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8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
1/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents1
ANNEX III PART 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS ANDCONDITIONS LAID DOWN
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
2/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents2
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
1a Boric acid, borates andtetraborates with the exceptionof substance No 1184 inAnnex II
(a) Talc
(b) Products for allhygiene
(c) Other products(excluding bathproducts and hairwaving products)
(a) 5% (by mass/massas boric acid)
(b) 0.1% (bymass/mass as boricacid)
(c) 3% (by mass/massas boric acid)
(a) 1. Not to be usedin products forchildren under 3years of age
2. Not to be usedon peeling orirritated skin ifthe concentrationof free solubleborates exceeds1.5% (bymass/mass asboric acid)
(b) Not to be used inproducts forchildren under 3years of age
(c) 1. Not to be usedin products forchildren under 3years of age
2. Not to be used
on peeling orirritated skin ifthe concentrationof free solubleborates exceeds1.5% (bymass/mass asboric acid)
(a) 1. Not to be used in productsfor children under 3 years of
age
2. Not to be used on peeling or
irritated skin
(b) 1. Not to be swallowed
2. Not to be used in productsfor children under 3 yearsof age
(c) 1. Not to be used in productsfor children under 3 yearsof age
2. Not to be used on peelingor irritated skin
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
3/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents3
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
1b Tetraborates (a) Bath products
(b) Hair wavingproducts
(a) 18% (by mass/massas boric acid)
(b) 8% (by mass/massas boric acid)
(a) Not to be used inproducts forchildren under 3years of age
(a) Not to be used for bathingchildren under 3 years of age
(b) Rinse well
2a Thioglycolic acid and its salts (a) Hair waving orstraighteningproducts:
1. General use
2. Professionaluse
(b) Depilatories
(c) Other hair careproducts which areremoved afterapplication
(a)1. 8% ready for use
at pH 7 9.5
2. 11% ready for useat pH 7- 9.5
(b) 5% ready for use atat pH 7-12.7
(c) 2% ready for use atpH 7-9.5
Percentages calculated
as total thioacids, i.e.,either singly (thiolacticacid or thioglycolic acidalone) or combination ofthiolactic acid andthioglycolic acid in agiven formula
(a) (b) (c)
The directions for usedrawn up in thenational or officiallanguage(s) mustobligatorily incorporate
the followingsentences:
Avoidcontact witheyes
In the event ofcontact with eyes,rinse immediatelywith plenty ofwater and seek
medical advice.Wear suitable
gloves (a) and (c)only.
(a)
Contains thioglycolate
Follow the instructions
Keep out of reach ofchildren.
For professional use only.
(b) and (c)
Contains thioglycolate
Follow the instructions
Keep out of reach ofchildren
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
4/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents4
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
2b Thioglycolic acid esters Hair waving orstraightening products:
1. General use
2. Professional use
1. 8% ready for use at
pH 6-9.5
2. 11% ready for use
at pH 6-9.5
Percentages calculatedas thioglycolic acid.
The directions for usedrawn up in thenational or officiallanguage(s) must
obligatorily incorporatethe followingsentences:
May causesensitisation in theevent of skincontact.
Avoid contact witheyes.
In the event ofcontact with eyes,rinse immediatelywith plenty of waterand seek medicaladvice.
Wear suitablegloves.
Contains thioglycolate.
Follow the instructions.
Keep out of reach of children.
For professional use only.
3 Oxalic acid, its esters andalkaline salts Hair care products 5% For professional use only
4 Ammonia 6% calculated as NH3 Above 2%: Contains ammonia
5 Tosylchloramide sodium (INN) 0.2%
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
5/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents5
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
6 Chlorates of alkali metals (a) Toothpaste
(b) Other uses
(a) 5%
(b) 3%
7 Entry left intentionally blank
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
6/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents6
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
8 N-substituted derivatives of p-Phenylenediamine and theirsalts; N-substituted derivativesof o-Phenylenediamine(
5), with
exception of those derivativeslisted elsewhere in this Annexand under reference numbers1309, 1311 and 1132 in AnnexII
Oxidizing colouringagents for hair dyeing:
1. General use
2. Professional use
6% calculated as freebase
1.Hair colorants can cause severe allergicreactions.
Read and follow instruc tions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines. Wear suitable
gloves.Do not use to dye eyelashes or eyebrows.
2.Hair colorants can cause severe allergicreactions. Read and follow instru ctions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines. Wear suitablegloves.
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
7/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents7
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
8a p-Phenylenediamine and itssalts (
5)
CAS No 106-50-3
p-PhenylenediamineHCl
CAS No 624-18-0
p-Phenylenediamine sulphate
CAS No 16245-77-5
Hair dye substance inoxidative hair dyeproducts:
1. General use
2. Professional use
1. and 2.
