FDA - Annex III Part 1revised as Per 17th ACSB-1

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 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


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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


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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


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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%


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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


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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:




Contains phenylenediamines. Wear suitablegloves.


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Ref #

Substance Restrictions Conditions of use and warning






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:




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:




The mixing ratio is printed on the label. Containsphenylenediamines. Wear suitable gloves.


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Ref #







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:




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:




Contains phenylenediamines(toluenediamines). Wear suitable gloves


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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:




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:




Contains phenylenediamines(toluenediamines).Wear suitable gloves. The mixing ratio is printedon the label.


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Ref #







A B C D E F

10 Entry leftintentionally blank

11 Dichlorophen (INN) 0.5% Contains dichlorophen


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Ref #







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


(i) Up to 6% H202present orreleased

(ii) 6 35 % H202present orreleased


(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.


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Ref #







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


Can cause blindness


2.

For professional use only


Can cause blindness

(c)




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Ref #







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


Can cause blindness


2.

For Professional use only


Can cause blindness

(b)

Contains alkali




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Ref #







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


Can cause blindness


(b)

Contains alkali




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Ref #







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


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Ref #







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


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Ref #







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 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:




(b) Contains resorcinol


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Ref #







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)



(b)



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


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)


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Ref #







A B C D E F

27 Sodium monofluorophosphate Ditto Ditto Ditto Contains sodiummonofluorophosphate


supervised brushing tominimize swallowing. In case ofintake of fluoride from othersources consult a dentist ordoctor(

12)

28 Potassiummonofluorophosphate

Ditto Ditto Ditto Contains potassiummonofluorophosphate


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



12)


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Ref #







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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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


12)


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Ref #







A B C D E F

36 Hexadecyl ammonium fluoride Ditto Ditto Ditto Contains Hexadecylammonium fluoride



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


12)


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Ref #







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


12)

39 Octadecenyl-ammoniumfluoride

Ditto Ditto Ditto Contains octadecenyl-ammonium fluoride


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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Ref #







A B C D E F

41 Potassium fluorosilicate Ditto Ditto Ditto Contains potassiumfluorosilicate



12)

42 Ammonium fluorosilicate Ditto Ditto Ditto Contains ammoniumfluorosilicate



12)

43 Magnesium fluorosilicate Ditto Ditto Ditto Contains magnesiumfluorosilicate



12)


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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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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

-


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


12)


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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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Ref #


which must be printed on thelabelsField of applicationand/or useMaximum authorisedconcentration in the



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%


Minimum purity:99%

Maximumsecondary aminecontent: 0.5%(applies to rawmaterials)

Maximumnitrosamine

content: 50 g/kg



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Ref #


which must be printed on thelabelsField of applicationand/or useMaximum authorisedconcentration in the



A B C D E F

62 Trialkylamines, trialkanolaminesand their salts

(a) non-rinse-offproducts

(b) other products

(a) 2.5% (a) (b):


Minimum purity:

99%

Maximumsecondary aminecontent: 0.5%(applies to rawmaterials)

Maximumnitrosamine

content: 50 g/kg


63 Strontium hydroxide pH-regulator indepilatory products

3.5% calculated asstrontium, max pH of12.7


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


Rinse eyes immediately if

product comes into contactwith them

For professional use only

Wear suitable gloves


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Ref #


which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in thefinished cosmetic

product


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


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)


Avoid skin contact



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product


A B C D E F

95 Hydroquinone methylether Artificial nail systems 0.02 % (After mixing foruse)


Contains hydroquinone, do notuse on children under the ageof 12 years

Avoid skin contact


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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product


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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product


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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product


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%


36/74


37/74



Ref #



product


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


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 ever experienced anyreaction after colouring your hair,

you have experienced a reaction to atemporary black henna tattoo in thepast


38/74




which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in the



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


0.5%

195 Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10- dioxoanthracene-2-sulphonate

(15)

Acid Blue 62CAS 4368-56-3CI 62045


0.5% Do not use withnitrosating systems

Maximumnitrosaminecontent: 50 g/kg


196 1-[(2-Methoxyethyl) amino]-2-nitro-4-[di-(2-hydroxyethyl)amino] benzene(15)

HC Blue No 11CAS 23920-15-2





197 1,5-Di-(beta-hydroxyethylamino)- 2-nitro-4-chlorobenzene

(15)

HC Yellow No 10CAS 109023-83-8



Maximum

nitrosaminecontent: 50 g/kg



39/74




which must be printed on thelabelsField of applicationand/or use Maximum authorisedconcentration in the



A B C D E F

198 3-Methylamino-4-nitrophenoxyethanol

(15);

CAS 59820-63-2





199 2,2-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol

(15)

HC Blue No 2CAS 33229-34-4




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





Can cause allergic reaction


40/74









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):




(a)The mixing ratio must be printed on thelabel.

