Schedule 4
SCHEDULE 5
PRESERVATIVES
Regulations 6(6) and 8(1)
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 or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. 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, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that–
(a)the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and
(b)the purpose for which any such excess is present in the product is apparent from the labelling of the product.
In this Schedule–
“salts” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;
“esters” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.
In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.
PART I
Preservatives listed in Annex VI, Part I of the Directive as preservatives allowed
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information 1 Benzoic acid, its salts and esters All products 0.5 per cent (acid) A – – 2 Propionic acid and its salts All products 2 per cent (acid) A – – 3 Salicylic acid and its salts All products 0.5 per cent (acid) A Not to be used in preparations for children under three years of age except for shampoos Not to be used for children under three years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin) 4 Sorbic acid (hexa–2,4–dienoic acid) and its salts All products 0.6 per cent (acid) A – – 5 Formaldehyde and paraformaldehyde Oral hygiene products
Other products (see also Part I of Schedule 2)
0.1 per cent (expressed as free formaldehyde)
0.2 per cent (expressed as free formaldehyde)
Not to be used in aerosol dispensers (sprays) – 6 Hexachlorophene (INN) All products 0.1 per cent –Not to be used in products for children less than three years old or in personal hygiene products.
–Purity criterion: absence of 2,3,7,8–tetrachlorodibenzo–p–dioxin
Not to be used for children under three years of age.
Contains hexachlorophene
7 Biphenyl–2–ol (o–phenylphenol) and its salts All products 0.2 per cent expressed as the phenol A – – 8 Pyrithione zinc (INN) Products rinsed off after use 0.5 per cent A Not to be used in oral hygiene products – 9 Inorganic sulphites and hydrogen sulphites All products 0.2 per cent Aexpressed as free SOd22 – – 10 Sodium iodate Products rinsed off after use 0.1 per cent – – 11 Chlorobutanol (INN) All products 0.5 per cent Not to be used in aerosol dispensers (sprays) Contains chlorobutanol 12 4–Hydroxybenzoic acid and its salts and esters All products 0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters A – – 13 3–Acetyl–6–methylpyran–2,4 (3H)–dione (Dehydracetic acid) and its salts All products 0.6 per cent (acid) Not to be used in aerosol dispensers (sprays) – 14 Formic acid All products 0.5 per cent (acid) A – – 15 3,3'–Dibromo–4,4' –hexamethylene –dioxydibenzamidine (Dibromohexamidine) and its salts (including isethionate) All products 0.1 per cent – – 16 Thiomersal (INN) Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent – Contains thiomersal 17 Phenylmercuric salts (including borate) Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent – Contains phenylmercuric compounds 18 Undec–10–enoic acid and its salts All products 0.2 per cent (acid) A See also Schedule 5, Part II, Item 8 – 19 Hexetidine (INN) Rinse-off products only 0.1 per cent A See also Schedule 5, Part II, Item 15 – 20 5–Bromo–5–nitro–1, 3–dioxane Rinse-off products only 0.1 per cent Avoid formation of nitrosamines
See Schedule 5, Part II, No. 7
– 21 Bronopol (INN) All products 0.1 per cent A Avoid formation of nitrosamines – 22 2,4–Dichlorobenzyl alcohol All products 0.15 per cent A – – 23 Triclocarban (INN) All products 0.2 per cent A Purity criteria:
3,3',4,4'–Tetrachloroazobenzene 1 ppm
3,3',4,4'–Tetrachloroazoxybenzene 1 ppm
