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The Cosmetic Products (Safety) Regulations 2004

Status:

This is the original version (as it was originally made).

Regulations 5(2), 6(1) and 7(2), 7(9)

SCHEDULE 4LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

This schedule has no associated Explanatory Memorandum

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(1).

Regulation 1(3) provides that until 24th March 2005 entries 14, 60, 61 and 62 shall be inserted into Part 1 of this Schedule as they appear in Part 1 of Schedule 4 to the Cosmetic (Products) (Safety) Regulations 2003(2). From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

Regulation 1(4) provides that entries 93,94 and 95 in Part 1 of this Schedule shall not form part of this Schedule until 24th March 2005.

PART 1SUBSTANCES LISTED IN ANNEX III, PART I OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1aBoric acid, borates, and tetraborates‘Talcum power5 per cent

Not to be used in products intended for children under three years old

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for bathing children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

Oral hygiene products0.1 per centNot to be used in products intended for children under three years old

Do not swallow

Not to be used for children under three years old

Other products (excluding bath products and hair waving products3 per cent

Not to be used in products intended for children under three years old

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

The above-mentioned percentages are calculated as boric acid
1bTetraboratesBath products18 per centNot to be used in products for children under three years oldNot to be used for bathing children under three years old
2aThioglycolic acid and its salts

(a)Hair waving or straightening products for general use

8 per centpH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children.

(b)Hair waving or straightening products for professional use

11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only

(c)Depilatories

5 per cent ready for usepH 7 to 12.7Contains thioglycolate. Follow the instructions. Keep out of reach of children

(d)Other hair-care products which are removed after application

2 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
The above-mentioned percentages are calculated as thioglycolic acid

(a), (b), (c) and (d): The directions for use must incorporate the following:

  • 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), (b) and (d) only)

2bThioglycolic acid esters

(a)Hair waving or straightening products for general use

8 per cent ready for usepH 6 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b)Hair waving or straightening products for professional use

11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
The above-mentioned percentages are calculated as thioglycolic acid

(a) and (b): The directions for use must incorporate the following:

  • 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

3Oxalic acid, its esters and alkaline saltsHair-care products5 per cent-For professional use only
4AmmoniaAll purposes and products6 per cent calculated as NH3-Contains ammonia (not required when concentration is not more than 2 per cent)
5Tosylchloramide sodium (INN) [Chloramine-T]All purposes and products0.2 per cent--
6Chlorates of alkali metalsToothpaste5 per cent--
Other uses3 per cent--
7DichloromethaneAll purposes and products35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)Purity of the dichloromethane must be not less than 99.8 per cent-
8

m- and p-Phenylenedi-amines, their

N-substituted derivatives and their salts;

N-substituted derivatives of o-phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule)

Oxidizing colouring agents for hair dyeing for general use6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
9Methylphenylenedimines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1,3-diamine and its salts), their N-substituted derivatives and their salts) (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
10Diaminophenols (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as free base, subject to the provisions of “Combination Rule A” set out below-Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves
11Dichlorophen (INN) [Dichlorophene]All purposes and products0.5 per cent-Contains dichlorophen
12Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide

(a)Hair-care preparations

12 per cent of H2O2 present or released-

(a):Wear suitable gloves Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(b)Skin-care preparations

4 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(c)Nail hardening preparations

2 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(d)Oral hygiene products

0.1 per cent of H2O2 present or released--
13Formaldehyde (see also Part I of Schedule 6)Nail hardeners5 per cent-Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14HydroquinoneOxidizing colouring agent for hair dyeing for general use0.3 per cent subject to the provisions of “Combination Rule B” set out below-Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
Oxidizing colouring agent for hair dyeing for professional use0.3 per cent subject to the provisions of “Combination Rule B” set out below-For professional use only. Contains hydroquinone. Rinse eyes immediately if product comes into contact with them
Artificial nail systems for professional use0.02 per cent (after mixing for use) subject to the provisions of “Combination Rule B” set out below-

For professional use only Avoid skin contact

Read directions for use carefully

15aPotassium hydroxide and sodium hydroxideNail cuticle solvent

5 per cent calculated as sodium hydroxide

(see Note 2)

