Cosmetic Products Order, 2000

L.N. 204 of 2000

QUALITY CONTROL

(EXPORTS, IMPORTS AND LOCAL GOODS) ACT

(CAP. 225)

Cosmetic Products Order, 2000

(Order No. 47 of 2000)

IN exercise of the powers conferred by article 3 of the Quality

Control (Exports, Imports and Local Goods) Act, the Malta Standards

Authority has made the following order:-

1

The title of this Order is the Cosmetic Products Order, 2000 Citation and

commencement.

and may be referred to as Order No. 47 of 2000.

1.2 This Mandatory Order shall come into effect as from 1st

January, 2001, provided that

1.2.1 imported products which have been ordered prior to

that date may continue to be marketed until 1st January, 2002,

provided that these products comply with the Cosmetics Products

Regulations, 1983,

1.2.2 the provisions of this Order shall not apply to cosmetic

products manufactured in Malta and marketed prior to 1st July,

2002, provided that these products comply with the Cosmetics

Products Regulations, 1983,

1.2.3 the provisions of paragraph 5.2 of this Mandatory

Order shall in any case apply to all cosmetic products as from 1st

January, 2001.

Illustrative list by category of cosmetic products

Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc).

Face masks (with the exception of peeling products).

Tinted bases (liquids, 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,

- cleaning products (lotions, powders, shampoos),

- conditioning products (lotions, creams, oils),

- hairdressing products (lotions, lacquers, brilliantines).

Shaving products (creams, foams, lotions, etc).

Products for making up and removing make-up from the face and eyes.

Products intended for application to the lips.

Products for the care of the teeth and the mouth.

Products for nail care and make-up.

Products for external intimate hygiene.

Sunbathing products.

Products for tanning without sun.

Skin-whitening products.

Anti-wrinkle products.

1

This Mandatory Order shall apply to all cosmetic products Applicability.

as defined in this Order.

2.2 Without prejudice to paragraph 3.1.1, the products to be

considered as cosmetic products within the meaning of this definition

are listed in the First Schedule to this Order.

List of substances which must not form part of the composition of

cosmetic products

(*) In this Schedule, names followed by an asterisk are those published in "Computer print-out 1975, International Non-

propriet;uy Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN", WHO, Geneva, August 1975.

1. N-5-Chlorobenzoxazol-2-ylacetamide

2. 2-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts)

3. Deanol aceglumate*

4. Spironolactone*

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

6. Methotrexate*

7. Arninocaproic acid* and its salts

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

9. Thyropropic acid* and its salts

1 In this Order, unless the context otherwise requires, the

following definitions shall apply

3.1.1 "cosmetic product" means any substance or

preparation intended to be placed in contact with the variou~

external parts of the human body (epidermis, hair system, nails,

lips and external genital organs) or with the teeth and the mucous

membranes of the oral cavity with a view exclusively or mainly to

cleaning them, perfuming them, changing their appearance and/or

correcting body odours and/or protecting them or keeping them in

good condition;

3.1.2 "Directive" means Directive 761768IEEC of the

European Community;

3.1.3 "competent authority" means the Director of

Consumer Affairs, provided that the Director may, in writing,

authorise any department or other public entity to act as a competent

authority for the purposes of notification under paragraph 7.5.

List of Substances which Cosmetic Products must not contain except subject to the restrictions and conditions laid down

(') In Ih" Schedule, names (ollolled hy an aslellSk are those puhllshed III "Computer print-out )<)75, Intcmatlonal Non-proprictary Namcs (INN) for pharmaccutical products, Lists 1-33 of proposed INN",

\\'1/0, (;enna, August 1'!75.

Restrictions

Field of application

Maximum authorized

Other limitations and

Conditions of use and

Substance

Reference

concentration in the

requirements

and/or use

warnings which must be

Number

finished cosmetic

printed on the label

product

d

c

e

f

b

a

(a) Talc

(a) 5% (by mass/mass

(a) I ,Not to be used in

(a) I, Not to be used for

la

Boric acid, borates and

as boric acid)

products for

tctraborates

children under three

children under

years of age

three years of age,

2, Not to be used on

2, Not to be used on

peeling or irritated skin

peeling or irritated skin,

if the concentration of

free soluble borates

exceeds 1,5% (by

mass/mass as boric

acid)

(b) Products for oral

(b) 0,1'% (by

(b) I ,Not to be used in

(b) LNottobe

hygiene

mass/mass as

products for

swallowed,

boric acid)

children under

three years of age,

2, Not to be used in

products for children

under three years of age,

(c) Other products

(c) 3% (by mass/mass

(c) I, Not to be used in

(c) L Not to be used for

(excluding bath

as boric acid)

products for

children under three

products and hair

children under

years of age

Restrictions

Substance

Field of application

Maximum authorized

Other limitations and

Reference

Conditions of use and

and/or use

concentration in the

Number

requirements

warnings which must be

finished cosmetic

printed on the label

product

b

d

c

a

e

f

waving products)

three years of age.

2. Not to be used on

2. Not to be used on

peeling or irritated skin

peeling or irritated skin.

if the concentration of

free soluble borates

exceeds 1.5% (by

mass/mass as boric

acid)

(a) 18% (by

Ib

Tetraborates

(d) Bath products

(a) Not to be used in

(a) Not to be used in

mass/mass as

bathing children

products for

boric acid)

children under 3

under 3 years of age

years of age

(b) Hair waving

(b) 8% (by mass/mass

(b) Rinse well

products

as boric acid)

(a) Hair waving or

(a)

2a

Thioglycollic acid and

(a) (b) (c)

(a)

its salts

straightening

The directions for use

Contains thioglycolate

-

products

drawn up in the official

Follow the

-

general use

8% ready for use,

languages must

instmctions

-

-

pH: 7-9.5

obligatorily incorporate

Keep out of reach of

-

professional use

11 % ready for

the following

children

-

-

use, pH : 7- 9.5

sentences

For professional use

-

\.void contact with

only

-

the eyes

(b) Depilatories

(b) 5% ready for use,

In the event of

(b) and (c)

-

-

pH ~ 12.7

contact with the

Contains thioglycolate

eyes, rinse

Follow the

-

(c) Other hair care

(c) 2% ready for use

inmlcdiately with

instmctions

0:1

- Keep out of reach of

products which are

pH 7 to 9.5

plenty of water and

-...l

VI

tl::1

--.J

0\

Restrictions

Conditions of use and

Other limitations and

Maximum authorized

Field of application

Rt:I~rence

Substance

warnings which must be

requirements

concentration in the

and/or usc

Numher

printed on the label

finished cosmetic

product

f

e

d

c

b

a

children

seek medical advice

percentages calculated

removed after

Wear suitable

as thioglycollic acid

application

-

gloves (a) and (c)

only

2b

Hair waving or

Thioglycollic aCId esters

The directions for use

straightening products

8% ready for use,

drawn up in the official

Contains thioglycolate

general use

-

-

-

languages must

Follow the

pH 6 to 9.5

-

obligatorily incorporate

instructions

I I% ready for

the following

Keep out of reach of

professional usc

-

-

-

lise, pH 6 to 9.5

sentences

children

May cause

For professional use

-

-

sensitization in the

The abovementioned

only

event of skin

percentages are

calculated as

contact

thioglycollic acid

Avoid contact with

-

the eyes

In the event of

-

contact with the

eyes, rinse

immediately with

plenty of water and

seek medical advice

Wear suitable

-

gloves

Oxalic acid, its esters

Hair care products

5'%

For professional use only

and alkaline salts

6'% calculated as NH 3

Ammonia

Above 2%: contains

Restrictions

:rence

Substance

Field of app Iication

Conditions of usc and

Maximum authorized

Other limitatlOns and

mbcr

wamings whIch must be

and/or use

concentration in the

reqUirements

printed on the label

finished cosmetic

product

[

a

b

e

d

e

ammoma

Tosylchloramide

.'i

0.2%

sodium*

Chlorates of alb II

(a) 5%

(a) Toothpaste

metals

(b) 3%

(b) Other uses

Dichloromethane

35%

0.2% as maXll11Um

(when mixed with

impurity content

1,1,1-trichloro-ethane,

total concentration

must not exceed 35%)

R

o and 111-

Oxidizing colouring

6% calculated as free

Phenylenediamines,

agents for hair dyeing

base

their N-substituted

(a) general use

(a) Can cause an allergic

derivatives and their

reaction. Contains

salts; N -substituted

phenylene-diamines.

derivatives ofp-

Do not use to dye

phenylenediamines

eyelashes or

eyebrows.

(b) professional use

(b) For professional use

only. Contains

phenylene-diamines.

Can cause an allergic

reaction. Wear

suitable gloves.

Methylphenyl-diamines,

Oxidizing colouring

10% calculated as free

;ubstances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to

mum level authorized for each of them does not exceed the value given in column d.

tx:l

-.)

--

Restrictions

Reference

Conditions of use and

Substance

Field of application

Maximum authorized

Other limitations and

Number

warnings which must be

and/or use

concentration in the

requirements

printed on the label

finished cosmetic

product

f

a

b

e

c

d

other N-substituted

agents for hair dyeing

base

(a) Can cause an allergic

derivatives and their

(a) general use

reaction. Contains

salts

phenylene-diamines.

Do not use to dye

eyelashes or

eyebrows.

(b) For professional use

(b) professional use

only. Contains

phenylene-diamines.

Can cause an allergic

reaction. Wear

suitable gloves.

10% calculated as free

Oxidizing colouring

Diaminophenols

agents for hair dyeing

base

(a) general use

(a) Can cause an allergic

reaction. Contains

diaminophenols. Do

not use to dye

eyelashes or

eyebrows.