After mixing underoxidative conditions
the maximumconcentration appliedto hair must notexceed 2 % calculatedas free base.
1.Hair colorants can cause severe allergicreactions.
Read and follow instruc tions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
The mixing ratio is printed on the label.
Contains phenylenediamines. Wear suitablegloves.Do not use to dye eyelashes or eyebrows.
2.Hair colorants can cause severe allergicreactions. Read and follow instru ctions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
The mixing ratio is printed on the label. Containsphenylenediamines. Wear suitable gloves.
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
8/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents8
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
9 Methylphenylenediamines, theirN-substituted derivatives andtheir salts (
1), with the exception
of the substance underreference number 9a in thisAnnex and substances underreference 364, 1310 and 1313in Annex II
Oxidizing colouringagents for hair dyeing:
1. General use
2. Professional use
10% calculated as freebase
1.
Hair colorants can cause severe allergic
reactions.Read and follow instruc tions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines(toluenediamines).Wear suitable gloves.Do not use to dyeeyelashes or eyebrows.
2.
Hair colorants can cause severe allergicreactions.Read and follow instruc tions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increase
your risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines(toluenediamines). Wear suitable gloves
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
9/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents9
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
9a Toluene-2,5-diamine and itssalts (
1)
CAS No 95-70-5
Toluene-2,5-diamine sulphate
CAS No 615-50-9
Hair dye substance inoxidative hair dyeproducts
1. General use
2. Professional use
1. and 2.
After mixing underoxidative conditionsthe maximum
concentration appliedto hair must notexceed 4% calculatedas free base
1.
Hair colorants can cause severe allergicreactions.Read and follow instruc tions.
This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines(toluenediamines).Wear suitable gloves.Do not use to dye
eyelashes or eyebrows. The mixing ratio isprinted on the label.2.
Hair colorants can cause severe allergicreactions.Read and follow instruc tions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
Contains phenylenediamines(toluenediamines).Wear suitable gloves. The mixing ratio is printedon the label.
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
10/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents10
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
10 Entry leftintentionally blank
11 Dichlorophen (INN) 0.5% Contains dichlorophen
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents11
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
12 Hydrogen peroxide, and othercompounds or mixtures thatrelease hydrogen peroxide,including carbamide peroxideand zinc peroxide
(a) Hair-carepreparations
(b) Skin-carepreparations
(c) Nail hardeningpreparations
(d) Oral hygieneproducts
(e) Tooth-whiteningproducts
(i) For use by theconsumer under
the supervisionof a qualifieddentalpractitioner.
(ii) For applicationby a qualifieddentalpractitioner only
(a) 12% H202(40volumes) present
or released
(b) 4% H202present
or released
(c) 2% H202presentor released
(d) 0.1% H202present orreleased
(e) Tooth-whiteningproducts
(i) Up to 6% H202present orreleased
(ii) 6 35 % H202present orreleased
(e) Tooth-whiteningproducts
(i) For supply onlythrough a qualifieddental practitioner.
Not for direct sale tothe general public
(ii) Only to be used bya qualified dental
practitioner.
Not for direct sale tothe general public.
(a) (b) (c)
Contains hydrogen peroxide.
Avoid contact with eyes.
Rinse eyes immediately if product
comes into contact with them.(a) Wear suitable gloves.
(e) Tooth-whitening products
(i) Not for direct sale to the public. Forsupply only through qualified dentalpractitioner. Read & follow theinstructions and use the productaccordingly. Do not use the productwithin two weeks prior to, orimmediately after dental restoration.
Not for use by pregnant women orhabitual tobacco and/or alcohol users.Stop using immediately if youexperience any tooth sensitivity, gumirritation, toothache, defectiverestorations, gingivitis, nausea etc.Store out of reach of children.
(ii) Not for direct sale to the public. Onlyto be used by a qualified dentalpractitioner. Do not use the productwithin two weeks prior to, or
immediately after dental restoration.Not for use by pregnant women orhabitual tobacco and/or alcohol users.Stop using immediately in cases oftooth sensitivity, gum irritation,toothache, defective restorations,gingivitis, nausea etc.
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
12/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents12
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
13 Formaldehyde Nail hardeners 5% calculated asformaldehyde
As a preservative, seeAnnex VI, Part1, No. 5
Protect cuticles with grease or oil.
Contains formaldehyde (2)
14 Hydroquinone Artificial nail systems 0.02% after mixing foruse
Professional use only For professional use only
Avoid skin contact
Read directions for usecarefully
15a Potassium or sodium hydroxide (a) Nail cuticle solvent
(b) Hair straightener
1. General use
2. Professional use
(c) pH adjuster fordepilatories
(d) Other uses as pHadjuster
(a) 5% by weight ( )
(b)
1. 2% by weight (4)
2. 4.5% by weight (4)
(c) up to pH 12.7
(d) up to pH 11
(a)
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
(b) 1.
