Cosmetic Products Regulations, 2004 (ln_2004_424) | MT

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Preamble — Cosmetic Products Regulations, 2004 Open official source

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,658, 1 ta’ Ottubru, 2004

L.N. 424 of 2004

PRODUCT SAFETY ACT, 2001

(ACT NO. V OF 2001)

Cosmetic Products Regulations, 2004

IN exercise of the powers conferred by article 39 of the Product

Safety Act, 2001, the Minister for Competitiveness and Communications

has, on the advice of the Malta Standards Authority, made the following

regulations>

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 1 — Cosmetic Products Regulations, 2004 Open official source

1 These regulations may be cited as the Cosmetic Products Citation and

commencement.

Regulations, 2004.

1.2 These regulations shall come into effect upon publication,

provided that>

1.2.1 cosmetic products which do not comply with regulation

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

First Schedule — Cosmetic Products Regulations, 2004 Open official source

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.

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Second Schedule — Cosmetic Products Regulations, 2004 Open official source

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-proprietary 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. Aminocaproic acid* and its salts

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

9. Thyropropic acid* and its salts

10. Trichloroacetic acid

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Third Schedule — Cosmetic Products Regulations, 2004 Open official source

finished cosmetic

as boric acid)

product

(b) 0.1% (by

as boric acid)

PART 1

d

acid)

Field of application

products and hair

(b) Products for oral

(excluding bath

(c) Other products

and/or use

c

hygiene

Restrictions

(a) Talc

Boric acid, borates and

Substance

b

tetraborates

Geneva, August 1975.

Reference

Number

1a

a

- Follow the instructions

bathing children under

- Contains thioglycolate

warnings which must be

- Keep out of reach of

Conditions of use and

- For professional use

peeling or irritated skin.

printed on the label

(a) Not to be used in

2. Not to be used on

3 years of age

f

(b) Rinse well

children

(b) and (c)

only

(a)

- Wear suitable gloves

mass/mass as boric acid)

seek medical advice

the following sentences

plenty of water and

obligatorily incorporate

- Avoid contact with

drawn up in the official

peeling or irritated skin

Other limitations and

if the concentration of

immediately with

The directions for use

(a) Not to be used in

children under 3

contact with the

2. Not to be used on

free soluble borates

requirements

- In the event of

(a) and (c) only

exceeds 1.5% (by

products for

years of age

languages must

eyes, rinse

e

the eyes

(a) (b) (c)

age.

mass/mass as boric

11% ready for use,

Maximum authorized

percentages calculated

8% ready for use,

(b) 5% ready for use,

(b) 8% (by mass/mass

concentration in the

(c) 2% ready for use

finished cosmetic

as thioglycollic acid

product

pH : 7- 9.5

pH : 7-9.5

pH ≤ 12.7

as boric acid)

(a) 18% (by

d

pH 7 to 9.5

acid)

(a)

-

(b) Hair waving products

products which are

Field of application

waving products)

professional use

(a) Hair waving or

(c) Other hair care

(a) Bath products

removed after

and/or use

straightening

(b) Depilatories

- general use

application

products

c

Restrictions

-

Thioglycollic acid and its

Substance

b

Tetraborates

salts

Reference

Number

1b

2a

a

Follow the instructions

Contains thioglycolate

warnings which must be

For professional use only

Keep out of reach of

Conditions of use and

For professional use

printed on the label

Above 2%: contains

f

children

ammonia

only

-

event of skin contact

seek medical advice

the following sentences

plenty of water and

obligatorily incorporate

- Avoid contact with

drawn up in the official

Wear suitable gloves

Other limitations and

sensitization in the

immediately with

The directions for use

contact with the

requirements

- In the event of

0.2% as maximum

impurity content

languages must

- May cause

eyes, rinse

e

the eyes

-

11% ready for use,

Maximum authorized

(when mixed with 1,1,1-

8% ready for use,

concentration in the

6% calculated as NH 3

The abovementioned

finished cosmetic

concentration must not

trichloro-ethane, total

thioglycollic acid

product

pH 6 to 9.5

percentages are

calculated as

d

exceed 35%)

(a) 5%

(b) 3%

0.2%

35%

5%

-

straightening products

Field of application

professional use

Hair care products

and/or use

- general use

(a) Toothpaste

(b) Other uses

Hair waving or

c

Restrictions

-

Tosylchloramide sodium*

Oxalic acid, its esters and

Chlorates of alkali metals

Thioglycollic acid esters

Substance

Dichloromethane

b

alkaline salts

Ammonia

Reference

Number

2b

a

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

phenylene-diamines. Can

phenylene-diamines. Do

not use to dye eyelashes

warnings which must be

reaction. Wear suitable

Conditions of use and

(a) Can cause an allergic

printed on the label

(b) For professional use

reaction. Contains

cause an allergic

only. Contains

or eyebrows.

f

gloves.

Other limitations and

requirements

e

Maximum authorized

10% calculated as free

concentration in the

6% calculated as free

finished cosmetic

product

d

base

Field of application

agents for hair dyeing

Oxidizing colouring

(b) professional use

and/or use

(a) general use

c

Restrictions

derivatives and their salts 3

Phenylenediamines, their

substituted derivatives of

N-substituted derivatives

( 3 ), with the exception of

Methylphenyl-diamines,

those derivatives listed

o-Phenylenediamines

other N-substituted

Substance

and their salts; N-

Diaminophenols 3

elsewhere in this

b

Schedule.

m- and p-

for each of them does not exceed 1. ’

Reference

Number

a

eyelashes or eyebrows.

reaction. Wear suitable

Protect cuticles with grease

warnings which must be

(a) Can cause an allergic

diaminophenols. Can

(b) For professional use

diaminophenols. Do

(a) 1. Do not use to dye

Conditions of use and

(a) Wear suitable gloves

peroxide. Avoid contact

comes into contact with

printed on the label

reaction. Contains

immediately if product

Contains dichlorophen

cause an allergic

only. Contains

Contains hydrogen

not use to dye

with eyes. Rinse

or oil. Contains

formaldehyde 4

f

gloves.

(a) (b) (c)

them

Other limitations and

requirements

e

present or released

Maximum authorized

concentration in the

volumes) present

finished cosmetic

(a) 12% H 2 O 2 (40

(d) 0.1% of H 2 O 2

5% calculated as

(b) 4% of H 2 O 2

(c) 2% of H 2 O 2

product

or released

formaldehyde

d

0.3 %

0.5%

base

(a) Oxidizing colouring

(a) Hair care products

Field of application

agents for hair dyeing

(b) professional use

(c) Nail hardening

and/or use

(d) Oral hygiene

preparations

(a) general use

Nail hardeners

(b) Skin care

products

c

Restrictions

Hydrogen peroxide, and

Only if the concentration exceeds 0.05%.

mixtures that release

including carbamide

other compounds or

hydrogen peroxide,

Substance

peroxide and zinc

Hydroquinone 5

Dichlorophen*

Formaldehyde

b

peroxide

Reference

Number

a

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

The concentration 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

eyelashes or eyebrows.

immediately if product

contact with eyes. Can

(a) Contains alkali. Avoid

blindness. Keep out of

cause blindness. Keep

warnings which must be

hydroquinone. Rinse

only. Avoid skin contact.

Conditions of use and

with them. Contains

2. For professional use

eyes immediately if

(b) For professional use

Avoid contact with

product comes into

printed on the label

comes into contact

Read directions for use

contact with them.

(b) 1. Contains alkali.

eyes. Can cause

out of reach of

hydroquinone.

only. Contains

Rinse eyes

f

children.

carefully.

Other limitations and

Professional use only

requirements

e

Maximum authorized

concentration in the

finished cosmetic

0.02 % (after mixing

(a) 5% by weight 6

1. 2% by weight 6

product

d

for use)

(b)

(b) artificial nail systems

(a) Nail cuticle solvent

Field of application

agents for hair dyeing

(b) Hair straightener

professional use

and/or use

1. general use

c

Restrictions

2. Potassium or sodium

Substance

b

hydroxide

for each of them does not exceed 2.

Reference

Number

in column d.

15a

a

with eyes. Can cause

(b) Contains alkali. Keep

warnings which must be

For professional use

with eyes. Can cause

blindness. Keep out

only. Avoid contact

of reach of children

(c) Keep out of reach of

Conditions of use and

For professional use

Avoid contact with

only. Avoid contact

printed on the label

contact with eyes.

reach of children.

eyes. Can cause

Contains alkali.

children. Avoid

out of reach of

blindness

blindness.

f

2.

1.

2. Other limitations and

exceed pH 12.7

(b) pH value not to

(c) pH value not to

requirements

e

4.5% ( 6 ) by weight

Maximum authorized

concentration in the

4.5% by weight 6

finished cosmetic

1. 2% ( 6 )by weight

(c) up to pH 12.7

(d) up to pH 11

product

d

(a)

2.

2. (a) Hair straighteners

Field of application

(c) Other uses – as pH

(d) Other uses as pH

(b) pH adjuster – for

Professional use

professional use

and/or use

1. General use

depilatories

(c) pH adjuster

- depilatories

c

adjuster

Restrictions

2.

2. Lithium hydroxide

Substance

b

Reference

Number

15b

a

of children. Avoid

Can cause allergie reaction

contact with eyes.

Keep out of reach

warnings which must be

cause blindness.

Conditions of use and

(a) Contains alkali.

(b) Contains alkali.

with eyes. Can

printed on the label

Avoid contact

of children

Contains phenol

f

secondary and/or tertiary

Other limitations and

hydrogen peroxide the

exceed pH 12.7

In combination with

(b) pH value not to

(c) pH value not to

substances forming

requirements

exceed pH 11

upon application

Do not use with

amines or other

maximum use

concentration

e

nitrosamines

is 1,0 %

Maximum authorized

concentration in the

1% calculated as phenol

finished cosmetic

(a) 7% by weight of

calcium hydroxide

product

d

2.0 %

0.3%

0.2%

and a guanidine salt

adjuster, processing

(c) Other uses (e.g. pH

calcium hydroxide

(a) Hair straighteners

Field of application

agents for hair dyeing

(b) pH adjuster – for

adjuster (for rinse-off

Soaps and shampoos

Oxidising colouring

and/or use

components

containing 2

depilatories

products only)

Rust inhibitor

c

Restrictions

aid)

Phenol and its alkali salts

1-Naphthol (CAS No

90-15-3) and its salts

Calcium hydroxide

Substance

Sodium nitrite

b

Nitromethane

Reference

Number

15c

a

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

application. Do not use

immediately if product

resorcinol. Rinse eyes

warnings which must be

eyebrows. Rinse eyes

(a) Keep out of reach of

Conditions of use and

Rinse hair well after

(b) Contains resorcinol.

For professional use

Contains resorcinol.

printed on the label

to dye eyelashes or

comes into contact

children. Avoid

only. Contains

with them.

f

[deleted]

(a)

1.

2. Other limitations and

requirements

e

(a) 0.5% calculated as

(b) 0.2% calculated as

Maximum authorized

(a)2% calculated as sulphur,

concentration in the

finished cosmetic

quinine base

product

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

d

[deleted]

(b) 0.5%

pH ≤ 12.7

(a) 5 %

(a) Oxidizing colouring

agent for hair dyeing

Field of application

Professional use

(b) Hair lotions and

and/or use

(a) Depilatories

General use

(b) Hair lotions

(a) Shampoos

shampoos

c

Restrictions

[deleted]

1.