(b) professional use

(b) For professional use

only. Contains

diaminophenols. Can

cause an allergic

2 These substances may be used singly or in combination provided that the sum of the ratios of the levels of them in the cosmetic product expressed with reference to the

maximum level authorized for each of them does not exceed the value given in column d.

Restrictions

Conditions of lise and

Maximum authorized

Other limitations and

Field of application

Reference

Substance

and/or use

concentration in the

requirements

warnings which must be

Number

printed on the label

finished cosmetic

product

c

d

e

f

a

b

reaction. Wear

suitable gloves.

II

Dichlorophen*

0.5%

Contains dichlorophen

(a) 12% HeO e (40

Hydrogen peroxide, and

(a) Hair care products

(a) (b) (c)

other compounds or

volumes) present

Contains hydrogen

mixtures that release

or released

peroxide. Avoid contact

hydrogen peroxide,

(b) Skin care

(b) 4% ofHeO e

with eyes. Rinse

including carbamide

preparations

present or

immediately if product

peroxide and zinc

released

comes into contact with

peroxide

them

(c) Nail hardening

(c) 2% ofHeO e

preparations

present or

(a) Wear suitable gloves

released

(d) Oral hygiene

(d) O.I%ofHeO e

products

present or

released

F0011aldehyde

Nail hardeners

5% calculated as

Protect cuticles with

f0011aldehyde

grease or oil. Contains

formaldehyde

Hydroquinone-

(a) Oxidizing colouring

2%

(a) I. Do not use to dye

agents for hair dyeing

eyelashes or

1. general use

eyebrows. Rinse eyes

immediately if

product comes into

contact with them.

tIl

3 Only if the concentration exceeds 0.05%.

-...l

\0

t;I:l

--.)

Restrictions

Reference

Substance

Field of application

Maximum authorized

Other limitations and

Conditions of use and

Number

requirements

warnings which must be

and/or use

concentration in the

finished cosmetic

printed on the label

product

f

a

c

d

e

b

Contains

hydroquinone.

2. professional use

2. For professional use

only. Contains

hydroquinone. Rinse

eyes immediately if

product comes into

contact with them.

2%

(b) Agents for localized

(b) Contains

skin lightener

hydroquinone. Avoid

contact with the eyes.

Apply to small areas. If

irritation develops

discontinue use. Do not

use on children under the

age of 12.

q

(a) 5% by weight

(a) Nail cuticle solvent

Potassium or sodium

(a) Contains alkali.

15a

Avoid contact with

hydroxide

eyes. Can cause

blindness. Keep out

of reach of children.

(b)

(b) Hair straightener

(b) 1. Contains alkali.

2% by weight

1. general use

Avoid contact with

1. eyes. Can cause

The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in

column d.

Restrictions

Conditions of use and

Other limitations and

MaXlIl1Um authorized

held of application

SlIhstJIll'l

R<:ILTl'I1Cl'

warnings which must be

requirements

concentratiun in the

and/or usc

!'lumber

printed on the label

finished cosmetic

product

f

d

e

c

b

a

blindness. Keep out

of reach of children.

"

45% by weight

For professional use

2. professional use

2. '-.

only. Avoid contact

with eyes. Can cause

blindness.

(c) up to pH 12.7

(c) Keep out of reach of

(c) pH adjuster

depilatories

childrcn. Avoid contact

-

with eyes.

(d) Other uses as pH

(d) up to pH 11

adjuster

(a)

(a) HaIr straightener

Lithium hydroxide

ISh

1. General use

2% by weight

Contains alkali.

1.

1. A void contact with

eyes. Can cause

blindness. Keep out

of reach of children

Professional use

2.

2.

2.

4.5% by wcight

For professional use

only. Avoid contact

with eyes. Can cause

blindness

0:;

(b) Other uses

:-;::!

Restrictions

Reference

Substance

Conditions of use and

Field of application

Maximum authorized

Other limitations and

Number

warnings which must be

ancIJor use

requirements

concentration in the

printed on the label

finished cosmetic

product

a

f

b

c

d

e

15c

Calcium hydroxide

(a) Hair straighteners

Contains alkali. Avoid

(a) 7% by weight of

containing 2

calcium hydroxide

contact with eyes. Can

components

cause blindness. Keep out

calcium hydroxide

of reach of children

and a guanidine

salt

(b) Other uses

Colouring agent for

0.5%

a-naphthol

Contains a-naphthol

hair dyeing

Sodium nitrite

0.2%

Rust inhibitor

Do not use with

secondary and/or

tertiary amines or other

substances forming

nitrosamines

Nitromethane

Rust inhibitor

0.3%

Phenol and its alkali

Soaps and shampoos

1% calculated as

Contains phenol

salts

phenol

[deleted]

[deleted]

[deleted]

[deleted]

Quinine and its salts

(a) Shampoos

(a) 0.5% calculated

as quinine base

(b) Hair lotions

(b) 0.2% calculated

as quinine base

(a) Oxidizing

(a) 5 %

Resorcinol'

(a)

colouring agent for

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to

the maximum level authorised for each of them does not exceed the value given in column d.

Restrictions

Conditions of use and

Other limitations and

MaximuIlJ authorized

Reference

Substance

Field of application

warnings which must be

concentration in the

requirements

and/or use

Number

printed on the label

finished cosmetic

product

e

f

d

b

c

a

hair dyeing

1. General use

Contains resorcinol.

l.

Rinse hair well atter

application. Do not

usc to dye eyelashes

or eyebrows. Rinse

eyes immediately if

product comes into

contact with them.

2.

2. Professional use

For professIOnal use

only. Contains

resorcinol. Rinse eyes

immediately if

product comes into

contact with them.

(b) Hair lotions and

(b) 0.5%

(b) Contains resorcinol.

shampoos

(a) Depilatories

(a) Alkali sulphides

(a) 2% calculated as

(a) Keep out of reach of

sulphur, pH S 12.7

children. Avoid

contact with eyes.

(b) Alkaline earth

(b) Depilatories

(b) 6% calculated as·

(b) Keep out of reach of

sulphides

sulphur, pH ~ 12.7

children. Avoid

contact with eyes.

Water soluble zinc salts

1 % calculated as zinc

t::C

with the exception of

-..J

\0

Uo.l

t:C

.....

-..J

\D

Restrictions

+:0.

Conditions of use and

Substance

Field of application

Maximum authorized

Other limitations and

Reference

warnings which must be

and/or use

concentration in the

requirements

Number

finished cosmetic

printed on the label

product

f

d

e

b

c

a

zinc 4-hydroxy-

benzenesulphonate and

zinc pyrithione

6% calculated as % of

Deodorants,

Avoid contact with eyes

Zinc 4-hydroxy-benzene

antiperspirants and

anhydrous substance

sulphonate

astringent lotions

0.15% calculated as F.

Oral hygiene products

Contains ammonium

Ammonium mono-

When mixed with

monofluoro-phosphate

fluorophosphate

other fluorine

compounds permitted

under this Schedule,

total F concentration

must not exceed

0.15%

0.15%

ditto

Contains sodium

Sodium mono-

ditto

monofluoro-phosphate

fluorophosphate

0.15%

ditto

Contains potassium

Potassium mono-

ditto

monofluoro-phosphate

fluorophosphate

0.15%

ditto

Contains calcium

Calcium mono-

ditto

monofluaro-phosphate

fluorophosphate

0.15%

ditto

Contains calcium fluoride

Calcium fluoride

ditto

ditto

0.15%

Contains sodium fluoride

Sodium fluoride

ditto

ditto

0.15%

Contains potassium

Potassium fluoride

ditto

fluoride

ditto

0.15%

Ammonium fluoride

Contains ammonium

ditto

fluoride

Restrictions

Field of application

Maximum authorized

Substance

Other limitations and

Conditions of use and

Reference

and/or use

concentration in the

requirements

warnings which must be

Number

finished cosmetic

printed on the label

product

c

d

e

f

b

a

0.15%

ditto

Contains aluminium

Aluminium fluoride

ditto

fluoride

ditto

0.15%

Stannous fluoride

Contains stannous

ditto

fluoride

0.15%

ditto

Hexadecyl ammonium

Contains hexadecyl

ditto

fluoride

ammonium fluoride

ditto

0.15%

3-(N-Hexadecyl-N-2-

Contains 3-(N-

hydroxy-ethylammonio)

ditto

Hexadecyl-N-2-hydroxy-

propylbis (2-

ethylammonio) propylbls

hydroxyethyl)

(2-hydroxyethyI)

ammonium di-fluoride

ammonium di-fluoride

NN' N'-Tris(polyoxy-

ditto

0.15%

Contains NN' N'-

ditto

ethylene)-N-hexadecyl-

Tris(polyoxy-ethylene)-

propylenediamine

N-hexadecyl-

dihydrofluoride

propylenediamine

dihydrofluoride

0.15%

ditto

Octadecenyl-ammonium

Contains Octadecenyl-

ditto

fluoride

ammonium fluoride

ditto

0.15%

Sodium fluorosilicate

Contains sodium

ditto

fluorosilicate

ditto

0.15%

Potassium fluorosilicate

Contains potassium

ditto

fluorosilicate

ditto

0.15%

Ammonium

Contains ammonium

ditto

fluorosilicate

fluorosilicate

ditto

0.15%

Magnesium

Contains magnesium

ditto

fluorosilicate

fluorosilicate

(a) Hair care

(a) Up to 2%

1,3-Bis(hydroxymethyl)

(a) Prohibited in

Contains 1,3-

t:x::I

preparations

imidazolidene-2-thione

aerosol dispensers

Bis(hydroxymethyl)

,....

