S.I. No. 503/2003 - European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2003

1. May not be placed on the market or used as a substance or as a constituent of substances or of preparations in concentrations higher than 0.1 % by mass.

2. Articles may not be placed on the market if they, or flame- retarded parts thereof, contain this substance in concentrations higher than 0.1% by mass.

”.

Schedule D

Regulation 4

(1)(a)

“Schedule 3

Foreword

Explanations of column headings used in this Schedule

Substances

The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous substances are designated by their Einecs (European Inventory of Existing Commercial Chemical Substances) or Elincs (European List of Notified Chemical Substances) names. Other entries not listed in Einecs or Elincs are designated using an internationally recognized chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.

Index number

The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number.

EC number

For each substance listed in the European Inventory of Existing Commercial Chemical Substances (Einecs) there is an identification code. The code starts at 200-001-8.

For each new substance notified under the Directive 67/548/EEC an identification code has been defined and published in the European List of Notified Chemical Substances (Elincs). The code starts at 400-010-9.

CAS number

Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification.

Notes

Certain substances listed in this Schedule have been assigned notes. The full text of the notes can be found in the foreword to Annex I of Directive 67/548/EEC, as set out in Annex 1A to Commission Directive 2001/59/EC (OJ L225, 21.8.2001, p1). The notes to be taken into account for the purposes of these Regulations are as follows

Note C

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In Annex I, to Directive 67/548/EECa general designation of the following type is sometimes used: “xylenol”.

In this case the manufacturer or any other person who markets such a substance must state on the label whether the substance is a specific isomer (a) or a mixture of isomers (b).

Example: (a) 2,4-dimethylphenol

(b) xylenol (mixture of isomers).

Note D

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words “non-stabilised”.

Example: methacrylic acid (non-stabilised).

Note E

Substances with specific effects on human health (see Chapter 4 of Annex VI to Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21 R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word “Also”.

Examples: R45-23 “May cause cancer. Also toxic by inhalation”

R46-27/28 “May cause heritable genetic damage. Also very toxic in contact with skin and if swallowed”.

Note J

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7). This note applies only to certain complex coal-and oil-derived substances.

Note K

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen, at least the S-phrases (2-)9-16 should apply. This note applies only to certain complex oil-derived substances.

Note L

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346. This note applies only to certain complex oil-derived substances.

Note M

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5). This note applies only to certain complex coal-derived substances.

Note N

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances.

Note P

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7). When the substance is classified as a carcinogen, Note E shall also apply. When the substance is not classified as a carcinogen, at least the S-phrases (2-)23-24-62 should apply. This note applies only to certain complex oil-derived substances.

Note R

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6µm.

Note S

This substance may not require a label according to Article 23 of Directive 67/548/EEC (see Section 8 of Annex VI to Directive 67/548/EEC as per Section 8 of Schedule 5 to the European Communities (Classification Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003 (

S.I. No. 116 of 2003

)).”.

Schedule E

Regulation 4

(1)(b)

“Point 29 (of Schedule 1) — Carcinogens

List 1, category 1 carcinogens

Substances

Index number

EC number

CAS number

Notes

Butane [containing 0,1 % Butadiene (203-450-8)] [1]

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C,S

Isobutane [containing 0,1%

Butadiene (203-450-8)] [2]

200-857-2[2]

75-28-5 [2]

1,3-Butadiene; buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

”.

Schedule F

Regulation 4

(1)(c)

“Point 29 (of Schedule 1) — Carcinogens

List 2, category 2 carcinogens

Substances

Index number

EC number

CAS number

Cobalt dichloride

027-004-00-5

231-589-4

7646-79-9

Cobalt sulphate

027-005-00-0

233-334-2

10124-43-3

Cadmium fluoride

048-006-00-2

232-222-0

7790-79-6

Chrysene

601-048-00-0

205-923-4

218-01-9

Benzo[

e

]pyrene

601-049-00-6

205-892-7

192-97-2

2,2'-Bioxirane; 1,2:3,4- diepoxybutane

603-060-00-1

215-979-1

1464-53-5

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

2,4-Dinitrotoluene [1]; dinitrotoluene [2]; dinitrotoluene, technical grade

609-007-00-9

204-450-0 [1] 246-836-1 [2]

