Statutory Instruments
CONSUMER PROTECTION
Made
4th July 2005
Laid before Parliament
6th July 2005
Coming into operation
28th July 2005
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1) 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;
Now, therefore, the Secretary of State in exercise of the powers conferred upon him by section 11 of the said Act hereby makes the following Regulations—
1.—(1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) Regulations 2005 and shall come into force on 28th July 2005.
(2) In these Regulations “the Principal Regulations” means the Cosmetic Products (Safety) Regulations 2004(2).
2. In Part 1 of Schedule 7 to the Principal Regulations after entry 27 there is inserted the entry listed in Part 1 of the Schedule to these Regulations.
3.—(1) The Principal Regulations are amended as follows.
(2) In regulation 5—
(a)at the end of paragraph (14)(b) after “finished product or its prototype;” there is inserted “and”;
(b)in paragraph (16) for “Paragraphs” there is substituted “Paragraph”.
(3) In Schedule 2 at the end there is inserted “42. Commission Directive 2005/9/EC (O.J. No. L27, 29.1.05, p.46).”
(4) In Schedule 3—
(a)in Part 1 for entries 29, 30, 63, 130, 182, 232 and 689 there are substituted the corresponding entries in Part 2 of the Schedule to these Regulations;
(b)in Part 2 for entries 2, 3 and 4 there are substituted the corresponding entries in Part 3 of the Schedule to these Regulations.
(5) In Schedule 4—
(a)in Part 1—
(i)in entry 1a in the first row in the sixth column “bathing” is omitted;
(ii)in entry 2b in the second row in the fifth column for “pH 7 to 9.5” there is substituted “pH 6 to 9.5”;
(iii)in entry 7 in the fourth column “(and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)” is omitted;
(iv)in entry 8 in the second row in the fourth column for “10 per cent” there is substituted “6 per cent”;
(v)in entry 9 in the first row (Oxidizing colouring agents for hair dying for general use)—
(aa)in the second column for “Methylphenylenedimines” there is substituted “Methylphenylenediamines”;
(bb)in the sixth column for “phenylene-diamines” there is substituted “phenylenediamines”
(vi)in entry 14 in the third row (Artificial nail systems for professional use) in the fourth column “subject to the provisions of “Combination Rule B” set out below” is omitted;
(vii)in entry 22 in the third row (Hair lotions and shampoos) “subject to the provisions of “Combination Rule B” set out below” is omitted;
(viii)in entry 50 for the text in the second column there is substituted “Aluminium zirconium chloride hydroxide complexes AlxZr(OH)y Clz and aluminium zirconium chloride hydroxide glycine complexes”;
(ix)in entry 58 in the sixth column for “Use by children is not advisable” there is substituted “Frequent use by children is not advisable”;
(x)for entries 1b, 21, 44 and 59 there are substituted the corresponding entries in Part 4 of the Schedule to these Regulations;
(b)in Part 2 in entry 20 in the sixth column “Can cause allergic reaction” is omitted.
(6) In Part 1 of Schedule 5—
(a)in the first column, for “15800” which appears between “15865*” and “15980” there is substituted “15880”;
(b)in the entry numbered “42051*”, in the fourth column (Other requirement) there is inserted “E131”;
(c)in the entry numbered “77000”, in the fourth column (Other requirement) there is inserted “E173”;
(7) In Part 1 of Schedule 6—
(a)for entries 5 and 23 there are substituted the corresponding entries in Part 5 of the Schedule to these Regulations;
(b)in entry 19 in the third column “Products rinsed off after use” is omitted;
(8) In Part 1 of Schedule 7—
(a)in entry 9 in the second column for “α-(Oxoborn-3-ylidine)” there is substituted “α-(Oxoborn-3-ylidene)”;
(b)for entries 18 and 19 there are substituted the corresponding entries in Part 6 of the Schedule to these Regulations;
(c)in entry 26 in the second column for “(Dimethicodiethylbenzyalmalonate)” which appears at the end before the CAS number there is substituted “(Dimethicodiethylbenzalmalonate)”.