-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contain alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)(3)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Keep out of reach of children Avoid contact with the eyes
Other uses as pH adjusterPH value not to exceed 11-
15bLithium hydroxideHair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Contains alkali. Keep out of reach of children. Avoid contact with eyes
Other uses as pH adjuster (for rinse-off products only)PH value not to exceed 11-
15cCalcium hydroxideHair straighteners containing two components; calcium hydroxide and a guanidine salt7 per cent by weight of calcium hydroxide-Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness
pH adjuster for depilatoriespH value not to exceed 12.7Contains alkali. Avoid contact with eyes. Keep out of reach of children.
Other uses e.g. pH adjuster processing aidpH value not to exceed 11
16α-Naphthol [1-Naphthol] and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction
17Sodium nitriteRust inhibitor0.2 per centDo not use with secondary and/or tertiary amines or other substances forming nitrosamines-
18NitromethaneRust inhibitor0.3 per cent--
19Phenol and its alkali saltsSoaps and shampoos1 per cent calculated as phenol-Contains phenol
20ENTRY DELETED
21Quinine and its saltsShampoos0.2 per cent calculated as quinine base--
Hair lotions0.5 per cent calculated as quinine base--
22ResorcinolOxidizing colouring agent for hair dyeing for general use5 per cent subject to the provisions of “Combination Rule B” set out below-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
Oxidizing colouring agent for hair dyeing for professional use5 per cent subject to the provisions of “Combination Rule B” set out below-Contain resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
Hair lotions and shampoos0.5 per cent subject to the provisions of “Combination Rule B” set out below-Contains resorcinol
23aAlkali sulphidesDepilatories2 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
23bAlkaline earth sulphidesDepilatories6 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
24Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonateAll purposes and products1 per cent calculated as zinc--
25

Zinc 4-hydroxybenzene-sulphonate

[Zinc phenolsulfonate]

Deodorants, antiperspirants and astringent lotions6 per cent calculated as percentage of anhydrous substance-Avoid contact with eyes
26Ammonium monofluoro-phosphateOral hygiene products0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains ammonium monofluorophosphate
27Sodium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium monofluoro-phosphate
28Potassium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium monofluorophosphate
29Calcium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium monofluorophosphate
30Calcium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium fluoride
31Sodium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluoride
32Potassium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium fluoride
33Ammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluoride
34Aluminium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains aluminium fluoride
35Stannous fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains stannous fluoride
36Hexadecylammonium fluoride [Cetylamine hydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains hexadecylammonium fluoride
37

3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxy-ethyl)ammonium difluoride

[Stearyl trihydroxyethyl propylenediamine dihydrofluoride]

Oral hygiene productsAs for ammonium monofluorophosphate-Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)-ammonium difluoride
38N,N’,N’—Tris(polyoxyethylene)-N-hexadecylpropylene-diamine dihydrofluoride [Palmityltrihydroxyethyl propylenediamine dihydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains N,N’,N’-tris (polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39Octadecenylammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains octadecenylammonium fluoride
40Sodium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluorosilicate
41Potassium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contain potassium fluorosilicate
42Ammonium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluorosilicate
43Magnesium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains magnesium fluorosilicate
441,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]Hair care preparations2 per centNot to be used in aerosol dispensersContains 1,3-bis(hydroxymethyl) imidazolidine-2-thione
45Benzyl alcohol (See also Part I of Schedule 6)Solvent, perfumes and flavourings--
466-Methylcoumarin0.003 per cent0.003 per cent--
47Nicomethanol hydrofluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains nicomethanol hydrofluoride
48Silver nitrateProducts to dye eyelashes or eyebrows4 per cent-Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49Selenium disulphide [Selenium sulphide]Anti-dandruff shampoos1 per cent-Contains selenium disulphide. Avoid contact with eyes or damaged skin
50Aluminium zirconium chloride hydroxide complexes AlxZr(OH)y Clz and aluminium hydroxide glycine complexesAnti-perspirants20 per cent anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium

The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 to 10

The ratio of the number of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1

Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin
51Quinolin-8-ol and bis(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulphate]Stabilizer for hydrogen peroxide in rinse-off hair care preparations0.3 per cent calculated as base--
Stabilizer for hydrogen peroxide in non rinse-off hair car preparations0.3 per cent calculated as base--
52MethanolDenaturant for ethanol and isopropyl alcohol5 per cent calculated as a percentage of ethanol and isopropyl alcohol--
53Etidronic acid and its saltsHair care1.5 per cent expressed as etidronic acid--
54

1-Phenoxy-propan-2-ol

(See also Part I of Schedule 6) [Phenoxyisopropanol]

Products rinsed off after use2 per centProhibited in oral hygiene products-
55Lead acetateOnly for hair dyeing0.6 per cent calculated as lead-Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches. If irritation develops discontinue use
56Magnesium fluorideDental hygiene products0.15 per cent calculated as fluoride. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains magnesium fluoride
57Strontium chloride hexahydrate

(a)Toothpaste

3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent-Contains strontium chloride Frequent use by children is not advisable

