N-5-Chlorobenzoxazol-2-ylacetamide

F12-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts

Deanol aceglumate7

Spironolactone*

F1[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts

Methotrexate*

Aminocaproic acid* and its salts

Cinchophen*, its salts, derivatives and salts of these derivatives

Thyropropic acid* and its salts

Trichloroacetic acid

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

Aconitine (principal alkaloid of Aconitum napellus L.) and its salts

Adonis vernalis L. and its preparations

Epinephrine*

Rauwolfia serpentina alkaloids and their salts

Alkyne alcohols, their esters, ethers and salts

Isoprenaline*

Allyl isothiocyanate

Alloclamide* and its salts

Nalorphine*, its salts and ethers

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

Aniline, its salts and its halogenated and sulphonated derivatives

Betoxycaine* and its salts

Zoxazolamine*

Procainamide*, its salts and derivatives

Benzidine

Tuaminoheptane*, its isomers and salts

Octodrine* and its salts

F12-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts

1,3-dimethylpentylamine and its salts

4-Aminosalicylic acid and its salts

Toluidines, their isomers, salts and halogenated and sulphonated derivatives

Xylidines, their isomers, salts and halogenated and sulphonated derivatives

F1Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one)

Ammi majus and its galenical preparations

2,3-Dichloro-2-methylbutane

Substances with androgenic effect

Anthracene oil

Antibiotics F2

Antimony and its compounds

Apocynum cannabinum L. and its preparations

F1Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4H-dibenzo [de,g]quinoline-10,11-diol) and its salts

Arsenic and its compounds

Atropa belladonna L. and its preparations

Atropine, its salts and derivatives

F3Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1, and lakes, salts and pigments prepared from the colouring agents listed with the reference (⁵) in Annex III, Part 2 and Annex IV, Part 2.

Benzene

F1Benzimidazol-2(3H)-one

F1Benzazepines and benzodiazepines

F11-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts

F12,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts

F1Isocarboxazid*

Bendroflumethiazide* and its derivatives

Beryllium and its compounds

Bromine, elemental

Bretylium tosilate*

Carbromal*

Bromisoval*

Brompheniramine* and its salts

Benzilonium bromide*

Tetrylammonium bromide*

Brucine

Tetracaine* and its salts

Mofebutazone*

Tolbutamide*

Carbutamide*

Phenylbutazone*

Cadmium and its compounds

Cantharides, Cantharis vesicatoria

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

Phenprobamate*

F1Nitroderivatives of carbazole

Carbon disulphide

Catalase

Cephaeline and its salts

Chenopodium ambrosioides (essential oil)

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

Chlorine

Chlorpropamide*

F1Diphenoxylate* hydrochloride

4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)

Chlorzoxazone*

2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)

Chlorprothixene* and its salts

Clofenamide*

F1N,N-bis(2-chloroethyl)methylamine N-oxide and its salts

Chlormethine* and its salts

Cyclophosphamide* and its salts

Mannomustine* and its salts

Butanilicaine* and its salts

F1Chlormezanone*

Triparanol*

2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)

Chlorphenoxamine*

F12-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO)

Chloroethane

Chromium; chromic acid and its salts

Claviceps purpurea Tul., its alkaloids and galenical preparations

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

Glycyclamide*

Cobalt benzenesulphonate

Colchicine, its salts and derivatives

Colchicoside and its derivatives

Golchicum autumnale L. and its galenical preparations

Convallatoxin

Anamirta cocculus L. (fruit)

Croton tiglium (oil)

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

Curare and curarine

Synthetic curarizants

Hydrogen cyanide and its salts

F12-α-Cyclohexylbenzyl(N,N,N',N',-tetraethyl)trimethylenediamine (phenetamine)

Cyclomenol* and its salts

Sodium hexacyclonate*

Hexapropymate*

Dextropropoxyphene*

F1O,O'-Diacetyl-N-allyl-N-normorphine

Pipazetate* and its salts

F15-(αβ-Dibromophenethyl)-5-methylhydantoin

F1N,N'-Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide*

F1N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e.g. azamethonium bromide*

