The Cosmetic Products (Safety) (Amendment) Regulations 1987
Now, therefore, the Secretary of State in exercise of powers conferred on him by section 11 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:
1.
(1)
These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) Regulations 1987 and except as provided by paragraph (2) below, shall come into force on 21st December 1987.
(2)
Regulation 2(y), regulation 2(bb) insofar as it relates only to entry Number 52 in Schedule 1 to these Regulations, regulation 2(cc), regulation 2(ee) and regulation 2(ff) shall come into force–
(a)
in relation to the supply, offering to supply, agreeing to supply, exposing for supply or possessing for supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products, manufactured in or imported into the United Kingdom on behalf of another person, by that other person, on 1st January 1988, except where the cosmetic products are supplied, agreed to be supplied, exposed for supply or possessed for supply by retail in which case they shall come into force on 1st January 1989; and
(b)
in all other cases, on 1st January 1989.
2.
(a)
“(j)
O.J. L228, 25.8.84, p.31
(k)
O.J. L224, 22.8.85, p.40
(l)
O.J. L295, 7.11.85, p.30
(m)
O.J. L138, 24.5.86, p.40
(n)
O.J. L149, 3.6.86, p.38”;
(b)
in regulation 5(2) by the insertion after the word “manufacturer” of the word “in”;
(c)
in regulation 6(3) by the substitution for the words “3, 4 and 5” of the words “3, 4, 5 and (in the case of Part II) 7”.
(d)
“(4)
A cosmetic product shall not contain–
(a)
any colouring agent listed in columns 1 and 2 of Schedule 3 unless–
(i)
the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or
(ii)
the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question is supplied on or before the date specified in column 5 of that Part;
(b)
any colouring agent which is not listed in that Schedule and which is intended to come into contact with the mucous membrane;”
(e)
in regulation 6 by the omission of paragraph (5);
(f)
“(a)
any preservative listed in column 2 of Schedule 5 unless–
(i)
the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or
(ii)
the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the preservative in question is supplied on or before the date specified in column 7 of that Part;”
(g)
“(c)
any preservative listed in column 2 of Part II of Schedule 5 after the date specified in column 7 of that Schedule”;
(h)
in regulation 6(7) by the omission of the word “and” between sub-paragraphs (a) and (b);
(i)
“(2)
Regulations 5, 6 and 8 above do not apply in any case in which the cosmetic product is supplied, offered for supply, agreed to be supplied, exposed or possessed for supply for the purposes of exporting that product to any country which is not a member State of the European Economic Community”;
(j)
in Schedule 1 by the substitution for the words in column 2 of entry Number 24 of the words–
“4-(orp-)Aminobenzoic acid esters except glycerol 1-(4-aminobenzoate) when provisionally permitted for use as a UV filter in accordance with the requirements specified at Item 4 of Part II of Schedule 6”;
(k)
in Schedule 1 by the substitution in column 2 of entry Number 64 for the letter “B” of the symbol “*”;
(l)
in Schedule 1 by the substitution for the words in column 2 of entry Number 85 of the words “4-Benzyloxyphenol”;
(m)
in Schedule 1 by the insertion in column 4 of entry Number 148A of the figure “366”;
(n)
in Schedule 1 by the substitution in column 2 of entry Number 212 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;
(o)
in Schedule 1 by the substitution in column 2 of entry Number 213 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;
(p)
in Schedule 1 by the insertion after entry Number 285 of the following entry–
“285A – 4-ethoxyphenol 348 178”;
(q)
in Schedule 1 by the substitution in column 2 of entry Number 348 for the words “Hydroquinone monobenzyl ether” of the words “Hydroquinone monobenzyl, monoethyl and monomethyl ethers”;
(r)
in Schedule 1 by the insertion in column 3 of entry Number 348 after the figure “431” of the figures “285A, 411A”;
(s)
in Schedule 1 by the substitution in column 2 of entry Number 395 for the words “Part II of Schedule 5” of the words “Part I of Schedule 5”;
(t)
in Schedule 1 by the substitution in column 2 of entry Number 397 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;
(u)
in Schedule 1 by the insertion after entry Number 411 of the following entry–
“411A 4-methoxyphenol 348 178”;
(v)
in Schedule 1 by the substitution in column 2 of entry Number 562 for the words “Selenium and its compounds” of the words “Selenium and its compounds except when permitted under the restrictions laid down against entry Number 50 in Part I of Schedule 2”;