121-14-2 [1] 25321-14-6 [2]

2,6-Dinitrotoluene

609-049-00-8

210-106-0

606-20-2

Hydrazine-tri-nitromethane

609-053-00-X

414-850-9

-

Azobenzene

611-001-00-6

203-102-5

103-33-3

o

-Dianisidine based azo dyes; 4,4'-diarylazo-3,3'- dimethoxybiphenyl dyes with the exception of those mentioned elsewhere in Annex I to Directive 67/548/EEC

611-029-00-9

-

-

o

-Tolidine based dyes; 4,4'- diarylazo-3,3'-dimethylbiphenyl dyes, with the exception of those mentioned elsewhere in Annex I to Directive 67/548/EEC

611-030-00-4

-

-

1,4,5,8-Tetraaminoanthraquinone; C.I. Disperse Blue 1

611-032-00-5

219-603-7

2475-45-8

”.

Schedule G

Regulation 4

(1)(d)

“Point 29 (of Schedule 1) — Carcinogens

List 2, category 2 carcinogens

Substances

Index number

EC number

CAS number

Notes

Beryllium oxide

004-003-00-8

215-133-1

1304-56-9

E

Sodium chromate

024-018-00-3

231-889-5

7775-11-3

E

Trichloroethylene; trichloroethene

602-027-00-9

201-167-4

79-01-6

α-Chlorotoluene; benzyl chloride

602-037-00-3

202-853-6

100-44-7

E

2,3-dibromopropan-1-ol; 2,3-dibromo-1- propanol

602-088-00-1

202-480-9

96-13-9

E

Propylene oxide; 1,2-epoxypropane; methyloxirane

603-055-00-4

200-879-2

75-56-9

E

Phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether; 1,2-epoxy-3-phenoxypropane

603-067-00-X

204-557-2

122-60-1

E

Furan

603-105-00-5

203-727-3

110-00-9

E

R-2,3-epoxy-1-propanol

603-143-00-2

404-660-4

57044-25-4

E

(R)-1-chloro-2,3-epoxypropane

603-166-00-8

424-280-2

51594-55-9

2,3-dinitrotoluene

609-050-00-3

210-013-5

602-01-7

E

3,4-dinitrotoluene

609-051-00-9

210-222-1

610-39-9

E

3,5-dinitrotoluene

609-052-00-4

210-566-2

618-85-9

E

2,5-dinitrotoluene

609-055-00-0

210-581-4

619-15-8

E

6-hydroxy-1-(3-isopropoxypropyl)-4-methyl- 2-oxo-5-[4-(phenylazo)phenylazo]-1,2- dihydro-3-pyridinecarbonitrile

611-057-00-1

400-340-3

85136-74-9

(6-(4-hydroxy-3-(2-methoxyphenylazo)-2- sulfonato-7-naphthylamino)-1,3,5-triazin- 2,4-diyl)bis[(amino-1-methylethyl)- ammonium] formate

611-058-00-7

402-060-7

108225-03-2

Trisodium-[4'-(8-acetylamino-3,6- disulfonato-2-naphthylazo)-4”-(6- benzoylamino-3-sulfonato-2- naphthylazo)biphenyl-1,3',3”,1”'-tetraolato-O, O',O”,O”']copper(II)

611-063-00-4

413-590-3

-

Phenylhydrazine [1]

612-023-00-9

202-873-5[1]

100-63-0 [1]

E

Phenylhydrazinium chloride [2]

200-444-7[2]

59-88-1 [2]

Phenylhydrazine hydrochloride [3]

248-259-0[3]

27140-08-5[3]

Phenylhydrazinium sulphate (2:1) [4]

257-622-2[4]

52033-74-6[4]

A mixture of: N-[3-hydroxy-2-(2- methylacryloylamino- methoxy)propoxymethyl]-2- methylacrylamide; N-[2,3-Bis-(2- methylacryloylamino- methoxy)propoxymethyl]-2- methylacrylamide; methacrylamide; 2- methyl-N-(2-methyl- acryloylaminomethoxymethyl)-acrylamide; N-2,3-dihydroxypropoxymethyl)-2- methylacrylamide

616-057-00-5

412-790-8

-

”.

