The Cosmetic Products (Safety) Regulations 2004
| (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 |
| 1 | Benzoic acid, its salts and esters | All products | 0.5 per cent (expressed as acid) | A — | — |
| 2 | Propionic acid and its salts | All products | 2 per cent (expressed as acid) | A — | — |
| 3 | Salicylic acid and its salts | All products | 0.5 per cent (expressed as 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 (expressed as acid) | A — | — |
| 5 | Formaldehyde and para-formaldehyde | For oral hygiene | 0.1 per cent (expressed as free formaldehyde) | Not to be used in aerosol dispensers (sprays) | — |
| 6 | ENTRY DELETED | ||||
| 7 | Biphenyl-2-ol [o-phenylphenol] and its salts | All products | 0.2 per cent (expressed as the phenol) | A — | — |
| 8 | Pyrithione zinc (INN) [Zinc pyrithione] | 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 (expressed as free SO₂) | A — | — |
| 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 [the Parabens] | All products | 0.4 per cent (expressed as acid) for 1 ester, 0.8 per cent (expressed as acid) for mixtures of esters | A — | — |
| 13 | 3-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its salts | All products | 0.6 per cent(expressed as acid) | Not to be used in aerosol dispensers (sprays) | — |
| 14 | Formic acid and its sodium salt | All products | 0.5 per cent (expressed as acid) | A — | — |
| 15 | 3,3’-Dibromo-4,4’-hexa-methylenedioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate) | All products | 0.1 per cent | — | — |
| 16 | Thiomersal (INN) [Thimerosal] | 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 [Undecylenic acid] and its salts | All products | 0.2 per cent (expressed as acid) | A — | — |
| 19 | Hexetidine (INN) | Products rinsed off after use | 0.1 per cent | A — | — |
| 20 | 5-Bromo-5-nitro-1,3-dioxane | Products rinsed off after use | 0.1 per cent | Avoid formatation of nitrosamines | — |
| 21 | Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol] | All products | 0.1 per cent | A Avoid formatation of nitrosamines | — |
| 22 | 2,4-Dichlorobenzyl alcohol [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’-tetra-chloroazobenzene < 1 mg/kg | — |
| 24 | 4-Chloro-m-cresol [p-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 [Chloroxylenol] | 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) [Polyaminopropyl biguanide] | All products | 0.3 per cent | A — | — |
| 29 | 2-Phenoxyethanol [Phenoxyethanol] | All products | 1.0 per cent | A — | — |
| 30 | Hexamethylenetetramine (Methenamine (INN)) [Methenamine] | All products | 0.15 per cent | A — | — |
| 31 | Methenamine 3-chloroallylo-chloride (INNM) [Quaternium-15] | All products | 0.2 per cent | — | — |
| 32 | 1-(4-Chlorophenoxy)-1-(imidazol-l-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] | All products | 0.5 per cent | A — | — |
| 33 | 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin] | All products | 0.6 per cent | A — | — |
| 34 | Benzyl alcohol (see also Part I of Schedule 4) | All products | 1.0 per cent | A — | — |
| 35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine] | Products rinsed off after use | 1.0 per cent | A — | — |
| Other products | 0.5 per cent | A — | |||
| 36 | 2-Bromo-2-(bromomethyl) glutaronitrile (1,2-dibromo-2,4-dicyanobutane)[Methyldibromo glutaronitrile] | Rinse-off products only | 0.1 per cent | — | — |
| 37 | 6,6-Dibromo-4,4-dichloro-2,2’-methylenediphenol [Bromochlorophen] | All products | 0.1 per cent | A — | — |
| 38 | 4-Isopropyl-m-cresol [o-Cymen-5-ol] | 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 [Methylchloroisothiazolinone and Methylisothiazolinone] | All products | 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one | — | — |
| 40 | 2-Benzyl-4-chlorophenol [Chlorophene] | All products | 0.2 per cent | — | — |
| 41 | 2-Chloroacetamide [Chloroacetamide] | All products | 0.3 per cent | — | Contains chloroacetamide |
| 42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | All products | 0.3 per cent | A — | — |
| 43 | 1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part 1 of Schedule 4) | Products rinsed off after use | 1.0 per cent | — | — |
