article 39 by

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,827, 10 ta’ Novembru, 2011

Taqsima B

Prime Minister

L.N. 446 of 2011

PRODUCT

SAFETY

ACT ACT

PRODUCT

SAFETY

(CAP. 427)

(CAP. 427)

Cosmetic

Products Products

(Amendment)

Regulations,

2011 2011

Cosmetic

(Amendment)

Regulations,

IN of exercise

of the

powers by conferred

article 39 by

article

39 of

IN exercise

the powers

conferred

of the

Product

Safety

the Product Safety Act, the Prime Minister, on the advice of the and

Act,

the

Prime

Minister,

on

the

advice

of

the

Malta

Competition

Malta Competition

and Consumer

has made Affairs

Authority,

has made the

Consumer

Affairs Authority,

the following

regulations

following regulations

The title of these regulations is the Cosmetic Products (Amendment)

1. The 2011,

title of

these

they regulations

shall be read is and

the construed

Cosmetic as Products

one with Citation.

Regulations,

and

the

(Amendment)

Regulations,

2011,

and hereinafter

they shall referred

be read to and

Cosmetic Products

Regulations,

2004,

as “the

construed

as

one

with

the

Cosmetic

Products

Regulations,

2004,

L.N. 424 of 2004.

principal regulations”.

hereinafter referred to as “the principal regulations”.

(a)

These regulations

shall come shall

come on

into 3 force

on 2012.

3 January

Commencement and

2. (a) These

regulations

into force

January

scope.

2012. (b) These (b) regulations

These regulations

implement implement

the provisions

the provisions

of Commission

of

Commission

Directive

2011/59/EU

of

May

2011,

Directive 2011/59/EU of 13 May 2011, amending for the

purpose

amending

for

the

purpose

of

adaptation

to

technical

progress,

of adaptation to technical progress, Annexes II and III to Council

Annexes 76/768/EEC

II and III to relating

Council to

Directive

cosmetic 76/768/EEC

products. relating

Directive

to cosmetic products.

In the Second Schedule to the principal regulations immediately after

3. In the Second Schedule to the principal regulations Amends the Second

Schedule to the

immediately after the entry “1371 Phytotonadione [INCI], principal regulations.

the entry “1371 Phytotonadione [INCI], phytomenadione [INN] CAS

phytomenadione [INN] CAS No 84-80-0/81818-54-4; EC No 201-

No 84-80-0/81818-54-4; EC No 201-564-2.” there shall be added the

564-2.”

there

shall be added the following entry

following

entry

Ref no.

Chemical Name

CAS No./EC No.

2-Aminophenol (o-Aminophenol;

“1372

CAS No 95-55-6/67845-79-8/51-19-4

CI 76520) and its salts

EC No 202-431-1/267-335-4”

The Third Schedule to the principal regulations shall be

Amends the Third

Schedule to the

amended as follows

principal regulations.

4. The Third Schedule to the principal regulations shall be amended as

(a) Part I shall be amended as follows:-

follows

(i) the following entries shall be added

(a) Part I shall be amended as follows:-

(i) the following entries shall be added

Ref

Substance

Restrictions

Conditions

No.

of use and

Field of

Max.

Other

warnings

application

authorised

limitations and

which must

and/or use

concentration

requirements

be printed on

in the

the label

finished

cosmetic

product

“215

4-amino-3-

(a) Hair dye

(a) After

(a) As

nitrophenol

substance in

mixing under

mentioned in

(CAS No 610-

oxidative

oxidative

reference

81-1) (EC No

hair dye

conditions the

number 205,

210-236-8)

products

maximum

column f

concentration

applied to hair

must not

exceed 1,5 %

(b) Hair dye

(b) 1,0 %

substance in

non-

oxidative

hair dye

products

2,7-

(a) Hair dye

(a) After

(a) As

Naphthalenedio

substance in

mixing under

mentioned in

l (CAS No 582-

oxidative

oxidative

reference

17-2) (EC No

hair dye

conditions the

number 205,

209-478-7)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 1,0 %

(b) Hair dye

(b) 1,0 %

substance in

non-

oxidative

hair dye

products

m-

Hair dye

After mixing

As

Aminophenol

substance in

under

mentioned in

(CAS No 591-

oxidative

oxidative

reference

27-5) (EC No

hair dye

conditions the

number 205,

209-711-2) and

products

maximum

column f (a)

its salts m-

concentration

Aminophenol

applied to hair

HCl (CAS No

must not

51- 81-0) (EC

exceed 1,2 %

No 200-125-2)

m-

Aminophenol

sulphate (CAS

No 68239-81-

6) (EC No 269-

475-1) sodium

m-Amino-

6) (EC No 269-

475-1) sodium

m-Amino-

phenol (CAS

No 38171-54-

9)