Schedule H

Regulation 4

(1)(f)

“Point 30 (of Schedule 1) — Mutagens

List 4, category 2 mutagens

Substances

Index number

EC number

CAS number

Cadmium fluoride

048-006-00-2

232-222-0

7790-79-6

Cadmium chloride

048-008-00-3

233-296-7

10108-64-2

2,2'-Bioxirane; 1,2:3,4- diepoxybutane

603-060-00-1

215-979-1

1464-53-5

”.

Schedule I

Regulation 4

(1)(g)

“Point 30 (of Schedule 1) — Mutagens

List 4, category 2 mutagens

Substances

Index number

EC number

CAS number

Notes

Sodium chromate

024-018-00-3

231-889-5

7775-11-3

E

Butane [containing 0,1 %

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

Butadiene (203-450-8)] [1]

Isobutane [containing 0,1 %

20-857-2 [2]

75-28-5 [2]

Butadiene (203-450-8)] [2]

1,3-Butadiene buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

Propylene oxide; 1,2-epoxypropane; Methyloxirane

603-055-00-4

200-879-2

75-56-9

E

1,3,5-tris-[(2S and 2R)-2,3- epoxypropyl]-1,3,5-triazine-2,4,6- (1H,3H,5H)-trione

616-091-00-0

423-400-0

59653-74-6

E

”.

Schedule J

Regulation 4

(1)(h)

“Point 31 (of Schedule 1) — Toxic for reproduction

List 5, category 1 substances toxic for reproduction

Substances

Index number

EC number

CAS number

Notes

2-bromopropane

602-085-00-5

200-855-1

75-26-3

E

”.

Schedule K

Regulation 4

(1)(i)

“Point 31 (of Schedule 1) — Toxic for reproduction

List 6, category 2 substances toxic for reproduction

Substances

Index number

EC number

CAS number

Cadmium fluoride

048-006-00-2

232-222-0

7790-79-6

Cadmium chloride

048-008-00-3

233-296-7

10108-64-2

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

2-Methoxypropanol

603-106-00-0

216-455-5

1589-47-5

4,4'-isobutylethylidenediphenol;

2,2-bis (4'-hydroxyphenyl)-4- methylpentane

604-024-00-8

401-720-1

6807-17-6

2-Methoxypropyl acetate

607-251-00-0

274-724-2

70657-70-4

Tridemorph (ISO); 2,6-dimethyl-

613-020-00-5

246-347-3

24602-86-6

4-tridecylmorpholine

Cycloheximide

613-140-00-8

200-636-0

66-81-9

”.

Schedule L

Regulation 4

(1)(j)

“Point 31 (of Schedule 1) — Toxic for reproduction

List 6, category 2 substances toxic for reproduction

Substances

Index number

EC number

CAS number

Notes

Flusilazole (ISO); bis(4- fluorophenyl)-(methyl)-(1H-1,2,4- triazol-1-ylmethyl)-silane

014-017-00-6

-

85509-19-9

E

A mixture of: 4-[[bis-(4- fluorophenyl)-methylsilyl]methyl]- 4H-1,2,4-triazole; 1-[[bis-(4- fluorophenyl)methyl-silyl]methyl]- 1H-1,2,4-triazole

014-019-00-7

403-250-2

-

E

Bis(2-methoxyethyl) ether

603-139-00-0

203-924-4

111-96-6

R-2,3-epoxy-1-propanol

603-143-002

404-660-4

57044-25-4

E

Fluazifop-butyl (ISO); butyl (RS)-2- [4-(5-trifluoromethyl-2- pyridyloxy)phenoxy]propionate

607-304-00-8

274-125-6

69806-50-4

Vinclozolin (ISO); N-3,5- Dichlorophenyl-5-methyl-5-vinyl- 1,3-oxazolidine-2,4-dione

607-307-00-4

256-599-6

50471-44-8

Methoxyacetic acid

607-312-00-1

210-894-6

625-45-6

E

Bis(2-ethylhexyl) phthalate; di-(2- ethylhexyl)phthalate; DEHP

607-317-00-9

204-211-0

117-81-7

Dibutyl phthalate; DBP

607-318-00-4

201-557-4

84-74-2

(+/−) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2- yloxy)phenyloxy]propionate

