S.I. No. 711/2005 - European Communities (Cosmetic Products) (Amendment) Regulations 2005

1. Schedule 2 of the Principal Regulations is amended by the addition of the following new entries

“1133. Costus root oil (

Saussurea lappa Clarke

) (CAS No. 8023-88-9), when used as a fragrance ingredient.

2. Part 1 of Schedule 4 is amended by the deletion of the following Colour Index Numbers from the list of colouring agents allowed

12150,

20170, and

27290.

3. Part 1 of Schedule 6 is amended as follows

(a) substance reference number 53 is replaced by the following

Reference number

Substance

Maximum authorised concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

C

d

e

‘53

Benzethonium chloride (INCI)

0.1 %

(a) Rinse-off products

(b) Leave-on products other than for oral care use’

(b) the following new entry is added as reference number 57

Reference number

Substance

Maximum authorised concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

C

d

e

‘57

Methylisothia- zolinone (INCI)

0.01 %’

4. Part 1 of Schedule 7 is amended by the insertion of the following new entry

Reference number

Substance

Maximum authorised concentration

Other limitations limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

C

d

e

‘28

Benzoic acid, 2-[4- (diethylamino)-2- hydroxybenzoyl], hexylester

10% in sunscreen products’

(INCI name: Diethylamino Hydroxybenzoyl Hexyl Benzoate;

CAS No. 302776- 68-7)

GIVEN under my Official Seal this 11

th

day of November 2005

__________

Mary Harney

Minister for Health and Children

EXPLANATORY NOTE

(

This note is not part of the Instrument and does not purport to be a legal interpretation

.)

The purpose of the Regulations is to update the law in relation to the manufacture marketing and sale of cosmetic products by the implementation of Commission Directives 2005/9/EC and 2005/42/EC. The relevant changes are being introduced to improve the safety of cosmetic products being placed on the market.

The Regulations provide for: (a) the prohibition of the use of certain substances as fragrances in cosmetic products; (b) the removal of certain colouring agents from the list of such agents permitted for use in cosmetic products; (c) a widening of the scope of use of a preservative used in cosmetic products; (d) an addition to the list of ultraviolet filters which cosmetic products may contain; (e) the correction of an error which has come to light since publication of the principal Regulations.

1

OJ L27, 29.1.2005, p.46

2

OJ L158, 21.6.2005, p.17

5. The Principal Regulations are amended by -

(a) the addition to the definition of “

Directive

”, in Regulation 4(1) thereof, of the references “2005/9/EC

1

” and “2005/42/EC

2

”; and

(b) the substitution of the following for paragraph (9) of Regulation 12 thereof-

“(9) Sub-paragraphs (d)(ii) and (h) of paragraph (1) and sub-paragraphs (d and (e) paragraph (2) shall not apply in respect of cosmetic products placed on the market in the Community prior to 31 December 2004.”.

6. The Schedules to the Principal Regulations are amended in the manner set out in the Schedule to these Regulations.

Schedule

1134. 7-Ethoxy-4-methylcoumarin (CAS No. 87-05-8), when used as a fragrance ingredient.

1135. Hexahydrocoumarin (CAS No. 700-82-3), when used as a fragrance ingredient.

1136. Peru balsam (INCI name: Myroxylon pereirae; CAS No. 8007-00-9) when used as a fragrance ingredient.”

S.I. No. 711 of 2005

European Communities (Cosmetic Products) (Amendment) Regulations 2005

I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by

section 3

of the

European Communities Act 1972

(

No 27 of 1972

), for the purpose of giving effect to Commission Directives 2005/9/EC and 2005/42/EC of 28 January 2005 and 20 June 2005 respectively, hereby make the following Regulations