2,6-Dihydroxy-

Hair dye

After mixing

As

3,4-

substance in

under

mentioned in

dimethylpyridi

oxidative

oxidative

reference

ne (CAS No

hair dye

conditions the

number 205,

84540- 47-6)

products

maximum

column f (a)

(EC No 283-

concentration

141-2)

applied to hair

must not

exceed 1,0 %

2-Hydroxyethyl

(a) Hair dye

(a) After

(a) As

picramic acid

substance in

mixing under

mentioned in

(CAS No

oxidative

oxidative

reference

99610-72-7)

hair dye

conditions the

number 205,

(EC No 412-

products

maximum

column f (a)

520-9)

concentration

applied to hair

must not

exceed 1,5 %

(b) Hair dye

(b) 2,0 %

For (a) and (b)

substance in

— Do not use

non-

with

oxidative

nitrosating

hair dye

agents

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

p-

Hair dye

After mixing

As

Methylaminoph

substance in

under

mentioned in

enol (CAS No

oxidative

oxidative

reference

150-75-4) (EC

hair dye

conditions the

number 205,

No 205-768-2)

products

maximum

column f (a)

and its sulphate

concentration

p-

applied to hair

Methylaminoph

must not

enol sulphate

exceed 0,68 %

(CAS No 55-

(as sulphate)

55-0/ 1936-57-

— Do not use

8) (EC No 200-

with

237-1/ 217-

nitrosating

706-1)

agents

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

Ethanol, 2-[4-

(a) Hair dye

(a) After

(a) As

[Ethyl[(2-

substance in

mixing under

mentioned in

Hydroxyethyl)

oxidative

oxidative

reference

Amino]-2-

hair dye

conditions the

number 205,

Nitrophenyl]-

products

maximum

column f (a)

Amino]-, (CAS

concentration

No 104516-93-

applied to hair

0) and its

must not

hydrochloride

exceed 0,75 %

HC Blue No 12

(as

(CAS No

hydrochloride)

132885- 85-9)

(b) Hair dye

(b) 1,5 % (as

For (a) and (b)

(EC No 407-

substance in

hydrochlorid

— Do not use

020-2)

non-

e)

with

oxidative

nitrosating

hair dye

agents

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

3-Amino-2,4-

(a) Hair dye

(a) After

(a) As

dichlorophenol

substance in

mixing under

mentioned in

(CAS No

oxidative

oxidative

reference

61693-42-3)

hair dye

conditions the

number 205,

(EC No 262-

products

maximum

column f (a)

909- 0) and its

concentration

hydrochloride

applied to hair

3-Amino-2,4-

must not

dichlorophenol

exceed 1,5 %

HCl (CAS No

(as

61693- 43-4)

hydrochloride)

b) Hair dye

(b) 1,5 % (as

substance in

hydrochlorid

non-

e)

oxidative

hair dye

products

Phenyl methyl

Hair dye

After mixing

As

pyrazolone

substance in

under

mentioned in

(CAS No 89-

oxidative

oxidative

reference

25-8) (EC No

hair dye

conditions the

number 205,

201-891-0)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 0,25 %

2-Methyl-5-

Hair dye

After mixing

As

hydroxyethyla

substance in

under

mentioned in

mino- phenol

oxidative

oxidative

reference

(CAS No

hair dye

conditions the

number 205,

55302-96-0)

products

maximum

column f (a)

(EC No 259-

concentration

583-7)

applied to hair

must not

exceed 1,5 %

— Do not use

with

nitrosating

agents

— Maximum

nitrosamine

content: 50

nitrosating

agents

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

Hydroxybenzo

Hair dye

After mixing

As

morpholine

substance in

under

mentioned in

(CAS No

oxidative

oxidative

reference

26021-57-8)

hair dye

conditions the

number 205,

(EC No 247-

products

maximum

column f (a)

