Cosmetic Products ReguIations, 1983 (compositionandsale)

L.N. 17 of 1983

FOOD, DRUGS AND DRINKING WATER ACT, 1972

(ACf NO. XL OF 1972)

Cosmetic Products ReguIations, 1983

IN exercise of the powers conferred by section 13 of the Food,

Drugs and Drinking Water Act, 1972, the Minister of Health. on the

advice of the Council of Health, has made the following regulations:-

These regulations shall be cited as the Cosmetic Products Re- Citation and

gulations, 1983, and shall come into force on the 1st July, 1983, pro- commencement.

vided that the provisions. of these regulations shall come into force on

the 1 st J une, 1983, in respect of imported cosmetics.

PROHIBITED SUBSTANCES

The alphabeticaI list set out in column 2 of this Schedule contains one or more of the

names of each of the substances referred to in regulation4(1)(a) incertain cases a name is

given of a group of substances, the names of particular examples of which are aIso given,

and in such a case all substances comprised in the group are incJuded, whether or not more

specifically named.

The numbers given in columns 1, 3 and 4 are for information on1y. Those in column 3

are cross-references to otl1er names listed for the S:lme substances (except that where a

name is that of a group of substances, the cross-references are to particular examples of that

group, and any cross-reference in p:lrenthesis is to the name of a group of substances within

which the particular substance falls) . Those in column 4 are cross-references to Annex II

of the Directive, from which this Schedule is derived.

.

~-

I

Column 2

Column 3

Column 4

I

Column 1

I

Cross-reference

Cross-reference

Number

to this

to Annex II

in this

Name of substance

of the Directive

Schedule

Schedule

Acenocoumarol

3-( a:-Acetonylbenzyl)-4-

354, 668

hydroxycoumarin and its salts

3-( a:-Acet onyI-p-ni tro benzyl)-4-

hydroxycoumarin

2-(or ~-)AcetoxyethyltrimethyI-

ammonium hydroxide and its salts

2-Acetylamino-5-chloro benzoxazole

AcetyJcholine and its salts

Acetylene chlorides

Acetylenic alcohols, their esters,

ethers and sa!ts

~-(7 a:-Acetylthio-17~-hydroxy-3-

oxoandrost-4-en-17o:-yl)propionic

acid lactone

I

-

Aconitine and its salts

-

Aconitum napellus L. (leaves, roots

and galenical preparations)

-

Adonis vernalis L. and its~preparations

236,279

Adrenaline

534-5, 564-5

Alkali pentacyanonitrosylferratc (2-)

O-Alkyldithiocarbonic acids, salts of

Alkyne alcohols, their esters, cthers

and salts

-

~-

"~1r<U&&

B

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

Alloclamide and its salts

Allyl isothiocyanate

-

-

2-( 4-Allyl-2-methoxyphenoxy)-

N,N-diethylacetamide and its salts

N-Allylnormorphine, its salts and

ethers

2-Allyloxy--4-chloro-N-(2 '-

diethylaminoethyl)benzamide and

its salts

Alypinc and its salts

42,97

Ambenomium chloride

(467)

4-(or p-)Aminobenzoic acid csters

-

(except 2,3-dihydroxypropyl estcr)

2-Amino-l,2-bis(4-methoxyphenyl)

-

ethanol and its salts

3-Amino-4-butoxybenzoic acid

89, 222

2-diethyJaminoethyl ester and its

salts

Aminocaproic acid and its salts

2-Amino-5-chlorobenzoxazole

4-Amino-N-(2' -diethylaminoethyl)

benzamide, its salts and derivatives

Aminoheptane, its isomers and salts

6-Aminohexanoic acid and .its salts

ct-(Aminomethyl)-3,4-

458, 459

dihydroxybenzyl aIcohol and its salts

4-Amino-NlO-methylfolic acid

2-Amino-6- methylheptane and its

371, 464

salts

2-Amino-4-methylhexane and its salts

252,419

4-(or p-)Aminosalicylic acid and its

-

salts

Aminotoluenes, their isomers, salts

and halogenated and sulphonated

derivatives

Aminoxylenes, their isomers, salts and

halogenated and sulphonated

derivativcs

..

B

Column 1

Column 2

Column 3

Column 4

N umber

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

Amitriptyline and its salts

Ammi majus and its gaIenicaI

-

preparations

Amphetamine, its salts and derivatives

(595)

and sa1ts of t):lOse derivatives

Amydricaine and its salts

22,97

Amylene chloride

Amyl nitrites

-

Amylobarbitone and its salts

(63)

Amylocaine and its salts

-

Anamirta cocculus L. (fruit)

Androgenic substances

-

Aniline, its salts and halogenated

-

and sulphonated derivatives

Anthracene oil

-

-

Antibiotics (except tyrothricin)

-

Antimony and its compounds

-

A!Jocynum callnabinum L. and its

preparations

Apomorphine and its salts

Apronalide

ArecoIine

Arsenic and its compounds

-

Atropa beiladonna L. and its

-

compounds

Atropine, its salts and derivatives

Azacyclonol and its salts

Azamethonium bromide

(420)

Barbitone and its salts

(63)

Bar bi tura tes

various

-

Barium salts (except barium sulpl1ate,

lakes prepared from barium sulphate

and pigments prepared from those

colouring agents listed in Sche(jule 3

whi.ch contain a barium,J'alt) -....,.

B

Column 3

Column 1

Column 2

Column 4

I

Cross-reference

Number

Cross-reference

in this

to this

Name of substance

to Annex II

Schedule

Schedule

of the Directive

295,296

Bemegride and !ts saIts

Benactyzine

Bendrofiuazid~ and its derivatives

68,81

67,81

Bendrofiumethiazide and its derivatives

Benzamine and its salts

Benzatropine and its salts

-

Benzazepines, their saIts and

derivatives

-

Benzene

2-Benzhydryloxyethyldimethylamine

and its saIts

Benzidine

Benzilonium bromide

2-Benziloyloxymethy l-

I,I-dimethylpyrrolidinium

methyIsulphate

78,232

Benzimidazolone

BenzimidazoI-2(3H)-one

Benzoates of 4-hydroxy-3-

methoxycinnamyI alcohoI (except

naturaI content of essences)

-

Benzodiazepines, their saIts and

derivatives

Benzothiadiazine and its derivatives

67,68

3-(N- Benzylhydrazinocarbonyl)-5-

methylisoxazole

Benzylideneacetone

3-Benzyloxy:"'l, l-diethy Ipyrrolidine

hydrobromide

p-BenzyloxyphenoI

348,431

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

552,656

ethyldimethylamine

-

BerylIium and its compounds

(320)

Betamethasone

I

Betoxycaine and its salts

26,222

B

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

BHC (gamma-BHC)

329, 331, 382

Bietami verine

1,6-Bis(2- chloroethylamino)-

1,6-dideoxymannitol and its salts

2 [Bis (2-chloroethyl) amino]-1-oxa-3-

96,200

aza-2-phosphacyclohexane 2-oxide

and its salts

N,N-Bis(2-chloroethyl)methylamine

141,433

and its salts

N,N- Bis(2-chloroethyl)methylamine

N-oxide and its sal ts

N,N-Bis(2-chloroethyI)-

93,200

N ',O- propylenephosphoramidc

anhydride and its salts

1, l-Bis( dimethylaminomethyl)propyl

22,42

benzoate and its salts

2,2-Bis(hydroxymethyl)butan- l-ol

trinitrate

2, 6- Bis(~-hyd roxyp henethy 1)-1-

methylpiperidine and its salts

Bithionol

Bretilium tosibte (or tosylatc)

Rrominf.?, eJ~me!lt~1

-

10Z

Bromisoval

$6

p- Bromo benzy lethyldimethy lammon-

ium p-toluenesulphonate

Bromodiethylacetylurea

106, 132

Bromo-Cl.4!thy l butyryl urea

105; 132

CI.-

Bromoisovalerylurea

1-p-bromophenyl-l-(2-pyridyl)-3-

dimethylaminopropane and its sal ts

Brompheniramineand its salts

-

Brucine

In

Butanilicaine a[ld its salts

(6)

Butobarbitone and its salts

Butopiprine and its salts .

-

I ,

Column 4

Column 3

Column 2

Column 1

Cross-reference

Cross-reference

Number

to Annex II

to this

in this

Name of substance

of the Directive

Schedule

Schedule

2-Butoxy-N-(2-diethylaminoethyI)

cinchoninamide and its salts

2-Butoxyethyl cx-phenyl-cx-

(N-piperidyl)acetate and its salts

1-Buty l- 3-(N~crotonoylsuI phanilyl)

-

urea

4-Butyl-1,2-diphenylpyrazolidine-

3,5- dione

4-Butyl- 1-phenylpyrazolidine-

3,5-dione

1-Butyl-3- (p-methyI benzenes ulphonyl)

urea

l-Butyl-3-sulphanilylurea

4-Butylthiobenzohydryl

dimethylaminoethyl sulphide

-

Cadmium and its compounds

Cala bar bean

Cantharides, Canflzaris vesicatoria

Cantharidin

Captodiame

Caramiphen and its salts

N-(3-Carbamoyl- 3,3-diphenylpropyl)-

N,N-diisopropylmethylammonium

salts

Carbazole, nitroderivativcs of

-

Carbon disulphide

Carbon tetrachloride

Carbromal

105, 106

Carbutamide

Carisoprodol

-

Catalase

-

Cepha'eline and its salts

-

Clzenopodium ambrosioides (essentiaI

oil)

Cherry Iaurel water

CoIumn 1

CoIumn 2

CoIumn 3

Column 4

Nuruber

Cross-reference

Cross-reference

to this

in this

Name of substance

to Annex II

ScheduIe

Schedule

of the Directive

-

ChIaral hydrate

-

Chlorine

7f!,

94,433

Chlormethine and its salts

Chlormezanone

5-Chlorobenzoxazolinone

N-5-ChIorobenzoxazol-2-ylacetamide

l

149, 185

2-Chloro-4-dimethylamino-6-

methylpyrimidine

2-Chloro-9-( o:.:.-dimethy lamino-

propyIidine)thioxanthene (frans-form)

and its salts

4-Chloro-1,3-disulphamoylbenzene

Chloroethane

2-ChIoro-6-methylpyrimidin- 4-

145, 185

yldimethylamine

Chlorophacinone

1-(p- ChIoro-o:-phenylbenzyl)-4-

(2-hydroxyethoxyethyl)piperazine

4-[4-(4-Chloropheriyl)-4-

hydroxypiperidin-l-yl]-

1-(4-fluorophenyl)butan-1-one

2-( 4-ChIorophenyl)-3-methy lbutane-

2,3-dioI

2-(4-Chlorophenyl--3-methyl-4-

metathiazonone-l,l-dioxide

2-[2-(4-Chlorophenyl)-2-

phenylacetyl]indan-l,3-dione

1-( 4-Chlorophenyl)-l-phenyl- l-

dimethyIaminoethoxyethane

-

Chloropicrine

163, 164

3 (4-Chloro-3-sulphamoylphenyl)-

3-hydroxyisoindolin-l-one

Chlorphenoxamine

(496)

Chlorpromazio.e

Chlorpropamide

Chlorprothixene and its salts

B

Column 3

Column 4

Column 2

Column l

Cross-reference

Cross-reference

Number

to this

to Annex II

in this

Name of substance

of the Directive

Schedule

Schedule

158,164

Chlortalidone

158,163

ChlorthaJidone

Chlorzoxazone

(667)

Cholecalciferol

-

ChoJinc salts and their esters

-

Chromium, chromic acid and salts of

the acid

Chrysoidine citrate hydrochloride

Cinchocaine and its salts

Cincophen, its salts and derivatives

a nd salts of those derivatives

Claviceps purpurea Tul., its alkaloids

and galenical preparations

Clofenamide

Clofenotane

202,643

Cobalt benzenesulphonate

-

Cocculin

-

Colchicine, its salts and derivatives

-

Colchicoside and its derivatives

Colchicum autumnale L. and its

-

galenical preparations

Coniferyl benzoate (except natural

content of essences)

COilii ne

-

Conium maculatum L. (fruit, powder,

galeniċa l preparations)

Convallatoxin

-

Coumetarol

Cr imidine

145, 149

. Croton tiglium (oil)

-

Curare and curarine

-

Curarizants, synthetic

-

Cyanides

345, 347

I

Column 2

Column 1

Column 3

Column 4

Cross-reference

Number

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

1-(3-Cyano-3,3-diphenylpropyl)-4-

phenyI-4-piperidinecarboxylic acid

ethyl ester hydrochloride

Cyclarbamate

Cyclizine and its salts

(63)