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
2.
For professional use only
Avoid contact with eyes
Can cause blindness
(c)
Keep out of reach of children
Avoid contact with eyes
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents13
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
15b Lithium hydroxide (a) Hair straightener
1. General use
2. Professional use
(b) pH adjuster fordepilatories
(c) Other uses as pHadjuster (for rinse-off products only)
(a)
1. 2% by weight (6)
2. 4.5% by weight (6)
(b) pH value not toexceed pH 12.7
(c) pH value not toexceed pH 11
(a) 1.
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
2.
For Professional use only
Avoid contact with eyes
Can cause blindness
(b)
Contains alkali
Keep out of reach of children
Avoid contact with eyes
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents14
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
15c Calcium hydroxide (a) Hair straightenerscontaining twocomponents:calciumhydroxide and aguanidine salt
(b) pH adjuster fordepilatories
(c) Other uses (eg. pHadjuster, processingaid)
(a)7% by weightcalcium hydroxide
(b) pH value not toexceed pH 12.7
(c) pH value not toexceed pH 11
(a)
Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children
(b)
Contains alkali
Keep out of reach of children
Avoid contact with eyes
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
15/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents15
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
16 1-Napthol (CAS No. 90-15-3)and its salts
Oxidizing colouringagents for hair dyeing
2% In combination withhydrogen peroxide themaximum useconcentration uponapplication is 1.0%.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for use onpersons und er the age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damaged scalp,
you have ever experienced any
reaction after colouring your hair, you have experienced a reaction to a
temporary black henna tattoo in thepast
17 Sodium nitrite Rust inhibitor 0.2% Do not use withsecondary and/ortertiary amines or othersubstances formingnitrosamines
18 Nitromethane Rust inhibitor 0.3%
19-20
Entries left intentionally blank
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents16
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
21 Quinine and its salts (a) Shampoos
(b) Hair lotions
(a) 0.5% calculated asquinine base
(b) 0.2% calculated asquinine base
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
17/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents17
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
22 Resorcinol (a) Oxidizing colouringagent for hair dyeing
1. General use
2. Professional use
(b) Hair lotions andshampoos
(a) 5%
(b) 0.5%
(a)
1. Contains resorcinol. Rinse hair well afterapplication. Do not use to dye eyelashes oreyebrows. Rinse eyes immediately if productcomes into contact with them.
Hair colorants can cause severe allergicreactions. Read and follow instru ctions.This product is no t intended for use onpersons un der the age of 16.Temporary blackhenna tattoos may increase your risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to a
temporary black henna tattoo in the past
2.
Contains resorcinol. Rinse eyes immediately ifproduct comes into contact with them.
Hair colorants can cause severe allergicreactions. Read and follow instru ctions.This product is no t intended for use onpersons un der the age of 16.Temporary black henna tattoos may increaseyour risk of allergy.Do not colour your hair if:
you have a rash on your face or sensitive,irritated and damaged scalp,
you have ever experienced any reactionafter colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the past
(b) Contains resorcinol
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
18/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents18
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
23 (a) Alkali sulphides
(b) Alkaline earth sulphides
(a) Depilatories
(b) Depilatories
(a) 2% calculated assulphur pH up to12.7
(b) 6% calculated as
sulphur pH up to12.7
(a)
Keep out of reach of children
Avoid contact with eyes
(b)
Keep out of reach of children
Avoid contact with eyes
24 Water-soluble zinc salts with theexception of zinc4-hydroxybenzenesulphonate(entry 25) and zinc pyrithione(entry 101 and Annex VI, entry8)
1% calculated as zinc
25 Zinc 4-hydroxybenzenesulphonate
Deodorants,antiperspirants andastringent lotions
6% calculated as % ofanhydrous substance
Avoid contact with eyes
26 Ammoniummonofluorophosphate
Oral hygiene products 0.15% calculated asF.When mixed withother fluorinecompounds permittedunder this Annex, total Fconcentration must notexceed 0.15%.
Thailand only0.11% calculated asF.When mixed withother fluorinecompounds permittedunder this Annex, totalF concentration mustnot exceed 0.11%.
