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The Cosmetic Products (Safety) Regulations 2004

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Regulations 1(3), 1(4) and 16(3)

SCHEDULE 1U.K.

PART 1U.K.

Commencement Information

I1Sch. 1 Pt. 1 in force at 11.9.2004, see reg. 1(1)

Schedules 3,4 and 6 to these Regulations shall have effect until 24th March 2005 with the insertion of the entries set out in Part 1 of this Schedule as they appear in the Cosmetic Products (Safety) Regulations 2003(1) in place of the corresponding entries in the those Schedules to these Regulations.

SubstanceReference number or entry numberSchedule and Part number in the Cosmetic Products (Safety) Regulations 2003
Benzoyl peroxide90Schedule 3, Part 1
Hydroquinone monobenzyl, monoethyl and monomethyl ethers391Schedule 3, Part 1
4-Methoxyphenol458Schedule 3, Part 1
Secondary dialkanolamines643Schedule 3, Part 1
Hydroquinone14Schedule 4, Part 1
Fatty acid dialkanolamides60Schedule 4, Part 1
Monoalkanolamines61Schedule 4, Part 1
Trialkanolamines62Schedule 4, Part 1
1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]36Schedule 6, Part 1

PART 2U.K.

Commencement Information

I2Sch. 1 Pt. 2 in force at 11.9.2004, see reg. 1(1)

Subject to regulation 1(3), the entries referred to in Part 2 of this Schedule shall not form part of the Schedules referred to in column 3 below until 24th March 2005.

SubstanceReference number or entry numberSchedule and Part number in these Regulations
Secondary alkyl- and alkanolamines and their salts643Schedule 3, Part 1
Hydroquinone monobenzyl and monoethyl ethers391Schedule 3, Part 1
Hydroquinone14Schedule 4, Part 1
Fatty acid dialkylamides and dialkanolamides60Schedule 4, Part 1

Monoalkylamines,

Monoalkanolamines and

their salts

61Schedule 4, Part 1
Trialkylamines, trialkanolamines and their salts62Schedule 4, Part 1

2,4-Diamino-pyrimidine-3-oxide

(CAS No 74638-76-9)

93Schedule 4, Part 1
Benzoyl peroxide94Schedule 4, Part 1
Hydroquinone methyl ether95Schedule 4, Part 1
1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]36Schedule 6, Part 1

Regulation 3(1)

SCHEDULE 2U.K.

Commencement Information

I3Sch. 2 in force at 11.9.2004, see reg. 1(1)

1.  Council Directive 82/368/EEC (N.J. No. L167, 15.6.82, p.1).U.K.

2.  Commission Directive 82/147/EEC (O.J. No. L63, 6.3.82, p.26).U.K.

3.  Commission Directive 83/191/EEC (O.J. No. L109, 26.4.83, p.25).U.K.

4.  Commission Directive 83/341/EEC (O.J. No. L188, 13.7.83, p.15).U.K.

5.  Council Directive 83/574/EEC (O.J. No. L332, 28.11.83, P.38.)U.K.

6.  Commission Directive 83/496/EEC (O.J. L275, 8.10.83, P.20).U.K.

7.  Commission Directive 84/415/EEC (O.J. No. L228, 25.8.84, p.31).U.K.

8.  Commission Directive 85/391/EEC (O.J. L224, 22.8.85, p.40).U.K.

9.  Commission Directive 86/179/EEC (O.J. No. L138, 24.5.86, p.40).U.K.

10.  Commission Directive 86/199/EEC (O.J. No. L149, 3.6.86, p.38).U.K.

11.  Commission Directive 87/137/EEC (O.J. No. L56, 26.2.87, p.20).U.K.

12.  Commission Directive 88/233/EEC (O.J. L105, 26.4.88, p.11).U.K.

13.  Council Directive 88/667/EEC (O.J. No. L382, 31.12.88, p.46).U.K.

14.  Commission Directive 89/174/EEC (O.J. No, L64, 8.3.89, p.10).U.K.

15.  Council Directive 89/679/EEC (O.J. No. L398, 30.12.89, p.25).U.K.

16.  Commission Directive 90/12/EEC (O.J. No. L71, 17.3.90, p.40).U.K.

17.  Commission Directive 91/184/EEC (O.J. No. L91, 12.4.91, p.59).U.K.

18.  Commission Directive 92/8/EEC (O.J. No. L70, 17.3.92, p.23)U.K.

19.  Commission Directive 92/86/EEC (O.J. No.L325, 11.11.92, p.18).U.K.

20.  Commission Directive 93/47/EEC (O.J. No. L203, 13.8.93, p.24).U.K.

21.  Council Directive 93/35/EEC (O.J. No. L151, 23.6.93, p.32).U.K.

22.  Commission Directive 94/32/EC (O.J. No. L181, 15.7.94, p.31).U.K.

23.  Commission Directive 95/34/EC (O.J. No. L167, 18,7.95, p.19)U.K.

24.  Commission Directive 96/41/EC (OJ No. L198, 8.8.96, p.36).U.K.

25.  Commission Directive 97/18/EC (O.J. No. L114, 1.5.97, p.43).U.K.

26.  Commission Directive 97/45/EC (O.J. No. L196, 24.7.97, p.77).U.K.

27.  Commission Directive 98/16/EC (O.J. No. L77, 14.3.98, p.44).U.K.

28.  Commission Directive 98/62/EC (O.J. No. L253, 15.9.98, p.20).U.K.

29.  Commission Directive 2000/6/EC (O.J. No. L56, 1.3.00, p.42).U.K.

30.  Commission Directive 2000/11/EC (O.J. No. L65, 14.3.00, p.22).U.K.

31.  Commission Directive 2000/41/EC (O.J. No. L145, 20.6.00, p.25).U.K.

32.  Commission Directive 2003/1/EC (O.J. No. L102, 18.4.02, p.19).U.K.

33.  Commission Directive 2003/1/EC (O.J. No. L5, 10.1.03, p.14).U.K.

34.  Commission Directive 2003/16/EC (O.J. No. L46, 20.2.03, p.24).U.K.

35.  Commission Directive 2003/15/EC (O.J. No. L66, 11.3.03, p.26).U.K.

36.  Commission Directive 2003/80/EC (O.J. No. L224, 6.9.2003, p.27).U.K.

37.  Commission Directive 2003/83/EC (O.J. No. L238, 25.9.03, p.23)U.K.

Regulations 5(2) and 6(1)

SCHEDULE 3U.K.LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

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 5(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 references given in columns 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substance (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 substances falls).

Regulation 1(3) provides that until 24th March 2005 entries 90, 391, 458 and 643 shall be inserted into Part 1 of this Schedule as they appear Part 1, Schedule 3 to the Cosmetic Products (Safety) Regulations 2003. From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

PART 1U.K.SUBSTANCES PROHIBITED IN ALL COSMETIC PRODUCTS

Commencement Information

I4Sch. 3 Pt. 1 in force at 11.9.2004, see reg. 1(1)

(1)(2)(3)(4)
Number in this ScheduleName of substanceCross-reference to this ScheduleCross-reference to Annex II of the Directive
1Acenocoumarol (INN)397254
2Acetonitrile393
33-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts399, 762203
42-Acetoxethyltrimethylammonium hydroxide and its salts62
52-Acetylamino-5-chlorobenzoxazole1631
6Acetylcholine and its salts42
7Acetylene chlorides250, 759126
8Acetylenic alcohols, their esters, ethers and salts1716
9Acetylethyltetramethyltetralin (AETT)342362
107α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone6524
11Aconitine and its salts12
12Aconitum napellus L. (leaves, roots and galenical preparations)11
13Adonis vernalis L. and its preparations13
14Adrenaline270,31514
15Alkali pentacyanonitrosylferrate(2-)-605-6, 647-8255
16O-Alkyldithiocarbonic acids, salts of763336
17Alkyne alcohols, their esters, ethers and salts816
18Alloclamide (INN) and its salts2218
19Allyl isothiocynate18
202-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts224
21N-Allylnormorphine, its salts and ethers49420
222-Allyloxy-4-chloro-N-[2-(diethylamino)ethyl]-benzamide and its salts1819
23Alypine and its salts45, 107143
24Ambenonium chloride (INN)(529)132
254-(or p-)Aminobenzonic acid esters167
262-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts29
27Aminocaproic acid (INN) and its salts317
282-Amino-5-chlorobenzoxazole76924
294-Amino-N-(2-diethylaniaminoethyl)benzamide, its salts and derivatives61025
30Aminoheptane, its isomers and salts75125
316-Aminohexanoic acid and its salts277
32α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts519-520257
334-Amino-N1o-methylfolic acid4526
342-Amino-6-methylheptane and its salts288, 52528
352-Amino-4-methylhexane and its salts289, 47130
362-Amino-4-nitrophenol383
372-Amino-5-nitrophenol384
384-Amino-2-nitrophenol412
394-(or p-)Aminosalicylic acid and its salts31
40Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives71932
41Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives76533
42Amitriptyline (INN) and its salts284146
43Ammi majus and its galenical preparations35
44Amphetamine (INN), its salts and derivatives and salts of those derivatives(681)21
45Amydricaine and its salts23, 107143
46Amylene chloride25136
47Amyl 4-dimethylaminobenzoate, mixed isomers534381
48Amyl nitrites247
49Amylobarbitone and its salts(69)220
50Amylocaine and its salts28250
51Anamirta cocculus L. (fruit)106
52Substances with androgenic effect37
53Aniline, its salts and halogenated and sulphonated derivatives22
54Anthracene oil38
55Anti-androgens with steroid structure390
56Antibiotics39
57Antimony and its compounds40
58Apocynum cannabinum L. and its preparations41
59Apomorphine and its salts69742
60Apronalide420216
61Arecoline482238
62Aristolochic acid and its salts365
63Arsenic and its preparations43
64Atropa belladonna L. and its preparations44
65Antropine, its salts and derivatives45
66Azacyclonol (INN) and its salts305286
67Azamethonium bromide (INN)(473)121
68Barbitone and its salts(69)220
69Barbituratesvarious220
70Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 4 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 5 by “*” immediately after the name or colour index number)46
71Bemegride (INN) and its salts337, 338183
72Benactyzine (INN)258157
73Bendrofluazide and its derivatives74, 8953
74Bendroflumethiazide (INN) and its derivatives73, 8953
75Benzamine and its salts74451
76Benzatropine (INN) and its salts301158
77Benzazepines, their salts and derivatives8849
78Benzene47
79Benzene-1,2-diol152, 630408
80Benzene-1,2,3-triol631409
812-Benzhydryloxyethyldimethylamine and its salts296339
82Benzidine24326
83Benzilonium bromide (INN)9360
842-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate602239
85Benzimidozolone86, 26748
86Benzimidazol-2(3H)-one;85, 26748
87Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences)211357
88Benzodiazepines, their salts and derivatives7749
89Benzothiadiazine and its derivatives73, 7453
90ENTRY DELETED
913-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole41552
92Benzylideneacetone567356
933-Benzyloxy-1,1-diethylpyrrolidine hydrobromide8360
944-Benzyloxyphenol(391), 487178
952-[Benzyl-N-(2-pyridyl)amino]ethyldimethylamine626, 748347
96Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
97Beryllium and its compounds54
98Betamethasone (INN)(361)300
99Betoxycaine (INN) and its salts25723
100BHC (ISO) (gamma-BHC)370, 372, 428195
101Bietammiverine (INN)261287
1021,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts43689
1032-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts106, 23188
104N,N-Bis(2-chloroethyl)methylamine and its salts159 49287
105N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts49386
106N,N-Bis(2chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine P-oxide and its salts103, 23188
1071,1-Bis(dimethylaminomethyl)propyl benzoate and its salts23, 45143
108Bis(hydroxyalkyl)amines, not further N-substituted255, 274, (643)411
1092,2-Bis(hydroxymethyl)butan-1-ol trinitrate616206
1102,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts430219
1113,3-Bis(4-hydroxyphenyl)phthalide560417
112Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 4(401, 533)395
113Bithionol (INN)708352
114Bretylium tosilate (INN) (Bretylium tosylate)11756
115Bromine, elemental55
116Bromisoval (INN)11958
117