415-5)

concentration

applied to hair

must not

exceed 1,0 %

— Do not use

with

nitrosating

agents

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

2,2’-[(4-

(a) Hair dye

(a) After

(a) As

Amino-3-

substance in

mixing under

mentioned in

nitrophenyl)imi

oxidative

oxidative

reference

no]bisethanol

hair dye

conditions the

number 205,

(CAS No

products

maximum

column f (a)

29705- 39-3)

concentration

and its

applied to hair

hydrochloride

must not

HC Red No 13

exceed 1,25 %

(CAS No

(as

94158- 13-1)

hydrochloride)

(EC No 303-

(b) Hair dye

(b) 2,5 % (as

083-4

substance in

hydrochloride )

non-

oxidative

hair dye

products

2,6-

Hair dye

After mixing

As

Dimethoxy-

substance in

under

mentioned in

3,5-

oxidative

oxidative

reference

pyridinediamin

hair dye

conditions the

number 205,

e (CAS No

products

maximum

column f (a)

85679-78-3

concentration

(free base)) and

applied to hair

its

must not

hydrochloride

exceed 0,25 %

2,6-

(as

Dimethoxy-

hydrochloride)

3,5-

pyridinediamin

e HCl (CAS No

56216-28-5)

(EC No 260-

062-1)

56216-28-5)

(EC No 260-

062-1)

HC Violet No 1

(a) Hair dye

(a) After

(a) As

(CAS No

substance in

mixing under

mentioned in

82576- 75-8)

oxidative

oxidative

reference

(EC No 417-

hair dye

conditions the

number 205,

600-7)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 0,25 %

(b) Hair dye

(b) 0,28 %

For (a) and (b)

(b) As

substance in

— Do not use

mentioned in

non-

with

reference

oxidative

nitrosating

number 208,

hair dye

agents

column f

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

1,5-

(a) Hair dye

(a) After

(a) As

Naphthalenedio

substance in

mixing under

mentioned in

l (CAS No 83-

oxidative

oxidative

reference

56-7) (EC No

hair dye

conditions the

number 205,

201-487-4

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 1,0 %

(b) Hair dye

(b) 1,0 %

substance in

non-

oxidative

hair dye

products

Hydroxypropyl

Hair dye

After mixing

As

bis(N-

substance in

under

mentioned in

hydroxyethyl-

oxidative

oxidative

reference

p-

hair dye

conditions the

number 205,

phenylenediami

products

maximum

column f (a)

ne) (CAS No

concentration

128729-30-6)

applied to hair

and its

must not

tetrahydrochlor

exceed 0,4 %

(as

ide

tetrahydrochloride)

Hydroxypropyl

bis(N-

hydroxyethyl-

p-

phenylenediami

ne) HCl (CAS

No 128729- 28-

2) (EC No 416-

320-2)

4-Amino-2-

Hair dye

After mixing

As

hydroxytoluene

substance in

under

mentioned in

(CAS No 2835-

oxidative

oxidative

reference

95- 2) (EC No

hair dye

conditions the

number 205,

220- 618-6)

products

maximum

column f (a)

concentration

applied to hair

(CAS No 2835-

oxidative

oxidative

reference

95- 2) (EC No

hair dye

conditions the

number 205,

220- 618-6)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 1,5 %

2,4-

Hair dye

After mixing

As

Diaminopheno

substance in

under

mentioned in

xyethanol

oxidative

oxidative

reference

(CAS No

hair dye

conditions the

number 205,

70643-19-5),

products

maximum

column f (a)

its

concentration

hydrochloride

applied to hair

and its sulphate

must not

2,4-

exceed 2,0 %

Diaminopheno

(as

xyethanol HCl

hydrochloride)

(CAS No

66422- 95-5)

(EC No 266-

357-1) 2,4-

Diaminopheno

xyethanol

sulphate (CAS

No 70643-20-

8) (EC No 274-

713-2)

2-

(a) Hair dye

(a) After

(a) As

Methylresorcin

substance in

mixing under

mentioned in

ol (CAS No

oxidative

oxidative

reference

608-25- 3) (EC

hair dye

conditions the

number 205,

No 210- 155-8)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 1,8 %

(b) Hair dye

(b) 1,8 %

substance in

non-

oxidative

hair dye

products

4-Amino-m-

Hair dye

After mixing

As

cresol (CAS No

substance in

under

mentioned in

2835-99- 6)

oxidative

oxidative

reference

(EC No 220-

hair dye

conditions the

number 205,

621-2)

products

maximum

column f (a)

concentration

applied to hair

must not

exceed 1,5 %

2-Amino-4-

Hair dye

After mixing

As

hydroxyethyla

substance in

under

mentioned in

minoanisole

oxidative

oxidative

reference

(CAS No

hair dye

conditions the

number 205,

83763-47-7)

products

maximum

column f (a)

