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Code AnnexesCode Annexes » List of Substances Which Cosmetic Products must not Contain Except Subject To Registration and Conditions Laid Down

List of Substances Which Cosmetic Products must not Contain Except Subject To Registration and Conditions Laid Down

ANNEX III – PART 1

LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTION AND CONDITIONS LAID DOWN

EU
Ref #
Substance Restrictions Conditions of Use and Warning Which Must be Printed on the Labels
Field of Application
And/or Use
Maximum Allowable Concentration In the Finished Cosmetic Product Other Limitations & Requirements
a b c d e f
1a Boric Acid, borates and tetraborates (a) Talc (a) 5% (by Mass/mass as boric acid) (a) 1. Not to be used in products for children under 3 years of age

2. Not to be use on peeling or irritated skin

(a) 1. Not to be used for children under 3 years old of age
2. Not to be use on peeling or irritated skin
(b) Products for oral hygiene (b) 0.1% (by mass/mass as boric acid) (b) 1. Not to be used in products for children under 3 years of age (b) 1. Not to be swallowed

2. Not to be used for children under 3 years of age

(c) Other products (excluding bath products and hair waving (c) 3% (by mass/mass as boric acid) (c) 1. Not to be used in products for children

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. Not to be used for children under 3 years

2. Not to be used on peeling or irritated skin

1b Tetraborates (a) Bath products (a) 18% (by mass/mass as boric acid) (a) 1. 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
2a Thioglycollic acid and its salts (a) Hair waving or straightening products:
(1) General use
8% ready for use pH 7-9.5 a) b) c)
The directions for use drawn up in the national or official languages(s) must obligatorily incorporate the following sentences:

  • Avoid contact with eyes
  • In the event of contact with eyes, rinse immediately with plenty of medical water and seek advice.
  • Wear suitable gloves (a) and (c) only
a)

  • Contains thioglycollate
  • Follow the instructions
  • Keep out of reach of children.

 

(2) Professional use 11% ready for use pH 7-9.5
  • For professional use only
(b) Depilatories (b) 5% ready for use pH 7-12.7 b) and c)

  • Contains Thioglycollate.
  • Follow the instruction
  • Keep out of reach children.

(c) Other hair care products which are removed after application

(c) 2% ready for use pH 7-9,5
Percentage calculated as Thioglycollic acid

2b Thioglycollic acid esters Hair waving or straightening products:

(a) General use

(b) Professional use

(a) 8% ready for use pH 6-9,5 The directions for use drawn up in the national or official language(s) must obligatorily incorporate the followimg sentences:

  • May cause sensitisation in the event of skin contact.
  • Avoid contact with eyes, rinse off with plenty of water andd seek medical advice.
  • Water suitable gloves
  • Contains thioglycollates.
  • Follow the instructions
  • Keep out of reach of children

 

  • For professional use only
3 Oxalic Acid, its esters and Alkaline 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 m-and p- Phenylenediamines, their
N- substituted derivatives and their salts;
N- substituted derivatives of
o-phenylenediamines (1)
Oxidizing colouring agents for hair dyeing
(a) General use(b) Professional use
6% calculated as free base (a)

  • Can cause an allergic reaction
  • Contains phenylenediamines
  • Do not use dye eyelashes eyebrows

(b)

  • For profesional use only
  • Contains phenylenediamines
  • Can cause an allergic reaction
  • Wear suitable gloves
9 Methylphenylenediamines, their N- substituted
derivatives and their salts (1) with
The of substance N°364 and 413 in
Annex II
Oxidizing colouring agents for hair dyeing

(a) General use

(b) Professional use

6% calculated as free base (a)

  • Can cause an allergic reaction
  • Contains phenylenediamines
  • Do not use dye eyelashes eyebrows

(b)

  • For profesional use only
  • Contains phenylenediamines
  • Can cause an allergic reaction
  • Wear suitable gloves
10 Diaminophenols (1) Oxidizing colouring agents for hair dyeing