2. (a) Alkali sulphides

Quinine and its salts

Substance

b

Resorcinol 7

[deleted]

Reference

Number

a

warnings which must be

Contains calcium fluoride

Contains sodium fluoride

(b) Keep out of reach of

Conditions of use and

Avoid contact with eyes

printed on the label

monofluoro-phosphate

contact with eyes.

Contains ammonium

children. Avoid

Contains potassium

Contains calcium

Contains sodium

f

fluoride

Other limitations and

requirements

e

When mixed with other

concentration must not

Maximum authorized

0.15% calculated as F.

6% calculated as % of

concentration in the

1% calculated as zinc

finished cosmetic

anhydrous substance

(b) 6% calculated as

permitted under this

fluorine compounds

sulphur, pH ≤ 12.7

Schedule, total F

product

exceed 0.15%

d

0.15%

ditto

Field of application

Oral hygiene products

antiperspirants and

and/or use

astringent lotions

(b) Depilatories

c

Deodorants,

Restrictions

ditto

with the exception of zinc

Zinc 4-hydroxy-benzene

Water soluble zinc salts

benzenesulphonate and

Ammonium mono-

(b) Alkaline earth

Potassium fluoride

Substance

Potassium mono-

Calcium fluoride

Sodium fluoride

fluorophosphate

Calcium mono-

zinc pyrithione

Sodium mono-

sulphides

b

4-hydroxy-

sulphonate

Reference

Number

a

Contains stannous fluoride

Tris(polyoxy-ethylene)-N-

Contains 3-(N-Hexadecyl-

warnings which must be

ethylammonio) propylbis

Conditions of use and

printed on the label

imidazolidene-2-thione

Contains Octadecenyl-

ammonium di-fluoride

Contains magnesium

Contains ammonium

Contains aluminium

Bis(hydroxymethyl)

ammonium fluoride

Contains potassium

Contains hexadecyl

Contains NN’ N’-

propylenediamine

(2-hydroxyethyl)

Contains sodium

dihydrofluoride

f

N-2-hydroxy-

Contains 1,3-

fluorosilicate

hexadecyl-

fluoride

Other limitations and

aerosol dispensers

requirements

(a) Prohibited in

e

(sprays)

Maximum authorized

concentration in the

finished cosmetic

product

(a) Up to 2%

d

0.15%

ditto

Field of application

and/or use

preparations

(a) Hair care

c

Restrictions

ditto

hydroxyethyl) ammonium

Ammonium fluorosilicate

Magnesium fluorosilicate

Octadecenyl-ammonium

hydroxy-ethylammonio)

1,3-Bis(hydroxymethyl)

Potassium fluorosilicate

ethylene)-N-hexadecyl-

imidazolidene-2-thione

Hexadecyl ammonium

NN’ N’-Tris(polyoxy-

3-(N-Hexadecyl-N-2-

Sodium fluorosilicate

Ammonium fluoride

Aluminium fluoride

Substance

propylenediamine

Stannous fluoride

dihydrofluoride

b

propylbis (2-

di-fluoride

fluoride

Reference

Number

a

immediately if product

Do not apply to irritated or

Contains silver nitrate

warnings which must be

eyes or damaged skin

Conditions of use and

- Avoid contact with

printed on the label

comes into contact

Contains nicomethanol

- Contains selenium

Rinse the eyes

disulphide

with them

f

damaged skin

hydrofluoride

-

number of Al atoms

must be less than 4

number of (Al+Zr)

Other limitations and

must be between 2

to that of Zr atoms

atoms to that of Cl

product as applied

The ratio of the

requirements

(b) The pH of the

e

and 10

1.

2. When mixed with other

concentration must not

Maximum authorized

0.15% calculated as F.

concentration in the

aluminium zirconium

finished cosmetic

permitted under this

fluorine compounds

chloride hydroxide

5.4% as zirconium

20% as anhydrous

Schedule, total F

product

exceed 0.15%

d

(b) up to 2%

0.003%

4%

1%

eyelashes and eyebrows

Antidandruff shampoos

Solvents, perfumes and

Field of application

intended for colouring

Oral hygiene products

Solely for products

and/or use

preparations

Antiperspirants

(b) Nair care

c

Restrictions

flavourings

complexes Al x Zr(OH) y Cl z

Aluminium zirconium

Selenium disulphide

chloride hydroxide

zirconium chloride

and the aluminium

6-methylcoumarin

Substance

hydroxide glycine

Benzyl alcohol

Nicomethanol

b

hydrofluoride

Silver nitrate

complexes

Reference

Number

a

Contains lead acetate. Do not

warnings which must be

eyes. Wash hands after use.

Conditions of use and

eyebrows or moustaches. If

printed on the label

Keep away from children.

Avoid all contact with the

Contains etidronic acid

use to dye eyelashes,

irritation develops,

discontinue use.

f

Prohibited in aerosol

between 0.9 and 2.1

dispensers (sprays)

Other limitations and

Fifth Schedule, No 43

As a preservative, see

requirements

atoms must be

e

3.

0.3% calculated as base

0.6% calculated as lead

Maximum authorized

5% calculated as % of

expressed as etidronic

concentration in the

ethanol and isopropyl

finished cosmetic

0.03% calculated as

product

d

(a) 1.5%

(b) 0.2%

alcohol

base

acid

2%

peroxide in non-rinse-off

peroxide in rinse-off hair

Stabilizer for hydrogen

Rinse off products

Denaturant for ethanol

Field of application

- Prohibited in oral

hair care preparations

and isopropyl alcohol

hygiene products

Only for hair-dyeing

and/or use

care preparations

(a) Hair care

c

Restrictions

(b) Soap

only

-

Etidronic acid and its salts

(1-hydroxy-ethylidene-di-

Quinolin-8-ol and bis(8-

phosphonic acid and its

1-Phenoxy-propan-2-ol

hydroxyqui-nolinium)

Substance

b

Lead acetate

Methanol

sulphate

salts)

Reference

Number

a

children’s nose and mouth

warnings which must be

chloride. Frequent use by

children is not advisable.

Conditions of use and

printed on the label

Powder products: Keep

Contains magnesium

Contains strontium

powder away from

f

fluoride

Other limitations and

Do not use with

requirements

e

-

content must not exceed

Sr content must not

F compounds permitted

When mixed with other

must not exceed 0.15%

(a) 3.5% calculated as

(b) 2.1% calculated as

Sr products the total Sr

Maximum authorized

0.15% calculated as F.

products, the total

3.5% calculated as Sr.

concentration in the

products the total

Maximum secondary

finished cosmetic

Sr. When mixed

total F concentration

under this Schedule,

exceed 2.1%.

exceed 3.5%

permitted Sr

product

with other

d

3.5%

Dental hygiene products

intended to be used

(b) Shampoos and face

(a) Powdery products

for children under

Field of application

three years of age

(b) other products

care products

and/or use

(a) Toothpaste

c

Restrictions

Toothpaste

Fatty acid dialkylamides

hydrated magnesium

Magnesium fluoride

Strontium chloride

Substance

Strontium acetate

b

hemihydrate

hexahydrate

silicate

Talc

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

content: 5% (applies

nitrosamine content

nitrosating systems

- Keep in nitrite-free

- Maximum secondary

Other limitations and

amine content: 0.5%

- Minimum purity

to raw materials)

secondary amine

- Do not use with

(applies to raw

requirements

content: 0.5%

- Maximum

containers

materials)

50 µg/kg

e

99%

(a) (b)

Maximum authorized

concentration in the

Maximum secondary

finished cosmetic

amine content: 0.5%

product

d

(a) 2.5%

Field of application

(b) other products

(a) Non-rinse-off

and/or use

products

c

Restrictions

trialkanolamines and their

monoalkanolamines and

and dialkanolamides

Monoalkylamines,

Substance

Trialkylamines,

b

their salts

salts

Reference

Number

a

immediately if product

(a) Avoid contact with the

warnings which must be

- Wear suitable gloves

Keep out of reach of

Conditions of use and

- For professional use

- Avoid contact with

printed on the label

comes into contact

- Rinse eyes

with them

f

children

only

eyes

-

nitrosamine content

(a) In the final products

not exceed 0.1% (as

the concentration of

Keep in nitrite-free

with an alkyl chain

All products must meet

Other limitations and

of C 14 or less must

the hydrogen peroxide

chloride, bromide

and saccharinate

release requirements

requirements

benzalkonium

(concerns raw

Maximum

containers

materials)

chloride)

50 µg/kg

e

-

4.5% calculated as Sr in

Maximum authorized

3.5% calculated as Sr,

concentration in the

finished cosmetic

benzalkonium

the ready-for-use

max. pH of 12.7

product

chloride)

d

preparation

(a) 3% (as

(a) Rinse off hair (head)

Field of application

depilatory products

Rinse-off hair care

care products

and/or use

professional use

preparations for

pH regulator in

c

Restrictions

bromide and saccharinate

Benzalkonium chloride,

Strontium hydroxide

Strontium peroxide

Substance

b

Reference

Number

a

(b) Avoid contact with the

warnings which must be

Conditions of use and

printed on the label

f

eyes

substance must be indicated

0.001 % in leave-on

0.01 % in rinse-off

Other limitations and

0.001 % in leave-on

(b) Maximum residual

(a) Maximum residual

0.01 % in rinse-off

referred to in regulation

in the list of ingredients

concentration exceeds

requirements

acrylamide content

The presence of the

6.1(g) when its

e

products

0,1 mg/kg

0,5 mg/kg

-

benzalkonium chloride

Maximum authorized

concentration in the

finished cosmetic

product

d

(b) 0.1% as

(a) Body-care leave-on

Field of application

(b) Other cosmetic

(b) Other products

and/or use

c

Restrictions

products

(CAS No 122-40-7)

(CAS No 100-51-6)

Substance

Polyacrylamides

Amyl cinnamal

Benzyl alcohol

b

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

- 0.01 % in rinse-off

0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

(CAS No 5392-40-5)

(CAS No 104-54-1)

(CAS No 97-53-0)

Substance

Cinnamyl alcohol

b

Eugenol

Citral

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

Amylcin namyl alcohol

(CAS No 107-75-5)

(CAS No 101-85-9)

Hydroxy-citronellal

(CAS No 97-54-1)

Substance

b

Isoeugenol

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

0.01 % in rinse-off

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

(CAS No 118-58-1)

(CAS No 104-55-2)

(CAS No 91-64-5)

Substance

Benzyl salicylate

b

Coumarin

Cinnamal

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

cyclohexenecarboxalde-

Hydroxy-methylpentyl-

(CAS No 31906-04-4)

(CAS No 106-24-1)

(CAS No 105-13-5)

Substance

Anisyl alcohol

b

Geraniol

hyde

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

0.001 % in leave-on

- 0.001 % in leave-on

0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

2-(4-tert-Butylbenzyl)

(CAS No 4602-84-0)

(CAS No 103-41-3)

(CAS No 80-54-6)

Substance

Benzyl cinnamate

propionaldehyde

b

Farnesol

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

- 0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

(CAS No 120-51-4)

(CAS No 106-22-9)

(CAS No 78-70-6)

Substance

Benzyl benzoate

b

Citronellol

Linalool

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

Methyl heptin carbonate

Hexyl cinnamaldehyde

(CAS No 5989-27-5)

(CAS No 101-86-0)

(CAS No 111-12-6)

Substance

b

d-Limonene

Reference

Number

a

warnings which must be

Conditions of use and

printed on the label

f

substance must be indicated

ingredients referred to in

- 0.001 % in leave-on

0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

indicated in the list of

referred to in regulation

in the list of ingredients

concentration exceeds

The presence of the

requirements

substance must be

The presence of the

its concentration

6.1(g) when its

e

products

exceeds

-

Maximum authorized

concentration in the

finished cosmetic

product

d

Field of application

and/or use

c

Restrictions

trimethyl-2-cyclohexen-1-

(CAS No 90028-68-5)

(CAS No 90028-67-4)

(CAS No 127-51-5)

3-Methyl-4-(2,6,6-

Substance

yl)-3-buten-2-one

Oak moss extract

Treemoss extract

b

Reference

Number

a

directions for use carefully.

warnings which must be

For professional use only.