| 44 | Alkyl (C₁₂-C₂₂)-trimethyl-ammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM)) | All products | 0.1 per cent | A — | — |
| 45 | 4,4-Dimethyl-1,3-oxazolidine [Dimethyloxazolidine] | All products | 0.1 per cent | The pH of the finished product must not be lower than 6 | — |
| 46 | 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea] | All products | 0.5 per cent | — | — |
| 47 | Hexamidine (INN) (4,4’-(Hexamethylenedioxy)-dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate | All products | 0.1 per cent | A — | — |
| 48 | Glutaraldehyde (pentane-1,5-dial) [Glutaral] | All products | 0.1 per cent | Prohibited in aerosols (sprays) | Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent) |
| 49 | 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane [7-Ethylbicyclo-oxazolidine] | All products | 0.3 per cent | Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes | — |
| 50 | Chlorphenesin (INN) [Chlorphensin] | All products | 0.3 per cent | — | — |
| 51 | Sodium N-hydroxymethyl-glycinate [Sodium hydroxymethylglycinate] | All products | 0.5 per cent | — | — |
| 52 | Silver chloride deposited on titanium dioxide | Not to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips | 0.004 per cent, calculated as silver chloride | The ratio of titanium dioxide to silver chloride shall be 4:1 by mass | — |
| 53 | Benzethonium chloride (INN) [Benzethonium chloride] | Products rinsed off after use | 0.1 per cent | — | — |
| 54 | Benzalkonium chloride, bromide and saccharinate | All products | 0.1 per cent calculated as benzalkonoium chloride | A — | Avoid contact with eyes |
| 55 | Benzylhemiformal | Products rinsed off after use | 0.15 per cent | — | — |
| 56 | 3-lodoprop-2-ynyl butylcarbamate [Iodopropynyl butylcarbamate] | Not to be used in oral hygiene and lip products | 0.05 per cent | — | Contains iodine (Only required where the 3-iodoprop-2-ynyl butylcarbamate concentration in products intended to remain on the skin exceeds 0.02 per cent) |
PART 2 — PRESERVATIVES LISTED IN ANNEX VI, PART 2 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LIAD DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
| (1) | (2) | (3) | (4) | (5) | (6) | (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 supply until |
| Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. |
SCHEDULE 7 — LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
In this schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. 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 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC [^f00025]
PART 1 — UV FILTERS LISTED IN ANNEX VII, PART 1 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
| (1) | (2) | (3) | (4) | (5) |
|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | 4-Aminobenzoic acid [PABA] | 5 per cent | — | — |
| 2 | N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate] | 6 per cent | — | — |
| 3 | Homosalate (INN) | 10 per cent | — | — |
| 4 | Oxybenzone (INN) [Benzophenone-3] | 10 per cent | — | Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product) |
| 5 | ENTRY DELETED | |||
| 6 | 2-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts | 8 per cent (expressed as acid) | — | — |
| 7 | 3,3-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts | 10 per cent (expressed as acid) | — | — |
| 8 | 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)-propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane] | 5 per cent | — | — |
| 9 | α-(2-Oxoborn-3-ylidine)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts | 6 per cent (expressed as acid) | — | — |
| 10 | 2-Ethylhexyl 2-cyano-3,3-diphenylacrylate [Octocrylene] | 10 per cent (expressed as acid) | — | — |
| 11 | Polymer of N-[(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl]acrylamide Polyacrylamidomethyl benzylidene camphor] | 6 per cent | — | — |
| 12 | 2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate] | 10 per cent | — | — |
| 13 | Ethoxylated ethyl-4-aminobenzoate [PEG-25 PABA] | 10 per cent | — | — |
| 14 | Isopentyl 4-methoxycinnamate [Isoamyl p-methoxycinnamate] | 10 per cent | — | — |
