ANNEX III

F2PART 1LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN

Annotations:
Amendments (Textual)

F2Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Field of application and/or use

Maximum authorized concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

F241a

F22Boric acid, borates and tetraborates with the exception of substance No in Annex II

(a)

Talc

(a)

5 % (by mass/mass as boric acid)

(a)

  1. 1.

    Not to be used in products for children under 3 years of age

  2. 2.

    Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid)

(a)

  1. 1.

    Not to be used for children under 3 years of age

  2. 2.

    Not to be used on peeling or irritated skin

(b)

Products for all hygiène

(b)

0,1 % (by mass/mass as boric acid)

(b)

  1. 1.

    Not to be used in products for children under 3 years of age

(b)

  1. 1.

    Not to be swallowed

  2. 2.

    Not to be used for children under 3 years of age

(c)

Other products (excluding bath products and hair waving products)

(c)

3 % (by mass/mass as boric acid)

(c)

  1. 1.

    Not to be used in products for children under 3 years of age

  2. 2.

    Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid)

(c)

  1. 1.

    Not to be used for children under 3 years of age

  2. 2.

    Not to be used on peeling or irritated skin

1b

Tetraborates

(a)

Bath products

(a)

18 % (by mass/mass as boric acid)

(a)

Not to be used in products for children under 3 years of age

(a)

Not to be used of bathing children under 3 years of age

(b)

Hair waving products

(b)

8 % (by mass/mass as boric acid)

(b)

Rinse well

F142a

Thioglycollic acid and its salts

(a)

Hair waving or straightening products:

(a) (b) (c):The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences:

  • Avoid contact with eyes

  • In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • Wear suitable gloves ((a) and (c) only)

(a):

  • Contains thioglycolate

  • Follow the instructions

  • Keep out of reach of children

  • For professional use only

(b) and (c):

  • Contains thioglycolate

  • Follow the instructions

  • Keep out of reach of children

general use

  • 8 % ready for use

    pH 7 to 9,5

professional use

  • 11 % ready for use

    pH 7 to 9,5

(b)

Depilatories

  • 5 % ready for use

    pH 7 to 12,7

(c)

Other hair-caire products which are removed after application

  • 2 % ready for use

    pH to 9,5

The abovementioned percentages are calculated as thioglycollic acid

2b

Thioglycollic acid esters

Hair waving or straightening products:

The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences:

  • May cause sensitization in the event of skin contact

  • Avoid contact with eyes

  • In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • Wear suitable gloves

  • Contains thioglycolate

  • Follow the instructions

  • Keep out of reach of children

general use

8 % ready for use pH 6 to 9,5

professional use

11 % ready for use pH 6 to 9,5

For professional use only

The abovementioned percentages are calculated as thioglycollic acid

F23

Oxalic acid, its esters and alcaline salts

Hair care products

5 %

For professional use only

4

Ammonia

6 % calculated as NH3

Above 2 %: contains ammonia

5

Tosylchloramide sodium (*)

0·2 %

6

Chlorates of alkali metals

(a)

Toothpaste

(b)

Other uses

(a)

5 %

(b)

3 %

7

Dichloromethane

35 %

(when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 %)

0·2 % as maximum impurity content

8

F25X1p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine16, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

Oxidizing colouring agents for hair dyeing

6 % calculated as free base

(a)

general use

(a)

Can cause an allergic reaction. F26Contains phenylenediamines. Do not use to dye eyelashes or eyebrows

(b)

professional use

(b)

For professional use only. Contains phenylenediamines. Can cause an allergic reaction. F26F16Wear suitable gloves.

9

F25X1Methylphenylenediamines, their N-substituted derivatives and their salts12 with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II

Oxidizing colouring agents for hair dyeing

10 % calculated as free base

(a)

general use

(a)

Can cause an allergic reaction. F26Contains phenylenediamines. Do not use to dye eyelashes or eyebrows

(b)

professional use

(b)

For professional use only. Contains phenylenediamines. Can cause en allergic reaction. F26F16Wear suitable gloves.