(w)
in Schedule 1 by the substitution in column 2 of entry Number 603 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;
(x)
in Schedule 1 entry number 645A by the insertion in column 4 of the figure “366”;
(y)
“676 2, 3, 7, 8-Tetrachlorodibenzo-p-dioxin – 367
677 2, 6-Dimethyl-1, 3-dioxan-4-yl acetate (Dimethoxane) – 368
678 Pyrithione sodium (INNM) – 369”;
(z)
in Part I of Schedule 2 by the substitution in column 3 of entry Number 11 for the words “use other than as a preservative (see also Part II of Schedule 5)” of the words “all purposes and products”;
(aa)
“45
1, 3-Bis (hydroxymethyl) imidazolidiene-2-thione
(a)
Hair-care preparations
2 per cent
Not to be used in aerosol dispensers (sprays)
Contains 1, 3-Bis (hydroxymethyl) imidazolidine-2-thione
(b)
Nail-care preparations2 per cent
pH as applied value must be less than 4”;
(bb)
in Part I of Schedule 2 by the insertion after entry Number 49 of the additional entries set out in Schedule 1 to these Regulations;
(cc)
in Schedule 2 by the substitution for Part II of Schedule 2 of the Part set out in Schedule 2 to these Regulations;
(dd)
in Part III of Schedule 2 by the substitution in column 3 of entry number 4 for the words “(See also Part II of Schedule 5)” of the words “(See also Part I of Schedule 5)”;
(ee)
by the substitution for Schedule 3 of the Schedule set out in Schedule 3 to these Regulations and by the omission of Schedule 4;
(ff)
by the substitution for Schedule 5 of the schedule set out in Schedule 4 to these Regulations;
(gg)
in Schedule 7 by the insertion in paragraph 1 after the words “Commission Directive No. 83/514/EEC;” of the words ““Annex D” means the Annex to Commission Directive No. 85/490/EEC(a)” and by the insertion as a footnote at the foot of the relevant page of “(a) O.J. No. L295, 7.11.85, p.30.”
(hh)
“(27)
Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.
(28)
Any test to determine the amount of chlorobutanol in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.
(29)
Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.
(30)
Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.
(31)
Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.
(32)
Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.”.
SCHEDULE 1
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 |
50 | Selenium disulphide | Anti-dandruff shampoos | 1 per cent | Contains selenium disulphide. Avoid contact with eyes or damaged skin | |
51 | Aluminium zirconium chloride hydroxide complexes Ald2xZr(OH)d2y CLd2z 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 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 |
52 | Quinolin–8–ol and bis (8–hydroxyquinolinium) sulphate | Stabilizer for hydrogen peroxide in rinse-off hair-care preparations | 0.3 per cent calculated as base |
SCHEDULE 2
PART IISubstances listed in Annex IV, Part I of the Directive as substances provisionally allowed
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 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 | Methanol | Denaturant for ethanol and isopropyl alcohol | 5 per cent calculated as a percentage of ethanol and isopropyl alcohol | – | – | 31.12.1987 |
2 | 1,1,1–Trichloroethane (methyl chloroform) | Aerosol spray | 35 per cent (When mixed with dichloromethane total concentration must not exceed 35 per cent) | – | Do not spray on a naked flame or any incandescent material | 31.12.1987 |
3 | 3,4',5–Tribromosalicylanilide (Tribromsalan) | Deodorant soaps | 1 per cent | Purity of the 3,4',5– Tribromosalicylanilide: must be not less than 98.5 per cent Other bromosalicylanilides: not to exceed 1.5 per cent 4',5–dibromosalicylanilide: not to exceed 0.1 per cent Inorganic bromide: not to exceed 0.1 per cent expressed as NaBr | Contains tribromosalicylanilide | 31.12.1987 |
4 | 2,2'–Dithiobis (pyridine 1–oxide), addition product with magnesium sulphate trihydrate | Rinsed off hair care products | 1 per cent | – | – | 31.12.1987 |
5 | 1–Phenoxypropan–2–ol | –Rinse-off products only –Prohibited in oral hygiene products | 2 per cent | For preservative use see Schedule 5 – Part II – No 11 | – | 31.12.1987 |
SCHEDULE 3
SCHEDULE 3COLOURING AGENTS
In this Schedule the colouring agents referred to in regulation 6(4)(a) are–
(i)
those identified either by name or by colour index number (the colour index numbers being those specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists);
(ii)
lakes or salts of these colouring agents which do not use substances prohibited under Annex II or which are excluded under Annex V from the scope of the Cosmetics Directive (76/768/EEC).
