The Cosmetic Products (Safety) (Amendment) Regulations 1987
S.I. 1987/1920 · Made 10 November 1987
CONSUMER PROTECTION
Made 10th November 1987
Laid before Parliament 23rd November 1987
Coming into force (except as provided in regulation 1) 21st December 1987
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987f1, consulted such organisations as appear to him to be representative of interests substantially affected by these Regulations, such other persons as he considers appropriate and the Health and Safety Commission;
And whereas the Secretary of State is a Minister designatedf2 for the purposes of section 2 of the European Communities Act 1972f3 in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods;
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:
Annotations to the whole text
Footnotes
- f1
- f2
- f3
Contents
- 1Regulation 1
- 2Regulation 2
- Signature
- Schedule 1Schedule 1
- Schedule 2
- IISubstances listed in Annex IV, Part I of the Directive as substances provisionally allowed
- Schedule 3Schedule 3
- Schedule 4Schedule 4
- Explanatory note
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.
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–
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
in all other cases, on 1st January 1989.
2
The Cosmetic Products (Safety) Regulations 1984f1 are hereby amended–
in regulation 4(1), in the definition of “the Directive”, by the omission of the word “and” between “Council Directive No. 83/574/EEC” and “Commission Directive No. 83/496/EEC” and by the addition of the words “Commission Directive No. 84/415/EEC(j), Commission Directive No. 85/391/EEC(k), Commission Directive No. 85/490/EEC(l), Commission Directive No. 86/179/EEC(m) and Commission Directive No. 86/199/EEC(n)” and by the insertion as footnotes at the foot of the relevant page of the following–
“(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”;
in regulation 5(2) by the insertion after the word “manufacturer” of the word “in”;
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”.
in regulation 6 by the substitution for paragraph (4) of the following paragraph–
“(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;”
in regulation 6 by the omission of paragraph (5);
in regulation 6(6) by the substitution for sub-paragraph (a) of the following sub-paragraph–
“(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;”
in regulation 6(6) by the omission of the word “and” between sub-paragraphs (a) and (b) and by the addition of the following sub-paragraph–
“(c)any preservative listed in column 2 of Part II of Schedule 5 after the date specified in column 7 of that Schedule”;
in regulation 6(7) by the omission of the word “and” between sub-paragraphs (a) and (b);
in regulation 9 by the substitution for paragraph (2) of the following paragraph–
“(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”;
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”;
in Schedule 1 by the substitution in column 2 of entry Number 64 for the letter “B” of the symbol “*”;
in Schedule 1 by the substitution for the words in column 2 of entry Number 85 of the words “4-Benzyloxyphenol”;
in Schedule 1 by the insertion in column 4 of entry Number 148A of the figure “366”;
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”;
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”;
in Schedule 1 by the insertion after entry Number 285 of the following entry–
“285A – 4-ethoxyphenol 348 178”;
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”;
in Schedule 1 by the insertion in column 3 of entry Number 348 after the figure “431” of the figures “285A, 411A”;
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”;
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”;
in Schedule 1 by the insertion after entry Number 411 of the following entry–
“411A 4-methoxyphenol 348 178”;
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”;
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”;
in Schedule 1 entry number 645A by the insertion in column 4 of the figure “366”;
in Schedule 1 by the renumbering and appropriate relocation in numerical order of entry Number 675 (Aristolochic acid and its salts) as entry Number 56A and by the insertion after entry Number 674 of following–
“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”;
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”;
in Part I of Schedule 2 by the substitution for entry Number 45 of the following–
“451, 3-Bis (hydroxymethyl) imidazolidiene-2-thione
Hair-care preparations
2 per cent Not to be used in aerosol dispensers (sprays) Contains 1, 3-Bis (hydroxymethyl) imidazolidine-2-thione Nail-care preparations2 per cent
pH as applied value must be less than 4 ”;
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;
in Schedule 2 by the substitution for Part II of Schedule 2 of the Part set out in Schedule 2 to these Regulations;
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)”;
by the substitution for Schedule 3 of the Schedule set out in Schedule 3 to these Regulations and by the omission of Schedule 4;
by the substitution for Schedule 5 of the schedule set out in Schedule 4 to these Regulations;
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.”
in Schedule 7 by the insertion after entry Number 6(26) of the following–
“(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”.”.
Signature
Francis Maude
Parliamentary Under-Secretary of State,
Department of Trade and Industry
10th November 1987
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 |
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 3
COLOURING AGENTS
Regulation 6(4)
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 mattersf1, as amended,f2 and adaptedf3 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 I
Colouring 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 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 1Sub-column 2 Colouring agents allowed in all cosmetic products;
Sub-column 3 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 4 Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
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 PART II
Colouring 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 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 1Sub-column 2 Colouring agents allowed in all cosmetic products;
Sub-column 3 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 4 Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
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
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
Explanatory note
(This note is not part of the Regulations)
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)).