p-Bromobenzylethyldimethylammonium

p-toluenesulphonate

11456
1182-Bromo-2-ethylbutyrylurea14857
1192-Bromo-3-methylbutylrylurea11658
1201-p-Bromophenyl-l-(2-pyridyl)-3-dimethylaminopropane and its salts12159
121Brompheniramine (INN) and its salts12059
122Brucine62
123Butanilicaine (INN) and its salts46690
124Butobarbitone and its salts(69)220
125Butopiprine (INN) and its salts127288
1262-Butoxy-N-(2-diethylaminoethyl)cinchoninamide and its salts190129
1272-Butoxyethyl phenyl(piperidino)acetate and its salts125288
1281-Butyl-3-(N-crotonoylsulphanilyl)urea108
1294-Butyl-1,2-diphenylpylpyrazolidine-3,5-dione56667
1304-tert-Butyl-3-methhoxy-2,6-dinitrotoluene490414
1314-Butyl-l-phenylpyrazolidine-3,5-dione48664
1321-Butyl-3-(p-methylenzenesulphonyl)urea71865
1331-Butyl-3-sulphanilylurea14966
1344-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide142140
1351-tert-Butyl-3,4,5-trimethyl-2,6-dinitrobenzene491422
136Cadmium and its compounds68
137Calabar bean588281
138Calciferol317, (761)335
139Cantharides, Cantharis vesicatoria65069
140Cantharidin37970
141Captan (ISO)737370
142Captodiame (INN)134140
143Caramiphen (INN) and its salts570169
144N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts419156
145Carbazole, nitroderivatives of51072
146Carbon disulphide73
147Carbon tetrachloride693315
148Carbromal (INN)11857
149Carbutamide (INN)13366
150Carisoprodol (INN)480235
151Catalase74
152Catechol79, 630408
153Cells, tissues or products of human origin416
154Cephaeline and its salts75
155Chenopodium ambrosioides (essential oil)76
156Cherry laurel water621291
157Chloral hydrate73577
158Chlorine78
159Chlormethine (INN) and its salts104, 49287
160Chlormezanone (INN)17491
1614-Chlorobenzene-1,3-disulfonamide19385
1625-Chloro-1,3-benzoxazol-2(3H)-one18582
163N-5-Chlorobenzoxazol-2-ylacetamide51
1642-Chloro-9-[3-dimethylamino-6-methylpyrimidine168, 216,83
1652-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts18284
166Chloroethane32896
167Chloroform737366
1682-Chloro-6-methylpyrimidin-4-yldimethylamine164, 21683
169Chlorophacinone (ISO)17593
1701-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine402240
1712-(4-Chlorophenyl)-1-[4-2-diethyl-aminoethoxyl)]phenyl-1-p-tolyethanol74792
1724-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one369185
1732-(4-Chlorophenyl)-3-methylbutane-2,3-diol55495
1742-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide16091
1752-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione16993
1762-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine17994
177Chloropicrin738325
1783-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one183, 184262
179Chlorphenoxamine (INN)17694
180Chlorpromazine (INN)(561)320
181Chlorpropamide (INN)61779
182Chlorprohixene (INN) and its salts16584
183Chlortalidone (INN)178, 184262
184Chlorthalidone178, 184262
185Chlorzoxazone (INN)16282
186Cholecalciferol(761)335
187Choline salts and their esters168
188Chromium, chromic acid and salts of the acid97
189Chrysoidine citrate hydrochloride56581
190Cinchocaine (INN) and its salts126129
191Cincophen (INN), its salts and derivatives and salts of those derivatives5808
192Claviceps purpurea Tul., its alkaloids and galenical preparations31898
193Clofenamide (INN)16185
194Clofenotane (INN)734123
195Coal tar, crude and refined218420
196Cobalt benzenesulphonate101
197Cocculin592282
198Colchicine, its salts and derivatives102
199Colchicoside and its derivatives103
200Colchicum automnale L, and its galenical preparations104
201Colouring agent CI 12075 and its lakes, pigments and salts397
202Colouring agent CI 12140378
203Colouring agent CI 13065387
204Colouring agent CI 15585401
205Colouring agent CI 26105379
206Colouring agent CI 42535388
207Colouring agents CI 42555, 42555:1 and 42555:2380
208Colouring agent CI 42640386
209Colouring agent CI 45170 and CI 45170:1398
210Colouring agent CI 61554389
211Coniferyl benzoate (except natural content of essences)87357
212Coniine618290
213Conium maculatum L. (fruit, powder, galenical preparations)99
214Convallatoxin105
215Coumetarol (INN)454225
216Crimidine (ISO)164, 16883
217Croton tiglium (oil)107
218Crude and refined coal tars195420
219Curare and curarine109
220Curarizants, synthetic110
2211-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride29780
222Cyclarbamate (INN)230122
223Cyclizine (INN) and its salts302159
224Cyclobarbitone and its salts(69)220
225Cyclocoumarol268234
2262-a-Cyclohexylbenzyl(N,N,N’,N’-tetraethyl)trimethylenediamine555112
2272-Cyclohexyl-3,5-dimethylphenol and its salts229113
228Cyclohexyl-3-(p-methylbenzenesulphonyl)urea364100
229Cyclomenol (INN) and its salts227113
230Cyclopentane-1,1-dimethanol dicarbanilate222122
231Cyclophosphamide (INN) and its salts103, 10688
232Datura stranibuyn L. and its galenical preparations54301
233DDT (ISO) (pp’-DDT)194 734123
234Deanol aceglumate (INN)2793
235Decamethonuium bromide (INN)(236)214
236Decamethylene-bis(trimethylammonium) salts235214
237Dextromethorphan (INN) and its salts457226
238Dextropropoxyphene (INN)281116
239O,O’-Diacetyl-N-allyl-N-normorphine117
2402,4-Diaminoanisole and its salts455, 461376
2412,5-Diaminoanisole and its salts456, 460377
2421,2-Diaminobenzene and its salts573363
243p,p’-Diaminodiphenyl8226
2442-(2,4-Diaminophenyl)ethanol and its salts407
2451,4:3,6-Dianhydrosorbitol 2,5-dinitrate422148
2465-(α,β-Dibromophenethyl)-5-methylhydantoin119
247Dibromosalicylanilides248, 443351
248Dibromsalan (INN)(247)351
249Dichloroethanes330, 335125
250Dichloroethylenes7, 759126
2512,3-Dichloro-2-methylbutane4636
252Dichlorosalicylanilides349
253Dicoumarin254, 469231
254Dicoumarol (INN)253, 469231
255Diethanolamine(108, 643)411
256

