Cosmetic Products (Amendment) Regulations, 2010

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,586, 30 ta’ April, 2010

L.N. 245 of 2010

PRODUCT SAFETY ACT

(CAP. 427)

Cosmetic Products (Amendment) 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

(Amendment) Regulations, 2010, and they shall be read and

construed as one with the Cosmetic Products Regulations, 2004,

hereinafter referred to as “the principal regulations”.

(1) Regulations 3, 4(a) and 8 of these regulations shall Commencement

apply as from 1st June, 2010 while regulations 4(b) and 5 shall

apply as from 1st December, 2010. These regulations implement

the provisions of Commission Directive 2008/112/EC of the

European Parliament and of the Council of 16 December 2008

amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/

EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of

the European Parliament and of the Council in order to adapt them

to Regulation (EC) No 1272/2008 on classification, labelling and

packaging of substances and mixtures.

(2) Regulation 7(a)(ix) of these regulations shall

apply as from 15 October 2010. This regulation implements the

provisions of Commission Directive 2009/129/EC of 9 October

2009 amending Council Directive 76/768/EEC concerning

cosmetic products for the purposes of adapting Annex III thereto to

technical progress.

(3) Regulations 7(a)(i), 7(a)(iii), section B of 7(a)(iv),

7(a)(v) and 7(a)(vi) of these regulations shall apply as from 15 July

2010. These regulations implement the provisions of Commission

Directive 2009/130/EC of 12 October 2009 amending Council

Directive 76/768/EEC, concerning cosmetic products, for the

purpose of adapting Annex III thereto to technical progress.

(4) After 1st November, 2011, no cosmetic products,

which fail to comply with sub-regulations 7(a)(ii), section A

of 7(a)(iv), 7(a)(vii), 7(a)(viii), 7(a)(xii), 7(a)(xiii) and 7(b)(i) to

7(b)(vi) of these regulations should be placed on the market. The

conditions of use and warnings which must be printed on the label,

under column f, established in sub-regulations 7(a)(iii) and 7(a)

(v) of these regulations, should also apply as from 1st November,

2011. After 1st November, 2012, no cosmetic products which fail

to comply with these regulations should be sold or disposed of to

the final consumer. These regulations implement the provisions of

Commission Directive 2009/134/EC of 28 October 2009 amending

Council Directive 76/768/EEC concerning cosmetic products for

the purposes of adapting Annex III thereto to technical progress.

(5) Regulations 6, 7(a)(x), 7(a)(xi) and 7(a)(xiv) of

these regulations shall apply as from 15 February 2011. These

regulations implement the provisions of Commission Directive

2009/164/EU of 22 December 2009 amending, for the purpose

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

Directive 76/768/EEC concerning cosmetic products.

(6) Regulation 7(b)(vii) of these regulations shall be

deemed to have come into force on the 1st of January 2010. These

regulations implement the provisions of Commission Directive

2009/159/EU of 16 December 2009 amending, for the purpose of

adaptation to technical progress, Annex III to Council Directive

76/768/EEC concerning cosmetic products.

For the words “preparation” or “preparations”, wherever

they occur in the principal regulations, there shall be substituted

the words “mixture” or “mixtures” respectively.

Regulation 5 of the principal regulations shall be

amended as follows

(a) in sub-regulation 5.3, paragraph (d) shall be

substituted with the following

“(d) the performance on their territory of animal

testing of ingredients or combinations of ingredients

in order to meet the requirements of this regulation, no

later than the date on which such tests are required to

be replaced by one or more validated methods listed in

Commission Regulation (EC) No 440/2008 of 30 May

2008 laying down test methods pursuant to Regulation

(EC) No 1907/2006 of the European Parliament

and of the Council on the Registration, Evaluation,

Authorisation and Restriction of Chemicals (REACH)

or in the Tenth Schedule to their regulations.”; and

(b) immediately after sub-regulation 5.4, there shall be

added the following new sub-regulation

“5.5 The use in cosmetic products of substances

classified as carcinogenic, germ cell mutagenic or toxic

for reproduction, of category 1A, 1B and 2, under part

3 of Annex VI to Regulation (EC) No 1272/2008 of the

European Parliament and of the Council of 16 December

2008 on classification, labelling and packaging of

substances and mixtures shall be prohibited. A substance

classified in category 2 may be used in cosmetics if

the substance has been evaluated by the Scientific

Committee on Consumer Safety (SCCS) and found

acceptable for use in cosmetic products.”.

In regulation 7.1, in proviso 7.1.2 thereof, for the words Amends regulation

from “The quantitative information” to the words “Directive 7 regulations.

67/548/EEC” there shall be substituted the following

“ 7.1.2. The quantitative information required under

paragraph (a) to be made publicly accessible shall be limited

to substances fulfilling the criteria for any of the following

hazard classes or categories set out in Annex I to Regulation

(EC) No 1272/2008

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types

A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14

categories 1 and 2, 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects

on sexual function and fertility or on development, 3.8

effects other than narcotic effects, 3.9 and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1.”.

In the Second Schedule to the principal regulations

reference number 450, “Verbena oil (Lippia citriodora Kunth.)