Avoid skin contact. Read

Conditions of use and

printed on the label

f

ingredients referred to in

- 0.001 % in leave-on

- 0.01 % in rinse-off

Other limitations and

regulation 6.1(g) when

Professional use only

requirements

its concentration

e

products

exceeds

Maximum authorized

concentration in the

finished cosmetic

0.02 % (after mixing

0.7 % (after mixing)

(b) 0,56 % in eau de

(c) 0,042 % in other

(b) 0,4 % in eau de

(c) 0,03 % in other

(a) 1,0 % in fine

(a) 1,4 % in fine

product

d

fragrance

products

for use)

toilette

1.5 %

Hair care formulations

All cosmetic products,

Field of application

Artificial nail systems

oral hygiene products

with the exception of

and/or use

c

Restrictions

3-oxide (CAS No 74638-

2,4-Diamino-pyrimidine-

Musk xylene (CAS No

Musk ketone (CAS No

Substance

Benzoyl peroxide

Hydroquinone

b

methylether

81-15-2)

81-14-1)

76-9)

Reference

Number

a

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

(a) (b) Can cause

allergic reaction

F

reaction

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 0.5 %

concentration upon

requirements

maximum use

E

tration upon

application

List of Substances provisionally allowed

is 1.5 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

PART 2

product

(a) 3.0 %

(b) 3.0 %

(a) 3.0 %

(b) 3.0 %

0.2 %

D

1.0 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

(CAS No 603-85-0) and

(CAS No 610-81-1) and

(CAS no 582-17-2) and

2-Amino-3-nitrophenol

4-Amino-3-nitrophenol

Basic Blue 7 (CAS No

2,7-Naphthalenediol

Substance

B

2390-60-5)

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

(a) (b) Can cause

allergic reaction

F

reaction

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 1.0 %

concentration upon

requirements

maximum use

E

tration upon

application

is 2.6 %

is 1.5 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 5.2 %

(b) 2.6 %

(a) 3.0 %

(b) 2.0 %

D

2.0 %

3.0 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

colouring agent for

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

4-Hydroxypropylamino-

(CAS no 591-27-5) and

(CAS No 84540-47-6)

(CAS No 92952-81-3)

(CAS No 69825-83-8)

(CAS No 23920-15-2)

2,6-Dihydroxy-3,4-

Substance

dimethylpyridine

m-Aminophenol

pyridinediamine

HC Blue No 11

B

3-nitrophenol

6-Nitro-2,5-

and its salts

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

(a) (b) Can cause

allergic reaction

F

reaction

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 1.5 %

concentration upon

requirements

maximum use

E

tration upon

application

is 1.0 %

is 1.5 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 2.0 %

(b) 1.0 %

(b) 2.0 %

(a) 3.0%

D

3.0 %

2.0 %

3.0 %

Field of application

agent for hair dyeing

colouring agents for

Oxidising colouring

colouring agent for

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

acid (CAS No 99610-72-

2-Hydroxyethylpicramic

(CAS No 150-75-4) and

(CAS No 100418-33-5)

(CAS No 141614-05-3)

CAS No 104226-19-9)

methylphenoxyethanol

p-Methylaminophenol

Hydroxyethyl-2,6-

Substance

Hydroxyethyl-2-

nitro-p-toluidine

HC Violet No 2

2,4-Diamino-5-

7) and its salts

B

and its salts

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

(a) (b) Can cause

allergic reaction

F

reaction

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 1.0 %

concentration upon

requirements

maximum use

E

tration upon

application

is 0.75 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 1.5 %

(b) 1.5 %

D

2.0 %

0.5 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

colouring agent for

(b) Non-oxidising

and/or use

(a) Oxidising

C

hair dyeing

pyrazolone (CAS No 89-

81892-72-0) and its salts

(CAS No 122252-11-3)

(CAS No 104516-93-0)

CAS No 113715-25-6)

(CAS No 61693-43-4)

dinitro-p-anisidine

Substance

propane (CAS No

25-8) and its salts

diaminophenoxy)

2,4-Diamino-5-

HC Blue No 12

methylphenetol

dichlorophenol

Phenyl methyl

B

3-Amino-2,4-

1,3-Bis-(2,4-

and its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

F

reaction

hydrogen peroxide the

Other limitations and

application is 0.25 %

In combination with

application is 1.0 %

application is 0.5 %

concentration upon

requirements

maximum use

E

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 0.5 %

D

2.0 %

1.0 %

0.2 %

0.5 %

1.0 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

hydroxyethylaminophenol

Hydroxybenzomorpholine

HC Violet No 1 (CAS No

82576-75-8) and its salts

(CAS No 575-38-2) and

(CAS No 109023-83-8)

(CAS No 55302-96-0)

(CAS No 26021-57-8)

(CAS No 85679-78-3)

(CAS No 85765-48-6)

1,7-Naphthalenediol

2,6-Dimethoxy-3,5-

Substance

HC Yellow No 10

HC Orange No 2

pyridinediamine

B

2-Methyl-5-

and its salts

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

requirements

E

tration upon

application

is 0.25 %

is 1.25 %

is 1.0 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(b) 0.5 %

(a) 2.0 %

(b) 1.0 %

(a) 2.5 %

(b) 2.5 %

D

1.0 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

(CAS No 83-56-7) and its

phenylene-diamine (CAS

2-Hydroxy-ethylamino-

(CAS No 59820-63-2)

(CAS No 66095-81-6)

(CAS No 94158-13-1)

nitro-phenoxyethanol

1,5-Naphthalenediol

No 50610-28-1) and

2-Chloro-5-nitro-N-

3-Methylamino-4-

Substance

hydroxyethyl-p-

HC Red No 13

B

5-nitroanisole

and its salts

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

Can cause allergic

F

reaction

hydrogen peroxide the

Other limitations and

In combination with

application is 0.5 %

application is 1.5 %

application is 1.0 %

application is 1.5 %

application is 2.0 %

concentration upon

requirements

maximum use

E

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

D

3.0 %

2.0 %

3.0 %

4.0 %

2.0 %

agents for hair dyeing

Field of application

Oxidising colouring

and/or use

C

(CAS No 95-55-6) and its

(CAS No 2835-95-2) and

Diaminophenoxyethanol

CAS No 128729-30-6)

(CAS No 66422-95-5)

pphenylenediamine)

(CAS No 608-25-3)

2-Methylresorcinol

Hydroxypropyl bis

Substance

N-hydroxyethyl-

o-Aminophenol

hydroxytoluene

B

4-Amino-2-

and its salts

its salts

salts

2,4-

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

hydrogen peroxide the

Other limitations and

In combination with

application is 1.0 %

application is 1.5 %

application is 1.0 %

application is 1.5 %

concentration upon

requirements

maximum use

E

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

D

3.0 %

2.0 %

3.0 %

agents for hair dyeing

Field of application

Oxidising colouring

and/or use

C

CAS No 83763-47-7) and

(CAS No 2835-99-6) and

hydroxyethylaminoanisol

3,4-Diaminobenzoicacid

(CAS No 619-05-6) and

(CAS No 110952-46-0)

(CAS No 17672-22-9)

(CAS No 79352-72-0)

methyl-paminophenol

Hydroxyethylamino-

4-Amino-m-cresol

Substance

6-Amino-o-cresol

2-Aminomethyl-

paminophenol

B

2-Amino-4-

and its salts

its salts

e

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 1.5 %

application is 1.0 %

concentration upon

requirements

maximum use

E

tration upon

application

is 0.15 %

is 3.0 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 0.3 %

(b) 0.3 %

(a) 6.0 %

(b) 6.0 %

D

3.0 %

2.0 %

2.8 %

agents for hair dyeing

Field of application

colouring agents for

Oxidising colouring

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

hydroxyethylaminophenol

(CAS No 5307-14-2) and

No 33229-34-4) and its

methylenedioxyaniline

(CAS No 81329-90-0)

(CAS No 65235-31-6)

No 3618-58-4) and its

Acid Black 52 (CAS

HC Blue No 2 (CAS

Hydroxyethyl-3,4-

Substance

phenylenediamine

B

and its salts

2-Nitro-p-

3-Nitro-p-

its salts

salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

requirements

E

tration upon

application

is 0.25 %

is 1.0 %

is 0.5 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 0.5 %

(b) 0.5 %

(a) 2.0 %

(b) 1.0 %

(a) 2.0 %

(b) 1.0 %

(a) 1.0 %

(b) 0.5 %

D

Field of application

colouring agents for

(b) Non-oxidising

and/or use

(a) Oxidising

C

hair dyeing

104333-00-8) and its salts

HC Red No 10 + HC Red

89-9 + 95576-92-4) and

No 11 (CAS No 95576-

Yellow No 6 (CAS No

(CAS No 27080-42-8)

(CAS No 59320-13-7)

Substance

HC Yellow No 12

aminoethylurea

4-Nitrophenyl

B

and its salts

its salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

application is 1.0 %

application is 1.5 %

concentration upon

requirements

maximum use

E

tration upon

application

is 1.0 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(a) 2.0 %

(b) 1.0 %

(a) 3.0 %

(b) 3.0 %

(a) 2.0 %

(b) 2.0 %

(a) 0.5 %

D

2.0 %

agents for hair dyeing

Field of application

(a) Oxidising colouring

colouring agents for

Oxidising colouring

agents for hair dyeing

colouring agents for

(b) Non-oxidising

and/or use

(b) Non-oxidising

(a) Oxidising

C

hair dyeing

No 114087-47-1) and its

2-Chloro-6-ethylamino-

(CAS No 102767-27-1)

(CAS No 131657-78-8)

No 6358-09-4) and its

HC Blue No 9 (CAS

Basic Blue 26 (CAS

4-nitrophenol (CAS

44045) and its salts

2-Amino-6-chloro-

No 2580-56-5) (CI

Substance

HC Blue No 10

B

4-nitrophenol

and its salts

salts

Reference

Number

A

Allowed until

G

31.12.2005

be printed on the label

Conditions of use and

warnings which must

F

maximum use concen-

hydrogen peroxide the

Other limitations and

In combination with

requirements

E

tration upon

application

is 0.25 %

is 0.15 %

Maximum authorized

concentration in the

finished cosmetic

Restrictions

product

(b) 0.5 %

(a) 0.3 %

(b) 0.3 %

D

2.0 %

Field of application

colouring agents for

(b) Non-oxidising

and/or use

Non-oxidising

(a) Oxidising

C

hair dyeing

(CAS No 632-99-5)

17200) and its salts

14700) and its salts

Acid Red 33 (CAS

No 3567-66-6) (CI

No 4548-53-2) (CI

Ponceau SX (CAS

Substance

(CI 42510) and its

Basic Violet 14

B

salts

Reference

Number

A

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

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

Colouring agents whose number is preceded by the letter “E” in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfill the

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

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

3% maximum concentration in the finished

Other limitations and requirements 2

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

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

List of Colouring Agents allowed for use in Cosmetic Products 1

product

x

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Fourth Schedule — Cosmetic Products Regulations, 2004 Open official source

x

Field of application

x

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

Colouring agents allowed in all cosmetic products.

x

where the letter “E” has been deleted therefrom.

and eye make-up remover.