CycIobarbitone and its salts

Cyclocoumarol

2-a-Cyclohexyl benzyl(N,N,N ,N

f

f

_

tetraethyI)trimethylenediamine

2-Cyclohexyl-3,5-dimethylphenol

and its salts

1-Cyclohexyl-3-(p-

methylbenzenesulphonyl)urea

Cyclomenol and its salts

Cyclopentane- 1,1-dimethanol

dicar banilate

93,96

Cyclophosphamide and its salts

Datura stramonium L. and its

galenical preparations

DDT (p,p ~-DDT)

174,643

Deanol aceglumate

Decamethonium bromide

Decamethylenebis(trimethylam-

monium) salts

Dextromethorphan and its salts

Dextropropoxyphene

0,0 -Diacetyl-N-allyI-N--

-

f

normorphine

p, p f -Diaminodiphenyl

1,4 :3,6--Dianhydrosorbitol

2,5-dinitrate

5-( a,~-Dibromophenethyl) - 5 -

--

methylhydantoin

213, 397

Dibromosalicyianilides

2i2

(212)

Dibromsalan

290, 293

Dichloroethanes

Column 4

Column 3

Column 2

Column 1

~

Cross-referenee

Cross-reference

Number

to this

to Annex II

in this

Name of substance

of the Directive

Schedule

Schedule

7,666

Dichloroethylenes

2,3-Dichloro-2-methylbutane

-

Dichlorosalicylanilides

219, 417

Dicoumarin

2]9

218,417

Dicoumarol

2-(Diethylaminoethoxy)ethyl

a;-phenylpiperidine-l-acetate

dimethiodide

1-[ 4-«(3-Diethylaminoethoxy)phenyl]-

1-( 4-tolyl)-2-( 4-chlorophenyl)-

ethanol

26,89

2-Diethylaminc ethyl 3- amino-4-

butoxybenzoate and its saIts

,

2-Diethylaminoethyl benzilate and

its salts

364,474

2-Diethylaminoethyl

4-ethoxybenzoate and its salts

-

2-Diethylaminoethyl 3-hydroxy-4-

phenylbenzoate and its salts

2-Dicthylaminoethyl a;- phenyl-a;-

(N-piperidyl)acetate

-

3-Diethylaminopropyl cinnamate

Diethyl 4-nitrophenyl phosphate

O,O-Diethyl 0 - 4-nitrophenyI

phosphorothioate

Difencloxazine

Digita1ine and all heterosides of

-

Digitalis purpurea L.

4,5-Dihydrobenzimidazol-4-one

3,4-Dihydro-2- methoxy-2-methyl-4-

phenyl-2H,5H- pyrano [1,2-c]-[I]-

benzopyran-5- one

Dihydrotachysterol

-

.

3,4-Dihydroxy-a;-(isopropylamino-

372, 375

methyl)benzyl alcohol

3,4-Dihydroxy-a;-(methylamino-

13,279

methyl)benzyl alcohol

B

l

Column 3

Column 4

Column 2

Column l

Cross-reference

Cross-reference

Number

to this

to Annex II

Name of substance

in this

Schedule

of the Directlve

Schedule

-

4,4' -Dihydroxy-3,3' -(3-

methylthiopropylidene )dicoumarin

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

ethylaminopropan-l-01

5,5' -Di-isopropyl-2,2'-

dimethylbiphenyl-4,4' -diyl

dihypoiodite

4-[(3-(3,4-Dimethoxyphenyl)ethyl]-

1-(2-chlorophenyl)piperazine and

its saIts

-

Dimethylamine

2-Dimethylaminoethyl

lV-acetylglutamate

2-[ cx-(2- Dimethylaminoethoxy )-cx-

methylbenzyl]pyridine and its salts

2-Dimethylaminoethyl

p-butylaminobenzoate and its salts

2-[(2-DimetħylaminoetħyI)-2-

. thenylamino ]pyridine and its saIts

(+ )-4-Dimethylamino-3-metħyl-

1,2-diphenyl-2-propionyloxybutane

1-Dimethylaminomethyl-l-

methylpropyl benzoate and its salts

2-Dimethylaminopropiophenone

and itlii salta

3-(3- Dimetħylaminopropylidene)-

I

1,2 :4,5-dibenzocyclohepta-l ,4-diene

and its salts

lV,lV- Dimethyldiguanide and its salts

-

Dimcthylformamide

35, 419

1,3-Dimetħylpentylamine and its salts

1,2-Dimethyl-4-pħenyl-4-

carbmethoxyhexametħylencimine

and its sa1ts

1,3-Dimetħyl-4-pħenyl-4-

carboxyetbylħexamethyleneimine

and its salts

-

Dirnethyl sulphoxide

Dirnevamide and its salts

B

Colum.D. 3

Column 4

Column 2

Column

Cross-reference

Cross-reference

in this I

Number

to this

to Annex 11

Name of substance

Schedule

of the Directive

Schedule

Dinitrophenol isomers

-

-

Dioxane

Dioxethedrin and its salts

2,5-Dioxo-3,3-diethyl-5--.

1.33

methylpiperidine and its salts

Diphenhydramine and its saIts

~O

Diphenoxylate hydrocpJoride

2,2- Diphenyl-4-dimet hylamino-

vaIeramide and its saIts

-

5,5-Diphenyl-4-imidazolidone

4-Diphenylmethoxy-l-methylpiperidine

and its sal ts

3-Diphenylme't hoxytropane and its

salts

l-Diphenylmethyl-4-methylpiperazine

1,2-Diphenyl-4-(2-phenylsulphinyl-

ethyl)pyrazolidine-3,5-dione

cx,cx-Diphenyl-2-piperidinemethanol

cx-Di phenyl-4-piperidinemethanol

el,

Diphenylpyraline and its salts

2,5-Dipropoxy-3,6-bis( ethylene-

imino)-1 ,4-benzoq uinone

4-Dipropylsulphamylbenzoic acid

Disulfiram

614,625

Doxylamine and its sal ts

-

Emetine, its salts and derivatives

Endrin

-

Ephedrine and its salts

Epinephrine

13,236

ErgocaIciferol

(667)

Ergot, its alkaloids and galenical

preparations

Eserine and its salts

B

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

to Annex n

in this

to this

Name of substance

Schedule ·

Schedule

of the Directive

" - '-

Ethionamide

Ethoheptazine and its salts

(496)

Ethopropazine and its saIts

2-Ethylamino-5~phenyloxazolin-4-

one

Ethyl bis(4-hydroxyco!lmariI:yl)-

acetate and salts of the acid

Ethyl bis( 4-hydroxy.,..2-oxo-1-

benzopyran-3-yl)acetate and salts

of the acid

Ethyl chloride

Ethylene dichloride

-

Ethylene oxide

2-Ethyl-2,3~poxyhexamide and its

derivatives

Ethylidene chloride

3-Ethylisothionicotinamide

~-Ethyl-f,-methylglutarimide and its

65,296

salts

65, 295

4-Ethyl-4-methylpiperidine-

2,S-dione and its salts

~-Ethyl-~-methylvaleramide

Ethylphenacemide

300, 321

2-Ethyl-2-phenylglutarimide and its

salts

299, 321

3-Bthyl-3 -pħenylpiperidine-

3QO

2,6-dione and its salts

' 208

Fenadiazole

Fenozolone

512, 515

Fenyramidol

. FIuanisone

Fluoresone

4 '·-FI uoro-4-[ 4-hydroxy- 4-( \t , IX,!X-

trifluoro-m-tolyl)piperidino l-

butyrophenone

B

--

Column 4

Column 3

Column l

Column 2

Cross-reference

Cross-reference

Number

to Annex II

to this

in this

Name of substance

of the Directive

Schedule

Schedule

-

6cx-Fluoro-16cx-methyl-l1 ~,

17 cx,21-trihydroxypregna-

1,4-diene-3,20-dione

p-Fluorophenylcthylsulphone

1-( 4-Fluorophenyl)-4-[4-(2":'

methoxyphenyl)-l-piperazinyl]-

butan-l-one

5-Fluoropyrimidine-2,4-dione

Fluorouracil

(496)

Fluphenazine

Furazolidone

Furfuryltrimethylammonium salts

316, 412, 654

Furo [3,2-g]chrorp.eu-7-one and its

alkyl-substituted derivatives (except

naturaI content of esseuces)

35g

Furocoumarin and its alkyI-substituted

315,412,654

derivatives (except natural content of

essences)

Furtrethouium iodide

-

GaIantamiue

GalI amine triethiodide

Gh.1"mwrticoids

Glutcthimide and its salts

299, 300

3Z:l

Glycerol trinitrate

455, 542

Glycyc1ilmide

Gol,{ salt:.

-

Guaifi\li'Hl!!in

(}uanethldJne fii:i d itġ ġa!ta

3.26

- 327

N*(2--Guanidinottthyl)ħeptamethyl-

eneimine illld its salts

.

HalopuridQl

In these reguiations. unless the context otherwise requires _

"cosmetic product" means any substance or preparation in-

tended to be applied to any part of the external surfaces of the

human body, (that is to say, the epidermis, hair system, nails, lips

and external genital organs) or to the teeth or buccal mucosa

wholly or main1y for the purpose of cleaning. perfuming or pro-

tecting them or keeping them in good condition or changing their

appearance or combating body odour or perspiration, except where

such cleaning, perfuming, protecting, keeping, changing or combat-

ing is wholly for the purpose of treating or preventing disease. Cos-

metic products shall include the following categories of products:-

- creams, emulsions, lotions. gels and oils for the skin (hands,

face. feet, etc.)

- face masks (with the· exception of peeling products)

- tinted bases Oiquids, pastes, powders)

- make-up powders, after-bath powders, hygienic powders, etc.

- toilet soaps, deodorant soaps. etc.

- perfumes, toilet waters and eau de Cologne

- bath and shower preparations (salts, foams, oils, gels, etc.)

- depilatories

- deodorants and anti-perspirants

- hair care products

- hair tints and bleaches

- products for waving, straightening and fixing

- setting products

- cleansing products (lotions. powders, shampOOs)

- conditioning products (lotions. creams, oils)

- hairdressing products Ootions. lacquers. brilliantines>

- shaving products (creams. foams •. lotions. etc.)

- products for making-up and removing make-up from the face

and the eyes

- products intended for application to the lips

;- products for care of the teeth and the mouth

- products for nail care and make-up

- products for external intimate hygiene

-- sunbatħing products

-

products for tanning without sun

-

skin-whitening products

-

anti-wrinkle products;

"comestic product intended to come in to contact with the

mucous membranes" means a cosmetic product intended to be

applied in the vicinity of the eyes, on the lips, in the oral cavity or

to the external genital organs, and does not inc1ude any cosmetic

product which is intended to come into only brief contact with the

skin;

"the Directiv~" means the Council Directive No. 76/768/EEC

of the European Economic Community;

"Superintendent" means the Chief Government Medical Of-

ficer and Superintendent of Public Health.

RESTRICTED SUBSTANGES

In this Schedule, the matters specified in columns 2, 3, 4 and 5 which apply to a particular

substance are those set out to the right of its name as mentioned in column 1; and the

matters specified in columns 3, 4 and 5 which apply in any particular case are those set

out to the right of the matter specified in column 2 which applies in that case. The sub-

stance may not be used except for the purposes or contained other than in the typesof

product specified in column 2. The concentration of the substance in a product may

not exceed the Iimit specified in column 3: where the names of two or more substances

are mentioned in a single item as set out in column 1 and a product contains more than

one of those substances, the Iimit specilied in column 3 is the limit for all of those substances

ta ken together; and where a product is intended to be mixed with another pfoduct in

specified proportions before use, the level of concentration shall be calculated by reference

to the mixture. Other requirements are specified in column 4.

-

tl:l

~

--

Not to be used for babies.

Required information

For hairdressers only.

Column 5

-

-

-

-

-

-

--

-

Substances listed in Annex IIl, part 1 of the Directive as substances which cosmetic

pH value 110t to exceed

pH value not to exceed 9.5

pH value not to ~ x ceed 9.5

Not to be used in products

intended for children less

.......,

Other req uiremcnts

than thrett years oId.

Col umn 4

--

--

-

-

-

products must not contain except subject to the restrictions laid dawn.

12.65

-

mercapfoacetic acid) r~ady

8 per cent. (calculated as

mercaptoacetic acid) ready

2 per cent. (calculated as

11 per cent. (calculated as

5 per cent. (calculated as

---

Maximum concentration

of substance in prodEct

mercaptoacetic acid).

mercaptoacetic acid).

Co)umn 3

Part I

~.

0.5 per cent.

5 per cent.

5 per cent.

3 per cent.

for use.

for use.

- -

_

.

ing products for home use

which are removed after

Other hair care products

Hair waving or straighten-

Hair waving or straighten-

ing products for profes-

Pm:posc of substance

or type of product

Oral hygiene products

Hair care products

Column 2

_.