2-Diethylaminoethoxy)ethyl

α-phenylpiperidine-1-acetate dimethiodide

601137
2572-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts9923
2582-Diethylaminoethyl benzilate72157
2592-Diethylaminoethyl 4-ethoxybenzoate and its salts411, 538179
2602-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts128
2612-Diethylaminoethyl phenyl(piperidino)acetate101287
2623-Diethylaminopropyl cinnamate130
263Diethyl 4-nitrophenyl phosphate536170
264O,O-Diethyl O-4-nitrophenyl phosphorothioate537131
265Difencloxazine INN)569270
266Digitaline and all heterosides of Digitalis purpureaL.134
2674.5-Dihydrobenzimidazol-4-one85 8648
2683,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]]-benzopyran-5-one225234
269Dihydrotachacysterol (INN)342
2703,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol14, 31514
2714,4’-Dihydroxy-3,3’-(3-methylthiopropylideneI)dicoumarin207
2721-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts294136
2731-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol418, 42117
274Diisopropanolamine(108, 643)411
2755,5’-Di-isopropyl-2,2’-dimethylbiphenyl-4,4’-diyldihypoiodite413361
276Dimethoxane286368
2774-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts438141
278Dimethylamine142
2792-Dimethylaminoethyl N-acetylglutamate2343
2802-Dimethylaminoethyl p-butylaminobenzoate and its salts69063
281(+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane238116
2821-Dimethylaminomethyl-1-methylpropyl benzoate and its salts5050
2832-Dimethylaminopropiophenone and its salts445145
2843-(3-Dimethylaminopropylidene)-1,2,4,5-dibenzocyclohepta-1,4-diene and its salts42146
2851,1-Dimethylbiguanide and its salts447147
2862,6-Dimethyl-1,3-dioxan-4-yl- acetate276368
287Dimethylformamide355
2881,5-Dimethylhexylamine and its salts34, 52528
2891,3-Dimethylpentylamine and its salts35, 47130
290Dimethyl sulfoxide (INN)338
291Dimevamide (INN) and its salts298153
292Dinitrophenol isomers151
293Dioxane343
294Dioxethedrin (INN) and its salts272136
2952,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts483133
296Diphenhydramine (INN) and its salts81339
297Diphenoxylate hydrochloride (INNM)22180
2982,2-Diphenyl-4-dimethylaminovaleramide and its salts291153
2995,5-Diphenyl-4-imidazolidone160
3004-Diphenylmethoxy-1-methylpiperidine and its salts306154
3013-Diphenylmethoxytropane and its salts76158
3021-Diphenylmethyl-4-methylpiperazine and its salts223159
3031,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione664155
304α,α-Diphenyl-2-piperidinemethanol and its salts600285
305α,α-Diphenyl-4-piperidinemethanol and its salts66286
306Diphenylpyraline (INN) and its salts300154
3072,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone410152
3084-Dipropylsulphamoylbenzoic acid609161
309Disulfiram (INN)702, 713162
310Dithio-2,2’-bis(pyridine 1-oxide) 1,1’ (additive with trihydrated magnesium sulphate)628396
311Doxylamine (INN) and its salts579176
312Emetine, its salts and derivatives163
313Endrin (ISO)373196
314Ephedrine and its salts164
315Epinephrine (INN)14, 27014
3161,2-Epoxybutane400
317Ergocalciferol (INN)138 (761)335
318Ergot and its alkaloids19298
319Eserine and its salts589166
320Ethionamide (INN)336319
321Ethoheptazine (INN) and its salts476173
322Ethopropazine and its salts(561)320
3234-Ethoxyphenol(391)178
3244-Ethoxy-m-phenylenediamine and its salts406
3252-Ethylamino-5-phenyloxazolin-4-one345180
326Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid327204
327Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid326204
328Ethyl chloride16696
329Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts446171
330Ethylene dichloride(249)125
331Ethylene oxide182
3322-Ethyl-2,3-epoxyhexamide and its derivatives530165
333Ethyl p-fluorophenyl sulphone348189
334Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts532172
335Ethylidene dichloride(249)125
3363-Ethylisothionicotinamide320319
3373-Ethyl-3-methylglutarimide and its salts71, 338183
3384-Ethyl-4-methylpiperidine-2,6-dione and its salts71, 337183
3392-Ethyl-3-methylvaleramide755184
340Ethylphenacemide556, 568272
3412-Ethyl-2-phenylglutarimide and its salts362181
3423’-Ethyl-5’,6’,7’,8’-tetrahydro-5’,5’,8’,8’-tetramethyl-2’-acetonaphthone9362
343Ethyl urocanate(406)418
344Fenadiazole (INN)528208
345Fenozolone (INN)325180
346Fenyramidol (INN)578, 582274
347Fluanisone (INN)351187
348Fluoresone (INN)333189
3494’-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone741188
3506-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione535186
3511-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one347187
3525-Fluoropyrimidine-2,4-dione353190
353Fluorouracil (INN)352190
354Fluphenazine (INN)(561)320
355Furazolidone (INN)513252
356Furfuryltrimethylammonium salts358192
357Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg96, 462, 623, 746358
358Furtrethonium iodide (INN)(356)192
359Galantamine (INN)193
360Gallamine triethiodide (INN)518329
361Glucocorticoids98300
362Glutethimide (INN) and its salts341181
363Glycerol trinitrate514, 615253
364Glycyclamide (INN)228100
365Gold salts296
366Guaifenesin (INN)459230
367Guanethidine (INN) and its salts368259
368N-(2-Guanidinoethyl)azocane and its salts367259
369Haloperidol (INN)172185
370HCH (ISO) (gamma-HCH)100, 372, 428195
371HETP378316
3721,2,3,4,5,6-Hexachlorocyclohexane100, 370, 428195
373(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 dimethanonaphthalene313196
374Hexachloroethane197
3753,3’4,4’6,6’-Hexachloro-2,2’-methylenediphenol376371
376Hexachlorophene (INN)375371
377(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene416198
378Hexaethyl tetraphosphate371316
379(1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride14070
380(3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione639217
381Hexamethonium bromide (INN)(382)124
382N-N’-Hexamethylenebis(trimethylammonium) salts381124
383Hexapropymate (INN)619115
384Hydrastine, hydrastinine and their salts199
385Hydrazides and their salts200
386Hydrazine, its derivatives and their salts201
3872-Hydrazino-octane and its salts523202
388Hydrocyanic acid and its salts390, 409, 604111
389Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 4)191
390Hydrogen cyanide and its salts388, 409, 604111
391Hydroquinone monobenzyl and monoethyl ethers487178
3927-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline764135
393[4-[4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts7425
3943-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts7169
3952-Hydroxy-3-(2-methoxyphenyl)propyl carbamate450205
3961-Hydroxymethyl-1-cyclohexcylacetic acid, sodium salt646114
3974-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin1254
3988-Hydroxy-5-nitroquinoline and its salts517209
3994-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts3, 762203
40011α-Hydroxypregn-4-ene-3,20-dione and its esters385
401Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4112, 533, 633395
402Hydroxyzine (INN)170240
403Hyoscine, its salts and derivatives641295
404Hyoscyamine, its salts and derivatives210
405Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)211
4063-Imidazol-4-ylacrylic acid and its ethyl ester343, 753418
4072-Imino-5-phenyloxazolidin-4-one and its salts540212
408Imperatorin46534
409Inorganic cyanides(388, 390), 604111
410Inproquone (INN)307152
411Intracaine and its salts259, 538179
412Iodine213
413Iodothymol275361
414Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)215
415Isocarboxazid (INN)9152
416Isodrin377198
417Isometheptene (INN) and its salts463228
418Isoprenaline (INN)273, 42117
419Isopropamide iodide (INN)(144)156
420(2-Isopropylpent-4-enoyl)urea60216
421Isoproterenol273, 41817
422Isosorbide dinitrate (INN)245148
423Juniperus Sabina L (leaves, essential oil and galenical preparations)294
424Laurus nobilis L. (oil from seeds)359
425Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 4)289
426Levophacetoperane and its salts597284
427Lidocaine (INN) (Lignocaine)399
428Lindane100, 370, 372195
429Lobelia inflata L. and its galenical preparations218
430Lobeline (INN) and its salts110219
431LSD(433 434)127
432Lupinidine and its salts651299
433Lysergic acid diethylamide and its salts431, 434127
434Lysergide (INN) and its salts431, 433127
435Malononitrile149
436Mannomustine (INN) and its salts10289
437Mecamylamine (INN)701229
438Mefeclorazine (INN) and its salts277141
439Mephenesin (INN) and its esters721322
440Meprobamate (INN)481236
441Mercury and its compounds (except those listed in Part I of Schedule 6)221
442Mescaline and its salts743222
443Metabromsalan (INN)(247)351
444Metaldehyde603223
445Metamfepramone (INN) and its salts283145
446Metethoheptazine (INN) and its salts329171
447Metformin (INN) and its salts285147
448Methapyrilene (INN) and its salts627144
449Metheptazine (INN) and its salts468174
450Methocarbamol (INN)395205
451Methohexitone and its salts(69)220
452Methotrexate (INN)336
4532-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate625346
4541-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane215225
4551-Methoxy-2,4-diaminobenzene and its salts240, 461376
4561-Methoxy-2,5-diaminobenzene and its salts241, 460377
457(+)-3-Methoxy-N-methylmorphinan and its salts237226
458ENTRY DELETED
4593-(2-Methoxyphenoxy)propane-1,2-diol366230
4602-Methoxy-p-phenylenediamine and its salts241, 456377
4614-Methoxy-m-phenylenediamine and its salts240, 455376
462Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
4636-Methylamino-2-methylhept-2-ene and its salts417228
4642-Methyl-1,2-bis(3-pyridyl)propan-1-one484292
4659-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one40834
4662-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts12390
4671-Methyl-2,4-diaminobenzene and its salts477364
468Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts449174
4693,3-Methylenebis-(4-hydroxycoumarin)253, 254231
4702-Methylheptylamine and its salts227
4714-Methyl-2-hexylamine and its salts35, 28930
4721-Methylimidazole-2-thiol474, 707233
473N,N’ [Methylimino)diethylene]bis-(ethyldimethylammonium) salts67121
4741-Methyl-2-mercaptoimidazole472, 707233
475Methylphenidate (INN) and its salts575175
4761-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts321173
4774-Methyl-m-phenylenediamine and its salts467364
4782-Methyl-m-phenylenediamine413
4793-Methyl-2-phenylmorpholine, its derivatives and salts558232
4802-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane150235
4812-Methyl-2-propyltrimethylene dicarbamate440236
482N-Methyl-1,2,5,6-tetrahydro-3-nicotine acid methyl ester61238
483Methyprylon (INN) and its salts295133
484Metyrapone (INN)464292
485Minoxidil (INN), its salts and derivatives599372
486Mofebutazone (INN)13164
487Monobenzone (INN)94, (391)178
488Morpholine and its salts344
489Moskene546421
490Musk ambrette130414
491Musk tibetene135422
492Mustine and its salts104, 15987
493Mustine N-oxide and its salts10586
494Nalorphine (INN), its salts and ethers2120
495Naphazoline (INN) and its salts501244
4962-Naphthol497241
497β-Naphthol496241
4981-and 2-Naphthylamines and their salts499242
499α-and β-Naphthylamines and their salts498242
5003-(1-Naphthyl)-4-hydroxycoumarin243
5012-(1-Naphthylmethyl)-2-imidazoline and its salts495244
502Narcotics, 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
503Narcotine and its salts521258
504Neodymium and its salts309
505Neostigmine and its salts245
506Nicotine and its salts246
507Nitrites, inorganic (except sodium nitrite)248
508Nitrobenzene249
509Nitrocresols and their alkali metal salts250
510Nitroderivatives of carbazole14572
511Nitrofurantoin (INN)512251
512N-(5-Nitro-2-furfurylidene)-1-aminohydantoin511251
5133-(5-Nitrofurfurylideneamino)oxazolidin-2-one355252
514Nitroglycerine363, 615253
515Nitrosamines410
516Nitrostilbenes, their homologues and derivatives256
517Nitroxoline (INN) and its salts398209
518N,N,N,N’,N’,N”,N”,N”-Nonaethyl-2,2’2”-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide360329
519Noradrenaline and its salts32, 520257
520Norepinephrine (INN) and its salts32, 519257
521Noscapine (INN) and its salts503258
522Nux Vomica and its preparations(661)305
523Octamoxin (INN) and its salts387202
524Octamylamine (INN) and its salts267
525Octodrine (INN) and its salts34, 28828
526Oestrogens260
527Oleandrin261
5282-(1,3,4-Oxadiazol-2-yl)phenol344208
529[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts24132
530Oxanamide (INN) and its derivatives332165
5312-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11b-H-benzo[a]quinolizine and its salts688139
532Oxpheneridine (INN) and its salts334172
533Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4112, 401, 633395
534Padimate A47381
535Paramethasone (INN)350186
536Paraoxon263170
537Parathion (ISO)264131
538Parethoxycaine (INN) and its salts259, 411179
539Pelletierine and its salts598263
540Pemoline (INN) and its salts407212
541Pentachloroethane264
542Pentaerythritol chloral552266
543Pentaerythritol tetranitrate544, 551265
544Pentaerythrityl tetranitrate (INN)543, 551265
545Pentamethonium bromide (INN)(547)120
5461,1,3,3,5-Pentamethyl-4,6-dinitroindane489421
547N,N’-Pentamethylenebis(trimethylammonium) salts545120
548Pentobarbitone and its salts(69)220
549Perchloroethylene692314
550Perphenazine (INN) and its salts(561)320
551PETN543, 544265
552Petrichloral (INN)542266
553Phenacemide (INN)564269
554Phenaglycodol (INN)17395
555Phenetamine226112
556Pheneturide (INN)340, 568272
557Phenindone (INN)574271
558Phenmetrazine (INN), its derivatives and salts479232
559Phenobarbitone and its salts(69)220
560Phenolphthalein (INN)111417
561Phenothiazine (INN) and its compoundsvarious320
562Phenprobamate (INN)57671
563Phenprocoumon (INN)577273
564N-Phenylacetylurea553269
5654-Phenylazophenylene-1,3-diamine citrate hydrochloride18981
566Phenylbutazone (INN)12967
5674-Phenylbut-3-en-2-one92356
568(2-Phenylbutyryl)urea340, 556272
569N-[2-(α-Phenyl-p-chlorobenzyl)ethyl]morpholine265270
5701-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts143169
5712-Phenycyclopropylamine (trans-form) and its salts722324
5721-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one620138
573o-Phenylenediamine and its salts242363
5742-Phenylindan-1,3-dione557271
575α-Phenyl-2-piperidineacetic acid methyl ester and its salts475175
5763-Phenylpropyl carbamate56271
5773-(α-Phenylpropyl)-4-hydroxycoumarin563273
5781-Phenyl-2-(2-pyridylamino)ethanol346, 582274
5792-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts311176
5802-Phenylquinoline-4-carboxylic acid its salts and derivatives and salts of those derivatives1918
5816-Phenyl-2,4,7-triaminopteridine and its salts725275
582Phenyramidol346, 578274
583Phosphides, metal279
584Phosphorus279
5854-Phosphoryloxy-N,N-dimethyltryptamine622278
5863-Phthalimidopiperidine-2,6-dione and its salts704280
587Phthalylsulphathiazole (INN) and its salts(678)307
588Physostigma veneriosum Balf.137281
589Physostigmine and its salts319166
590Phytolacca spp and their preparations374
591Picric acid745268
592Picrotoxin197282
593Pilocarpine and its salts283
594Pilocarpus jaborandi Holmes and its galenical preparations311
595Pipazetate (INN) and its salts596118
5962-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts95118
597α-Piperidin-2-ylbenzyl acetate laevorotatory threo-form and its salts426284
5981-(2-Piperidyl)propan-2-one and its salts539263
5996-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives485372
600Pipradrol (INN) and its salts304285
601Piprocurarium idodide (INN)256137
602Poldine metilsulfate (INN) (Poldine methylsulphate)84239
603Polyacetaldehyde444223
604Potassium cyanide(388, 390, 409)111
605Potassium nitroferricyanide(15), 606255
606Potassium nitroprusside(15), 605255
607Pramocaine (INN)608405
608Pramoxine607405
609Probenecid (INN)308161
610Procainamide (INN) its salts and derivatives2925
611Prochlorperazine (INN) and its salts(561)320
612Progestogens194
613Promazine (INN) and its salts(561)320
614Promethazine (INN) and its salts(561)320
615Propane-1’,2,3-triyl trinitrate363, 514253
616Propatylnitrate (INN)109206
6171-Propyl-3-(4-chlorobenzenesulphonyl)urea18179
6182-Propylpiperidine212290
6191-(2-Propynyl)cyclohexyl carbamate383115
620Propyphenazone(INN)572138
621Prunus laurocerasus L.156291
622Psilocybine (INN)585278
623Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
624Pyrethrum album L. and its galenical preparations345
625Pyrianisamine maleate453346
626Pyribenzamine95, 748347
6272-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts448144
628Pyrithione disulphide + magnesium sulphate310396
629Pyrithione sodium369
630Pyrocatechol79, 152408
631Pyrogallol80409
632Quinalbarbitone and its salts(69)220
633Quinolin-8-ol (except for the uses provided for in entry number 51 in Part I of Schedule 4)(401, 533)395
634Radioactive substances (within the meaning of Article 1 of Council Directive 96/29/Euratom(a) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation)293
635Rauwlfia serpentine alkaloids and their salts63615
636Reserpine (INN) and its salts(635)15
637Retinoic acid and its salts724, 760375
638Safrole (except natural content of essences in cases where the concentration of such safrole in the cosmetic product does not exceed— (a) in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 mg/kg; or (b) in the case of products other than oral hygiene or dental products, 100 mg/kg)360
639α-Santonin380214
640Schoenocaulon officinale Lind. (seeds and galenical preparations)332
641Scopolamine, its salts and derivatives403295
642Secbutobarbitone and its salts(69)220
643Secondary alkyl- and alkanolamines and their salts108, 255, 274411
644Selenium and its compounds (except when permitted under the restrictions laid down in Part I of Schedule 4)297
645Sodium cyanide(388, 390, 409)111
646Sodium hexacyclonate (INN)396114
647Sodium nitroferricyanide(15), 648255
648Sodium nitroprusside(15), 647255
649Solanum nigrum L. and its galenical preparations298
650Spanish Fly13969
651Sparteine (INN) and its salts432299
652Spironolactone (INN)104
653Squill and its preparations752330
654Stramonium and its preparations232301
655Strontium lactate-402
656Strontium nitrate-403
657Strontium polycarboxylate-404
658Strophanthines and their aglucones and their respective derivatives-302
659Strophanthus species and their galenical preparations-303
660Strychnine and its salts-304
661Strychnos species and their galenical preparations522305
662Succinonitrile-150
663Succinylsulphathiazole and its salts(678)307
664Sulfinpyrazone (INN)303155
665Sulphacetamide and its salts(678)307
666Sulphadiazine and its salts(678)307
667Sulphadimethoxine and its salts(678)307
668Sulphadimidine and its salts(678)307
669Sulphafurazole and its salts(678)307
670Sulphaguanidine and its salts(678)307
671Sulphamethizole and its salts(678)307
672Sulphamethoxazole and its salts(678)307
673Sulphamethoxydiazine and its salts(678)307
674Sulphamethoxypyridazine and its salts(678)307
675Sulphanilamide and its salts(678)307
676Sulphapyridine and its salts(678)307
677Sulphathiazole and its salts(678)307
678Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts665-677307
679Sulthiame680, 699308
680Sultiame (INN)679, 699308
681Sympathomimetic 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 Europe4421
682Tefazoline (INN) and its salts698237
683Tellurium and its compounds-312
684TEPP (ISO)696276
6852-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts766313
6864-tert-Butylphenol-340
6874-tert-Butylpyrocatechol-341
688Tetrabenazine (INN) and its salts531139
689Tetrabromosalicylanilides-367
690Tetracaine (INN) and its salts28063
6912,3,7,8-Tetrachlorodibenzo-p-dioxin-367
692Tetrachloroethylene549314
693Tetrachloromethane147315
694Tetrachlorosalicylanilides-348
695Tetraethylammonium bromide70361
696Tetraethyl pyrophosphate684276
697(R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts5942
6982-(5,6,7,8-Tetrahydro-1-naphthylmethylmethyl)-2-imidazoline and its salts682237
6994-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide679, 680308
700Tetrahydrozoline and its salts-394
701N,2,3,3-Tetramethyl-2-nocamphanamine437229
702Tetramethylthiuram disulphide713162
703Tetrylammonium bromide (INN)69561
704Thalidomide (INN) and its salts586280
705Thallium and its compounds-317
706Thevetia neriifolia Juss., glycoside extract-318
707Thiamazole (INN)472, 474233
7082,2’-Thiobis(4,6-dichlorophenol)113352
709Thiopentone and its salts(69)220
710Thioridazine (INN) and its salts(561)320
711Thiotepa (INN)726310
712Thiourea and its derivatives (except those listed Part I of Schedule 4)-321
713Thiram (ISO)702162
714Thiuram disulphides-354
715Thuiram monosulphides-353
716Thyropropic acid (INN) and its salts3949
717Tolboxane (INN)720177
718Tolbutamide (INN)13265
719Toluidines, their isomers, salts and halogenated and sulphonated derivatives4032
720p-Tolyboric acid ester of 2-methyl-2-propylpropane-1,3-diol717177
7213-o-Tolyoxypropane-1,2-diol(439)322
722Tranylcypromine (INN) and its salts571324
723Tretamine (INN)727328
724Tretinoin (INN) and its salts637, 760375
725Triamterene (INN) and its salts581275
726Tri(aziridin-1-yl)phosphine sulphide711310
7272,4,6-Tri(aziridin-l-yl)-1,3-triazine723328
7282,2,2-Tribromeothanol(729)326
729Tribromoethyl alcohol728326
730Tribromsalan (INN)731373
7313,4’,5-Tribromosalicylanilde730373
732Trichlormethine (INN) and its salts749327
733Trichloroacetic acid-10
7341,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane194, 233123
7352,2,2-Trichloroethane-1,1-diol15777
736Trichloromethane167366
737N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide141370
738Trichloronitromethane177325
739Tricresyl phosphate750277
740Trifluoperazine (INN) and its salts(561)320
741Trifluperidol (INN)349188
7423,3’,5-Triiodothyroacetic acid and its salts3935
7433,4,5-Trimethoxyphenethylamine and its salts442222
7442.2,6-Trimethyl 1-4-piperidyl benzoate and its salts7551
7452,4,6-Trinitrophenol591268
746Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
747Triparanol (INN)17192
748Tripelennamine (INN)95, 626347
749Tris(2-chloroethyl)amine732327
750Tritolyl phosphate739277
751Tauminoheptane (INN), its isomers and salts3027
752Urginea scilla Stern. and its galenical preparations653330
753Urocanic acid(406)418
754Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC(a)-323
755Valnoctamide (INN)339184
756Veratrine, its salts and galenical preparations-331
757Veratrun spp and their preparations-333
758Vinyl chloride monomer-334
759Vinylidene chloride(7,250)126
760Vitamin A acid and its salts637, 724375
761Vitamins D2 and D3138, 186, 317335
762Warfarin (ISO) and its salts3, 399203
763Xanthates16336
764Xanthinol392135
765Xylidines, their isomers, salts and halogenated and sulphonated derivatives4133
766Xylometazoline (INN) and its salts685313
767Yohimbine and its salts-337
768Zirconium and its compounds (except aluminium chloride hyroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 4 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 Part I of Schedule 5 by “*” immediately after the name or colour index number)-391
769Zoxazolamine (INN)2824