Yellow

Orange

Colour

Green

Red

are equally allowed.

Field of application

denomination

Colour index

number or

Column 1

10316 3

12085 3

10006

10020

11680

11710

11725

11920

12010

12120

Column 2

Column 4

Column 3

3% maximum concentration in the finished

Other limitations and requirements 2

product

x

Field of application

x

Yellow

Orange

Yellow

Orange

Yellow

Colour

Brown

Red

denomination

Colour index

number or

15510 3

15630 3

15850 3

15865 3

15985 8

16255 8

17200 8

12150

12370

12420

12480

12490

12700

13015

14270

14700

14720

14815

15525

15580

15620

15800

15880

15980

16035

16185

16230

16290

18050

18130

18690

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

concentration in the colouring agent: 5 ppm

Other limitations and requirements 2

maximum 3,3’-dimethylbenzidine

1-(phenylazo)-2-naphthol ≤ 3%

4-aminoazobenzene ≤ 0.1%

2-naphthol ≤ 0.2%

aniline ≤ 0.2%

Purity criteria

E 161g

E 160e

E 160f

ditto

2%

x

Field of application

x

Yellow

Orange

Yellow

Orange

Colour

Green

Black

Blue

Red

denomination

Colour index

number or

19140 8

27290 8

42051 8

18736

18820

18965

20040

20170

20470

21100

21108

21230

24790

26100

27755

28440

40215

40800

40820

40825

40850

42045

42053

42080

9-yl) benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo-

when used in lipstick, the colouring agent is allowed

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

6% maximum concentration in the finished product

9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-

Other limitations and requirements 2

5 ppm maximum concentration in the finished

only in free acid form and in a maximum

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

3H-xanthen-9-yl) benzoic acid

concentration of 1%

E 127, ditto

product

ditto

x

Field of application

x

Yellow

Orange

Yellow

Colour

Violet

Green

Black

Blue

Red

denomination

Colour index

number or

45370 8

45380 8

45410 8

45430 8

42090

42100

42170

42510

42520

42735

44045

44090

45100

45190

45220

45350

45396

45405

45425

47000

47005

50325

50420

Other limitations and requirements 2

E 140 and E 141

E 160b

E 160d

E 161d

E 160a

x

Field of application

x

Orange

Yellow

Orange

Yellow

Orange

Yellow

Colour

Violet

White

Green

Blue

Red

denomination

Colour index

number or

51319

58000

59040

60724

60725

60730

61565

61570

61585

62045

69800

69825

71105

73000

73015

73360

73385

73900

73915

74100

74160

74180

74260

75100

75120

75125

75130

75135

75170

75300

75470

75810

Other limitations and requirements 2

free from chromate ion

free from cyanide ions

E 160c

Field of application

x

Orange

Yellow

Orange

Colour

Brown

Violet

White

Green

Black

Blue

Red

denomination

Colour index

Capsanthin,

Lactoflavin

capsorubin

number or

Caramel

77268:1

77000

77002

77004

77007

77015

77120

77163

77220

77231

77266

77267

77288

77289

77346

77400

77480

77489

77491

77492

77499

77510

77713

77742

77745

77820

77891

77947

Other limitations and requirements 2

x

Field of application

x

Colour

White

Green

Blue

Red

Aluminium, zinc,

calcium stearates

magnesium and

Bromothymol

Anthocyanins

Acid Red 195

denomination

Colour index

Bromocresol

Beetroot red

number or

green

blue

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Fifth Schedule — Cosmetic Products Regulations, 2004 Open official source

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 ethanolamines; 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%.

Not to be used for children under

Conditions of use and warnings

which must be printed on the

Contains chlorobutanol

three years of age ( 4 )

label

e

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

Not to be used in preparations for

children under three years of age,

Prohibited in aerosol dispensers

Authorized in products rinsed off

Limitations and requirements

Prohibited in aerosol dispensers

Forbidden in products for oral

Rinse-off products only

except for shampoos

d

(sprays)

hygiene

0.2% (except for products for

0.8% (acid) for mixtures of esters

0.1% (products for oral hygiene)

expressed as free formaldehyde

0.2% expressed as the phenol

Maximum authorized

0.2% expressed as free SO 2

concentration

0.4% (acid) for 1 ester,

c

oral hygiene)

0.5% (acid)

0.6% (acid)

0.5% (acid)

2% (acid)

0.5%

0.1%

0.5%

Benzoic acid, its salts and esters

Sorbic acid (hexa-2,4-dienoic

Inorganic sulphites and hydrogen

Formic acid and its sodium salt

4-Hydroxybenzoic acid and its

(3H)-dione (Dehydracetic acid

Propionic acid and its salts (*)

Biphenyl-2-ol (o-polyphenol)

Salicylic acid and its salts (*)

3-Acetyl-6-methylpyran-2,4

Pyrithione zinc (INN) (*)

Substance

Chlorobutanol (INN)

acid) and its salts (*)

3,3’-Dibromo-4,4’-

salts and esters (*)

paraformaldehyde

b

and its salts (*)

Formaldehyde,

Sodium iodate

and its salts)

sulphites (*)

[deleted]

(*)

Reference

number

a

Conditions of use and warnings

which must be printed on the

Contains phenylmercuric

Contains thiomersal

label

compounds

Prohibited in products intended to

Avoid formation of nitrosamines

3,3’,4,4’-Tetrachloroazobenzene

For eye make-up and eye make-

Limitations and requirements

come into contact with mucous

Tetrachloroazoxybenzene < 1

Rinse-off products only

up remover only

Purity criteria

membranes

3,3’,4,4’-

< 1 ppm

Ditto

ppm

concentration of Hg remains fixed at

Maximum authorized

compounds authorised by this

If mixed with other mercurial

concentration

Directive, the maximum

0.007% (of Hg)

0.2% (acid)

0.007%

0.15%

0.2%

0.3%

0.1%

0.2%

0.3%

0.5%

0.6%

Ditto

Poly (1-hexamethylenebiguanide

Phenylmercuric salts (including

3,3’-Bis (1-hydroxymethyl-2,5-

2,4-Dichlorobenzyl alcohol (*)

Undec-10-enoic acid and salts (*)

dioxoimidazolidin-4-yl)-1,1’-

(Dibromohexamidine) and its

5-Bromo-5-nitro-1,3-dioxane

salts (including isethionate)

(“Imidazolidinyl urea”) (*)

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

Triclocarban (INN) (*)

4-Chloro-m-cresol (*)

Substance

Hexetidine (INN) (*)

Tricolosan (INN) (*)

dioxydibenzamidine

Bronopol (INN) (*)

Thiomersal (INN)

methylenediurea

hexamethylene-

borate)

Reference

number

Conditions of use and warnings

which must be printed on the

Contains chloroacetamide

label

Limitations and requirements

Only for rinse-off products

Rinse off products only

Products rinsed off

For other products

0.3% expressed as chlorhexidine

methylisothiazol-3(2H)-one and

2-methylisothiazol-3(2H)-one

0.0015% (of a mixture in the

Maximum authorized

concentration

ratio 3:1 of 5-chloro-2-

0.15%

0.2%

0.5%

0.6%

1.0%

0.5%

0.1%

0.2%

0.3%

1.0%

1%

dimethylimidazolidine-2,4-dione

1,2-Dibromo-2,4-dicyanobutane

trimethylpentyl)-2-pyridone and

methylisothiazol-3(2H)-one and

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

(methyldibromo glutaronitrile)

2-methylisothiazol-3(2H)-one

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

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

with magnesium chloride and

chloroallylochloride (INNM)

Hexamethylenetetramine (*)

Chlorhexidine (INN) and its

digluconate, diacetate and

its methanolamine salt (*)

2-Benzyl-4-chlorophenol

dimethylbutan-2-one (*)

1-(4-Chlorophenoxy)-1-

(Bromochlorophen) (*)

Mixture of 5-Chloro-2-

1-Phenoxypropan-2-ol

Substance

(methenamine) (INN)

2-Phenoxyethanol (*)

4-Isopropyl-m-cresol

(imidazol-1-yl)-3,3-

dihydrochloride (*)

methylenediphenol

2-Chloroacetamide

Benzyl alcohol (*)

magnesium nitrate

hydrochloride) (*)

Methenamine 3-

(Chlorophene)

(*)

Reference

number

Conditions of use and warnings

Contains glutaraldehyde (where

glutaraldehyde concentration in

which must be printed on the

the finished product exceeds

Avoid contact with the eyes

label

0.05%)

products and in products intended

to come into contact with mucous

children under three years of age,

products intended for application

Limitations and requirements

around the eyes and on the lips.

in oral hygiene products and in

The pH of the finished product

Prohibited in aerosols (sprays)

Not for oral hygiene and lip

20% AgCl (w/w) on TiO 2 .

Prohibited in oral hygiene

Prohibited in products for

must not be lower than 6

Rinse-off products only

membranes

0.1% calculated as benzalkonium

Maximum authorized

0.004% calculated as AgCl

concentration

0.1%

0.5%

0.1%

0.3%

0.5%

0.1%

salts (including isethionate and p-

(dihydroxymethyl-1,3-dioxo-2,5-

ammonium bromide and chloride

Benzalkonium chloride, bromide

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

3-(p-chlorophenoxy)-propane-

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

Sodium hydroxymethylamino

Glutaraldehyde (Pentane-1,5-

4,4-dimethyl-1,3-oxazolidine

hexane (Hexamidine) and its

Silver chloride deposited on

Alkyl (C12-C22) trimethyl

hydroxymethylglycinate)

1,2-diol (chlorphenesin)

N-(Hydroxymethyl)-N-

Benzethonium chloride

Substance

(hydroxymethyl) urea

imidazolidinyl-4)-N’-

hydroxybenzoate) (*)

titanium dioxide

acetate (Sodium

[3.3.0] octane

dial)

(*)

Reference

number

Conditions of use and warnings

which must be printed on the

label

Contains iodine.

hygiene and lipcare products

Only for products to be removed

products intended to remain

Limitations and requirements

on the skin exceeds 0.02%

add the phrase: Contains

1. Not to be used for oral

2. If the concentration in

iodine

by rinsing

products

Maximum authorized

concentration

chloride

0.15%

0.05%

propynylbutylcarbamate

Substance

and saccharinate (+)

Benzylhemiformal

3-Iodo-2-

Reference

number

For the purposes of these Regulations, UV filters are substances which, contained in cosmetic sunscreen preparations, are specifically intended to filter certain UV rays in

Contains oxybenzone ( 5 )

warnings which must be

Conditions of use and

printed on the label

e

Other UV filters used in cosmetic products solely for the purpose of protecting the product against UV rays are not included in this list.

These UV filters may be added to other cosmetic products within the limits and under the conditions laid down in this Schedule.