(CAS No 8024-12-2), when used as a fragrance ingredient” shall

be substituted by “Verbena essential oils (Lippia citriodora Kunth.)

and derivatives other than absolute (CAS No 8024-12-2), when

used as a fragrance ingredient.”.

The Third Schedule to the principal regulations shall be

amended as follows

(a) in Part I thereof –

(i)

in column ‘b’ of reference number 8,

the words “p-Phenylenediamine, its N-substituted

derivatives and its salts; N-substituted derivatives

of o-Phenylenediamine, with the exception of those

derivatives listed elsewhere in this Annex and under

reference numbers 1309, 1311, and 1312 in Annex II”

there shall be substituted the following

“N-substituted derivatives of

p-Phenylenediamine and their salts; N-substituted

salts; N-

“N-substituted derivatives

derivatives of of p-Phenylenediamine

o-Phenylenediamine

and ( their

), with

exception of of o-Phenylenediamine

those derivatives listed

elsewhere

in of

substituted derivatives

( ), with

exception

this Schedule and under reference numbers 1309,

those derivatives

listed

elsewhere

in

this

Schedule

and

under

reference

numbers 1309, 1311,

1311, and

and 1312

1312 in in the

the Second

Second Schedule.”;

Schedule.”;

(ii) under

8, in reference

column f, number

for the 8, words

in column

“Can f, cause

for an

(ii) under reference number

the words

“Can be

cause

an allergic

the reaction”

following: there shall be

allergic reaction”

there shall

substituted

substituted the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

(iii) the following reference number 8a shall be inserted immediately after

reference number 8

Restrictions

Maximum

authorised

Field of

Other

concentration

Conditions of use and warnings

application

limitations

Substance

in the finished

which must be printed on the

and/or use

and

cosmetic

label

requirements

product

b

c

d

e

f

Hair dye

(a) and (b)

(a)

Phenylenediamine

substance in

After mixing

and its salts ( 5 )

oxidative

under

hair dye

oxidative

CAS No 106-50-3

products

conditions

the

Hair colorants can cause

Einecs 203-404-7

(a) general

maximum

severe allergic reactions.

use

concentratio

Read and follow instructions.

n applied to

This product is not intended

Phenylenediamine

(b)

hair must

for use on persons under the

HCl

professional

not exceed 2

age of 16.

use

% calculated

Temporary “black henna”

CAS No 624-18-0

as free base.

tattoos may increase your risk

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic

product expressed with reference to the maximum level authorised for each of them does not exceed 1.

B

Einecs 210-834-9

of allergy.

Do not colour your hair if

p-

— you have a rash on your

Phenylenediamine

face or sensitive, irritated and

sulphate

damaged scalp,

— you have ever experienced

CAS No 16245-77-

any reaction after colouring

your hair,

— you have experienced a

Einecs 240-357-1

reaction to a temporary “black

henna” tattoo in the past.

Contains phenylenediamines.

Do not use to dye eyelashes

or eyebrows.

The mixing ratio is printed on

the label.

(b) For professional use only.

Contains phenylenediamines.

Hair colorants can cause

severe allergic reactions.

Read and follow instructions.

This product is not intended

for use on 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 temporary “black

henna” tattoo in the past.

Wear suitable gloves.

The mixing ratio is printed on

the label.”;

(iv) under reference number 9,

A. for the words “(a) (b) Can cause allergic reaction” in column f, there

shall be substituted the following

“(a)

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo

in the past.

Contains phenylenediamines (toluenediamines). Do not use to dye

eyelashes or eyebrows.

(b) For professional use only.

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo

in the past.

Contains phenylenediamines (toluenediamines). Wear suitable gloves.”.

B. in column ‘b’ of reference number 9, for the words

“Methylphenylenediamines, their N-substituted derivatives and their salts

with the exception of substances under reference numbers 364, 1310 and

1313 in Annex II” there shall be substituted the following

B

“Methylphenylenediamines, their N-substituted derivatives and their

salts ( 2 ), with the exception of the substance under reference number

9a in this Schedule and substances under reference numbers 364,

1310 and 1313 in the Second Schedule.”;

(v) the following reference number 9a shall be inserted immediately after

reference number 9

Restrictions

Maximum

authorised

Field of

Other

concentration

Conditions of use and warnings

application

limitations

in the finished

which must be printed on the

and/or use

and

cosmetic

label

requirements

product

c

d

e

f

Hair dye

(a) and (b)

(a)

diamine and its

substance in

After mixing

oxidative

under

hair dye

oxidative

CAS No 95-70-5

products

conditions

the

Hair colorants can cause

Einecs 202-442-1

(a) general

maximum

severe allergic reactions.

use

concentratio

Read and follow instructions.

n applied to

This product is not intended

diamine sulphate

(b)

hair must

for use on persons under the

professional

not exceed

age of 16.

CAS No 615-50-9

use

4%

Temporary “black henna”

calculated as

tattoos may increase your risk

Einecs 210-431-8

free base.

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 temporary “black

henna” tattoo in the past.

Contains phenylenediamines

(toluenediamines). Do not use

to dye eyelashes or eyebrows.