.Hair colorants can causesevere allergicreactions.


This product is not intended for use onpersons under t he age of 16.





you have experienced a reaction to atemporary black henna tattoo in the

past


41/74



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.



This product is not intended for useon persons under th e age of 16.



you have a rash on your face orsensitive, irritated and damagedscalp,


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


42/74



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)



(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):


Maximum nitrosaminecontent: 50 g/kg


(a)The mixing ratio must be printed onthe label.

.Hair colorants can causesevere allergicreactions.



Temporary black henna tattoos may

increase your risk of allergy.




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


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


43/74



205 4-Hydroxypropylamino-3-nitrophenol

(15);

CAS 92952-81-3


(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):













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


44/74



208 1-(beta- Aminoethyl)amino-4-(beta-hydroxyethyl)oxy-2-nitrobenzene and its salts

HC Orange No 2

CAS No 85765-48-6













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




210-214




45/74



215 4-Amino-3-nitrophenolCAS No 610-81-1



(b) 1.0%

(a) After mixing underoxidative conditionsthe maximumconcentration appliedto hair must notexceed 1.5%










(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,





46/74



216 2,7-NaphthalenediolCAS No 582-17-2



(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.







you have ever experienced any

reaction after colouring your hair,




47/74

p p j


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.











48/74


218 2,6-Dihydroxy-3,4-dimethylpyridine

CAS No 84540-47-6


products


maximum concentrationapplied to hair must notexceed 1.0%

The mixing ratio must be printed onthelabel.









219-221 Entries left intentionally blank



49/74


222 2-Hydroxyethyl picramic acid

CAS No 99610-72-7

(a) Hair dye substance inoxidative hair dye

products


(b) 2.0 %

(a) After mixing underoxidative conditions the

maximum concentrationapplied to hair must notexceed 1.5 %

For (a) and (b):




(a) The mixing ratio must be printedonthe label.












50/74


223 p-Methylaminophenol (CAS No 150-75-4) and its sulphate

p-Methylaminophenol sulphate

CAS No 55-55-0 / 1936-57-8


products


maximum concentrationapplied to hair must notexceed 0.68 % (assulphate)

















51/74


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


products


(b) 1.5% (ashydrochloride)

(a) After mixing underoxidative conditions

the maximumconcentration appliedto hair must notexceed 0.75 % (ashydrochloride)

For (a) an (b):














226 Entry leftintentionally blank



52/74


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


products


(b) 1.5% (ashydrochloride)


the maximumconcentration appliedto hair must notexceed 1.5 % (ashydrochloride)











228-229




53/74


230 Phenyl methyl pyrazolone

CAS No 89-25-8


products
















54/74


232 2-Methyl-5-hydroxyethylaminophenol

CAS No 55302-96-0


products



















55/74


234 Hydroxybenzomorpholine

CAS No 26021-57-8


products
















235-236



56/74



57/74


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


products


maximum concentrationapplied to hair must notexceed 0.25 % (ashydrochloride)













58/74


239 HC Violet No 1CAS No 82576-75-8


products


(b) 0.28 %


the maximumconcentration appliedto hair must notexceed 0.25 %

For (a) and (b):













(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:






59/74



241 1,5-Naphthalenediol

CAS No 83-56-7

(a) Hair dye substance in

oxidative hair dyeproducts


(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.










60/74


61/74



62/74


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


products


maximum concentrationapplied to hair must notexceed 2.0 % (ashydrochloride)












63/74



64/74


246 4-Amino-m-cresol

CAS No 2835-99-6


products















Th i i ti t b i t d th


65/74


248 2-Amino-4-hydroxyethylaminoanisole(CAS

No 83763-47-7)and its sulphate

2-Amino-4-hydroxyethylaminoanisolesulfate

CAS No 83763-48-8


products


maximum concentrationapplied to hair must notexceed 1.5 % (assulphate)


Maximum nitrosamine

content: 50 g/kg












ANNEX III-Part 1-List of substances which cosmetic products must not contain except subject to restrict ions and condit io