Other limitations and

List of UV Filters which cosmetic products may contain

List of permitted UV filters which cosmetic products may contain

requirements

d

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 6 — Cosmetic Products Regulations, 2004 Open official source

1(c)(iii) or with regulation 6.4 of these regulations but which comply

with the Cosmetic Products Regulations, 2002 (L.N. 143 of 2002) may

continue to be placed on the market until 11th March 2005 and sold or

disposed of to the final consumer until stocks are exhausted<

1.2.2 products which do not comply with the following entries

in the Schedules but which comply in all other respects with these

regulations and with any corresponding entries in the Schedules to the

Cosmetic Products Regulations, 2002, may continue to be placed on

the market until the 24th March, 2005 and sold or disposed of to the

final consumer until the 24th September 2005>

–

Reference No 178 in the Second Schedule,

–

Reference No 382 in the Second Schedule,

–

Reference No 411 in the Second Schedule,

–

Reference No 14 in the Third Schedule, Part I,

–

References No 60, 61 and 62 in the Third Schedule, Part I,

–

Reference No 36 in the Fifth Schedule, Part I

1.3 These regulations implement the provisions of Council

Directive 76#768#EEC of the 27th July, 1976, as amended by>

–

Council Directive 79#661#EEC of 24 July, 1979

–

Commission Directive 82#147#EEC of 11 February, 1982

–

Council Directive 82#368#EEC of 17 May, 1982

–

Commission Directive 83#191#EEC of 30 March, 1983

–

Commission Directive 83#341#EEC of 29 June, 1983

–

Commission Directive 83#496#EEC of 22 September,

– Council Directive 83#574#EEC of 26 October, 1983

– Commission Directive 84#415#EEC of 18 July, 1984

– Commission Directive 85#391#EEC of 16 July, 1985

– Commission Directive 86#179#EEC of 28 February, 1986

– Commission Directive 86#199#EEC of 26 March, 1986

– Commission Directive 87#137#EEC of 2 February, 1987

– Commission Directive 88#233#EEC of 2 March, 1988

– Council Directive 88#667#EEC of 21 December, 1988

– Commission Directive 89#174#EEC of 21 February, 1989

– Council Directive 89#679#EEC of 21 December, 1989

– Commission Directive 90#121#EEC of 20 February, 1990

– Commission Directive 91#184#EEC of 12 March, 1991

– Commission Directive 92#8#EEC of 18 February, 1992

– Commission Directive 92#86#EEC of 21 October, 1992

– Council Directive 93#35#EEC of 14 June, 1993

– Commission Directive 93#47#EEC of 22 June, 1993

– Commission Directive 94#32#EC of 29 June, 1994

– Commission Directive 95#34#EC of 10 July, 1995

– Commission Directive 96#41#EC of 25 June, 1996

– Commission Directive 97#1#EC of 10 January, 1997

– Commission Directive 97#18#EC of 17 April, l997

– Commission Directive 97#45#EC of 14 July, 1997

– Commission Directive 98#16#EC of 5 March, 1998

– Commission Directive 98#62#EC of 3 September, 1998

– Commission Directive 2000#6#EC of 29 February, 2000

– Commission Directive 2000#11#EC of 10 March, 2000

– Commission Directive 2000#41#EC of 19 June, 2000

– Commission Directive 2002#34#EC of 15 April, 2002

– Commission Directive 2003#1#EC of 6 January, 2003

– Commission Directive 2003#16#EC of 19 February, 2003

– Directive 2003#15#EC of the European Parliament and of

the Council of 27 February, 2003

– Commission Directive 2003#80#EC of 5 September, 2003

– Commission Directive 2003#83#EC of 24 September,

2003.

2.1 These regulations shall apply to all cosmetic products as

defined in regulation 3.1.1.

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 these regulations.

3.1 In these regulations, unless the context otherwise requires, Interpretation.

the following definitions shall apply>

3.1.1 “Cosmetic product” shall mean any substance or

preparation intended to be placed in contact with the various 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” shall mean Directive 76#768#EEC of the

European Community<

3.1.3 “Competent authority” for the purposes of regulation 6.8

and regulation 7 shall refer to the Directorate responsible for cosmetic

products within the Malta Standards Authority<

3.1.4 “OECD” shall mean the Organization for Economic

Cooperation and Development<

“animals” shall mean vertebrate animals<

3.1.5

3.1.6 “finished cosmetic product” means the cosmetic product

in its final formulation, as placed on the market and made available to

the final consumer, or its prototype<

3.1.7 “prototype” means a first model or design that has not been

produced in batches, and from which the finished cosmetic product is

copied or fully developed.

4.1 A cosmetic product put on the market must not cause damage General

Requirements.

to human health when applied under normal or reasonably foreseeable

conditions of use, taking account, in particular of the productís

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 these regulations.

5.1 Only cosmetic products that conform to the provisions of

these regulations may be placed on the market.

Without prejudice to the general obligations laid down in

5.2

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 Fifth

Schedule<

(f) preservatives listed in the Fifth 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 Sixth Schedule<

(h) UV filters listed in the Sixth Schedule, beyond the limits

and outside the conditions laid down therein.

5.3 Without prejudice to the general obligations deriving from

regulation 4, the following are prohibited>

(a) the marketing of cosmetic products where the final

formulation, in order to meet the requirements of these regulations,

has been the subject of animal testing using a method other than

an alternative method after such alternative method has been

validated and adopted at Community level with due regard to the

development of validation within the OECD<

(b) the marketing of cosmetic products containing

ingredients or combinations of ingredients which, in order to meet

the requirements of these regulations, have been the subject of

animal testing using a method other than an alternative method

after such alternative method has been validated and adopted at

Community level with due regard to the development of validation

within the OECD<

(c) the performance of animal testing of finished cosmetic

products in order to meet the requirements of these regulations<

(d) the performance of animal testing of ingredients or

combinations of ingredients in order to meet the requirements of

these regulations, no later than the date on which such tests are

required to be replaced by one or more validated alternative

methods listed in Annex V to Council Directive 67#548#EEC of

the 27th June, 1967 on the approximation of laws, regulations and

administrative provisions relating to the classification, packaging

and labelling of dangerous substances or in the Tenth Schedule of

these regulations.

5.4 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 to

paragraph 4.1.

6.1 Cosmetic products may be marketed only if the container Labelling of

cosmetic products.

and packaging bear the following information in indelible, easily legible

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 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 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 information 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 before the end of” followed by either>

–

the date itself, or

–

details of where it appears on the packaging.

(ii) The date shall be clearly expressed and shall consist

of either the month and year or the day, month and year in

that order. If necessary, this information shall be supplemented

by an indication of the conditions that must be satisfied to

guarantee the stated durability.

(iii) Indication of the date of durability shall not be

mandatory for cosmetic products with a minimum durability

of more than 30 months. For such products, there shall be an

indication of the period of time after opening for which the

product can be used without any harm to the consumer. This

information shall be indicated by the symbol given in the Ninth

Schedule followed by the period (in months and#or years).<

(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, Fifth and Sixth

Schedules, which must appear on the container and packaging as

well as any special precautionary information 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 information or the symbol given in

the Seventh 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

information 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 Ninth Schedule, which must appear on

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 these regulations>

–

impurities in the raw materials used,

– subsidiary technical materials used in the 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”. However, the

presence of substances, the mention of which is required under the

column ‘other limitations and requirements’ in the Third Schedule, shall

be indicated in the list irrespective of their function in the product.

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 words “may contain” or the symbol “+#-” are added.

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#335#EC, 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 Pharmacopoeia 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 that 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 purchaserís 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, the manufacturer

or the person responsible for placing the product on the Community

market may take advantage, on the product packaging or in any

document, notice, label, ring or collar accompanying or referring to the

product, of the fact that no animal tests have been carried out only if the

manufacturer and his suppliers have not carried out or commissioned

any animal tests on the finished product, or its prototype, or any of the

ingredients contained in it, or used any ingredients that have been tested

on animals by others for the purpose of developing new cosmetic

products.

Information to be kept accessible.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Sixth Schedule — Cosmetic Products Regulations, 2004 Open official source

Maximum authorized

(expressed as acid)

concentration

10%

5%

6%

8%

5%

6%

c

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

2-Phenylbenzimidazole-5-sulphonic acid and its

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

potassium, sodium and triethanolamine salts

1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)

3,3’-(1,4-Phenylenedimethylene) bis (7,7-

ylidenemethyl) anilinium methyl sulphate

alpha-(2-Oxoborn-3-ylidene)-toluene-4-

dimethyl-2-oxo-bicyclo-[2,2,1] hept-1-

ylmethanesulphonic acid) and its salts

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

sulphonic acid and its salts

b

4-Aminobenzoic acid

Oxybenzone (INN)

ester (Octocrylene)

Homosalate (INN)

propane-1,3-dione

Substances

[deleted]

Reference

No

a

warnings which must be

Conditions of use and

printed on the label

e

Other limitations and

requirements

d

Maximum authorized

10% (of acid)

concentration

5% (of acid)

10%

15%

10%

6%

5%

4%

2%

5%

8%

c

Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)

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

2,2’-Methylene-bis-6-(2H-benzotriazol-2-yl)-4-

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

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

Ethoxylated ethyl-4-aminobenzoate (PEG-25

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

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

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

Isopentyl-4-methoxycinnamate (Isoamyl p-

3-(4’-methylbenzylidene)-d-1 camphor (4-

sulphonic acid (Benzophenone-5) and its

(trimethylsilyl)oxy)-disilo-xanyl)propyl)

2-Ethylhexyl salicylate (octyl-salicylate)

2-Hydroxy-4-methoxybenzophenone-5-

3-Benzylidene camphor (3-Benzylidene

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

1H-benzimidazole-4,6-disulphonic acid

Benzoic acid, 4,4-((6-(((1,1-dimethyl-

Oxy)-1,3,5-Triazine (Octyl Triazone)

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

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

(tetramethyl-butyl)-1,1,3,3-phenol

Methylbenzylidene Camphor)

methyl] benzyl} acrylamide

(Drometrizole Trisiloxane)

Octyl methoxycinnamate

b

(octyl dimethyl PABA)

methoxycinnamate)

ethylhexyl)ester)

sodium salt

Substances

Camphor)

PABA)

Reference

No

a

warnings which must be

Conditions of use and

printed on the label

e

Other limitations and

requirements

d

Maximum authorized

concentration

10 %

25 %

c

Dimethicodiethylbenzalmalonate

b

(CAS No 207574-74-1)

Titanium dioxide

Substances

Reference

No

a

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 7 — Cosmetic Products Regulations, 2004 Open official source

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

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 physicochemical 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 Community law or, failing

that, laid down by Maltese law< the person responsible for

manufacture or importation must possess an appropriate level of

professional qualification or experience<

(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 ingredients, their chemical

structure and their level of exposure. It shall take particular account

of the specific exposure characteristics of the areas on which the

product will be applied or of the population for which it is intended.

There shall be inter alia a specific assessment for cosmetic products

intended for use on children under the age of three and for cosmetic

products intended exclusively for use in external intimate hygiene<

(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<

(h) data on any animal testing performed by the

manufacturer, his agents or suppliers, relating to the development

or safety evaluation of the product or its ingredients, including

any animal testing performed to meet the legislative or regulatory

requirements of non-member countries.

Provided that -

7.1.1 should the same product be manufactured at several places

within Community territory, the manufacturer may choose a single place

of manufacture where that information will be available. In this

connection, and when so requested for monitoring purposes, it shall be

obliged to indicate the places so chosen to the monitoring authority or

authorities concerned. In this case this information shall be easily

accessible< and

7.1.2 without prejudice to the protection, in particular, of

commercial secrecy and of intellectual property rights, the information

required under regulation 7.1, points (a) and (f) shall be made easily

accessible to the public by any appropriate means, including electronic

means. The quantitative information required under (a) to be made

publicly accessible shall be limited to dangerous substances covered

by Directive 67#548#EEC.

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 the Good Laboratory Practice

Regulations, 2004.