TalcuIl1 pov\·dcr

I Other products

application

Depilatories

sional use

--

\

l

-

acid and

Oxalic acid, its esters and

Name of su b:;tance

its sa!ts and esters

Column 1

]\f erca ptoacetic

alkaline salts

Boric acid

--

-

txl

centration is not more than

-1----------------------1-----------------------

[Not required when con-

Do not spray on a naked

I Do not use to dye eyelashes

[Not required except when

the prod uct is contained in

Can cause an allergic reac-

flame or any incandescent

tion. Sensitivity test advis-

Contains phenylenediamines.

Can cause an allergic rt>-

Do not use to dye eyelashes

Contains phenylenediamines.

Required information

Not to be used in aerosol I Contains chlorobutanol.

action. Sensitivity test

an aerosol dispenser.]

advisable before .use.

Contains ammonia.

Column 5

.

able before use.

---j or eyebrows . .

or eyebrows.

2 per cent.]

material.

-

Purity of the dichloro-

methane must be not less

J

I

Other requirements

than 99.8 per cent.

Column 4

dispensers.

-J

-f-S-U-b-s-ta-n- c-e-- 11--M-a-X-im-u-m-c-o-n-c-en-t-r-a-ti-o-n-I

1,1,1-tri-

tration must not exceed

per cent. calculated as

35 per cent. (and when

free base, subject to the

provisions of "Combina-

chloroethane total concen-

6 per cent. calculated as a

free base, subject to the

provisions of " Combina-

10 . per cent. calculated as a

tion Rule A" set 014t below.

tion Rule A" set out below.

of substance in product

--------~i-·-----------I------------

Column 3

with

35 per cent.)

0.5 per cent.

I All purposes and products I 0.2 per cent.

3 per cent.

5 per cent.

mixed

I All purposes and products 6 NH3·

Oxidising colouring agents

Oxidising colouring agents

All purposes and products

or type of product

Column 2

for hair dyeing

for hair dyeing

Other products

I --p-u-r-p-o-s-e-O

Preservati\'e

I Toothpaste

I I

.

mines, their N-substituted

and m-phenylenedia-

alkali

N-substituted derivatives

derivatives and their salts;

their N-substituted deri-

Methylpheny!enediamines,

j

·--1

Tosylchloramide sodium

of p-phenylenedia mine

vatives and their salts

Name of substance

of the

Column 1

Dichloromethane

Chorobutanol

Ammonia

Chlorates

metals

0-

to

.....

~

--

formaldehyde. [Percentage

[Not required when con-

must be actual percentage

drogen peroxide. [Percent-

age must be actual percent-

Protect cuticles with grease

Contains [x] per cent. hy-

when concentration is not

centration is not more than

;00 not use to dye eyelashes

Not to be used for babies.

in product.] [Not required

Contains hexachlorophene.

-

Can cuuse an allergic re-

Contains diaminophenols.

more than 0.1 per cent.]

Required information

action. Sensitivity test

Contains dichlorophen.

Contains formaldehyde.

Contains [x] per cent.

advisable before use.

Column 5

age in product.]

0.1 per cent.]

or eyebrows.

-

or oil.

Not to be used in products

Not to be used in aerosol

for children or in personal

Other requirements

Column 4

hygiene products.

--

-

-

-

-

dispensers.

provisions of "Combina-

free base, subject to the

10 per cent. caIculated as a

tion Rule A" set out beIow.

Maximum concentration

of substance in product

Column 3

12.1 per cent.

0.2 per cent.

0.1 per cent.

0.1 per cent.

0.5 per cent.

5 per cent.

Oxidising colouring agents

All purposes and products

Preservative (other than in

Purpose of substance

oral hygiene products)

or type of product

Oral hygiene products

Hair care products

Column 2

for hair dyeing

Nail hardeners

Preservative

Name of substance

Hydrogen peroxide

Column 1

Hexachlorophene

Diaminophenols

Forma1dehyde

Dichlorophen

0;

l--'

ffi

-

_. -

---

imrnediately if product

Rinse eyes immcdiately if

_.-

----

or eyebrows. Rinse eyes

comes into contact with

Do not use to dye eyelashes

cause bJindness. Keep away

A void contact with eyes. Can

Avoid contact with eyes. Can

cause blindness. Keep away

----,_-.

----

product comes into con-

Do not use to dye eyelashes

them. Contains pyrogallol.

Required information

_

Contains hydroquinone.

~

Contains cx-naphthol.

Contains picric acid.

Column 5

. ..

Contains phenol.

- - '.- - - .

or eyebrows. .

tact with them.

from childre;n.

from children.

-

-

-

I

Not to be used with second-

=

pH value not to exceed 11.

Other requirements

Column 4

--

-

-

=

-

-

-

-

-

aryamines.

,. ... --..

tion Rule B" set out belo\V.

provisions of "Combina-

5 per cent., 6ubject to the

2 per cent. by weight calcu-

5 per cent. by weight calcu-

tion Rule B" set out below.

- 2 per cent., -- subject to the

provisions of . "Combina-

lated as sodi urn hydroxide.

latcd as sodium hydroxide.

Maximum concentration

of sl,lbstance in product

Column 3

-

0.5 per cent.

0.2 per cent.

0.3 per cent.

1 per cent.

1 per cent.

Hair straightening products

All purposes and products

Other uses as a neutraliser

Purpose of substance

or type of product

Soaps and shampoos

Nail cuticle solvent

Column 2

Rust inhibitor

Rust inhibitor

Rust inhi bi tor

Hair dyes

Hair dyes

Name of substance

Potassium and sodium

Column 1

Sodium nitrite

Hydroq uinone

Nitromethane

cx-Naphthol

hydroxides

Picric acid

Pyrogallol

Phenol

~

t::C

.....

Rinse eyes immediately if

ation. Do not use to dye

Can cause an allergic reac-

product comes into contact

Can cause an allergic reac-

Rinse hair well after applic-

Can cause an allergic reac-

Rinse hair well after applic-

ir.~---------------------

eyela.shes or eye-brows.

-~------------------:~------------------

tion. Contains resorcinol.

tion. Contains resorcinol.

tion. Contains resorcino1.

Nrun::~:::tan~ pu~o::~:~::'tance I·· M~~~: Othe~:::::e:en~-- Required information

Column 5

with them.

ation.

r .- - -·-------1

.

-------------------~--------------------I--------------------~

I

tion Rule B" set out below.

provisions of "Combina-

tion Rule B" set out below.

tion Rule B" set out below.

0.5 'p~r cent. calculated as

I()i~i~~~~~~i-!e-· .-c~~t~~-,

5 per cent., subject to the

0.5 per cent., subject to the

provisions of "Combina-

0.5 per cent., subject to the

provisions of "Combina-

2 per cent. in pastes, 20 per

cent. for monosulphides

in aqueous solution with-

1 per cent. calculated as

L of substance in product

qumme base.

out additive.

zinc.

l

-

Zinc chloride and sulphate I All purposes and products

I All purposes and products

or type of product

Hair lotions

Hair lotions

Shampoos

Shampoos

Hair dyes

I

alkali and alkaline earth

Ammonium sulphides,

Quinine and its salts

Resorcinol

sulphides

-

t:l:l

~

Contains sodiurn rnonofluo-

COl1tains potassiurn rnono-

rnono-

Contains amrnonium rnono-

Contains 2, 3-dihydroxypro-

I Not to be used for babies.

Contains sodiurn fluoride.

Contains phenylmercuric

Required information

pyl 4-arninobenzoate.

Contaim. calciurn

Column 5

fluorophosphate.

fluorophosphate.

fluorophosphate.

rophosphate.

-

compounds.

Other requirements

Column 4

-

-

-

-

-

-

-

-

-

total fluorine concentra-

fiuorine. When rnixed with

other fluorine compounds,

tion must not exceed 0.15

0.15 per cent. calculated as

Maximum concentration

of substance in product

As for sodi urn fluoride.

As for sodi urn fluoride.

As for sodiurn fluoride.

As for sodi urn fluoride.

0.3 per cent. in base.

Column 3

As for thiomersal.

4 per cent.

5 per cent.

per cent.

(i) products appliedafter

All purposes and products

(ii) talcurn powder for

Preservative in eye makeup

[See . also part III of this

All purposes and products

Purpose of substance \

or type of product

Oral hygiene products

Oral hygiene products

Oral hygiene products

Oral hygiene products

Oral hygiene products

Column 2

sunbathing, and

other than-

Toothpaste

Schedule]

babies

rnonofluoro-

monofluoro-

Sodiurn rnonofluorophos-

Quinolin-8-ol and bis(8-

Calciurn rnonofluorophos-

2,3-dihydroxypropyl 4-

Name of substance

hydroxyquinolinium)

.

Column 1

amino benzoate

Sodiurn fluoride

Phenylmercuric

cornpounds

Arnrnonium

Chloroforrn

phosphate

phosphate

Potassiurn

sulphate

phate

phate

tlj

l-'

~

Contains 3-(N-hexadecyl-N-

Contains ammonium fluo-

Contains aluminium fluoride

Contains hexodccyltrimethy-

Contains potassium fluoride.

propylenediamine dihydro-

Contains octadecylammon-

Contains sodium fluorosili-

Contains potassium fluoro-

oxyethylene)-N-hexodecyl-

propy lbis(2-hydroxyethyl)-

Contains stannous fluoride.

Contains NN' N' -tris(poly-

2-hydroxyethylammonio)-

Contains calcium fluoride.

Required information

ammonium difluoride.

lammonium f1uoride.

Column 5

ium fluoride ..

fluoride.

silicate.

ride .

cate.

Other requirements

Column 4

-

-

-

-

-

-

-

-

-

-

-

.

I

Maximum concentration

of $ubstance in product

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride.

As. for sodium fluoride.

As for sodium fluoride.

As for sodium fluoride

Co!umn 3

Purpose of substance

or type of product

Ora! hygiene products

Ora! hygiene products

Oral hygiene products

Oral hygiene products

Ora! hygiene products

Oral hygienc products

Gral hygiene products

Oral hygiene products

Oral hygiene products

I Ora! hygiene products

Oral hygiene products

Column 2

propylbis(2-hydroxyethyl)-

Hexadecyltrimethylammo-

hydroxyethylammonio )-

NN' N' -tris(polyoxyeth-

Potassium fluorosiJicate

Name of substance

ammonium difluoride

ylene)-N-hexadecyl-

3-N-hexadecyl-N-2-

Octadecylammonium

Sodium fluorosilicate

Ammonium fluoride

Aluminium fluoride

propylenediamine

Co!umn l

Potassium fluoride

Stannous fluoride

Calcium fluoride

dihydrofluoride

---~ ~-~

nium fluoride

fluoride

t:t1

..-

~

use. Contains 1-morph-

Rinse hair thoroughly after

use. Contains l-hydroxy-

Rinse hair thoroughly .after

use. Contain.s 1,3-bis(hy-

Rinse hair thoroughly after

use. [Not required when

Rinse hair thoroughly after

use. Contains hydroxy-

Contains 1 ,3 - bis(hydroxy-

Rinse hair thoroughly after

concentration is not more

Contains ammonium f1uoro-

Contains magnesium f1uoro-

droxymethyl)-2-thiourea.

methyl)imidazolidine-2-

olinomethyl-2-thiourea.

methylimidazolidine-2-

Required information

methyl-2-thiourea.

Column 5

than 2 per cent.]

si!icate.

silicate.

thione.

thione.

I

I

Not to be used in aerosol

Not to be used in aerosol

Not to be used in aerosol

Not to be used in aerosol

Net to -be used in aerosol

Other requirements

Column 4

-

-

-

dispensers.

dispensers.

dispensers.

dispensers.

dispensers.

Maximum concentration

of substance in product

As for sodium f1uoride.

I As for sodium f1uoride.

Column 3

0.01 per cent.

6 per cent.

6 per certt.

6 per cent.

6 per cent.

8 per cent.

All purposes and products

Purpose of substance

or type of product

Oral hygiene products

Oral hygiene products

Hair care products .

Hair care products

Hair care products

Hair care products

I Hal, cace product,

Column 2

l-hydroxymethylimidazo-

Ammonium f1uorosi1icate

Magnesium f1uorosilicate

1,3-bis(hydroxymethyl)-

l-morpholinomethyl-2-

i midazolidine-2-thione

1,3-bis(hydroxymethyl)-

Name of substance

.

Column 1

Hydroxymethyl-2-

lidine-2-thione

2-thiourea

thiourea

thiourea

Safrole

tx:l

.....

~

1,3bis-

Rinse hair thoroughly after

Do not spray on a naked

flame or on any incandes-

Contains tribromosaIicylan-

Wash hands after use. Do

not use on broken or

abraded skin. Keep out of

Required information

(morpholinomethyl)-2-

Required information

Column 5

Column 5

reach of children.

Contains

cent materjal.

thiourea.

ilides.

use.

Not to be used in aerosol

Other requirements

Other requirements

Substances excluded from the scope of the Dilective (mentioned in Annex V)

Column 4

Column 4

-

-

-

dispensers.

ane, total concentration

must not exceed 35 per

35 per cent. (and when

mixed with dichlorometh-

Maximum concentration

Maximum conccntration

of .s ubstance in product

. of substance in product

Column 3

Column 3

Par t III

1 per cent.

