1989 No. 2233
CONSUMER PROTECTION

The Cosmetic Products (Safety) Regulations 1989

Made
Laid before Parliament
Coming into force
(except as provided in regulation 1)
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 19871, 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 designated2 for the purposes of section 2 of the European Communities Act 19723 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 sections 11, 28 and 30 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:–

Citation, commencement and revocation

1.

(1)

These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1989 and except as provided by paragraphs (2) to (5) below shall come into force on 1st January 1990.

(2)

Regulation 4(2) and Schedule 1, in so far as they relate only to entry numbers 37, 38, 47 (cross-referenced in column 3 with entry number 496) and 87 and to entry numbers 247, 558 and 680 (cross-referenced in column 3 with entry numbers 351, 454 and 132 respectively) in that Schedule, regulation 4(3) and Part I of Schedule 2, in so far as they relate only to entry number 52 in that Part, and regulation 4(5) and Part I of Schedule 4, in so far as they relate only to entry number 40 and the deletion of entry number 6 in that Part, shall come into force–

(a)

on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1991; and

(b)

in all other cases, on 1st January 1991.

(3)

Regulation 4(3) and Schedule 2, in so far as they relate only to entry numbers 53 and 54 in Part 1 of Schedule 2, regulation 4(4)(a)(i) and Part I of Schedule 3, in so far as they relate to the deletion of colouring agent 13065, and regulation 4(5) and Part II of Schedule 4, in so far as they relate to the deletion of entry numbers 7 to 10, 14, 18, 22 and 24 in that Part, shall come into force–

(a)

on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1992; and

(b)

in all other cases, on 1st January 1992.

(4)

Regulation 4(3) and Part II of Schedule 2, in so far as they relate only to entry number 1 in that Part, regulation 4(4) and Part II of Schedule 3, in so far as they relate only to the deletion of entry numbers 15800, 19120, 20470, 21115, 42170, 45190, 47000, 73905 and 75660 and the requirement in column 4 relating to entry number 42535 in that Part, regulation 4(5) and Part I of Schedule 4, in so far as they relate only to the requirement in column 4 relating to entry number 39 in that Part, and Part II of Schedule 4, in so far as they relate only to entry number 26 and the deletion of entry numbers 1, 3, 5, 19 and 25 in that Part, and regulation 4(6)(a)(ii) and Part II of Schedule 5 shall come into force–

(a)

on 1st January 1991 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1993; and

(b)

in all other cases, on 1st January 1993.

(5)

Regulation 6 shall come into force–

(a)

on 1st January 1992 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case it shall come into force on 1st January 1994; and

(b)

in all other cases on 1st January 1994.

(6)

Subject to paragraph (7) below, the Regulations specified in Schedule 7 are hereby revoked:

(7)

The notes in Schedules 3 and 4 shall apply.

Interpretation

2.

(1)

In these Regulations–

“the Directive” means Council Directive No. 76/768/EEC4 as amended by Council Directive No. 82/368/EEC5, Commission Directive No. 82/147/EEC6, Commission Directive No. 83/191/EEC7, Commission Directive No. 83/341/EEC8, Council Directive No. 83/574/EEC9, Commission Directive No. 83/496/EEC10, Commission Directive No. 84/415/EEC11, Commission Directive No. 85/391/EEC12, Commission Directive No. 86/179/EEC13, Commission Directive No. 86/199/EEC14, Commission Directive No. 87/137/EEC15, Commission Directive No. 88/233/EEC16, Council Directive No. 88/667/EEC17 and Commission Directive No. 89/174/EEC18;

“cosmetic product” means any substance or preparation intended to be applied to any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or to the teeth or buccal mucosa wholly or mainly for the purpose of cleaning, perfuming or protecting them or keeping them in good condition or changing their appearance or combating body odour or perspiration except where such cleaning, perfuming, protecting, keeping, changing or combating is wholly for the purpose of treating or preventing disease;

“cosmetic product intended to come into contact with the mucous membranes” means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin;

“market research experiment” means any activities conducted for the purpose of ascertaining the opinion of persons of–

(a)

any cosmetic product; or

(b)

anything in, on or with which the cosmetic product is supplied; or

(c)

the appearance or any other characteristic of the cosmetic product or any such thing; or

(d)

the name or description under which the cosmetic product is supplied.

A cosmetic product is not the subject of a market research experiment unless–

(a)

any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment and

(b)

no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison.

“preservative” means a substance which is added to a cosmetic product for the primary purpose of inhibiting the development of micro-organisms in that product;

“supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply, and cognate expressions shall be construed accordingly; and

“UV filter” means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering ultra violet rays for the purpose of protecting the epidermis of the user from harmful effects of such ultra violet rays.

(2)

References in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations.

General Requirements

3.

(1)

Subject to paragraph (2) below, a cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use.

(2)

For the purposes of regulation 8, paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person.

Particular requirements

4.

(1)

The following provisions of this regulation are without prejudice to regulation 3 and are subject to regulation 5.

(2)

A cosmetic product shall not contain any substance listed in column 2 of Schedule 1:

Provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture.

(3)

A cosmetic product shall not contain any substance listed in column 2 of Schedule 2 unless the requirements in columns 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied.

(4)

A cosmetic product shall not contain–

(a)

any colouring agent listed in columns 1 and 2 of Schedule 3 with the exception of cosmetic products containing colouring agents intended solely to colour hair 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 was supplied on or before the date specified in column 5 of that Part;

(b)

any colouring agent which is not listed in that Schedule with the exception of cosmetic products containing colouring agents intended solely to colour hair;

(5)

A cosmetic product shall not contain–

(a)

any preservative listed in column 2 of Schedule 4 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;

(b)

any preservative which is not listed in that Schedule;

(c)

any preservative listed in column 2 of Part II of Schedule 4 after the date specified in column 7 of that Part.

(6)

A cosmetic product shall not contain–

(a)

any UV filter listed in column 2 of Schedule 5 unless–

(i)

the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or

(ii)

the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the UV filter in question is supplied on or before the date specified in column 6 of that Part;

(b)

any UV filter which is not listed in that Schedule.

5.

(1)

The Secretary of State may authorise the use in a cosmetic product of a particular substance, not being a substance listed in Schedule 1 or 2.

(2)

In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product. The conditions may relate to any matter which the Secretary of State considers appropriate including–

(a)

the purpose of the substance;

(b)

the type of cosmetic product;

(c)

the maximum concentration of the substance in any cosmetic product; and

(d)

information and marking requirements.

(3)

The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.

(4)

On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.

(5)

No person shall be convicted of an offence under section 12 of the Consumer Protection Act 1987 by reason of a cosmetic product’s containing a particular substance provided that at the time when but for this regulation an offence would have been committed–

(a)

the use of that particular substance in that cosmetic product was duly authorised; and

(b)

all of the conditions imposed by the authorisation were complied with.

Marking

6.

(1)

Subject to the following provisions of this regulation, the container and the outer packaging (if any) in which a cosmetic product is supplied or delivered pursuant to any supply, or a label affixed to the product, the container and the outer packaging, shall bear the following particulars:–

(a)

the name or trade name and the address or registered office of the manufacturer of the product or of a supplier thereof, being a manufacturer or supplier established within a member State of the European Economic Community;

(b)

in the case of a cosmetic product likely within 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 3 or to fulfil the purpose for which it was intended, the words “Best before ” immediately followed by

(i)

the earliest date on which it is likely to so cease; or

(ii)

an indication of where that date appears on the labelling

and any particular precautions to be observed to ensure that the product does not so cease before that date.

(c)

in the case of a cosmetic product containing a substance listed in column 2 of Schedule 2, the information specified in column 6 of that Schedule in relation to that substance;

(d)

in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that preservative;

(e)

in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 5, the information specified in column 5 of that Schedule in relation to that UV filter;

(f)

any particular precautions to be observed in use (not being precautions included in the information referred to in sub-paragraphs (b), (c), (d) and (e) above);

(g)

a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified):

Provided that the requirements specified in sub-paragraphs (b) and (g) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.

(2)

The particulars referred to in sub-paragraphs (a) to (g) of paragraph (1) above shall be in lettering which is visible, indelible and easily legible.

(3)

The particulars referred to in sub-paragraph (a) of paragraph (1) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.

(4)

The date referred to in sub-paragraph (b) of paragraph (1) above shall include the month and the year, and the month shall precede the year.

(5)

The particulars referred to in sub-paragraphs (b) to (f ) of paragraph (1) above shall be in the English language; but this shall not prohibit the additional use of other languages.

(6)

The particulars referred to in sub-paragraphs (c) to (f ) of paragraph (1) above and any special precautionary information on cosmetic products for professional use, in particular, in hairdressing shall appear on the container or on a label attached thereto: provided that where–

(a)

it is impracticable by reason of the size or shape of the container for the said particulars so to appear, or

(b)

two or more products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in outer packaging which bears clear and conspicuous instructions to the effect that the product must be mixed together in specified proportions before use,

the said particulars shall appear on an enclosed leaflet and an indication shall appear on both the container and the outer packaging (if any) or on a label if attached thereto referring the consumer to the information in the leaflet.

(7)

Where it is impracticable, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (1) above to appear on the container and outer packaging, the said particulars shall appear on the packaging in which the product is exposed for supply.

(8)

In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) of paragraph (1) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.

Enforcement

7.

(1)

No proceedings for an offence under section 12 of the Consumer Protection Act 1987 in respect of a contravention of regulation 8 by reason of the requirements of regulation 3 being not satisfied shall be brought in England or Wales except by or with the consent of the Secretary of State or the Director of Public Prosecutions and in Northern Ireland except by or with the consent of the Secretary of State or the Director of Public Prosecutions for Northern Ireland.