(a) General use

(b) Professional use

10% calculated as free base (a)

  • Can cause an allergic reaction
  • Contains phenylenediamines
  • Do not use dye eyelashes eyebrows

(b)

  • For profesional use only
  • Contains phenylenediamines
  • Can cause an allergic reaction
  • Wear suitable gloves
11 Dichlorophen (*) 0.50% Contains dichlorophen
12 Hydrogen peroxide, and other compounds
or mixture that release hydrogen peroxide
including carbamide eroxide and zinc
peroxide
(a) Hair-care preparations

(b) Skin-Care preparations

(c) Nail hardening preparations

(d) Oral hygiene products

12% H2O2 (40 volumes) present or released

4% of H2O2 present or released

2% of H2O2 present or released

0.1% of H2O2 present or released

(a) (b) (c)

  • Contains hydrogen peroxide
  • Avoid contact with eyes rinse eyes immediately
  • if product comes into contact with them.
13 Formaldehyde Nail hardeners 5% calculated as formaldehyde
  • Protect cuticles with grease or oil
  • Contains formaldehyde (2)
14 Hydroquinone (1) Oxidizing colouring agent for hair dyeing

(a) General use

(b) Professional use

0.30% (a)
1.

  • Contains phenylenediamines
  • Rinse the eyes immediately if the product comes into contact with eyes
  • Contains hydroquinone

2.

  • For Professional use only
  • Contains hydroquinone
  • Rinse the eyes immediately if the product comes into contact with eyes

(b)

  • Contains hydroquinone
  • Avoid contact with eyes
  • If irritation develops discontinue use areas
  • Do not use n children under the age of 12
15a Potassium or sodium hydroxide (a) Nail cuticle solvent

(b) Hair straightener

(1) Generaluse

(2) Professional use

(c) pH adjuste – depilatories

(d) Other uses as pH adjuster

(a) 5% by weight (3)

(b)

(1) 2% by weight (3)

(2) 4.5% by weight

(c) up to pH 12.7

(d) up to pH 11

(a)

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

(b)(1)

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

(2)

  • For Professional use only
  • Avoid contact with eyes
  • Can cause blindness

(c)

  • Keep out of reach of children
  • Avoid contact with eyes
15b Lithium hydroxide (a) Hair straightener

(1) General use

(2) Professional use

(b) Other uses

(a)
(1) 2% by weight (1)(2) 4.5% by weight (1)
(a) (1)

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

(2)

  • For professional use only
  • Avoid contact with eyes
  • Can cause blindness
15c Calcium hydroxide (a) Hair straighteners containing two
componets: calcium hydroxide and a
guanidine salts(b) Other uses
(a) 7% by weight calcium hydroxide (a)

  • Contains alkali
  • Avoid contact with eyes
  • Can cause blindness
  • Keep out of reach of children
16 Alpha-naphthol Colouring agent for hair dyeing 0.50% Contains alpha-naphthol
17 Sodium nitrite 0.20% Do not use with secondary and/ or
Tertiary amines or other substances
Forming nitrosamines
18 Nitromethane Rust inhibitor 0.30%
19 Phenol and its alkali
salts
Soaps and /shampoos 1% calculated as phenol
  • Contains phenol
20 Quinine and its salts (a) Shampoos

(b) Hair lotions

(a) 0.5% calculated as quinine base

(b) 0.2% calculated as quinine base

21 Resorcinol (1) (a) Oxidizing colouring agent for hair dyeing

(1) General use

(2) Professional use

(b) Hair lotions and shampoos

(a) 5%

(b) Hair lotions and shampoos

(a)
(1)

  • Contains resorcinol
  • Rinse hair well after application
  • Do not use to dye eyelashes or eyebrows
  • Rinse eye immediately if product comes into contact with them

(2)

  • For professional use only
  • Contains resorcinol
  • Rinse eye immediately if product comes into contact with them

