# The Cosmetic Products (Safety) (Amendment) Regulations 1987, 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
(a) 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

---
Source: https://www.legislation.gov.uk/uksi/1987/1920/schedule/4 (the official version)
Page: https://openlegislation.uk/cosmetic-products-safety-amendment-regulations-1987/schedule-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.