-.....l

\0

VI

ttl

- .)

-

\0

Restrictions

0\

Maximum authorized

Other limitations and

Conditions of use and

Reference

Substance

Field of application

and/or use

concentration in the

requirements

warnings which must be

Numher

finished cosmetic

printed on the label

product

d

f

b

c

e

a

(sprays)

imidazolidene-2-thione

(b) Hair care

(b) up to 2%

(b) The pH of the

preparations

product as applied

must be less than 4

Benzyl alcohol

Solvents, perfumes and

flavourings

4()

6-methyIcoumari n

Oral hygiene products

0.003%

Oral hygiene products

0.15% calculated as F.

Nicomethanol

Contains nicomethanol

When mixed with

hydrofluoride

hydrofluoride

other fluorine

compounds permitted

under this Schedule,

total F concentration

must not exceed

0.15%

4g

Silver nitrate

Solely for products

4%

Contains silver nitrate

-

intended for colouring

Rinse the eyes

-

eyelashes and eyebrows

immediately if

product comes into

contact with them

Selenium disulphide

Antidandruff shampoos

1%

Contains selenium

-

disulphide

Avoid contact with

-

eyes or damaged skin

Aluminium zirconium

Antiperspirants

I.

20% as anhydrous

The ratio of the

Do not apply to irritated

chloride hydroxide

aluminium zirconium

number of AI

or damaged skin

complexes

chloride hydroxide

atoms to that of Zr

AI,Zr(OHLC'lz and the

5.4% as zirconium

atoms must be

Restrictions

Substance

Field of application

Maximum authorized

Reference

Other limitations and

Conditions of use and

and/or use

Number

concentration in the

requirements

warnings which must be

finished cosmetic

printed on the label

product

c

a

b

d

e

f

aluminium zirconium

between 2 and 10

chloride hydroxide

2. The ratio of the

glycine complexes

number of (Al+Zr)

atoms to that of CI

atoms must be

between 0.9 and

2.1

3. Prohibited in

aerosol dispensers

(sprays)

Quinolin-8-o1 and bis(8-

Stabilizer for hydrogen

0.3% calculated as

hydroxyqui-nolinium)

peroxide in rinse-off

base

hair care preparations

sulphate

Stabilizer for hydrogen

0.03% calculated as

peroxide in non-l ....;e-

base

off hair care

preparations

Methanol

Denaturant for ethanol

5% calculated as % of

and isopropyl alcohol

ethanol and isopropyl

alcohol

Etidronic acid and its

(a) Hair care

(a) 1.5%

Contains etidronic acid

salts (l-hydroxy-

(b) Soap

(b) 0.2%

ethylidene-di-

phosphonic acid and its

expressed as etidronic

salts)

acid

-

I-Phenoxy-propan-2-ol

Rinse off products

2%

As a preservative, see

only

Sixth Schedule, No 43

-

t:P

Prohibited in oral

-

-...l

\CI

-...l

ttl

--.J

\D

RestrlctiOJlS

Conditions of use and

Maximum authorized

Other limitations and

SuhstaJlce

held of appllcatlOJl

Ref\:reJlce

and/or use

warnings which must be

concentration in the

requirements

I\'umhcr

finished cosmetic

printed on the label

product

I'

h

c

d

e

a

hygiene products

Lead acetate

Only for hair-dyeing

0.6% calculated as

Keep away from children.

lead

Avoid all contact with the

eyes. Wash hands after

use. Contains lead acetate.

Do not use to dye

eyelashes, eyebrows or

moustaches. If irritation

develops, discontinue use.

0.15'% calculated as F.

Magnesium fluonde

Dental hygiene

Contains magnesium

When mixed with

products

fluoride

other F compounds

permitted under this

Schedule, total F

concentration must not

exceed 0.15%

Strontium chloride

Toothpaste

3.5% calculated as Sr.

Contams strontium

hexahydrate

When mixed with

chloride. Frequent use by

other Sr products the

children is not advisable.

total Sr content must

not exceed 3.5%

51\

Strontium acetate

(a) Toothpaste

(a) 3.5% calculated as

Contams strontium

hemihydrate

Sr. When mixed

chloride. Frequent use by

with other

children is not advisable.

pennitted Sr

products the total

Sr content must

not exceed 3.5%

Restrictions

Substance

Field of application

Maximum authorized

Reference

Other limitations and

Conditions of use and

and/or use

concentration in the

Number

requirements

warnings which must be

finished cosmetic

printed on the label

product

c

a

b

d

e

f

(b) Shampoos and face

(b) 2.1 % calculated as

care products

Sr. When mixed

with other

pennitted Sr

products, the total

Sr content must

not exceed 2.1 %.

(a) Powdery products

Talc

Powder products: Keep

hydrated magnesium

intended to be used

powder away from

for children under

children's nose and mouth

silicate

three years of age

(b) other products

-

Fatty acid

Maximum

Do not use with

dialkanolamine

dialkanolamides

nitrosating systems

content: 0.5%

Maximum

-

dialkanolamine

content: 5%

(concerns raw

materials)

Maximum N-

-

nitroso-

dialkanolamine

content: 50 ~g/kg

Keep in nitrite-free

-

containers

Monoalklanol-amines

Maximum

Do not use with

-

dialkanolarnine

nitrosating systems

content: 0.5%

Minimum purity

-

OJ

-

99%

- -.I

\0

\0

t:O

Restrictions

Conditions of use and

Other limitations and

Maximum authorized

held of application

Suhstance

Reference

warnings which must be

requirements

concentration in the

and/or use

0Jumher

printed on the label

finished cosmetic

product

f

e

d

h

c

a

Maximum

-

secondary

alkanolamine

content: 0.5%

(concerns raw

materials)

Maximum N-

-

nitroso-

dialkanolamine

content: 50 ).lglkg

Keep in nitrite-free

-

containers

(a) 2.5'Yo

(a) (b)

(a) Non-rinse-off

·rrialkanolamincs

Do not use with

-

products

nitrosating systems

(b) other products

Minimum purity

-

99%

Maximum

-

secondary

alkanolamine

content: 0.5%

(concerns raw

materials)

Maximum N-

-

nitroso-

dialkanolamine

content: 50 ).lglkg

Keep in nitrite-free

-

containers

Restrictions

Reference

Conditions of use and

Substance

Othcr limitations and

Field of application

Maximum authorized

concentration in the

requirements

warnings which must be

Number

and/or use

printed on the label

finished cosmetic

product

d

a

c

f

b

e

Keep out of reach of

Strontium hydroxide

3.5% calculated as Sr,

pH regulator in

-

max. pH of 12.7

depilatory products

children

Avoid contact with

-

eyes

4.5% calculated as Sr

All products must meet

Rinse-ofl hair care

Strontium peroxide

Avoid contact with

-

preparations for

in the ready-for-use

the hydrogen peroxide

eyes

- Rinse eyes

preparation

re lease requirements

professional use

immediately if

product comes into

contact with lht:II1

For professional use

-

only

- Wear suitable gloves

Benzalkonium chloride,

(a) Rinse off hair

(a) 3% (as

(a) In the final

(a) Avoid contact with

benzalkonium

(head) care products

products the

the eyes

bromide and

chloride)

concentratiun of

saccharinate

benzalkonium chloride,

bromide and

saccharinate with an

alkyl chain ofC J4 or

less must not exceed

0.1 % (as benzalkonium

chloride)

(b) Other products

(b) 0.1% as

(b) Avoid contact with the

benzalkonium chloride

eyes

o:::l

.....

o

1 A cosmetic product put on the market must not cause damage

to human health when applied under normal or reasonably forseeable

conditions of use, taking account, in particular of the product's

presentation, its labelling, any instructions for its use and disposal as

well as any other indication or information provided by the manufacturer

or his authorized agent or by any other person responsible for placing

the product on the market. The provision of such warnings shall not, in

any event, exempt any person from compliance with the other

requirements laid down in this Order.

List of Colouring Agents allowed for use in Cosmetic Products

hcld of application

Column I

Colouring agents allowed in all cosmetic products.

Colouring agents allowed in all cosmetic products except those intended to be applied 111 the vicinity of the eyes, in particular eye

Column 2

make-up and eye make-up remover.

ColourIng agents allowed exclusIvely in cosmetic products intended not to come into contact with the mucous membranes.

Column :\

Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

Column 4

Field of application

('olour index

I

Colour

Other limitations and requirements

number or

denomination

x

Green

10006

x

Green

10020

x

10316'

Yellow

11680

Yellow

x

x

11710

Yellow

x

11725

Orange

11920

Orange

x

Red

x

12010

12085'

Red

x

3% maximum concentration in the finished

product

12120

Red

x

(, Lakes or salts of these colouring agents using substances not prohibited under the Second Schedule or not excluded under the Fifth Schedule from the scope of this Order

are equally allowed.

7 Colouring agents whose number is preceded by the letter HE" in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfill the

purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters

where the letter HE" has been deleted therefrom.

R The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will

be determined by the procedure laid down in Article 8 of the Directive.

Field of application

Colour

ColO'l1r index

Other limitations and requirements

number or

denomination

x

Red

12150

Red

x

12370

Red

x

12420

Brown

x

12480

Red

12490

x

Yellow

x

12700

Yellow

13015

x

Orange

x

14270

Red

14700

x

14720

Red

x

14815

Red

x

K

Orange

x

15510

Red

15525

x

Red

15580

x

15620

Red

x

J

15630

Red

3% maximum concentration in the finished

x

product

Red

15800

x

K

Red

15850

x

..