(2)

Regulations 3, 4 and 6 do not apply in any case in which the cosmetic product is supplied for the purposes of exporting that product to any country which is not a member State of the European Economic Community.

(3)

Regulation 6(5) does not apply in any case in which the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom.

8.

Subject to regulations 5 and 7(2) and (3), no person shall supply any cosmetic product in respect of which any of the requirements of regulation 3, 4 or 6 is not satisfied.

9.

Any test of goods purchased under section 28, or seized under section 29, of the Consumer Protection Act 1987 (which relates to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 of Schedule 6 and any test for which a method is specified in paragraph 6 of that Schedule shall be carried out in accordance with that method.

Eric Forth
Parliamentary Under-Secretary of State,
Department of Trade and Industry

SCHEDULE 1LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

Regulation 4(2)

The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 4(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named.

The numbers given in columns 1, 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substances (except that where a name is that of a group of substances, the cross-references are to particular examples of that group, and any cross-reference in parenthesis is to the name of a group of substances within which the particular substance falls). Those in column 4 are cross-references to Annex II of the Directive, from which this Schedule is derived.

(1)

(2)

(3)

(4)

Number in this Schedule

Name of substance

Cross-reference to this Schedule

Cross-reference to Annex II of the Directive

1

Acenocoumarol (INN)

3

254

2

3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts

372, 704

203

3

3-(α-Acetonyl-p-nitrobenzyl)-4-hydroxycoumarin

1

254

4

2-(or β-)Acetoxyethyltrimethylammonium hydroxide and its salts

6

2

5

2-Acetylamino-5-chlorobenzoxazole

151

1

6

Acetylcholine and its salts

4

2

7

Acetylene chlorides

227, 702

126

8

Acetylenic alcohols, their esters, ethers and salts

17

16

9

Acetylethyltetramethyltetralin (AETT)

317

362

10

β-(7α-Acetylthio-17β-hydroxy-3-oxoandrost-4-en-17α-yl)propionic acid lactone

599

4

11

Aconitine and its salts

—

12

12

Aconitum napellus L.(leaves, roots and galenical preparations)

—

11

13

Adonis vernalis L. and its preparations

—

13

14

Adrenaline

249, 294

14

15

Alkali pentacyanonitrosylferrate (2-)

563–4, 594–5

255

16

O-Alkyldithiocarbonic acids, salts of

705

336

17

Alkyne alcohols, their esters, ethers and salts

8

16

18

Alloclamide (INN) and its salts

22

19

19

Allyl isothiocyanate

—

18

20

2-(4-Allyl-2-methoxyphenoxy)—N,N-diethylacetamide and its salts

—

224

21

N-Allylnormorphine, its salts and ethers

460

20

22

2-Allyloxy-4-chloro—N-[2'-(diethylamino)ethyl]benzamide and its salts

18

19

23

Alypine and its salts

45, 103

143

24

Ambenomium chloride (INN)

(492)

132

25

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 in item 4 of Part II of Schedule 5

—

167

26

2-Amino-1,2-bis(4-methoxyphenyl) ethanol and its salts

—

29

27

3-Amino-4-butoxybenzoic acid 2-diethylaminoethyl ester and its salts

95, 234

23

28

Aminocaproic acid (INN) and its salts

32

7

29

2-Amino-5-chlorobenzoxazole

710

24

30

4-Amino—N-(2'-diethylaminoethyl) benzamide, its salts and derivatives

566

23

31

Aminoheptane, its isomers and salts

695

27

32

6-Aminohexanoic acid and its salts

28

7

33

α-(Aminomethyl)-3,4-dihydroxybenzyl alcoholand its salts

483, 484

257

34

4-Amino—N10-methylfolic acid

425

6

35

2-Amino-6-methylheptane and its salts

390, 489

28

36

2-Amino-4-methylhexane and its salts

267, 442

30

37

2-Amino-4-nitrophenol

—

383

38

2-Amino-5-nitrophenol

—

384

39

4-(orp-)Aminosalicylic acid and its salts

—

31

40

Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives

662

32

41

Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives

707

33

42

Amitriptyline (INN) and its salts

263

146

43

Ammi majus and its galenical preparations

—

35

44

Amphetamine (INN), its salts and derivatives and salts of those derivatives

(625)

21

45

Amydricaine and its salts

23, 103

143

46

Amylene chloride

228

36

47

Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))

496

381

48

Amyl nitrites

—

247

49

Amylobarbitone and its salts

(68)

220

50

Amylocaine and its salts

261

50

51

Anamirta cocculus L.(fruit)

—

106

52

Substances with androgenic effect

—

37

53

Aniline, its salts and halogenated and sulphonated derivatives

—

22

54

Anthracene oil

—

38

55

Antibiotics (except tyrothricin)

—

39

56

Antimony and its compounds

—

40

57

Apocynum cannabinum L. and its preparations

—

41

58

Apomorphine and its salts

641

42

59

Apronalide

393

216

60

Arecoline

451

238

61

Aristolochic acid and its salts

—

365

62

Arsenic and its compounds

—

43

63

Atropa belladonna L. and its compounds

—

44

64

Atropine, its salts and derivatives

—

45

65

Azacyclonol (INN) and its salts

285

286

66

Azamethonium bromide (INN)

443

121

67

Barbitone and its salts

(68)

220

68

Barbiturates

various

220

69

Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 2, for alkaline earth sulphides and lakes, salts and pigments prepared from those colouring agents identified in Column 1 of Schedule 3 by “*” immediately after the name or colour index number)

—

46

70

Bemegride (INN) and its salts

311, 312

183

71

Benactyzine (INN)

235

157

72

Bendrofluazide and its derivatives

73, 86

53

73

Bendroflumethiazide (INN) and its derivatives

72, 86

53

74

Benzamine and its salts

688

51

75

Benzatropine (INN) and its salts

281

158

76

Benzazepines, their salts and derivatives

85

49

77

Benzene

—

47

78

2-Benzhydryloxyethyldimethylamine and its salts

276

339

79

Benzidine

221

26

80

Benzilonium bromide (INN)

90

60

81

2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methylsulphate

561

239

82

Benzimidazolone

83, 244

48

83

Benzimidazol-2(3H)-one

82, 244

48

84

Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences)

191

357

85

Benzodiazepines, their salts and derivatives

76

49

86

Benzothiadiazine and its derivatives

72, 73

53

87

Benzoyl peroxide

—

382

88

3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole

387

52

89

Benzylideneacetone

527

356

90

3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide

80

60

91

4-Benzyloxyphenol

(366, 456)

178

92

2-[Benzyl—N-(2-pyridyl)amino]-ethyldimethylamine

581, 692

347

93

Beryllium and its compounds

—

54

94

Betamethasone (INN)

(337)

300

95

Betoxycaine (INN) and its salts

27, 95, 234

23

96

BHC (ISO) (gamma-BHC)

346, 348, 401

195

97

Bietamiverine (INN)

238

287

98

1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts

409

89

99

2-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts

102, 211

88

100

N,N-Bis(2-chloroethyl)methylamine and its salts

148, 458

87

101

N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts

459

86

102

N,N-Bis(2-chloroethyl)—N',O-propylenephosphoramide anhydride and its salts

99, 211

88

103

1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts

23, 45

143

104

2,2-Bis(hydroxymethyl)butan-1-ol trinitrate

572

206

105

2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts

403

219

106

Bithionol (INN)

651

352

107

Bretylium tosilate (INN) (or tosylate)

110

56

108

Bromine, elemental

—

55

109

Bromisoval (INN)

113

58

110

p-Bromobenzylethyldimethylammoniump-toluenesulphonate

107

56

111

Bromodiethylacetylurea

112, 139

57

112

α-Bromo-α-ethylbutyrylurea

111, 139

57

113

Bromoisovalerylurea

109

58

114

1—p-bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts

115

59

115

Brompheniramine (INN) and its salts

114

59

116

Brucine

—

62

117

Butanilicaine (INN) and its salts

438

90

118

Butobarbitone and its salts

(68)

220

119

Butopiprine (INN) and its salts

121

288

120

2-Butoxy—N-(2-diethylaminoethyl) cinchoninamide and its salts

178

129

121

2-Butoxyethyl α-phenyl-α-(N-piperidino)acetate and its salts

119

288

122

1-Butyl-3-(N-crotonoylsulphanilyl) urea

—

108

123

4-Butyl-1,2-diphenylpyrazolidine-3,5-dione

526

67

124

4-Butyl-1-phenylpyrazolidine-3,5-dione

455

64

125

1-Butyl-3-(p-methylbenzenesulphonyl) urea

661

65

126

1-Butyl-3-sulphanilylurea

140

66

127

4-Butylthiobenzohydryl dimethylaminoethyl sulphide

133

140

128

Cadmium and its compounds

—

68

129

Calabar bean

547

281

130

Cantharides,Cantharis vesicatoria

597

69

131

Cantharidin

354

70

132

Captan (ISO)

680

370

133

Captodiame (INN)

127

140

134

Caramiphen (INN) and its salts

530

169

135

N-(3-Carbamoyl-3,3-diphenylpropyl)—N,N-diisopropylmethylammonium salts

392

156

136

Carbazole, nitroderivatives of

476

72

137

Carbon disulphide

—

73

138

Carbon tetrachloride

637

315

139

Carbromal (INN)

111, 112

57

140

Carbutamide (INN)

126

66

141

Carisoprodol (INN)

449

235

142

Catalase

—

74

143

Cephaeline and its salts

—

75

144

Chenopodium ambrosioides(essential oil)