| 15 | Tris(2-ethylhexyl) 4,4’4”-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate [Octyl triazone] | 5 per cent | — | — |
| 16 | 2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-l-(trimethylsilyloxy)-disiloxan-1-yl]propyl]phenol [Drometrizole trisiloxane] | 15 per cent | — | — |
| 17 | Bis(2-ethylhexyl) 4,4’-[6-tert-butylcarbamoylanilino)-1,3,5-triazine-2,4-diyldiimino]dibenzoate | 10 per cent | — | — |
| 18 | 3-(4-Methylbenzylidine)bornan-2-one [4-Methylbenzylidene camphor] | 4 per cent | — | — |
| 19 | 3-Benzylodenebornan-2-one [3-Benzylidene camphor | 2 per cent | — | — |
| 20 | 2-Ethylhexyl salicylate [Octyl salicylate] | 5 per cent | — | — |
| 21 | 2-Ethylhexyl 4-dimethylaminobenzoate [Octyl dimethyl PABA] | 8 per cent | — | — |
| 22 | 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM)) | 5 per cent (expressed as acid) | — | — |
| 23 | 2-2’-Methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol] | 10 per cent | — | — |
| 24 | diSodium 2,2’-(1,4-phenylene)bis(lH-benzimidazole-4,6-disulfonate) | 10 per cent (expressed as acid) | — | — |
| 25 | 5,5’-Bis(2-ethylhexyloxy)-2,2’-(6-p-methoxyphenyl-1,3,5-triazine-2, 4-diyl)diphenol | 10 per cent | — | — |
| 26 | α-(Trimethylsilyl)-w-(trimethylsilyloxy)poly-[oxy(dimethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl]phenoxy]-1-methyleneethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl)]phenoxy]prop-1-enyl)silylene] where there are usually 60 polymeric units, of which the first part of the copolymer provides 56 (Dimethicodiethylbenzyalmalonate) (CAS No. 207574-74-1) | 10 per cent | — | — |
| 27 | Titanium dioxide | 25 per cent | — | — |
PART II — UV FILTERS LISTED IN ANNEX VIII, PART 2 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information | UV filter supplied until |
| Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. |
SCHEDULE 8 — METHODS OF MANUFACTURE OF TALLOW DERIVATIVES
The following are the methods of manufacture referred to in regulation 5(5)—
- (a) transesterification or hydrolysis at a temperature of at least 200ºC and at an appropriate corresponding pressure for 20 minutes (glycerol, fatty acids and fatty acid esters);
- (b) saponification with sodium hydroxide solution, c(NaOH) = 12mol/l (glycerol and soap)—
- (i) batch process: at 95°C for three hours; or
- (ii) continuous process: at 140°C, two bars (2,000hPa) for eight minutes, or equivalent conditions.
SCHEDULE 9
PART 1 — SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 7(6) AND 7(11)
PART 2 — SYMBOL IN ANNEX VIIIa OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATION 7(2)(c)
SCHEDULE 10
PART 1 — PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY
1
The name or trade name and address or registered office of the applicant.
2
Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—
- (a) where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;
- (b) the European List of Notified Chemical Substances (ELINCS) name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC[^f00026] and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;
- (c) where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents.
3
The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 9(1)(d)and (e) and carried out in accordance with the requirements of regulations 9(2), 9(3) and 9(4).
4
The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.
5
A detailed justification of why confidentiality is sought addressing for example—
- (a) the fact that the identify of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;
- (b) the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;
- (c) the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.
6
- (1) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other Member States, precise details of each one of them.
- (2) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.
- (3) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.
7
A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.
PART II — PROCEDURE FOR GRANT OF REGISTRATION NUMBER
1
The registration number referred to in regulation 12(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each Member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.
2
The code allocated to the United Kingdom is 06.