3 per cent.

6 per cent.

cent.)

---_ . _~-- -- --------

dis-

Purpose of substance

Purpose of substance

or type of product

or type of product

aerosol

Hair care products

1,3 bis(morphoIinomethyI)- Hair care products

Column 2

Column 2

Solvent for

pensers

I Soaps

. _I

Name of substance

~

Name of substance

Tribromosalicylanilides

(methyl chloroform)

1,1,1-trichloroethane

Column 1

Column 1

Lead acetate

2-thiourea

.

.

-

-

te

tion. Sensitivity test ad vi s-

to dye eyelashes or eye-

Can cause an aIIergic reac-

able before use. Do not use

Required information

Column 5

-

-

-

-

brows.

----

Other requirements

Column 4

-

-

-

-

-

Rule A, as set out in Part-

pounds the total mercury

bination RuJe C as so· set

with other mercury com-

mercury. When mixed

other preservatives ineffec- concentration must not

or more of the substances

to which Combination

of p-phenyJ-

substances shalI not exceed

the concentration in the

enediamine and any of its

salts shall be such that the

To preserve concentrated 0.003 per cent. caIculated as

product also contains one

I of this ScheduJe, applies,

out) for all of the aforesaid

free base; and where the

sum of the relevant quot-

ients (as defined in Com-

6 per cent. caIculated as a

Maximum concentration

of substance in product

exceed 0.007 per cent.

Column 3

0.004 per cent.

product

No Iimit

No Iimit

1. tive [See also part II of

which contain non-ionic

emulsifiers which render

shampoos and hair creams

Oxidis'ing colouring agents

Abti-perspirants and deo-

Anti-perspirants and deo-

All purposes and products

Purpose of substance

or type of product

Column 2

for hair dyeing

-- --

this Schedulel

dorants

dorants

Thiomersal and phenyl-

and

Name of substance

chlorohydrate gJycine

Zirconium aluminium

Zirconium aluminium

mercuric compounds

p-phenylenediamine

-

Column 1

chlorohydrate

Oestrone

salts

B

Regulation 4(2)

No person may manufacture, prepare, import, advertise or sell

any cosmetic product which is liable to cause damage to human health

when it is applied under normal conditions of use, or which does not

otherwise comply with the requirements of these regulations.

COL OURING A GENTS

In this Schedule, the colouring agents referred to in Regulation 4(2) are-

(i) those identified in column 1 either by name or by colour index number (the colour index

numbers being those specified in the third edition of The Colour Index published in 1971 by

the Society of Dyers and Colourists of the United Kingdom); and

(i i) the lakes and salts of those of the said agents which do not incIude any substance

listed in Schedule 1 or zirconium or any zirconium derivative or strontium or any

strontium salt other than one contained in any colouring agent identified in column

l of this Schedule or in Schedule 4.

In column 2 of this Schedule-

" E " followed by a number means that the requirements as to purity which are set out in the

Directive of the European Economic Community of 23 October 1962 on the aproximation of

the rules of the Member States concerning the colouring matters authorised for use in foodstuffs

intended for human consumption , as amended (a) and adapted (b), and which relate to the

colouring agent designated by that number in that Directive must be complied with ;

"MC" followed by a percentage indicates the maximum permitted concentration of the

agent in the cosmetic product in which it is contained;

"R" indicates that the agent may not be contained in eye make-up, eye make-up remover

or other cosmetic products which in the normal course of use may come into contact

with the mucous membranes of the eye.

Par t I

Colouring agents listed in Annex 111, part 2 of the Directive as colouring agents which

can be contained in cosmetic products intended to come into contact with the mucous

membranes.

Column 1

Column 2

Requirements

Name or colour index number

Group (a): Reds

12085

M C 3 per cent.

12150

12490

(a) Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/758/EEC, 76/399/EEC

and.78/l44/EEC.

(b) Annexes I and VII to the Act of Accession of 22 January 1972, as adjusted by the Council

Decision of l January 1973

B

Column 2

Column 1

-

Requirements

Name or colour index number

14720

-

14815

15525

-

--

15580

R

15585

l Me

15630

3 per cent. for all three colouring

15630:1

J

agents taken together

-

-

15630:3

15850

-

15850(Al)

-

15850:1

-

15865

-

15865:3

r-----

15880

-

16185

16255

-

16290

45170

R

45170 :1

R

45370

Not more than 1 per cent. 2-(6-hydroxy-

3-oxo-3H-xanthen-9-yl)benzoic acid

and 2 per cent. 2-(bromo- 6- hydroxy-

3-oxo-3H-xanthen-9-yl)benzoic acid

45380

As for 45370

45405

R

Acid concentration limited as for 45370

45410

As for 45370

45425

Not more than 1 per cent. 2- (6-hydroxy-

3-oxo-3H-xanthen-9- yl)benzoic acid

and 3 per cent. 2-(iodo-6-hydroxy-3-

oxo-3H-xanthen-9-yl)benzoic acid

45430

Acid concentration limited as for 45425

58000

-

73360

-

-

75470

Column l

Column 2

:Naule or colour index number

Req uirements

77015

-

77491

Colouring agent numbered E 163 in

Council Directive of 23 October 1962

Colouring agent numbered E 162 in

Council Directive of 23 October 1962

Group (b): Oranges and yellows

10316

R

-

11920

-

12075

13015

-

-

14270

15510

R

-

15980

15985

19140

45350

MC 6 per cent.

47005

75100

-

- -

E 160b

75120

E 160d

75125

E 160a

75130

E 161d

75135

75300

77489

77492

E 160e

40820

E 160f

40825

E fi)}

Colouring agent numbered E 101 in

Council Directive of 23 October 1962

In lipstick the colouring agent must be in

45395

free acid form and of a concentration

not exceeding 1 per cent.

-

E 160c

Colouring agent numbered E 160c in

Council Directive of 23 October 1962

B

Column 2

Column 1

Requirements

Name or colour index number

Greens and blues

Group (c)

42051

-

42053

-

42090

-

44090

61565

-

-

61570

69825

-

73000

-

73015

R

74260

75810

Colouring agent numbered E 141 in

Council Directive of 23 October 1962

-

77007

-

77346

The product must be free from cyanide

77510

ions (except for any trace which cannot

reasonably be removed during or after

manufacture)

69800

-

Group (d)

Violets, browns, blacks and whites

28440

42640

I

60725

73385

"I

77000

-

77002

-

77004

-

77120

77220

l

77231

77266

B

Column l

Column 2

Name or colour index number

Requirements

77267

-

77400

-

77480

77499

77713

-

77742

-

77745

-

77820

-

77891

(titanium dioxide and its mixturcs

with mica)

77947

-

75170

-

(guanine or pearl essence)

(White 9) Aluminium, zinc, magnesium

-

and calcium stearates

Cara mel

Part 11

Colouring agents listed in Annex IV, part 2 of the Directive as colouring agents pro-

visionally allowed which may be contained in cosmetic products intended to come into

contact with the mucous membranes in accordance with articIe 5.

Column 1

Column 2

Name or colour index number

Requirements

Group (a)

Reds

-

12120

-

12350

-

12385

R

14700

15500

-

May not be used in lipsticks

15500:1

-

15585:1

-

15620

-

-

15800

B

Column 2

Column 1

Requirements

Name or colour index number

-

-

16035

26100

-

27290

-

45160

-

75480

-

75580

-

Group (b)

Oranges and yellows

18965

R

47000

Group (c)

Greens and blues

-

42040

42140

-

-

42170

-

42735

-

44040

44045

-

-

59040

-

-

61554

62085

-

77288

The product must be free from chromate

ions (except for any trace which cannot

reasonably be rernoved during or after

manufacture)

77289

As for 77288

77520

-

74160

Group (d)

Violets, browns, blacks and whites

20170

-

,

27755

-

42580

-

45190

-

77019

-

-

B

Column 2

Column 1

Name or colour index number

Requirements

77163

(bismuth chloride oxide and its mixtures

with mica)

77265

77718

B

Regulation 4(3)

(1) Without prejudice to the generality of regulation 3 of

these regulations, 110 cosmetic product may contain -

(a) any substance listed in Schedu1e 1 to these regulations

Provided that no account shall be taken of any such sub-

stance which is present only as a trace and which could not reason-

ably have been removed during or after manufacture;

(b) any substance listed in Column l of Schedule 2 of these

regulations; unless the matters and requirements specified in

Columns 2, 3 and 4 of such Schedule in relation to that substance

are complied with.

(2) . No cosmetic product intended to come into contact with

the mucous membranes, may contain any colouring agent listed in

Schedule 3 unless the requirements specified in Column 2 of that

Schedule in relation to that colouring agent are complied with, and no

such cosmetic product shall contain any colouring agent which is not

listed in that Schedule.

(3) No cosmetic product shall contain any colouring agent

which is listed in Schedule 4 to these regulations unless the product is

intended to come into only brief contact with the skin.

Colouring agents listed in Annex IV, part 3(B) of the Directive as colouring

agents provisionally aUowed for cosmetic products which come into contact

only briefly with the skin.

In this Schedule, the colouring agents referred . to in Regulation 4(5) are identified by

colour index number, as specified in the thira edition of The Colour Index published in

1971 by the Society of Dyers l,lnd Colourists of the United Kingdom_

Reds

11210,12090,12155,12170,12315,12370,12459, 12460, 13020, 14895, 14905, 16045, 16180,

18125, 1.8130,24790,27300,27306,28160,45220,60505,60710, 62015, 73300

Yellows and oranges

11720,11725,11730,11765,11850,11855,11860,11870,12055, 12140, 12700, 12740, 12770,

12790,13900,14600,15970,15975,18820,18900, 19555,21090,21096,21100,21108,21110,

21115,22910,25135,25220,26090, 29020, 40215,40640,41000,45376,47035,48040,48055,

56205

Blues and greens

10025,26360,42052,42085,42095,42100,50315, 50320, 50400, 50405, 51175, 52015, 52020,

52030, 61505, 61585, 62045, 62100, 62105, 62125, 62130, 62500, 62560, 63010, 64500, 74180

Violets, browns, blacks and wħites

14805,15685,17580,20285,20470,21010,25410, 30045, 30235,40625,42510,42520,42525,

42535,42650,48013, 57020, 60730, 61100, 61105, 61105, 62030, 63615

Ippubblikat mit-Taqsima tat -Tagħri f - Kastilja - Published by the Information Division - Kastilja

Mitbugh fI·Istamperija tal-Gvem - Printed at the Government Printing Press

(1) Subject to the following provisions of this regulation, the

container or the outer packing (if any) in which a cosmetic product

is sold or delivered pursuant to a sale, or a label affixed to the product,

the container or the outer packaging, shall bear the following particu-

lars:-

(a) the name or trade name and the address or registered

office of the manufacturer of the product or of a seHer thereof, and

the country or origin;

(b) in the case of a cosmetic product containing a substance

listed in Column l of Schedule 2 to these regulations, the informa-

tion specified in Column 5 of such Schedule in relation to that

substance;

(c) in the case of a cosmetic product containing "lanolin",

the words "contains lanolin";

(d) any ])arti~:.ular Pf~cautions to be observed in use (not

being prt!c~lUtioIlf.! ln.cluded in t110 information referred to in sub-

parllgraph (b) ()f this regulation): and

meuml of ide:i1tifYing the

batch in which the product

(0)

WIlS, manufactured (Of. if the prwuct was not manufactured in a

batch; li n~fere:<Hce itoffl which the date and place of manufacture

cnn be identjfied).

(2) The p~uticul'ifs n~ferred to in sub-paragraphs (a) to (d)

parfigraph (l) Qf this regulatiotl sha11 be in lettering and numbers

i;)f

Whh)h are vii:lible. indelible ftnd easUy legible, and the particulars

teferred to in sub,pf.lmgn~ph (I}) o,f P(ITf\graph (1) of this regulation shall

b~ indiAibh'l:.

(3) The particulars referred to in sub-paragraph (a) of parag-

raph (1) of this regulation may be abbreviated if such abbreviation does

not prevent the person concemed from being identified.

(4) The particulars referred to in sub-paragraphs (b) to (d)

of paragraph (1) of this regulation shall be in one of the official lan-

guages of Malta, but this does not prohibit the additional use of any

other language.