Regulation 5(2)

PART 2U.K.SUBSTANCES PROHIBITED WHEN USED AS A FRAGRANCE INGREDIENT

Commencement Information

I5Sch. 3 Pt. 2 in force at 11.9.2004, see reg. 1(1)

(1)(2)(3)(4)
Number in this ScheduleName of substanceCross-reference to this ScheduleCross-reference to Annex II of the Directive
1Alanroot oil (Inula helenium)-423
2Benzyl cyanide31424
3Cyclamen alcohol22425
4Decahydro-6-isopropyl-2-naphthol21441
5Diethyl maleate-426
6Dihydrocoumarin8427
76,7-Dihydrogeraniol10429
83,4-Dihydroxycoumarin6427
92,4-Dihydroxy-3-methylbenzaldehyde-428
103,7-Dimethyl-2-octen-1-ol7429
114,6-Dimethyl-8-tert-butylcoumarin-430
12Dimethyl citraconate-431
137,11-Dimethyl-4,6-10-dodecatrien-3-one-432
146,10-Dimethyl-3,5,9-undecatrien-2-one-433
15Diphenylamine-434
16Ethyl acrylate-435
17Fig leaf absolute (Ficus carica)-436
18trans-2-Heptenal-437
19trans-2-Hexenal diethyl acetal-438
20trans-2-Hexenal dimethyl acetal-439
21Hydroabietyl alcohol-440
226-Isopropyl-2-decahydronaphthalenol4441
233-(4-Isopropylphenyl)-2-methylpropan-1-ol3425
247-Methoxycoumarin-442
254-(4-Methoxyphenyl)-3-butene-2-one-443
261-(4-Methoxyphenyl)-1-penten-3-one-444
27Methyl trans-2-butenoate-445
287-Methylcoumarin-446
29

Methyleugenol (except for normal content in the natural essences used, and provided that the concentration does not exceed:

(a)

0.01 per cent in fine fragrance;

(b)

0.004 per cent in eau de toilette;

(c)

0.002 per cent in fragrance cream;

(d)

0.001 per cent in rinse-off products; and

(e)

0.0002 per cent in other leave-on products and oral hygiene products)

-451
305-Methyl-2,3-hexanedione447
312-Pentylidenecyclohexanone-448
322-Phenylacetonitrile2424
333,6,10-Trimethyl-3,5,9-undecatrien-2-one-449
34Verbena oil (Lippia citriodora Kunth.)-450

Regulations 5(2), 6(1) and 7(2), 7(9)

SCHEDULE 4U.K.LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

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.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(2).