Containsammoniummonofluorophosphate
Children of 6 years and under:Use a pea sized amount for
supervised brushing to minimizeswallowing. In case of intake offluoride from other sources consulta dentist or doctor (
12)
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
19/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents19
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
27 Sodium monofluorophosphate Ditto Ditto Ditto Contains sodiummonofluorophosphate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In case ofintake of fluoride from othersources consult a dentist ordoctor(
12)
28 Potassiummonofluorophosphate
Ditto Ditto Ditto Contains potassiummonofluorophosphate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
29 Calcium monofluorophosphate Ditto Ditto Ditto Contains calciummonofluorophosphate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
20/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents20
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
30 Calcium fluoride Ditto Ditto Ditto Contains calcium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing to
minimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
31 Sodium fluoride Ditto Ditto Ditto Contains sodium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In case
of intake of f luoride from othersources consult a dentist ordoctor(
12)
32 Potassium fluoride Ditto Ditto Ditto Contains potassium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
33 Ammonium fluoride Ditto Ditto Ditto Contains ammonium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing to
minimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
34 Aluminium fluoride Ditto Ditto Ditto Contains aluminium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In case
of intake of f luoride from othersources consult a dentist ordoctor(
12)
35 Stannous fluoride Ditto Ditto Ditto Contains stannous fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents22
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
36 Hexadecyl ammonium fluoride Ditto Ditto Ditto Contains Hexadecylammonium fluoride
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
37 3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis (2-hydroxyethyl)ammonium difluoride
Ditto Ditto Ditto Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis (2-hydroxyethyl)ammonium difluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents23
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
38 N,N,N-Tris(polyoxyethylene)-N-hexadecylpropylenediaminedihydrofluoride
Ditto Ditto Ditto Contains N,N,N-Tris(polyoxyethylene)-N-hexadecylpropylenediaminedihydrofluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
39 Octadecenyl-ammoniumfluoride
Ditto Ditto Ditto Contains octadecenyl-ammonium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
40 Sodium fluorosilicate Ditto Ditto Ditto Contains sodium fluorosilicate
Children of 6 years and under:
Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents24
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
41 Potassium fluorosilicate Ditto Ditto Ditto Contains potassiumfluorosilicate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
42 Ammonium fluorosilicate Ditto Ditto Ditto Contains ammoniumfluorosilicate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
43 Magnesium fluorosilicate Ditto Ditto Ditto Contains magnesiumfluorosilicate
Children of 6 years and under:Use a pea sized amount for
supervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents25
Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
44 1,3-Bis(hydroxymethyl)imidazolidine-2-thione
(a) Hair carepreparations
(b) Nail care
preparations
(a) Up to 2%
(b) Up to 2%
(a) Prohibited inaerosol dispensers(sprays)
(b) The pH of the
product asapplied must beless than 4
Contains 1, 3-Bis(hydroxymethyl) imidazolidine-2-thione
45 Benzyl alcoholCAS No 100-51-6
(a) Solvents(b) fragrance/aromatic
compositions/theirraw materials
As a preservative,see Annex VI,Part1, No. 34
46 6-Methylcoumarin Oral hygiene products 0.003%
47 Nicomethanol hydrofluoride Oral hygiene products 0.15% calculated as F.When mixed with otherfluorine compoundspermitted under thisAnnex, total Fconcentration must notexceed 0.15%
Thailand only0.11% calculated asF when mixed withother fluorinecompoundspermitted under thisAnnex, total Fconcentration mustnot exceed 0.11%.
Contains nicomethanolhydrofluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor
12
48 Silver nitrate Solely for productsintended for colouringeyelashes andeyebrows
4% Contains silver nitrate Rinse the eyes immediately if
product comes into contactwith them
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
52 Methanol Denaturant for ethanoland isopropyl alcohol
5% calculated as a % ofethanol and isopropylalcohol
53 Etidronic acid and its salts (1-
hydroxyethylidene-di-phosphonic acid and its salts)
(a) Hair-care
(b) Soap
(a) 1.5% expressedas
etidronicacid(b) 0.2% expressedas
etidronic acid
54 1-Phenoxypropan-2-ol Rinse-off productsonly
Prohibited in oralhygiene products
2% As a preservative,see Annex VI, Part1, No 43
-
55 Entry left intentionally blank
56 Magnesium fluoride Dentalhygiene products 0.15% calculated as F.When mixed with otherfluorine compoundspermitted under thisAnnex, total Fconcentration must notexceed 0.15%
Thailand only0.11% calculated asF when mixed withother fluorinecompoundspermitted under thisAnnex, total Fconcentration mustnot exceed 0.11%.