Gerry Sutcliffe
Parliamentary Under Secretary of State for Employment Relations and Consumer Affairs
Department of Trade and Industry
Date 4th July 2005
Regulations 2 and 3
Entry to be inserted in Part 1 of Schedule 7 to the Principal Regulations.
| (1) | (2) | (3) | (4) | (5) |
|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information |
| 28 | Benzoic acid, 2-[-4-(diethyl-lamino)-2-hydroxybenzoyl]-,hexylester (INCI name: Diethylamino Hydroxybenzoyl Hexyl Benzoate; CAS No 302776-68-7) | 10% in sunscreen products |
Entries to be substituted for the corresponding entries in Part 1 of Schedule 3 to the Principal Regulations.
| (1) | (2) | (3) | (4) |
|---|---|---|---|
| Number in this Schedule | Name of substance | Cross-reference to this Schedule | Cross-reference to Annex II of the Directive |
| 29 | 4-Amino-N-(2-diethylaminoethyl)benzamide, its salts and derivatives | 610 | 25 |
| 30 | Aminoheptane, its isomers and salts | 751 | 27 |
| 63 | Arsenic and its compounds | - | 43 |
| 130 | 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene | 490 | 414 |
| 182 | Chlorprothixene (INN) and its salts | 165 | 84 |
| 232 | Datura stramonium L. and its galenical preparations | 301 | |
| 689 | Tetrabromosalicylanilides | - | 350 |
Entries to be substituted for the corresponding entries in Part 2 of Schedule 3 to the Principal Regulations.
| (1) | (2) | (3) | (4) |
|---|---|---|---|
| Number in this Schedule | Name of substance | Cross-reference to this Schedule | Cross-reference to Annex II of the Directive |
| 2 | Benzyl cyanide | 32 | 424 |
| 3 | Cyclamen alcohol | 23 | 425 |
| 4 | Decahydro-6-isopropyl-2-naphthol | 22 | 441 |
Entries to be substituted for the corresponding entries in Part 1 of Schedule 4 to the Principal Regulations.
| (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 |
| 1b | Tetraborates | (a) Bath products | 18 per cent | Not to be used in products for children under three years old | Not to be used for bathing children under three years old |
| (b) Hair waving products | 8 per cent | Rinse well | |||
| The above mentioned percentages are calculated as boric acid | |||||
| 21 | Quinine and its salts | Shampoos | 0.5 per cent calculated as quinine base | - | - |
| Hair lotions | 0.2 per cent calculated as quinine base | - | - | ||
| 44 | 1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea] | Hair care preparations | 2 per cent | Not to be used in aerosol dispensers | Contains 1,3-bis(hydroxymethyl) imidazolidine-2-thione |
| Nail care preparations | 2 per cent | The pH of the product as applied must be less than 4 | Contains 1,3-bis(hydroxymethyl) imidazolidine-2-thione | ||
| 59 | Talc: hydrated magnesium silicate | (a) Powdery products intended to be used for children under three years of age | - | - | (a): Keep powder away from children’s noses and mouths |
| (b) other products | - | - | - |
Entries to be substituted for the corresponding entries in Part 1 of Schedule 6 to the Principal Regulations.
| (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 |
| 5 | Formaldehyde and para-formaldehyde | For oral hygiene | 0.1 per cent (expressed as free formaldehyde) | Not to be used in aerosol dispensers (sprays) | - |
| Except for oral hygiene (see also Part 1 of Schedule 4) | 0.2 per cent (expressed as free formaldehyde) | Not to be used in aerosol dispensers (sprays) | - | ||
| 23 | Triclocarban (INN) | All products | 0.2 per cent | A Purity criteria: 3,3',4,4'-tetra-chloroazobenzene < 1 mg/kg 3,3',4,4' -tetrachloroazoxybenzene < 1 mg/kg | - |
Entries to be substituted for the corresponding entries in Part 1 of Schedule 7 to the Principal Regulations.
| (1) | (2) | (3) | (4) | (5) |
|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information |
| 18 | 3-(4-Methylbenzylidene)bornan-2-one [4-Methylbenzylidene camphor] | 4 per cent | - | - |
| 19 | 3-Benzylidenebornan-2-one [3-Benzylidene camphor] | 2 per cent | - | - |
(This note is not part of the Regulations)
These Regulations amend the Cosmetic Products (Safety) Regulations 2004 (“the Principal Regulations”) to give effect to Commission Directive 2005/9/EC (O.J. L27, 29.1.2005, p. 46). The Principal Regulations implement Directive 76/768/EEC (O.J. L262, 27.9.1976, p.169) on the approximation of the laws of the Member States on cosmetic products as amended.
Directive 2005/9/EC inserts an additional substance into the list of ultra violet filters subject to restrictions in Annex VII to Directive 76/768/EEC. This is implemented by regulation 2 which inserts a new entry 28 into the table in Part 1 of Schedule 7 to the Principal Regulations.
Regulation 3 makes a number of minor amendments to correct typographical errors in the Principal Regulations.
A regulatory impact assessment of the effect that these Regulations will have on costs to business is available from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET. Copies of a transposition note relating to these Regulations have been placed in the libraries of both Houses of Parliament. Copies are also available to the public from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET and on the DTI website (www.dti.gov.uk).