SCHEDULE 11 — SAMPLING AND TESTING
1
In this Schedule—
- “Annex A” means the Annex to Commission Directive No. 80/1335/EEC[^f00027] as amended by Commission Directive No.87/143/EEC[^f00028]
- “Annex B” means the Annex to Commission Directive No. 82/434/EEC[^f00029] as amended by Commission Directive No.90/207/EEC[^f00030]
- “Annex C” means the Annex to Commission Directive No. 83/514/EEC[^f00031];
- “Annex D” means the Annex to Commission Directive No. 85/490/EEC[^f00032];
- “Annex E” means the Annex to Commission Directive No. 93/73/EEC[^f00033];
- “Annex F” means the Annex to Commission Directive No. 95/32/EC[^f00034];
- “Annex G” means the Annex to Commission Directive No. 96/45/EC[^f00035];
- “purchase” means purchase for the purpose of carrying out a test.
2
An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part 1 of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part 1 of Annex A; samples shall be regarded as having the sample batch number if—
- (a) the means of identifying the batch referred to in regulation 7(2)(h) above shows that they were manufactured in the same batch;
- (b) in the case of a product not manufactured in a batch, the reference referred to in regulation 7(2)(h) above shows that they are derived from the same unit of production; or
- (c) in the case of a product which does not comply with the requirements of regulation 7(2)(h) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.
3
The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.
4
As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—
- (a) either—
- (i) place a seal on the product’s container or outer packaging; or
- (ii) place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and
- (b) attach to the product a label indicating—
- (i) the name of the product,
- (ii) the date, time and place at which the product was purchased,
- (iii) his own name, and
- (iv) the name of the enforcement authority making the purchase.
5
- (1) Subject to sub-paragraph (2) below, the provisions of Part 1 of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.
- (2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.
6
- (1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.
- (2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.
- (3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.
- (4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.
- (5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzene- sulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC[^f00036], and shall take into account paragraph 11 of Part VII of Annex A.
- (6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzene-sulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.
- (7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.
- (8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part 1 of Annex B.
- (9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.
- (10) Any test to determine whether a hair dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.
- (11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.
- (12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.
- (13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.
- (14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.
- (15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.
- (16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol-and bis(8-hydroxyquinolinium) sulphate”.
- (17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.
- (18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.
- (19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair waving, hair straightening and depilatory products”.
- (20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.
- (21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.
- (22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.
- (23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.
- (24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.
- (25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.
- (26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.
- (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 (INN) 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”.
- (33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.
- (34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.
- (35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.
- (36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.
- (37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.
- (38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.
- (39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.
- (40) Any test for the identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether in cosmetic products”.
- (41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.
SCHEDULE 12 — List of Alternative Methods to Animal Testing
PART 1
Part 1 of this Schedule lists the alternative methods validated by the European Centre for the Validation of Alternative Methods (“ECVAM”) which are necessary to meet the requirements of these Regulations and which are listed in Annex V to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances [^f00037].
The reference number given in the second column of the table in Part 1 refers to the reference number under which the type of test is listed in Annex V to Directive 67/548/EEC.
| Entry Number | Reference Number | Type of Test (toxicological endpoint) | Alternative Test Method | Date after which this method is required to be used |
|---|---|---|---|---|
| 1 | B40 | Skin corrosion | Rat skin TER assay | 11.9.04 |
| 2 | B40 | Skin corrosion | Human skin model assay | 11.9.04 |
| 3 | B41 | Phototoxicity | In vitro 3T3 NRU phototoxicity test | 11.9.04 |
PART 2
Part 2 of this Schedule lists the alternative methods validated by ECVAM which are necessary to meet the requirements of these Regulations and which are listed in Annex IX to the Directive. As an alternative method may not replace completely the experimentation on animals, column 3 of the table below specifies whether the alternative method fully or partially replaces the animal test.
| Entry Number | Reference Number | Nature of replacement | Alternative Test Method | Date after which this method is required to be used |
|---|---|---|---|---|
| Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. |
SCHEDULE 13 — LIST OF SUBSTANCES CLASSIFIED AS CARCINOGENIC, MUTAGENIC OR TOXIC FOR REPRODUCTION OF CATEGORY 3 UNDER DIRECTIVE 67/548/EEC WHICH APPEAR IN THE APPROVED SUPPLY LIST
The substances listed in this table are classified as carcinogenic, mutagenic or toxic for reproduction under directive 67/548/EEC[^f00038] and in the approved supply list. These substances have been evaluated as safe by the Scientific Committee on Cosmetic Products[^f00039] in accordance with article 4b of the Directive and are permitted for use in cosmetic products.