In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.
Colouring agents whose number is preceded by the letter `E' in accordance with the EEC Directive of 23 October 1962 on the approximation of the rules of Member States concerning foodstuffs and colouring matters5, as amended,6 and adapted7 must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter `E' has been deleted therefrom.PART IColouring agents listed in annex iii part 2 of the directive as colouring agents allowed for use in cosmetic products
Column 1
Column 2
Column 3
Column 4
Name or colour index number
Colour
Type of product Field of application
Other requirements
1
2
3
4
10006
Green
X
10020
Green
X
10316*
Yellow
X
11680
Yellow
X
11710
Yellow
X
11725
Orange
X
11920
Orange
X
12010
Red
X
12075*
Orange
X
12085*
Red
X
3 per cent maximum concentration in the finished product
12120
Red
X
12150
Red
X
12370
Red
X
12420
Red
X
12480
Brown
X
12490
Red
X
12700
Yellow
X
See also Part 2
13015
Yellow
X
E 105
13065
Yellow
X
See also Part 2
14270
Orange
X
E 103
14700
Red
X
14720
Red
X
E 122
14815
Red
X
E 125
15510*
Orange
X
15525
Red
X
15580
Red
X
15585*
Red
X
15620
Red
X
15630*
Red
X
3 per cent maximum concentration in the finished product
15800
Red
X
See also Part 2
15850*
Red
X
15865*
Red
X
15880
Red
X
15980
Orange
X
E 111
15985*
Yellow
X
E 110
16035
Red
X
16185
Red
X
E 123
16230
Orange
X
16255*
Red
X
E 124
16290
Red
X
E 126
17200
Red
X
18050
Red
X
18130
Red
X
18690
Yellow
X
18736
Red
X
18820
Yellow
X
18965
Yellow
X
19140*
Yellow
X
E 102
20040
Yellow
X
Maximum 3, 3'–dimethylbenzidine concentration in the colouring agent : 5 ppm
20170
Orange
X
20470
Black
X
See also Part 2
21100
Yellow
X
Maximum 3, 3'–dichloro-benzidine concentration in the colouring agent : 5 ppm
21108
Yellow
X
Maximum 3, 3'–dichloro-benzidine concentration in the colouring agent : 5 ppm
21230
Yellow
X
24790
Red
X
27290*
Red
X
27755
Black
X
E 152
28440
Black
X
E 151
40215
Orange
X
40800
Orange
X
40820
Orange
X
E 160 e
40825
Orange
X
E 160 f
40850
Orange
X
E 161 g
42045
Blue
X
See also Part 2
42051*
Blue
X
E 131
42053
Green
X
42080
Blue
X
42090
Blue
X
42100
Green
X
42170
Green
X
See also Part 2
42510
Violet
X
42520
Violet
X
5 ppm max concentration in the finished product
42640
Violet
X
42735
Blue
X
44045
Blue
X
See also Part 2
44090
Green
X
E 142
45100
Red
X
45170*
Red
X
45170:1
X
45190
Violet
X
See also Part 2
45220
Red
X
45350
Yellow
X
6 per cent max concentration in the finished product
45370*
Orange
X
Not more than 1 per cent 2–(6–hydroxy–3–oxo–3H– xanthen–9–yl) benzoic acid and 2 per cent 2–(bromo–6– hydroxy–3–oxo–3H–xanthen– 9–yl) benzoic acid
45380*
Red
X
as immediately above
45396
Orange
X
When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405
Red
X
Not more than 1 per cent 2–(6–hydroxy–3–oxo–3H– xanthen–9–yl) benzoic acid and 2 per cent 2–(bromo–6– hydroxy–3–oxo–3H–xanthen– 9–yl) benzoic acid
45410*
Red
X
as immediately above
45425
Red
X
Not more than 1 per cent 2–(6–hydroxy–3–oxo–3H– xanthen–9–yl) benzoic acid and 3 per cent 2–(iodo–6– hydroxy–3–oxo–3H–xanthen– 9–yl) benzoic acid
45430*
Red
