ANNEX A
 
Vapor Product Refill and Cartridge Standards
 
 
 
GUIDELINES
 
 
1.
Contents
of
vapor
product
refill
shall
meet
the
regulations
stipulated
below
and
 
 
 
 
 
 
 
 
 
 
 
 
shall not contain any impurities that will redound to harm or adverse health.
 
 
 
1.1.
Propylene
glycol
(CAS
No.
57-55-6),
when
used,
shall
comply
with
the
 
 
 
 
 
 
 
 
 
 
 
requirements
of
the
pharmacopoeia
adopted
and
recognized
by
the
FDA.
Purity
 
 
 
 
 
 
 
 
 
 
 
shall be rated at 99.5% or higher.
 
 
1.2.
Vegetable
glycerin
(CAS
No.
56-81-5),
when
used,
shall
comply
with
the
 
 
 
 
 
 
 
 
 
 
 
requirements
of
the
pharmacopoeia
adopted
and
recognized
by
the
FDA.
The
 
 
 
 
 
 
 
 
 
 
 
glycerol
to
be
used
in
electronic
cigarette
refill
solutions
should
be
of
plant
origin,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
from vegetable glycerin.
 
 
1.3.
Water,
if
used,
shall
be
purified
in
bulk
and
shall
conform
to
the
Philippine
 
 
 
 
 
 
 
 
 
 
 
 
 
 
National Standards for Drinking Water.
 
 
1.4.
Ethanol
(CAS
No.
64-17-5),
when
used,
shall
be
of
food
grade,
with
purity
rated
 
 
 
 
 
 
 
 
 
 
 
 
 
 
at not less than 95%.
 
 
1.5.
Nicotine
shall
comply
with
the
requirements
of
the
pharmacopoeia
adopted
and
 
 
 
 
 
 
 
 
 
 
 
recognized by the FDA.
 
 
1.6.
Only
plain
menthol
and
tobacco
flavors
shall
be
allowed
in
the
formulation
of
 
 
 
 
 
 
 
 
 
 
 
 
 
vapor product refills and cartridges.
 
 
2.
The following ingredients shall be banned from the contents of vapor product refills.
 
 
2.1.
Ingredients
that
are
considered
as
pharmacologically
active
molecules,
except
for
 
 
 
 
 
 
 
 
 
 
nicotine,
shall
not
be
used
in
the
formulation/manufacture
of
vapor
product
refills
 
 
 
 
 
 
 
 
 
 
 
 
and
cartridges.
These
include
all
medicinal,
stimulant,
anabolic
and
narcotic
 
 
 
 
 
 
 
 
 
 
substances
especially
those
listed
under
RA
9165
or
the
Comprehensive
 
 
 
 
 
 
 
 
 
 
Dangerous
Drugs
Act
of
2002
and
its
related
implementing
rules
and
regulations
 
 
 
 
 
 
 
 
 
 
 
 
and issuances.
 
 
2.2.
Likewise,
herbal
medicine
and
therapy,
nutraceuticals,
cosmeceuticals,
 
 
 
 
 
 
 
aromatherapy
ingredients,
and
vitamins
and
minerals,
and
other
articles
 
 
 
 
 
 
 
 
 
considered
as
food
supplements
shall
not
be
used
as
ingredients
in
the
 
 
 
 
 
 
 
 
 
 
 
 
formulation/manufacture of vapor product refills.
 
 
2.3.
No
oil
or
fat,
of
mineral
origin
including
essential
or
aromatic
oils
shall
be
used
as
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
an ingredient in the manufacture of a vapor product refills.
  
2.4.
Ingredients
that
are
considered
as
carcinogenic,
mutagenic,
and/or
reprotoxic
 
 
 
 
 
 
 
 
 
(CMR)
and
those
that
are
known
to
have
Specific
Target
Organ
Toxicity
(STOT)
 
 
 
 
 
 
 
 
 
 
 
 
 
such
as,
but
not
limited
to,
items
under
​
Table
1
​
“Substances
with
 
 
 
 
 
 
 
 
 
 
 
 
Carcinogenicity,
Mutagenicity,
Reproductive
Toxicity
and/or
Specific
Target
 
 
 
 
 
 
 
Organ
Toxicity,”
shall
not
be
used
as
ingredients
in
the
formulation
of
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
product refills.
 
 
2.4.1.
Releasers
of
formaldehyde
and
other
carcinogenic
intermediates
such
as,
 
 
 
 
 
 
 
 
 
but
not
limited
to,
items
under
​
Table
2
​
“Releasers
of
Aldehydes
and
 
 
 
 
 
 
 
 
 
 
 
 
Other
Carcinogenic
Intermediates”
are
banned
from
vapor
product
 
 
 
 
 
 
 
 
refills.
 
 
2.4.2.
There shall be no radioactive substances used in vapor product refills.
 
 
2.5.
Irritants
and
sensitizers
such
as
those
in
the
non-exhaustive
list
in
​
Table
3
 
 
 
 
 
 
 
 
 
 
 
 
 
“Irritants and Sensitizers”
​
 shall not be allowed for use in vapor product refills.
 