| Substance | Index Number | EC Number | CAS Number |
|---|---|---|---|
| Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. | Note: There are no entries in this Part at the date that these Regulations are made. |
Signed
Gerry Sutcliffe, — Parliamentary Under Secretary of State for Employment Relations, Competition and Consumers — Department of Trade and Industry — 17th August 2004
Explanatory note
(This note is not part of the Order)
These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2003 (S.I. 2003/835) (“the 2003 Regulations”). The 2003 Regulations give effect to Council Directive 76/768/EEC (O.J. No. L262, 27.9.76, p.169) (“the Directive”) on the approximation of the laws of the Member States relating to cosmetic products, as amended by the Community instruments listed in Schedule 2 to these Regulations.
These Regulations also give effect for the first time to Council Directive 2003/15/EC (O.J. L66, 11.3.2003, p.26) which amends Directive 67/548/EEC for the 7th time, as follows:
- (a) Prohibit the supply of cosmetic products where the final formulation or ingredients have been tested on animals using a method other than an “alternative method”. The Regulations also introduce an outright prohibition in respect of the supply of cosmetic products after specified dates (2009 and 2013);
- (b) Prohibit the testing of “finished cosmetic products” on animals with immediate effect;
- (c) Prohibit the testing of ingredients for use in cosmetic products after specified dates;
- (d) Introduce provisions governing the use by cosmetic product manufacturers of claims in respect of animal testing;
- (e) Prohibit the use in cosmetic products of substances which are classified under directive 67/548/EEC as carcinogenic, mutagenic or toxic to reproduction (and listed in the approved supply list) subject to an exemption in respect of substances which have been evaluated as safe by the Scientific Committee on Cosmetic Products[^f00040];
- (f) Requires manufacturers to label products with a symbol (contained in Schedule 9, Part 2) indicating the time after opening after which the product may harm the consumer (this only applies to products with a minimum durability of more than 30 months);
- (g) Requires certain perfumes and aromatic compositions to be specifically listed on product packaging;
- (h) Requires a specific safety assessment to be undertaken in respect of cosmetic products intended for children or for intimate hygiene;
- (i) Inserts further entries into Schedule 4 to these Regulations;
These Regulations also give effect to Council Directive 2003/80/EC (O.J. No. 224, 6.9.2003, p.27) which amends the Directive for the 30th time. Directive 2003/80/EC amends the Directive by inserting a new Annex VIIIa containing a symbol to be used by manufacturers to indicate the time after opening after which the product may harm the consumer (as required by Directive 2003/15/EC).
These Regulations also give effect to Council Directive 2003/83 (O.J. No. L238, 25.9.2003, p.23) which amends the Directive by inserting, deleting or amending entries in Annexes II, III and VI. These Regulations make appropriate amendments to Schedules 3,4 and 6, which implement those Annexes. Directive 2003/83/EC requires Member States to ensure that cosmetic products, which fail to comply with that directive, shall not be placed on the market from 24th March 2005 and that they shall not be supplied to the final consumer from 24th September 2005. Accordingly, regulations 1(3) and 1(4) provide that newly inserted or amended entries in the schedules to the regulations shall not have effect until 24th March 2005. Equally, these regulations provide that certain entries, which are amended or deleted by 2003/83, shall continue to operate in their existing form (i.e. as they appear in the Cosmetic Products (Safety) Regulations 2003) until 24th March 2005. Regulation 16(3) provides that no proceedings or enforcement action shall be taken in respect of the new or amended entries where the cosmetic product in question is placed on the market before 24th March 2005 and is supplied before 24th September 2005.
The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists by on-line subscription at http://www.colour-index.org/.
A full regulatory impact assessment of the effect that this instrument 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.