X
as immediately above E 127
47000
Yellow
X
See also Part 2
47005
Yellow
X
E 104
50325
Violet
X
50420
Black
X
51319
Violet
X
58000
Red
X
59040
Green
X
60724
Violet
X
60725
Violet
X
60730
Violet
X
61565
Green
X
61570
Green
X
61585
Blue
X
62045
Blue
X
69800
Blue
X
E 130
69825
Blue
X
71105
Orange
X
73000
Blue
X
73015
Blue
X
E 132
73360
Red
X
73385
Violet
X
73900
Violet
X
See also Part 2
73915
Red
X
74100
Blue
X
74160
Blue
X
74180
Blue
X
See also Part 2
74260
Green
X
75100
Yellow
X
75120
Orange
X
E 160 b
75125
Yellow
X
E 160 d
75130
Orange
X
E 160 a
75135
Yellow
X
E 161 d
75170
White
X
75300
Yellow
X
E 100
75470
Red
X
E 120
75810
Green
X
E 140 and E 141
77000
White
X
E 173
77002
White
X
77004
White
X
77007
Blue
X
77015
Red
X
77120
White
X
77163
White
X
77220
White
X
E 170
77231
White
X
77266
Black
X
77267
Black
X
77268:1
Black
X
E 153
77288
Green
X
Free from chromate ions
77289
Green
X
Free from chromate ions
77346
Green
X
77400
Brown
X
77480
Brown
X
E 175
77489
Orange
X
E 172
77491
Red
X
E 172
77492
Yellow
X
E 172
77499
Black
X
E 172
77510
Blue
X
Free from cyanide ions
77713
White
X
77742
Violet
X
77745
Red
X
77820
White
X
E 174
77891
White
X
E 171
77947
White
X
Lactoflavin
Yellow
X
E 101
Caramel
Brown
X
E 150
Capsanthin, capsorubin
Orange
X
E 160 c
Beetroot red
Red
X
E 162
Anthocyanins
Red
X
E 163
Aluminium, zinc, magnesium and calcium stearates
White
X
Bromothymol blue
Blue
X
Bromocresol green
Green
X
Field of application
In column 3 of this Schedule, the entry “x” in a sub-column means that the colouring agent must not be used other than as follows–
- Sub-column 1
Colouring agents allowed in all cosmetic products;
- Sub-column 2
Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
- Sub-column 3
Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
- Sub-column 4
Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
PART IIColouring agents listed in Annex IV Part 2 of the directive as colouring agents provisonally allowed for use in cosmetic products
Column 1
Column 2
Column 3
Column 4
Column 5
Name or colour index number
Colour
Type of product Field of application
Other requirements
Authorization valid until
1
2
3
4
12700
Yellow
X
See also Part I
31.12.1987
13065
Yellow
X
See also Part I
31.12.1987
15800
Red
X
See also Part I
31.12.1988
19120
Yellow
X
31.12.1988
20470
Black
X
See also Part I
31.12.1988
21110
Orange
X
Maximum 3,3'–dichloro-benzidine concentration in the colouring agent: 5 ppm
31.12.1987
21115
Orange
X
as immediately above
31.12.1988
26100
Red
X
31.12.1988
42045
Blue
X
See also Part I
31.12.1988
42170
Green
X
See also Part I
31.12.1988
42535
Violet
X
31.12.1987
44025
Green
X
31.12.1987
44045
Blue
X
See also Part I
31.12.1987
45190
Violet
X
See also Part I
31.12.1988
47000
Yellow
X
See also Part I
31.12.1988
61554
Blue
X
Only in hair-care preparations in a maximum concentration of 50 ppm
31.12.1987
73312
Red
X
31.12.1987
73900
Violet
X
See also Part I
31.12.1987
73905
Red
X
31.12.1988
74180
Blue
X
See also Part I
31.12.1988
75660
Yellow
X
31.12.1988
Acid red 195
Red
X
31.12.1987
Field of application