10

Diaminophenols12

Oxidizing colouring agents for hair dyeing

10 % calculated as free base

(a)

general use

(a)

Can cause an allergic reaction. F26Contains diaminophenols. Do not use to dye eyelashes or eyebrows

(b)

professional use

(b)For professional use only. Contains diaminophenols. Can cause allergic reaction. F26

F16Wear suitable gloves.

F1311

Dichlorophen (*)

0,5 %

Contains dichlorophen

F1512

Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide

(a)

Hair-caire preparations

12 % of H2O2 (40 volumes), present or released

F16(a):

Wear suitable gloves

(b)

Skin-care preparations

4 % of H2O2, present or released

(a) (b) (c):

Contains hydrogen peroxide.

(c)

Nail hardening preparations

2 % of H2O2, present or released

Avoid contact with eyes.

Rinse immediately if product comes into contact with them

(d)

Oral hygiene products

0,1 % of H2O2, present or released

F213

Formaldehyde

Nail hardeners

5 % calculated as formaldehyde

Protect cuticles with grease or oil. Contains formaldehyde13.

F614

Hydroquinone14

(a)

Oxidising colouring agent for hair-dying:

0,3 %

(a)

  1. 1.
    • Do not use to dye eyelashes or eyebrows

1.

General use

  • Rinse the eyes immediately if the product comes into contact with them

  • Contains hydroquinone

2.

Professional use

2.

  • For professional use only

  • Contains hydroquinone

  • Rinse the eyes immediately if the product comes into contact with them

(b)

Artificial nail systems

0,02 % (after mixing for use)

Professional use only

(b)

  • For professional use only

  • Avoid skin contact

  • Read directions for use carefully

F1815a

Potassium or sodium hydroxide

(a)

Nail cuticle solvent

(a)

5 % by weight15

(a)

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

(b)

Hair straightener

(b)

(b)

1.

General use

1.

2 % by weight15

1.

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

2.

Professional use

2.

4,5 % by weight15

2.

For professional use only. Avoid contact with eyes. Can cause blindness.

(c)pH adjuster

  • depilatories

(c)

Up to pH 12,7

(c)

Keep out of reach of children. Avoid contact with eyes

(d)

Other uses as pH adjuster

(d)

Up to pH 11

F1015b

Lithium hydroxide

(a)

Hair straighteners

(a)

(a)

1.

General use

1.

2 %17 by weight

1.Contains alkali

Avoid contact with eyes

Can cause blindness

Keep out of reach of children

2.

Professional use

2.

4,5 %17 by weight

2.For professional use only

Avoid contact with eyes

Can cause blindness

(b)

pH ajuster — for depilatories

(b)

pH value not to exceed pH 12,7

(b)Contains alkali

Keep out of reach of children

Avoid contact with eyes

(c)

Other uses — as pH adjuster (for rinse-off products only)

(c)

pH value not to exceed pH 11

15c

Calcium hydroxide

Hair straighteners containing two components: calcium hydroxide and a guanidine salt

(a)

7 % by weight of calcium hydroxide

(a)Contains alkali

Avoid contact with eyes

Keep out of reach of children

Can cause blindness

(b)

pH ajuster — for depilatories

(b)

pH value not to exceed pH 12,7

(b)Contains alkali

Keep out of reach of children

Avoid contact with eyes

(c)

Other uses (e.g. pH adjuster, processing aid)

(c)

pH value not to exceed pH 11

F2F1016

1-Naphthol (CAS No 90-15-3) and its salts

Oxidising colouring agents for hair dyening

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergie reaction

17

Sodium nitrite

Rust inhibitor

0,2 %

Do not use with secondary and/or tertiary amines or other substances forming nitrosamines

18

Nitromethane

Rust inhibitor

0,3 %

F21. . . . .