Contains magnesium fluoride
Children of 6 years and under:Use a pea sized amount forsupervised brushing tominimize swallowing. In caseof intake of f luoride from othersources consult a dentist ordoctor(
12)
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
57 Strontium chloride hexahydrate (a) Toothpaste
(b) Shampoo and facecare products
(a) 3.5% calculated asstrontium. Whenmixed with otherpermitted strontiumproducts the total
strontium contentmust not exceed3.5%
(b) 2.1% calculated asstrontium. Whenmixed with otherpermitted strontiumcompounds, the total
strontium contentmust not exceed2.1%
- Contains strontium chloride
Frequent use by children is notadvisable
58 Strontium acetate hemihydrate Toothpaste 3.5% calculated asstrontium. When mixedwith other permittedstrontium products thetotal strontium contentmust not exceed 3.5%
Contains strontium acetate
Frequent use by children is notadvisable
59 Talc: Hydrated magnesiumsilicate
a) Powdery productsintended to be usedby children
b) Other products
a) Keep powder away fromchildrens nose andmouth
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Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or useMaximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
60 Fatty acid dialkylamides anddialkanolamides
Maximum secondaryamine content: 0.5%
Do not use withnitrosating systems
Maximumsecondary amine
content : 5%(applies to rawmaterials)
Maximumnitrosamine
content : 50 g/kg
Keep in nitrite-freecontainers
61 Monoalkylamines,monoalkanolamines and theirsalts
Maximum secondaryamine content: 0.5%
Do not use withnitrosating systems
Minimum purity:99%
Maximumsecondary aminecontent: 0.5%(applies to rawmaterials)
Maximumnitrosamine
content: 50 g/kg
Keep in nitrite-freecontainers
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Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or useMaximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
62 Trialkylamines, trialkanolaminesand their salts
(a) non-rinse-offproducts
(b) other products
(a) 2.5% (a) (b):
Do not use withnitrosating systems
Minimum purity:
99%
Maximumsecondary aminecontent: 0.5%(applies to rawmaterials)
Maximumnitrosamine
content: 50 g/kg
Keep in nitrite-freecontainers
63 Strontium hydroxide pH-regulator indepilatory products
3.5% calculated asstrontium, max pH of12.7
Keep out of reach of children
Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair carepreparationsprofessional use
4.5% calculated asstrontium in the ready-for-use preparation
All products must meetthe hydrogen peroxiderelease requirements
Avoid contact with eyes
Rinse eyes immediately if
product comes into contactwith them
For professional use only
Wear suitable gloves
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
65 Benzalkonium chloride, bromideand saccharinate
(a) Rinse-off hair (head)care products
(b) Other products
(a) 3% (asbenzalkoniumchloride)
(b) 0.1% (asbenzalkoniumchloride)
(a) In the finalproductstheconcentrations ofbenzalkoniumchloride, bromide
and saccharinatewith an alkyl chainof C14, or less mustnot exceed 0.1%(as benzalkoniumchloride)
As a preservative, seeAnnex VI, Part 1,No.54
(b) Avoid contact with the eyes
(c) Avoid contact with the eyes
66 Polyacrylamides (a) Body-care leave-onproducts
(b) Other cosmeticproducts
(a) Maximum residualacrylamidecontent; 0.1 mg/kg
(b) Maximum residualacrylamidecontent; 0.5 mg/kg
67to92
Entries left intentionally blank
93 2,4-Diamino-pyrimidine- 3-oxideCAS No 74638-76-9
Hair care formulations 1.5 %
94 Benzoyl peroxide Artificial nail systems 0.7 % (After mixing foruse)
Professional use only For professional use only
Avoid skin contact
Read directions for usecarefully
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
95 Hydroquinone methylether Artificial nail systems 0.02 % (After mixing foruse)
Professional use only For professional use only
Contains hydroquinone, do notuse on children under the ageof 12 years
Avoid skin contact
Read directions for usecarefully
96 Musk xyleneCAS No 81-15-2
All cosmetic products,with the exception oforal care products
(a) 1.0 % in finefragrance
(b) 0.4 % in eau detoilette
(c) 0.03 % in otherproducts
97 Musk ketoneCAS No 81-14-1
All cosmetic products,with the exception oforal care products
(a) 1.4 % in finefragrance
(b) 0.56 % in eau detoilette
(c) 0.042 % in otherproducts
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Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
98 Salicylic acidCAS No 69-72-7
(a) Rinse-off hairproducts
(b) Other products
(a) 3.0 %
(b) 2.0%
Not to be used inpreparations forchildren under threeyears of age, exceptfor shampoos
For purposes otherthan inhibiting thedevelopment ofmicroorganisms in theproduct. This purposehas to be apparentfrom the presentationof the product
Not to be used for children underthree years of age
(8)
99 Inorganic sulphites and
bisulphites(9)
(a) Oxidative hair dye
products
(b) Hair straighteningproducts
(c) Self- tanningproducts for the face
(d) Other self- tanningproducts
(a) 0.67 % expressed
as free SO2
(b) 6.7 % expressed asfree SO2
(c) 0.45 % expressedas free SO2
(d) 0.40 % expressedas free SO2
For purposes other
than inhibiting thedevelopment ofmicroorganisms in theproduct. This purposehas to be apparentfrom the presentationof the product
