Statutory Instrument 1989 No. 2233
The Cosmetic Products (Safety) Regulations 1989 - continued

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SCHEDULE 2
Regulations 4(3) and 6(1)

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.


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
    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
    2 (a) Thioglycollic acid, its salts and esters Hair waving or straightening products for general use 8 per cent (calculated as thioglycollic acid) ready for use pH value 7 to 9.5 Contains thioglycollate. Follow the instructions. Keep out of reach of children. For professional use only (where applicable)
    Hair waving or straightening products for professional use 11 per cent (calculated as thioglycollic acid) ready for use pH value 7 to 9.5
    Depilatories 5 per cent (calculated as thioglycollic acid) ready for use pH value 7 to 12.7
    Other hair care products which are removed after application 2 per cent (calculated as thioglycollic acid) ready for use

      pH value 7 to 9.5


      The directions for use drawn up in national or official languages must incorporate the following instructions—Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves (this latter instruction does not apply to Depilatories)
    (b) Thioglycollic acid esters Hair waving or straightening products for general use 8 per cent (calculated as thioglycollic acid) ready for use pH value 6 to 9.5
    Hair waving or straightening products for professional use 11 per cent (calculated as thioglycollic acid) ready for use

      pH value 6 to 9.5


      The directions for use drawn up in national or official languages must incorporate the following instructions—May cause sensitisation in the event of contact with the skin. Avoid contact with eyes. In the event of contact with the 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 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-andp -Phenylenediamines, theirN -substituted derivativesand their salts;N -substituted derivatives ofo -phenylenediamines
    Oxidizing colouring agents for hair dyeing for general use 6 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. Sensitivity test advisable before use. 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. Sensitivity test advisable before use
    9 Methylphenylenediamines (other than 4-methyl—m -phenylenediamine and its salts), theirN -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. Sensitivity test advisable before use. 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. Sensitivity test advisable before use
    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 an allergic reaction. Sensitivity test advisable before use. 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 diaminophenols. For professional use only. Can cause allergic reaction. Sensitivity test advisable before use
    11 Dichlorophen All purposes and products 0.5 per cent Contains dichlorophen
    12 Hydrogen peroxide
    Hair care products preparations 12 per cent of H2O2 (40 volumes) Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them
    Skin hygiene preparations 4 per cent of H2O2 Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them
    Nail hardening preparations 2 per cent of H2O2 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 provision 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
    15 Potassium and sodium hydroxide
    Nail cuticle solvent 5 per cent calculated as sodium hydroxide 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 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 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 Keep out of reach of children. Avoid contact with eyes
    16 α-Naphthol Colouring agent for hair dyeing 0.5 per cent Contains α-naphthol
    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 Pyrogallol
    Oxidizing colouring agent for hair dyeing for general use 5 per cent subject to the provisions of "Combination Rule B" set out below Contains pyrogallol. 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 pyrogallol. For professional use only. Rinse eyes immediately if product comes into contact with them
    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
    23
    (a) 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
    (b) 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-hydroxybenzenesulphonate 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 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 Hexadecyl ammonium fluoride Oral hygiene products As for ammonium monofluorophosphate Contains hexadecyl ammonium fluoride
    37 3-(n -Hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride Oral hygiene products As for ammonium monofluorophosphate Contains 3-(n -hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride
    38 NN'N'-Tris(polyoxyethylene)—N -hexadecylpropylenediamine dihydrofluoride Oral hygiene products As for ammonium monofluorophosphate ContainsNN'N'-tris(polyoxyethylene)—N -hexadecylpropylenediamine dihydrofluoride
    39 Octadecenyl ammonium fluoride Oral hygiene products As for ammonium monofluorophosphate Contains octadecenyl ammonium 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
    Hair care preparations 2 per cent Not to be used in aerosol dispensers Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione
    Nail care preparations 2 per cent pH as applied value must be less than 4 Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-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 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 the 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 betweeen 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-hydroxy-quinolinium sulphate) (See also Part II of this Schedule)
    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-hydroxy-ethylidene-diphosphonic acid and its salts)
    Hair care 1.5 per cent expressed as etidronic acid
    Soap 0.2 per cent expressed as etidronic acid
    54 1-Phenoxypropan-2-ol (See also Part I of Schedule 4) Products rinsed off after use. Prohibited in oral hygiene products 2 per cent
    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.


PART II

substances listed in annex iii, part 2 (formerly annex iv, part i) of the directive[21] 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
1 Quinolin-8-ol and bis(8 hydroxy-quinolium)-sulphate (See also Part I of this Schedule) Skin hygiene products not rinsed off after use 0.02 per cent calculated as base Contains Quinolin-8-ol 31.12.1990
Foot hygiene products not rinsed off after use 0.04 per cent calculated as base
Mouth hygiene products 0.01 per cent calculated as base
2 1,1,1-Trichloroethane (methyl chloroform) Aerosol Spray 35 per cent (and when mixed with dichloromethane total concentration must not exceed 35 per cent) Do not spray on a naked flame or any incandescent material 31.12.1989
3 ENTRY DELETED
4 2,2'-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate Rinsed-off hair care products 1 per cent 31.12.1989
5 ENTRY DELETED


PART III

substances excluded from the scope of the directive (mentioned in annex v)
(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
1 Lead acetate Hair care products 3 per cent Contains lead acetate. Wash hands after use. Do not use on broken or abraded skin. Keep out of reach of children
2 Thiomersal and phenylmercuric compounds To preserve concentrated shampoos and hair creams which contain non-ionic emulsifiers which render other preservatives ineffective 0.003 per cent calculated as mercury. When mixed with other mercury compounds the total mercury concentration must not exceed 0.007 per cent



Notes:

[21] See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC. back

 
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