—

76

145

Cherry laurel water

577

291

146

Chloral hydrate

677

77

147

Chlorine

—

78

148

Chlormethine (INN) and its salts

100,458

87

149

Chlormezanone (INN)

162

91

150

5-Chlorobenzoxazolinone

173

82

151

N-5-Chlorobenzoxazol-2-ylacetamide

5

1

152

2-Chloro-4-dimethylamino-6-methylpyrimidine

157, 196

83

153

2-Chloro-9-(α-dimethylamino-propylidine)thioxanthene (trans-form) and its salts

170

84

154

4-Chloro-1,3-disulphamoylbenzene

181

85

155

Chloroethane

305

96

156

Chloroform

679

366

157

2-Chloro-6-methylpyrimidin-4-yldimethylamine

152, 196

83

158

Chlorophacinone (ISO)

163

93

159

1-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine

376

240

160

4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one

345

185

161

2-(4-Chlorophenyl)-3-methylbutane-2,3-diol

516

95

162

2-(4-Chlorophenyl-3-methyl-4-metathiazonone-1,1-dioxide

149

91

163

2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan-1,3-dione

158

93

164

1-(4-Chlorophenyl)-1-phenyl-1-dimethylaminoethoxyethane

167

94

165

Chloropicrine

—

325

166

3-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one

171, 172

262

167

Chlorphenoxamine (INN)

164

94

168

Chlorpromazine (INN)

(521)

320

169

Chlorpropamide (INN)

573

79

170

Chlorprothixene (INN) and its salts

153

84

171

Chlortalidone (INN)

166, 172

262

172

Chlorthalidone

166, 171

262

173

Chlorzoxazone (INN)

150

82

174

Cholecalciferol

(703)

335

175

Choline salts and their esters

—

168

176

Chromium, chromic acid and salts of the acid

—

97

177

Chrysoidine citrate hydrochloride

525

81

178

Cinchocaine (INN) and its salts

120

129

179

Cincophen (INN), its salts and derivatives and salts of those derivatives

539

8

180

Claviceps purpurea Tul., its alkaloids and galenical preparations

296

98

181

Clofenamide (INN)

154

85

182

Clofenotane (INN)

213, 676

123

183

Cobalt benzenesulphonate

—

101

184

Cocculin

551

282

185

Colchicine, its salts and derivatives

—

102

186

Colchicoside and its derivatives

—

103

187

Colchicum autumnale L. and its galenical preparations

—

104

188

Colouring agent CI 12140

—

378

189

Colouring agent CI 26105

—

379

190

Colouring agents CI 42555, 42555–1 and 42555–2

—

380

191

Coniferyl benzoate (except natural content of essences)

84

357

192

Coniine

574

290

193

Conium maculatum L. (fruit, powder, galenical preparations)

—

99

194

Convallatoxin

—

105

195

Coumetarol (INN)

427

225

196

Crimidine (ISO)

152, 157

83

197

Croton tiglium(oil)

—

107

198

Curare and curarine

—

109

199

Curarizants, synthetic

—

110

200

Cyanides

363, 365

111

201

1-(3-Cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylic acid ethyl ester hydrochloride

277

80

202

Cyclarbamate (INN)

210

122

203

Cyclizine (INN) and its salts

282

159

204

Cyclobarbitone and its salts

(68)

220

205

Cyclocoumarol

245

234

206

2-α-Cyclohexylbenzyl(N,N,N',N'-tetraethyl)trimethylenediamine

517

112

207

2-Cyclohexyl-3,5-dimethylphenol and its salts

209

113

208

1-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea

340

100

209

Cyclomenol (INN) and its salts

207

113

210

Cyclopentane-1,1-dimethanol dicarbanilate

202

122

211

Cyclophosphamide (INN) and its salts

99, 102

88

212

Datura stramonium L. and its galenical preparations

601

301

213

DDT (ISO) (p,p'-DDT)

182, 676

123

214

Deanol aceglumate (INN)

256

3

215

Decamethonium bromide (INN)

216

214

216

Decamethylenebis(trimethylammonium) salts

215

214

217

Dextromethorphan (INN) and its salts

430

226

218

Dextropropoxyphene (INN)

260

116

219

O,O'-Diacetyl-N-allyl—N-normorphine

—

117

220

1,2-Diaminobenzene and its salts

533

363

221

p,p'-Diaminodiphenyl

79

26

222

1,4:3,6-Dianhydrosorbitol 2,5-dinitrate

395

148

223

5-(α, β-Dibromophenethyl)-5-methylhydantoin

—

119

224

Dibromosalicylanilides

225, 416

351

225

Dibromsalan (INN)

(224)

351

226

Dichloroethanes

306, 309

125

227

Dichloroethylenes

7, 702

126

228

2,3-Dichloro-2-methylbutane

46

36

229

Dichlorosalicylanilides

—

349

230

Dicoumarin

231, 440

231

231

Dicoumarol (INN)

230, 440

231

232

2-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide

560

137

233

1-[4-(β-Diethylaminoethoxy)phenyl]-1-(4-tolyl)-2-(4-chlorophenyl)-ethanol

691

92

234

2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts

27, 95

23

235

2-Diethylaminoethyl benzilate and its salts

71

157

236

2-Diethylaminoethyl 4-ethoxybenzoate and its salts

383, 500

179

237

2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts

—

128

238

2-Diethylaminoethyl α-phenyl-α-(N-piperidino)acetate

97

287

239

3-Diethylaminopropyl cinnamate

—

130

240

Diethyl 4-nitrophenyl phosphate

498

170

241

O,O-DiethylO-4-nitrophenyl phosphorothioate

499

131

242

Difencloxazine (INN)

529

270

243

Digitaline and all heterosides ofDigitalis purpurea L.

—

134

244

4,5-Dihydrobenzimidazol-4-one

82, 83

48

245

3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H, 5H-pyrano [3,2—c]-[1]-benzopyran-5-one

205

234

246

Dihydrotachysterol (INN)

—

342

247

2,2'-Dihydroxy-3,3',5,5'6,6'-hexachlorodiphenylmethane (hexachlorophene)

351

371

248

3,4-Dihydroxy-α-(isopropylaminomethyl)benzyl alcohol

391, 394

17

249

3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol

14, 294

14

250

4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin

—

207

251

1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol

274

136

252

5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite

385

361

253

Dimethoxane

265

368

254

4-[β-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts

411

141

255

Dimethylamine

—

142

256

2-DimethylaminoethylN-acetylglutamate

214

3

257

2-[α-(2-Dimethylaminoethoxy)-α-methylbenzyl]pyridine and its salts

290

176

258

2-Dimethylaminoethylp-butylaminobenzoate and its salts

634

63

259

2-[(2-Dimethylaminoethyl)-2-thienylamino]pyridine and its salts

421

144

260

(+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane

218

116

261

1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts

50

50

262

2-Dimethylaminopropiophenone and its salts

418

145

263

3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts

42

146

264

N,N-Dimethyldiguanide and its salts

420

147

265

2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)

253

368

266

Dimethylformamide

—

355

267

1,3-Dimethylpentylamine and its salts

36, 442

30

268

1,2-Dimethyl-4-phenyl-4-carbmethoxyhexamethyleneimine and its salts

422

174

269

1,3-Dimethyl-4-phenyl-4-carboxyethylhexamethyleneimine and its salts

419

171

270

Dimethyl sulphoxide (INN)

—

338

271

Dimevamide (INN) and its salts

278

153

272

Dinitrophenol isomers

—

151

273

Dioxane

—

343

274

Dioxethedrin (INN) and its salts

251

136

275

2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts

452

133

276

Diphenhydramine (INN) and its salts

78

339

277

Diphenoxylate hydrochloride (INNM)

201

80

278

2,2-Diphenyl-4-dimethylamino-valeramide and its salts

271

153

279

5,5-Diphenyl-4-imidazolidone

—

160

280

4-Diphenylmethoxy-1-methylpiperidine and its salts

286

154

281

3-Diphenylmethoxytropane and its salts

75

158

282

1-Diphenylmethyl-4-methylpiperazine

203

159

283

1,2-Diphenyl-4-(2-phenylsulphinylethyl)pyrazolidine-3,5-dione

608

155

284

α,α-Diphenyl-2-piperidinemethanol

559

285

285

α,α-Diphenyl-4-piperidinemethanol

65

286

286

Diphenylpyraline (INN) and its salts

280

154

287

2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone

382

152

288

4-Dipropylsulphamylbenzoic acid

565

161

289

Disulfiram (INN)

645, 656

162

290

Doxylamine (INN) and its salts

257

176

291

Emetine, its salts and derivatives

—

163

292

Endrin (ISO)

349

196

293

Ephedrine and its salts

—

164

294

Epinephrine (INN)

14, 249

14

295

Ergocalciferol (INN)

(703)

335

296

Ergot, its alkaloids and galenical preparations

180

98

297

Eserine and its salts

548

166

298

Ethionamide (INN)

310

319

299

Ethoheptazine (INN) and its salts

446

173

300

Ethopropazine and its salts

(521)

320

301

4-Ethoxyphenol

(366, 456)

178

302

2-Ethylamino-5-phenyloxazolin-4-one

319

180

303

Ethyl bis(4-hydroxycoumarinyl)-acetate and salts of the acid

304

204

304

Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid

303

204

305

Ethyl chloride

155

96

306

Ethylene dichloride

(226)

125

307

Ethylene oxide

—

182

308

2-Ethyl-2,3-epoxyhexamide and its derivatives

493

165

309

Ethylidene chloride

(226)