(5) The' particulars referred to in sub-paragraphs (b) to (d) of

paragraph (l) of this regulation shall appear on the container or on a

label attached thereto

Provided that where it is impracticable by reason of the size

or shape of the container,. for the said particulars so to appear and the

container is enc10sed in outer packaging, or where two or more products

are sold together by retail as a single item, each product being in a

separate container and the containers being enc10sed together in outer

packaging which bears c1ear and conspicuous instructions to the effect

that the products must be mixed together in ~pecified p.mportioU8 befQr~

use, then and in any such case the said particulars may appear on the

outer packaging or on a label attached thereto. or on a leaflet enc10sed

in the outer packaging (and in the case of a leaflet, an indication shall

appear on the container referring to the information in the leaflet),

(6) Where it is impracticable, because of size, for the parti-

culars referred to in sub-paragraph (e) of paragraph (I) of this regula-

tion to appear on the container or outer packaging or on a label attached

to either thereof, the said particulars shall appear on the packaging in

which the product is displayed for retail sale.

.

(7) In the case of a sale of soap which is not in a container.

either the soap itself or the packaging in which it is displayed for sale,

or the container in which it was last contained before sale shall bear the

particulars referred to in sub-paragraphs (a) and (e) of paragraph (l) of

this regulation and in so far as any of the particulars referred to in sub-

paragraphs (b) to (d) 6f paragraph (l) of this regulation are required.

they shalI appear on a leaflet which shall be de1ivered to the buyer with

the soap. and where either of the particulars referred to in sub-parag-

raphs (a) and(e) of paragraph (1) of this regulation appears on the soa1'

it~elf. the requirement gf indelibility sha11 apply only until it has been

put iIito Ug~.

.

(l) Any manufacturer or importer of a cosmetic product

shaH, when required, give to the Superintendent such information

regarding substances contained in cosmetic products as may be neces-

sary for purposes of prompt and appropriate medical treatment in the

event of difficulties.

(2) The Superintendent shaH ensure that the information

given as provided for in this regulation shaH not be used for any purpose

other than such treatment as aforesaid.

The Cosmetics (Composition and Sale) Regulations, 1976,

published by Legal Notice 119 of 1976 are hereby revoked.

1976. B

Regultion 4(l)(a)

9

HCH (gamma-HCm

90, 331, 382

HEl'P

1,2,3A I 5,6- Haxl1ch1 ofl)ċYcIQhexaue

90, 329, 382

B

- J~~~ CoIurnn 4

~-

Column 1

Column 2

Column 3

,

J __ to

Number

Cross-referenc

e

c_ro_s_s_-r_e_ference

in this

to this

Name of substance

Annex II

Schedule

Schedule

of the Directive

(1R, 4S, 5R, 8S)-1 ,2,3,4,1O,10-

Hexachloro-6, 7- epoxy-1 ,4,4a,

5,6,7,8,8a-octahydro-l,4 :5,8-

dimethanonaphthalene

-

Hexachloroethane

(1R, 4S, 5R, 8S)-1,2,3,4,10,10-

Hexachloro-1,4,4a,5,8,8a-

hexahydro-l,4:5,8-

dimethanonaphthalene

HexaethyI tetraphosphate

(1 R, 2S)- Hexahydro-1 ,2-dimethyI-

3,6-epoxyphthaIic anhydride

(3S, 5aR, 9bS)-3,3a,4,5,5a,9b-

Hexahydro-3,5a,9-trimethylnaphtho-

[1 ,2-b ]furan-2,8-dione

(339)

Hexamethonium bromide

N,N' -Hexamethylenebis(trirnethyl-

ammonium) salts

Hexapropymate

-

Hydrastine, hydrastinine and their salts

-

Hydrazides and their salts

-

Hydrazine, its derivatives and their

salts

2-Hydrazino-octane and its saIts

189, 347

Hydrocyanic acid and its salts

-

Hydroftuoric acid, its normaI salts,

compIexes and hydroftuorides (except

those listed in par t li of ScheduIe 2)

189, 345

Hydrogen cyanide and its saIts

85, 431

Hydroquinone monobenzy! ether

7-[2-Hydroxy-3-(2-hydroxyethyl-N-

methyIamino)propyl]theophyIline

[4-(4-Hydroxy-3-iodophenoxy)-3,5-

diiodophenyI]acetic acid and its saIts

3-[4-(4-HydrQxy-3-iodophenoxy)-3,5-

diiodophenyJ]propionic acid and its

sa1ts

1-Hydroxymethyl-1-cyclohexyIacetic

acid, sodi urn salt

B

--

Column 4

Column 3

Column 1

Column 2

Cross-reference

Cross-reference

Number

to Annex 11

to this

Name of substance

in this

of the Directive

Schedule

Schedule

8-Hydroxy-5( or 6)-ni troq uinoline

and its salts

2,668

4-Hydroxy-3-(3-oxo-l-phenyl butyl)-

coumarin and its salts

1-(4-Hydroxy-13-phenylethyl)-4-

355 .

phenyl-4-carbethoxypiperidine and

its salts

2-(4-Hydroxyphenyl)-I,3,4-

oxadiazole

Hydroxyzine

Hyoscine, its saIts and derivatives

Hyoscyamine, its salts and derivatives

-

Hyoscyamus niger L. (leaves, seeds,

-

powder and galenical preparations)

2-Imino-5-phenyloxazolidin-4-one

and its salts

Imperatorin

Inproquone

Intracaine and its salts

224,474

-

Iodine

Iodothymol

-

Ipecacuanha (Cephaelis ipecacuanha

Brot. and related species) (roots,

powder and galenical pr~parations)

Isocarboxazid

Isodrin

Isometheptene and its salts

2-Isooctylamine and its salts

34,464

Isoprenaline

235, 375

(sopropamide iodide

(2-Isopropylpent-4-enoyl)urea

Isoproterenol

235,372

Isosorbide dinitrate

Juniperus sabina L. (leaves, essential

-

~

oil aTld galcnical preparations)

-

I

B

Column 2

Column 3

Column 4

Column 1

I

Cross-reference

Number

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

of the Directive

Schedule

Lal1reloil

Laurus nobilis L. (oil from seeds)

-

Lead and its compounds (except lead

acetate)

Levophacetoperane and its salts

90,329, 331

Lindane

-

Lobelia inflata L. and its galenical

preparations

Lobeline and its saIts

387, 388

LSD

Lupinidine and its salts

385, 388

Lysergic acid diethylamide and its

salts

385, 387

Lysergide and its salts

-

Malononitrile

Mannomustine and its salts

Mecamylamine

Mefeclorazine and its salts

I I

Mephenesin and its esters

Meprobamate

I

-

. Mercury and its compounds (except

thiomersal and phenylmercuric

compounds)

Mescaline and its salts

Mctabromsalan

Metaldehyde

Metamfepramone and its salts

Metethoheptazine and its saIts

Metformin· and its salts

I

I

Methapyrilene and its salts

I

I

Mctheptazine and its salts

Methocarbamol

-

I

B

Column 3

Column 4

Column 1

Column 2

Cross-reference

Cross-reference

Number

to Annex 11

in this

to this

Name of substance

of the Directive

Schedule

Schedule

(63)

Methohexitone and its salts

Methotrexate

2-[4-Methoxy benzyl- N-(2-

pyridyl)amino ]ethyldimethylamine

maleate

1-Methoxy-2,2-bis( 4-hydroxy-3-

coumarinyl)ethane

( + )-3-Methoxy-N-methylmorphinan

and its sa1ts

3-(4-Methoxyphenoxy )propane-

1,2-diol

3-(2-Methoxyphenoxy)propane-

1,2-diol l-carbamate

8-Methoxypsoralen (except natural

315, 316

content of essences)

6-Methylamino-2-methylhept-2-ene

and its salts

2-Methyl-l ,2-bis(3-pyridyl)-

propan-1-one

9-(3-Methylbut-2-enyloxy)furo-

[3,2-g ]chromen-7-one

2-Methyl-6-chloroanilide of

n-butylaminoacetic acid and its sa1ts

3,3-Methy lenebis-

218, 219

( 4-hydroxycoumarin)

-

2-Methylheptylamine and its salts

4-Methyl-2-hexylamine and its salts

35,252

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

(ethyldimethylammonium) salts

1-Methyl-2-mercaptoimidazole

Methylphenidate and its salts

l-Methyl-4-phenyl-4-

carbetQ.oxyhexamethyleneimine and

,

its salts

3-Methyl-2-phenylmorpholine, its

derivatives and sal ts

2-Methyl-2-propyl-1-

isopropylcarbamoyloxy-3-

carbamoyloxypropane

B

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

2-Methyl-2-propylpropane-l,3-diol

dicarbamate

N-Methyl-l,2,5,6-tetrahydro-3-

nicotinic acid methyl ester

Methyprylon and its salts

Metyrapone

Mofebutazone

Monobenzone

85,348

-

Morpholine and . its salts

Mustine and its salts

94, 141

Mustine N-oxide and its salts

Nalorphine, its salts and ethers

Naphazoline and its salts

2-Naphthol

~-Naphthol

l- and 2-Naphthylamines and their

salts

and ~-Naphthylamines and their

440 ·

rt.-

salts

3-t l-Naphthyl)-4-hydroxycoumarin

-

2-(1-Naphthylmethyl)imidazoline and

its salts

-

Narcotics, natural and synthetic

All substances listed in Tables I and

II of the Single Convention on

Narcotic Drugs 1961 (Treaty

Series No. 34 (1965), Cmnd. 2631)

Narcotine and its salts

-

Neodymium and its salts

--

Neostigmine and its salts

--

Nicotine and its salt:>

-

Nitrites, inorganic (except sodium

nitrite)

-

Nitrobenzene

---

Nitrocresols and their alkali meta I

-

salts ·

-~

B

Column 3

Column 2

Column 4

Column l

Cross-refercnce

Number

Cross-reference

to this

to Annex II

in this

Name of substance

Schedule

Schedule

of the Directive

N itroderivatives of carbazole

Nitrofurantoin

N-(5- Nitro-2-furfurylidene)-I-

aminohydaI1toin

3-(5-Ni trofurfurylideneamino)-

oxazolidin-2-one

322, 542

Nitroglycerine

NitrostiIbenes, their homologues and

-

derivatives

Nitroxoline and its salts

Noradrenaline and its salts

32,459

Norepinephrine and its salts

32,458

Noscapine and its salts

N ux vomica and its preparations

Octamoxin and its saIts

Octamylamine and its salts

Octodrine and its salts

34, 371

-

Oestrogens (except oestradiol,

oestriol and oestrone)

-

Oleandrin

[Oxalyl bis(imi noethylene)J bi s-

[(o-chlorobenzyI)diethylammonium]

salts

Oxanamide and its derivatives

2-0xo-3-isobutyl-9,10-dimethoxy-

1,2,3,4,6,7-hexahydro-l1 bH-benzo-

[a]quinoline and its saIts

Oxpheneridine and its salts

Paramethasone

Paraoxon

Parathion

Parethoxycaine and its salts

224,364

PeIletierine and its salts

Pemoline and its salts

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

Pentachloroethane

-

Pentaerythritol chlaral

480,487

Pentaerythritol tetranitrate

479,487

Pentaerythrityl tetranitrate

Pentamethonium bromide

N,N' -Pentamethylenebis-

(trimethylammonium) salts

(63)

Pentobarbitone and its salts

Pentylaminomethylheptane, its

isomers and salts

PerchloroethyJene

(496)

Perphenazine and its salts

479,480

PETN

Petrichloral

Phenacemide

Phenaglycodol

Phenetamine

Phenindione

Phenmctrazine, its derivatives and

sc.lts

(63)

Phenobarbitone and its salts

Phenol alkali salts (except as may

-

be formed as a result of the use of

phenol as permitted by Schedule 2)

various

Phenothiazine and its compouJ;lds

Phenprobamate

Phenprocoumon

N- PhellY lacety l urea

. 4-Phenylazophenylene-1 ,3-diamine

citrate hydrochloride

Phenylbutazone

4-Phenylbut- 3--en-2-one

N-(2-PhenyJbutyryl)urea

,

" .

B

Column 3

Column 4

Column 2

Column 1

Cross-reference

Cross-reference

Number

to this

to Annex II

Name of substance

in this

of the Directive

Schedule

Schedule

N-[2-( CI.-Phenyl-p-chlorobenzyl)-

ethyl]morpholine

l-Phenylcyclopentanecarboxylic .acid

diethylaminoethyl estcr and its salts

2- Phenylcyclopropylamine (trans-form)

634,635

and its salts

l-Phenyl-2,3-dimethyl-4-

isopropylpyrazol-5-one

2-Phenylindan-1,3-dione

Cl- Phenyl-2- piperidineacetic acid

methyl ester and its salts

1-Phenylpropan-1-01 carbamate

3-( CI.- Phenylpropyl)-4-hydroxy-

coumarin

l-Phenyl-2- (2-":pyridylamino )ethanol

303,515

2-Phenylquinoline-4-carboxylic acid,

its salts and derivatives and salts of

those derivatives

6-Phenyl-2,4, 7 -triaminoptcridine

and its salts

Phenyramidol

303, 512

Phosphides, metal

-

Phosphorus

4-Phosphoryloxy-

N,N-di mcthyltryptamine

3-Phthalimidopi peridine-

2,6-dione and its salts

(592)

Phthalylsulphathiazole and its salts

Physostigma venerzosum Balf.