– 24 4–Chloro–m–cresol Not to be used in products intended to come into contact with mucous membranes 0.2 per cent A – – 25 Triclosan (INN) All products 0.3 per cent A – – 26 4–Chloro–3,5–xylenol All products 0.5 per cent A – – 27 3,3'–Bis(l–hydroxymethyl –2,5–dioxoimidazolidin–4–yl) –1,1'–methylenediurea (“Imidazolidinyl urea”) All products 0.6 per cent A – – 28 Poly(l–hexamethylenebiguanide hydrochloride) All products 0.3 per cent A – – 29 2–Phenoxyethanol All products 1.0 per cent A – – 30 Hexamethylenetetramine (methenamine (INN)) All products 0.15 per cent A – – 31 Methenamine 3–chloroallylochloride (INNM) All products 0.2 per cent – – 32 1–(4–Chlorophenoxy)–1 –(imidazol–l–yl)–3,3–di– methylbutan–2–one All products 0.5 per cent A – – 33 1,3–Bis(hydroxymethyl)–5,5– dimethylimidazolidine–2,4–dione All products 0.6 per cent A – – 34 Benzyl alcohol All products (See also Schedule 2 Part I, No. 46) 1.0 per cent A – – 35 1–Hydroxy–4–methyl–6–(2,4,4– trimethylpentyl)–2–pyridone and its monoethanolamine salt Rinse-off products only
For other products
1.0 per cent A
0.5 per cent A
– – 36 1,2–Dibromo–2,4–dicyanobutane All products 0.1 per cent Not to be used in cosmetic sunscreen products – 37 6,6–Dibromo–4,4–dichloro–2,2'– methylenediphenol (Bromochlorophen) All products 0.1 per cent A – – 38 4–Isopropyl–m–cresol All products 0.1 per cent – – 39 Mixture of 5–Chloro–2–methylisothiazol– 3(2H)–one and 2– methylisothiazol–3(2H)–one with magnesium chloride and magnesium nitrate All products 0.003 per cent of a mixture in the ratio 3:1 of 5–chloro–2–methylisothiazol– 3(2H)–one and 2– methylisothiazol–3(2H)–one – – PART II
Preservatives listed in annex VI Part 2 of the Directive as preservatives provisionally allowed
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 a b c d e f Reference Number Name of substance Type of product Maximum concentration of substance in product Other limitations and requirements Required informationConditions of use and warnings which must be printed on the label Allowed until 1 Boric acid Products for oral hygiene
(b)Other products (see also Schedule 2 Part 1, No. 1)
0.5 per cent A
3.0 per cent A
– – 31.12.1988 2 Chlorphenesin (INN) All products 0.5 per cent A – – 31.12.1987 3 Dibromopropamidine (INN) and its salts (including isethionate (INN)) All products 0.1 per cent – – 31.12.1988 4 Alkyl (C12–C22) trimethyl–ammonium bromide and chloride (including Cetrimonium bromide (INN)) All products 0.1 per cent A – – 31.12.1988 5 3–Heptyl–2–(3–heptyl–4 methyl–4–thiazolin–2– ylidenemethyl)–4–methyl– thiazolinium iodide Creams, toilet lotions and shampoos 0.002 per cent – – 31.12.1988 6 4,4–Dimethyl– 1,3–oxazolidine Products rinsed off after use 0.1 per cent The pH of the finished product shall not be lower than 6 – 31.12.1989 7 5–Bromo–5–nitro–1,3– dioxane Non rinse-off products 0.1 per cent Avoid formation of nitrosamines (See Schedule 5–Part I, No. 20) – 31.12.1987 8 Undec–10–enoic acid: esters, the amide, the mono–and bis(2–hydroxethyl) amides and their sulphosuccinates All products (See Schedule 5–Part I, No. 18) 0.2 per cent (acid) A – – 31.12.1987 9 Clorofene (INN) All products 0.2 per cent – – 31.12.1987 10 2–Chloro–N– (hydroxymethyl) acetamide Products rinsed off after use 0.3 per cent expressed as the chloracetamide – – 31.12.1987 11 1–Phenoxypropan–2–ol Products rinsed off after use 1.0 per cent For other uses see Schedule 2–Part II–No. 5 – 31.12.1987 12 Benzethonium chloride (INN) Not to be used in products intended to come into contact with mucous membranes 0.1 per cent A – – 31.12.1988 13 Benzalkonium chloride (INN) bromide and saccharinate All products 0.25 per cent A – – 31.12.1987 14 1–[1,3–Bis(hydroxymethyl)– 2,5– dioxoimidazolidin–4– yl] 1,3–bis(hydroxymethyl) urea All products 0.5 per cent – – 31.12.1987 15 Hexetidine (INN) All products (See also Schedule 5, Part I, No. 19) 0.1 per cent – – 31.12.1987 16 4–Hydroxybenzoic acid benzyl ester All products 0.1 per cent (acid) – – 31.12.1988 17 Hexamidine (INN) and its salts (including isethionate and 4–hydroxybenzoate) All products 0.1 per cent A – – 31.12.1988 18 Benzylformal (a 1:1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol) All products 0.2 per cent – – 31.12.1987 19 2–Chloroacetamide All products 0.3 per cent – Contains chloroacetamide 31.12.1987 20 Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride All products 0.3 per cent A – – 31.12.1987 21 1,3,5–Tris(2–hydroxyethyl) hexahydro–1,3,5–triazine Products rinsed off after use 0.2 per cent – Contains 1,3,5–Tris(2–hydroxyethyl) hexahydro–1,3,5 triazine 31.12.1988