607-373-00-4

414-200-4

119738-06-6

E

Flumioxazin (ISO); N-(7-Fluoro-3,4- dihydro-3-oxo-4-prop-2-ynyl-2H-1,4- benzoxazin-6-yl)cyclohex-1-ene-1,2- dicarboxamide

613-166-00-X

-

103361-09-7

(2RS,3RS)-3-(2-Chlorophenyl)-2-(4- fluorophenyl)-[(1H-1,2,4-triazol-1- yl)-methyl]oxirane

613-175-00-9

406-850-2

106325-08-0

N, N-Dimethylacetamide

616-011-00-4

204-826-4

127-19-5

E

Formamide

616-052-00-8

200-842-0

75-12-7

N-methylacetamide

616-053-00-3

201-182-6

79-16-3

N-methylformamide

616-056-00-X

204-624-6

123-39-7

E

”.

Schedule M

Regulation 4

(1)(k)

“Point 43 (of Schedule 1) - Azocolourants

List of aromatic amines

CAS number

Index number

EC number

Substances

1

92-67-1

612-072-00-6

202-177-1

biphenyl-4-ylamine 4-aminobiphenyl xenylamine

2

92-87-5

612-042-00-2

202-199-1

benzidine

3

95-69-2

202-441-6

4-chloro-o-toluidine

4

91-59-8

612-022-00-3

202-080-4

2-naphthylamine

5

97-56-3

611-006-00-3

202-591-2

o-aminoazotoluene 4-amino-2',3- dimethylazobenzene 4-o-tolylazo-o-toluidine

6

99-55-8

202-765-8

5-nitro-o-toluidine

7

106-47-8

612-137-00-9

203-401-0

4-chloroaniline

8

615-05-4

210-406-1

4-methoxy-m-phenylenediamine

9

101-77-9

612-051-00-1

202-974-4

4,4'-methylenedianiline 4,4'-diaminodiphenylmethane

10

91-94-1

612-068-00-4

202-109-0

3,3'-dichlorobenzidine 3,3'-dichlorobiphenyl-4,4'- ylenediamine

11

119-90-4

612-036-00-X

204-355-4

3,3'-dimethoxybenzidine o-dianisidine

12

119-93-7

612-041-00-7

204-358-0

3,3'-dimethylbenzidine 4,4'-bi-o-toluidine

13

838-88-0

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

14

120-71-8

204-419-1

6-methoxy-m-toluidine p-cresidine

15

101-14-4

612-078-00-9

202-918-9

4,4'-methylene-bis-(2-chloro- aniline) 2,2'-dichloro-4,4'-methylene- dianiline

16

101-80-4

202-977-0

4,4'-oxydianiline

17

139-65-1

205-370-9

4,4'-thiodianiline

18

95-53-4

612-091-00-X

202-429-0

o-toluidine 2-aminotoluene

19

95-80-7

612-099-00-3

202-453-1

4-methyl-m-phenylenediamine

20

137-17-7

205-282-0

2,4,5-trimethylaniline

21

90-04-0

612-035-00-4

201-963-1

o-anisidine 2-methoxyaniline

22

60-09-3

611-008-00-4

200-453-6

4-amino azobenzene

List of azodyes

CAS number

Index number

EC number

Substances

1

Not allocated

Component 1: CAS-No.: 118685-33-9 C

39

H

23

ClCrN

7

O

12

S.2Na

611-070-00-2

405-665-4

A mixture of: disodium (6- (4-anisidino)-3-sulfonato- 2-(3,5-dinitro-2- oxidophenylazo)- 1-naphtholato)(1-(5- chloro-2-oxidophenylazo)- 2- naphtholato)chromate(1-);

Component 2: C

46

H

30

CrN

10

O

20

S

2

.3Na

trisodium bis(6-(4- anisidino)-3-sulfonato-2- (3,5-dinitro-2- oxidophenylazo)-1- naphtholato)chromate(1-)

”.

GIVEN under my Official Seal,

24 October

2003.

___________________

Minister for Enterprise,

Trade and Employment.