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 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.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Eighth Schedule — Cosmetic Products Regulations, 2004 Open official source

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 III

and potassium hydroxides

Identification and determination of oxalic acid

Commission Directive 80/1335/EEC, Method IV

and alkaline salts in hair care products

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

and

determination

of Commission Directive 80/1335/EEC, Method VII

phenolsulphonic acid

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 IV,

formaldehyde

as amended by Commission Directive

90/207/EEC

Determination of resorcinol in shampoos and hair Commission Directive 82/434/EEC, Method V

lotion

Determination of methanol in relation to ethanol Commission Directive 82/434/EEC, Method VI

or propan-2-ol

Determination of dichloromethane and 1,1,1- Commission Directive 83/514/EEC, Method I

trichloroethane

Identification and determination of quinolin-8-ol Commission Directive 83/514/EEC, Method II

and bis(8-hydroxyquinolinium) sulphate

Determination of ammonia

Commission Directive 83/514/EEC, Method III

Identification and determination of nitromethane

Commission Directive 83/514/EEC, Method IV

Identification

and

determination

of Commission Directive 83/514/EEC, Method V

mercaptoacetic acid in hair-waving, hair-

straightening and depilatory products

Identification

and

determination

of Commission Directive 83/514/EEC, Method VI

hexachlorophene (INN)

Determination of tosylchloramide, sodium (INN) Commission Directive 83/514/EEC, Method VII

Determination of total fluorine in dental creams

Commission Directive 83/514/EEC, Method VIII

Identification

and

determination

of Commission Directive 83/514/EEC, Method IX

organomercury compounds

Determination of alkali and alkaline earth Commission Directive 83/514/EEC, Method X

sulphides

Identification and determination of glycerol 1-(4- Commission Directive 85/490/EEC, Method I

aminobenzoate)

Determination of chlorobutanol

Commission Directive 85/490/EEC, Method II

Identification and determination of quinine

Commission Directive 85/490/EEC, Method III

Identification and determination of inorganic

Commission Directive 85/490/EEC, Method IV

sulphites and hydrogen sulphites

Identification and determination of chlorates of

Commission Directive 85/490/EEC, Method V

the alkali metals

Identification and determination of sodium iodate

Commission Directive 85/490/EEC, Method VI

Identification and determination of silver nitrate

Commission Directive 93/73/EEC, Method I

Identification and determination of selenium

Commission Directive 93/73/EEC, Method II

disulphide in anti-dandruff shampoos

Determination of soluble barium and soluble

Commission Directive 93/73/EEC, Method III

strontium in pigments in the form of salts or lakes

Identification and determination of benzyl

Commission Directive 93/73/EEC, Method IV

alcohol

Identification of zirconium, and determination of

Commission Directive 93/73/EEC, Method V

zirconium, aluminium and chlorine in non-

aerosol antiperspirants

Identification and determination of hexamidine,

Commission Directive 93/73/EEC, Method VI

dibromohexamidine, dibromopropamidine and

chlorhexidine

Identification and determination of benzoic acid,

Commission Directive 95/32/EC, Method I

4-hydroxybenzoic acid, sorbic acid, salicylic acid

and propionic acid

Identification

and

determination

of

Commission Directive 95/32/EC, Method II

hydroquinone, hydroquinone monomethylether,

hydroquinone monoethylether and hydroquinone

monobenzylether

Identification and determination of 2-

Commission Directive 96/45/EC

phenoxyethanol, 1-phenoxypropan-2-ol and

methyl, ethyl, propyl, butyl and benzyl 4-

hydroxybenzoate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 8 — Cosmetic Products Regulations, 2004 Open official source

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

prohibition of

justification and on the advice of the Directorate responsible for cosmetic marketing.

products within the Malta Standards Authority, provisionally prohibit

or subject to special conditions the marketing of a cosmetic product

which, although complying with the requirements of these regulations,

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.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Ninth Schedule — Cosmetic Products Regulations, 2004 Open official source

Symbol indicating the durability of cosmetic products

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 9 — Cosmetic Products Regulations, 2004 Open official source

1 Where an official test method is given in the Eighth 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 Eighth Schedule.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Tenth Schedule — Cosmetic Products Regulations, 2004 Open official source

List of Validated Alternative Methods to Animal Testing

This Schedule lists the alternative methods validated by European Centre on Validation of

Alternative Methods (ECVAM) of the Joint Research Centre available to meet the

requirements of this Directive and which are not listed in Annex V to Council Directive

67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative

provisions relating to the classification, packaging and labelling of dangerous substances. As

animal testing may not be replaced completely by an alternative method, it should be

mentioned in the Tenth Schedule whether the alternative method fully or partially replaces

animal testing.

Reference

Validated alternative methods

Nature of replacement

number

full or partial

A

B

C

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 10 — Cosmetic Products Regulations, 2004 Open official source

1 The Cosmetic Products Regulations, 2002 (L.N. 143 of Repeal of L.N. 143

of 2002.

2002) are hereby repealed.

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 11 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 12 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 13 — Cosmetic Products Regulations, 2004 Open official source

Adonis vernalis L. and its preparations

14. Epinephrine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 15 — Cosmetic Products Regulations, 2004 Open official source

Rauwolfia serpentina alkaloids and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 16 — Cosmetic Products Regulations, 2004 Open official source

Alkyne alcohols, their esters, ethers and salts

17. Isoprenaline*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 18 — Cosmetic Products Regulations, 2004 Open official source

Allyl isothiocyanate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 19 — Cosmetic Products Regulations, 2004 Open official source

Alloclamide* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 20 — Cosmetic Products Regulations, 2004 Open official source

Nalorphine*, its salts and ethers

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 21 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 22 — Cosmetic Products Regulations, 2004 Open official source

Aniline, its salts and its halogenated and sulphonated derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 23 — Cosmetic Products Regulations, 2004 Open official source

Betoxycaine* and its salts

24. Zoxazolamine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 25 — Cosmetic Products Regulations, 2004 Open official source

Procainamide*, its salts and derivatives

26. Benzidine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 27 — Cosmetic Products Regulations, 2004 Open official source

Tuaminoheptane*, its isomers and salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 28 — Cosmetic Products Regulations, 2004 Open official source

Octodrine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 29 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 30 — Cosmetic Products Regulations, 2004 Open official source

1,3-dimethylpentylamine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 31 — Cosmetic Products Regulations, 2004 Open official source

4-Aminosalicylic acid and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 32 — Cosmetic Products Regulations, 2004 Open official source

Toluidines, their isomers, salts and halogenated and sulphonated derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 33 — Cosmetic Products Regulations, 2004 Open official source

Xylidines, their isomers, salts and halogenated and sulphonated derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 34 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 35 — Cosmetic Products Regulations, 2004 Open official source

Ammi majus and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 36 — Cosmetic Products Regulations, 2004 Open official source

2,3-Dichloro-2-methylbutane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 37 — Cosmetic Products Regulations, 2004 Open official source

Substances with androgenic effect

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 38 — Cosmetic Products Regulations, 2004 Open official source

Anthracene oil

39. Antibiotics

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 40 — Cosmetic Products Regulations, 2004 Open official source

Antimony and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 41 — Cosmetic Products Regulations, 2004 Open official source

Apocynum cannabinum L. and its preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 42 — Cosmetic Products Regulations, 2004 Open official source

Apomorphine (R5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de,g]-quinoline-10,11-diol) and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 43 — Cosmetic Products Regulations, 2004 Open official source

Arsenic and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 44 — Cosmetic Products Regulations, 2004 Open official source

Atropa belladonna L. and its preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 45 — Cosmetic Products Regulations, 2004 Open official source

Atropine, its salts and derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 46 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 48 — Cosmetic Products Regulations, 2004 Open official source

4,5-Dihydrobenzimidazol-4-one

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 49 — Cosmetic Products Regulations, 2004 Open official source

Benzazepines and benzadiazepines

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 50 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 51 — Cosmetic Products Regulations, 2004 Open official source

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

52. Isocarboxazid*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 53 — Cosmetic Products Regulations, 2004 Open official source

Bendroflumethiazide* and its derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 54 — Cosmetic Products Regulations, 2004 Open official source

Beryllium and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 55 — Cosmetic Products Regulations, 2004 Open official source

Bromine, elemental

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 56 — Cosmetic Products Regulations, 2004 Open official source

Bretylium tosilate*

57. Carbromal*

58. Bromisoval*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 59 — Cosmetic Products Regulations, 2004 Open official source

Brompheniramine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 60 — Cosmetic Products Regulations, 2004 Open official source

Benzilonium bromide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 61 — Cosmetic Products Regulations, 2004 Open official source

Tetrylammonium bromide*

62. Brucine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 63 — Cosmetic Products Regulations, 2004 Open official source

Tetracaine* and its salts

64. Mofebutazone*

65. Tolbutamide*

66. Carbutamide*

67. Phenylbutazone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 68 — Cosmetic Products Regulations, 2004 Open official source

Cadmium and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 69 — Cosmetic Products Regulations, 2004 Open official source

Cantharides, Cantharis vesicatoria

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 70 — Cosmetic Products Regulations, 2004 Open official source

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

71. Phenprobamate*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 72 — Cosmetic Products Regulations, 2004 Open official source

Nitroderivatives of carbazol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 73 — Cosmetic Products Regulations, 2004 Open official source

Carbon disulphide

74. Catalase

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 75 — Cosmetic Products Regulations, 2004 Open official source

Cephaeline and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 76 — Cosmetic Products Regulations, 2004 Open official source

Chenopodium ambrosioides (essential oil)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 77 — Cosmetic Products Regulations, 2004 Open official source

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

78. Chlorine

79. Chlorpropamide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 80 — Cosmetic Products Regulations, 2004 Open official source

Diphenoxylate* (hydrochloride)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 81 — Cosmetic Products Regulations, 2004 Open official source

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

82. Chlorzoxazone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 83 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 84 — Cosmetic Products Regulations, 2004 Open official source

Chlorprothixene* and its salts

85. Clofenamide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 86 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 87 — Cosmetic Products Regulations, 2004 Open official source

Chlormethine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 88 — Cosmetic Products Regulations, 2004 Open official source

Cyclophosphamide* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 89 — Cosmetic Products Regulations, 2004 Open official source

Mannomustine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 90 — Cosmetic Products Regulations, 2004 Open official source

Butanilicaine* and its salts

91. Chloromezanone*

92. Triparanol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 93 — Cosmetic Products Regulations, 2004 Open official source

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

94. Chlorphenoxamine*

95. Phenaglycodol*

96. Chloroethane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 97 — Cosmetic Products Regulations, 2004 Open official source

Chromium, chromic acid and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 98 — Cosmetic Products Regulations, 2004 Open official source

Claviceps purpurea Tul., its alkaloids and gelanical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 99 — Cosmetic Products Regulations, 2004 Open official source

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

100. Glycyclamide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 101 — Cosmetic Products Regulations, 2004 Open official source

Cobalt benzenesulphonate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 102 — Cosmetic Products Regulations, 2004 Open official source

Colchicine, its salts and derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 103 — Cosmetic Products Regulations, 2004 Open official source

Colchicoside and its derivatives3

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 104 — Cosmetic Products Regulations, 2004 Open official source

Colchicum autumnale L. and its galenical preparations

105. Convallotoxin

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 106 — Cosmetic Products Regulations, 2004 Open official source

Anamirta cocculus L. (fruit)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 107 — Cosmetic Products Regulations, 2004 Open official source

Croton tiglium (oil)

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 108 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 109 — Cosmetic Products Regulations, 2004 Open official source

Curare and curarine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 110 — Cosmetic Products Regulations, 2004 Open official source

Synthetic curarizants

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 111 — Cosmetic Products Regulations, 2004 Open official source

Hydrogen cyanide and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 112 — Cosmetic Products Regulations, 2004 Open official source

2-α-Cyclohexylbenzyl (N N N’ N’-tetraethyl)trimethylenediamine (phenetamine)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 113 — Cosmetic Products Regulations, 2004 Open official source

Cyclomenol* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 114 — Cosmetic Products Regulations, 2004 Open official source