,

15865"

Red

x

'~

15880

Red

x

Orange

15980

x

E III

K

Yellow

15985

x

16035

Red

x

Red

16185

x

Orange

16230

x

16255"

Red

x

x

Red

16290

1720()K

Red

x

x

18050

Red

\jj

-

Red

18130

x

o

V)

to

Field of application

·

Colour index

Colour

~

Other limitations and requirements

number or

denomination

x

18690

Yellow

x

18736

Red

x

18820

Yellow

x

18965

Yellow

19140~

x

Yellow

maximum 3,3'-dimethylbenzidine

x

20040

Yellow

concentration in the colouring agent: 5 ppm

x

20170

Orange

x

20470

Black

maximum 3,3'-dimethylbenzidine

x

21100

Yellow

concentration in the colouring agent: 5 ppm

ditto

x

21108

Yellow

x

Yellow

21230

x

24790

Red

x

Purity criteria

26100

Red

aniline :5: 0.2%

2-naphthol :5: 0.2%

4-aminoazobenzene :5: 0.1 %

1-(phenylazo)-2-naphthol :5: 3%

1-[2-(phenylazo)phenylazo]-2-naphthalenol

:5:2%

27290~

x

Red

x

Black

27755

x

Black

28440

x

Orange

40215

Orange

x

40800

E 160e

Orange

x

40820

E 160f

x

Orange

40825

Ora1)ge

x

E 161g

40850

x

Blue

42045

42051~

x

Blue

x

Green

42053

Field of application

Colour index

Colour

Other limitations and requirements

number or

denomination

Blue

x

42080

42090

Blue

x

x

42100

Green

x

42170

Green

Violet

x

42510

x

5 ppm maximum concentration in the

42520

Violet

finished product

42735

Blue

x

x

Blue

44045

x

44090

Green

x

45100

Red

x

45190

Violet

45220

Red

x

Yellow

6% maximum concentration in the finished

x

45350

product

45370~

Not more than 1% 2-(6-hydroxy-3-oxo-3H-

Orange

x

xanthen-9-yl) benzoic acid and 2% 2-

(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)

benzoic acid

Red

x

ditto

45380

Orange

x

when used in lipstick, the colouring agent is

45396

allowed only in free acid form and in a

maximum concentration of 1%

x

45405

Red

Not more than 1% 2-(6-hydroxy-3-oxo-3H-

xanthen-9-yl) benzoic acid and 2% 2-

(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)

benzoic acid

45410~

Red

x

ditto

Red

x

Not more than 1% 2-(6-hydroxy-3-oxo-3H-

45425

xanthen-9-yl) benzoic acid and 3% 2-(iodo-

-

t:l:I

6-hydroxy-3-oxo-3H-xanthen-9-yl) benzOIC

flcicl

t:J:l

,......

Field of application

o

Colour index

Colour

I

Other limitations and requirements

number or

denomination

45430~

E 127, ditto

x

Red

x

Yellow

47000

x

Yellow

47005

x

50325

Violet

x

Black

50420

x

51319

Violet

x

Red

58000

x

Green

59040

x

Violet

60724

x

Violet

60725

x

Violet

60730

x

61565

Green

x

61570

Green

x

61585

Blue

x

62045

Blue

x

69800

Blue

x

69825

Blue

x

71105

Orange

x

73000

Blue

x

73015

Blue

x

73360

Red

x

73385

Violet

x

73900

Violet

x

73915

Red

x

74100

Blue

x

74160

Blue

x

74180

Blue

x

74260

Green

x

Yellow

75100

x

Orange

75120

E 160b

x

Yellow

75125

E 160d

Field of application

I

Colour

Colour index

Other limitations and requirements

numher or

denomination

E 160a

x

Orange

75130

E 161d

x

Yellow

75135

x

White

75170

x

Yellow

75300

x

Red

75470

E 140 and E 141

x

Green

75810

x

White

77000

x

White

77002

x

White

77004

x

Blue

77007

x

77015

Red

x

77120

White

x

White

77163

x

77220

White

x

White

77231

x

Black

77266

x

Black

77267

x

77268:1

Black

x

77288

Green

free from chromate ion

x

Green

free from chromate ion

77289

x

77346

Green

x

77400

Brown

x

77480

Brown

x

77489

Orange

x

77491

Red

x

Yellow

77492

x

77499

Black

x

77510

Blue

free from cyanide ions

x

77713

White

t:C

x

77742

Violet

x

77745

Red

t:C

Field of application

Colour index

Colour

Other limitations and requirements!

o

number or

denomination

77820

White

x

77891

White

x

White

77947

x

Lactoflavin

Yellow

x

Caramel

Brown

x

Capsanthin,

Orange

x

E 160c

capsorubin

Beetroot red

Red

x

x

Anthocyanins

Red

x

Aluminium, zinc,

White

magnesium and

calcium stearates

Bromothymol

Blue

x

blue

x

Bromocresol

Green

green

x

Acid Red 195

Red

1 Only cosmetic products which conform to the provisions of

this Order and its Schedules may be put on the market.

5.2 Without prejudice to the general obligations laid down in

paragraph 4.1, the use in cosmetic products of the following substances

is prohibited

(a)

substances listed in the Second Schedule;

(b) substances listed in the Third Schedule, beyond the limits

and outside the conditions laid down;

(c) colouring agents other than those listed in the Fourth

Schedule, with the exception of cosmetic products containing

colouring agents intended solely to colour hair;

(d) colouring agents listed in the Fourth Schedule, used

outside the conditions laid down, with the exception of cosmetic

products containing colouring agents intended solely to colour hair;

(e) preservatives other than those listed in the Sixth

Schedule;

(f) preservatives listed in the Sixth Schedule, beyond the

limits and outside the conditions laid down, unless other

concentrations are used for specific purposes apparent from the

presentation of the product;

(g) UV filters other than those listed in the Seventh

Schedule;

(h) UV filters listed in the Seventh Schedule, beyond the

limits and outside the conditions laid down therein;

(i) ingredients or combinations of ingredients tested on

animals after 30 June 2002 in order to meet the requirements of

this Order.

5.3 The presence of traces of the substances listed in the Second

Schedule shall be allowed provided that such presence is technically

unavoidable in good manufacturing practice and that it conforms with

paragraph 4.1.

List of Substances Excluded from the Scope of the Order

[deleted]

1.

2. [deleted]

3. [deleted]

4. [deleted]

5. Strontium and its compounds, with the exception of strontium lactate,

strontium nitrate and strontium polycarboxylate listed in the Second Schedule,

strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide,

strontium peroxide, under the conditions laid down in the Third Schedule,

and of strontium salts, lakes and pigments of the colouring agents listed with

reference (8) in the Fourth Schedule.

6. [deleted]

7. [deleted]

8. [deleted].

9. [deleted]

.SIXTH SCHEDULE

List of Preservatives which Cosmetic Products may contain

PREAMBLE

1. Preservatives are substances which may be added to cosmetic products for

the primary purpose of inhibiting the development of micro-organisms in such products.

2. The substances marked with the symbol (*) may also be added to cosmetic

products in concentrations other than those laid down in this Schedule for other specific

purposes apparent from the presentation of the products, e.g. as deodorants in soaps or

as anti-dandruff agents in shampoos.

3. Other substances used in the formulation of cosmetic products may also have

anti-microbial properties and thus help in the preservation of the products, as, for

instance, many essential oils and some alcohols. These substances are not included in

this Schedule.

4. For the purposes of this list

- "Salts" is taken to mean: salts of the cations sodium, potassium, calcium,

magnesium, ammonium and ethanolarnines; salts of the anions chloride, bromide,

sulphate, acetate.

- "Esters" is taken to mean: esters of methyl, ethyl, propyl, isopropyl,

butyl, isobutyl, phenyl.

5. All finished products containing formaldehyde or substances in this Schedule

and which release formaldehyde must be labelled with the warning "contains

formaldehyde" where the concentration of formaldehyde in the finished product exceeds

0.05%.

Maximum authorized

Limitations and requirements

Conditions of use and wamings

Substance

Reference

concentration

which must be printed on the

number

label

c

e

b

d

a

Benzoic acid, its salts and esters

0.5% (acid)

I

(*)

Propionic acid and its salts (*)

2% (acid)

Salicylic acid and its salts (*)

0.5% (acid)

Not to be used for children

Not to be used in preparations

under three years of age (6)

for children under three years

of age, except for shampoos

Sorbic acid (hexa-2,4-dienoic

0.6% (acid)

acid) and its salts (*)

0.2% (except for products for

Fonnaldehyde.

Prohibited in aerosol dispensers

parafonnaldehyde

oral hygiene)

(sprays)

0.1%

(products

for

oral

hygiene)

expressed as free fom1aldehyde

[deleted]

Biphenyl-2-ol (o-polyphenol)

0.2% expressed as the phenol

and its salts (*)

Pyrithione zinc (INN) (*)

0.5%

Authorized in products rinsed

off

Forbidden in products for oral

hygiene

Inorganic sulphites and

0.2% expressed as free S02

hydrogen sulphites (*)

Sodium iodate

0.1%

Rinse-off products only

II

Chlorobutanol (INN)

0.5%

Prohibited in aerosol dispensers

Contains chlorobutanol

(sprays)

4-Hydroxybenzoic acid and its

0.4% (acid) for 1 ester,

salts and esters (*)

0.8% (acid) for mixtures of

esters

0;

Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.

IJj

.....

.....