F26

21

Quinine and its salts

(a)

Shampoos

(a)

0,5 % calculated as quinine base

(b)

Hair lotions

(b)

0,2 % calculated as quinine base

22

Resorcinol14

(a)

Oxidizing colouring agent for hair dyeing

(a)

5 %

(a)

1.

general use

1.Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows.

Rinse eyes immediately if product comes into contact with them

2.

professional use

2.For professional use only. Contains resorcinol.

Rinse eyes immediately if product comes into contact with them

(b)

Hair lotions and shampoos

(b)

0,5 %

(b)

Contains resorcinol

23

(a)

Alkali sulphides

(a)

Depilatories

(a)

2 % calculated as sulphur pH ≤ 12,7

(a)

Keep out of reach of children. Avoid contact with eyes

(b)

Alkaline earth sulphides

(b)

Depilatories

(b)

6 % calculated as sulphur pH ≤ 12,7

(b)

Keep out of reach of children. Avoid contact with eyes

24

Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione

1 % calculated as zinc

25

Zinc 4-hydroxybenzene sulphonate

Deodorants, antiperspirants and astringent lotions

6 % calculated as % of anhydrous substance

Avoid contact with eyes

26

Sodium monofluorophosphate

Oral hygiene products

0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains ammonium monofluorophosphate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

27

Sodium monofluorophosphate

Ditto

0,15 %

Ditto

Contains sodium monofluorophosphate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

28

Potassium monofluorophosphate

Ditto

0,15 %

Ditto

Contains potassium monofluorophosphate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

29

Calcium monofluorophosphate

Ditto

0,15 %

Ditto

Contains calcium monofluorophosphate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

30

Calcium fluoride

Ditto

0,15 %

Ditto

Contains calcium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

31

Sodium fluoride

Ditto

0,15 %

Ditto

Contains sodium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

32

Potassium fluoride

Ditto

0,15 %

Ditto

Contains potassium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

33

Ammonium fluoride

Ditto

0,15 %

Ditto

Contains ammonium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

34

Aluminium fluoride

Ditto

0,15 %

Ditto

Contains aluminium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

35

Stannous fluoride

Ditto

0,15 %

Ditto

Contains stannous fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

36

Hexadecyl ammonium fluoride

Ditto

0,15 %

Ditto

Contains hexadecyl ammonium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

37

3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride

Ditto

0,15 %

Ditto

Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

38

NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride

Ditto

0,15 %

Ditto

Contains NN'N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

39

Octadecenyl-ammonium fluoride

Ditto

0,15 %

Ditto

Contains octadecenyl-ammonium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

40

Sodium fluorosilicate

Ditto

0,15 %

Ditto

Contains sodium fluorosilicate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

41

Potassium fluorosilicate

Ditto

0,15 %

Ditto

Contains potassium fluorosilicate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

42

Ammonium fluorosilicate

Ditto

0,15 %

Ditto

Contains ammonium fluorosilicate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

43

Magnesium fluorosilicate

Ditto

0,15 %

Ditto

Containes (SIC! Contains) magnesium fluorosilicate. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

F1244

1,3-Bis (hydroxymethyl)imidazolidine-2-thione

(a)

Hair-care preparations

(b)

Nail-care preparations.

(a)

Up to 2 %

(b)

Up to 2 %

(a)

Prohibited in aerosol dispensers (sprays)

(b)

The pH of the product as applied must be less than 4

Contains 1,3-bis (hydroxymethyl) immidazolidine-2-thione

F245

Benzyl alcohol

Solvents, perfumes and flavourings

F446

6-methylcoumarin

Oral hygiene products

0,003 %

F1147

Nicomethanol hydrofluoride

Oral hygiene products

0,15 %

calculated as F

When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains nicomethanol hydrofluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

48

Silver nitrate

Solely for products intended for colouring eyelashes and eyebrows

4 %

  • Contains silver nitrate

  • Rinse the eyes immediately if product comes into contact with them

F549

Selenium disulphide

Antidandruff shampoos

1 %

  • Contains selenium disulphide

  • Avoid contact with eyes or damaged skin

50

Aluminium zirconium chloride hydroxyde complexes

AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes

Antiperspirants

20 % as anhydrous aluminium zirconium chloride hydroxide

5,4 % as zirconium

1.