(b)

  • Contains resorcinol
22 (a) Alkali sulphides

(b) Alkaline earth sulphides

(a) Depilatories

(b) Depilatories

(a) 2% calculated as sulphur pH to 12.7

(b) 6% calculated as sulphur pH up to 12.7

(a)

  • Keep out of reach of children
  • Avoid contact with eyes

(b)

  • Keep out of reach of children
23 Water Soluble zinc salts with
exception of zinc-4-
hydrobenzenesulphonate and zinc
pyrithione
1% calculated as zinc
24 Zinc 4-hydroxyybenzene sulphonate Deodorants, antiperspirant and astringent lotions 6% calculated as 5 of anhydrous substance Avoid contact with eyes
25 Amomonium 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 monofluorophosphste
26 Sodium monoflourophosphate Ditto 0.15%
Ditto
Contains sodium monoflourophosphate
27 Potassium monofluorophosphate Ditto 0.50%
Ditto
Contains potassium monoflourophosphate
28 Calcium monofluorophosphate Ditto 0.50%
Ditto
Contains monoflourophosphate
29 Calcium fluoride Ditto 0.15%
Ditto
Contains calcium flouride
30 Soduim fluoride Ditto 0.15%
Ditto
Contains Soduim flouride
31 Potassium fluoride Ditto 0.15%
Ditto
Contains potassiun flouride
32 Ammonium fluoride Ditto 0.50%
Ditto
Contains ammonium flouride
33 Aluminum fluoride Ditto 0.15%
Ditto
Contains ammonium flouride
34 Aluminum fluoride Ditto 0.15%
Ditto
Contains Stannous flouride
35 Hexadecyl ammonium fluoride Ditto 0.15%
Ditto
Contains hexadecyl ammonium fluoride
36 3-(N-Hexadecyl-N-2 hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium dihy-Droflouride Ditto 0.15%
Ditto
Contains3-(N-Hexadecyl-N-2 hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium dihydrofluoride
37 NN’N-Tris (polyoxyethylene)-N- hexadedecylpropy-lenediamine dihydrofluoride Ditto 0.15%
Ditto
Contains NN’N-Tris (polyoxyethylene) -N- hexadedecylpropylenediamine dihydrofluoride
38 Octadecynyl-ammonium fluoride Ditto 0.15%
Ditto
Conatains octadecyl-ammonium fluoride
39 Sodium fluorosilicate Ditto 0.15%
Ditto
Contains Sodium fluorosilicate
40 Potassium fluorosilicate Ditto 0.15%
Ditto
Contains ammonium fluorosilicate
40 Magnesium fluorosilicate Ditto 0.15%
Ditto
Contains magnesium fluorosilicate
41 Ammonium fluorosilicate Ditto 0.15%
Ditto
Contains ammonium fluorosilicate
42 Magnesium fluorosilicate Ditto 0.15%
Ditto
ƒ Contains magnesium fluorosilicate
43 1,3-Bis(hydroxymethyl) imidazolidine-2-thione (a) Hair care preparations (a) Up to 2% (a) Prohibited in aerosol dispensers(spray) Contains 1,3-bis (hydroxymethyl) imidazolidin-2-thione
(b) Nail care preparations (b) Up to 2% (b) The pH of the product as applied must be less than 4
44 Benzyl alcohol Solvents, perfumes and flavouring
45 6-Methylcoumarin Oral hygiene products 0.00%
46 Nicomethanol hydrofluoride Oral hygiene products 0.15% calculated as F. When mixed other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% Contains nicomethanol hydroflouride
47 Silver Nitrate Solely for products intended 4% ƒ Contains silver nitrate
ƒ Rinse the eyes immediately if
ƒ Products comes into contact with them
48 Selenium disulphide Anti-dandruff shampoo 1% ƒ Contains selenium disulphide
ƒ Avoid contact with eyes or damaged skin
49 Aluminium zirconium chloride hydroxide complexes alxZR (OH)yCLz and the Aluminium zirconium chloride hydroxide glycine complexes Antiperspirant 20% as anhydrous aluminum zirconium chloride hydroxide (1) The ratio of the number of aluminum atoms to that of zirconium atoms must be between 2 and 10

