observed
during
these
studies.
Overall,
the
CIR
assessment
concluded
that
carnauba
wax
is
safe
as
used
in
cosmetics
under
present
practices
of
concentration
and
use.

Special
Considerations
for
Infants
and
Children:

At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

Hazard
Characterization:

Taking
into
consideration
all
available
information
on
carnauba
wax,
including
FDA's
GRAS
designation,
its
use
in
food
products
and
cosmetics
and
its
history
of
use
without
apparent
incident,
the
use
of
carnauba
wax
as
an
inert
ingredient
in
pesticide
products
is
considered
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup.

V.
Risk
Characterization:

Exposure
to
carnauba
wax
would
result
from
its
FDA­
approved
GRAS
use
as
a
food
additive
and
through
its
use
in
the
numerous
cosmetic
products
mentioned
above.
During
use
of
such
cosmetics,
carnauba
wax
may
contact
the
skin
and
the
mucous
membranes
of
the
eyes,
nose
and
mouth
for
a
period
of
several
hours
to
several
days.
The
use
of
carnauba
wax
in
pesticide
products
is
expected
to
result
in
much
lower
exposure
than
through
the
existing
food
and
cosmetic
uses
of
this
compound.
Exposures
from
pesticide
inert
uses
are
expected
to
result
in
human
exposure
well
below
any
dose
level
that
could
produce
an
adverse
effect.
Therefore,
a
screening­
level
quantitative
exposure
assessment
has
not
been
conducted.

VI.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

EFED's
exposure
and
hazard
characterization
is
based
on
the
fact
that
carnauba
wax
is
naturally
occurring
and,
as
such,
it
is
believed
that
there
is
no
concern
for
exposures
to
non­
target
organisms
and
the
environment
from
releases
through
approved
uses.

Natural
waxes
such
as
carnauba
wax,
unlike
most
synthetic
waxes
(
i.
e.,
paraffins),
are
esters
of
the
general
formula:

O
5
R­
C­
C­
O­
R
0
Page
7
of
8
Carnauba
was
is
obtained
from
the
leaves
of
a
palm
grown
in
Brazil
(
Copornica
cerifera),
and
candelilla
wax,
produced
by
a
Mexican
plant
(
Euphorbia
antisyphilitica).
These
compounds
are
insoluble
in
water,
non­
volatile,
have
a
low
air:
water
partitioning
coefficient
(
Henry's
Law
Coefficient)
and
are
poorly
mobile
in
soils
and
sediments.
The
ultimate
sink
for
carnauba
wax
released
into
the
environment
is
soil
and
sediments.
Carnauba
wax
will
undergo
primary
biodegradation
of
various
components
in
days
to
weeks
aerobically
and
longer
anaerobically.
Because
carnauba
wax
is
a
"
mixture"
of
compounds,
component
analysis
is
considered
the
optimal
approach
to
understanding
the
behavior
and
toxicity
in
the
environment.

Components
of
carnauba
wax
include
various
esters
of
monohydroxy
alcohols,
other
esters,
free
fatty
acids,
free
alcohols
and
long
chain
hydrocarbons.
The
esters
are
generally
insoluble
in
water
(
est.
water
solubilities
less
than
1.0E­
10),
non­
volatile
(
est.
vapor
pressures
of
less
than
1.0E­
10),
and
poorly
mobile
in
soils
and
sediments
(
est.
Log
K
oc
s:
>
8).
Primary
degradation
of
the
esters
occurs
in
days
to
weeks
and
ultimate
degradation
in
weeks
to
months.
The
principal
sink
in
the
environment
is
soil
and
sediments.
It
is
unlikely
to
undergo
hydrolysis
and
photolysis,
but,
will
react
in
the
atmosphere
with
hydroxyl
radicals
with
a
half­
life
of
hours.
Bioconcentration
and/
or
biomagnification
is
unlikely
for
the
ester
compounds
based
on
estimated
K
ow
s
greater
than
the
analytical
stability
of
available
models
(
est.
Log
K
ow
:
>
10).

Alcohol,
fatty
acids
and
hydrocarbon
components
will
tend
to
be
more
soluble,
volatile,
and
mobile
depending
on
moiety
than
the
esters.
Like
the
esters,
they
will
undergo
degradation
in
the
environment
in
hours
to
days
which
will
tend
to
reduce
the
potential
for
movement
into
ground
and
surface
water
as
the
parent
material.
The
principle
sink
will
be
soils
and
sediments.
Atmospheric
degradation
will
be
similar
to
the
esters
depending
on
the
moiety.
like
the
esters,
most
of
the
components
will
not
undergo
direct
photolysis
in
soil
and
water.

Toxicity
of
carnauba
wax
and
the
ester
components
to
aquatic
organisms
is
not
expected
due
the
low
water
solubility
and
high
log
K
ow.
Toxicity
to
wild
mammals,
using
the
rat
as
a
surrogate
species,
is
likewise
not
expected.
By
analogy,
birds
and
other
terrestrial
organisms
are
unlikely
to
exhibit
adverse
effects
when
exposed.
The
remaining
components
will
also
tend
to
be
of
low
ecological
toxicity
although
their
water
solubility
will
not
be
the
limiting
factor.

VII.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
carnauba
wax
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
carnauba
wax
and
any
other
substances
and
Page
8
of
8
carnauba
wax
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
carnauba
wax
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website.

References:

Cosmetic
Ingredient
Review
(
CIR).
1984.
Final
Report
on
the
Safety
Assessment
of
Candelilla
Wax,
Carnauba
Wax,
Japan
Wax,
and
Beeswax.
Journal
of
the
American
College
of
Toxicology
3(
3)

European
Commission.
Opinion
of
the
Scientific
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