125

310

3-Ethylisothionicotinamide

298

319

311

β-Ethyl-β-methylglutarimide and its salts

70, 312

183

312

4-Ethyl-4-methylpiperidine-2,6-dione and its salts

70, 311

183

313

β-Ethyl-β-methylvaleramide

698

184

314

Ethylphenacemide (INN)

528

272

315

2-Ethyl-2-phenylglutarimide and its salts

316, 338

181

316

3-Ethyl-3-phenylpiperidine-2,6-dione and its salts

315, 338

181

317

3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone

9

362

318

Fenadiazole (INN)

374

208

319

Fenozolone (INN)

302

180

320

Fenyramidol (INN)

538, 541

274

321

Fluanisone (INN)

326

187

322

Fluoresone (INN)

325

189

323

4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro—m-tolyl)piperidino]-butyrophenone

685

188

324

6-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione

497

186

325

p-Fluorophenylethylsulphone

322

189

326

1-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]-butan-1-one

321

187

327

5-Fluoropyrimidine-2,4-dione

328

190

328

Fluorouracil (INN)

327

190

329

Fluphenazine (INN)

(521)

320

330

Furazolidone (INN)

479

252

331

Furfuryltrimethylammonium salts

334

192

332

Furo[3,2—g]chromen-7-one and its alkyl-substituted derivatives (except natural content of essences)

333, 434, 690

358

333

Furocoumarin and its alkyl-substituted derivatives (except natural content of essences)

332, 434, 690

358

334

Furtrethonium iodide (INN)

331

192

335

Galantamine (INN)

—

193

336

Gallamine triethiodide (INN)

693

329

337

Glucocorticoids

94

300

338

Glutethimide (INN) and its salts

315, 316

181

339

Glycerol trinitrate

480, 571

253

340

Glycyclamide (INN)

208

100

341

Gold salts

—

296

342

Guaifenesin (INN)

432

230

343

Guanethidine (INN) and its salts

344

259

344

N-(2-Guanidinoethyl)heptamethyleneimine and its salts

343

259

345

Haloperidol (INN)

160

185

346

HCH (ISO) (gamma-HCH)

96, 348, 401

195

347

HETP

353

316

348

1,2,3,4,5,6-Hexachlorocyclohexane

96, 346, 401

195

349

(1R, 4S, 5R, 8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethanonaphthalene

292

196

350

Hexachloroethane

—

197

351

Hexachlorophene (INN)

247

371

352

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene

388

198

353

Hexaethyl tetraphosphate

347

316

354

(1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride

131

70

355

(3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho-[1,2-b]furan-2,8-dione

587

217

356

Hexamethonium bromide (INN)

(357)

124

357

N,N'-Hexamethylenebis(trimethylammonium) salts

356

124

358

Hexapropymate (INN)

575

115

359

Hydrastine, hydrastinine and their salts

—

199

360

Hydrazides and their salts

—

200

361

Hydrazine, its derivatives and their salts

—

201

362

2-Hydrazino-octane and its salts

487

202

363

Hydrocyanic acid and its salts

200, 365

111

364

Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2)

—

191

365

Hydrogen cyanide and its salts

200, 363

111

366

Hydroquinone monobenzyl, monoethyl and monomethyl ethers

91, 301, 431, (456)

178

367

7-[2-Hydroxy-3-(2-hydroxyethyl—N-methylamino)propyl]theophylline

706

135

368

[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts

686

5

369

3-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts

659

9

370

1-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt

593

114

371

8-Hydroxy-5(or 6)-nitroquinoline and its salts

482

209

372

4-Hydroxy-3-(3-oxo-1-phenylbutyl)-coumarin and its salts

2, 704

203

373

1-(4-Hydroxy-β-phenylethyl)-4-phenyl-4-carbethoxypiperidine and its salts

495

172

374

2-(4-Hydroxyphenyl-1,3,4-oxadiazole

318

208

375

1-Hydroxy-2,4,6-trinitrobenzene

550, 689

268

376

Hydroxyzine (INN)

159

240

377

Hyoscine, its salts and derivatives

590

295

378

Hyoscyamine, its salts and derivatives

—

210

379

Hyoscyamus niger L(leaves, seeds powder and galenical preparations)

—

211

380

2-Imino-5-phenyloxazolidin-4-one and its salts

502

212

381

Imperatorin

437

34

382

Inproquone (INN)

287

152

383

Intracaine and its salts

236, 500

179

384

Iodine

—

213

385

Iodothymol

252

361

386

Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)

—

215

387

Isocarboxazid (INN)

88

52

388

Isodrin

352

198

389

Isometheptene (INN) and its salts

435

228

390

2-Isooctylamine and its salts

35, 489

28

391

Isoprenaline (INN)

248, 394

17

392

Isopropamide iodide (INN)

135

156

393

(2-Isopropylpent-4-enoyl)urea

59

216

394

Isoproterenol

248, 391

17

395

Isosorbide dinitrate (INN)

222

148

396

Juniperus sabina L. (leaves, essential oil and galenical preparations)

—

294

397

Laurel oil

398

359

398

Laurus nobilis L. (oil from seeds)

397

359

399

Lead and its compounds (except lead acetate)

—

289

400

Levophacetoperane and its salts

556

284

401

Lindane

96, 346, 348

195

402

Lobelia inflata L. and its galenical preparations

—

218

403

Lobeline (INN) and its salts

105

219

404

LSD

406, 407

127

405

Lupinidine and its salts

598

299

406

Lysergic acid diethylamide and its salts

404, 407

127

407

Lysergide (INN) and its salts

404, 406

127

408

Malononitrile

—

149

409

Mannomustine (INN) and its salts

98

89

410

Mecamylamine (INN)

644

229

411

Mefeclorazine (INN) and its salts

254

141

412

Mephenesin (INN) and its esters

664

322

413

Meprobamate (INN)

450

236

414

Mercury and its compounds (except those listed in Part III of Schedule 2 or in Part I of Schedule 4)

—

221

415

Mescaline and its salts

687

222

416

Metabromsalan (INN)

(224)

351

417

Metaldehyde

562

223

418

Metamfepramone (INN) and its salts

262

145

419

Metethoheptazine (INN) and its salts

269

171

420

Metformin (INN) and its salts

264

147

421

Methapyrilene (INN) and its salts

259

144

422

Metheptazine (INN) and its salts

268

174

423

Methocarbamol (INN)

433

205

424

Methohexitone and its salts

(68)

220

425

Methotrexate (INN)

34

6

426

2-[4-Methoxybenzyl—N-(2-pyridyl)amino]ethyldimethylamine maleate

580

346

427

1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane

195

225

428

1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole-CI 76050)

—

376

429

1-Methoxy-2,5 diaminobenzene (2,5-diaminoanisole)

—

377

430

(+)-3-Methoxy—N-methylmorphinan and its salts

217

226

431

4-Methoxyphenol

(366, 456)

178

432

3-(4-Methoxyphenoxy)propane-1,2-diol

342

230

433

3-(2-Methoxyphenoxy)propane-1,2-diol 1-carbamate

423

205

434

8-Methoxypsoralen (except natural content of essences)

332, 333, 690

358

435

6-Methylamino-2-methylhept-2-ene and its salts

389

228

436

2-Methyl-1,2-bis(3-pyridyl)-propan-1-one

453

292

437

9-(3-Methylbut-2-enyloxy)furo-[3,2—g]chromen-7-one

381

34

438

2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts

117

90

439

1-Methyl-2,4-diaminobenzene and its salts

447

364

440

3,3-Methylenebis-(4-hydroxycoumarin)

230, 231

231

441

2-Methylheptylamine and its salts

—

227

442

4-Methyl-2-hexylamine and its salts

36, 267

30

443

N,N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts

66

121

444

1-Methyl-2-mercaptoimidazole

650

233

445

Methylphenidate (INN) and its salts

535

175

446

1-Methyl-4-phenyl-4-carbethoxyhexamethyleneimine and its salts

299

173

447

4-Methyl—m-phenylenediamine and its salts

439

364

448

3-Methyl-2-phenylmorpholine, its derivatives and salts

519

232

449

2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane

141

235

450

2-Methyl-2-propylpropane-1,3-diol dicarbamate

413

236

451

N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester

60

238

452

Methyprylon (INN) and its salts

275

133

453

Metyrapone (INN)

436

292

454

Minoxidil (INN), its salts and derivatives

558

372

455

Mofebutazone (INN)

124

64

456

Monobenzone (INN)

91, 301, (366) 431

178

457

Morpholine and its salts

—

344

458

Mustine and its salts

100, 148

87

459

MustineN-oxide and its salts

101

86

460

Nalorphine (INN), its salts and ethers

21

20

461

Naphazoline (INN) and its salts

467

244

462

2-Naphthol

463

241

463

β-Naphthol

462

241

464

1-and 2-Naphthylamines and their salts

465

242

465

α-and β-Naphthylamines and their salts

464

242

466

3-(1-Naphthyl)-4-hydroxycoumarin

—

243

467

2-(1-Naphthylmethyl)imidazoline and its salts

461

244

468

Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs 1961 (Treaty Series No. 34(1965), Cmnd. 2631)

—

306

469

Narcotine and its salts

485

258

470

Neodymium and its salts

—

309

471

Neostigmine and its salts

—

245

472

Nicotine and its salts

—

246

473

Nitrites, inorganic (except sodium nitrite)

—

248

474

Nitrobenzene

—

249

475

Nitrocresols and their alkali metal salts

—

250

476

Nitroderivatives of carbazole

136

72

477

Nitrofurantoin (INN)