Regulation 1(3) provides that until 24th March 2005 entries 14, 60, 61 and 62 shall be inserted into Part 1 of this Schedule as they appear in Part 1 of Schedule 4 to the Cosmetic (Products) (Safety) Regulations 2003(3). From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

Regulation 1(4) provides that entries 93,94 and 95 in Part 1 of this Schedule shall not form part of this Schedule until 24th March 2005.

PART 1U.K.SUBSTANCES LISTED IN ANNEX III, PART I OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Commencement Information

I6Sch. 4 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing regs. 5(2), 6(1), see reg. 1(1)

I7Sch. 4 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)

(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1aBoric acid, borates, and tetraborates‘Talcum power5 per cent

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

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for bathing children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

Oral hygiene products0.1 per centNot to be used in products intended for children under three years old

Do not swallow

Not to be used for children under three years old

Other products (excluding bath products and hair waving products3 per cent

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

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

The above-mentioned percentages are calculated as boric acid
1bTetraboratesBath products18 per centNot to be used in products for children under three years oldNot to be used for bathing children under three years old
2aThioglycolic acid and its salts

(a)Hair waving or straightening products for general use

8 per centpH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children.

(b)Hair waving or straightening products for professional use

11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only

(c)Depilatories

5 per cent ready for usepH 7 to 12.7Contains thioglycolate. Follow the instructions. Keep out of reach of children

(d)Other hair-care products which are removed after application

2 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
The above-mentioned percentages are calculated as thioglycolic acid

(a), (b), (c) and (d): The directions for use must incorporate the following:

  • Avoid contact with eyes

  • In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • Wear suitable gloves ((a), (b) and (d) only)

2bThioglycolic acid esters

(a)Hair waving or straightening products for general use

8 per cent ready for usepH 6 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b)Hair waving or straightening products for professional use

11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
The above-mentioned percentages are calculated as thioglycolic acid

(a) and (b): The directions for use must incorporate the following:

  • May cause sensitization in the event of skin contact

  • Avoid contact with eyes

  • In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • Wear suitable gloves

3Oxalic acid, its esters and alkaline saltsHair-care products5 per cent-For professional use only
4AmmoniaAll purposes and products6 per cent calculated as NH3-Contains ammonia (not required when concentration is not more than 2 per cent)
5Tosylchloramide sodium (INN) [Chloramine-T]All purposes and products0.2 per cent--
6Chlorates of alkali metalsToothpaste5 per cent--
Other uses3 per cent--
7DichloromethaneAll purposes and products35 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- and p-Phenylenedi-amines, their

N-substituted derivatives and their salts;

N-substituted derivatives of o-phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule)

Oxidizing colouring agents for hair dyeing for general use6 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. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 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. Wear suitable gloves
9Methylphenylenedimines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1,3-diamine and its salts), their N-substituted derivatives and their salts) (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 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. Wear suitable gloves
10Diaminophenols (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as free base, subject to the provisions of “Combination Rule A” set out below-Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 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. Wear suitable gloves
11Dichlorophen (INN) [Dichlorophene]All purposes and products0.5 per cent-Contains dichlorophen
12Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide

(a)Hair-care preparations

12 per cent of H2O2 present or released-

(a):Wear suitable gloves Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(b)Skin-care preparations

4 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(c)Nail hardening preparations

2 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

(d)Oral hygiene products

0.1 per cent of H2O2 present or released--
13Formaldehyde (see also Part I of Schedule 6)Nail hardeners5 per cent-Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14HydroquinoneOxidizing colouring agent for hair dyeing for general use0.3 per cent subject to the provisions 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 use0.3 per cent subject to the provisions of “Combination Rule B” set out below-For professional use only. Contains hydroquinone. Rinse eyes immediately if product comes into contact with them
Artificial nail systems for professional use0.02 per cent (after mixing for use) subject to the provisions of “Combination Rule B” set out below-

For professional use only Avoid skin contact

Read directions for use carefully

15aPotassium hydroxide and sodium hydroxideNail cuticle solvent

5 per cent calculated as sodium hydroxide

(see Note 2)

-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contain alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)(4)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Keep out of reach of children Avoid contact with the eyes
Other uses as pH adjusterPH value not to exceed 11-
15bLithium hydroxideHair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Contains alkali. Keep out of reach of children. Avoid contact with eyes
Other uses as pH adjuster (for rinse-off products only)PH value not to exceed 11-
15cCalcium hydroxideHair straighteners containing two components; calcium hydroxide and a guanidine salt7 per cent by weight of calcium hydroxide-Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness
pH adjuster for depilatoriespH value not to exceed 12.7Contains alkali. Avoid contact with eyes. Keep out of reach of children.
Other uses e.g. pH adjuster processing aidpH value not to exceed 11
16α-Naphthol [1-Naphthol] and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction
17Sodium nitriteRust inhibitor0.2 per centDo not use with secondary and/or tertiary amines or other substances forming nitrosamines-
18NitromethaneRust inhibitor0.3 per cent--
19Phenol and its alkali saltsSoaps and shampoos1 per cent calculated as phenol-Contains phenol
20ENTRY DELETED
21Quinine and its saltsShampoos0.2 per cent calculated as quinine base--
Hair lotions0.5 per cent calculated as quinine base--
22ResorcinolOxidizing colouring agent for hair dyeing for general use5 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 use5 per cent subject to the provisions of “Combination Rule B” set out below-Contain resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
Hair lotions and shampoos0.5 per cent subject to the provisions of “Combination Rule B” set out below-Contains resorcinol
23aAlkali sulphidesDepilatories2 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
23bAlkaline earth sulphidesDepilatories6 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
24Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonateAll purposes and products1 per cent calculated as zinc--
25

Zinc 4-hydroxybenzene-sulphonate

[Zinc phenolsulfonate]

Deodorants, antiperspirants and astringent lotions6 per cent calculated as percentage of anhydrous substance-Avoid contact with eyes
26Ammonium monofluoro-phosphateOral hygiene products0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains ammonium monofluorophosphate
27Sodium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium monofluoro-phosphate
28Potassium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium monofluorophosphate
29Calcium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium monofluorophosphate
30Calcium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium fluoride
31Sodium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluoride
32Potassium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium fluoride
33Ammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluoride
34Aluminium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains aluminium fluoride
35Stannous fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains stannous fluoride
36Hexadecylammonium fluoride [Cetylamine hydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains hexadecylammonium fluoride
37

3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxy-ethyl)ammonium difluoride

[Stearyl trihydroxyethyl propylenediamine dihydrofluoride]

Oral hygiene productsAs for ammonium monofluorophosphate-Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)-ammonium difluoride
38N,N’,N’—Tris(polyoxyethylene)-N-hexadecylpropylene-diamine dihydrofluoride [Palmityltrihydroxyethyl propylenediamine dihydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains N,N’,N’-tris (polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39Octadecenylammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains octadecenylammonium fluoride
40Sodium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluorosilicate
41Potassium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contain potassium fluorosilicate
42Ammonium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluorosilicate
43Magnesium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains magnesium fluorosilicate
441,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]Hair care preparations2 per centNot to be used in aerosol dispensersContains 1,3-bis(hydroxymethyl) imidazolidine-2-thione
45Benzyl alcohol (See also Part I of Schedule 6)Solvent, perfumes and flavourings--
466-Methylcoumarin0.003 per cent0.003 per cent--
47Nicomethanol hydrofluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains nicomethanol hydrofluoride
48Silver nitrateProducts to dye eyelashes or eyebrows4 per cent-Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49Selenium disulphide [Selenium sulphide]Anti-dandruff shampoos1 per cent-Contains selenium disulphide. Avoid contact with eyes or damaged skin
50Aluminium zirconium chloride hydroxide complexes AlxZr(OH)y Clz and aluminium hydroxide glycine complexesAnti-perspirants20 per cent anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium

The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 to 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
51Quinolin-8-ol and bis(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulphate]Stabilizer for hydrogen peroxide in rinse-off hair care preparations0.3 per cent calculated as base--
Stabilizer for hydrogen peroxide in non rinse-off hair car preparations0.3 per cent calculated as base--
52MethanolDenaturant for ethanol and isopropyl alcohol5 per cent calculated as a percentage of ethanol and isopropyl alcohol--
53Etidronic acid and its saltsHair care1.5 per cent expressed as etidronic acid--
54

1-Phenoxy-propan-2-ol

(See also Part I of Schedule 6) [Phenoxyisopropanol]

Products rinsed off after use2 per centProhibited in oral hygiene products-
55Lead acetateOnly for hair dyeing0.6 per cent calculated as lead-Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches. If irritation develops discontinue use
56Magnesium fluorideDental hygiene products0.15 per cent calculated as fluoride. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains magnesium fluoride
57Strontium chloride hexahydrate

(a)Toothpaste

3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent-Contains strontium chloride Frequent use by children is not advisable

(b)Shampoo and face care products

2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent--
58Strontium acetate hemihydrateToothpaste3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent-Contains strontium acetate. Use by children is not advisable
59Talc: hydrated magnesium

(a)Powdery products intended to be used for children under three years of age

--

(a):Keep powder away from children’s and mouth

(b)other products

---
60Fatty acid dialkylamides and dialkanolamidesAll purposes and productsMaximum secondary amine content: 0.5 per centDo not use with nitrosating systems. Maximum secondary amine content: 5 per cent (applies to raw materials. Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers-
61Monoalkylamines, Monoalkanolamines and their saltsAll purposes and productsMaximum secondary amine content: 0.5 per cent

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials). Maximum nitrosamine content: 50 μg/kg (applies to raw materials).

Keep in nitrite-free containers.