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
100 TriclocarbanCAS No 101-20-2
Rinse-off products 1.5 % Purity criteria:
3,3,4,4-Tetrachloroazobenzene 1 ppm
3,3,4,4-Tetrachloroazoxybenzene 1 ppm
For purposes otherthan inhibiting thedevelopment ofmicroorganisms in theproduct. This purposehas to be apparent
from the presentationof the product
101 Zinc pyrithioneCAS No 13463-41-7
Leave-on hair products
Rinse-off hair products
0.1 %
2.0%
For purposes otherthan inhibiting thedevelopment ofmicroorganisms in theproduct. This purposehas to be apparentfrom the presentation
of the product
102 GlyoxalCAS 107-22-2
100mg/kg
103to
184Entries left intentionally blank
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
185 TolueneCAS 108-88-3
Nail products 25% Keep out of reach of childrenTo be used by adults only
186 Diethylene glycol (DEG)CAS 111-46-62,2-oxydiethanol
Traces in ingredients 0.1%
187 Butoxydiglycol CAS 112-34-5
Diethylene glycol monobutylether (DEGBE)
Solvent in hair dyeproducts
9% No use in aerosoldispensers (sprays)
188 Butoxyethanol CAS 111-76-2;ethylene glycol monobutyl ether(EGBE)
(a) Solvent in oxidativehair dye products
(b) Solvent in non-oxidative hair dye
products
(a) 4.0%
(b) 2.0%
(a) No use in aerosoldispensers(sprays)
(b) No use in aerosoldispensers
(sprays)
189 Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophe-nylazo)pyrazole-3-carboxylateand aluminium lake
(15)
Acid Yellow 23CAS 1934-21-0
Acid Yellow 23 Aluminium lakeCAS 12225-21-7
Hair dye substance innon-oxidative hair dyeproducts
0.5%
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Ref #
Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic
product
Other limit ations andrequirements
A B C D E F
192 Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4,6,8-trisulphonate and aluminiumlake
(15)
Acid Red 18CAS 2611-82-7
AcidRed 18 AluminumlakeCAS 12227-64-4CI 16255
Hair dye substance innon-oxidative hair dyeproducts
0.5%
193 Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium,sodium salt
(15)
AcidRed 52CAS 3520-42-1CI 45100
(a) Hair dye substancein oxidative hair dyeproducts
(b) Hair dye substancein non-oxidative hairdye products
(b) 0.6%
(a) After mixing underoxidative conditionsthe maximumconcentration
applied to hair mustnot exceed 1.5 %.
(a) The mixing ratio must be printed on thelabel.
Hair colorants can cause severe allergicreactions.Read and follow instructions.This product is not intended for use onpersons und er the age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damaged scalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in thepast
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Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
194 Disodium 5-amino-4-hydroxy- 3-(phenylazo)naphthalene-2,7-disulphonate
(15)
AcidRed 33
CAS 3567-66-6CI 17200
Hair dye substance innon-oxidative hair dyeproducts
0.5%
195 Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10- dioxoanthracene-2-sulphonate
(15)
Acid Blue 62CAS 4368-56-3CI 62045
Hair dye substance innon-oxidative hair dyeproducts
0.5% Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
196 1-[(2-Methoxyethyl) amino]-2-nitro-4-[di-(2-hydroxyethyl)amino] benzene(15)
HC Blue No 11CAS 23920-15-2
Hair dye substance innon-oxidative hair dyeproducts
2.0% Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
197 1,5-Di-(beta-hydroxyethylamino)- 2-nitro-4-chlorobenzene
(15)
HC Yellow No 10CAS 109023-83-8
Hair dye substance innon-oxidative hair dyeproducts
0.1% Do not use withnitrosating systems
Maximum
nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
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Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
198 3-Methylamino-4-nitrophenoxyethanol
(15);
CAS 59820-63-2
Hair dye substance innon-oxidative hair dyeproducts
0.15% Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
199 2,2-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
(15)
HC Blue No 2CAS 33229-34-4
Hair dye substance innon-oxidative hair dyeproducts
2.8% Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-free
containers
Can cause allergic reaction
200 1-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino]
(15)
HC Violet No 2CAS 104226-19-9
Hair dye substance innon-oxidative hair dyeproducts
2.0% Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
Can cause allergic reaction
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents40
Ref #Substance Restrictions Conditions of use and warning
which must be printed on thelabels
Field of applicationand/or use
Maximum authorisedconcentration in the
finished cosmeticproduct
Other limit ations andrequirements
A B C D E F
201 2-Chloro-6-ethylamino-4-nitrophenol
(15)
CAS 131657-78-8
(a) Hair dye substancein oxidative hair dyeproducts
(b) Hair dye substancein non-oxidative hairdye products
(b) 3.0 %
(a) After mixing underoxidative conditionsthe maximumconcentrationapplied to hair must
not exceed 1.5 %
For (a) and (b):
Do not use withnitrosating systems
Maximumnitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a)The mixing ratio must be printed on thelabel.
.Hair colorants can causesevere allergicreactions.
Read and follow instructions.
