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S.I. No. 553/2003 -- European Communities (Cosmetic Products) (Amendment) (No. 5) Regulations, 2003

S.I. No. 553/2003 -- European Communities (Cosmetic Products) (Amendment) (No. 5) Regulations, 2003 2003 553

Statutory Instrument

S.I. No. 553 of 2003

European Communities (Cosmetic Products) (Amendment) (No. 5) Regulations, 2003

Dublin

Published by the Stationery Office

DUBLIN

S.I. No. 553 of 2003

European Communities (Cosmetic Products) (Amendment) (No. 5) Regulations, 2003

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 2002/34/EC, 2003/1/EC and 2003/16/EC of the 15 April 2003, 6 January 2003 and 19 February 2003 respectively and to the second paragraph of Article 4 of Directive 2003/15/EC⁴⁸ of the 27 February 2003, hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) (No. 5) Regulations 2003.

2. These Regulations shall be construed as one with the European Communities (Cosmetic Products) Regulations 1997 (S.I. No. 87 of 1997 ), the European Communities(Cosmetic Products) Regulations 1998 (S.I. No. 213 of 1998 ), the European Communities(Cosmetic Products) (Amendment No. 2) Regulations 2000 (S.I. No. 150 of 2000 ), the European Communities(Cosmetic Products) (Amendment No. 3) Regulations 2000 (S.I. No. 203 of 2000 ) and the European Communities (Cosmetic Products) (Amendment No. 4) Regulations 2004 (S.I. No. 227 of 2000 ) and may be cited together with those Regulations as the European Communities (Cosmetic Products) Regulations 1997 to 2003.

3. In these Regulations “the Principal Regulations” mean the European Communities (Cosmetic Products) Regulations 1997 (S.I. No 87 of 1987 ).

4. The Principal Regulations are amended by --

(a) the addition to the definition of “the Principal Directive”, in regulation 4(1) thereof of the references “2002/34/EC⁴⁹ ”, “2003/1/EC⁵⁰ ” and “2003/16/EC⁵¹ ”,

and

(b) the deletion of sub-paragraph (f) in regulation 7(1) thereof.

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

6. The provisions of these Regulations, as they apply to those substances that are included in the Annex to Commission Directive 2002/34/EC, shall not apply to the sale or supply of cosmetic products to the final consumer until 15^th April 2004.

Schedule

1. Schedule 2 to the Principal Regulations is amended as follows:

(a) The following new entries are added:

423. Alanroot oil (Inula helenium) (CAS No. 97676-35-2), when used as a fragrance ingredient

424. Benzyl cyanide (CAS No. 140-29-4), when used as a fragrance ingredient.

425. Cyclamen alcohol (CAS No. 4756-19-8), when used as a fragrance ingredient.

426. Diethyl maleate (CAS No. 141-05-9), when used as a fragrance ingredient.

427. Dihydrocoumarine (CAS No. 119-84-6), when used as a fragrance ingredient.

428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No. 6248-20-0), when used as a fragrance ingredient.

429. 3,7-Dimethy1-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No. 40607-48-5), when used as a fragrance ingredient.

430. 4,6-Dimethyl-8-tert-butylcoumarin (CAS No. 17874-34-9), when used as a fragrance ingredient.

431. Dimethyl citraconate (CAS No. 617-54-9), when used as a fragrance ingredient.

432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No. 26651-96-7), when used as a fragrance ingredient.

433. 6, 10-Dimethyl-3,5,9-undecatrien-2-one (CAS No. 141-10-6), when used as a fragrance ingredient.

434. Diphenylamine (CAS No. 122-39-4), when used as a fragrance ingredient.

435. Ethyl acrylate (CAS No. 140-88-5), when used as a fragrance ingredient.

436. Fig leaf absolute (Ficus carica) (CAS No. 68916-52-9), when used as a fragrance ingredient.

437. trans-2-Heptenal (CAS No. 18829-55-5), when used as a fragrance ingredient.

438. trans-2-Hexenal diethyl acetal (CAS No. 67746-30-9), when used as a fragrance ingredient.

439. trans-2-Hexenal dimethyl acetal (CAS No. 18318-83-7), when used as a fragrance ingredient.

440. Hydroabietyl alcohol (CAS No. 13393-93-6), when used as a fragrance ingredient.

441. 6-Isopropyl-2-decahydronaphthalenol (CAS No. 34131-99-2), when used as a fragrance ingredient.

442. 7-Methoxycoumarin (CAS No. 531-59-9), when used as a fragrance ingredient.

443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No. 943-88-4), when used as a fragrance ingredient.

444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No. 104-27-8), when used as a fragrance ingredient.

