Cosmetic Products (Amendment) (No. 2) Regulations, 2010

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,629, 6 ta’ Awwissu, 2010

L.N. 391 of 2010

PRODUCT SAFETY ACT

(CAP. 427)

Cosmetic Products (Amendment) (No. 2) Regulations, 2010

IN exercise of the powers conferred by article 39 of the

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

Malta Standards Authority, made the following regulations:-

The title of these regulations is the Cosmetic Products Citation.

(Amendment) (No. 2) Regulations, 2010, and they shall be read

and construed as one with the Cosmetic Products Regulations, L.N. 424 of 2004.

2004, hereinafter referred to as “the principal regulations”.

(1) Reference number 207 of regulation 3(a) and

regulation 4 of these regulations shall apply as from 1st March,

2011. These regulations implement the provisions of Commission

Directive 2010/3/EU of 1 February 2010 amending, for the purpose

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

Directive 76/768/EEC concerning cosmetic products.

(2) Reference numbers 208 and 209 of regulation 3(a)

and regulation 3(b) of these regulations, except the obligations

concerning the labelling set out in column (f) of reference number

208, shall apply as from 1st December, 2010. This regulation

implements the provisions of Commission Directive 2010/4/EU

of 8 February 2010 amending, for the purpose of adaptation to

technical progress, Annex III to Council Directive 76/768/EEC

concerning cosmetic products.

(3) After 1st November 2011 no cosmetic products

which fail to comply with the obligations concerning the labelling

set out in column (f) of reference number 208 of regulation 3(a)

of these regulations shall be placed on the market. After 1st

November 2012 no cosmetic products which fail to comply with

the obligations concerning the labelling set out in column (f) of

reference number 208 of regulation 3(a) of these regulations, shall

be sold or disposed of to the final consumer.

The Third Schedule to the principal regulations shall be

amended as follows

(a) In the table set out in Part 1, the following reference

numbers 207, 208 and 209 shall be inserted immediately after

reference number 206

Amends the Third Schedule to the principal regulations.

The Third Schedule to the principal regulations shall be amended as follows

3. VERŻJONI

ELETTRONIKA

(a) In the table set out

in Part 1,

the following reference numbers 207, 208 and

209 shall be inserted immediately after reference number 206: B 4693

Restrictions

Maximum

authorised

Field of

concentrati

Conditions of use and

Reference

application

on in the

Other limitations

Substance

warnings which must

Number

and/or use

finished

and requirements

be printed on the label

cosmetic

product

a

b

c

d

e

f

“207

Ethyl Lauroyl Arginate

(a) soap (b)

0,8 %

For purposes

HCl (INCI) (*)

anti-dandruff

other than

shampoos (c)

inhibiting the

Ethyl-! " -dodecanoyl-

deodorants,

development of

L-arginate

not in form of

micro-organisms

hydrochloride

spray

in the product.

This purpose has

CAS No 60372-77-2

to be apparent

EC No 434-630-6

from the

presentation of

the product.

1-(beta-

Hair dye

1,0 %

— Do not use

Aminoethyl)amino-4-

substance in

with nitrosating

(beta-

non-oxidative

systems —

hydroxyethyl)oxy-2-

hair dye

Maximum

nitrobenzene and its

products

nitrosamine

Hair colourants can

salts

content: 50

cause severe allergic

µg/kg — Keep in

reactions.

HC Orange No 2

nitrite-free

Read and follow

containers

instructions.

CAS No 85765-48-6

This product is not

intended for use on

EINECS 416-410-1

persons under the

age of 16.

Temporary “black

henna” tattoos may

increase your risk of

allergy.

Do not colour your

hair if

— You have a rash

on your face or

sensitive, irritated

and damaged scalp.

— You have ever

experienced any

reaction after

colouring your hair.

— You have

experienced a

reaction to a

B

temporary “black

henna

2-[(2-methoxy-4-

Hair dye

0,2 %

— Do not use

nitrophenyl)amino]etha substance in

with nitrosating

nol and its salts

non-oxidative

systems —

2-Hydroxyethylamino-

hair dye

Maximum

temporary “black

5-nitroanisole

products

nitrosamine

henna

CAS No 66095-81-6

content: 50

2-[(2-methoxy-4-

Hair dye

0,2 %

— Do not use

EINECS 266-138-0

µg/kg — Keep in

nitrophenyl)amino]etha substance in

with nitrosating

nitrite-free

nol and its salts

non-oxidative

systems —

containers

2-Hydroxyethylamino-

hair dye

Maximum

(*) For use as a preservative, see Fifth Schedule, Part 1, entry No 58.”.

5-nitroanisole

products

nitrosamine

CAS No 66095-81-6

content: 50

EINECS 266-138-0

µg/kg — Keep in

nitrite-free

(b) In Part 2, the entries relating to reference numbers

26 and 29 shall be deleted.

(b) In Part 2, the entries relating to reference numbers

containers

26 to

and

29 principal

shall be deleted.

(*) For use as a preservative, see Fifth Schedule, Part 1, entry No 58.”.

Amends the Fifth Schedule

the

regulations.

In Part

1 of

the 2, Fifth

Schedule

to the

principal numbers

regulations,

the 29

following

shall be reference

(b) In

Part

the entries

relating

to reference

26 and

deleted.

the Fifth 58 shall be 4.

In Part

1 of the

Fifth

Schedule

to 57

the principal

Amends

number

inserted

immediately

after

reference

number

Schedule to the

regulations, the following reference number 58 shall be inserted

principal the

regulations.

Amends

Fifth Schedule to the principal regulations.

immediately after reference

Maximum number 57

Limitations and

Conditions of use and

Reference

authorised

Substance

requirements

warnings which must be

4. Number In Part 1 of the Fifth Schedule concentration

to the principal regulations, the following

printed on reference

the label

number 58 shall b be inserted immediately

after reference

d number 57

a

c

e

“58

Ethyl Lauroyl Arginate HCl

0,4%

Not to be used in lip

Maximum

(INCI) (*) (**)

products,

oral products

Limitations

and

Conditions of use and

Reference Ethyl-! " -dodecanoyl- L-

authorised

and spray

products.

Substance

requirements

warnings which must be

Number

concentration

arginate hydrochloride

printed on the label

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a

b

c

d

e

EC No 434-630-6

“58

Ethyl Lauroyl Arginate HCl

0,4%

Not to be used in lip

(**) For other uses than preservatives, see Third Schedule, Part I, entry No 207.”.

(INCI) (*) (**)

products, oral products

Ethyl-! " -dodecanoyl- L-

and spray products.

arginate hydrochloride

CAS No 60372-77-2

EC No 434-630-6

(**) For other uses than preservatives, see Third Schedule, Part I, entry No 207.”.

€0.19