Reference

Substance

Maximum authorized

Limitations and requirements

Conditions of use and warnings

N

number

which must be printed on the

concentration

label

3-Acetyl-6-methylpyran-2,4

0.6% (acid)

Prohibited in aerosol dispensers

(sprays)

(3H)-dione (Dehydracetic acid

and its salts)

0.5% (acid)

Formic acid and its sodium salt

(*)

3,3'-Dibromo-4,4'-

0.1%

hexamethylene-

dioxydibenzamidine

(Dibromohexamidine) and its

salts (including isethionate)

0.007% (of Hg)

For eye make-up and eye make-

Thiomersal (INN)

Contains thiomersal

If mixed with other mercurial

up remover only

compounds authorised by this

Directive, the maximum

concentration of Hg remains

fixed at 0.007%

Ditto

Ditto

Phenylmercuric salts (including

Contains phenylmercuric

borate)

compounds

Undec-l0-enoic acid and salts

0.2% (acid)

(*)

Hexetidine (INN) (*)

0.1%

0.1%

5-Bromo-5-nitro-l,3-dioxane

Rinse-off products only

Avoid formation of

nitrosamines

0.1%

Bronopol(INN)(*)

Avoid formation of

nitrosamines

2,4-Dichlorobenzyl alcohol (*)

0.15%

Triclocarban (INN) (*)

0.2%

Purity criteria

3,3',4,4'-

Tetrachloroazobenzene < 1 ppm

3,3',4,4'-

Maximum authorized

Limitations and requirements

Conditions of use and warnings

Substance

Reference

concentration

which must be printed on the

number

label

Tetrachloroazoxybenzene < 1

ppm

4-Chloro-m-cresol (*)

0.2%

Prohibited in products intended

to come into contact with

mucous membranes

Tricolosan (INN) (*)

0.3%

4-Chloro-3,5-xylenol (*)

0.5%

3,3' -Bis (l-hydroxymethyl-2,5-

0.6%

dioxoimidazolidin-4-y1)-1,1'-

methylenediurea

("Imidazolidinyl urea") (*)

Poly (1-

0.3%

hexamethylenebiguanide

hydrochloride) (*)

2-Phcnoxyethanol (*)

1%

Hexamethylenetetramine (*)

0.15%

(methenamine) (INN)

Methenamine 3-

0.2%

chloroallylochloride (INNM)

1-(4-Chlorophenoxy)-1-

0.5%

(imidazol-l-yl)-3,3-

dimethylbutan-2-one (*)

1,3-Bis (hydroxymethyl)-5,5-

0.6%

dimethylimidazolidine-2,4-

dione (*)

Benzyl alcohol (*)

1%

I-Hydroxy-4-methyl-6(2,4,4-

1.0%

Products rinsed off

trimethyIpenty1)-2-pyridone

0.5%

For other products

and its methanolamine salt (*)

1,2-Dibromo-2,4-

0.1%

Not to be used in cosmetic

tJ:l

dicyanobutane

sunscreen products at a

VJ

to

...

Reference

Substance

Maximum authorized

Limitations and requirements

Conditions of use and wamings

number

concentration

which must be printed on the

label

concentration exceeding

0.025%

6,6-Dibromo-4,4-dichloro-2,2-

0.1%

methylenediphenol

(Bromochlorophen) (*)

4-Isopropyl-m-cresol

0.1%

Mixture of 5-Chloro-2-

0.0015% (ofa mixture in the

methylisothiazol-3(2H)-one and

ratio 3: 1 of 5-chloro-2-

2-methylisothiazol-3(2H)-one

methylisothiazol-3(2H)-one and

with magnesium chloride and

2-methylisothiazol-3(2H)-one

magnesium nitrate

2-Benzyl-4-chlorophenol

0.2%

(Chlorophene)

2-Chloroacetamide

0.3%

Contains chloroacetamide

Chlorhexidine (INN) and its

0.3% expressed as

chlorhexidine

digluconate, diacetate and

dihydrochloride (*)

1.0%

I-Phenoxypropan-2-ol

Only for rinse-off products

Alkyl (CI2-C22) trimethyl

0.1%

ammonium bromide and

chloride (*)

4,4-dimethyl-l,3-oxazolidine

0.1%

The pH of the finished product

must not be lower than 6

0.5%

N-(Hydroxymethyl)-N-

(dihydroxymethyl-l,3-dioxo-

2,5-imidazolidinyl-4)-N'-

(hydroxymethyl) urea

0.1%

1,6-Di(4-amidinophenoxy)-n-

hexane (Hexamidine) and its

salts (including isethionate and

p-hydroxybenzoate) (*)

Conditions of use and warnings

Limitations and requirements

Maximum authorized

Refen:m.:t

Substance

concentration

which must be printed on the

number

label

Contains glutaraldehyde (where

Prohibited in aerosols (sprays)

Glutaraldehyde (Pentane-1 ,5-

0.1%

glutaraldt:hyde concentration in

dial)

the finished product exceeds

0.05%)

0.3%

Prohibited in oral hygiene

5-Ethyl-3,7-dioxa-1-azabicyclo

[3.3.0] octane

products and in products

intended to come into contact

with mucous membranes

0.3%

3-(p-chlorophenoxy)-propane-

1,2-diol (chlorphenesin)

0.5%

Sodium hydroxymethylamino

acetate (Sodium

hydroxymethylglycinate)

0.004% calculated as AgCl

20% AgCl (w/w) on TiO z.

Silver chloride deposited on

titanium dioxide

Prohibited in products for

children under three years of

age, in oral hygiene products

and in products intended for

application around the eyes and

on the lips.

Benzethonium chloride

0.1%

Rinse-off products only

0.1 % calculated as

Not for oral hygiene and lip

Avoid contact with the eyes

Benzalkonium chloride,

benzalkonium chloride

bromide and saccharinate (+)

products

0.15%

Benzylhemiformal

Only for products to be

removed by rinsing

0.05%

1. Not to be used for oral

3-Iodo-2-

propynylbutylcarbamate

hygiene and lipcare

products

Contains iodine.

2. If the concentration in

products intended to remain

t:P

011 the skin exceeds 0.02%

.....

ex

tx::l

Rekrence

Suhstance

Maximum authorized

Limitations and requirements

Conditions of use and warnings

numher

concentration

which must be printed on the

label

0\

add the phrase: Contains

iodine

1

Cosmetic products may be marketed only if the container Labelling of

and packaging bear the following information in indelible, easily legible cosmetic products.

and visible lettering, provided that the information mentioned in point

(g) may, however, be indicated on the packaging alone

a) the name or style and the address or registered office of

the manufacturer or importer or the person responsible for

marketing the cosmetic product who is established within Malta

or the European Community. Such information may be abbreviated

in so far as the abbreviation makes it generally possible to identify

the undertaking. The country of origin shall be specified for goods

not manufactured in Malta or in the European Community;

b) the nominal content at the time of packaging, given by

weight or by volume, except in the case of packaging containing

less than five grams or five millilitres, free samples and single

application packs; for pre-packages normally sold as a number of

items, for which details of weight or volume are not significant,

the content need not be given provided the number of items appears

on the packaging. This infonnation need not be given if the number

of items is easy to see from the outside or if the product is normally

only sold individually;

c) the date of minimum durability. The date of minimum

durability of a cosmetic product shall be the date until which this

product, stored under appropriate conditions, continues to fulfil

its initial function and, in particular, remains in conformity with

paragraph 4.1.

i) The date of minimum durability shall be indicated

by the words: "Best used before the end of

" followed

by either

the date itself, or

details of where the date appears on the packaging;

ii) If necessary, this infonnation shall be supplemented

by an indication of the conditions which must be satisfied in

order to guarantee the stated durability;

iii) The date shall be clearly expressed and shall consist

of the month and the year in that order;

iv) Indication of the date of durability shall not be

mandatory for cosmetic products the minimum durability of

which exceeds 30 months;

d) particular precautions to be observed in use, especially

those listed in the column "Conditions of use and warnings which

must be printed on the label" in the Third, Fourth, Sixth and Seventh

Schedules, which must appear on the container and packaging as

well as any special precautionary infonnation on cosmetic products

for professional use, in particular in hairdressing. Where this is

impossible for practical reasons, an enclosed leaflet, label, tape or

card must contain that information to which the consumer is

referred either by abbreviated infonnation or the symbol given in

the Eighth Schedule, which must appear on the container and the

packaging;

e) The batch number of manufacture or the reference for

identifying the goods, provided that where this is impossible for

practical reasons because the cosmetic products are too small, such

infonnation need appear only on the packaging;

f) the function of the product, unless it is clear from the

presentation of the product;

g) a list of ingredients in descending order of weight at the

time they are added. That list shall be preceded by the word

"ingredients". Where that is impossible for practical reasons, an

enclosed leaflet, label, tape or card must contain the ingredients to

which the consumer is referred either by abbreviated information

or the symbol given in the Eighth Schedule, which must appear on

the container and the packaging.

6.2 The particulars provided for in paragraphs 6.1 (d) and (f), if

required, must at least be expressed in Maltese or English.

6.3 The following shall not be regarded as ingredients for the

purposes of this Order

impurities in the raw materials used,

subsidiary technical materials used inthe preparation but

not present in the final product,

- materials used in strictly necessary quantities as solvents

or as carriers for perfume and aromatic compositions.

6.4 Perfume and aromatic compositions and their raw materials

shall be referred to by the word "parfum" or "aroma".

6.5 Ingredients in concentrations of less than 1 % may be listed

in any order after those in concentrations of more than 1%. Colouring

agents may be listed in any order after the other ingredients, in

accordance with the colour index number or denomination adopted in

the Fourth Schedule.

6.6 For decorative cosmetic products marketed in several colour

shades, all colouring agents used in the range may be listed, provided

that the list of such ingredients is given in square brackets and preceded

by the sign "+1-".