478

251

478

N-(5-Nitro-2-furfurylidene)-1-aminohydantoin

477

251

479

3-(5-Nitrofurfurylideneamino)-oxazolidin-2-one

330

252

480

Nitroglycerine

339, 571

253

481

Nitrostilbenes, their homologues and derivatives

—

256

482

Nitroxoline (INN) and its salts

371

209

483

Noradrenaline and its salts

33, 484

257

484

Norepinephrine and its salts

33, 483

257

485

Noscapine (INN) and its salts

469

258

486

Nux vomica and its preparations

605

305

487

Octamoxin (INN) and its salts

362

202

488

Octamylamine (INN) and its salts

510

267

489

Octodrine (INN) and its salts

35, 390

28

490

Oestrogens

—

260

491

Oleandrin

—

261

492

[Oxalylbis(iminoethylene)]bis-[(o-chlorobenzyl)diethylammonium] salts

24

132

493

Oxanamide (INN) and its derivatives

308

165

494

2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo-[a]quinolizine and its salts

632

139

495

Oxpheneridine (INN) and its salts

373

172

496

Padimate A

47

381

497

Paramethasone (INN)

324

186

498

Paraoxon

240

170

499

Parathion (ISO)

241

131

500

Parethoxycaine (INN) and its salts

236, 383

179

501

Pelletierine and its salts

557

263

502

Pemoline (INN) and its salts

380

212

503

Pentachloroethane

—

264

504

Pentaerythritol chloral

514

266

505

Pentaerythritol tetranitrate

506, 513

265

506

Pentaerythrityl tetranitrate (INN)

505, 513

265

507

Pentamethonium bromide (INN)

508

120

508

N,N'-Pentamethylenebis-(trimethylammonium) salts

507

120

509

Pentobarbitone and its salts

68

220

510

Pentylaminomethylheptane, its isomers and salts

488

267

511

Perchloroethylene

636

314

512

Perphenazine (INN) and its salts

(521)

320

513

PETN

505, 506

265

514

Petrichloral (INN)

504

266

515

Phenacemide (INN)

524

269

516

Phenaglycodol (INN)

161

95

517

Phenetamine

206

112

518

Phenindone (INN)

534

271

519

Phenmetrazine (INN), its derivatives and salts

448

232

520

Phenobarbitone and its salts

(68)

220

521

Phenothiazine (INN) and its compounds

various

320

522

Phenprobamate (INN)

536

71

523

Phenprocoumon (INN)

537

273

524

N-Phenylacetylurea

515

269

525

4-Phenylazophenylene-1,3-diamine citrate hydrochloride

177

81

526

Phenylbutazone (INN)

123

67

527

4-Phenylbut-3-en-2-one

89

356

528

N-(2-Phenylbutyryl)urea

314

272

529

N-[2-(α-Phenyl—p-chlorobenzyl)-ethyl]morpholine

242

270

530

1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts

134

169

531

2-Phenylcyclopropylamine (trans-form) and its salts

665, 666

324

532

1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one

576

138

533

o-Phenylenediamine and its salts

220

363

534

2-Phenylindan-1,3-dione

518

271

535

α-Phenyl-2-piperidineacetic acid methyl ester and its salts

445

175

536

1-Phenylpropan-1-ol carbamate

522

71

537

3-(α-Phenylpropyl)-4-hydroxycoumarin

523

273

538

1-Phenyl-2-(2-pyridylamino)ethanol

320, 541

274

539

2-Phenylquinoline-4-carboxylic acid, its saltsand derivatives and salts of those derivatives

179

8

540

6-Phenyl-2,4,7-triaminopteridine and its salts

669

275

541

Phenyramidol

320, 538

274

542

Phosphides, metal

543

279

543

Phosphorus

542

279

544

4-Phosphoryloxy—N,N-dimethyl-tryptamine

578

278

545

3-Phthalimidopiperidine-2,6-dione and its salts

647

280

546

Phthalylsulphathiazole (INN) and its salts

(622)

307

547

Physostigma venenosum Balf.

129

281

548

Physostigmine and its salts

297

166

549

Phytolacca Spp and their preparations

—

374

550

Picric acid

375, 689

268

551

Picrotoxin

184

282

552

Pilocarpine and its salts

—

283

553

Pilocarpus jaborandi Holmes and its galenical preparations

—

311

554

Pipazetate (INN) and its salts

555

118

555

2-(2-Piperidinoethoxy)ethyl-10-thia-1,9-diazaanthracene-9-carboxylate and its salts

554

118

556

α-Piperidin-2-ylbenzyl acetate, laevorotatorythreo-form

400

284

557

β-(2-Piperidyl)propionaldehyde and its salts

501

263

558

6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts and derivatives

454

372

559

Pipradrol (INN) and its salts

284

285

560

Piprocurarium iodide (INN)

232

137

561

Poldine metilsulfate (INN) (or methylsulphate)

81

239

562

Polyacetaldehyde

417

223

563

Potassium nitroferricyanide

15, 564, 594–5

255

564

Potassium nitroprusside

15, 563, 594–5

255

565

Probenecid (INN)

288

161

566

Procainamide (INN), its salts and derivatives

30

25

567

Prochlorperazine (INN) and its salts

(521)

320

568

Progestogens (except progesterone and ethisterone)

—

194

569

Promazine (INN) and its salts

(521)

320

570

Promethazine (INN) and its salts

(521)

320

571

Propane-1,2,3-triyl trinitrate

339, 480

253

572

Propatylnitrate (INN)

104

206

573

1-Propyl-3-(4-chlorobenzene-sulphonyl)urea

169

79

574

2-Propylpiperidine

192

290

575

1-(2-Propynyl)cyclohexyl carbamate

358

115

576

Propyphenazone (INN)

532

138

577

Prunus laurocerasus L.

145

291

578

Psilocybine (INN)

544

278

579

Pyrethrum album L. and its galenical preparations

—

345

580

Pyrianisamine maleate

426

346

581

Pyribenzamine

92, 692

347

582

Pyrithione sodium (INNM)

—

369

583

Quinalbarbitone and its salts

(68)

220

584

Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and of which the concentration complies with Council Directive No. 76/579/Euratom19)

—

293

585

Rauwolfia serpentina alkaloids and their salts

586

15

586

Reserpine (INN) and its salts

(585)

15

587

α-Santonin

355

217

588

Safrole (except natural content of essences in cases where the concentration of such safrole in the cosmetic product does not exceed–

  1. (a)

    in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 ppm; or

  2. (b)

    in the case of products other than oral hygiene or dental products, 100 ppm.)

—

360

589

Schoenocaulon officinale Lind.(seeds and galenical preparations)

—

332

590

Scopolamine, its salts and derivatives

377

295

591

Secbutobarbitone and its salts

(68)

220

592

Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2

—

297

593

Sodium hexacyclonate (INN)

370

114

594

Sodium nitroferricyanide

15, 563, 564, 595

255

595

Sodium nitroprusside

15, 563, 564,594

255

596

Solanum nigrum L. and its galenical preparations

—

298

597

Spanish Fly

130

69

598

Sparteine (INN) and its salts

405

299

599

Spironolactone (INN)

10

4

600

Squill and its preparations

696

330

601

Stramonium and its preparations

212

301

602

Strophanthines and their aglucones and their respective derivatives

—

302

603

Strophanthus species and their galenical preparations

—

303

604

Strychnine and its salts

—

304

605

Strychnos species and their galenical preparations

486

305

606

Succinonitrile

—

150

607

Succinylsulphathiazole and its salts

(622)

307

608

Sulfinpyrazone (INN)

283

155

609

Sulphacetamide and its salts

(622)

307

610

Sulphadiazine and its salts

(622)

307

611

Sulphadimethoxine and its salts

(622)

307

612

Sulphadimidine and its salts

(622)

307

613

Sulphafurazole and its salts

(622)

307

614

Sulphaguanidine and its salts

(622)

307

615

Sulphamethizole and its salts

(622)

307

616

Sulphamethoxazole and its salts

(622)

307

617

Sulphamethoxydiazine and its salts

(622)

307

618

Sulphamethoxypyridazine and its salts

(622)

307

619

Sulphanilamide and its salts

(622)

307

620

Sulphapyridine and its salts

(622)

307

621

Sulphathiazole and its salts

(622)

307

622

Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the —NH2 groups) and their salts

various

307

623

Sulthiame

624, 643

308

624

Sultiame (INN)

623, 643

308

625

Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe

44

21

626

Tefazoline (INN) and its salts

642

237

627

Tellurium and its compounds

—

312

628

TEPP (ISO)

640

276

629

2-(4—tert-Butyl-2,6-dimethylbenzyl)-imidazoline and its salts

708

313

630

4—tert-Butylphenol

—

340

631

4—tert-butylpyrocatechol

—

341

632

Tetrabenazine (INN) and its salts

494

139

633

Tetrabromosalicylanilides

—

350

634

Tetracaine (INN) and its salts

258

63

635

2,3,7,8-Tetrachlorodibenzo—p-dioxin

—

367

636

Tetrachloroethylene

511

314

637

Tetrachloromethane

138

315

638

Tetrachlorosalicylanilides

—

348

639

Tetraethylammonium bromide

646

61

640

Tetraethyl pyrophosphate

628

276

641

5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-dihydric alcohol and its salts

58

42

642

2-(5,6,7,8-Tetrahydro-1-methyl-2-naphthyl)-2-imidazoline and its salts

626

237

643

4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamideS,S-dioxide

623, 624

308

644

N,2,3,3-Tetramethyl-2-norcamphanamine

410

229

645

Tetramethylthiuam disulphide

289, 656

162

646

Tetrylammonium bromide (INN)