Footnotes
[^f00001]: 1987 c. 43.
[^f00002]: S.I. 1972/1811, S.I. 1975/1707 and S.I. 1993/2661.
[^f00003]: 1972 c. 68.
[^f00004]: S.I. 2003/835
[^f00005]: O.J. No. L132, 1.6.96, p.1.
[^f00006]: O.J. No L140, 23.6.95, p. 26.
[^f00007]: O.J. No. L262, 27.9.76, p. 169.
[^f00008]: O.J No. L147, 31.5.01, p.1.
[^f00009]: An ingredient’s CTFA name is the name given to it by the Cosmetics, Toiletries and Fragrances Association (CTFA) and listed in the tenth edition of the International Cosmetic Ingredient Dictionary and Handbook (ISBN 1-882621-34-4) published in 2004 by The Cosmetic Toiletry and Fragrance Association. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient’s colour index number is the number specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J.No. L132, 1.6.96, p.1.).
[^f00010]: O.J. No. L50, 20.2.2004, p. 44, implemented by the Good Laboratory Practice (Codification Amendment Etc.) Regulations (S.I. 2004/994).
[^f00011]: 1954 c. 61.
[^f00012]: 1983 c. 54.
[^f00013]: S.I. 1991/824, to which there is an amendment not relevant to these Regulations.
[^f00014]: SI 2003/835 revoked by these regulations
[^f00015]: S.I. 2003/835.
[^f00016]: O.J. No. L132, 1.6.1996, p.1.
[^f00017]: SI 2003/835
[^f00018]: Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.
[^f00019]: O.J. No. 115, 11.11.62, p.2645.
[^f00020]: Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and 85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p. 4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108,26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22).
[^f00021]: Annexes 1 and VII to the Act of Accession of 22nd January 1972, as adjusted by the Council Decision of 1st January 1973 (O.J. No. L2, 1.1.73, p.1).
[^f00022]: Council Directive 94/36/EC (O.J) No. L237, 10.9.94, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.95, p.1).
[^f00023]: O. J. No. L132, 1.6..96, p.1.
[^f00024]: SI 2003/835
[^f00025]: O.J. No. L132, 1.6.96, p.1.
[^f00026]: O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EEC (O.J. L152, 30.4.2004, p.1)
[^f00027]: O.J. No. L383, 31.12.80, p.27.
[^f00028]: O,J. No. L57, 27.2.87, p.56.
[^f00029]: O.J. No. L185, 30.6.82, p.1.
[^f00030]: O.J. No. L108, 28.4.90, p.92.
[^f00031]: O.J. No. L291, 24.10.83, p.9.
[^f00032]: O.J. No. L295, 7.11.85, p.30.
[^f00033]: O.J. No. L231, 14.9.93, p.34.
[^f00034]: O.J. No.L178, 28.7.95, p.20.
[^f00035]: O.J. No. L213, 2.7.96, p.8.
[^f00036]: O.J. No. L57, 27.2.87, p.56.