The ratio of the number of aluminium atoms to that of zirconium atoms must be between two an 10

2.

The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1

3.

Prohibited in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin

F1451

Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate

Stabilizer for hydrogen peroxide in rinse-off hair-care preparations

0,3 % calculated as base

Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations

0,03 % calculated as base

F1352

Methanol

Denaturant for ethanol and isopropyl alcohol

5 % calculated as a % ethanol and isopropyl acohol

F1453

Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts)

(a)

Hair-care

1,5 % expressed as etidronic acid

F9

(b)

Soap

0,2 % expressed as etidronic acid

54

1-Phenoxy-propan-2-ol

Rinse-off products only

2 %

As a preservative, see Annex VI, Part 1, No 43

Prohibited in oral hygiene products

F28. . . . .

F856

Magnesium fluoride

Dental hygiene products

0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains magnesium fluoride. F27For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligator:

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

F1957

Strontium chloride hexahydrate

(a)

Toothpaste

3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %

Contains strontium chloride. Frequent use by children is not advisable

(b)

Shampoo and face care products

2,1 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 2,1 %

F1558

Strontium acetate hemihydrate

Toothpaste

3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %

Contains strontium acetate. Frequent use by children is not advisable

F1759

Talc: Hydrated magnesium silicate

(a)

Powdery products intended to be used for children under three years of age

(b)

other products

X2(a)

Keep powder away from children's nose and mouth

F660

Fatty acid dialkylamides and dialkanolamides

Maximum secondary amine content: 0,5 %

  • Do not use with nitrosating systems

  • Maximum secondary amine content: 5 % (applies to raw materials)

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

61

Monoalkylamines, monoalkanolamines and their salts

Maximum secondary amine content: 0,5 %

  • Do not use with nitrosating systems

  • Minimum purity: 99 %

  • Maximum secondary amine content: 0,5 % (applies to raw materials)

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

62

Trialkylamines, trialkanolamines and their salts

(a)

Non-rinse-off products

(b)

Other products

(a)

2,5 %

(a) (b)

  • Do not use with nitrosating systems

  • Minimum purity: 99 %

  • Maximum secondary amine content: 0,5 % (applies to raw materials)

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

F1763

Strontium hydroxide

pH-regulator in depilatory products

3,5 % calculated as strontium, max. pH of 12,7

  • Keep out of reach of children

  • Avoid contact with the eyes

64

Strontium peroxide

Rinse-off hair care preparations professional use

4,5 % calculated as strontium in the ready-for-use preparation

All products must meet the hydrogen peroxide release requirements

  • Avoid contact with eyes

  • Rinse eyes immediately if product comes into contact with them

  • For professional use only

  • Wear suitable gloves

F2965

Benzalkonium Chloride, bromide and saccharinate

(a)

Rinse-off hair (head) care products

(a)

3 % (as benzalkonium chloride)

(a)

In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0,1 % (as benzalkonium chloride)

(a)

Avoid contact with the eyes

(b)

Other products

(b)

0,1 % (as benzalkonium chloride)

(b)

Avoid contact with the eyes

F2066

Polyacrylamides

(a)

Body-care leave-on products

(a)

Maximum residual acrylamide content 0,1 mg/kg

(b)

Other cosmetic products

(b)