The mixing ratio is printed on

the label.

(b) For professional use only.

Hair colorants can cause

severe allergic reactions.

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 authorized for each of them does not exceed 1.

Read and follow instructions.

This product is not intended

for use on 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 temporary “black

henna” tattoo in the past.

Contains phenylenediamines

(toluenediamines). Wear

suitable gloves.

The mixing ratio is printed on

the label.”;

(vi) in reference number 14, the following shall be deleted

(i)

the maximum authorised concentration in the finished cosmetic

product of 0.3 % in column ‘d’; and

(ii)

paragraph (a) in column ‘f’;

(vii) under reference number 16, in column f, for the words “(a)(b) Can

cause allergic reaction” there shall be substituted the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

B

(viii) under reference number 22, in column f, sub-points 1 and 2 of point

(a), the following text is added

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

(ix) in column ‘f’, corresponding to reference numbers 26 to 43, 47 and 56,

the words “For any toothpaste containing 0.1 to 0.15% fluoride unless it is

already labelled as contraindicated for children (e.g. “for adult use only”)

the following labelling is obligatory: “Children of 6 years and younger

Use a pea sized amount for supervised brushing to minimize swallowing.

In case of intake of fluoride from other sources consult a dentist or

doctor.”.” there shall be substituted the following

“For any toothpaste with compounds containing fluorine in a

concentration of 0.1 to 0.15 % calculated as F unless it is already

labelled as contra-indicated for children (e.g. “for adult use only”) the

following labelling is obligatory

“Children of 6 years and younger: use a pea-sized amount for

supervised brushing to minimise swallowing. In case of intake

of fluoride from other sources consult a dentist or doctor.”.”;

(x) in column ‘b’ of the entry relating to reference number 130, the words

“Terpene terpenoids sinpine” shall be substituted with “Terpenes and

terpenoids”;

(xi) the following shall be inserted immediately after the entry with reference

number 151

Substance

Restrictions

Conditions of

use

and

Field of

Maximum

Other

limitations and warnings

applicati

authorised

which must be

on

concentration

requirements

printed on the

and/or

in

the

label

use

finished

cosmetic

product

b

c

d

e

f

Allyl

Level of free

phenethyl

allyl alcohol in

ether

CAS

the

ether

No

14289-

should be less

65-7 EC No

than 0,1 %”;

238-212-2

(xii) under reference numbers 193 and 205, in column f, point (a), the

following text is added

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

B

(xiii) under reference numbers 202 and 203, in column f, point (a), the text

“Can cause allergic reaction.” is substituted with the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

(xiv)

the following entry is added after reference number 205

Substance

Restrictions

Conditions of

use

and

Field of Maximum

Other

limitations and warnings

applicati authorised

which must be

on

concentration

requirements

printed on the

and/or

in

the

label

use

finished

cosmetic

product

b

c

d

e

f

Verbena

0,2 %”.

absolute

(Lippia

citriodora

Kunth.) CAS

No 8024-12-

(b) In Part II thereof

(i) under reference number 3 in column f, the text “(a) (b) Can cause allergic

reaction” there shall be substituted the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

(ii) under reference numbers 4, 20, 26, 32, 34, 35, 36, 37, 38, 39 and 44,

column f, the following text is added

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

B

(iii) under reference numbers 5, 6, 12, 19, 21, 22, 25 and 33, in column f, the

text “Can cause allergic reaction.” is substituted with the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

(iv) under reference numbers 10, 11 and 16

A. in column f, the text “(a) Can cause allergic reaction” there shall be

substituted the following

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna”

tattoo in the past.”; and

B. column f, point (b) is deleted;

(v) under reference numbers 27, 48 and 56, in column f, the following points

(a) and (b) are added

“(a)

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past;

(b)

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”;

B

(vi) under reference numbers 31, 49, 50 and 55, in column f, point (a), the

following text is added

“

Hair colorants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on 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 temporary “black henna” tattoo in the

past.”; and

(vii) in reference numbers 3, 4, 5, 6, 10, 11, 12, 16, 19, 20, 21, 22, 25, 26,

27, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 48, 49, 50, 55, and 56 of

column g, the date “31.12.2009” shall be substituted with “31.12.2010”.

Amends the Tenth Schedule to the principal regulations.

Tenth

In the

Tenth Schedule

to the regulations

principal regulations

for from

Amends

the Tenth

In the

Schedule

to the principal

for the words

“This

Schedule

8. Schedule to the

the words from “This Schedule lists” to the words “ of dangerous principal regulations.

to

the

words

“

of

dangerous

substances.”

there

shall

be

substituted

the

words

substances.” there shall be substituted the words

“This Schedule lists the alternative methods validated by the European Centre

on “This

Schedule

lists the alternative

methods validated

Validation

of Alternative

Methods (ECVAM)

of the Joint Research Centre

by the

European

Centre

the on

Validation of

of Alternative

Methods

available

to meet

requirements

this Regulation

and which are not listed

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

in

Regulation

(EC)

No

440/2008.”.

requirements of this Regulation and which are not listed in

Regulation (EC) No 440/2008.”.

B

€0.75