This product is not intended for use onpersons under t he age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damaged scalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction to atemporary black henna tattoo in the
past
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202 4,4-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and itstetrahydrochloride salt(15);
1,3-bis-(2,4-Diaminophenoxy)propaneCAS 81892-72-0
1,3-bis-(2,4-Diaminophenoxy)propane HClCAS 74918-21-1
(a) Hair dye substance inoxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.2% as free base(1.8% astetrahydrochloridesalt)
(a) After mixing underoxidative conditionsthe maximumconcentration appliedto hair must notexceed 1.2%calculated as freebase (1.8% astetrahydrochloridesalt).
(a) The mixing ratio must be printed onthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past.
b) Can cause allergic reaction
ANNEX III P t 1 Li t f b t hi h ti d t t t t i t b j t t t i t i d dit i l id d
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203 6-Methoxy-N2-methyl-2,3-pyri-dinediamine hydrochloride anddihydrochloride salt(15)
6-Methoxy-2-methylamino-3-aminopyridineHCl
CAS 90817-34-8 (HCl)CAS 83732-72-3 (2HCl)
(a) Hair dye substance inoxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hairdye products
(b) 0.68 % as freebase (1.0 % asdihydrochloride)
(a) After mixing underoxidative conditionsthe maximumconcentration appliedto hair must notexceed 0.68 %calculated as freebase (1.0 % asdihydrochloride).
For a) and b):
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a)The mixing ratio must be printed onthe label.
.Hair colorants can causesevere allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
b) Can cause allergic reaction
204 2,3-Dihydro-1H-indole-5,6-dioland its hydrobromide salt
(15)
DihydroxyindolineCAS 29539-03-5
DihydroxyindolineHBrCAS 138937-28-7
Hair dye substance innon-oxidative hair dyeproducts
2.0% Can cause allergic reaction
ANNEX III Part 1 List of s bstances hich cosmetic prod cts m st not contain e cept s bject to restrict ions and condit ions laid do n
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
43/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents43
205 4-Hydroxypropylamino-3-nitrophenol
(15);
CAS 92952-81-3
(a) Hair dye substance inoxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hair dyeproducts
(b) 2.6 %
(a) After mixing underoxidative conditions themaximum concentrationapplied to hair must notexceed 2.6 % calculatedas free base.
For (a) and (b):
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a) The mixing ratio must be printed onthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
206 Verbena absolute (Lippiacitriodora Kunth.)CAS No 8024-12-2
0.2%
207 Ethyl LauroylArginateHCl(INCI)
(16)Ethyl-alpha -
dodecanoyl- L-arginatehydrochloride
CAS No 60372-77-2
a. soapb. anti-dandruff
shampoosc. deodorants, not in
form of spray
0.8% For purposes other thaninhibiting thedevelopment of micro-organisms in the product.This purpose has to beapparent from thepresentation of the
product.
ANNEX III Part 1 List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
44/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents44
208 1-(beta- Aminoethyl)amino-4-(beta-hydroxyethyl)oxy-2-nitrobenzene and its salts
HC Orange No 2
CAS No 85765-48-6
Hair dye substance innon-oxidative hair dyeproducts
1.0% Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
209 2-[(2-methoxy-4-nitrophenyl)amino]ethanol and
its salts
2-Hydroxyethylamino- 5-nitroanisole
CAS No 66095-81-6
Hair dye substance innon-oxidative hair dye
products
0.2% Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
210-214
Entries left intentionally blank
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
45/74
ANNEX III Part 1 List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents45
215 4-Amino-3-nitrophenolCAS No 610-81-1
(a) Hair dye substance inoxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.0%
(a) After mixing underoxidative conditionsthe maximumconcentration appliedto hair must notexceed 1.5%
(a) The mixing ratio must be printed onthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
(b)
Hair colorants can cause severe allergicreactions.Read and follow instructions.This product is not intended for useon persons under th e age of 16.Temporary black henna tattoos mayincrease your risk of allergy.Do not colour your hair if:
you have a rash on your face or
sensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
46/74
ANNEX III Part 1 List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents46
216 2,7-NaphthalenediolCAS No 582-17-2
(a) Hair dye substance inoxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.0%
(a) After mixing underoxidative conditions themaximum concentrationapplied to hair must notexceed 1.0%
(a) The mixing ratio must be printed on
the label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced any
reaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
47/74
p p j
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents47
217 m-Aminophenol (CAS No 591-27-5) and its salts
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.2%
The mixing ratio must be printed on thelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
48/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents48
218 2,6-Dihydroxy-3,4-dimethylpyridine
CAS No 84540-47-6
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.0%
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
219-221 Entries left intentionally blank
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
49/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents49
222 2-Hydroxyethyl picramic acid
CAS No 99610-72-7
(a) Hair dye substance inoxidative hair dye
products
(b) Hair dye substance innon-oxidative hairdye products
(b) 2.0 %
(a) After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.5 %
For (a) and (b):
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a) The mixing ratio must be printedonthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
50/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents50
223 p-Methylaminophenol (CAS No 150-75-4) and its sulphate
p-Methylaminophenol sulphate
CAS No 55-55-0 / 1936-57-8