Physostigmine and its saIts

Picrotoxin

-

Piloca rpine and its salts

-

Pilocarpus j aborandi Holmes and its

ga)enical preparations

Pipazetate and its salts

,

B

Column 1

Column 2

I

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

,

2-(2-Piperidinoethoxy )ethyl-l 0-

thia - I ,9-diazaanthracene-9-

carboxylate and its salts

IX-Piperidin-2-ylbenzyl acetate,

laevorotatory threo-form

~-(2-Pjperidyl)propionaldehyde and

its salts

Pipradrol and its salt~

Piprocurarium iodide

Poldine metilsulfate (or methylsulph"te)

Polyacetaldehyde

Potassium nitroferricyanide

14, 535

Potassium nitroprusside

14, 534

Probenecid

Procainamide, its salts and derivatives

Prochlorperazine and its salts

(496)

Progestogens (except progesterone

-

and ethisterone)

Promazine and its salts

(496)

Promethazine and its salts

(496)

Propane-I,2,3-triyl trinitrate

322,455

Propatylnitrate

l-Propyl-3-(4-chlorobenzene-

sulphonyl)urea

2-Propylpiperidine

1-(2- Propynyl)cyclohexyl carbamate

Propyphenazone

Prunus laurocerasus L.

Psilocybine

-

Pyrethrum album L. and its

galenical preparations

pyrianisamine maJeate

Pyri benzamine

86,656

B

l

Column 3

Column 4

Colilmn 2

Column 1

Cross-reference

Cross-reference

Number

in this

to this

to Annex II

Name of substance

of the Directive

Schedule

Schedule

(63)

Quinalbarbitone and its salts

-

Radioactive substances (except

substances which are radioactive

naturally or by reason of contamina~

tion from the environment, which

have not been enriched for

manufacturing purposes, and of

which the concentration complies

with Directive No. 76/579/Euratom

of the European Economic Community

RaulVolfia serpentina alkaloids and

their saJts

Reserpine and its salts

(555)

a-Santonin

-

Sassafras officinale Nees oil

containing safrole

Schoenocaulon officinale Lind.

-

(seeds and galenical preparations)

Scopolamine, its salts and derivatives

Secbutobarbitone and its salts

(63)

Selenium and its compounds

-

Sodi urn hexacyclonate

Sodium nitroferricyanide

14, 565

Sodium nitroprusside

14, 564

Solanum nigrum L. and its galenicaI

-

preparations

Spanish Fly

Sparteine and its sal ts

S pironolactone

Squill and its preparations

Stramonium and its preparations

-

Strophantines and their aglucones

and theit respective derivatives

Strophantus species and their

-

galenical preparations

Strychnine and its salts

-

B

Column 1

Column 2

Colilmn 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

Strychnos species and their

galenicaI preparations

SuccinonitriIe

-

SuccinyIsulphathiazole and its salts

(592)

Sulfinpyrazone

Sulphacetamide and its salts

(592)

Sulphadiazine and its salts

(592)

Sulphadimethoxine and its salts

(592)

Sulphadimidine and its salts

(592)

Sulphafurazole and its saIts

(592)

Sulphaguanidine'and its saIts

(592)

Sulphamethizole and its saIts

(592)

Sulphamethoxazole and its saIts

(592)

Sulphamethoxydiazine and its saIts

(592)

Sulphamethoxypyridazine and its salts

(592)

Sulphanilamide and its saIts

(592)

Sulphapyridine and its salts

(592)

Sulphathiazole and its salts

(592)

Sulphonamides (sulphanilamide and

various

its derivatives obtained by

substitution of one or more H-atoms

of the -NH 2 groups) and their sal ts

Sulthiame

594,612

Sultiame

593, 612

Sympathomimetic amines acting on

the central nervous system: any

substance contained in the first !ist

of medicaments which are subject to

medical prescription and are referred

to in resolution AP (69) 2 of the

Council of Europe

Tefazoline and its salts

-

TelIurium and itl; compounds

TEPP

B

Column 3

Column 1

Column 2

Column 4

Number

Cross-refere-nce

Cross-reference

in this

to this

Name of substance

to Annex II

Schedule

Schedule

of the Directive

2-(4-tert-Butyl-2,6-dimethylbenzyl)-

imidazoline and its saIts

4-tert-Butylphenol

-

-

4-tert-Butylpyrocatechol

Tetrabenazine and its salts

-

Tetrabromosalicylanilides

Tetracaine and its salts

Tetrachloroethylene

Tetrachloromethane

-

Tetrachlorosalicylanilides

Tetraethylammonium bromide

Tetraethyl pyrophosphate

5,6,6a, 7-Tetrahydro-6-methyl-4H-

dibenzo[de, g]quinoline-l0,11-

dihydric aIchohol and its salts

2-(5,6,7,8-Tetrahydro-l-methyl-2-

naphthyl)-2-imidazoline and its salts

4-(Tetrahydro-2H-l,2-thiazin-2-yl)-

593, 594

benzenesulphonamide S,S-dioxide

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

norcamphanamine

Tetramethylthiuram disulphide

274,625

Tetrylammonium bromide

Thalidomide and its salts

ThaUium and its compounds

-

Thevetia nerii/olia Juss ., glycoside

-

extract

Thiamazole

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

Thiopentone and its salts

(63)

Thioridazine and its salts

(496)

Thiotepa

638,648

Thiourea and its derivatives (except

-

those listed in part II of Schedule 2)

B

Column 1

Column 2

Column 3

Column 4

Number

Cross-reference

Cross-reference

in this

Name of substance

to this

to Annex II

Schedule

Schedule

of the Directive

Thiram

274, 614

Thiuram disulphides

--

Thiuram monosulphides

-

Thyropropic acid and its salts

Tolboxane

Tolbutamide

Toluidines, their isomers, salts and

halogenated and sulphonated

derivatives

p-Tolylboric acid ester of 2-methyI-2-

propylpropane-1,3-diol

3-Tolyloxypropane-l,2-dioI

trans-2-Phenylcyclopropylamine and

506, 635

its salts

Tranylcypromine and its salts

506, 634

Tretamine

Triamterene and iti salts

Tri~ziridin-l-ylphosphine sulphide

623,648

2,2,2-Tribromoethanol

TribromoethyI alcohol

TrichIormethine and its salts

-

TrichIoroacetic acid

1,1,1-Trichloro-2,2-bis( 4-

174,202

chIorophenyI)ethane

2,2,2-Trichloroethane-l,l-dioI

Tri(~-chIoroethyI)amine and its salts

Tricresyl phosphate

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

triazine

N,N,N- Triethylenethiophosphamide

623,638

Trifluoperazine <;lnd its salts

(496)

Trifluperidol

3,3 ',5-Triiodothyroacetic acid and

its salts

B

-

i

Column 3

Column 4

Column 2

Column l

r

Cross-reference

Cross-reference

Number

I

to Annex II

to this

Name of substance

in this

of the Directive

Schedule

Schedule .

I

3,4,5-Trimethoxyphenethylamine

and its salts

2,2,6-Trimethyl-4-piperidyl benzoa.te

and its salts .

315, 316

Trioxysalan (except natural content

of essences)

Triparanol

86, 552

Tri peIennamine

1,2,3-Tris(2-tricthylammonium-

ethoxy) benzene triiodide

Tritolyl phosphatc

Tuaminoheptane, its isomers and salts

Urginea seWa Stern. and its galenical

preparations

Vaccines, toxins and serums listed in

-

the Annex to Council Directive

No. 75j319jEEC(a)

Valnoctamide

-

Veratrine, its salts and galenical

preparations

-

Veratrum album L. (roots and galenical

preparations)

Vinyl chloride monomer

-

7,215

Vinylidene chloride

Vitamins D~ and D"

166,280

I

2, 354

Warfarin and its salts

Xanthates.

Xanthinol

Xylidines, thcir isomers, salts and

I I

haJogenated and sulphonated

derivatives

I

I

Xylometazoline and its salts

I

Y ohimbine and its saJts

-

I

_: __ ..

Zoxazolamine

i

--

-

Regulations 4(1)(b) and 5(1)

419

1.2-Dimethyl-4- phenyl-4-

carbmethoxyhexamethyleneimine

u s-sa/ts tiegħu ·

1,3- Dimethyl-4-phenyl-4-

I

carboxyethylhexilmethyleneimine

u s-sa/ts tiegħu

-

Dimethyl sulphoxide

Dimevamide u s-sa/ts tiegħu

B

Kolonna 1

Kolohna3

Kolonna 4

Kolonna 2

Riferenza

Riferenza

Numru

Isem tas-sustanza

għal Annex II

għal din

rdin

tad-Direttiva

l-Iskeda

l-Iskeda

Dinitrophenol isomers

-

Dioxane

-

Dioxethedrin u s-sa/ts tiegħu

2,5-Dioxo- 3,3-diethyl-5-

methylpiperidine u s-sa/ts tiegħu

Diphenhydramine u s-sa/ts tiegħu

Diphenoxylate hydrochloride

2,2-Diphenyl-4-dimethylamino-

va1eramide u s-sa/ts tiegħu

5,5-Diphenyl-4-irnidazolidone

-

4-Diphenyhnethoxy-l-methylpiperidine

u s-sa/ts tiegħu

3-Diphenylmethoxytropane

u s-sa/ts tiegħu

l-Diphenylmethyl-4-methylpiperazine

1,2-Diphenyl-4-(2-phenylsul phinyl-

ethyl)pyrazolidine-3,5-dione

Diphenyl-2-piperidinemethanol

IX, IX-

1X,Ct.-Diphenyl-4-piperidinemethanol

Diphenylpyraline u s-sa/ts tiegħu

2,5-Dipropoxy-3,6-bis(ethylene-

imino )-1 ,4-benzoquinone

4-Dipropylsulphamylbenzoic acid

Disulfiram

614, 625

Doxylamine u s-sa/ts tiegħu

Emetine, s-sa/ts u d-derivattivi tiegħu

-

Endrin

Ephedrine u s-sa/ts tiegħu

-

Epinephrine

13,236

Ergocalciferol

(667)

Ergot, l-alkaloids u l-preparattivi

tiegħu

Eserine u s-sa/ts tiegħu

B

Kolonna 2

Kolonna 4

Kolonna 3

Kolonna 1

.

. -

Riferenza

Numru

Riferenza

għal Annex 11

fdin

Isem tas-sustanza

għal din

tad-Direttiva

l-Iskeda

l-Iskeda

Ethionamide

Ethoheptazine u s-salts tiegħu

Ethopropazine u s-salts tiegħu

(496)

2~Ethylamino-5-phenyloxazolin-4-

one

Ethyl bis( 4-hydroxycoumarinyl).

acetate u s-sa/ts ta' l-aċidu

Ethyl bis( 4-hydroxy-2-oxo:-l-

benzopyean-3-y) acetate u s-salts

ta'l-aċidu

Ethyl chloride

Ethylene dichloride

-

Ethylene oxide

2-Ethyl-2,3-epoxyhexamide

u d-derivattivi tiegħu

Ethylidene chloride

3-Ethylisothionicotinamide

(3-Ethyl-~methylglutarimide

65,296

u s-salts tiegħu

4-Ethyl-4-methyl~lperidine-

65,295

2,6-dione u s-salts tiegħu

~Ethyl-{3-methylvaleramide

.