639

61

647

Thalidomide (INN) and its salts

545

280

648

Thallium and its compounds

—

317

649

Thevetia neriifolia Juss., glycoside extract

—

318

650

Thiamazole (INN)

444

233

651

2,2'-Thiobis(4,6-dichlorophenol)

106

352

652

Thiopentone and its salts

(68)

220

653

Thioridazine (INN) and its salts

(521)

320

654

Thiotepa (INN)

670, 683

310

655

Thiourea and its derivatives (except the one listed in Part I of Schedule 2)

—

321

656

Thiram (ISO)

289, 645

162

657

Thiuram disulphides

—

354

658

Thiuram monosulphides

—

353

659

Thyropropic acid (INN) and its salts

369

9

660

Tolboxane (INN)

663

177

661

Tolbutamide (INN)

125

65

662

Toluidines, their isomers, salts and halogenated and sulphonated derivatives

40

32

663

p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol

660

177

664

3—o-Tolyloxypropane-1,2-diol

412

322

665

trans-2-Phenylcyclopropylamine and its salts

531, 666

324

666

Tranylcypromine (INN) and its salts

531, 665

324

667

Tretamine (INN)

682

328

668

Tretinoin (INN) (retinoic acid and its salts)

—

375

669

Triamterene (INN) and its salts

540

275

670

Triaziridin-1-ylphosphine sulphide

654, 683

310

671

2,2,2-Tribromoethanol

672

326

672

Tribromoethyl alcohol

671

326

673

3,4,5-Tribromosalicylanilide (Tribromsalan)

—

373

674

Trichlormethine (INN) and its salts

678

327

675

Trichloroacetic acid

—

10

676

1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane

182, 213

123

677

2,2,2-Trichloroethane-1,1-diol

146

77

678

Tri(β-chloroethyl)amine and its salts

674

327

679

Trichloromethane

156

366

680

N-(Trichloromethylthio)-4-cyclohex-4-ene-1,2-dicarboximide (Captan)

132

370

681

Tricresyl phosphate

694

277

682

2,4,6-Triethyleneimino-1,3,5-triazine

667

328

683

N,N,N-Triethylenethiophosphamide

654, 670

310

684

Trifluoperazine (INN) and its salts

(521)

320

685

Trifluperidol (INN)

323

188

686

3,3',5-Triiodothyroacetic acid and its salts

368

5

687

3,4,5-Trimethoxyphenethylamine and its salts

415

222

688

2-2-6-Trimethyl-4-piperidyl benzoate and its salts

74

51

689

2,4,6-Trinitrophenol

375, 550

268

690

Trioxysalan (INN) (except natural content ofessences)

332, 333, 434

358

691

Triparanol (INN)

233

92

692

Tripelennamine (INN)

92, 581

347

693

1,2,3-Tris(2-triethylammonium-ethoxy)benzene triiodide

336

329

694

Tritolyl phosphate

681

277

695

Tuaminoheptane (INN), its isomers and salts

31

27

696

Urginea scilla Stern. and its galenical preparations

600

330

697

Vaccines, toxins and serums listed in the Annex to Council Directive No.75/319/EEC20

—

323

698

Valnoctamide (INN)

313

184

699

Veratrine, its salts and galenical preparations

—

331

700

Veratrum spp and their preparations

—

333

701

Vinyl chloride monomer

—

334

702

Vinylidene chloride

7, 227

126

703

Vitamins D2 and D3

174, 295

335

704

Warfarin (ISO) and its salts

2,372

203

705

Xanthates

16

336

706

Xanthinol

367

135

707

Xylidines, their isomers, salts and halogenated and sulphonated derivatives

41

33

708

Xylometazoline (INN) and its salts

629

313

709

Yohimbine and its salts

—

337

710

Zoxazolamine (INN)

29

24

SCHEDULE 2LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

Regulations 4(3) and 6(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 except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and 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, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

PART Isubstances listed in annex iii, part i of the directive as substances which cosmetic products must not contain except subject to the restrictions laid down

(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

Boric acid

Talcum powder

5 per cent

Not to be used in products intended for children less than three years old

Not to be used for children under three years of age

Oral hygiene products

0.5 per cent

—

—

Other products

3 per cent

—

—

2

(a) Thioglycollic acid, its salts and esters

Hair waving or straightening products for general use

8 per cent (calculated as thioglycollic acid) ready for use

pH value 7 to 9.5

Contains thioglycollate. Follow the instructions. Keep out of reach of children. For professional use only (where applicable)

Hair waving or straightening products for professional use

11 per cent (calculated as thioglycollic acid) ready for use

pH value 7 to 9.5

Depilatories

5 per cent (calculated as thioglycollic acid) ready for use

pH value 7 to 12.7

Other hair care products which are removed after application

2 per cent (calculated as thioglycollic acid) ready for use

pH value 7 to 9.5

The directions for use drawn up in national or official languages must incorporate the following instructions—Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves (this latter instruction does not apply to Depilatories)

(b) Thioglycollic acid esters

Hair waving or straightening products for general use

8 per cent (calculated as thioglycollic acid) ready for use

pH value 6 to 9.5

Hair waving or straightening products for professional use

11 per cent (calculated as thioglycollic acid) ready for use

pH value 6 to 9.5

The directions for use drawn up in national or official languages must incorporate the following instructions—May cause sensitisation in the event of contact with the skin. Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves

3

Oxalic acid, its esters and alkaline salts

Hair care products

5 per cent

—

For professional use only

4

Ammonia

All purposes and products

6 per cent calculated as NH3

—

Contains ammonia (not required when concentration is not more than 2 per cent)

5

Tosylchloramide Sodium

All purposes and products

0.2 per cent

—

—

6

Chlorates of alkali metals

Toothpaste

5 per cent

—

—

Other uses

3 per cent

—

—

7

Dichloromethane

All purposes and products

35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)

Purity of the dichloromethane must be not less than 99.8 per cent

—

8

m-andp-Phenylenediamines, theirN-substituted derivativesand their salts;N-substituted derivatives ofo-phenylenediamines

Oxidizing colouring agents for hair dyeing for general use

6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains phenylenediamines. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows

Oxidizing colouring agents for hair dyeing for professional use

6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Sensitivity test advisable before use

9

Methylphenylenediamines (other than 4-methyl—m-phenylenediamine and its salts), theirN-substituted derivatives and their salts

Oxidizing colouring agents for hair dyeing for general use

10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains phenylenediamines. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows

Oxidizing colouring agents for hair dyeing for professional use

10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Sensitivity test advisable before use

10

Diaminophenols

Oxidizing colouring agents for hair dyeing for general use

10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains diaminophenols. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows

Oxidizing colouring agents for hair dyeing for professional use

10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

—

Contains diaminophenols. For professional use only. Can cause allergic reaction. Sensitivity test advisable before use

11

Dichlorophen

All purposes and products

0.5 per cent

—

Contains dichlorophen

12

Hydrogen peroxide

Hair care products preparations

12 per cent of H2O2 (40 volumes)

—

Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

Skin hygiene preparations

4 per cent of H2O2

—

Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

Nail hardening preparations

2 per cent of H2O2

—

Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

13

Formaldehyde (See also Part I of Schedule 4)

Nail hardeners

5 per cent

—

Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)

14

Hydroquinone

Oxidizing colouring agent for hair dyeing for general use

2 per cent subject to the provision of “Combination Rule B” set out below

—

Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them

Oxidizing colouring agent for hair dyeing for professional use

2 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them

Agents for localised skin lightener

2 per cent

—

Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12

15

Potassium and sodium hydroxide

Nail cuticle solvent

5 per cent calculated as sodium hydroxide

—

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Hair straightener for general use

2 per cent calculated as sodium hydroxide

—

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Hair straightener for professional use

4.5 per cent calculated as sodium hydroxide

—

For professional use only. Avoid contact with eyes. Can cause blindness

pH adjuster for depilatories

—

pH value not to exceed 12.7

Keep out of reach of children. Avoid contact with eyes

Other uses as pH adjuster

—

pH value not to exceed 11

Keep out of reach of children. Avoid contact with eyes

16

α-Naphthol

Colouring agent for hair dyeing

0.5 per cent

—

Contains α-naphthol

17

Sodium nitrite

Rust inhibitor

0.2 per cent

Do not use with secondary and/or tertiary amines or other substances forming nitrosamines

—

18

Nitromethane

Rust inhibitor

0.3 per cent

—

—

19

Phenol and its alkali salts

Soaps and shampoos

1 per cent calculated as phenol

—

Contains phenol

20

Pyrogallol

Oxidizing colouring agent for hair dyeing for general use

5 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains pyrogallol. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them

Oxidizing colouring agent for hair dyeing for professional use

5 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains pyrogallol. For professional use only. Rinse eyes immediately if product comes into contact with them

21

Quinine and its salts

Shampoos

0.5 per cent calculated as quinine base

—

—

Hair lotions

0.2 per cent calculated as quinine base

—

—

22

Resorcinol

Oxidizing colouring agent for hair dyeing for general use

5 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them

Oxidizing colouring agent for hair dyeing for professional use

5 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them

Hair lotions and shampoos

0.5 per cent subject to the provisions of “Combination Rule B” set out below

—

Contains resorcinol

23

(a) Alkali sulphides

Depilatories

2 per cent calculated as sulphur

pH value not to exceed 12.7

Keep out of reach of children. Avoid contact with eyes

(b) Alkaline earth sulphides

Depilatories

6 per cent calculated as sulphur

pH value not to exceed 12.7

Keep out of reach of children. Avoid contact with eyes

24

Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate

All purposes and products

1 per cent calculated as zinc

—

—

25

Zinc 4-hydroxybenzenesulphonate

Deodorants, antiperspirants and astringent lotions

6 per cent calculated as percentage of anhydrous substance

—

Avoid contact with eyes

26

Ammonium monofluorophosphate

Oral hygiene products

0.15 per cent calculated as fluorine. When mixed with other fluorine compounds total fluorine concentration must not exceed 0.15 per cent