[^f00037]: O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EC (O.J. L152, 30.4.2004, p.1)
[^f00038]: Council Directive 1967/548/EEC (OJ 196,16.8.67, p.1) as last amended by 2004/73/EC (O.J. L152, 30.4.2004, p.1)
[^f00039]: the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”)
[^f00040]: the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”)
Editorial notes
[^key-002eaf968cd9238088a42cc212b22da1]: Reg. 16 in force at 11.9.2004, see reg. 1(1)
[^key-0296e912c2d0ac2c3404a61cc9d654dc]: Sch. 13 in force at 11.9.2004, see reg. 1(1)
[^key-035284c348d5c1f95fbf377b7dd60893]: Sch. 9 Pt. 1 in force at 11.9.2004 as commenced by inducing reg. 7(6)(11) , see reg. 1(1)
[^key-0ef5421905588c5e99bce695b466f5c8]: Sch. 3 Pt. 1 in force at 11.9.2004, see reg. 1(1)
[^key-13be55c659dc0017436d6b7710c35c87]: Reg. 13 in force at 11.9.2004, see reg. 1(1)
[^key-1739f5c56dc446f1a90b734f36e18d9d]: Sch. 11 para. 2 in force at 11.9.2004, see reg. 1(1)
[^key-1f42b08da19284acca896ed80b61c6fd]: Sch. 10 Pt. II para. 2 in force at 11.9.2004, see reg. 1(1)
[^key-203afbebc52338b11c7a150cde4498e0]: Sch. 1 Pt. 1 in force at 11.9.2004, see reg. 1(1)
[^key-2434e222dc82d2693db641a0d8bffb27]: Sch. 10 Pt. 1 para. 2 in force at 11.9.2004, see reg. 1(1)
[^key-280e61397c4b5cde9ecbb5d3a4f67171]: Reg. 15 in force at 11.9.2004, see reg. 1(1)
[^key-2a9b136d5fde90b2317ba65486018bf7]: Sch. 11 para. 1 in force at 11.9.2004, see reg. 1(1)
[^key-2fe38ca2329eee0b1f1f379865faac3b]: Sch. 10 para. 7 in force at 11.9.2004, see reg. 1(1)
[^key-32a24924043d12c9cc732a259b01de8f]: Sch. 1 Pt. 2 in force at 11.9.2004, see reg. 1(1)
[^key-39433c348f08031181ef66dc410bb178]: Sch. 9 Pt. 2 in force at 11.3.2005 as commenced by reg. 7(2), see reg. 1(2)
[^key-3c2b68362cb3ae31ae65a32712e2ae44]: Reg. 18 in force at 11.9.2004, see reg. 1(1)
[^key-3d4b51c22ef6c5753f60e82c5fa127e7]: Sch. 7 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-3efa1f88dc682bf91a9e99f0e1122528]: Sch. 8 in force at 11.9.2004, see reg. 1(1)
[^key-4914e8f333bc411636b6df3a1c4c2109]: Sch. 4 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing regs. 5(2), 6(1), see reg. 1(1)
[^key-4c08853e021734f70a6d6b31409ca2ba]: Reg. 8 in force at 11.9.2004, see reg. 1(1)
[^key-4eb6df6ba51c89f2d69c6ceb57f90952]: Sch. 4 Pt. 2 in force at 11.9.2004 in so far as commencd by inducing regs. 5(2), 6(1), see reg. 1(1)
[^key-4ecdfdf2acac4efa301c3d09e61202e1]: Reg. 7(2)(c)(9)(b) in force at 11.3.2005, see reg. 1(2)
[^key-5bc499e02b60140a9e5a8dded5b25b97]: Sch. 10 Pt. II para. 1 in force at 11.9.2004, see reg. 1(1)
[^key-5c7c97c6ab2846908d87830df503b28b]: Sch. 10 Pt. 1 para. 1 in force at 11.9.2004, see reg. 1(1)
[^key-60540642b4298e8454d19c19a9eec72b]: Sch. 12 Pt. 2 in force at 11.9.2004, see reg. 1(1)
[^key-611575801454be13e55b3c1f0b994cf6]: Sch. 10 para. 4 in force at 11.9.2004, see reg. 1(1)
[^key-61a91337864b282dbd1a2f3cde843d66]: Sch. 11 para. 4 in force at 11.9.2004, see reg. 1(1)
[^key-6529c9c79458800848ed23ef9dc92db3]: Sch. 4 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)
[^key-68857320c3ddc5fa56aa2e748f79e901]: Reg. 4 in force at 11.9.2004, see reg. 1(1)
[^key-6eee70717a47ba93a53169e0e697da6c]: Sch. 6 Pt. 2 in force at 11.3.2005 in so far as commenced by indcuing reg. 7(2), see reg. 1(2)