(b)Shampoo and face care products

2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent--
58Strontium acetate hemihydrateToothpaste3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent-Contains strontium acetate. Use by children is not advisable
59Talc: hydrated magnesium

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

--

(a):Keep powder away from children’s and mouth

(b)other products

---
60Fatty acid dialkylamides and dialkanolamidesAll purposes and productsMaximum secondary amine content: 0.5 per centDo not use with nitrosating systems. Maximum secondary amine content: 5 per cent (applies to raw materials. Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers-
61Monoalkylamines, Monoalkanolamines and their saltsAll purposes and productsMaximum secondary amine content: 0.5 per cent

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials). Maximum nitrosamine content: 50 μg/kg (applies to raw materials).

Keep in nitrite-free containers.

-
62Trialkylamines, trialkanolamines and their salts

(a)non-rinse-off products

(a)2.5 per cent

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials) Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers-

(b)other products

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials)

Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers

-
63Strontium hydroxidepH-regulator in depilatory products3.5 per cent calculated as strontiumpH value not to exceed 12.7Keep out of reach of children. Avoid contact with the eyes
64Sodium peroxideRinse-off hair care preparations for professional use4.5 per cent calculated as strontium in the ready-for-use preparationAll products must meet the hydrogen peroxide release requirementsAvoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves
65Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide)Hair care products rinsed off after use3 per cent calculated as benzalkonium chlorideIn the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C14 or less must not exceed 0.1 per cent calculated as benzalkonium chlorideAvoid contact with the eyes
66PolyacrylamidesBody-care leave-on productsMaximum residual acrylamide content 0.1 mg/kg Maximum residual acrylamide content 0.5 mg/kg-
67

Amyl cinnamal

(CAS No 122-40-7)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
72Hydroxycitronellal (CAS No 107-75-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
74

Amylcinnamylalcohol

(CAS No 101-85-9)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
79

Hydroxymethylpentyl-cyclohexene-carboxaldehyde

(CAS No 31906-04-4)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
87

Hexyl cinnamaldehyde

(CAS No 101-86-0)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
90

3-Methyl-4(2,6,6-trimethyl-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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent 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 regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
93

2,4-Diaminopyrimidine 3-oxide

(CAS No 74638-76-9)

Hair care formulations1.5 per cent--
94

Benzoyl peroxide

(CAS No 94-36-0)

Artificial nail systems for professional use0.7 per cent (after mixing for use)-

For professional use only Avoid skin contact

Read directions for use carefully

95Hydroquinone methyl ether (4-methoxyphenol) (CAS No 150-76-5)Artificial nail systems for professional use0.02 per cent (after mixing for use)-

For professional use only Avoid skin contact

Read directions for use carefully

PART 2SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED

(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for supply until

Combination Rules

A.

Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1.

B.

Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substances shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.

C.

The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.

Note 1: 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.
Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.
1

C.I. Basic Blue 7

(CAS No 2390-60-5)