(2) The ratio of the number of (AI + Zr) atoms to that chlorine atoms must be Between 0.9 and 2.1

(3) Prohibited in aerosol dispensers (sprays)

Do not apply to irritated or damaged
50 Quinolin-8-ol and bis (8-hydroxyquinolinium) sulphate ƒ stabilizer for hydrogen peroxide in rinse-off hair care preparations ƒ calculated as base
ƒ stabilizer for hydrogen peroxide in non-rinse ƒ 0.03% calculated as base
51 Methanol Denaturant for ethanol and isopropyl alcohol 5% calculated as a % of ethanol and isopropyl alcohol
52 Etidronic acids and its salts (1-hydroxy-ethylidene- diphosphonic acid and its salts) (a) Hair – care (a) 1.5% expressed as etidronic acid
(b) Soap (b) 0.2% expressed as etidronic acid
53 Rinse of products only

Prohibited in oral hygiene products

2% As a preservative, see Annex VI, Part 1, No43
54 Lead Acetate Only for hair dyeing 0.6% calculated in lead ƒ Keep away from children.
ƒ Avoid contact with the eyes
ƒ Wash hands after use
ƒ Contains lead acetate
ƒ Do not use to dye eyelashes, eyes or moustaches
ƒ If irritation develops, discontinue
55 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
56 Strontium chloride hexahydrate (a) Toothpaste (a) 3.5% calculated as strontium. When mixed with other permitted Strontium products the total Strontium content must not Exceed 3.5% ƒ Contains strontium chloride
ƒ Frequent use by children is not advisable
(b) Shampoo and face care products (b) 2.1% calculated as strontium compounds, the total strontium content must not exceed 2.10%
57 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% ƒ Contains strontium acetate
ƒ Frequent use by children is not advisable
58 Talc: hydrated magnesium silicate (a) Powdery products intended to be used by children

(b) Other products

(a) Keep powder away from children’s nose & mouth
59 Fatty acid dialkanolamides Maximum dialkanolamine content: 0.5% ƒ Do not use withnitrosating systems
ƒ Maximum dialkanolamine content : 50 ug/kg
ƒ Keep in nitrate-free containers
60 Monoalkanolamines Maximum dialkanolamine content: 0.5% ƒ Do not use with nitrosating system
ƒ Minimum purity : 99%
ƒ Maximum secondary alkanolamine content:
ƒ 0.5% (concerns raw materials)
ƒ Maximum N- Nitroso- dialkanolamine content: 50 ug/kg
ƒ Keep in nitrate-free containers
61 Trialkanolamines (a) Non rinse-off products (a) 2.5% (a) (b):
ƒ Do not use with nitrosating system
ƒ Minimum purity: 99%
ƒ Maximum secondary alkanolamine content:
ƒ 0.5% ( concerns raw materials)
ƒ Maximum N-nitroso-dialkanolamine content: 50ug/kg
ƒ Keep in nitrite-free containers
(b) Other products
62 Strontium hydroxide pH-regulator in depilatory products 3.5% calculated as strontium, max pH of 12.7 ƒ Keep out of reach of children
ƒ Avoid contact with the eyes
63 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 ƒ Avoid contact with eyes
ƒ Rinse eyes immediately if products comes into contact with them
ƒ For professional use only
ƒ Wear suitable gloves
64 Benzalkonium choloride, 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 Sacchinate with an alkyl chain of C14, or Less must not exceed 0.1% (as benzalkoinium chloride) (a) Avoid contact with the eyes
(b) other products (b) 0.1% (as benzalkonium chloride (b) Avoid contact with the eyes

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