[^key-7186ff9ab2b01b0669333858509a4908]: Sch. 11 para. 3 in force at 11.9.2004, see reg. 1(1)
[^key-7490bc771701f204bfca449d842177e3]: Sch. 11 para. 5 in force at 11.9.2004, see reg. 1(1)
[^key-74c35b6d07a7b61ba741e59b95dc411f]: Sch. 5 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(9), see reg. 1(2)
[^key-7ec742ddc2b7bdcf831b06166d34e99c]: Reg. 5 in force at 11.9.2004, see reg. 1(1)
[^key-7f8760f18a2d95435ef97dec5675bb11]: Reg. 14 in force at 11.9.2004, see reg. 1(1)
[^key-923b0ddf358746c86161735d8aed4946]: Sch. 7 Pt. II in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)
[^key-9be35073cb0af5177c9df017c40eb4b3]: Sch. 6 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-9dc5e82c803fa999ac302e4f9299ac21]: Sch. 10 para. 5 in force at 11.9.2004, see reg. 1(1)
[^key-9f9d38db4c0bd89954390ab064754874]: Reg. 3 in force at 11.9.2004, see reg. 1(1)
[^key-a37d9223a870bc3a1767413e6c759d04]: Reg. 2 in force at 11.9.2004, see reg. 1(1)
[^key-a56825a13bca72a746aac65db22e62a4]: Sch. 6 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(2), see reg. 1(2)
[^key-a9ddb20d1be89f4b427a1ceaa9471ec6]: Sch. 10 para. 6 in force at 11.9.2004, see reg. 1(1)
[^key-ac079ed2ff6be96fb03f2c7cc6fec0bc]: Sch. 5 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-ac65e220839261790bc2423686923da9]: Sch. 7 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-ae951a6fe424621d100169600b71061b]: Reg. 17 in force at 11.9.2004, see reg. 1(1)
[^key-b4cf3042ddb59c3fc029e14b1dd6c4e9]: Reg. 7(1)(2)(a)(b)(d)-(i)(3)-(9)(a)(c)-(f)(10)-(15) in force at 11.9.2004, see reg. 1(1)
[^key-bf74ceea08d5046a54733b841871af09]: Reg. 1 in force at 11.9.2004, see reg. 1(1)
[^key-c08b8111d0baf55c896bb13eb783c2a2]: Sch. 12 Pt. 1 in force at 11.9.2004, see reg. 1(1)
[^key-cfaae500e11f298b02b4d70266b0799a]: Sch. 5 Pt. II in force at 11.3.2005 in so far as commence by inducing reg. 7(9), see reg. 1(2)
[^key-d30af101fcf9b40cf4eb8db9f8ec002a]: Sch. 7 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)
[^key-d4efe9dd655b4e75824c7d1a03eebf59]: Sch. 3 Pt. 2 in force at 11.9.2004, see reg. 1(1)
[^key-d56f161403c87c1ec864c86fd91e7adc]: Reg. 11 in force at 11.9.2004, see reg. 1(1)
[^key-d6e0f73cd5cbf8b114a212d7581f956f]: Reg. 9 in force at 11.9.2004, see reg. 1(1)
[^key-df8c63d06cbcb6ffc8b7b8e0b303e5f6]: Reg. 6 in force at 11.9.2004, see reg. 1(1)
[^key-e410fbc6bb31678c0198ba5e469ddf84]: Sch. 10 para. 3 in force at 11.9.2004, see reg. 1(1)
[^key-e6e61c7bebe0c84d61381246d94056f4]: Sch. 11 para. 6 in force at 11.9.2004, see reg. 1(1)
[^key-eabaf41d58c1e7e72495cf41fada0731]: Reg. 10 in force at 11.9.2004, see reg. 1(1)
[^key-eb8e4406e2754d22237ea295284f29f5]: Sch. 5 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-efd3226636ca5878b362232cc754a215]: Sch. 6 Pt. 2 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)
[^key-f3ae742f9ae4556914facdfac2be4bd6]: Reg. 12 in force at 11.9.2004, see reg. 1(1)
[^key-fd2b22817c71ae39fe868924b3a524b9]: Sch. 4 Pt. 2 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)
[^M_I_4034da92-f90e-4585-b090-bf96b46a17b8]: Sch. 2 in force at 11.9.2004, see reg. 1(1)
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