-
62Trialkylamines, trialkanolamines and their salts

(a)non-rinse-off products

(a)2.5 per cent

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials) Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers-

(b)other products

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials)

Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers

-
63Strontium hydroxidepH-regulator in depilatory products3.5 per cent calculated as strontiumpH value not to exceed 12.7Keep out of reach of children. Avoid contact with the eyes
64Sodium peroxideRinse-off hair care preparations for professional use4.5 per cent calculated as strontium in the ready-for-use preparationAll products must meet the hydrogen peroxide release requirementsAvoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves
65Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide)Hair care products rinsed off after use3 per cent calculated as benzalkonium chlorideIn the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C14 or less must not exceed 0.1 per cent calculated as benzalkonium chlorideAvoid contact with the eyes
66PolyacrylamidesBody-care leave-on productsMaximum residual acrylamide content 0.1 mg/kg Maximum residual acrylamide content 0.5 mg/kg-
67

Amyl cinnamal

(CAS No 122-40-7)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
68

Benzyl alcohol

(CAS No 100-51-6)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
69

Cinnamyl alcohol

(CAS No 104-54-1)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse off products

-
70

Citral

(CAS No 5392-40-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse off products

-
71

Eugenol

(CAS No 97-53-0)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
72Hydroxycitronellal (CAS No 107-75-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
73

Isoeugenol

(CAS No 97-54-1)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
74

Amylcinnamylalcohol

(CAS No 101-85-9)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
75

Benzyl salicylate

(CAS No 118-58-1)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
76

Cinnamal

(CAS No 104-55-2)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
77

Coumarin

(CAS No 91-64-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
78

Geraniol

(CAS No 106-24-1)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
79

Hydroxymethylpentyl-cyclohexene-carboxaldehyde

(CAS No 31906-04-4)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
80

Anisyl alcohol

(CAS No 105-13-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
81

Benzyl cinnamate

(CAS No 103-41-3)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
82

Farnesol

(CAS No 4602-84-0)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
83

2-(4-tert-Butylbenzyl) propionaldehyde

(CAS No 80-54-6)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
84

Linalool

(CAS No 78-70-6)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
85

Benzyl benzoate

(CAS No 120-51-4)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
86

Citronellol

(CAS No 106-22-9)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
87

Hexyl cinnamaldehyde

(CAS No 101-86-0)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
88

d-Limonene

(CAS No 5989-27-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
89

Methyl heptin carbonate

(CAS No 111-12-6)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
90

3-Methyl-4(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

(CAS No 127-51-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
91

Oak moss extract

(CAS No 90028-68-5)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
92

Treemoss extract

(CAS No 90028-67-4)

The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds:

  • 0.001 per cent in leave-on products

  • 0.01 per cent in rinse-off products

-
93

2,4-Diaminopyrimidine 3-oxide

(CAS No 74638-76-9)

Hair care formulations1.5 per cent--
94

Benzoyl peroxide

(CAS No 94-36-0)

Artificial nail systems for professional use0.7 per cent (after mixing for use)-

For professional use only Avoid skin contact

Read directions for use carefully

95Hydroquinone methyl ether (4-methoxyphenol) (CAS No 150-76-5)Artificial nail systems for professional use0.02 per cent (after mixing for use)-

For professional use only Avoid skin contact

Read directions for use carefully

PART 2U.K.SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED

Commencement Information

I8Sch. 4 Pt. 2 in force at 11.9.2004 in so far as commencd by inducing regs. 5(2), 6(1), see reg. 1(1)

I9Sch. 4 Pt. 2 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)

(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for supply until

Combination Rules

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.

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 substances shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.

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.

Note 1: May be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.
1

C.I. Basic Blue 7

(CAS No 2390-60-5)

Non-oxidising colouring agents for hair dyeing0.2 per centCan cause allergic reaction30.9.2004
22-Amino-3-nitrophenol (CAS No 603-85-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
34-Amino-3-nitrophenol (CAS No 610-81-1) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
4Naphthalene-2,7-diol (CAS No 582-17-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
53-Aminophenol (CAS No 591-27-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
63,4-Dimethylpyridine-2,6-diol (CAS No 84540-47-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
74-(3-Hydroxypropyl)amino-3-nitrophenol (CAS No 92952-81-3) and its saltsOxidising colouring agents for hair dyeing5.2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2.6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
86-Nitropyridine-2,5-diamine (CAS No 69825-83-8) and its saltsNon-oxidising colouring agent for hair dyeing3 per centCan cause allergic reaction30.9.2004
9HC Blue No. 11 (CAS No 23920-15-2) and its saltsOxidising colouring agent for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
102-(2-Nitro-p-toluidino)-ethanol (CAS No 100418-33-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
112-(2-Hydroxyethylamino)-4,6-dinitrophenol (CAS No 99610-72-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
124-Methylaminophenol (CAS No 150-75-4) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
132-(2,4-Diamino-5-methylphenoxy)ethanol (CAS No 141614-05-3) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
14HC Violet No. 2 (CAS No 104226-19-9) and its saltsNon-oxidising colouring agent for hair dyeing2 per cent30.9.2004
152-(2,6-Dinitro-p-anisidino)ethanol (CAS No 122252-11-3) and its saltsNon-oxidising colouring agent for hair dyeing3 per centCan cause allergic reaction30.9.2004
16HC Blue No. 12 (CAS No 104516-93-0) and its saltsOxidising colouring agents for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agent for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
174-Ethoxy-6-methyl-m-phenylenediamine (CAS No 113715-25-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
184,4’-(Trimethylenedioxy)di-m-phenylenediamine (CAS No 81892-72-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
193-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
203-Methyl-l-phenyl-5-pyrazolone (CAS No 89-25-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
215-(2-Hydroxyethyl)amino- o-cresol (CAS No 55302-96-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
223,4 Dihydro-2H-1,4-benzoxazin-6-ol (CAS No 26021-57-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
23Naphthalene-1,7-diol (CAS No 575-38-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per centCan cause allergic reaction30.9.2004
24HC Yellow No.10 (CAS No 109023-83-8) and its saltsNon-oxidising colouring agents for hair dyeing0.2 per cent30.9.2004
252,6-Dimethoxy-3,5- pyridinediamine (CAS No 85679-78-3) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
26HC Orange No.2 (CAS No 85765-48-6) and its saltsNon-oxidising colouring agent for hair dyeing1 per cent30.9.2004
27HC Violet No.1 (CAS No 82576-75-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
282-(3-Methylamino-4-nitrophenoxy)ethanol (CAS No 59820-63-2) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent30.9.2004
292-(2-Methoxy-4-nitroanilino)ethanol (CAS No 66095-81-6) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent30.9.2004
302-(4-Amino-2-chloro-5-nitroanilino)ethanol (CAS No 50610-28-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
31HC Red No. 13 (CAS No 94158-13-1)Oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent30.9.2004
32Naphthalene-1,5-diol (CAS No 83-56-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
332,2’-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino]diethanol (CAS No 128729-30-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
342-Aminophenol (CAS No 95-55-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
355-Amino-o-cresol (CAS No 2835-95-2) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
362-(2,4-Diamino-phenoxy)ethanol (CAS No 66422-95-5) and its saltsOxidising colouring agents for hair dyeing4 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent30.9.2004
372-Methylresorcinol (CAS No 608-25-3) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
384-Amino-m-cresol (CAS No 2835-99-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
392-Amino-4-hydroxyethyl-aminoanisole (CAS No 83763-47-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
403,4-Diaminobenzoic acid (CAS No 619-05-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
416-Amino-o-cresol (CAS No 17672-22-9) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
422-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
432-Amino-2-(2-hydroxyethylaminomethyl) (CAS No 110952-46-0 and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
44N-(2-Hydroxyethyl)-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
45C.I. Acid Black 52 (CAS No 3618-58-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.per cent30.9.2004
462-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its saltsOxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
47HC Blue No.2 (CAS No 33229-34-4) and its saltsNon-oxidising colouring agents for hair dyeing2.8 per cent30.9.2004
484-(2-Hydroxyethylamino)-3-nitrophenol (CAS No 65235-31-6) and its saltsOxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent30.9.2004
492-(4-Nitrophenylamino)-ethylurea (CAS No 27080-42-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
50HC Red No. 10 (CAS No 95576-89-9) + HC Red No. 11 (CAS No 95576-92-4) and their saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
51HC Yellow No. 6 (CAS No 104333-00-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
52HC Yellow No.12 (CAS No 59320-13-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent30.9.2004
53HC Blue No. 10 (CAS No 102767-27-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
54HC Blue No. 9 (CAS No 114087-47-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
552-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent30.9.2004
562-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent30.9.2004
57C.I. Basic Blue 26 (CAS No 2580-56-5) (C.I. No. 44045)Oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent30.9.2004
58

C.I. Acid Red 33 (CAS No 3567-66-6)

(C.I. No. 17200)

Non-oxidising colouring agents for hair dyeing2 per cent30.9.2004
59

C. I. Food Red 1 (CAS No 4548-53-2)

(C.I. No. 14700)

Non-oxidising colouring agents for hair dyeing2 per cent30.9.2004
60

C.I. Basic Violet 14 (CAS No 632-99-5)

(C.I. No. 42510)

Oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent30.9.2004
61

1-tert-Butyl-3,5-dimethyl-2,4,6-trinitrobenzene (CAS No 81-15-2)

(musk xylene)

All cosmetic products, with the exception of oral care products

1 per cent in fine fragrance

0.4 per cent in eau de toilette

0.03 per cent in other products

30.9.2004
624’-tert-Butyl-2’,6’-dimethyl-3’, 5’-dinitroacetophenone (CAS No 81-14-1) (musk ketone)All cosmetic products, with the exception of oral care products

1.4 per cent in fine fragrance

0.56 per cent in eau de toilette

0.042 per cent in other products

30.9.2004

Regulation 5(2) and 7(9)

SCHEDULE 5U.K.LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR AND EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule the colouring agents referred to in regulation 5(2)(d) are—

(i)those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). ;

(ii)lakes or salts of these colouring agents which do not use substances prohibited under Schedule 3.

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 23rd October 1962 on the approximation of the rules of Member States concerning foodstuffs and colouring matter (5), as amended (6) adapted (7) and replaced in part (8) must fulfil the purity requirements laid down in those Directives.

PART IU.K.COLOURING AGENTS LISTED IN ANNEX IV, PART 1 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Commencement Information

I10Sch. 5 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I11Sch. 5 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(9), see reg. 1(2)

Field of applicationU.K.

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)
Name or colour index numberColourType of production Field of applicationOther requirement
1234
10006GreenX
10020GreenX
10316*YellowX
11680YellowX
11710YellowX
11725OrangeX
11920OrangeX
12010RedX
12085*RedX3 per cent maximum concentration in the finished product
12120RedX
12150RedX
12370RedX
12420RedX
12480BrownX
12490RedX
12700YellowX
13015YellowXE 105
14270OrangeXE 103
14700RedX
14720RedXE 122
14815RedXE 125
15510*OrangeX
15525RedX
15580RedX
15620RedX
15630*RedX3 per cent maximum concentration in the finished product
15800RedX
15850*RedX
15865*RedX
15800RedX
15980OrangeXE 111
15985*YellowXE 110
16035RedX
16185RedXE 123
16230OrangeX
16255*RedXE 124
16290RedXE 126
17200*RedX
18050RedX
18130RedX
18690YellowX
18736RedX
18820YellowX
18965YellowX
19140*YellowXE 102
20040YellowX

Maximum 3,3’-dimethyl-benzidine concentration in the colouring agent:

5 mg/kg

20170OrangeX
20470BlackX
21100YellowXMaximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21108YellowXMaximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21230YellowX
24790RedX
26100RedXPurity criteria: aniline ≤ 0.2 per cent, 2-naphthol ≤ 0.2 per cent, azobenzen-4-amine ≤ 0.1 per cent, 1-phenylazo-2- naphthol ≤ 3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤ 2 per cent
27290*RedX
27755BlackXE 152
28440BlackXE 151
40215OrangeX
40800OrangeX
40820OrangeXE 160e
40825OrangeXE 160f
40850OrangeXE 161g
42045BlueX
42051*BlueX
42053GreenX
42080BlueX
42090BlueX
42100GreenX
42170GreenX
42510VioletX
42520VioletXMaximum concentration in the finished product: 5 mg/kg
42735BlueX
44045BlueX
44090GreenXE 142
45100RedX
45190VioletX
45220RedX
45350YellowX6 per cent. maximum concentration in the finished product
45370OrangeXNot 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*RedXAs immediately above
45396OrangeXWhen used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405RedXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45410*RedXAs immediately above
45425RedXNot 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*RedXAs immediately above, E 127
47000YellowX
47005YellowXE 104
50325VioletX
50420BlackX
51319VioletX
58000RedX
59040GreenX
60724VioletX
60725VioletX
60730VioletX
61565GreenX
61570GreenX
61585BlueX
62045BlueX
69800BlueXE 130
69825BlueX
71105OrangeX
73000BlueX
73015BlueXE 132
73360RedX
73385VioletX
73900VioletX
73915RedX
74100BlueX
74160BlueX
74180BlueX
74260GreenX
75100YellowX
75120OrangeXE 160b
75125YellowXE 160d
75130OrangeXE 160a
75135YellowXE 161d
75170WhiteX
75300YellowXE 100
75470RedXE 120
75810GreenXE 140 and E 141
77000WhiteX
77002WhiteX
77004WhiteX
77007BlueX
77015RedX
77120WhiteX
77163WhiteX
77220WhiteXE 170
77231WhiteX
77266BlackX
77267BlackX
77268:1BlackXE 153
77288GreenXFree from chromate ions
77289GreenXFree from chromate ions
77346GreenX
77400BrownX
77480BrownXE 175
77489OrangeXE 172
77491RedXE 172
77492YellowXE 172
77499BlackXE 172
77510BlueXFree from cyanide ions
77713WhiteX
77742VioletX
77745RedX
77820WhiteXE 174
77891WhiteXE 171
77947WhiteX
Acid Red 195RedX
Aluminium, zinc, magnesium and calcium stearatesWhiteX
AnthocyaninsRedXE 163
Beetroot redRedXE 162
Bromocresol greenGreenX
Bromothymol blueBlueX
CaramelBrownXE 150
Capsanthin, capsorubinOrangeXE 160c
LactoflavinYellowXE 101

PART IIU.K.COLOURING AGENTS LISTED IN ANNEX IV, PART 2 OF THE DIRECTIVE 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

Commencement Information

I12Sch. 5 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I13Sch. 5 Pt. II in force at 11.3.2005 in so far as commence by inducing reg. 7(9), see reg. 1(2)

Field of applicationU.K.

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-section 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)
Name or colour index numberColourType of production Field of applicationOther requirementCosmetic product supplied until
Note: There are no entries in this Part at the date that these Regulations are made.
1234

Regulations 5(2) and 7(2)

SCHEDULE 6U.K.LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

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 column 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 not 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 —

(b)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

(c)the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule—

“salt” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;

“ester” 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.

Names which appear in square brackets in column 2 of this Schedule are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC (9).

Regulation 1(3) provides that until 24th March 2005 entry 36 in Part 1 of this Schedule shall be inserted into Part 1 of this Schedule as it appears in the Cosmetic Products (Safety) Regulations 2003(10). From 24th March 2004 entry 36 shall have effect as it appears in Part 1 of this schedule.

PART IU.K.PRESERVATIVES LISTED IN ANNEX VI, PART 1 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Commencement Information

I14Sch. 6 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I15Sch. 6 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(2), see reg. 1(2)

(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1Benzoic acid, its salts and estersAll products0.5 per cent (expressed as acid)A —
2Propionic acid and its saltsAll products2 per cent (expressed as acid)A —
3Salicylic acid and its saltsAll products0.5 per cent (expressed as acid)A Not to be used in preparations for children under three years of age except for shampoosNot 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)
4Sorbic acid (hexa-2,4-dienoic acid) and its saltsAll products0.6 per cent (expressed as acid)A —
5Formaldehyde and para-formaldehydeFor oral hygiene0.1 per cent (expressed as free formaldehyde)Not to be used in aerosol dispensers (sprays)
6ENTRY DELETED
7

Biphenyl-2-ol

[o-phenylphenol] and its salts

All products0.2 per cent (expressed as the phenol)A —
8

Pyrithione zinc (INN)

[Zinc pyrithione]

Products rinsed off after use0.5 per centA Not to be used in oral hygiene products
9Inorganic sulphites and hydrogen sulphitesAll products0.2 per cent (expressed as free SO2)A —
10Sodium iodateProducts rinsed off after use0.1 per cent
11Chlorobutanol (INN)All products0.5 per centNot to be used in aerosol dispensers (sprays)Contains chlorobutanol
12

4-Hydroxybenzoic acid and its salts and esters

[the Parabens]

All products0.4 per cent (expressed as acid) for 1 ester, 0.8 per cent (expressed as acid) for mixtures of estersA —
133-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its saltsAll products0.6 per cent(expressed as acid)Not to be used in aerosol dispensers (sprays)
14Formic acid and its sodium saltAll products0.5 per cent (expressed as acid)A —
153,3’-Dibromo-4,4’-hexa-methylenedioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate)All products0.1 per cent
16

Thiomersal (INN)

[Thimerosal]

Eye make-up and eye make-up remover0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per centContains thiomersal
17

Phenylmercuric salts

(including borate)

Eye make-up and eye make-up remover0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per centContains phenylmercuric compounds
18Undec-10-enoic acid [Undecylenic acid] and its saltsAll products0.2 per cent (expressed as acid)A —
19Hexetidine (INN)Products rinsed off after use0.1 per centA —
205-Bromo-5-nitro-1,3-dioxaneProducts rinsed off after use0.1 per centAvoid formatation of nitrosamines
21Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol]All products0.1 per centA Avoid formatation of nitrosamines
222,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol]All products0.15 per centA —
23Triclocarban (INN)All products0.2 per centA Purity criteria: 3,3’,4,4’-tetra-chloroazobenzene < 1 mg/kg
24

4-Chloro-m-cresol

[p-Chloro-m-cresol]

Not to be used in products intended to come into contact with mucous membranes0.2 per centA —
25Triclosan (INN)All products0.3 per centA —
264-Chloro-3,5-xylenol [Chloroxylenol]All products0.5 per centA —
27

3,3’-Bis(l-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1’-methylenediurea

[Imidazolidinyl urea]

All products0.6 per centA —
28Poly(l-hexamethylenebiguanide hydrochloride) [Polyaminopropyl biguanide]All products0.3 per centA —
292-Phenoxyethanol [Phenoxyethanol]All products1.0 per centA —
30Hexamethylenetetramine (Methenamine (INN)) [Methenamine]All products0.15 per centA —
31

Methenamine 3-chloroallylo-chloride (INNM)

[Quaternium-15]

All products0.2 per cent
32

1-(4-Chlorophenoxy)-1-(imidazol-l-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole]

All products0.5 per centA —
331,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin]All products0.6 per centA —
34

Benzyl alcohol (see also Part I of Schedule 4)

All products1.0 per centA —
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine]Products rinsed off after use1.0 per centA —
Other products0.5 per centA —
362-Bromo-2-(bromomethyl) glutaronitrile (1,2-dibromo-2,4-dicyanobutane)[Methyldibromo glutaronitrile]Rinse-off products only0.1 per cent
376,6-Dibromo-4,4-dichloro-2,2’-methylenediphenol [Bromochlorophen]All products0.1 per centA —
38

4-Isopropyl-m-cresol

[o-Cymen-5-ol]

All products0.1 per cent
39Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone]All products0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one
402-Benzyl-4-chlorophenol [Chlorophene]All products0.2 per cent
412-Chloroacetamide [Chloroacetamide]All products0.3 per centContains chloroacetamide
42Chlorhexidine (INN) and its digluconate, diacetate and dihydrochlorideAll products0.3 per centA —
431-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part 1 of Schedule 4)Products rinsed off after use1.0 per cent
44Alkyl (C12-C22)-trimethyl-ammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM))All products0.1 per centA —
454,4-Dimethyl-1,3-oxazolidine [Dimethyloxazolidine]All products0.1 per centThe pH of the finished product must not be lower than 6
461-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea]All products0.5 per cent
47

Hexamidine (INN)

(4,4’-(Hexamethylenedioxy)-dibenzamidine) and its salts, including isethionate and

p-hydroxybenzoate

All products0.1 per centA —
48Glutaraldehyde (pentane-1,5-dial) [Glutaral]All products0.1 per centProhibited in aerosols (sprays)Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
49

5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane

[7-Ethylbicyclo-oxazolidine]

All products0.3 per centProhibited in oral hygiene products and in products intended to come into contact with mucous membranes
50Chlorphenesin (INN) [Chlorphensin]All products0.3 per cent
51Sodium N-hydroxymethyl-glycinate [Sodium hydroxymethylglycinate]All products0.5 per cent
52Silver chloride deposited on titanium dioxideNot to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips0.004 per cent, calculated as silver chlorideThe ratio of titanium dioxide to silver chloride shall be 4:1 by mass
53Benzethonium chloride (INN) [Benzethonium chloride]Products rinsed off after use0.1 per cent
54Benzalkonium chloride, bromide and saccharinateAll products0.1 per cent calculated as benzalkonoium chlorideA —Avoid contact with eyes
55BenzylhemiformalProducts rinsed off after use0.15 per cent
56

3-lodoprop-2-ynyl butylcarbamate

[Iodopropynyl butylcarbamate]

Not to be used in oral hygiene and lip products0.05 per centContains iodine (Only required where the 3-iodoprop-2-ynyl butylcarbamate concentration in products intended to remain on the skin exceeds 0.02 per cent)

PART 2U.K.PRESERVATIVES LISTED IN ANNEX VI, PART 2 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LIAD DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

Commencement Information

I16Sch. 6 Pt. 2 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I17Sch. 6 Pt. 2 in force at 11.3.2005 in so far as commenced by indcuing reg. 7(2), see reg. 1(2)

(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for supply until
Note: There are no entries in this Part at the date that these Regulations are made.

Regulations 5(2), 7(2) and 7(9)

SCHEDULE 7U.K.LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC (11)

PART 1U.K.UV FILTERS LISTED IN ANNEX VII, PART 1 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Commencement Information

I18Sch. 7 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I19Sch. 7 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)

(1)(2)(3)(4)(5)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired information
14-Aminobenzoic acid [PABA]5 per cent
2N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate]6 per cent
3Homosalate (INN)10 per cent
4

Oxybenzone (INN)

[Benzophenone-3]

10 per centContains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product)
5ENTRY DELETED
62-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts8 per cent (expressed as acid)
73,3-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts10 per cent (expressed as acid)
8

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

[Butyl methoxy dibenzoylmethane]

5 per cent
9α-(2-Oxoborn-3-ylidine)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts6 per cent (expressed as acid)
102-Ethylhexyl 2-cyano-3,3-diphenylacrylate [Octocrylene]10 per cent (expressed as acid)
11

Polymer of N-[(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl]acrylamide

Polyacrylamidomethyl benzylidene camphor]

6 per cent
12

2-Ethylhexyl 4-methoxycinnamate

[Octyl methoxycinnamate]

10 per cent
13

Ethoxylated ethyl-4-aminobenzoate

[PEG-25 PABA]

10 per cent
14

Isopentyl 4-methoxycinnamate

[Isoamyl p-methoxycinnamate]

10 per cent
15

Tris(2-ethylhexyl) 4,4’4”-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate

[Octyl triazone]

5 per cent
16

2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-l-(trimethylsilyloxy)-disiloxan-1-yl]propyl]phenol

[Drometrizole trisiloxane]

15 per cent
17Bis(2-ethylhexyl) 4,4’-[6-tert-butylcarbamoylanilino)-1,3,5-triazine-2,4-diyldiimino]dibenzoate10 per cent
18

3-(4-Methylbenzylidine)bornan-2-one

[4-Methylbenzylidene camphor]

4 per cent
19

3-Benzylodenebornan-2-one

[3-Benzylidene camphor

2 per cent
20

2-Ethylhexyl salicylate

[Octyl salicylate]

5 per cent
21

2-Ethylhexyl 4-dimethylaminobenzoate

[Octyl dimethyl PABA]

8 per cent
222-Hydroxy-4-methoxybenzophenone-5-sulfonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM))5 per cent (expressed as acid)
232-2’-Methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol]10 per cent
24diSodium 2,2’-(1,4-phenylene)bis(lH-benzimidazole-4,6-disulfonate)10 per cent (expressed as acid)
255,5’-Bis(2-ethylhexyloxy)-2,2’-(6-p-methoxyphenyl-1,3,5-triazine-2, 4-diyl)diphenol10 per cent
26

α-(Trimethylsilyl)-w-(trimethylsilyloxy)poly-[oxy(dimethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl]phenoxy]-1-methyleneethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl)]phenoxy]prop-1-enyl)silylene] where there are usually 60 polymeric units, of which the first part of the copolymer provides 56 (Dimethicodiethylbenzyalmalonate)

(CAS No. 207574-74-1)

10 per cent
27Titanium dioxide25 per cent

PART IIU.K.UV FILTERS LISTED IN ANNEX VIII, PART 2 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

Commencement Information

I20Sch. 7 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)

I21Sch. 7 Pt. II in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)

(1)(2)(3)(4)(5)(6)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired informationUV filter supplied until
Note: There are no entries in this Part at the date that these Regulations are made.