6.7 An ingredient must be identified by the common name given

in the International Nomenclature of Cosmetic Ingredients (INCI) and

pursuant to Commission Decision 96/3351EC, as amended, or, where

such common name does not exist, by one of the following names

(i)

its chemical name, or

(ii)

its CTFA name, or

(iii)

its European Phannacopeia name, or

(iv) its international non-proprietary name recommended

by the World Health Organisation, or

(v)

its Einecs number, or

(vi)

its Iupac number, or

(vii)

its CAS number, or

(viii)

its colour index number.

6.8 A manufacturer may, for reasons of trade secrecy, not include

one or more ingredients on the list mentioned in paragraph 6.1 provided

that the competent authority has granted such an authorisation or is

satisfied that an authorisation for such omission has been granted. In all

cases, the authorization must be given in accordance with the procedure

laid down in Commission Directive 95/17/EC.

6.9 Where it is impracticable, for reasons of size or shape, for

the particulars referred to in paragraphs 6.1 (d) and 6.1 (g) to appear in

an enclosed leaflet, those particulars shall appear on a label, tape or

card which is enclosed or attached to the cosmetic product.

6.10 In the case of soap, bath balls and other small products where

it is impracticable, for reasons of size or shape, for the particulars referred

to in paragraph 6.1 (g) to appear on a label, tag, tape or card or in an

enclosed leaflet, those particulars shall appear on a notice in immediate

proximity to the container in which the cosmetic product is exposed for

sale.

6.11 For cosmetic products which are not pre-packaged, are

packaged at the point of sale at the purchaser's request, or are pre-

packaged for immediate sale, the seller shall make available to the

purchaser, on request, a leaflet or similar document, containing the

particulars referred to in paragraph 6.1.

6.12 No text, names, trade marks, pictures and figurative or other

signs may be used in the labelling, putting up for sale and advertising

of cosmetic products so as to imply that these products have

characteristics which they do not have. Furthermore, any reference to

testing on animals must state clearly whether the tests carried out

involved the finished product and/or its ingredients.

List of UV Filters which cosmetic products may contain

For the purposes of this Order, UV (ultraviolet) filters are substances which,

contained in cosmetic sunscreen preparations, are specifically intended to filter certain

UV rays in order to protect the skin from certain harmful effects of these rays.

These UV filters may be added to other cosmetic products within the limits and

under the conditions laid down in this Schedule.

Other UV filters used in cosmetic products solely for the purpose of protecting

the product against UV rays are not included in this list.

OJ

List of permitted UV filters which cosmetic products may contain

.....

Conditions of use and

Other limitations and

Maximum authorized

Reference

Substances

warnings which must be

requirements

concentration

No

printed on the label

e

c

d

a

b

5%

I

4-Aminobenzoic acid

6%

N,N ,N-Trimethyl-4-(2-oxoborn-3-

ylidenemethyl) anilinium methyl sulphate

10%

Homosalate (INN)

Contains oxybenzone C)

Oxybenzone (INN)

10%

[deleted]

2-Phenylbenzimidazole-5-sulphonic acid and

8%

its potassium, sodium and triethanolamine

(expressed as acid)

salts

3,3'-(I,4-Phenylenedimethylene) bis (7,7-

10%

dimethyl-2-oxo-bicyclo-[2,2, I] hept-I-

(expressed as acid)

ylmethanesulphonic acid) and its salts

1-(4-tert-but l' lpheny1)-3-(4-methoxyphenyI)

5%

propane-I,3-dione

6%

alpha-(2-0xoborn- 3- l' lidene)-toluene-4-

(expressed as acid)

sulphonic acid and its salts

2-Cyano-3,3-diphenyl acrylic acid, 2-

10%

ethylhexyl ester (Octocrylene)

(expressed as acid)

II

Polymer ofN-{(2 and 4)-[(2-oxoborn-3-

6%

ylidene) methyl] benzyl} acrylamide

Oct1'1 methoxycinnamate

10%

Ethoxylated ethyl-4-aminobenzoate (PEG-25

10%

PABA)

Isopentyl-4-methoxycinnamate (Isoamyl p-

10%

methoxycinnamate)

2,4,6-Trianilino-(p-Carbo-2'-Ethylhexyl-1 '-

5%

Oxy)-1,3,5-Triazine (Oct1'1 Triazone)

Phenol, 2-(2H -Benzotriazol-2-yl)-4-methyl-6-

15%

7 Not required if concentration is 0.5% or less and when it is used only for product protection purposes.

Substances

Maximum authorized

Other limitations and

Reference

Conditions of use and

concentration

No

requirements

wamings which must be

printed on the label

c

b

d

a

e

(2-methyl-3-(1,3,3,3-tetra-methyl-l-

(trimethyIsilyI)oxy)-disilo-xanyI)propyI)

(Drometrizole Trisiloxane)

Benzoic acid, 4,4-«6-«(l,I-dimethyl-

10%

ethyl)amino)carbonyl)phenyl)amino) 1,3,5-

triazine-2,4-diyI)diimino)bis-,bis-(2-

ethylhexyl)ester)

3-(4' -methylbenzylidene)-d-l camphor (4-

4%

Methylbenzylidene Camphor)

3-Benzylidene camphor (3-Benzylidene

2%

Camphor)

2-Ethylhexyl salicylate (octyl-salicylate)

5%

4-Dimethyl-amino-benzoate of ethyl-2-hexyl

8%

(octyl dimethyl PABA)

2-Hydroxy-4-methoxybenzophenone-5-

5% (of acid)

sulphonic acid (Benzophenone-5) and its

sodium salt

2,2'-Methylene-bis-6-(2H-benzotriazol-2-yl)-

10%

4-(tetramethyl-butyl)-I,I,3,3-phenol

Monosodium salt of 2,2'-bis-(1 ,4-phenylene)

10% (of acid)

1H-benzimidazole-4,6-disulphonic acid

(1,3,5)-Triazine-2,4-bis((4-(2-ethy1-hexloxy)-

10%

2-hydroxy)-phenyl)-6-(4-methoxyphenyl)

to

.....

.....

\0

1 The manufacturer or his agent or the person to whose order a kept

Infonnation to be

cosmetic product is manufactured or the person responsible for placing

an imported cosmetic product on the market shall for control purposes

keep the following information readily accessible to the competent

authority at a specified address

a) the qualitative and quantitative composition of the

product; in the case of perfume compositions and perfume, the

name and code number of the composition and the identity of the

supplier;

b) the physico-chemical and microbiological specifications

of the raw materials and the finished product and the purity and

microbiological control criteria of the cosmetic product;

c) the method of manufacture complying with the good

manufacturing practice laid down by European Community law

or, failing that, laid down by Maltese law; the person responsible

for manufacture or importation must hold a first degree or

equivalent qualification in the field of pharmacy, chemistry,

toxicology, dermatology, medicine or a similar discipline;

d) assessment of the safety for human health of the finished

product. To that end the manufacturer shall take into consideration

the general toxicological profile of the ingredient, its chemical

structure and its level of exposure;

e) the name and address of the qualified person or persons

responsible for the assessment referred to in (d), which person

must hold a first degree or equivalent qualification in the field of

pharmacy, toxicology, dermatology, medicine or a similar

discipline;

f) existing data on undesirable effects on human health

resulting from use of the cosmetic product;

g) proof of the effect claimed for the cosmetic product,

where justified by the nature of the effect or product.

Provided that

7.1.1 if the cosmetic product is imported into Malta from within

the European Community or if the cosmetic product has already been

placed on the market within the European Community, then the importer

may, instead of the information required by paragraph 7.1, provide the

competent authority with a declaration, signed by the manufacturer or

fIrst importer into the Community, to the effect that the cosmetic product

complies with all the requirements of the Directive as well as an

indication of the place of initial importation or manufacture within the

Community, and that

7.1.2 the qualification requirements for the person responsible

for importation laid down by paragraph 7.1(c)shall not apply in the

case of cosmetic products imported into Malta from within the European

Community or which have already been placed on the market within

the European Community.

7.2 The assessment of the safety for human health referred to in

paragraph 7.1(d) shall be carried out in accordance with the principle

of good laboratory practice laid down in Council Directive 87/18/EEC

of 18 December, 1986 on the harmonization of laws, regulations and

administrative provisions relating to the application of the principles of

good laboratory practice and the verification of their application for

tests on chemical substances.

7.3 The information referred to in paragraph 7.1 must be available

in Maltese or English or Italian.

7.4 The manufacturer or his agent, or the person to whose order

a cosmetic product is manufactured, or the person responsible for placing

imported cosmetic products on the market, shall notify the competent

authority of the address of the place of manufacture or of importation

of the cosmetic products before the latter are placed on the market,

provided that such notification shall not be necessary in the case of

products imported from within the European Community or which have

already been placed on the market within the European Community.

7.5 The person placing a cosmetic product on the market shall

ensure that he is in possession, or has access to, appropriate and adequate

information on substances used in that product. Such information shall

be made available on request to the competent authority or to any other

person or body indicated by the competent authority for the purposes of

prompt and appropriate medical treatment in the event of difficulties.

7.6 The competent authority or any person or body indicated

under paragraph 7.5 shall ensure that any information received is used

only for the purposes of such treatment.

Symbol to be Used

1 The competent authority may, on the basis of a substantiated

justification, provisionally prohibit or subject to special conditions the

marketing of a cosmetic product which, although complying with the

requirements of this Order, represents a hazard to health.

8.2

When placing any restriction or ban on the marketing of

cosmetic products pursuant to paragraph 8.1, the competent authority

shall state precise reasons for any individual measures. Such reasons

shall be notified to the party concerned together with particulars of the

remedies available to him under Maltese law and of the time limits

allowed for the exercise of such remedies.