445. Methyl trans-2-butenoate (CAS No. 623-43-8), when used as a fragrance ingredient.

446. 7-Methylcoumarin (CAS No. 2445-83-2), when used as a fragrance ingredient.

447. 5-Methyl-2,3-hexanedione (CAS No. 13706-86-0), when used as a fragrance ingredient.

448. 2-Pentylidenecyclohexanone (CAS No. 25677-40-1), when used as a fragrance ingredient.

449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No. 1117-41-5), when used as a fragrance ingredient.

450. Verbena oil (Lippia citriodora Kunth.) (CAS No. 8024-12-2), when used as a fragrance ingredient.

451. Methyleugenol (CAS No. 95-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed:

(a) 0.01% in fine fragrance

(b) 0.004% in eau de toilette

(c) 0.002% in fragrance cream

(d) 0.001% in rinse-off products

(e) 0.0002% in other leave-on products and oral hygiene products

(b) The entries numbered 293 and 419 are substituted as follows:-

293. Radioactive substances, as defined by Directive 96/29/Euratom¹ laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.

419. From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council² , the specified risk materials as designated in Annex V to that Regulation and ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom.

However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:

- transesterification or hydrolysis at at least: 200 °C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters),

- saponification with NaOH 12M (glycerol and soap):

- batch process: at 95 °C for 3 hours, or

- continuous process: at 140 °C, 2 bars (2 000 hPa) for 8 minutes or equivalent

2. Part 1 of Schedule 3 to the Principal Regulations is amended as follows:

(a) The entry in Column b for substance No. 8 is replaced by the following:

“m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines³ , with the exception of those derivatives listed elsewhere in this Schedule”

(b) The entries for substances numbered 15b, 15c, 16 and 66 are substituted as set out in the following Table:-

		RESTRICTIONS
Reference Number	Substance	Field of Application and/or use	Maximum authorised concentration in the finished cosmetic product	other limitations and requirements	Conditions of use and warnings which must be printed on the label
A	b	c	d	e	f
15b	Lithium hydroxide	(a) Hair straighteners	(a)		(a)
		1. General use	1. 2%⁴ by weight		1. Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children
		2. Professional use	2. 4.5%⁵ by weight		2. For professional use only Avoid contact with eyes Can cause blindness
		(b)pH adjuster -- for depilatories		(b) pH value not to exceed pH 12.7	(b)Contains alkali Keep out of reach of children Avoid contact with eyes
		c) Other uses -- as pH adjuster (for rinse-off[illegible] products only)		c) pH value not to exceed pH 11
15c.	Calcium hydroxide	(a) Hair straighteners containing two components : Calcium hydroxide and a guanidine salt	(a) 7% by weight of Calcium hydroxide		(a) Contains alkali Avoid contact with eyes Keep out of reach of children Can cause blindness
		(b) pH adjuster -- for depilatories		(b) pH value not to exceed pH 12.7	(b) Contains alkali Keep out of reach of children Avoid contact with eyes
		(c) Other uses (e.g. pH adjuster, processing aid)		(c) pH value not to exceed pH 11
16.	1-Naphthol (CAS No 90-15-3) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction.
66.	Polyacrylamides	(a) Body-care leave-on products		(a) Maximum residual Acrylamide content 0.1 mg/kg
		(b) Other cosmetic products		(b) Maximum residual Acrylamide content 0.5 mg/kg.

3. In Part 2 of Schedule 3 to the Principal Regulations, the entries for substances 1 to 62 are substituted as set out in the following Table:

		RESTRICTIONS
Reference Number	Substance	Field of Application and/or use	Maximum authorised concentrati on in the finished cosmetic product	Other limitations and requirements	Conditions of use and warnings which must be printed on the label	Allowed until
A	b	c	d	e	f	g
1.	Basic Blue 7 (CAS No. 2390-60-5)	Non-oxidising colouring agents for hair dyeing	0.2%		Can cause allergic reaction	30.9.2004
2.	2-Amino-3-nitrophenol (CAS No. 603-85-0) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) Can cause allergic reaction	30.9.2004
		(b)Non-oxidising colouring agent for hair dyeing	(b) 3.0%		(b) Can cause allergic reaction
3.	4-Amino-3-nitrophenol (CAS No. 610-81-1) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 3.0%		(b) Can cause allergic reaction
4.	2, 7-Naphthalenediol (CAS No. 582-17-2) and its salts	Oxidising colouring agents for hair dyeing	1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%		30.9.2004
5.	m-Aminophenol (CAS No.591-27-5) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
6.	2,6-Dihydroxy-3,4-di-methylpyridine (CAS No. 84540-47-6) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
7.	4-Hydroxypropylamino-3-nitrophenol (CAS No. 92952-81-3) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 5.2%	In combination with hydrogen peroxide the maximum use concentration upon application is 2.6%	(a) Can cause allergic reaction	30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 2.6%		(b)Can cause allergic reaction
8.	6-Nitro-2,5-pyridinediamine (CAS No. 69825-83-8) and its salts	Non-oxidising colouring agents for hair dyeing	3.0%		Can cause allergic reaction	30.9.2004
9.	HC Blue No. 11 (CAS No. 23920-15-2) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2.0%		(b) Can cause allergic reaction
10.	Hydroxyethyl-2-nitro-p-toluidine (CAS No. 100418-33-5) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	(a) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%		(b)Can cause allergic reaction
11.	2-Hydroxyethylpicramic acid (CAS No. 99610-72-7) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	(a)Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2.0%		(b)Can cause allergic reaction
12.	p-Methylaminophenol (CAS No. 150-75-4) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	Can cause allergic reaction	30.9.2004
13.	2,4-Diamino-5-methyl-phenoxyethanol (CAS No. 141614-05-3) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	Can cause allergic reaction	30.9.2004
14.	HC Violet No. 2 (CAS No. 104226-19-9) and its salts	Non-oxidising colouring agents for hair dyeing	2.0%			30.9.2004
15.	Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No. 122252-11-3) and its salts	Non-oxidising colouring agents for hair dyeing	3.0%		Can cause allergic reaction	30.9.2004
16.	HC Blue No. 12 (CAS No.104516-93-0) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 1.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.75%	(a)Can cause allergic reaction	30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 1.5%		(b)Can cause allergic reaction
17.	2,4-Diamino-5 methyphenetol (CAS No 113715-25-6) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
18.	1,3-Bis-(2,4-diamino-phenoxy)propane (CAS No.81892-72-0) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
19.	3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
20.	Phenyl methylpyrazolone (CAS No.89-25-8) and its salts	Oxidising colouring agents for hair dyeing	0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		30.9.2004
21.	2-Methyl-5-hydroxy-ethylaminophenol (CAS No.55302-96-0) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%	Can cause allergic reaction	30.9.2004
22.	Hydroxybenzomorpholine (CAS No.26021-57-8) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon	Can cause allergic reaction	30.9.2004
				application is 1.0%
23.	1,7-Naphthalenediol (CAS No. 575-38-2) and its salts	Oxidising colouring agents for hair dyeing	1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%	Can cause allergic reaction	30.9.2004
24.	HC Yellow No. 10 (CAS No. 109023-83-8) and its salts	Non-oxidising colouring agents for hair dyeing	0.2%			30.9.2004
25.	2,6-Dimethoxy-3,5-pyridinediamine (CAS No. 85679-78-3) and its salts	Oxidising colouring agents for hair dyeing	0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%	Can cause allergic reaction	30.9.2004
26.	HC Orange No. 2 (CAS No. 85765-48-6) and its salts	Non-oxidising colouring agents for hair dyeing	1.0%			30.9.2004
27.	HC Violet No. 1 (CAS No. 82576-75-8) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 0.5%
28.	3-Methylamino-4-nitro-phenoxyethanol (CAS No. 59820-63-2) and its salts	Non-oxidising colouring agents for hair dyeing	1.0%			30.9.2004
29.	2-Hydroxyethylamino-5-nitroanisole (CAS No. 66095-81-6) and its salts	Non-oxidising colouring agents for hair dyeing	1.0%			30.9.2004
30.	2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No.50610-28-1) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 1.0%
31.	HC Red No 13 (CAS No 94158-13-1) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.25%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 2.5%
32.	1,5-Naphthalenediol (CAS No.83-56-7) and its salts	Oxidising colouring agents for hair dyeing	1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%		30.9.2004
33.	Hydroxypropyl bis (N-hydroxyethyl-p-phenylene-diamine) (CAS No.128729-30-6) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%	Can cause allergic reaction	30.9.2004
34.	o-Aminophenol (CAS No.95-55-6) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
35.	4-Amino-2-hydroxy-toluene (CAS No. 2835-95-2) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
36.	2,4-Diaminophenoxy-ethanol (CAS No 66422-95-5) and its salts	Oxidising colouring agents for hair dyeing	4.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 2.0%		30.9.2004
37.	2-Methylresorcinol (CAS No.608-25-3) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
38.	4-Amino-m-cresol (CAS No.2835-99-6) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is		30.9.2004
				1.5%
39.	2-Amino-4-hydroxyethyl-aminoanisole (CAS No.83763-47-7) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
40.	3,4-Diaminobenzoic acid (CAS No.619-05-6) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
41.	6-Amino-o-cresol (CAS No.17672-22-9) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
42.	2-Aminomethyl-p-amino-phenol (CAS No.79352-72-0) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
43.	Hydroxyethylaminomethyl-p-aminophenol (CAS No. 110952-46-0) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
44.	Hydroxyethyl-3,4-methyl-enedioxyaniline (CAS No. 81329-90-0) and its salts	Oxidising colouring agents for hair dyeing	3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
45.	Acid Black 52 (CAS No 3618-58-4) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
46.	2-Nitro-p-phenylene-diamine (CAS No. 5307-14-2) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 0.3%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.15%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 0.3%
47.	HC Blue No. 2 (CAS No. 33229-34-4) and its salts	Non-oxidising colouring agents for hair dyeing	2.8%			30.9.2004
48.	3-Nitro-p-hydroxyethyl-aminophenol (CAS No. 65235-31-6) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 6.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 3.0%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 6.0%
49.	4-Nitrophenylamino-ethylurea (CAS No.27080-42-8) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0.5%
50.	HC Red No. 10 + HC Red No. 11 (CAS No.95576-89-9 + 95576-92-4) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 1.0%
51.	Yellow No. 6 (CAS No. 104333-00-8) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1.0%
52.	HC Yellow No. 12 (CAS No.59320-13-7) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 1.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0.5%
53.	HC Blue No 10 (CAS No 102767-27-1) and its salts	Oxidising colouring agents for hair dyeing	2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
54.	HC Blue No. 9 (CAS No. 114087-47-1) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 1.0%
55.	2-Chloro-6-ethylamino-4-nitrophenol (CAS No. 131657-78-8) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 3.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 3.0%
56.	2-Amino-6-chloro-4-nitrophenol (CAS No. 6358-09-4) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 2.0%	In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 2.0%
57.	Basic Blue 26 (CAS No. 2580-56-5) (CI 44045) and its salts	(a)Oxidising colouring agents for hair dyeing	(a) 0.5%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%		30.9.2004
		(b)Non-oxidising colouring agents for hair dyeing	(b) 0.5%
58.	Acid Red 33 (CAS No.3567-66-6) (CI 17200) and its salts	Non-oxidising colouring agents for hair dyeing	2.0%			30.9.2004
59.	Ponceau SX (CAS No.4548-53-2) (CI 14700) and its salts	Non-oxidising colouring agents for hair dyeing	2.0%			30.9.2004
60.	Basic Violet 14 (CAS No.632-99-5) (CI 42510) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0.3%	In combination with hydrogen peroxide the maximum use concentration upon application is 0.15%		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0.3%
61.	Musk xylene (CAS No.81-15-2)	All cosmetic products, with the exception of oral care products	(a) 1.0% in fine fragrance (b) 0.4% in eau de toilette (c) 0.03% in other products			30.9.2004
62.	Musk ketone (CAS No. 81-14-1)	All cosmetic products, with the exception of oral care products	(a)1.4% in fine fragrance (b)0.56% in eau de toilette (c) 0.042% in other products			30.9.2004