—

Contains ammonium monofluorophosphate

27

Sodium monofluorophosphate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains sodium monofluorophosphate

28

Potassium monofluorophosphate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains potassium monofluorophosphate

29

Calcium monofluorophosphate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains calcium monofluorophosphate

30

Calcium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains calcium fluoride

31

Sodium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains sodium fluoride

32

Potassium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains potassium fluoride

33

Ammonium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains ammonium fluoride

34

Aluminium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains aluminium fluoride

35

Stannous fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains stannous fluoride

36

Hexadecyl ammonium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains hexadecyl ammonium fluoride

37

3-(n-Hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride

38

NN'N'-Tris(polyoxyethylene)—N-hexadecylpropylenediamine dihydrofluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

ContainsNN'N'-tris(polyoxyethylene)—N-hexadecylpropylenediamine dihydrofluoride

39

Octadecenyl ammonium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains octadecenyl ammonium fluoride

40

Sodium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains sodium fluorosilicate

41

Potassium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains potassium fluorosilicate

42

Ammonium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains ammonium fluorosilicate

43

Magnesium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains magnesium fluorosilicate

44

1,3-Bis(hydroxymethyl)-imidazolidene-2-thione

Hair care preparations

2 per cent

Not to be used in aerosol dispensers

Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione

Nail care preparations

2 per cent

pH as applied value must be less than 4

Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione

45

Benzyl alcohol (See also Part I of Schedule 4)

Solvent, perfumes and flavourings

—

—

—

46

6-Methylcoumarin

Oral hygiene products

0.003 per cent

—

—

47

Nicomethanol hydrofluoride

Oral hygiene products

As for ammonium monofluorophosphate

—

Contains nicomethanol hydrofluoride

48

Silver nitrate

Products to dye eyelashes or eyebrows

4 per cent

—

Contains silver nitrate. Rinse eyes immediately if product comes into contact with them

49

Selenium disulphide

Anti-dandruff shampoos

1 per cent

—

Contains selenium disulphide. Avoid contact with eyes or damaged skin

50

Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yCLz 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 betweeen 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

51

Quinolin-8-ol and bis(8-hydroxy-quinolinium sulphate) (See also Part II of this Schedule)

Stabilizer for hydrogen peroxide in rinse-off hair care preparations

0.3 per cent calculated as base

—

—

Stabilizer for hydrogen peroxide in non-rinse-off hair care preparations

0.03 per cent calculated as base

—

—

52

Methanol

Denaturant for ethanol and isopropyl alcohol

5 per cent calculated as a percentage of ethanol and isopropyl alcohol

—

—

53

Etidronic acid and its salts (1-hydroxy-ethylidene-diphosphonic acid and its salts)

Hair care

1.5 per cent expressed as etidronic acid

—

—

Soap

0.2 per cent expressed as etidronic acid

—

—

54

1-Phenoxypropan-2-ol (See also Part I of Schedule 4)

Products rinsed off after use. Prohibited in oral hygiene products

2 per cent

—

—

Combination Rules

  1. A.

    Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1.

  2. B.

    Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.

  3. C.

    The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.

PART IIsubstances listed in annex iii, part 2 (formerly annex iv, part i) of the directive21 as substances provisionally allowed

(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 use until

1

Quinolin-8-ol and bis(8 hydroxy-quinolium)-sulphate (See also Part I of this Schedule)

Skin hygiene products not rinsed off after use

0.02 per cent calculated as base

—

Contains Quinolin-8-ol

31.12.1990

Foot hygiene products not rinsed off after use

0.04 per cent calculated as base

—

Mouth hygiene products

0.01 per cent calculated as base

—

2

1,1,1-Trichloroethane (methyl chloroform)

Aerosol Spray

35 per cent (and when mixed with dichloromethane total concentration must not exceed 35 per cent)

—

Do not spray on a naked flame or any incandescent material

31.12.1989

3

ENTRY DELETED

—

—

—

—

—

4

2,2'-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate

Rinsed-off hair care products

1 per cent

—

—

31.12.1989

5

ENTRY DELETED

PART IIIsubstances excluded from the scope of the directive (mentioned in annex v)

(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

Lead acetate

Hair care products

3 per cent

—

Contains lead acetate. Wash hands after use. Do not use on broken or abraded skin. Keep out of reach of children

2

Thiomersal and phenylmercuric compounds

To preserve concentrated shampoos and hair creams which contain non-ionic emulsifiers which render other preservatives ineffective

0.003 per cent calculated as mercury. When mixed with other mercury compounds the total mercury concentration must not exceed 0.007 per cent

—

—

SCHEDULE 3LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR

Regulation 4(4)

In this Schedule the colouring agents referred to in regulation 4(4)(a) are–

(i)

those identified in column 1 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 Directive.

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 matter22, as amended,23 and adapted24 must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter “E” has been deleted therefrom.

PART Icolouring agents listed in annex iv part 1 (formerly annex iii part 2) of the directive25 as colouring agents which cosmetic products must not contain except subject to the restrictions laid down

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows–

  • Sub-column 1=Colouring agents allowed in all cosmetic products;

  • Sub-column 2=Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

  • Sub-column 3=Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

  • Sub-column 4=Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1)

(2)

(3)

(4)

Type of product

Field of application

Name or colour index number

Colour

1

2

3

4

Other requirements

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

13015

Yellow

X

E 105

13065(1)1000

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

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

21100

Yellow

X

Maximum 3,3'-dichlorobenzidine concentration in the colouring agent: 5 ppm

21108

Yellow

X

Maximum 3,3'dichlorobenzidine concentration in the colouring agent: 5 ppm

21230

Yellow

X

24790

Red

X

27290*

Red

X

27755

Black

X

E152

28440

Black

X

E151

40215

Orange

X

40800

Orange

X

40820

Orange

X

E 160e

40825

Orange

X

E 160f

40850

Orange

X

E 161g

42045

Blue

X

See also Part II

42051*

Blue

X

E 131

42053

Green

X

42080

Blue

X

42090

Blue

X

42100

Green

X

42170

Green

X

42510

Violet

X

42520

Violet

X

5 ppm maximum concentration in the finished product

42640

Violet

X

42735

Blue

X

44045

Blue

X

See also Part II

44090

Green

X

E 142

45100

Red

X

45170*

Red

X

45170:1

Red

X

45190

Violet

X

45220

Red

X

45350

Yellow

X

6 per cent maximum 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, thecolouring 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

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 II

73915

Red

X

74100

Blue

X

74160

Blue

X

74180

Blue

X

See also Part II

74260

Green

X

75100

Yellow

X

75120

Orange

X

E 160b

75125

Yellow

X

E 160d

75130

Orange

X

E 160a

75135

Yellow

X

E 161d

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

Acid red 195

Red

X

Aluminium, Zinc, magnesium and calcium stearates

White

X

Anthocyanins

Red

X

E 163

Beetroot red

Red

X

E 162

Bromocresol green

Green

X

Bromothymol blue

Blue

X

Caramel

Brown

X

E 150

Capsanthin capsorubin

Orange

X

E 160c

Lactoflavin

Yellow

X

E 101

1000

Note: (1) This entry is deleted with effect from the dates specified in regulation 1(3). Until then the corresponding entry in Part I of Schedule 3 to S.I. 1984/1260 (substituted by Schedule 3 to S.I. 1987/1920) continues in force.

PART IIcolouring agents listed in annex iv part 2 of the directive26 as colouring agents which cosmetic products must not contain except subject to the restrictions laid down and where cosmetic product supplied before a certain date

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows–

  • Sub-column 1=Colouring agents allowed in all cosmetic products;

  • Sub-column 2=Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

  • Sub-column 3=Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

  • Sub-column 4=Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1)

(2)

(3)

(4)

(5)

Type of product

Field of application

Name or colour index number

Colour

1

2

3

4

Other requirements

Cosmetic product supplied until

13065

Yellow

X

31.12.1989

15800(1)1001

19120(1)1001

20470(1)1001

21110

Orange

X

Maximum 3,3-dichlorobenzidine concentration in the colouring agent: 5 ppm

31.12.1989

21115(1)1001

26100

Red

X

31.12.1989

42045

Blue

X

See also Part I

31.12.1989

42170(1)1001

42535

Violet

X

Solely in hair preparations at a maximum concentration of 100 ppm

31.12.1989

44045

Blue

X

See also Part I

31.12.1989

45190(1)1001

47000(1)1001

61554

Blue

X

Only in hair-care preparations in a maximum concentration of 50 ppm

31.12.1989

73900

Violet

X

See also Part I

31.12.1989

73905(1)1001

74180

Blue

X

See also Part I

31.12.1989

75660(1)1001

1001

Note: (1) This entry is deleted with effect from the dates specified in regulation 1(4). Until then the corresponding entry in Part II of Schedule 3 to S.I. 1984/1260 (substituted by Schedule 3 to S.I. 1987/1920) continues in force.

SCHEDULE 4LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

Regulations 4(5) and 6(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.