In column 3 of this Schedule the entry “X” in a sub-column means that the columns agent must not be used other than as follows–
- Sub-column 1
Colouring agents allowed in all cosmetic products;
- Sub-column 2
Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
- Sub-column 3
Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
- Sub-column 4
Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
SCHEDULE 4
SCHEDULE 5PRESERVATIVES
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.
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
–
–
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
These Regulations amend the Cosmetic Products (Safety) Regulations 1984 (“the Principal Regulations”) as amended by the Cosmetic Products (Safety) (Amendment) Regulations 1985, and implement Commission Directives No. 85/391/EEC (O.J. L224, 22.8.85, p. 40), No. 85/490/EEC (O.J. L295, 7.11.85, p. 30), No. 86/179/EEC (O.J. L138, 24.5.86 p. 40) and No. 86/199/EEC (O.J. L149, 3.6.86 p. 38) on cosmetic products, and as permitted by the Directives impose certain additional requirements on the composition of cosmetic products. The Regulations are made under the Consumer Protection Act 1987 and the European Communities Act 1972.
The main changes are–
the deletion of Schedules 3 and 4 of the principal Regulations and their replacement by the Schedule set out in Schedule 3 to these Regulations. The replacement Schedule lists colouring agents which are acceptable throughout the European Community and take account of the review of provisionally approved colourants undertaken to satisfy Article 5 of the Cosmetics Directive (76/768/EEC) (regulation 2(ee));
the replacement of Schedule 5 of the principal Regulations by the Schedule set out in Schedule 4 to the Regulations. The Schedule lists the preservatives which may be used in cosmetic products and takes account of the review of provisionally approved preservatives undertaken to satisfy Article 5 of the Cosmetics Directive (76/768/EEC) (regulation 2(ff));
the amendment of the wording of regulations 5(2) and 9(2) to make it clear that the controls over supply also apply to products exported to other member States of the European Economic Community (regulation 2(b) and (i));
the prohibition of the use of 2,3,7,8–tetrachlorodibenzo–p–dioxin, dimethoxane, pyrithione sodium and heightened versions of hydroquinone (regulation 2 (q) and (y));
the restriction of the use of selenium disulphide, aluminium zirconium hydroxides, quinolin–8–ol and bis (8–hydroxyquinolinium) sulphate, 2, 2' diothiobis (pyridine 1–oxide), addition product with magnesium sulphate trihydrate and 1–phenoxy-propan–2–ol and the modification of the restriction on the use of 1,3–Bis (Hydroxymethyl) imidazolidene–2–thione (regulation 2(aa) (bb) and (cc));
the specification of methods in certain cases for identifying and in all cases for determining the presence in cosmetic products of glycerol 1–(4 aminobenzoate);, chlorobutanol, quinine, inorganic sulphites and hydrogen sulphites, chlorates of the alkali metal and sodium iodate (regulation 2(hh)).