(EC No 280-

concentration

733-2) and its

applied to hair

sulphate 2-

must not

Amino-4-

exceed 1,5 %

hydroxyethyla

(as sulphate)

minoanisole

— Do not use

sulphate (CAS

with

No 83763- 48-

nitrosating

Amino-4-

exceed 1,5 %

hydroxyethyla

(as sulphate)

minoanisole

— Do not use

sulphate (CAS

with

No 83763- 48-

nitrosating

8) (EC No 280-

agents

734-8)

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

Hydroxyethyl-

Hair dye

After mixing

As

3,4-

substance in

under

mentioned in

methylenediox

oxidative

oxidative

reference

yaniline and its

hair dye

conditions the

number 205,

hydrochloride

products

maximum

column f (a)

Hydroxyethyl-

concentration

3,4-

applied to hair

methylenediox

must not

yaniline HCl

exceed 1,5 %

(CAS No

— Do not use

94158-14-2)

with

(EC No 303-

nitrosating

085-5)

agents

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

3-Nitro-p-

(a) Hair dye

(a) After

(a) As

hydroxyethyla

substance in

mixing under

mentioned in

mino- phenol

oxidative

oxidative

reference

(CAS No

hair dye

conditions the

number 205,

65235-31-6)

products

maximum

column f (a)

(EC No 265-

concentration

648-0)

applied to hair

must not

exceed 3,0 %

(b) Hair dye

(b) 1,85 %

For (a) and (b)

(b) As

substance in

— Do not use

mentioned in

non-

with

reference

oxidative

nitrosating

number 208,

hair dye

systems

column f

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

4-Nitrophenyl

(a) Hair dye

(a) After

(a) As

aminoethylurea

substance in

mixing under

mentioned in

(CAS No

oxidative

oxidative

reference

27080- 42-8)

hair dye

conditions the

number 205,

(EC No 410-

products

maximum

column f (a)

700-1)

concentration

applied to hair

must not

exceed 0,25 %

8 dye

(b) Hair

(b) 0,5 %

For (a) and (b)

substance in

— Do not use

applied to hair

must not

exceed 0,25 %

(b) Hair dye

(b) 0,5 %

For (a) and (b)

substance in

— Do not use

non-

with

oxidative

nitrosating

hair dye

agents

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

2-Amino-6-

(a) Hair dye

(a) After

(a) As

chloro- 4-

substance in

mixing under

mentioned in

nitrophenol

oxidative

oxidative

reference

(CAS No 6358-

hair dye

conditions the

number 205,

09- 4) (EC No

products

maximum

column f (a)

228- 762-1)

concentration

applied to hair

must not

exceed 2,0 %

(b) Hair dye

(b) 2,0 %

(b) As

substance in

mentioned in

non-

reference

oxidative

number 208,

hair dye

column f”

products

(ii) the following entry with reference number 201 shall be

substituted with the following

“210

2-Chloro-6-

(a) Hair dye

(a) After

(a) As

ethylamino-4-

substance in

mixing under

mentioned in

nitrophenol

oxidative

oxidative

reference

(CAS No

hair dye

conditions the

number 205,

131657-78-8)

products

maximum

column f (a)”

(EC No 411-

concentration

440-1)

applied to hair

must not

exceed 1,5 %

(b) Hair dye

(b) 3,0 %

(a) and (b)

substance in

— Do not use

non-

with

oxidative

nitrosating

hair dye

agents

products

— Maximum

nitrosamine

content: 50

µg/kg

— Keep in

nitrite-free

containers

(b) Part 2 shall be amended as follows

(i) the entries with reference numbers 3 to 6, 11,

12, 16, 19 to 22, 25, 27, 31 to 39, 44, 48, 49, 55 and 56

shall be deleted;

(ii) in column g of the entries with reference

numbers 10 and 50, for the words “31.12.2010” there

shall be substituted the words “31.12.2011”.

€0.54