 
2.6.
The
preservatives
and
antiseptics
in
​
Table
4
“Banned
Preservatives
and
 
 
 
 
 
 
 
 
 
 
Antiseptics”
shall
not
be
used
as
ingredients
in
the
manufacture
of
vapor
product
 
 
 
 
 
 
 
 
 
 
 
 
 
refills.
 
 
2.7.
All
ingredients
that
serve
the
sole
purpose
of
colorants
are
banned
for
use
in
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
product refills.
 
 
2.8.
The
limits
in
​
Table
5
​
“Maximum
Allowed
Trace
Levels”
shall
constitute
 
 
 
 
 
 
 
 
 
 
 
technically
unavoidable
trace
levels
of
contaminants
of
vapor
product
refills,
for
 
 
 
 
 
 
 
 
 
 
 
the purposes of this Circular..
 
 
2.9.
Vapor
product
refill
and
cartridge
formulations
falling
under
Globally
 
 
 
 
 
 
 
 
 
Harmonized
System
for
the
Classification
and
Labelling
of
Chemicals
(GHS),
 
 
 
 
 
 
 
 
 
 
Acute Toxicity Categories 1 and 2 per final formulation shall not be allowed.
 
 
 
 Table 1
 
Substances with Carcinogenicity, Mutagenicity, Reproductive Toxicity and/or Specific
 
Target Organ Toxicity
 
Ingredient
 
CAS Number
 
Cinnamaldehyde
 
104-55-2
 
Diacetyl
 
431-03-8
 
2,3-Butanedione
 
600-14-6
 
Tocopheryl acetate
 
7695-91-2
 
Acetyl propionyl
 
600-14-6
 
Ethylene glycol
 
107-21-1
 
Diethylene glycol
 
111-46-6
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Table 2
 
Releasers of Aldehydes and Other Carcinogenic Intermediates
 
Ingredient
 
CAS Number
 
Sugars
 
Glucose
 
50-99-7
 
Fructose
 
57-48-7
 
Lactose
 
63-42-3
 
Maltose
 
6363-53-7
 
Saccharose
 
126-14-7
 
Acesulfame potassium
 
55589-62-3
 
Aspartame
 
22839-47-0
 
Sodium saccharinate
 
128-44-9
 
Rebaudioside-A (Stevia)
 
58543-16-1
 
Formaldehyde Formers
 Quartenium 15
 
4080-31-3
 
Imidazolidinyl Urea
 
39236-46-9
 
Diazolidinyl Urea
 
78491-02-8
 
2-bromo-2-nitropropane-1,3-diol or
 
2-Bromo-2nitro-1,3-propanediol
 
52-51-7
 
DMDM hydantoin or dimethyloldimethyl hydantoin
 
6440-58-0
 
(Benzyloxy)methanol or Phenylmethoxymethanol
 
14548-60-8
 
2-Chloro-N-(Hydroxymethyl) acetamide 2832-19-1
 
2832-19-1
 
Hexahydro-1,3,5-tris(hydroxyethyl)-s-triazine
 
4719-04-4
 
Sodium hydroxymethyl glycinate
 
70161-44-3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Table 3
 
Irritants and Sensitizers
 
Ingredient
 
CAS Number
 
Phenoxyethanol
 
122-99-6
 
2,5-Dimethypyrazine
 
123-32-0
 
Vanillin
 
121-33-5
 
 
 
Table 4
 
Banned Preservatives
 
Ingredient
 
CAS Number
 
DMDM hydantoin or dimethyloldimethyl hydantoin
 
6440-58-0
 
Triclosan
 
3380-34-5
 
Isopropylparaben (and its salts)
 
4191-73-5
 
Isobutylparaben
 
4247-02-3
 
Phenylparaben
 
17696-62-7
 
Benzylparaben
 
94-18-8
 Pentylparaben
 
6521-29-5
 
Isothiazolinone
 
1003-07-02
 
Methylisothiazolinone
 
​
2682-20-4
 
Methylchloroisothiazolinone
 
26172-55-4
 
Table 5
 
Table 5
 
Trace levels of the following substances may be allowed in the formulation provided that
 
the chemical is not directly added to the product and the proponent would be able to show
 
that the levels are brought about by (a) background natural levels, (b) risk assessment
 
would not be detrimental to health and (c) unintended product which cannot be removed in
 
the manufacturing processes
 
Compound
 
Aldehydes
 
Formaldehyde (CAS No. 50-00-0)
 
 
 
Acrolein (CAS No. 
​
107-02-08)
 
 
 
Acetaldehyde  (CAS No. 75-07-0)
 
Heavy metals
 
Lead (Pb) (CAS No. 7439-92-1)
 
 
 
Arsenic (As) (CAS No. 7440-38-2)
 
 
 
Cadmium (Cd) (CAS No. 1306-19-0)
  
 
Mercury (Hg) (CAS No. 7439-97-6)
 
 
 
Antimony (Sb) (CAS No. 7440-36-0)