EXPLANATORY NOTE

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

The purpose of these Regulations is to amend Schedules 1 and 3 to the European Communities (Dangerous Substances and Preparations) (Marketing and Use) Regulations 2003 (

S.I. No. 220 of 2003

) to transpose Commission Directive 2003/2/EC of 6 January 2003 Commission Directive 2003/3/EC of 6 January 2003, Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003, Directive 2003/34/EC of the European Parliament and of the Council of 26 May 2003 and Directive 2003/36/EC of the European Parliament and of the Council of 26 May 2003, which amend Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations.

The Regulations, from 30 June 2004 —

(i) place further restrictions in relation to the marketing and use of arsenic-treated wood, through the provisions of Regulation 3(1)(a) and Schedule A to the Regulations, which transpose the provisions of Commission Directive 2003/2/EC and

(ii) place further restrictions on the marketing and use of dangerous substances by prohibiting the use of azodyes (blue colourant) for colouring textile and leather articles, through the provisions of Regulations 3(1)(b) and 4(1)(k) and Schedules B and M to the Regulations, which transpose the provisions of Commission Directive 2003/3/EC.

The Regulations, from 15 August 2004, place restrictions on the marketing and use of diphenylether, pentabromo derivative and diphenylether, octabromo derivative through the provisions of Regulation 3(1)(c) and Schedule C to the Regulations, which transpose the provisions of Directive 2003/11/EC of the European Parliament and of the Council.

The Regulations, from 15 January 2005, place further restrictions on the marketing and use of substances classified as carcinogens, mutagens or substances toxic for reproduction through the provisions of Regulation 4(1)(c), (f) and (i) and Schedules F, H and K to the Regulations which transpose the provisions of Directive 2003/34/EC of the European Parliament and of the Council,

The Regulations, from 25 December 2004, place further restrictions on the marketing and use of two substances newly classified as category 1 carcinogens, nineteen substances newly classified as category 2 carcinogens, five substances newly classified as category 2 mutagens one substance newly classified as category 1 toxic for reproduction and sixteen substances newly classified as category 2 toxic for reproduction, through the provisions of Regulation 4(1)(b), (d), (e), (g), (h) and (j) and Schedules E, G, I, J and L to the Regulations, which transpose the provisions of Directive 2003/36/EC of the European Parliament and of the Council.

Regulations 3(2) and (3) and 4(2), (3) and (4) specify the commencement dates for the various provisions of the Regulations, as referred to above.

1

OJ No. L 262, 27.9.1976, p. 201

2

OJ No. L 4, 9.1.2003, p. 9

3

OJ No. L 4, 9.1.2003, p. 12

4

OJ No. L 42, 15.2.2003, p.45

5

OJ No. L 156, 25.6.2003, p. 14

6

OJ No. L 156, 25.6.2003, p.26

7

OJ L 398, 30.12.1989, p.24

3. Azodyes, which are contained in the “List of azodyes” set out in Schedule M to these Regulations, may not be placed on the market or used for colouring textile and leather articles as a substance or constituent of preparations in concentrations higher than 0.1% by mass.

4. Not later than 11 September 2005, the Commission shall, in the light of new scientific knowledge, review the provisions on azocolourants.

”.

Schedule C

Regulation 3

(1)(c)

“

20. Commission Directive No. 2003/2/EC

Arsenic compounds

43. Commission Directive No. 2003/3/EC

Azocolourants (See lists of aromatic amines and azodyes in Schedule M to these Regulations.)

44. Directive No. 2003/11/EC of the European Parliament and of the Council

diphenylether, pentabromo derivative C

12

H

5

Br

5

O

45. Directive No. 2003/11/EC of the European Parliament and of the Council

diphenylether, octabromo derivative C

12

H

2

Br

8

O

I, Mary Harney, Minister for Enterprise, Trade and Employment in exercise of the powers conferred on me by

section 3

of the

European Communities Act 1972

(No. 27 of 1972) and for the purpose of giving further effect to Council Directive 76/769/EEC of 27 July 1976

1

as amended by Commission Directive 2003/2/EC of 6 January 2003

2

, Commission Directive 2003/3/EC of 6 January 2003

3

, Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003

4

, Directive 2003/34/EC of the European Parliament and of the Council of 26 May 2003

5

and Directive 2003/36/EC of the European Parliament and of the Council of 26 May 2003

6

, hereby make the following regulations