Sodium hexacyclonate*

115. Hexapropymate*

116. Dextropropoxyphene*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 117 — Cosmetic Products Regulations, 2004 Open official source

O O-Diacetyl-N-allyl-N-normorphine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 118 — Cosmetic Products Regulations, 2004 Open official source

Pipazetate* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 119 — Cosmetic Products Regulations, 2004 Open official source

5-(α,β-dibromo-phenethyl)-5-methylhydantoin

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 120 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 121 — Cosmetic Products Regulations, 2004 Open official source

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

122. Cyclarbamate*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 123 — Cosmetic Products Regulations, 2004 Open official source

Clofenotane*; DDT (ISO)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 124 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 125 — Cosmetic Products Regulations, 2004 Open official source

Dichloroethanes (ethylene chlorides)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 126 — Cosmetic Products Regulations, 2004 Open official source

Dichloroethylenes (acetylene chlorides)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 127 — Cosmetic Products Regulations, 2004 Open official source

Lysergide* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 128 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 129 — Cosmetic Products Regulations, 2004 Open official source

Cinchocaine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 130 — Cosmetic Products Regulations, 2004 Open official source

3-Diethylaminopropyl cinnamate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 131 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 132 — Cosmetic Products Regulations, 2004 Open official source

[Oxalylbis(iminoethylene)] bis [(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 133 — Cosmetic Products Regulations, 2004 Open official source

Methyprylon* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 134 — Cosmetic Products Regulations, 2004 Open official source

Digitaline and all heterosides of Digitalis purpurea L.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 135 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 136 — Cosmetic Products Regulations, 2004 Open official source

Dioxethedrin* and its salts

137. Piprocurarium*

138. Propyphenazone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 139 — Cosmetic Products Regulations, 2004 Open official source

Tetrabenazine* and its salts

140. Captodiame*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 141 — Cosmetic Products Regulations, 2004 Open official source

Mefeclorazine* and its salts

142. Dimethylamine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 143 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 144 — Cosmetic Products Regulations, 2004 Open official source

Methapyrilene* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 145 — Cosmetic Products Regulations, 2004 Open official source

Metamfepramone* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 146 — Cosmetic Products Regulations, 2004 Open official source

Amitriptylene* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 147 — Cosmetic Products Regulations, 2004 Open official source

Metformin* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 148 — Cosmetic Products Regulations, 2004 Open official source

Isosorbide dinitrate*

149. Malononitrile

150. Succinonitrile

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 151 — Cosmetic Products Regulations, 2004 Open official source

Dinitrophenol isomers

152. Inproquone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 153 — Cosmetic Products Regulations, 2004 Open official source

Dimevamide* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 154 — Cosmetic Products Regulations, 2004 Open official source

Diphenylpyraline* and its salts

155. Sulfinpyrazone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 156 — Cosmetic Products Regulations, 2004 Open official source

N-(3-Carbamoyl-3,3-diphenylpropyl)-N N-diisopropylmethylammonium salts, e.g. isopropamide iodide*

157. Benactyzine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 158 — Cosmetic Products Regulations, 2004 Open official source

Benzatropine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 159 — Cosmetic Products Regulations, 2004 Open official source

Cyclizine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 160 — Cosmetic Products Regulations, 2004 Open official source

5,5-Diphenyl-4-imidazolidone

161. Probenecid*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 162 — Cosmetic Products Regulations, 2004 Open official source

Disulfiram*, thiram (ISO)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 163 — Cosmetic Products Regulations, 2004 Open official source

Emetine, its salts and derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 164 — Cosmetic Products Regulations, 2004 Open official source

Ephedrine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 165 — Cosmetic Products Regulations, 2004 Open official source

Oxanamide* and its derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 166 — Cosmetic Products Regulations, 2004 Open official source

Eserine or physostigmine and its salts

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 167 — Cosmetic Products Regulations, 2004 Open official source

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

Part 2.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 168 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 169 — Cosmetic Products Regulations, 2004 Open official source

Caramiphen* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 170 — Cosmetic Products Regulations, 2004 Open official source

Diethyl 4-nitrophenyl phosphate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 171 — Cosmetic Products Regulations, 2004 Open official source

Metethoheptazine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 172 — Cosmetic Products Regulations, 2004 Open official source

Oxpheneridine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 173 — Cosmetic Products Regulations, 2004 Open official source

Ethoheptazine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 174 — Cosmetic Products Regulations, 2004 Open official source

Metheptazine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 175 — Cosmetic Products Regulations, 2004 Open official source

Methylphenidate* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 176 — Cosmetic Products Regulations, 2004 Open official source

Doxylamine* and its salts

177. Tolboxane*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 178 — Cosmetic Products Regulations, 2004 Open official source

4-Benzyloxyphenol and 4-ethoxyphenol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 179 — Cosmetic Products Regulations, 2004 Open official source

Parethoxycaine* and its salts

180. Fenozolone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 181 — Cosmetic Products Regulations, 2004 Open official source

Glutethimide* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 182 — Cosmetic Products Regulations, 2004 Open official source

Ethylene oxide

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 183 — Cosmetic Products Regulations, 2004 Open official source

Bemegride* and its salts

184. Valnoctamide*

185. Haloperidol*

186. Paramethasone*

187. Fluanisone*

188. Trifluperidol*

189. Fluoresone*

190. Fluorouracil*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 191 — Cosmetic Products Regulations, 2004 Open official source

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in

the Third Schedule.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 192 — Cosmetic Products Regulations, 2004 Open official source

Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*

193. Galantamine*

194. Progestogens

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 195 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 196 — Cosmetic Products Regulations, 2004 Open official source

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

dimethanonaphthalene (endrin-ISO)

197. Hexachloroethane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 198 — Cosmetic Products Regulations, 2004 Open official source

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

ISO)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 199 — Cosmetic Products Regulations, 2004 Open official source

Hydrastine, hydrastinine and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 200 — Cosmetic Products Regulations, 2004 Open official source

Hydrazides and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 201 — Cosmetic Products Regulations, 2004 Open official source

Hydrazine, its derivatives and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 202 — Cosmetic Products Regulations, 2004 Open official source

Octamoxin* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 203 — Cosmetic Products Regulations, 2004 Open official source

Warfarin* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 204 — Cosmetic Products Regulations, 2004 Open official source

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

205. Methocarbamol*

206. Propatylnitrate*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 207 — Cosmetic Products Regulations, 2004 Open official source

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

208. Fenadiazole*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 209 — Cosmetic Products Regulations, 2004 Open official source

Nitroxoline* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 210 — Cosmetic Products Regulations, 2004 Open official source

Hyoscyamine, its salts and derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 211 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 212 — Cosmetic Products Regulations, 2004 Open official source

Pemoline* and its salts

213. Iodine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 214 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 215 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 216 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 217 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 218 — Cosmetic Products Regulations, 2004 Open official source

Lobelia inflata L. and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 219 — Cosmetic Products Regulations, 2004 Open official source

Lobeline* and its salts

220. Barbiturates

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 221 — Cosmetic Products Regulations, 2004 Open official source

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

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 222 — Cosmetic Products Regulations, 2004 Open official source

3,4,5-Trimethoxyphenethylamine and its salts

223. Metaldehyde

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 224 — Cosmetic Products Regulations, 2004 Open official source

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

225. Coumetarol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 226 — Cosmetic Products Regulations, 2004 Open official source

Dextromethorphan* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 227 — Cosmetic Products Regulations, 2004 Open official source

2-Methylheptylamine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 228 — Cosmetic Products Regulations, 2004 Open official source

Isometheptene* and its salts

229. Mecamylamine*

230. Guaifenesin*

231. Dicoumarol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 232 — Cosmetic Products Regulations, 2004 Open official source

Phenmetrazine*, its derivatives and salts

233. Thiamazole*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 234 — Cosmetic Products Regulations, 2004 Open official source

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

235. Carisoprodol*

236. Meprobamate*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 237 — Cosmetic Products Regulations, 2004 Open official source

Tefazoline* and its salts

238. Arecoline

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 239 — Cosmetic Products Regulations, 2004 Open official source

Poldine metilsulfate*

240. Hydroxyzine*

241. 2-Naphthol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 242 — Cosmetic Products Regulations, 2004 Open official source

1- and 2-Naphthylamines and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 243 — Cosmetic Products Regulations, 2004 Open official source

3-(1-naphthyl)-4-hydroxycoumarin

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 244 — Cosmetic Products Regulations, 2004 Open official source

Naphazoline* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 245 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 246 — Cosmetic Products Regulations, 2004 Open official source

Nicotine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 247 — Cosmetic Products Regulations, 2004 Open official source

Amyl nitrites

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 248 — Cosmetic Products Regulations, 2004 Open official source

Inorganic nitrites, with the exception of sodium nitrite

249. Nitrobenzene

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 250 — Cosmetic Products Regulations, 2004 Open official source

Nitrocresols and their alkali metal salts

251. Nitrofurantoin*

252. Furazolidone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 253 — Cosmetic Products Regulations, 2004 Open official source

Propane-1,2,3-triyl trinitrate

254. Acenocoumarol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 255 — Cosmetic Products Regulations, 2004 Open official source

Alkali pentacyanonitrosylferrate (2-)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 256 — Cosmetic Products Regulations, 2004 Open official source

Nitrostilbenes, their homologues and their derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 257 — Cosmetic Products Regulations, 2004 Open official source

Noradrenaline and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 258 — Cosmetic Products Regulations, 2004 Open official source

Noscapine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 259 — Cosmetic Products Regulations, 2004 Open official source

Guanethidine* and its salts

260. Oestrogens

261. Oleandrin

262. Chlortalidone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 263 — Cosmetic Products Regulations, 2004 Open official source

Pelletierine and its salts

264. Pentachloroethane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 265 — Cosmetic Products Regulations, 2004 Open official source

Pentaerithrityl tetranitrate*

266. Petrichloral*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 267 — Cosmetic Products Regulations, 2004 Open official source

Octamylamine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 268 — Cosmetic Products Regulations, 2004 Open official source

Picric acid

269. Phenacemide*

270. Difencloxazine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 271 — Cosmetic Products Regulations, 2004 Open official source

2-Phenylindane-1,3-dione (phenindione)

272. Ethylphenacemide*

273. Phenprocoumon*

274. Fenyramidol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 275 — Cosmetic Products Regulations, 2004 Open official source

Triamterene* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 276 — Cosmetic Products Regulations, 2004 Open official source

Tetraethylpyrophosphate; TEPP (ISO)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 277 — Cosmetic Products Regulations, 2004 Open official source

Tritolyl phosphate

278. Psilocybine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 279 — Cosmetic Products Regulations, 2004 Open official source

Phosphorus and metal phosphides

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 280 — Cosmetic Products Regulations, 2004 Open official source

Thalidomide* and its salts

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 281 — Cosmetic Products Regulations, 2004 Open official source

Physostigma venenosum Balf.