Regulation 5(5)

SCHEDULE 8U.K.METHODS OF MANUFACTURE OF TALLOW DERIVATIVES

Commencement Information

I22Sch. 8 in force at 11.9.2004, see reg. 1(1)

The following are the methods of manufacture referred to in regulation 5(5)—

(a)transesterification or hydrolysis at a temperature of at least 200ºC and at an appropriate corresponding pressure for 20 minutes (glycerol, fatty acids and fatty acid esters);

(b)saponification with sodium hydroxide solution, c(NaOH) = 12mol/l (glycerol and soap)—

(i)batch process: at 95°C for three hours; or

(ii)continuous process: at 140°C, two bars (2,000hPa) for eight minutes, or equivalent conditions.

Regulations 7(2), 7(6) and 7(11)

SCHEDULE 9U.K.

PART 1U.K.SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 7(6) AND 7(11)

Commencement Information

I23Sch. 9 Pt. 1 in force at 11.9.2004 as commenced by inducing reg. 7(6)(11) , see reg. 1(1)

Prospective

PART 2U.K.SYMBOL IN ANNEX VIIIa OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATION 7(2)(c)

Commencement Information

I24Sch. 9 Pt. 2 in force at 11.3.2005 as commenced by reg. 7(2), see reg. 1(2)

Regulation 12(3) and (5)

SCHEDULE 10U.K.

PART 1U.K.PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY

1.  The name or trade name and address or registered office of the applicant.U.K.

Commencement Information

I25Sch. 10 Pt. 1 para. 1 in force at 11.9.2004, see reg. 1(1)

2.  Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—U.K.

(a)where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;

(b)the European List of Notified Chemical Substances (ELINCS) name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC(12) and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;

(c)where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents.

Commencement Information

I26Sch. 10 Pt. 1 para. 2 in force at 11.9.2004, see reg. 1(1)

3.  The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 9(1)(d)and (e) and carried out in accordance with the requirements of regulations 9(2), 9(3) and 9(4).U.K.

Commencement Information

I27Sch. 10 para. 3 in force at 11.9.2004, see reg. 1(1)

4.  The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.U.K.

Commencement Information

I28Sch. 10 para. 4 in force at 11.9.2004, see reg. 1(1)

5.  A detailed justification of why confidentiality is sought addressing for example—U.K.

(a)the fact that the identify of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;

(b)the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;

(c)the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.

Commencement Information

I29Sch. 10 para. 5 in force at 11.9.2004, see reg. 1(1)

6.—(1) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other Member States, precise details of each one of them.U.K.

(2) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.

(3) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.

Commencement Information

I30Sch. 10 para. 6 in force at 11.9.2004, see reg. 1(1)

7.  A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.U.K.

Commencement Information

I31Sch. 10 para. 7 in force at 11.9.2004, see reg. 1(1)

PART IIU.K.PROCEDURE FOR GRANT OF REGISTRATION NUMBER

1.  The registration number referred to in regulation 12(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each Member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.U.K.

Commencement Information

I32Sch. 10 Pt. II para. 1 in force at 11.9.2004, see reg. 1(1)

2.  The code allocated to the United Kingdom is 06.U.K.

Commencement Information

I33Sch. 10 Pt. II para. 2 in force at 11.9.2004, see reg. 1(1)

Regulation 17

SCHEDULE 11U.K.SAMPLING AND TESTING

1.  In this Schedule—U.K.

“Annex A” means the Annex to Commission Directive No. 80/1335/EEC(13) as amended by Commission Directive No.87/143/EEC(14)

“Annex B” means the Annex to Commission Directive No. 82/434/EEC(15) as amended by Commission Directive No.90/207/EEC(16)

“Annex C” means the Annex to Commission Directive No. 83/514/EEC(17);

“Annex D” means the Annex to Commission Directive No. 85/490/EEC(18);

“Annex E” means the Annex to Commission Directive No. 93/73/EEC(19);

“Annex F” means the Annex to Commission Directive No. 95/32/EC(20);

“Annex G” means the Annex to Commission Directive No. 96/45/EC(21);

“purchase” means purchase for the purpose of carrying out a test.

Commencement Information

I34Sch. 11 para. 1 in force at 11.9.2004, see reg. 1(1)

2.  An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part 1 of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part 1 of Annex A; samples shall be regarded as having the sample batch number if—U.K.

(a)the means of identifying the batch referred to in regulation 7(2)(h) above shows that they were manufactured in the same batch;

(b)in the case of a product not manufactured in a batch, the reference referred to in regulation 7(2)(h) above shows that they are derived from the same unit of production; or

(c)in the case of a product which does not comply with the requirements of regulation 7(2)(h) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.

Commencement Information

I35Sch. 11 para. 2 in force at 11.9.2004, see reg. 1(1)

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.U.K.

Commencement Information

I36Sch. 11 para. 3 in force at 11.9.2004, see reg. 1(1)

4.  As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—U.K.

(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.

Commencement Information

I37Sch. 11 para. 4 in force at 11.9.2004, see reg. 1(1)

5.—(1) Subject to sub-paragraph (2) below, the provisions of Part 1 of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.U.K.

(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.

Commencement Information

I38Sch. 11 para. 5 in force at 11.9.2004, see reg. 1(1)

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.U.K.

(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.

(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.

(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.

(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzene- sulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC(22), and shall take into account paragraph 11 of Part VII of Annex A.

(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzene-sulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.

(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.

(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part 1 of Annex B.

(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.

(10) Any test to determine whether a hair dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.

(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.

(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.

(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.

(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.

(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.

(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol-and bis(8-hydroxyquinolinium) sulphate”.

(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.

(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.

(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair waving, hair straightening and depilatory products”.

(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.

(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.

(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.

(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.

(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.

(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.

(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.

(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.

(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.

(33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.

(34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.

(35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.

(36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.

(37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.

(38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.

(39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.

(40) Any test for the identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether in cosmetic products”.

(41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.

Commencement Information

I39Sch. 11 para. 6 in force at 11.9.2004, see reg. 1(1)

Regulation 3(1), 5(7), (9) and (12)

SCHEDULE 12U.K.List of Alternative Methods to Animal Testing

PART 1U.K.

Commencement Information

I40Sch. 12 Pt. 1 in force at 11.9.2004, see reg. 1(1)

Part 1 of this Schedule lists the alternative methods validated by the European Centre for the Validation of Alternative Methods (“ECVAM”) which are necessary to meet the requirements of these Regulations and which are listed in Annex V to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances (23).

The reference number given in the second column of the table in Part 1 refers to the reference number under which the type of test is listed in Annex V to Directive 67/548/EEC.

Entry NumberReference NumberType of Test (toxicological endpoint)Alternative Test MethodDate after which this method is required to be used
1B40Skin corrosionRat skin TER assay11.9.04
2B40Skin corrosionHuman skin model assay11.9.04
3B41PhototoxicityIn vitro 3T3 NRU phototoxicity test11.9.04

PART 2U.K.

Commencement Information

I41Sch. 12 Pt. 2 in force at 11.9.2004, see reg. 1(1)

Part 2 of this Schedule lists the alternative methods validated by ECVAM which are necessary to meet the requirements of these Regulations and which are listed in Annex IX to the Directive. As an alternative method may not replace completely the experimentation on animals, column 3 of the table below specifies whether the alternative method fully or partially replaces the animal test.

Entry NumberReference NumberNature of replacementAlternative Test MethodDate after which this method is required to be used
Note: There are no entries in this Part at the date that these Regulations are made.

Regulation 5(15)

SCHEDULE 13U.K.LIST OF SUBSTANCES CLASSIFIED AS CARCINOGENIC, MUTAGENIC OR TOXIC FOR REPRODUCTION OF CATEGORY 3 UNDER DIRECTIVE 67/548/EEC WHICH APPEAR IN THE APPROVED SUPPLY LIST

Commencement Information

I42Sch. 13 in force at 11.9.2004, see reg. 1(1)

The substances listed in this table are classified as carcinogenic, mutagenic or toxic for reproduction under directive 67/548/EEC(24) and in the approved supply list. These substances have been evaluated as safe by the Scientific Committee on Cosmetic Products(25) in accordance with article 4b of the Directive and are permitted for use in cosmetic products.

SubstanceIndex NumberEC NumberCAS Number
Note: There are no entries in this Part at the date that these Regulations are made.
(2)

O.J. No. L132, 1.6.1996, p.1.

(4)

Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.

(5)

O.J. No. 115, 11.11.62, p.2645.

(6)

Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and

85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p. 4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108,26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22).

(7)

Annexes 1 and VII to the Act of Accession of 22nd January 1972, as adjusted by the Council Decision of 1st January 1973 (O.J. No. L2, 1.1.73, p.1).

(8)

Council Directive 94/36/EC (O.J) No. L237, 10.9.94, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.95, p.1).

(9)

O. J. No. L132, 1.6..96, p.1.

(11)

O.J. No. L132, 1.6.96, p.1.

(12)

O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EEC (O.J. L152, 30.4.2004, p.1)

(13)

O.J. No. L383, 31.12.80, p.27.

(14)

O,J. No. L57, 27.2.87, p.56.

(15)

O.J. No. L185, 30.6.82, p.1.

(16)

O.J. No. L108, 28.4.90, p.92.

(17)

O.J. No. L291, 24.10.83, p.9.

(18)

O.J. No. L295, 7.11.85, p.30.

(19)

O.J. No. L231, 14.9.93, p.34.

(20)

O.J. No.L178, 28.7.95, p.20.

(21)

O.J. No. L213, 2.7.96, p.8.

(22)

O.J. No. L57, 27.2.87, p.56.

(23)

O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EC (O.J. L152, 30.4.2004, p.1)

(24)

Council Directive 1967/548/EEC (OJ 196,16.8.67, p.1) as last amended by 2004/73/EC (O.J. L152, 30.4.2004, p.1)

(25)

the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”)

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