Maximum residual acrylamide content 0,5 mg/kg

F367

Amyl cinnamal

(CAS No 122-40-7)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

68

Benzyl alcohol

(CAS No 100-51-6)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

69

Cinnamyl alcohol

(CAS No 104-54-1)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

70

Citral

(CAS No 5392-40-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

71

Eugenol

(CAS No 97-53-0)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

72

Hydroxy-citronellal

(CAS No 107-75-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

73

Isoeugenol

(CAS No 97-54-1)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

74

Amylcin namyl alcohol

(CAS No 101-85-9)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

75

Benzyl salicylate

(CAS No 118-58-1)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

76

Cinnamal

(CAS No 104-55-2)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

77

Coumarin

(CAS No 91-64-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

78

Geraniol

(CAS No 106-24-1)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

79

Hydroxy-methylpentylcyclohexenecarboxaldehyde

(CAS No 31906-04-4)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

80

Anisyl alcohol

(CAS No 105-13-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

81

Benzyl cinnamate

(CAS No 103-41-3)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

82

Farnesol

(CAS No 4602-84-0)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

83

2-(4-tert-Butylbenzyl) propionaldehyde

(CAS No 80-54-6)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

84

Linalool

(CAS No 78-70-6)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

85

Benzyl benzoate

(CAS No 120-51-4)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

86

Citronellol

(CAS No 106-22-9)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

87

Hexyl cinnam-aldehyde

(CAS No 101-86-0)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

88

d-Limonene

(CAS No 5989-27-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

89

Methyl heptin carbonate

(CAS No 111-12-6)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

90

3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one

(CAS No 127-51-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

91

Oak moss extract

(CAS No 90028-68-5)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

92

Treemoss extract

(CAS No 90028-67-4)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

F3093

2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9)

Hair care formulations

1,5 %

94

Benzoyl peroxide

Artificial nail systems

0,7 % (after mixing)

Professional use only

  • For professional use only

  • Avoid skin contact

  • Read directions for use carefully

95

Hydroquinone methylether

Artificial nail systems

0,02 % (after mixing for use)

Professional use only

  • For professional use only

  • Avoid skin contact

  • Read directions for use carefully

F3196

Musk xylene (CAS No 81-15-2)

All cosmetic products, with the exception of oral care products

  1. (a)

    1,0 % in fine fragrance

  2. (b)

    0,4 % in eau de toilette

  3. (c)

    0,03 % in other products

97

Musk ketone (CAS No 81-14-1)

All cosmetic products, with the exception of oral care products

  1. (a)

    1,4 % in fine fragrance

  2. (b)

    0,56 % in eau de toilette

  3. (c)

    0,042 % in other products

F2398

Salicylic acid18

(CAS No 69-72-7)

a)

Rinse-off hair products

b)

Other products

a)

3,0 %

b)

2,0 %

Not to be used in preparations for children under three years of age, except for shampoos.

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

Not to be used for children under three years of age19

99

Inorganic sulfites and bisulfites20

a)

Oxidative hair dye products

b)

Hair straightening products

c)

Self tanning products for the face

d)

Other self tanning products

a)

0,67 % expressed as free SO2

b)

6,7 % expressed as free SO2

c)

0,45 % expressed as free SO2

d)

0,40 % expressed as free SO2

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

100

Triclocarban21

(CAS 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 other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

101

Zinc pyrithione22

(CAS No 13463-41-7)

Leave-on hair products

0,1 %

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 1.

Only if the concentration exceeds 0,05 %.

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 2.

The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column d.

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.

The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.

As a preservative, see Annex VI, Part 1, No 3.

Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.

As a preservative, see Annex VI, Part 1, No 9.

As a preservative, See Annex VI, Part 1, No 23.

As a preservative, see Annex VI, Part 1, No 8.

F7F1PART 2LIST OF SUBSTANCES PROVISIONALLY ALLOWED

Annotations:

Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Allowed until

Field of application and/or use

Maximum authorized concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

g

F32

F32

F32

F203

4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

(a) (b)

Can cause allergic reaction

F3331.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

3,0 %

4

2,7-Naphthalenediol (CAS no 582-17-2) and its salts

Oxidising colouring agents for hair dyeing

1,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %

31.12.2007

5

m-Aminophenol (CAS no 591-27-5) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

6

2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

7

4-Hydroxypropylamino-3-nitrophenol (CAS No 92952-81-3) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

5,2 %

In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 %

(a) (b)

Can cause allergic reaction

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

2,6 %

F32

9

HC Blue No 11 (CAS No 23920-15-2) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