Cyclarbamate*

Clofenotane*; DDT (ISO)

F1N,N'-Hexamethylenebis(trimethylammonium) salts, e.g. hexamethonium bromide*

Dichloroethanes (ethylene chlorides)

Dichloroethylenes (acetylene chlorides)

Lysergide* and its salts

F12-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts

Cinchocaine* and its salts

3-Diethylaminopropyl cinnamate

F1O,O'-Diethyl O-4-nitrophenyl phosphorothioate (parathion-lSO)

F1[Oxalylbisiminoethylene)]bis[(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium cloride*

Methyprylon* and its salts

Digitaline and all heterosides of Digitalis purpurea L.

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

Dioxethedrin* and its salts

Piprocurarium*

Propyphenazone*

Tetrabenazine* and its salts

Captodiame*

Mefeclorazine* and its salts

Dimethylamine

F11,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts

Methapyrilene* and its salts

Metamfepramone* and its salts

Amitriptyline* and its salts

Metformin* and its salts

Isosorbide dinitrate*

Malononitrile

Succinonitrile

Dinitrophenol isomers

Inproquone*

Dimevamide* and its salts

Diphenylpyraline* and its salts

Sulfinpyrazone*

F1N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e.g. isopropamide iodide*

Benactyzine*

Benzatropine* and its salts

Cyclizine* and its salts

F15,5-Diphenyl-4-imidazolidone

Probenecid*

Disulfiram*; thiram (ISO)

Emetine, its salts and derivatives

Ephedrine and its salts

Oxanamide* and its derivatives

Eserine or physostigmine and its salts

Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in F4Annex VII, Part 2

Choline salts and their esters, e.g. choline chloride

Caramiphen* and its salts

Diethyl 4-nitrophenyl phosphate

Metethoheptazine* and its salts

Oxpheneridine* and its salts

Ethoheptazine* and its salts

Metheptazine* and its salts

Methylphenidate* and its salts

Doxylamine* and its salts

Tolboxane*

F5X14-Benzyloxyphenol and 4-ethoxyphenol

Parethoxycaine* and its salts

Fenozolone*

Glutethimide* and its salts

Ethylene oxide

Bemegride* and its salts

Valnoctamide*

Haloperidol*

Paramethasone*

Fluanisone*

Trifluperidol*

Fluoresone*

Fluorouracil*

F1Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1

Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*

Galantamine*

Progestogens F2

1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)

F1(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-dimethano-naphthalene (endrin-ISO)

Hexachloroethane

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethano-naphthalene (isodrin-ISO)

Hydrastine, hydrastinine and their salts

Hydrazides and their salts

Hydrazine, its derivatives and their salts

Octamoxin* and its salts

Warfarin* and its salts

F1Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid

Methocarbamol*

Propatylnitrate*

F14,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin

Fenadiazole*

Nitroxoline* and its salts

Hyoscyamine, its salts and derivatives

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

Pemoline* and its salts

Iodine

F1Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide

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

(2-Isopropylpent.4-enoyl)urea (apronalide)

F1α-Santonin [(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]

Lobelia inflata L. and its galenical preparations

Lobeline* and its salts

Barbiturates

F6Mercury and its compounds, except those special cases included F7in Annex VI, Part 1

3,4,5-Trimethoxyphenethylamine and its salts

Metaldehyde

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

Coumetarol*

Dextromethorphan* and its salts

2-Methylheptylamine and its salts

Isometheptene* and its salts

Mecamylamine*

Guaifenesin*

Dicoumarol*

Phenmetrazine*, its derivatives and salts

Thiamazole*

F13,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)