282. Picrotoxin

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 283 — Cosmetic Products Regulations, 2004 Open official source

Pilocarpine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 284 — Cosmetic Products Regulations, 2004 Open official source

α-Piperidin-2-yl benzyl acetate laevorotatory threoform (Levophacetoperane) and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 285 — Cosmetic Products Regulations, 2004 Open official source

Pipradrol* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 286 — Cosmetic Products Regulations, 2004 Open official source

Azacyclonol* and its salts

287. Bietamiverine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 288 — Cosmetic Products Regulations, 2004 Open official source

Butopiprine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 289 — Cosmetic Products Regulations, 2004 Open official source

Lead and its compounds, with the exception of that mentioned in the Third Schedule, No 55 under the

conditions stated

290. Coniine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 291 — Cosmetic Products Regulations, 2004 Open official source

Prunus laurocerasus L. (‘cherry laurel water’)

292. Metyrapone*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 293 — Cosmetic Products Regulations, 2004 Open official source

Radioactive substances, as defined by Directive 96/29/Euratom ( 1 ) laying down basic safety standards for

the protection of the health of workers and the general public against the dangers arising from ionizing

radiation.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 294 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 295 — Cosmetic Products Regulations, 2004 Open official source

Hyoscine, its salts and derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 296 — Cosmetic Products Regulations, 2004 Open official source

Gold salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 297 — Cosmetic Products Regulations, 2004 Open official source

Selenium and its compounds with the exception of selenium disulphide under the conditions set out under

reference No 49 in the Third Schedule

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 298 — Cosmetic Products Regulations, 2004 Open official source

Solanum nigrum L. and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 299 — Cosmetic Products Regulations, 2004 Open official source

Sparteine and its salts

300. Glucocorticoids

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 301 — Cosmetic Products Regulations, 2004 Open official source

Datura stramonium L. and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 302 — Cosmetic Products Regulations, 2004 Open official source

Strophantines, their aglucones and their respective derivatives

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 303 — Cosmetic Products Regulations, 2004 Open official source

Strophantus species and their galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 304 — Cosmetic Products Regulations, 2004 Open official source

Strychnine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 305 — Cosmetic Products Regulations, 2004 Open official source

Strychnos species and their galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 306 — Cosmetic Products Regulations, 2004 Open official source

Narcotics, natural and synthetic: all substances listed in Tables I and II of the single Convention on narcotic

drugs signed in New York on 30 March 1961

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 307 — Cosmetic Products Regulations, 2004 Open official source

Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the

–NH 2 groups) and their salts

308. Sultiame*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 309 — Cosmetic Products Regulations, 2004 Open official source

Neodymium and its salts

310. Thiotepa*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 311 — Cosmetic Products Regulations, 2004 Open official source

Pilocarpus jaborandi Holmes and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 312 — Cosmetic Products Regulations, 2004 Open official source

Tellurium and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 313 — Cosmetic Products Regulations, 2004 Open official source

Xylometazoline and its salts

314. Tetrachloroethylene

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 315 — Cosmetic Products Regulations, 2004 Open official source

Carbon tetrachloride

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 316 — Cosmetic Products Regulations, 2004 Open official source

Hexaethyl tetraphosphate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 317 — Cosmetic Products Regulations, 2004 Open official source

Thallium and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 318 — Cosmetic Products Regulations, 2004 Open official source

Thevetia neriifolia Juss., glycoside extract

319. Ethionamide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 320 — Cosmetic Products Regulations, 2004 Open official source

Phenothiazine* and its compounds

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 321 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 322 — Cosmetic Products Regulations, 2004 Open official source

Mephenesin* and its esters

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 323 — Cosmetic Products Regulations, 2004 Open official source

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)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 324 — Cosmetic Products Regulations, 2004 Open official source

Trancylcypromine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 325 — Cosmetic Products Regulations, 2004 Open official source

Trichloronitromethane (chloropicrine)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 326 — Cosmetic Products Regulations, 2004 Open official source

2,2,2-Tribromoethanol (tribromoethyl alcohol)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 327 — Cosmetic Products Regulations, 2004 Open official source

Trichlormethine* and its salts

328. Tretamine*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 329 — Cosmetic Products Regulations, 2004 Open official source

Gallamine triethiodide*

OJ L 159, 29.6.1996, p.1.

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 330 — Cosmetic Products Regulations, 2004 Open official source

Urginea scilla Stern. and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 331 — Cosmetic Products Regulations, 2004 Open official source

Veratrine, its salts and galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 332 — Cosmetic Products Regulations, 2004 Open official source

Schoenocaulon officinale Lind. (seeds and galenical preparations)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 333 — Cosmetic Products Regulations, 2004 Open official source

Veratrum Spp. and their preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 334 — Cosmetic Products Regulations, 2004 Open official source

Vinyl chloride monomer

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 335 — Cosmetic Products Regulations, 2004 Open official source

Ergocalciferol* and cholecalciferol (vitamins D 2 and D 3 )

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 336 — Cosmetic Products Regulations, 2004 Open official source

Salts of O-alkyldithiocarbonic acids

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 337 — Cosmetic Products Regulations, 2004 Open official source

Yohimbine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 338 — Cosmetic Products Regulations, 2004 Open official source

Dimethyl sulfoxide*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 339 — Cosmetic Products Regulations, 2004 Open official source

Diphenhydramine* and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 340 — Cosmetic Products Regulations, 2004 Open official source

4-tert-Butylphenol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 341 — Cosmetic Products Regulations, 2004 Open official source

4-tert-Butylpyrocatechol

342. Dihydrotachysterol*

343. Dioxane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 344 — Cosmetic Products Regulations, 2004 Open official source

Morpholine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 345 — Cosmetic Products Regulations, 2004 Open official source

Pyrethrum album L. and its galenical preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 346 — Cosmetic Products Regulations, 2004 Open official source

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

347. Tripelennamine*

348. Tetrachlorosalicylanilides

349. Dichlorosalicylanilides

350. Tetrabromosalicylanilides

351. Dibromosalicylanilides

352. Bithionol*

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 353 — Cosmetic Products Regulations, 2004 Open official source

Thiuram monosulphides

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 354 — Cosmetic Products Regulations, 2004 Open official source

Thiuram disulphides

355. Dimethylformamide

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 356 — Cosmetic Products Regulations, 2004 Open official source

4-Phenylbut-3-en-2-one

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 357 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 358 — Cosmetic Products Regulations, 2004 Open official source

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.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 359 — Cosmetic Products Regulations, 2004 Open official source

Oil from the seeds of Laurus nobilis L.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 360 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 361 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 362 — Cosmetic Products Regulations, 2004 Open official source

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

tetramethyl-1,2,3,4-tetrahydronapthalen

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 363 — Cosmetic Products Regulations, 2004 Open official source

O-phenylenediamine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 364 — Cosmetic Products Regulations, 2004 Open official source

4-methyl-m-phenylenediamine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 365 — Cosmetic Products Regulations, 2004 Open official source

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

366. Chloroform

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 367 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 368 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 369 — Cosmetic Products Regulations, 2004 Open official source

Pyrithione sodium (INNM)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 370 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 371 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 372 — Cosmetic Products Regulations, 2004 Open official source

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

373. 3,4’,5-Tribromosalicylanide

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 374 — Cosmetic Products Regulations, 2004 Open official source

Phytolacca spp. and their preparations

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 375 — Cosmetic Products Regulations, 2004 Open official source

Tretinoin* (retinoic acid and its salts)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 376 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 377 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 378 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 12140

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 379 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 26105

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 380 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 42555

Colouring agent CI 42555-1

B

Colouring agent CI 42555-2

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 381 — Cosmetic Products Regulations, 2004 Open official source

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

382. [deleted]

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 383 — Cosmetic Products Regulations, 2004 Open official source

2-Amino-4-nitrophenol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 384 — Cosmetic Products Regulations, 2004 Open official source

2-Amino-5-nitrophenol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 385 — Cosmetic Products Regulations, 2004 Open official source

11α-Hydroxypregn-4-ene-3,20-dione and its esters

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 386 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 42640

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 387 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 13065

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 388 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 42535

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 389 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 61554

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 390 — Cosmetic Products Regulations, 2004 Open official source

Antiandrogens of steroidal structure

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 391 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 394 — Cosmetic Products Regulations, 2004 Open official source

Tetrahydrozoline and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 395 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 396 — Cosmetic Products Regulations, 2004 Open official source

Dithio-2,2’-bispyridine-dioxide 1,1’ (additive with trihydrated magnesium sulphate) – (pyrithione

disulphide + magnesium sulphate)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 397 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 12075 and its lakes, pigments and salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 398 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 45170 and CI 45170:1

399. Lidocaine

400. 1,2-Epoxybutane

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 401 — Cosmetic Products Regulations, 2004 Open official source

Colouring agent CI 15585

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 402 — Cosmetic Products Regulations, 2004 Open official source

Strontium lactate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 403 — Cosmetic Products Regulations, 2004 Open official source

Strontium nitrate

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 404 — Cosmetic Products Regulations, 2004 Open official source

Strontium polycarboxylate

405. Pramocaine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 406 — Cosmetic Products Regulations, 2004 Open official source

4-Ethoxy-m-phenylenediamine and its salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 407 — Cosmetic Products Regulations, 2004 Open official source

2,4-diaminophenylethanol and its salts

408. Catechol

409. Pyrogallol

410. Nitrosamines

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 411 — Cosmetic Products Regulations, 2004 Open official source

Secondary alkyl- and alkanolamines and their salts

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 412 — Cosmetic Products Regulations, 2004 Open official source

4-Amino-2-nitrophenol

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 413 — Cosmetic Products Regulations, 2004 Open official source

2-Methyl-m-phenylenediamine

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 414 — Cosmetic Products Regulations, 2004 Open official source

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

415. [deleted]

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 416 — Cosmetic Products Regulations, 2004 Open official source

Cells, tissues or products of human origin

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 417 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 418 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 419 — Cosmetic Products Regulations, 2004 Open official source

From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament

and of the Council ( 2 ), the specified risk materials as designated in Annex V to that Regulation, and

ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation 999/2001,

and ingredients derived therefrom.

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

strictly certified by the producer

- transesterification or hydrolysis at at least 200 ºC 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 ºC for three hours

or

- Continuous process: at 140 ºC, two bars (2000 hPa) for eight minutes or equivalent conditions

OJ L 147, 31.5.2001,p.1

B

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 420 — Cosmetic Products Regulations, 2004 Open official source

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)

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 423 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 424 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 425 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 426 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 427 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 428 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 429 — Cosmetic Products Regulations, 2004 Open official source

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

ingredient.

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 430 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 431 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 432 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 433 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 434 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 435 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 436 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 437 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 438 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 439 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 440 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 441 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 442 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 443 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 444 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 445 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 446 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 447 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 448 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 449 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 450 — Cosmetic Products Regulations, 2004 Open official source

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

Malta Government Gazette — Legal Notice 2004 424 — Cosmetic Products Regulations, 2004

Reg. 451 — Cosmetic Products Regulations, 2004 Open official source

Methyleugenol (CAS No 93-15-2) except for normal content in the natural essences used and provided

that the concentration does not exceed

(a) 0,01 % in fine fragrance

(b) 0,004 % in eau de toilette

(c) 0,002 % in fragrance cream

(d) 0,001 % in rinse-off products

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

(*) In this Schedule, names followed by an asterisk are those published in “Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN”, WHO,

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

products for children under

warnings which must be

(a) 1. Not to be used for

(c) 1. Not to be used for

Conditions of use and

children under three

peeling or irritated skin.

printed on the label

2. Not to be used on

2. Not to be used in

three years of age.

years of age

(b) 1. Not to be

swallowed.

f

mass/mass as boric acid)

children under three

(c) 1. Not to be used in

(a) 1.Not to be used in

(b) 1.Not to be used in

peeling or irritated skin

products for children

Other limitations and

under three years of

if the concentration of

2. Not to be used on

free soluble borates

requirements

exceeds 1.5% (by

years of age.

products for

e

mass/mass as boric

(a) 5% (by mass/mass

Maximum authorized

concentration in the

(c) 3% (by mass/mass

Cosmetic Products Regulations, 2004

Table of Provisions (341)

Statutory Text (341 Articles)

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