Non-oxidising colouring agents for hair dyeing0.2 per centCan cause allergic reaction30.9.2004
22-Amino-3-nitrophenol (CAS No 603-85-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
34-Amino-3-nitrophenol (CAS No 610-81-1) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
4Naphthalene-2,7-diol (CAS No 582-17-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
53-Aminophenol (CAS No 591-27-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
63,4-Dimethylpyridine-2,6-diol (CAS No 84540-47-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
74-(3-Hydroxypropyl)amino-3-nitrophenol (CAS No 92952-81-3) and its saltsOxidising colouring agents for hair dyeing5.2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2.6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
86-Nitropyridine-2,5-diamine (CAS No 69825-83-8) and its saltsNon-oxidising colouring agent for hair dyeing3 per centCan cause allergic reaction30.9.2004
9HC Blue No. 11 (CAS No 23920-15-2) and its saltsOxidising colouring agent for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
102-(2-Nitro-p-toluidino)-ethanol (CAS No 100418-33-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
112-(2-Hydroxyethylamino)-4,6-dinitrophenol (CAS No 99610-72-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
124-Methylaminophenol (CAS No 150-75-4) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
132-(2,4-Diamino-5-methylphenoxy)ethanol (CAS No 141614-05-3) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
14HC Violet No. 2 (CAS No 104226-19-9) and its saltsNon-oxidising colouring agent for hair dyeing2 per cent30.9.2004
152-(2,6-Dinitro-p-anisidino)ethanol (CAS No 122252-11-3) and its saltsNon-oxidising colouring agent for hair dyeing3 per centCan cause allergic reaction30.9.2004
16HC Blue No. 12 (CAS No 104516-93-0) and its saltsOxidising colouring agents for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agent for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
174-Ethoxy-6-methyl-m-phenylenediamine (CAS No 113715-25-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
184,4’-(Trimethylenedioxy)di-m-phenylenediamine (CAS No 81892-72-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
193-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
203-Methyl-l-phenyl-5-pyrazolone (CAS No 89-25-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
215-(2-Hydroxyethyl)amino- o-cresol (CAS No 55302-96-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
223,4 Dihydro-2H-1,4-benzoxazin-6-ol (CAS No 26021-57-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
23Naphthalene-1,7-diol (CAS No 575-38-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per centCan cause allergic reaction30.9.2004
24HC Yellow No.10 (CAS No 109023-83-8) and its saltsNon-oxidising colouring agents for hair dyeing0.2 per cent30.9.2004
252,6-Dimethoxy-3,5- pyridinediamine (CAS No 85679-78-3) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
26HC Orange No.2 (CAS No 85765-48-6) and its saltsNon-oxidising colouring agent for hair dyeing1 per cent30.9.2004
27HC Violet No.1 (CAS No 82576-75-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
282-(3-Methylamino-4-nitrophenoxy)ethanol (CAS No 59820-63-2) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent30.9.2004
292-(2-Methoxy-4-nitroanilino)ethanol (CAS No 66095-81-6) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent30.9.2004
302-(4-Amino-2-chloro-5-nitroanilino)ethanol (CAS No 50610-28-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
31HC Red No. 13 (CAS No 94158-13-1)Oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent30.9.2004
32Naphthalene-1,5-diol (CAS No 83-56-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
332,2’-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino]diethanol (CAS No 128729-30-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
342-Aminophenol (CAS No 95-55-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
355-Amino-o-cresol (CAS No 2835-95-2) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
362-(2,4-Diamino-phenoxy)ethanol (CAS No 66422-95-5) and its saltsOxidising colouring agents for hair dyeing4 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent30.9.2004
372-Methylresorcinol (CAS No 608-25-3) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
384-Amino-m-cresol (CAS No 2835-99-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
392-Amino-4-hydroxyethyl-aminoanisole (CAS No 83763-47-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
403,4-Diaminobenzoic acid (CAS No 619-05-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
416-Amino-o-cresol (CAS No 17672-22-9) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
422-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
432-Amino-2-(2-hydroxyethylaminomethyl) (CAS No 110952-46-0 and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
44N-(2-Hydroxyethyl)-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
45C.I. Acid Black 52 (CAS No 3618-58-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.per cent30.9.2004
462-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its saltsOxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
47HC Blue No.2 (CAS No 33229-34-4) and its saltsNon-oxidising colouring agents for hair dyeing2.8 per cent30.9.2004
484-(2-Hydroxyethylamino)-3-nitrophenol (CAS No 65235-31-6) and its saltsOxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent30.9.2004
492-(4-Nitrophenylamino)-ethylurea (CAS No 27080-42-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
50HC Red No. 10 (CAS No 95576-89-9) + HC Red No. 11 (CAS No 95576-92-4) and their saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
51HC Yellow No. 6 (CAS No 104333-00-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
52HC Yellow No.12 (CAS No 59320-13-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
53HC Blue No. 10 (CAS No 102767-27-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
54HC Blue No. 9 (CAS No 114087-47-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
552-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
562-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
57C.I. Basic Blue 26 (CAS No 2580-56-5) (C.I. No. 44045)Oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
58

C.I. Acid Red 33 (CAS No 3567-66-6)

(C.I. No. 17200)

Non-oxidising colouring agents for hair dyeing2 per cent30.9.2004
59

C. I. Food Red 1 (CAS No 4548-53-2)

(C.I. No. 14700)

Non-oxidising colouring agents for hair dyeing2 per cent30.9.2004
60

C.I. Basic Violet 14 (CAS No 632-99-5)

(C.I. No. 42510)

Oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
61

1-tert-Butyl-3,5-dimethyl-2,4,6-trinitrobenzene (CAS No 81-15-2)

(musk xylene)

All cosmetic products, with the exception of oral care products

1 per cent in fine fragrance

0.4 per cent in eau de toilette

0.03 per cent in other products

30.9.2004
624’-tert-Butyl-2’,6’-dimethyl-3’, 5’-dinitroacetophenone (CAS No 81-14-1) (musk ketone)All cosmetic products, with the exception of oral care products

1.4 per cent in fine fragrance

0.56 per cent in eau de toilette

0.042 per cent in other products

30.9.2004
(1)

O.J. No. L132, 1.6.1996, p.1.

(3)

Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.

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