Statutory Instrument 1996 No. 2925
The Cosmetic Products (Safety) Regulations 1996 - continued

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SCHEDULE 2
Regulations 4(2), 5(1) and 6(2)

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

    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[40].


PART I

SUBSTANCES 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 Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information


    Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force.


    Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4).
1 Boric acid Talcum powder 5 per cent Not to be used in products intended for children less than three years old Not to be used for children under three years of age
    Oral hygiene products 0.5 per cent — —
    Other products 3 per cent — —
2a Thioglycolic acid and its salts (a) Hair waving or straightening products for general use 8 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
    (b) Hair waving or straightening products for professional use 11 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
    (c) Depilatories 5 per cent ready for use pH 7 to 12.7 Contains 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 use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
      The abovementioned 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)
  
2b Thioglycolic acid esters (a) Hair waving or straightening products for general use 8 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
    (b) Hair waving or straightening products for professional use 11 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
      The abovementioned 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
  
3 Oxalic acid, its esters and alkaline salts Hair care products 5 per cent — For professional use only
4 Ammonia All purposes and products 6 per cent calculated as NH3 — Contains ammonia (not required when concentration is not more than 2 per cent)
5 Tosylchloramide sodium (INN) [Chloramine-T] All purposes and products 0.2 per cent — —
6 Chlorates of alkali metals Toothpaste 5 per cent — —
    Other uses 3 per cent — —
7 Dichloromethane All purposes and products 35 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-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines Oxidizing colouring agents for hair-dyeing for general use 6 per cent calculated as a free base, subject to the provision 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 use 6 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
9 Methylphenylenediamines (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) Oxidizing colouring agents for hair-dyeing for general use 10 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 use 10 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
10 Diaminophenols Oxidizing colouring agents for hair-dyeing for general use 10 per cent calculated as a 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 use 10 per cent calculated as afree 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
11 Dichlorophen (INN) [Dichlorophene] All purposes and products 0.5 per cent — Contains dichlorophen
12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide
    (a)  Hair-care preparations