Carisoprodol*

Meprobamate*

Tefazoline* and its salts

Arecoline

Poldine metilsulfate*

Hydroxyzine*

2-Naphthol

1-and 2-Naphthylamines and their salts

F13-(1-Naphthyl)-4-hydroxycoumarin

Naphazoline* and its salts

Neostigmine and its salts (e.g. neostigmine bromide*)

Nicotine and its salts

Amyl nitrites

Inorganic nitrites, with the exception of sodium nitrite

Nitrobenzene

Nitrocresols and their alkali metal salts

Nitrofurantoin*

Furazolidone*

Propane-1,2,3-triyl trinitrate

Acenocoumarol*

Alkali pentacyanonitrosylferrate (2-)

Nitrostilbenes, their homologues and their derivatives

Noradrenaline and its salts

Noscapine* and its salts

Guanethidine* and its salts

Oestrogens F8

Oleandrin

Chlortalidone*

Pelletierine and its salts

Pentachloroethane

Pentaerithrityl tetranitrate*

Petrichloral*

Octamylamine* and its salts

F1Picric acid

Phenacemide*

Difendoxazine*

F12-Phenylindan-1,3-dione (phenindione)

Ethylphenacemide*

Phenprocoumon*

Fenyramidol*

Triamterene* and its salts

F1Tetraethyl pyrophosphate; TEPP (ISO)

Tritolyl phosphate

Psilocybine*

Phosphorus and metal phosphides

Thalidomide* and its salts

Physostigma venenosum Balf.

Picrotoxin

Pilocarpine and its salts

F1α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform (levophacetoperane) and its salts

Pipradrol* and its salts

Azacyclonol* and its salts

Bietamiverine*

Butopiprine* and its salts

Lead and its F9compounds, with the exception of that mentioned in Annex III, No 55 under the conditions stated

Coniine

Prunus laurocerasus L. (‘cherry laurel water’)

Metyrapone*

F10Radioactive substances, as defined by Directive 96/29/Euratom8 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.

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

Hyoscine, its salts and derivatives

Gold salts

F4Selenium and its compounds with the exception of selenium disulphiele under the conditions set out under reference No 49 in Annex Ill, Part 1

Solanum nigrum L. and its galenical preparations

Sparteine and its salts

Glucocorticoids

Datura stramonium L. and its galenical preparations

Strophantines, their aglucones and their respective derivatives

Strophantus species and their galenical preparations

Strychnine and its salts

Strychnos species and their galenical preparations

Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961

F1Sulphonamides (sulphanilamide and its derivatives…) and their salts obtained by substitution of one or more H-atoms of the -NH₂ groups) and their salts

Sultiame*

Neodymium and its salts

Thiotepa*

Pilocarpus jaborandi Holmes and its galenical preparations

Tellurium and its compounds

F1Xylometazoline* and its salts

Tetrachloroethylene

Carbon tetrachloride

Hexaethyl tetraphosphate

Thallium and its compounds

Thevetia neriifolia Juss., glycoside extract

Ethionamide*

Phenothiazine* and its compounds

F1Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1

Mephenesin* and its esters

Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9. 6. 1975, p. 13)

Tranylcypromine* and its salts

Trichloronitromethane (chloropicrine)

2,2,2-Tribromoethanol (tribromoethyl alcohol)

Trichiormethine* and its salts

Tretamine*

Gallamine triethiodide*

Urginea scilla Stern. and its galenical preparations

Veratrine, its salts and galenical preparations

Schoenocaulon olficinale Lind. (seeds and galenical preparations)

F11Veratrum Spp. and their preparations

Vinyl chloride monomer

Ergocalciferol* and cholecalciferol (vitamins D₂ and D₃)

Salts of O-alkyldithiocarbonic acids

Yobimbine and its salts

Dimethyl sulfoxide*

Diphenhydramine* and its salts

4-tert-Butylphenol

4-tert-Butylpyrocatechol

Dihydrotachysterol

Dioxane

Morpholine and its salts

Pyretbrum album L. and its galenical preparations

F12-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate

Tripelennamine*

Tetrachlorosalicylanilides

Dichlorosalicylanilides

F1Tetrabromosalicylanilides F12

Dibromosalicylanilides F12

Bithionol*

Thiuram monosulphides

Thiuram disulphides

Dimethylformamide

4-Phenylbut-3-en-2-one

Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used

F13Furocoumarines (e.g. trioxysalan*, 8-methoxypsoralen, 5-methoxypsoralen) except for normal content in natural essences used.