4. The following new entries are added to Part 1 of Schedule 7:

Reference number	Substance	Maximum authorized concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
26.	Dimethicodiethylbenzalmalonate (CAS No. 207574-74-1)	10%
27.	Titanium dioxide	25%

../images/seal.jpg

GIVEN under my Official Seal

13th November 2003

MICHEÁL MARTIN

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 principal purpose of these Regulations is to up-date the law in relation to the manufacture, marketing and sale of cosmetic products by the implementation of Commission Directives 2002/34/EC, 2003/1/EC and 2003/16/EC relating to cosmetic products.

The purposes of the changes are to improve the safety of cosmetic products being placed on the market. They have been introduced following safety assessments carried out by the EU Scientific Committee on Cosmetic Products and Non Food Products (SCCNFP). Amongst the changes that are being introduced in these Regulations is the prohibition of twenty eight fragrance ingredients that must not be used as such in cosmetic products.

⁴⁸ Official Journal of the European Communities, No. L. 66, 11.3.2003 (pages 26 to 35).

⁴⁹ Official Journal of the European Communities, No. L. 102, 18.4.2002 (pages 19-31) (and corrigenda published in the Official Journal on 17.12.2002).

⁵⁰ Official Journal of the European Communities, No. L. 5, 10.1.2003 (pages 14-15).

⁵¹ Official Journal of the European Communities, No. L. 46, 20.2.2003 (page 24).

¹ OJ No. L. 159, 29.6.1996, p.1.

² OJ No. L 147 of 31.05.2001, p. 1.

³ 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 l..

⁴ The concentration of Sodium, Potassium or Lithium hydroxide is expressed as weight of Sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.

⁵ 5 Idem.