(a) (b)

Can cause allergic reaction

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

2,0 %

10

Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

(a) (b)

Can cause allergic reaction

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

1,0 %

11

2-Hydroxyethylpicramic acid (CAS No 99610-72-7) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

(a) (b)

Can cause allergic reaction

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

2,0 %

12

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

Oxidising colouring agent for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Can cause allergic reaction

31.12.2007

F32

14

HC Violet No 2 CAS No 104226-19-9) and its salts

Non-oxidising colouring agent for hair dyeing

2,0 %

31.12.2007

F32

16

HC Blue No 12 (CAS No 104516-93-0) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

1,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 %

(a) (b)

Can cause allergic reaction

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

1,5 %

F34

18

1,3-Bis-(2,4-diaminophenoxy)propane (CAS No 81892-72-0) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

19

X33-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

20

Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts

Oxidising colouring agents for hair dyeing

0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

31.12.2007

21

2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

22

Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause allergic reaction

31.12.2007

F34

24

HC Yellow No 10 (CAS No 109023-83-8) and its salts

Non-oxidising colouring agents for hair dyeing

0,2 %

31.12.2007

25

2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3) and its salts

Oxidising colouring agents for hair dyeing

0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Can cause allergic reaction

31.12.2007

26

HC Orange No 2 (CAS No 85765-48-6) and its salts

Non-oxidising colouring agents for hair dyeing

1,0 %

31.12.2007

27

HC Violet No 1 (CAS No 82576-75-8) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

0,5 %

28

3-Methylamino-4-nitro-phenoxyethanol (CAS No 59820-63-2) and its salts

Non-oxidising colouring agents for hair dyeing

1,0 %

31.12.2007

29

2-Hydroxy-ethylamino-5-nitro-anisole (CAS No 66095-81-6) and its salts

Non-oxidising colouring agents for hair dyeing

1,0 %

31.12.2007

F32

F32

31

X3HC Red No 13 (CAS No 94158-13-1) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

2,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

2,5 %

32

1,5-Naphthalenediol (CAS No 83-56-7) and its salts

Oxidising colouring agents for hair dyeing

1,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %

31.12.2007

33

Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its salts

Oxidising colouring agents for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Can cause allergic reaction

31.12.2007

34

o-Aminophenol (CAS No 95-55-6) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

F3331.12.2007

35

4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts

Oxidising colouring agents for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

31.12.2007

36

X32,4-Diaminophenoxyethanol (CAS No 66422-95-5) and its salts

Oxidising colouring agents for hair dyeing

4,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 %

31.12.2007

37

2-Methylresorcinol (CAS No 608-25-3) and its salts

Oxidising colouring agents for hair dyeing

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

31.12.2007

38

4-Amino-m-cresol (CAS No 2835-99-6) and its salts

Oxidising colouring agents for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

31.12.2007

39

2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts

Oxidising colouring agents for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

31.12.2007

F34

F32

F34

F32

44

Hydroxyethyl-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its salts

Oxidising colouring agents for hair dyeing

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

31.12.2007

F32

F32

F32

47

HC Blue No 2 (CAS No 33229-34-4) and its salts

Non-oxidising colouring agents for hair dyeing

2,8 %

31.12.2007

48

3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

6,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

6,0 %

49

4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

0,5 %

50

HC Red No 10 + HC Red No 11 (CAS No 95576-89-9 + 95576-92-4) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

1,0 %

F32

F32

F32

F32

F32

F32

F32

55

2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

3,0 %

56

2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

2,0 %

57

Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

0,5 %

58

Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts

Non-oxidising colouring agents for hair dyeing

2,0 %

31.12.2007

59

Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts

Non-oxidising colouring agents for hair dyeing

2,0 %

31.12.2007

60

Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts

(a)

Oxidising colouring agents for hair dyeing

(a)

0,3 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 %

31.12.2007

(b)

Non-oxidising colouring agents for hair dyeing

(b)

0,3 %

F35

F35

F35

F35

F35

F35