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 0.68 % (assulphate)
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
224 Entry left intentionally blank
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
51/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents51
225 Ethanol, 2-[4-[Ethyl[(2-Hydroxyethyl)Amino]-2-
Nitrophenyl]Amino]-, (CAS No104516-93-0) and itshydrochloride
HC Blue No 12
CAS No 132885-85-9
(a) Hair dye substance inoxidative hair dye
products
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.5% (ashydrochloride)
(a) After mixing underoxidative conditions
the maximumconcentration appliedto hair must notexceed 0.75 % (ashydrochloride)
For (a) an (b):
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a) The mixing ratio must be printedonthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
226 Entry leftintentionally blank
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52/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents52
227 3-Amino-2,4-dichlorophenol(CAS No 61693-42-3)
and its hydrochloride
3-Amino-2,4-dichlorophenol HCl
CAS No 61693-43-4
(a) Hair dye substance inoxidative hair dye
products
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.5% (ashydrochloride)
(a) After mixing underoxidative conditions
the maximumconcentration appliedto hair must notexceed 1.5 % (ashydrochloride)
(a) The mixing ratio must be printedonthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
228-229
Entries left intentionally blank
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53/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents53
230 Phenyl methyl pyrazolone
CAS No 89-25-8
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 0.25 %
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
231 Entry left intentionally blank
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
54/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents54
232 2-Methyl-5-hydroxyethylaminophenol
CAS No 55302-96-0
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.5 %
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
233 Entry left intentionally blank
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55/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents55
234 Hydroxybenzomorpholine
CAS No 26021-57-8
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.0 %
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
235-236
Entries left intentionally blank
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ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
57/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents57
238 2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-
78-3 (free base)) and itshydrochloride
2,6-Dimethoxy-3,5-pyridinediamine HCl
CAS No 56216-28-5
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 0.25 % (ashydrochloride)
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
58/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents58
239 HC Violet No 1CAS No 82576-75-8
(a) Hair dye substance inoxidative hair dye
products
(b) Hair dye substance innon-oxidative hairdye products
(b) 0.28 %
(a) After mixing underoxidative conditions
the maximumconcentration appliedto hair must notexceed 0.25 %
For (a) and (b):
Do not use withnitrosating systems
Maximum nitrosaminecontent: 50 g/kg
Keep in nitrite-freecontainers
(a) The mixing ratio must be printed onthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
(b)
Hair colorants can cause severe allergicreactions.Read and follow instructions.This product is not intended for useon persons under th e age of 16.Temporary black henna tattoos mayincrease your risk of allergy.Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
59/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents59
240 Entry left intentionally blank
241 1,5-Naphthalenediol
CAS No 83-56-7
(a) Hair dye substance in
oxidative hair dyeproducts
(b) Hair dye substance innon-oxidative hairdye products
(b) 1.0 %
(a) After mixing under
oxidative conditionsthe maximumconcentration appliedto hair must notexceed 1.0 %
(a) The mixing ratio must be printed
onthe label.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos mayincrease your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
60/74
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
61/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
62/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents62
244 2,4-Diaminophenoxyethanol(CAS No 70643-19-5), its
hydrochloride and its sulphate
2,4-Diaminophenoxyethanol HCl
CAS No 66422-95-5
2,4-Diaminophenoxyethanolsulfate
CAS No 70643-20-8
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 2.0 % (ashydrochloride)
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
63/74
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
64/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents64
246 4-Amino-m-cresol
CAS No 2835-99-6
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.5 %
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
247 Entry left intentionally blank
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit ions laid down
Th i i ti t b i t d th
8/9/2019 FDA - Annex III Part 1revised as Per 17th ACSB-1
65/74
Revised based on agreement of 17thACSB Meeting ASEAN Cosmetic Documents65
248 2-Amino-4-hydroxyethylaminoanisole(CAS
No 83763-47-7)and its sulphate
2-Amino-4-hydroxyethylaminoanisolesulfate
CAS No 83763-48-8
Hair dye substance inoxidative hair dye
products
After mixing underoxidative conditions the
maximum concentrationapplied to hair must notexceed 1.5 % (assulphate)
Do not use withnitrosating systems
Maximum nitrosamine
content: 50 g/kg
Keep in nitrite-freecontainers
The mixing ratio must be printed onthelabel.
Hair colorants can cause severe allergicreactions.
Read and follow instructions.
This product is not intended for useon persons under th e age of 16.
Temporary black henna tattoos may
increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face orsensitive, irritated and damagedscalp,
you have ever experienced anyreaction after colouring your hair,
you have experienced a reaction toa temporary black henna tattoo inthe past
ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit io
Recommended