Methods of Analysis necessary for checking the composition of cosmetic products

Area of Analysis

Method to be used

Sampling

Commission Directive 80/1335/EEC, Method I

Laboratory preparation of test samples

Commission Directive 80/1335/EEC, Method

II

Identification and determination of free sodium

Commission Directive 80/1335/EEC, Method

and potassium hydroxides

III

Identification and determination of oxalic acid

Commission Directive 80/1335/EEC, Method

and alkaline salts in hair care products

IV

Determination of chloroform in toothpastes

Commission Directive 80/1335/EEC, Method

V

Determination of zinc

Commission Directive 80/1335/EEC, Method

VI, as amended by Commission Directive

87/143/EEC

Identification

determination

and

of

Commission Directive 80/1335/EEC, Method

phenolsulphonic acid

VII

Identification of oxidizing agents and

Commission Directive 82/434/EEC, Method I

determination of hydrogen peroxide in hair

care products

Identification

and

semi-quantitative

Commission Directive 82/434/EEC, Method II

determination of certain oxidation colorants in

hair dyes

Identification and determination of nitrite

Commission Directive 82/434/EEC, Method III

Identification and determination of free

Commission Directive 82/434/EEC, Method

formaldehyde

IV, as amended by Commission Directive

90/207/EEC

Determination of resorcinol in shampoos and

Commission Directive 82/434/EEC, Method V

hair lotion

Determination of methanol m relation to

Commission Directive 82/434/EEC, Method

ethanol or propan-2-01

VI

Commission Directive 83/514/EEC, Method I

Determination of dichloromethane and 1,1,1-

trichloroethane

Commission Directive 83/514/EEC, Method II

Identification and determination of quinolin-8-

01 and bis(8-hydroxyquinolinium) sulphate

Commission Directive 83/514/EEC, Method III

Detemlination of alllffionia

Commission Directive 83/514/EEC, Method

determination

of

Identification

and

IV

nitromethane

Commission Directive 83/514/EEC, Method V

determination

of

and

Identification

mercaptoacetic acid in hair-waving, hair-

straightening and depilatory products

Commission Directive 83/514/EEC, Method

determination

of

and

Identification

VI

hexachlorophene (INN)

Commission Directive 83/514/EEC, Method

Determination of tosylchloramide, sodium

VII

(INN)

Commission Directive 83/514/EEC, Method

Detennination of total fluorine in dental creams

VIII

Commission Directive 83/514/EEC, Method

determination

of

and

Identification

IX

organomercury compounds

Commission Directive 83/514/EEC, Method X

Detennination of alkali and alkaline earth

sulphides

Identification and detennination of glycerol 1-

Commission Directive 85/490/EEC, Method I

(4-aminobenzoate)

Commission Directive 85/490/EEC, Method II

Detennination of chlorobutanol

Commission Directive 85/490/EEC, Method III

Identification and detemlination of quinine

Commission Directive 85/490/EEC, Method

Identification and detennination of inorganic

sulphites and hydrogen sulphites

IV

Commission Directive 85/490/EEC, Method V

Identification and detemlination of chlorates of

the alkali metals

Commission Directive 85/490/EEC, Method

Identification and detennination of sodium

iodate

VI

Identification and detemlination of silver

Commission Directive 93/73/EEC, Method I

nitrate

Commission Directive 93/73/EEC, Method II

Identification and detennination of selenium

disulphide in anti-dandruff shampoos

Detennination of soluble barium and soluble

Commission Directive 93/73/EEC, Method III

strontium in pigments in the fonn of salts or

lakes

Identification and detennination of benzyl

Commission Directive 93/73/EEC, Method IV

alcohol

Identification of zirconium, and detennination

Conunission Directive 93/73/EEC, Method V

of zirconium, aluminium and chlorine in non-

aerosol antiperspirants

Identification

and

detennination

of

Conunission Directive 93/73/EEC, Method VI

hexamidine,

dibromohexamidine,

dibromopropamidine and chlorhexidine

Identification and detennination of benzoic

Conunission Directive 95/32/EC, Method I

acid, 4-hydroxybenzoic acid, sorbic acid,

salicylic acid and propionic acid

detennination

Identification

and

of

Conmlission Directive 95/32/EC, Method II

hydroquinone,

hydroquinone

monomethylether,

hydroquinone

monoethylether

hydroquinone

and

monobenzylether

Identification and detennination of 2-

Conunission Directive 96/45/EC

phenoxyethanol, I-phenoxypropan-2-01 and

methyl, ethyl, propyl, butyl and benzyl 4-

hydroxybenzoate

1 Where an official test method is given in the Ninth Schedule, Methods of

analysis.

then that method shall be used for the official testing of cosmetic products

in accordance with the methods described in the Ninth Schedule.

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

13.

Epinephrine*

Rauwolfia serpentina alkaloids and their salts

15.

Alkyne alcohols, their esters, ethers and salts

17. Isoprenaline*

Allyl isothiocyanate

Alloc1amide* 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

24. Zoxazolamine*

Procainamide*, its salts and derivatives

26. Benzidine

Tuaminoheptane*, its isomers and salts

Octodrine* and its salts

2-Amino-l,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

Imperatorin (9-(3-methoxylbut-2-enyloxy) fUfo [3,2-g] chromen-7-one)

Ammi majus and its galenical preparations

35.

2,3-Dichloro-2-methylbutane

Substances with androgenic effect

Anthracene oil

39. Antibiotics

Antimony and its compounds

Apocynum cannabinum L. and its preparations

Apomorphine (R5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de,g]-quinoline-

10, ll-diol) and its salts

Arsenic and its compounds

Atropa belladonna L. and its preparations

Atropine, its salts and derivatives

Barium salts, with the exception of barium sulphate, barium sulphide under the

conditions laid down in Part 1 of the Third Schedule and lakes and pigments

prepared from the colouring agents listed with reference (8) in the Fourth

Schedule.

47. Benzene

4,5-Dihydrobenzimidazol-4-one

Benzazepines and benzadiazepines

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

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

52. Isocarboxazid*

Bendroflumethiazide* and its derivatives

Beryllium and its compounds

Bromine, elemental

Bretylium tosilate*

57. Carbromal*

58. Bromisoval*

Brompheniramine* and its salts

Benzilonium bromide*

Tetrylammonium bromide*

62. Brucine

Tetracaine* and its salts

64. Mofebutazone*

65. Tolbutmride*

66. Carbutamide*

67. Phenylbutazone*

Cadmium and its compounds

Cantharides, Cantharis vesicatoria

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

71. Phenprobamate*

Nitroderivatives of carbazo1

Carbon disulphide

74. Catalase

Cephaeline and its salts

Chenopodium ambrosioides (essential oil)

2,2,2-Trichloroethane-I, l-diol

78. Chlorine

79. Chlorpropamide*

Diphenoxylate* (hydrochloride)

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

hydrochloride)

82. Chlorzoxazone*

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

Chlorprothixene* and its salts

85. Clofenamide*

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

Chlonnethine* and its salts

Cyclophosphamide* and its salts

Mannomustine* and its salts

Butanilicaine* and its salts

91. Chloromezanone*

92. Triparanol*

2-[2(4-Chlorophenyl)-2-pheny1acety1]indane-l,3-dione (chlorophacinone-ISO)

94. Chlorphenoxamine*

95. Phenaglycodol*

96. Chloroethane

Chromium, chromic acid and its salts

Claviceps purpurea Tul., its alkaloids and gelanical preparations

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

100. Glycyclamide*

Cobalt benzenesulphonate

Colchicine, its salts and derivatives

Colchicoside and its derivatives

Colchicum autumnale L. and its galenical preparations

105. Convallotoxin

Anamirta cocculus L. (fruit)

Croton tiglium (oil)

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

Curare and curarine

Synthetic curarizants

Hydrogen cyanide and its salts

2-ex-Cyclohexy1benzy I (N N N' N' -tetraethyl)trimethy1enediamine (phenetarnine)

112.

Cyclomenol* and its salts

Sodium hexacyclonate*

115. Hexapropymate*

116. Dextropropoxyphene*

OO-Diacetyl-N-allyl-N-normorphine

Pipazetate* and its salts

5-(ex,B-dibromo-phenethyl)-5-methylhydantoin

N N-Pentamethylenebis (trimethylammonium salts) e.g. Pentamethonium

bromide*

N N' -[Methylimino diethylene] bis (ethy1dimethylammonium salts), e.g.

azamethonium bromide*

122. Cyclarbamate*

Clofenotane*; DDT (ISO)

Hexamethylenebis (trimethylammonium salts), e.g. hexamethonium bromide*

Dichloroethanes (ethylene chlorides)

Dichloroethylenes (acetylene chlorides)

Lysergide* and its salts

2-Diethylaminoethyl-3-hydroxy-4-pheny1benzoate and its salts

Cinchocaine* and its salts

3-Diethylaminopropyl cinnamate

0 O-Diethyl 0-4-nitrophenyl phosphorothioate (parathion-ISO)

[Oxalylbis(iminoethylene)] bis [(o-cWorobenzyl)diethylammonium salts], e.g.

ambenomium chloride*

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

137. Piprocurarium*

138. Propyphenazone*

Tetrabenazine* and its salts

140. Captodiame*

Mefeclorazine* and its salts

142. Dimethylamine

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

alypine)

Methapyrilene* and its salts

Metamfepramone* and its salts

Amitriptylene* and its salts

Metformin* and its salts

Isosorbide dinitrate*

149. Malononitri1e

150. Succinonitrile

Dinitrophenol isomers

152. Inproquone*

Dimevamide* and its salts

Diphenylpyraline* and its salts

155. Sulfinpyrazone*

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

e.g. isopropamide iodide*

157. Benactyzine*

Benzatropine* and its salts

Cyclizine* and its salts

5,5-Diphenyl-4-imidazolidone

161. 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 Schedule 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

177. Tolboxane*

4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol

Parethoxycaine* and its salts

180. Fenozolone*

Glutethimide* and its salts

Ethylene oxide

Bemegride* and its salts

184. Valnoctamide*

185. Haloperidol*

186. Paramethasone*

187. Fluanisone*

188. Trifluperidol*

189. Fluoresone*

190. Fluorouracil*

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the

exception of those given in the Third Schedule.

Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*

193. Galantamine*

194. Progestogens

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

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

1,4:5,8-dimethanonaphthalene (endrin-ISO)

197. Hexachloroethane

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

dimethanonapthalene (isodrin-IS 0)

Hydrastine, hydrastinine and their salts

Hydrazides and their salts

Hydrazine, its derivatives and their salts

Octamoxin* and its salts

Warfarin* and its salts

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

205. Methocarbamol*

206. Propatylnitrate*

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

208. Fenadiazole*

Nitroxoline* and its salts

Hyoscyamine, its salts and derivatives

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

211.

Pemoline* and its salts

213. Iodine

Decamethylenebis (trimethylammonium salts), e.g. decamethonium bromide*

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

and galenical preparations)

(2-IsopropyIpent-4-enoyl)urea (apronalide)

a-Santonin(3S,

5aR,

9bS)-3.3a.4.5.5a,9b-hexahydro-3,5a,9-

trimethylnaphtho[ I,2b]furan-2,8-dione

Lobelia inflata L. and its galenical preparations

Lobeline* and its salts

220. Barbiturates

Mercury and its compounds, except those special cases included in the Sixth

Schedule

3,4,5-Trimethoxyphenethylarnine and its salts

223. Metaldehyde

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

225. Coumetarol*

Dextromethorphan* and its salts

2-Methylheptylamine and its salts

Isometheptene* and its salts

229. Mecamylamine*

230. Guaifenesin*

231. Dicoumarol*

Phenmetrazine*, its derivatives and salts

233. Thiamazole*

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

benzopyran-5-one (cyclocoumarol)

235. Carisoprodol*

236. Meprobamate*

Tefazoline* and its salts

238. Arecoline

Poldine metilsulfate*

240. Hydroxyzine*

241. 2-Naphthol

1- and 2-Naphthylarnines and their salts

3( I-Naphthylmethyl)-2-imidazoline

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

249. Nitrobenzene

Nitrocresols and their alkali metal salts

251. Nitrofurantoin*

252. Furazolidone*

Propane-1,2,3-triyl trinitrate

254. Acenocoumarol*

Alkali pentacyanonitrosylferrate (2-)

Nitrostilbenes, their homologues and their derivatives

Noradrenaline and its salts

Noscapine* and its salts

Guanethidine* and its salts

260. Oestrogens

261. Oleandrin

262. Chlortalidone*

Pelletierine and its salts

264. Pentachloroethane

Pentaerithrityl tetranitrate*

266. Petrichloral*

Octamylamine* and its salts

Picric acid

269. Phenacemide*

270. Difencloxazine*

2-Phenylindane-l,3-dione (phenindione)

272. Ethylphenacemide*

273. Phenprocoumon*

274. Fenyramidol*

Triamterene* and its salts

Tetraethylpyrophosphate; TEPP (ISO)

Tritolyl phosphate

278. Psilocybine*

Phosphorus and metal phosphides

Thalidomide* and its salts

Physostigma venenosum Balf.

282. Picrotoxin

Pilocarpine and its salts

a-Piperidin-2-yl benzyl acetate laevorotatory threoform (Levophacetoperane)

and its salts

Pipradrol* and its salts

Azacyclonol* and its salts

287. Bietamiverine*

Butopiprine* and its salts

Lead and its compounds, with the exception of that mentioned in the Third

Schedule, No 55 under the conditions stated

Coniine

Prunus laurocerasus L. ('cherry laurel water')

291.

Metyrapone*

Radioactive substances 0

293.

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

Hyoscine, its salts and derivatives

Gold salts

Selenium and its compounds with the exception of selenium disulphide under

the conditions set out under reference No 49 in the Third Schedule

Solanum nigrum L. and its galenical preparations

Sparteine and its salts

300. 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

304.

Strychnos species and their galenical preparations

Narcotics, natural and synthetic: all substances listed in Tables I and IT of the

single Convention on narcotic drugs signed in New York on 30 March 1961

Sulphonamides (sulphanylamide and its derivatives obtained by substitution of

one or more H-atoms of the -NH 2 groups) and their salts

Sultiame*

Neodymium and its salts

309.

310. Thiotepa*

Pilocarpus jaborandi Holmes and its galenical preparations

Tellurium and its compounds

Xylometazoline and its salts

314. Tetrachloroethylene

Carbon tetrachloride

Hexaethyl tetraphosphate

Thallium and its compounds

Thevetia neriifolia Juss., glycoside extract

319. Ethionarnide*

Phenothiazine* and its compounds

Thiourea and its derivatives, with the exception of the one listed in the Third

Schedule

Mephenesin* and its esters

Vaccines, toxins or serums listed in the Schedule 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)

Trancylcypromine* and its salts

Trich10ronitromethane (chloropicrine)

2,2,2-Tribromoethanol (tribromoethyl alcohol)

IThe presence of natural radioactive substances and of radioactive substances caused by artificial

contamination from the environment is permitted. provided that the radioactive substances are not enriched

for the manufacture of cosmetic products and that their concentration falls within the limits set in the

Directive laying down the basic standards for the protection of the health of workers and the general

public against the dangers arising from ionizing radiations (OJ No I 1,20.2.1959, p.22I/59).

Trichlonnethine* and its salts

328. Tretamine*

Gallamine triethiodide*

Urginea scilla Stem. and its galenical preparations

Veratrine, its salts and galenical preparations

Schoenocaulon officinale Lind. (seeds and galenical preparations)

Veratrum Spp. and their preparations

Vinyl cWoride monomer

Ergocalciferol* and cholecalciferol (vitamins D2 and D3)

Salts of O-alkyldithiocarbonic acids

Yohimbine and its salts

Dimethyl sulfoxide*

Diphenhydramine* and its salts

4-tert-Butylphenol

4-tert-Butylpyrocatechol

342. Dihydrotachysterol*

343. Dioxane

Morpholine and its salts

Pyrethrum album L. and its galenical preparations

2-[4-Methoxybenzy1-N-(2-pyridy1)amino]ethyldimethylamine

347. Tripelennamine*

348. TetracWorosalicylanilides

349. Dichlorosalicylanilides

350. Tetrabromosalicylanilides

351. Dibromosalicylanilides

352. Bithionol*

Thiuram monosulphides

Thiuram disulphides

355. Dimethylformamide

4-Phenylbut-3-en-2-one

Benzoates of 4-hydroxy-3-rnethoxycinnamyl alcohol exceptfor normal content

in natural essences used

Furocoumarines (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.

359.

Safrole 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

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

acetyl-6-ethyl-l, 1,4,4-tetramethyl-l ,2,3,4-tetrahydronapthalen

O-phenylenediamine and its salts

4-methyl-m-phenylenediamine and its salts

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

366. Chloroform

2,3,7,8-Tetrachlorodibenzo-p-dioxin

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

Pyrithione sodium (INNM)

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

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

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

3,4' ,5-Tribromosalicylanide

Phytolacca spp. and their preparations

374.

Tretinoin* (retinoic acid and its salts)

I-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) and their salts

I-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and their salts

Colouring agent CI 12140

Colouring agent CI 26105

Colouring agent CI 42555

Colouring agent CI42555-1

Colouring agent CI 42555-2

AmyI4-dimethylaminobenzoate, mixed isomers (Padimate A (INN»

381.

Benzoyl peroxide

2-Amino-4-nitrophenol

2-Amino-5-nitrophenol

lla-Hydroxypregn-4-ene-3,20-dione and its esters

Colouring agent CI 42640

Colouring agent CI 13065

Colouring agent CI 42535

Colouring agent CI 61554

Antiandrogens of steroidal structure

Zirconium and its compounds, with the exception of the substances under

reference number 50 in the Third Schedule and the zirconium lakes, salts and

pigments of the colouring agents listed with reference number 3 in the Fourth

Schedule

392. Thyrothricine

393. Acetonitrile

Tetrahydrozoline and its salts

Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51

in the Third Schedule

Dithio-2,2' -bispyridine-dioxide 1, I' (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: I

399. Lidocaine

400. 1,2-Epoxybutane

Colouring agent CI 15585

Strontium lactate

Strontium nitrate

Strontium po1ycarboxy1ate

405. Pramocaine

4-Ethoxy-m-phenylenediamine and its salts

2,4-diaminophenylethanol and its salts

408. Catechol

409. Pyrogallol

410. Nitrosamines

Secondary dialkanolamines

4-Amino-2-nitrophenol

2-Methyl-m-phenylenediamine

4-tert-Buty 1- 3-methoxy-2,6-dinitrotoluene (Musk Ambrette)

414.

415. [deleted]

Cells, tissues or products of human origin

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

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

(a) the skull, including the brain and eyes, tonsils and spinal cord of

- bovine animals aged 12 months;

- ovine and caprine animals which are aged over 12 months or have a

permanent incisor tooth erupted through the gum;

and ingredients derived therefrom;

the spleens of ovine and caprine animals and ingredients derived therefrom.

(b)

However, tallow derivatives may be used provided that the following methods

have been used and strictly certified by the producer

- transesterification 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 (2000 hPa) for eight minutes

or equivalent conditions

Crude and refined coal tars.

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

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