Ethylphenacemide

300,321

2-Ethyl-2-phenylglutarimide

u s-sa/ts tiegħu

299,321

3-Ethyl-3-pħe.!1}'lpip~ridine-

2,6-dione u s-salts tiegħu

Fenadiazole

Fenozolone

512, 515

Fenyramidol

FIuanisone

FIuoresone

4' -FIuoro-4-[4-hydroxy-4-( oc, oc, oc-

trifluoro-m-tolyl)piperidino ]-

butyrophenone

B

--

Kolonna 4

Kolonna 3

Kolonna 2

Kolonna 1

Riferenza

Riferenza

Numru

għal Annex II

għal din

Isem tas-sustanza

fdin

tad-Direttiva

l-Iskeda

l-Iskeda

6 lX-FI uoro-16lX-methyl- ll~,

17 lX,21 - trihydroxypregna-

1,4-diene-3,20-dione

p-FluorophenyIcthylsulphone

1-(4-FI uorophenyI)-4-[ 4-(2-

methoxyphenyl)-I - piperazinyI]-

butan-l-one

5-FIuoropyrimidine-2,4-dione

FIuorouraciI

(496)

FIuphenazine

Furazolidone

FurfuryltrimethyIammonium salts

Furo[3,2-g]chromen-7-one u d-

316, 412, 654

derivattivi alkyl-substituted tiegħu

(minbarra l-kontenut naturali ta'essenzi)

315,412, 654

Furocoumarin u d-derivattivi alkyl-

substituted (minbarra l-kontenut

naturali ta' essenzi)

Furtrethonium iodide

Galantamine

-

GaIIamine triethiodide

GIucocorticoids

Glutethimide u s-sa/ts tiegħu

299, 300

455, 542

Glycerol trinitrate

Glycyclamide

Salts tad-deheb

-

7 30

Guaifenesin

Guanethidine u s-salts tiegħu

N- (2- Guanidinoethyl)heptamethyl-

eneimine u s-sa/tS tiegħu

Haloperidol

90, 331, 382

HCH (gamma-HCH)

HETP

90, 329, 382

1,2,3,4.5,6-Hexachlorocyclohexane

B

-

Kolonna 2

Kolonna 1

Kolonna 4

Kolonna 3

RifereQZa

Numru

Riferenza

Isem tas-sustanza.

għal din

għal Annex 11

fdin

l-Iskeda

tad-Direttiva

l-Iskeda

(lR, 4S, 5R, &S)-1,2,3,4,10,10-

Hexachloro'-:'6, 7-epoxy-1 ,4,4a,

5,6,7 ,8,8a-octahydro-1 ,4 :5,8-

dimethanonaphthalene

Hexachloroethane

-

(1R, 4S, 5R, 8S)-1,2,3,4,1O,10-

Hexachloro-l,4,4a,5,8,8a-

hexahydro-l ,4 :5,8-

dimethanonaphthalene

I

Hexaethyl tetraphosphate

(1 R, 2S)- Hexahydro-1 ,2-dimethyl-

3,6-epoxyphthalic anhydride

(3S, 5aR, 9bS)-3,3a,4,5,5a,9b- .

Hexahydro-3,5a,9-trimethylnaphtho-

[1 ,2-b ]furan-2,8-dione

(339)

Hexamethonium bromide

N,N' - Hexamethylenebis( trimethyl-

ammonium) sa1ts

Hexapropymate

-

Hydrastine, hydrastinine u s-salts

tagħhom

Hydrazides u s-salts . tagħhom

-

Hydrazine, 'id-derivattivi tiegħu u s-

-

salts tagħhom

2-Hydrazino-octane u s-salts tiegħu

Hydrocyanic acid u s-salts tiegħu

189, 347

Hydroftuorlc acid, is-salts normali

-

tiegħu, complexes · u hydroftuorides

(barra minn dawk imniżżlin fit-Taq-

sima 11 ta ' l-Iskeda 2)

Hydrogen cyanide u s-salts tiegħu

189,345

Hydroquinone monobenzyl ether

85,431

7-[2-Hydroxy-3-(2-hydroxyethyl-N-

methylamino )propyl]theophylline

[4-(4-Hydroxy-3-iodophenoxy)-3.5-

diiodophenyl]acetic acid u s-sa/ts tiegħu

3-[4-( 4-Hydroxy-3-iodophenoxy )-3,5-

diiodophenyl]propionic acid

u s-sa/ts tiegħu

-

l-l!rd!,_Q'!}'meth~-l-cycIohexylacetic

acid, salt tas-sodju

B

Kolonna 2

Kolonna 4

Kolonna 1

Kolonn::t3

Numru

Riferenza

Riferenza

Isem tas-sustanza

fdin

għal Annex 11

għal din

l-Iskeda

tad-Direttiva

l-Iskeda

8-Hydroxy-5(or 6)-hitroquinoline

u s~salts tiegħu

4-Hydroxy-3-(3-oxo-l-phenylbutyl)·

2,668

coumarin u s-salts tiegħu

1-(4-Hydroxy-l3-phenylethyl)-4-

phenyl-4-carbethoxypiperidine

u s-salts tiegħu

2-(4-Hydroxyphenyl)-1,3,4;-

oxadiazole

Hydroxyzine

Hyoscine, ·s-salts u d-derivattivi tiegħu

Hyoscyamine , s-salts u d-derivattivi

-

tiegħu

Hyoscamusniger L. (weraq, żerriegħa,

-

trab u preparati galenical)

2-Imino-5-phenyloxazolidin-4-one

u s-sa/ts tiegħu

Imperatorin

Inproquone

Intracaine u s-sa/ts tiegħu

224,474

-

Jodju

Iodothymol

Ipecacuanha (Cephaelis ipecacuanha

-'-

Brot. u speċji bħalhom (għeruq, trab u

preparati galenical)

Isocarboxazid

Isodrin

Isometheptene . u s-sa/ts tiegħu

2- Isooctylamine u s-sa/ts tiegħu

34,464

Isoprenaline

235, 375

Isopropamide iodide

(2-Isopropylpent-4-enoyl)urea

Isoproterenol

235,372

Isosorbide dinitrate

Juniperus sabina L. (weraq, żejt, es-

senzjali u preparati galenicaI)

-

Kolonna 1

Kolonna 2

Kolonna 4

Kolonna 3

.

Numru

Riferenza

Riferenza

Isem tas-sustanza

fdin

għal din

għal Annex 11

l-Iskeda

l-Iskeda

tad-Direttiva

,"

,Żejt tal-Iawru

Laurus nobilis L. (żejt fiiż-żerriegħa)

Ċomb u l-komputi tiegħu (minbarra

-

ċomb acetate)

Levophacetoperane u s-sa/ts tiegħu

90, 329, 331

Lindane

Lobelia inflata L. u l-preparati

-

tiegħu

Lobeline u s-sa/ts tiegħu

387, 388

LSD

Lupinidine u s-sa/ts tiegħu

Lysergic acid diethylamide u' s-sa/ts

385, 388

tiegħu

385, 387

Lysergide u s-sa/ts tiegħu

Malononitrile

-

Mannomustine u s-sa/ts tiegħu

Mecamylamine

Mefeclorazine u s-sa/ts tiegħu

Mephensin u l-esters tiegħu

Meprobamate

I

Mercury u l-komputi tiegħu (minbarra

-

thiomersal u phenylmercuric u

'komposti)-

Mescaline u s-sa/ts tiegħu

Metabromsalan

Metaldehyde

Metamfepramone u s-sa/ts tiegħu

Metethoheptazine u s-sa/ts tiegħu

Metformin u s-sa/ts tiegħu

Methapyrilene u s-sa/ts tiegħu

I

Metheptazine u s-sa/ts tiegħu

Methocarbamol

B

Kolonna 4

Kolonna 1

Kolonna 2

Kolonna 3

Riferenza

Riferenza

Numru

Isem tas-sustanza

, għal din

għal Annex II

fdin

tad-Direttiva

l-Iskeda

l-Iskeda

Methohexitone u s-sa/ts tiegħu

(63)

Methotrexate

2-[4-Methoxybenzyl-N-(2-

pyridyl)amino ]ethyldimethylamine

maleate

l-Methoxy-2,2-bis( 4-hydroxy-3-

coumarinyl)ethane

( + )-3-Methoxy-N-meth.ylmorphinan

u s-sa/ts tiegħu

3-(4-Methoxyphenoxy)propane-

1,2-diol

3-(2-Methoxyphenoxy )propane-

1,2-diol l-carbamate

8-Methoxypsoralen (minbarra l-kon-

315, 316

tenut ta' essenzi naturali)

6-Methylamino-2-methylhept-2-ene

u s-sa/ts tiegħu '

2-Methyl-l ,2-bis(3-pyridyl)-

propan-l-one

9-(3-Methylbut-2-enyloxy)furo-

[3,2-g ]chromen-7 -one

2-Methyl-6-chloroanilide ta'

n-butylaminoacetic acid u s-sa/ts

tiegħu

3,3-Methylenebis-

218, 219

( 4-hydroxycoumarin)

-

2-Methylheptylamine u s-sa/ts tiegħu

4-Methyl-2-hexylamine u s-sa/ts tiegħu

35,252

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

(ethyldimethylammonium) salts

l-Methyl-2-mercaptoimidazole

Methylphenidate u s-salis tiegħu

l-Methyl-4-phenyl-4-

~arbethoxyhexamethyleneimine

u s-sa/ts tiegħu

3-:Methyl-2-pħenytmorpholine,

id-derivattivi u s-sa/ts tiegħu

2-Methyl-2-propyl-l-

isopropylcarbamoyloxy-3-

carbamoyloxypropane

B

Kolonna 1

Kolonna 2

Kolonna 3

Kolonna 4

Numru

Riferenza

Riferenza

Isem tas-sustania

għal din

rdin

għal Annex 11

l-Iskeda

l-Iskeda

tad-Direttiva

2-Methyl-2-propylpropane-l,3-diol

dicarbamate

N- Methyl-l ,2,5,6-tetrahydro-3-

nicotinic acid methyl ester

Methyprylon u s-salts tiegħu

Metyrapone

Mofebutazone

Monobenzone

85,348

Morpholine u s-salts tiegħu

-

Mustine u s-salts tiegħu

94, 141

Mustine N-oxide u s-salts tiegħu

Nalorphine, is-salts u l-ethers tiegħu

Naphazoline u s-salts tiegħu

2-Naphthol

~-Naphthol

l- and 2-Naphthylamines u s-salts

tagħhom

a- and ~-Naphthylamines u s-salts

tagħhom

-

3-(1-N aphthyl)-4-hydroxycoumarin

2-(1-Naphthylmethyl)imidazoline

u s-salts tiegħu

-

Narkotiċi, naturali u sintetiċi

Is-sustanzi kollha msemmija fit-

Tabelli I u 11 tas-Single Convention on

Narcotic Drugs 1961 (Treaty Series No.

34 (1965), Cmnd. 2631)

Narcotine u s-salts tiegħu

-

Neodymium u s-salts tiegħu

Neostigmine u s-salts tiegħu

-

246'

-

, Nikotma u s-sa/ts tagħha

. Nitriti, inorganiċi (minbarra nitrit tas-

-

sodi u)

-

Nitrobenżina

-

Nltrocresols u l-aIk<ifi metal salts

tagħhom

Kolonna 2

Kolonna)

Kolonna 4

Kolonna 1

Riferenza

Riferenza

Numru

Isem tas-sustanza

għal din

għal Annex 11

fdin

l-Iskeda

tad-Direttiva

l-Iskeda

Nitroderivattivi ta' carbazole

Nitrofurantoin

· 251

N-(5- Nitro-2-furfurylidene)-:-I-

aminohydantoin

3-( 5-Ni trofurfurylideneaminp)-

oxazolidin-2-one

Nitrogliċerina

322, 542

-

Nitrostilbenes, il-homologues u

d-derivattivi tagħhom

Nitroxoline u s-sa/ts tiegħu

N oradrenaline u s-sa/ts tiegħu

32,459

Norepinephrine u s-sa/ts tiegħu

32, 458

I

Noscapine u s-sa/ts tiegħu

Nux vomica u l-preparati tiegħu

Octamoxin u s-sa/ts tiegħu

Octamylamine u s-sa/ts tiegħu

Octodrine u s-sa/ts tiegħu

34, 371

-

Oestrogens (ħlief oestradiol,

oestriol u oestrone)

-

Oleandrin

[Oxalyl bis(imi noethylene) ]bis-

[(o-chlorobenzyl)diethylammonium]

salts

Oxanamide u d-derivattivi tiegħu

2-0xo-3-isobutyl-9, 1 O-dimethoxy-

1,2,3,4,6. 7-hexahydro-l1 bH-benzo-

[a]quinoline u s-sa/ts tiegħu

Oxpheneridine u s-sa/ts tiegħu

Paramethasone

Paraoxon

Parathion

Parethoxycaine u s-sa/ts tiegħu

224, 364

Pelletierine 'u s-sa/ts tiegħu

Pemoline u s-sa/ts tiegħu

B

Kolonna 1

Kolonna 3

Kolonna 2

Kolonna 4

Numru

Riferenza

Riferenza

Isem tas-sustanza

fdin

għal din

għal Annex II

l-Iskeda

l-Iskeda

tad-Direttiva

Pentachloroethane

-

Pentaerythritol chloral

· 479

480, 487

Pentaerythritol tetranitrate

Pentaerythrityl tetranitrate

479, 487

~

Pentamethonium bromide

N,N' -Pentamethylenebis-

(trimethylammonium) salts

Pentobarbitone u s-sa/ts tiegħu

(63)

Pentylaminomethylheptane,

l-isomers u s-sa/ts tiegħu

Perchloroethylene

Perphenazine u s-sa/ts tiegħu

(496)

PETN

479, 480

Petrichloral

Phenacemide

Phenaglycodol

Phenetamine

Phenrndione

Phenmetrazine, id-derivattivi

u s-salts tiegħu

(63)

Phenobarbitone u s-salts tiegħu

-

PhenoI alkali salts (minbarra kif jista' ·

jiġi format minħabba l-użu tal-phenol

kif permess bI-Iskeda 2)