In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg.

Oil from the seeds of Laurus nobilis L.

F1Safrole except for normal content in the natural essences used and provided the concentration does not exceed:

• 100 ppm in the finished product,

• 50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children

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

F14. . . . .

F153'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen

F16O-phenylenediamine and its salts

4-methyl-m-phenylenediamine and its salts.

F14. . . . .

F15Aristolochic acid and its salts; Aristolochia spp. and their preparations

F17Chloroform

F14. . . . .

F152,3,7,8-Tetra chlorodibenzo-p-dioxin

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

Pyrithione sodium (INNM)

F18N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan)

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

F14. . . . .

F14. . . . .

. . . . .

F19F156-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and its salts

3,4',5-Tribromosalicylanilide

Phytolacca spp. and their preparations

Tretinoin (retinoic acid and its salts)

1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) F9and their salts

1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) F9and their salts

Colouring agent CI 12140

Colouring agent CI 26105

Colouring agent CI 42555

Colouring agent CI 42555-1

Colouring agent CI 42555-2

F20Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))

F21. . . . .

2-Amino.4-nitrophenol

2-Amino-5-nitrophenol

F911 α-Hydroxypregn-4-ene-3,20-dione and its esters

F1511α-Hydroxypregn-4-ene-3, 20-dione) and its esters

F14. . . . .

F15Colouring agent C.I. 42 640

Colouring agent CI 13 065

Colouring agent CI 42 535

Colouring agent CI 61 554

F14. . . . .

. . . . .

. . . . .

. . . . .

. . . . .

F15Anti-androgens of steroidal structure

Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, Part One, and the zirconium lakes, pigments or salts of the colouring agents listed in Annex IV, Part One, with reference number 3

Acetonitrile

Tetrahydrozoline and its salts

F7Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1

Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)

Colouring agent CI 12075 and its lakes, pigments and salts

Colouring agent CI 45170 and CI 45170:1

Lidocaine

F221,2-epoxybutane

Colouring agent CI 15585

Strontium lactate

Strontium nitrate

Strontium polycarboxylate

Pramocaine

4-ethoxy-m-phenylenediamine and its salts

2,4-diaminophenylethanol and its salts

Catechol

Pyrogallol

Nitrosamines

F5Secondary alkyl- and alkanolamines and their salts

F234-Amino-2-nitrophenol

F242-Methyl-m-phenylenediamine

F134-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)

F25. . . . .

F13Cells, tissues or products of human origin

3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*)

F263-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid)

F27F28From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council9, the specified risk materials as designated in Annex V to that Regulation, and ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom.

However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:

• F29Transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters),

• Saponification with NaOH 12M (glycerol and soap):

  • Batch process: at 95 °C for three hours

    or

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

F30Crude and refined coal tars

F311,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)

5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).

F32Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient.

Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.

Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient.

Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.

Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient.

2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient.

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient.

4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.

Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient.

7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient.

6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient.

Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.

Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.

Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient.

trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.

trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.

trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.

Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient.

6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient.

7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient.

4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient.

1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient.

Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.

7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient.

5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient.

2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient.

3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient.

Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.

X2Methyleugenol (CAS No 93-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed:

1. (a)

   0,01 % in fine fragrance

2. (b)

   0,004 % in eau de toilette

3. (c)

   0,002 % in fragrance cream

4. (d)

   0,001 % in rinse-off products

5. (e)

   0,0002 % in other leave-on products and oral hygiene products.