    (b)  Skin-care preparations

    (c)  Nail hardening preparations

    (d)  Oral hygiene products

    12 per cent of H2O2 present or released


    4 per cent of H2O2 present or released


    2 per cent of H2O2 present or released


    0.1 per cent of H2O2 present or released

    —


    —


    —


    —

    (a): Wear suitable gloves


    (a)(b)(c): Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them


    —
13 Formaldehyde (see also Part I of Schedule 4) Nail hardeners 5 per cent — Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14 Hydroquinone Oxidizing colouring agent for hair dyeing for general use 2 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 use 2 per cent subject to the provisions of "Combination Rule B" set out below — Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them
    Agents for localised skin lightener 2 per cent — Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12
15a Potassium hydroxide and sodium hydroxide (see Note 1) Nail 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 use 2 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 use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness
    pH adjuster for depilatories — pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes
    Other uses as pH adjuster — pH value not to exceed 11 —
15b Lithium hydroxide Hair straightener for general use 2 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 use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness
    Other uses — — —
15c Calcium hydroxide Hair straighteners containing two components: calcium hydroxide and guanidine salt 7 per cent — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
    Other uses — — —
16 α-Naphthol[1-Naphthol] Colouring agent for hair dyeing 0.5 per cent — Contains α-napthol
17 Sodium nitrite Rust inhibitor 0.2 per cent Do not use with secondary and/or tertiary amines or other substances forming nitrosamines —
18 Nitromethane Rust inhibitor 0.3 per cent — —
19 Phenol and its alkali salts Soaps and shampoos 1 per cent calculated as phenol — Contains phenol
20 ENTRY DELETED        
21 Quinine and its salts Shampoos 0.5 per cent calculated as quinine base — —
    Hair lotions 0.2 per cent calculated as quinine base — —
22 Resorcinol Oxidizing colouring agent for hair dyeing for general use 5 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 use 5 per cent subject to the provisions of "Combination Rule B" set out below — Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
    Hair lotions and shampoos 0.5 per cent subject to the provisions of "Combination Rule B" set out below — Contains resorcinol
23a Alkali sulphides Depilatories 2 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes
23b Alkaline earth sulphides Depilatories 6 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes
24 Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate All purposes and products 1 per cent calculated as zinc — —
25 Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate] Deodorants, antiperspirants and astringent lotions 6 per cent calculated as percentage of anhydrous substance — Avoid contact with eyes
26 Ammonium monofluorophosphate Oral hygiene products 0.15 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
27 Sodium monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium monofluorophosphate
28 Potassium monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium monofluorophosphate
29 Calcium monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains calcium monofluorophosphate
30 Calcium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains calcium fluoride
31 Sodium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluoride
32 Potassium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluoride
33 Ammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluoride
34 Aluminium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains aluminium fluoride
35 Stannous fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains stannous fluoride
36 Hexadecylammonium fluoride [Cetylamine hydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains hexadecylammonium fluoride
37 3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl)ammonium difluoride
38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39 Octadecenylammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains octadecenylammonium fluoride
40 Sodium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluorosilicate
41 Potassium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluorosilicate
42 Ammonium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluorosilicate
43 Magnesium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains magnesium fluorosilicate
44 1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea] Hair care preparations 2 per cent Not to be used in aerosol dispensers Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione
    Nail care preparations 2 per cent pH value as applied must be less than 4 Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione
45 Benzyl alcohol (See also Part I of Schedule 4) Solvent, perfumes and flavourings — — —
46 6-Methylcoumarin Oral hygiene products 0.003 per cent — —
47 Nicomethanol hydrofluoride Oral hygiene products As for ammonium monofluorophosphate — Contains nicomethanol hydrofluoride
48 Silver nitrate Products to dye eyelashes or eyebrows 4 per cent — Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49 Selenium disulphide [Selenium sulfide] Anti-dandruff shampoos 1 per cent — Contains selenium disulphide. Avoid contact with eyes or damaged skin
50 Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and aluminium zirconium chloride hydroxide glycine complexes Anti-perspirants 20 per cent as 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 and 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
51 Quinolin-8-ol and bis(8-hydroxyquinolinium sulphate) (See also Part II of this Schedule) [Oxyquinoline and Oxyquinoline sulfate] Stabilizer for hydrogen peroxide in rinse-off hair care preparations 0.3 per cent calculated as base — —
    Stabilizer for hydrogen peroxide in non rinse-off hair care preparations 0.03 per cent calculated as base — —
52 Methanol Denaturant for ethanol and isopropyl alcohol 5 per cent calculated as a percentage of ethanol and isopropyl alcohol — —
53 Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts)

    Hair care


    Soap

    1.5 per cent expressed as etidronic acid


    0.2 per cent expressed as etidronic acid

    —


    —

    —


    —
54 1-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol] Products rinsed off after use. Prohibited in oral hygiene products 2 per cent — —
55 Lead acetate Only for hair dyeing 0.6 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
56 Magnesium fluoride Dental hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains magnesium fluoride
57 Strontium chloride hexahydrate 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. Use by children is not advisable
58 Strontium acetate hemihydrate Toothpaste 3.5 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
59 Talc: hydrated magnesium silicate (a) Powdery products intended to be used for children under three years of age — — (a): Keep powder away from children's nose and mouth
    (b) other products — —  
60 Fatty acid dialkanolamides All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Maximum dialkanolamine content: 5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
61 Monoalkanolamines All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
62 Trialkanolamines
    (a)  non-rinse-off

    (b)  other products
    (a)  2.5 per cent

    —
 (a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
63 Strontium hydroxide pH-regulator in depilatory products 3.5 per cent calculated as strontium pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair care preparations for professional use 4.5 per cent 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


PART II

SUBSTANCES LISTED IN ANNEX III, PART 2 (FORMERLY ANNEX IV, PART 1) OF THE DIRECTIVE [41] AS SUBSTANCES PROVISIONALLY ALLOWED
(1) (2) (3) (4) (5) (6) (7)
Reference Number Name of Substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Permitted for use until


    NOTE—There are presently no entries in this Part.
    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 substance 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.
             
             
             


Notes:

[40] O.J. No. L132, 1.6.1996, p.1. back

[41] See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC. back

 
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