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

1. Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children

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%

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

.

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

293. Radioactive substances, as defined by Directive 96/29/Euratom

1

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 Council

2

, 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

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:-

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/EC

48

of the 27 February 2003, hereby make the following regulations