(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 (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

For oral hygiene

0.1 per cent (concentrations expressed as free formaldehyde)

Not to be used in aerosol dispensers (sprays)

—

Except for oral hygiene (see also Part I of Schedule 2)

0.2 per cent (concentrations expressed as free formaldehyde)

6

Hexachlorophene (INN) (1)1002

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 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

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

—

—

19

Hexetidine (INN)

Products rised 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 formation of nitrosamines

—

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(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (“Imidazolidinyl urea”)

All products

0.3 per cent A

—

—

28

Poly(1-hexamethylene-biguanide 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-1-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 (See also Part I of Schedule 2)

All products

1.0 per cent A

—

—

35

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt

Products rinsed off after use

1.0 per cent A

—

—

For other products

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

0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol,3(2H)-one and 2-methylisothiazol-3(2H)-one

—

—

40

2-Benzyl-4-chlorophenol (Chlorophene)

All products

0.2 per cent

—

—

41

2-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 (see also Part I, of Schedule 2)

Products rinsed off after use

1.0 per cent

—

—

1002

Note: (1) This entry is deleted with effect from the dates specified in regulation 1(2). Until then the corresponding entry in Part I of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continues in force.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

Reference Number in Annex VI Part 2 of the Directive

Name of substance

Purpose of substance or type of product

Maximum concentration of substance in product

Other requirements

Required information

Preservative supplied until

1

ENTRY DELETED (2)1004

2

Chlorphenesin (INN) (see note (1))1003

All products

0.3 per cent

—

—

31.12.1989

3

ENTRY DELETED (2)1004

4

Alkyl (C12–C22) trimethylammonium bromide and chloride (including Cetrimonium bromide (INN))

All products

0.1 per cent A

—

—

31.12.1989

5

ENTRY DELETED (2)1004

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 to 14

ENTRIES DELETED (2)1004

15

Benzethonium chloride (INN)

Not to be used in products intended to come into contact with mucous membranes

0.1 per cent A

—

—

31.12.1989

16

Benzalkonium chloride (INN) bromide and saccharinate

All products

0.25 per cent A

—

—

31.12.1989

17

1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea

All products

0.5 per cent

—

—

31.12.1989

18 to 19

ENTRY DELETED (2)1004

20

Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate)

All products

0.1 per cent A

—

—

31.12.1989

21

Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol)

All products

0.2 per cent

—

—

31.12.1989

22 to 25

ENTRIES DELETED (2)1004

26

Glutaraldehyde

Prohibited in aerosols (sprays)

0.1 per cent

Contains glutaraldehyde where the glutaraldehyde concentration in the finished product exceeds 0.05 per cent

—

31.12.1991

1004
  1. (1)

    Certain entries are deleted with effect from the dates specified in regulation 1(3) or (4). Until then the corresponding entries relating to the substances in question where appropriate in Part II of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continue in force.

1003

Notes:

  1. (1)

    Prior to the coming into force of article 1(7) to Directive 88/233/EEC Chlorophensin (INN) item 2 above is permitted to be used up to a maximum concentration figure of 0.5 per cent.

SCHEDULE 5LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

Regulations 4(6) and 6(1)

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.

PART Iuv filters listed in annex vii, part i, of the directive29 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

5 per cent

—

—

2

N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate

6 per cent

—

—

3

Homosalate (INN)

10 per cent

—

—

4

Oxybenzone (INN)

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

3-Imidazol-4-ylacrylic acid and its ethyl ester

2 per cent (expressed as acid)

—

—

6

2-Phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts

8 per cent (expressed as acid)

—

—

PART IIuv filters listed in annex vii, part 2 of the directive30 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

1

N-Propoxylated ethyl 4—bis aminobenzoate, mixed isomers

5 per cent

—

—

31.12.1991

2

Ethoxylated ethyl 4-aminobenzoate

10 per cent

—

—

31.12.1991

3

ENTRY DELETED

4

Glycerol 1-(4-aminobenzoate)

5 per cent

Must not contain any benzocaine (INN)

—

31.12.1991

5

2-Ethylhexyl 4-dimethylaminobenzoate

8 per cent

—

—

31.12.1991

6

2-Ethylhexyl salicylate

5 per cent

—

—

31.12.1991

7–11

ENTRIES DELETED

12

Isopentyl 4-methoxycinnamate mixed isomers

10 per cent

—

—

31.12.1991

13

2-Ethylhexyl 4-methoxycinnamate

10 per cent

—

—

31.12.1991

14–15

ENTRIES DELETED

16

2-Hydroxy-4-methoxy-4-methylbenzophenone (Mexenone)

4 per cent

—

Contains Mexenone (Not required when concentration is not more 0.5 per cent and when the substance is only intended to protect the product)

31.12.1991

17

2-Hydroxy-4-methoxybenzophenone-5 sulphonic acid and sodium salt (Sulisobenzone and Sulisobenzone sodium)

5 per cent (expressed as acid)

—

—

31.12.1991

18–23

ENTRIES DELETED

24

α-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts

6 per cent (expressed as acid)

—

—

31.12.1991

25

3-(4-Methylbenzylidene)-d-1-camphor

6 per cent

—

—

31.12.1991

26

3-Benzylidene camphor

6 per cent

—

—

31.12.1991

27

ENTRY DELETED

28

4-Isopropyl dibenzoylmethane

5 per cent

—

—

31.12.1991

29

4-Isopropylbenzyl salicylate

4 per cent

—

—

31.12.1991

30

ENTRY DELETED

31

1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane 1,3-dione

5 per cent

—

—

31.12.1991

32

2,4,6-Trianilino-(p-carbo-2' ethylhexyl-1'-oxi)-1,3,5-triazine

5 per cent

—

—

31.12.1991

SCHEDULE 6SAMPLING AND TESTING

Regulation 9

1.

In this Schedule–

“Annex A” means the Annex to Commission Directive No. 80/1335/EEC31, as amended by Commission Directive No. 87/143/EEC32;
“Annex B” means the Annex to Commission Directive No. 82/434/EEC33;
“Annex C” means the Annex to Commission Directive No. 83/514/EEC34;
“Annex D” means the Annex to Commission Directive No. 85/490/EEC35;

“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 I 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 I of Annex A, samples shall be regarded as having the same batch number if:

(a)

the means of identifying the batch referred to in regulation 6(1)(g) above shows that they were manufactured in the same batch; or

(b)

in the case of a product not manufactured in a batch, the reference referred to in regulation 6(1)(g) 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 6(1)(g) 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 I 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-hydroxybenzenesulphonate 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/EEC36, 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-hydroxybenzenesulphonic 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 1 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 1 of Annex B.

(10)

Any test to determine whether a hair-dye contains any of the oxidation colorants 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, 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”.

SCHEDULE 7REVOCATIONS

Regulation 1(6)

(1)

(2)

Regulations revoked

References

The Cosmetic Products (Safety) Regulations 1984

S.I.1984/1260

The Cosmetic Products (Safety) (Amendment) Regulations 1985

S.I.1985/2045

The Cosmetic Products (Safety) (Amendment) Regulations 1987

S.I.1987/1920

The Cosmetic Products (Safety) (Amendment) Regulations 1988

S.I.1988/802

The Cosmetic Products (Safety) (Amendment No. 2) Regulations 1988

S.I.1988/2121

(This note is not part of the Regulations)

These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1984 as amended. They implement the requirements of Council Directives No. 76/768/EEC, as amended the last amendments being Council Directive No. 88/667/EEC and Commission Directive 89/174/EEC, and of Commission Directives No. 80/1335/EEC, as amended, No. 82/434/EEC, No. 83/514/EEC and No. 85/490/EEC, relating to cosmetic products, and, as permitted by the Directives, impose certain additional requirements relating to the composition of cosmetic products. The Regulations are made under the Consumer Protection Act 1987 and the European Communities Act 1972.

The last amending Council and Commission Directives which are implemented for the first time by these Regulations–

1.

Require that marking information shall, if practicable, be borne on both the internal container and the outer packaging (regulation 6).

2.

Prohibit four substances from use in cosmetic products by the addition of their names to Schedule 1 to these Regulations. The substances being Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)), Benzoyl peroxide, 2-Amino-4-nitrophenol and 2-Amino-5-nitrophenol (Schedule 1, items 37, 38, 47 (496) and 87).

3.

Remove the authority to use oestrone by deleting the exemptions previously given for item 490 of Schedule 1 (Schedule 1, item 490).

4.

Remove the need for the requirement that the marking of hair care and soap products containing etidronic acid shall declare the fact (Schedule 2, Part I, item 53).

5.

Approve, provisionally and until 31st December 1990, the use of Quinolin-8-ol and bis (8-hydroxyquinolium) sulphate in certain stated types of cosmetics and at concentrations set out (Schedule 2, Part II, item 1).

6.

Delete from the list of provisionally approved colouring agents nine formerly allowed colouring agents, extend the authorisation dates for all other provisionally approved colouring agents to 31st December 1989 and limit the use of colouring agent 42535 in hair preparations to a maximum concentration of one hundred parts per million (Schedule 3, Part II).

7.

Reduce the permitted concentration for the use of 5-chloro-2-methyl-isothiazol-3(2H) one and 2-methyl-isothiazol-3(2H) one with magnesium chloride and magnesium nitrate as a preservative from 0.003 per cent to 0.0015 per cent (Schedule 4, Part I, item 39).

8.

Permit the use on a provisional basis, and until 31st December 1991, of Glutaraldehyde as a preservative (Schedule 4, Part II, item 26).

9.

Remove five provisionally approved preservatives and extend the allowed use of four others to 31st December 1989 (Schedule 4, Part II, items 1, 3, 4, 5, 15, 16, 19, 20 and 25).

10.

Reissue the list of currently provisionally approved ultra violet filters and extend their allowed use until 31st December 1991 (Schedule 5, Part 2).

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82, Grattan Road, Bradford BD1 2JB.