S.I. No. 150/2000 - European Communities (Cosmetic Products) (Amendment No. 2) Regulations, 2000.

1. Not to be used for oral hygiene and lipcare products

2.If the concentration in products intended to remain on the skin exceeds 0.02%, add the phrase “Contains Iodine”

2. Contains Iodine

(

b

) In Part 2 the entries numbered 16, 21 and 29 are deleted.

3. Schedule VI to the Principal Regulations is amended as follows:—

(

a

) In Part I the following new entries are added:—

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

54

Benzalkonium chloride, bromide and saccharate (O)

0.1% calculated as benzalkonium chloride

Avoid contact with the eyes

55

Benzylhemiformal

0.15%

Only for products to be removed by rinsing

56

3-Iodo-2- propynylbuty Icarbamate

0.05%

4. The following new entries are added to Part 1 of Schedule 7 to the Principal Regulations

Reference Number

Substance

Maximum authorised concentration

Other Limitations and requirements

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

a

b

c

d

e

13

Ethoxylated Ethyl 4- aminobenzoate (PEG-25 PABA)

10%

14

Isopentyl 4- methoxy- cinnamate (Isoamyl p- methoxycinnamate)

10%

15

2,4,6-Trianilino- (p-carbo-2'- ethylhexyl-1'- oxy)-1,3,5- triazine (Octyl triazone)

5%

16

Phenol,2-(2H- benzotriazol-2- yl)-4-methyl-6- (2-methyl-3- (1.3.3.3- tetramethyl-1- (trimethylsilyl) oxy)-disiloxanyl) propyl (Drometrizole trisiloxane)

15%

17

Benzoic acid, 4,4-{(6((((1,1- Dimethylethyl) amino)carbonyl) phenyl)amino)- 1,3,5-triazine- 2,4-diyl)diimino} bis-,bis(2- ethylhexyl)ester

10%

18

3-(4'- Methylbenzy lidene) dl- camphor (4- Methylbenzy lidene camphor)

4%

19

3-Benzylidene camphor

2%

20

2-Ethylhexyl salicylate (Octylsalicylate)

5%

21

Ethyl-2-hexyl 4- dimethylamino benzoate (Octyldimethyl PABA)

8%

22

2-Hydroxy-4- methoxybenz ophen one-5- sulphonic acid (Benzophenone- 5) and its sodium salt

5% (as acid)

23

2,2'-Methylene- bis-6-(2H- benzotriazol-2- yl)-4- (tetramethyl butyl)-1,1,3,3- phenol

10%

24

Monosodium 2,2'-

bis

-(1,4- phenylene)-1H- benzimidazole- 4,6-disulphonate

10% (as acid)

25

2,4-

bis

((4-(2- Ethylhexyloxy)- 2-hydroxy)- phenyl)-6-(4- methoxyphenyl)- (1,3,5)-triazine

10%

5. Part 2 of Schedule 7 to the Principal Regulations is amended by the deletion of those substances having the reference numbers 2, 5, 6, 12, 17, 25, 26, 29 and 32 respectively.

GIVEN under my Official Seal, this 30th day of May, 2000.

MICHEÁL MARTIN TD,

Minister for Health and Children.

EXPLANATORY NOTE.

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

These Regulations update the law in relation to the manufacure, placing on the market and sale of cosmetic products in accordance with the twenty-third, twenty-fourth and twenty-fifth Commission Directives as referred to above. In general the principal effects of the Regulations include the making available of further substances which, in accordance with the prescribed conditions, may be used as preservatives or as UV filters for sunscreen products. Also the use and placing on the market of skin lightening products containing hydroquinone is prohibited. The Regulations also assign powers of enforcement in regard to cosmetic products to officers of the Irish Medicines Board.

44.

98/62/EC - Official Journal of the European Communities, No. L.253, 15/9/1998 (pages 20-23) (

Twenty-third Commission Directive

).

45.

2000/6/EC - Official Journal of the European Communities, No. L56, 1/3/2000 (pages 42-46) (

Twenty-fourth Commission Directive

).

46.

2000/11/EC - Official Journal of the European Communities, No. L65, 14/2/2000 (pages 22-25) (

Twenty-fifth Commission Directive

).

6. (1) The provisions of these Regulations, as they apply to those substances referred to in the Schedule hereto that are included in the Annex to Commission Directive 98/62/EC, shall not apply to the sale or supply of cosmetic products to the final consumer until 1st July 2000.

(2) The provisions of these Regulations, as they apply to those substances referred to in the Schedule hereto that are included in the Annex to Commission Directive 2000/6/EC, shall not apply to the sale or supply of cosmetic products to the final consumer until 2nd January 2001.

Schedule

I, MICHEÁL MARTIN, 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 98/62/EC, 2000/6/EC and 2000/11/EC of the 3 September 1998, 29 February 2000 and 10 March 2000 respectively, hereby make the following Regulations:—