Phenothiazine u l-komposti tiegħu

dIverSI

Phenprobamate

Phenprocoumon

N-Phenylacetylurea

4-Phenylazophenylene-1 ,3-diamine

citrate hydrochloride

Phenylbutazone

4-Phenylbut-3--en-2-one

N-(2-Phenylbutyryl)urea

B

-

Kolonna 1

Kolonna 4

Kolonna 2

Kolonna 3

Numru

R iferenza

Riferenza

Isem tas-sustanza

għal Annex II

rdin

għal din

l-Iskeda

tad-Direttiva

l-Iskeda

N-[2-( cx-PhenyI-p-chlorobenzy!)-

ethy\]morpholine

I

l-PhenyJcyclopentanecarboxylic acid

diethylaminoethyl ester u s-sa/ts tiegħu

2-PhenyIcyclopropylamine (frans-form)

634, 635

u s-sa/ts tiegħu

l-Phenyl-2,3-dimethyI-4-

isopropylpyrazoi-5-one

2-Phenylindan-l ,3-dione

cx-Phenyl-2-pipcridineacetic acid

methyl ester u s-sa/ts tiegħu

l -Phenylpropan-l-ol carbamate

3-( cx-Phenyi propyl)-4-hydroxy-

coumarin

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

303,515

2-Phcnylqu inoline-4-carboxylic acid,

is-sa/ts u d-derivattivi tiegħu u

s-sa/ts ta' dawk id-derivattivi

6-Phenyl- 2,4, 7 -triaminopteridine

u s-sa/ts tiegħu

PhenyramidoI

303, 512

Phosphides, metall

-

-

Fosforu

4-Phosphory!oxy-

N,N-dimethyltryptamine

3-Phtha!imidopi peridine-

2,6-dione u s-sa/ts tiegħu

Phthalylsulphathiazole u s-sa/ts tiegħu

(592)

Physostigma venenosum Balf

Physostigmine u s-sa/ts tiegħu

Picrotoxin

Pi!ocarpine u s-sa/ts tiegħu

-

-

Pilocarpus jaborandi Ho/mes u

l-preparattivi galenical tiegħu

Pipazetate u s-sa/ts tiegħu

I

. .. :~~.~~}X

B

I

Kolonna 1

Kolonna 2

I

Kolonna 3

Kolonna 4

Numru

Riferenza

Riferenza

rdin

Isem tas-sustanza

għal din

għal Annex II

l-Iskeda

l-Iskeda

tad-Direttiva

2-(2-Piperidinoethoxy)ethyl-1 0-

. 118

thia -1 ,9-diazaanthracene- 9-

carboxylate u s-sa/ts tiegħu

cr:....:Piperidin-2- ylbenzyl acetate,

laevorotatory threo-fqrm

~-(2 -Piperidyl)propionaldehyde

u s-sa/ts tiegħu

Pipradrol u s-sa/ts tiegħu

Piprocurarium iodide

Poldine metilsulfate (jew

methylsulphate)

Polyacetaldehyde

Potassium nitroferricyanide

14, 535

Potassium nitroprusside

14, 534

Probenecid

Procainamide, is-sa/ts u d-c:k ,i vattivi

tiegħu

.

Prochlorperazine u s-salċs tIegħu

(496)

Progestogens (minbarra progesterone

-

u ethisterone)

Promazine u s-sa/ts tiegħu

(496)

Promethazine u s-sa/ts tiegħu

(496)

Propane-l,2,3-triyI trinitrate

322,455

. Propatylnitrate

l-Propyl-3-( 4-chlorobenzene-

sulphonyI)urea

2-Propylpiperidine

1- (2- PropynyI)cyclohexyI carbamate

Propyphenazone

Prunus laurocerasus L.

Psilocybine

Pyrethrum a/bum L. u l-preparattivi

-

galenical tiegħu

Pyrianisamine maleate

Pyribenzamine

86, 656

-

-

Kolonna 2

Kolonna 4

Kolonna 1

Kolonna 3

Numru

Riferenza

Riferenza

Isem tas-sustanza

rdin

għal Annex 11

għal din

l-Iskeda

tad-Direttiva

l-Iskeda

Quinalbarbitone us-salts tiegħu

(63)

Sustanzi radjoattivi (hlief sustanzi li

-

huma radjoattivi naturali jew

minħabba kontaminazzjoni mill-

ambjent, li ma ġewx miżjuda għal

għanijiet ta' manifattura, u li

l-konċentrazzjoni

taqbel

mad-

Direttiva Nru. 76/579/Euratom of

the European Economic Community

Rauwolfia serpentina alkaloids u

s-salts tiegħu

. Reserpine u s-salts tiegħu

(555)

(X-Santonin

-

Sassafras officinale Nees żejt li fih

safrole

-

Schoenocaulon officinale Lind.

(żerriegħa u preparauivi galenical)

Scopolamine, is-salts u d-derivattivi

' _ tiegħu

Secbutobarbitone u s-salts tiegħu

(63)

Selenium u l-komposti tiegħu

-

Sodium hexacyclonate

Sodium nitroferricyanide

14, 565

Sodium nitroprusside

14, 564

Solanum nigrum L. u l-preparattivi

-

galenical tiegħu

Spanish Fly

Sparteine u s-salts tiegħu

Spironolactone

SquilI u l-preparattivi tiegħu

Stramonium u l-preparattivi tiegħu

Strophantines ul-aglucones

-

tagħhom u d-derivattivirispettivi

tagħhom

-

Strophantus species u l-preparati

galenical taghhom

Strychnine u s-salts tieghu

-

B

Kolonna 2

Kolonna 1

Kolonna 4

Kolonna 3

Riferenza

Numru

Riferenza

Isem tas~sustanza

għal Annex 11

fdin

għal din

' tad-Direttiva

l-Iskeda

l-Iskeda

Strychnos species u l-preparati

galenical tagħhom

-

SuccinonitriIe

(592)

SuccinylsulphathiazoJei u s-sa/ts tiegħu

Sulfinpyrazone

(592)

Sulphacetamide u s-sa/ts tiegħu

Sulphadiazine u s-sa/ts tiegħu

(592)

Sulphadimethoxine u s-sa/ts tiegħu

(592)

~ulphadimidine u s-sa/ts tiegħu

(592)

Sulphafurazole u s-sa/ts tiegħu

(592)

Sulphaguanidine u s-salts tiegħu

(592)

Sulphamethlzole u s-sa/ts tiegħu

(592)

Sulphamethoxazole u s-sa/ts tiegħu

(592)

Sulphamethoxydiazine u s-sa/ts tiegħu

(592)

Sulphamethoxypyridazine u s-sa/ts tiegħu

(592)

' Sulphanilamide u s-sa/ts tiegħu

(592)

Sufphapyridine u s-sa/ts tiegħu

(592)

Sulphathiazole u s-sa/ts tiegħu

(592)

various

Sulphanamides (sulphanilamide u

d-derivattivi tieghu miksuba minn

sostituzzjoni ta' grupp wieħed _

jew iktar ta' H-atoms ta' l-NW) u s-

sa/ts tagħhom

- --

Sulthiame

' 594, 612

Sultiame

593,612

.S:Ympathomimetic amines li jaħdlnu

fuq is-sistema nervuża ċentrali

kull sistema li hemm fl-ewwel

lista ta' medikamenti li huma

sl1ġġetti ghal riċetta medika u li huma

msemmija fir-riżoluzzjoni AP (69) 2

tal-Council of Europe

Tefazoline u s-sa/t9 tieghu

-

Tellurium u J-kompost1 tiegħu

-

TEPP

B

lt;.(:,ll:)tmn 1

K()jl)(UUI. :2

Kolonna 4

Kolonna 3

.. ~

.w.w.·.·.~,~·.·.·.·.·.~.~.~,,~·w~.=·~ .. =,·.:.:.:.:"".:* .. : •..... ~.,~.~ ... =

... w ..•. ~~~~~~-I-~~~~~~~~~

. ~

. ~~~

Ni.)mrV

Riferenza

Riferenza

għal din

għal Annex II

f' din

hem t.!l!HHlstnnza

Hsk~da

l-Iskeda

tad-Direttiva

2-(4-4ert-Butyl-2.6~dimethylbenzyl)-

imidl1zolir'lti li s·'.5'lilts tiegħu

4-tert-BlltylphellQl

4-tt\rt~ButylpYfQeateQhol

Tetrabtna'l,ine u ~d'alts tiegħu

Tetrabromosalicylaoilides

Tetracaine u s-sa/ts tiegħu

Tetrachloroethylene

Tetrachloromethane

Tetrachlorosalicy lanili des

Tetraethylammonium bromide

Tetraethyl pyrophosphme

5,6,6a, 7-Tetrabydro-6-methyl-4H-

dibenzo[de, g]quinoline-lO.ll-

dihydric aIchohol u s-sa/ts tiegħu

2- (5,6,7,8-Tetrahydro-l-methyl-2-

naphthyl)-2-imidazoline u s-sa/ts tiegħu ,

593,594

4- (Tetrahydro-'2H-l,2-thiazin-2-yl)-

bem.enesulphonamide S,S-dioxide

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

norcamphanamine

Tetramethylthiuram disulphide

274, 625

Tetrylammonium bromide

Thalidomide u s-sa/ts tiegħu

Thallium u l-komposti tiegħu

Thevetia neriifolia Juss .) estratt

tal-glycoside

Thiamazole

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

Thiopentone u s-sa/ts tiegħu

(63)

Thioridazine u s-sa/ts tiegħu

(496)

Thiotepa

638,648

Thiourea u d-derivattivi tiegħu

(minbarra dawk imsemmija

fit-Taqsima II ta' l-Iskeda 2)

B

Kolonna 1

Kolonna 2

Kolonna 3

Kolonna 4

Numru

Riferenza

Riferenza

Isem tas-sustanza

rdin

għal din

għal Annex 11

l-Iskeda

l-Iskeda

tad-Direttiva

Thiram

274,614

Thiuram disulphides

-

Thiuram monosulphidfl:s

-

Thyropropic acid u s-salts tiegħu

Tolboxane

Tolbutamide

Toluidines, l-isomers, is-salts

tagħhom u halogenated u

sulphonated derivatives

p-Tolylboric acid ester of 2-methyl-2-

propylpropane-1,3-diol

3-Tolyloxypropane-1 ,2-diol

506, 635

trans-2-Phenylcyclopropylamine u

s-salts tiegħu

Tranylcypromine u s-salts tiegħu

506, 634

Tretamine

Triamterene u s-salts tiegħu

, 514

Triaziridin-1-ylphosphine sulphide

623, 648

2,2,2-Tribromoethanol

'rribron1oethyi aicohoi

Trichlonnethine u s-salts tiegħu

Triċh1oroacetic acid

-

1 , 1.1~Trichloro-2,2-bis(4-

174, 202

chlorophenyl)etbane

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

Tri(~-'Chloroethyl)amine ' u s-salts tiegħu

Tricresyl phosphate

2,4,6- Triethyleneifiiino~ 1,3,5-

triazine

N,N,N- TrietħylenethiophQsphamide

623,638

Trifluoperazin'e u ifdalts tiegħu

(496)

Trifluperidol

3,3 ',5-Triiodothyroacetic acid u

s"cmlis tieg;ħll

-

-_.-

-

---~

i

Kolonna 4

Kolonna 3

Kolonna 1 ~

Kolonna 2

Riferenza

Riferenza

Numru I

l

għal Annex II

Isem tas-sustanza

għal din

rdin

tad-Direttiva

l-Iskt'da

l-Iskeda

- --

i 3,4,5-T rimethoxyphenethylamine

u s-sa lts tiegħu

2,2,6-T rimethyl-4-piperidyl benzoate

u s-sa lts tiegħu

I

I Trioxy salan (minbarra l-kontenut ta'

315, 316

esse nzi naturali)

Tripar anol

86, 552

Tripele nnamine

1,2,3- T ris(2-tricthylammonium-

ethox y) benzene triiodide

Tritoly l phosphat0

Tuam inoheptane, l-isomers u s-salts

tiegħu

Urgine a scWa Stern, u l-preparattivi

J?ale nical tiegħu

-

Vaccin es, toxins u serums

imse mmija fl-Annex għal Council

Dire ctive No. 75/319/EEC(a)

Valnoc 'tamide

Veratr ine, is-salts tiegħu u

-

I

l-pre parattivi galenical

Veratr um album L. (għeruq u

-

prep arattivi galenical)

Vinyl c hloride monomer

-

7, 215

Vinylid ene chloride

166, 280

Vitami ns D" and f) ,

Warfar in u s-sa/ts tiegħu

2, 354

Xnotha tes

Xanthi nol

Xylidin es, l-isomers, is-salts

tagħ horn u derivattivi halogenated

I

usul phonated

Xylom etazoline u s-salts tiegħu

Yohim bine u s-salts tiegħu

-

Zoxazo lamine

-

....... ; ........... __ . ..,.''';''

• . 9 - " - ''''~''''"",,",W<n' .~..,.._-....-.

--~---_._-

B

Regolamenti 4(1) u 5 (1)