| |
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 19761
as amended by Commission Directive 2003/2/EC of 6 January 20032
, Commission Directive 2003/3/EC of 6 January 20033
, Directive 2003/11/EC of the European Parliament and of the Council of 6 February 20034
, Directive 2003/34/EC of the European Parliament and of the Council of 26 May 20035
and Directive 2003/36/EC of the European Parliament and of the Council of 26 May 20036
, hereby make the following regulations:
1. These Regulations may be cited as the European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2003.
2. (1) In these Regulations “Principal Regulations” means the European Communities (Dangerous Substances and Preparations) (Marketing and Use Regulations 2003 (
S.I. No. 220 of 2003
).
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(2) A word or expression that is used in these Regulations and is also used in Council Directive 76/769/EEC of 27 July 1976, 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 has, unless the contrary intention appears, the same meaning in these Regulations as in the Directive concerned.
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(3) In these Regulations—
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(a) a reference to a paragraph is to a paragraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended, and
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(b) a reference to a Schedule is to a Schedule to these Regulations unless it is indicated that reference to some other Regulations in intended.
3. (1) Schedule 1 to the Principal Regulations is amended -
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(a) by substituting the provisions set out in Schedule A for reference number 20,
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(b) by substituting the provisions set out in Schedule B for reference number 43, and
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(c) by adding the provisions set out in Schedule C after reference number 43.
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(2) Paragraphs (1)(a) and (b) comes into operation on 30 June 2004.
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(3) Paragraph (1)(c) comes into operation on 15 August 2004.
4. (1) Schedule 3 to the Principal Regulations is amended —
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(a) by substituting the Foreword set out in Schedule D for the Foreword set out in the said Schedule 3,
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(b) under the heading “Point 29 (of Schedule 1) — Carcinogens List 1, category 1 carcinogens”, by adding the provisions set out in Schedule E,
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(c) under the heading “Point 29 (of Schedule 1) — Carcinogens List 2, category 2 carcinogens”, by adding the provisions set out in Schedule F,
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(d) under the heading “Point 29 (of Schedule 1) — Carcinogens List 2, category 2 carcinogens”, by adding the provisions set out in Schedule G,
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(e) under the heading “Point 29 (of Schedule 1) — Carcinogens List 2, category 2 carcinogens”, by deleting the following entries —
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“
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Substances
|
Index Number
|
EC Number
|
CAS Number
|
Notes
|
|
butane [1] and isobutane [2]
|
601-004-01-8
|
203-448-7[1]
|
106-97-8[1]
|
|
|
(containing ≥ 0.1 % butadiene (203-450-8))
|
|
200-857-2[2]
|
75-28-5[2]
|
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|
1,3-butadiene; buta-1,3-diene
|
601-013-00-X
|
203-450-8
|
106-99-0
|
|
|
|
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|
”,
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|
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(f) under the heading “Point 30 (of Schedule 1) — Mutagens, List 4, category 2 mutagens”, by adding the provisions set out in Schedule H,
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(g) under the heading “Point 30 (of Schedule 1) — Mutagens, List 4, category 2 mutagens”, by adding the provisions set out in Schedule I,
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(h) under the heading “Point 31 (of Schedule 1) — Toxic for reproduction, List 5, category 1 substances toxic for reproduction”, by adding the provisions set out in Schedule J,
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(i) under the heading “Point 31 (of Schedule 1) — Toxic for reproduction, List 6, category 2 substances toxic for reproduction”, by adding the provisions set out in Schedule K,
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(j) under the heading “Point 31 (of Schedule 1) — Toxic for reproduction, List 6, category 2 substances toxic for reproduction”, by adding the provisions set out in Schedule L and
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(k) under the heading “Point 43 (of Schedule 1) — Azocolourants” by substituting the provisions set out in Schedule M.
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(2) Paragraph (k) comes into operation on 30 June 2004.
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(3) Paragraphs (a), (b), (d), (e), (g), (h) and (j) come into operation on 25 December 2004.
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(4) Paragraphs (c), (f) and (i) come into operation on 15 January 2005.
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Schedule A
|
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Regulation 3
(1)(a)
|
| | |
“
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|
20. Commission Directive No. 2003/2/EC
|
Arsenic compounds
|
1. May not be used as substances and constituents of preparations intended for use:
(a) to prevent the fouling by micro-organisms, plants or animals of:
- the hulls of boats,
- cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,
- any totally or partly submerged appliances or equipment;
(b) in the preservation of wood. Furthermore, wood so treated may not be placed on the market;
(c) however, by way of derogation:
(i) Relating to the substances and preparations in the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C. Wood so treated may not be placed on the market before fixation of the preservative is completed.
(ii) Relating to wood treated with CCA solutions in industrial installations according to point (i): this may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:
- as structural timber in public and agricultural buildings, office buildings, and industrial premises,
- in bridges and bridgework,
- as constructional timber in freshwater areas and brackish waters e.g. jetties and bridges,
- as noise barriers,
- in avalanche control,
- in highway safety fencing and barriers,
- as debarked round conifer livestock fence posts,
- in earth retaining structures,
- as electric power transmission and telecommunications poles,
- as underground railway sleepers.
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, all treated wood placed on the market shall be individually labelled “For professional and industrial installation and use only, contains arsenic”. In addition, all wood placed on the market in packs shall also bear a label stating “Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking”.
(iii) Treated wood referred to under points (i) and (ii) may not be used:
- in residential or domestic constructions, whatever the purpose,
- in any application where there is a risk of repeated skin contact,
- in marine waters,
- for agricultural purposes other than for livestock fence posts and structural uses in accordance with point (ii),
- in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.
2. May not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use.
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|
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”.
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Schedule B
|
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Regulation 3
(1)(b)
|
| | |
“
|
|
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|
43. Commission Directive No. 2003/3/EC
|
Azocolourants (See lists of aromatic amines and azodyes in Schedule M to these Regulations.)
|
1. Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in Schedule M to these Regulations, in detectable concentrations, i.e. above 30 ppm in the finished articles or in the dyed parts thereof, according to the testing method established in accordance with Article 2(a) of Council Directive 76/769/EEC introduced by Council Directive 89/678/EEC7
, may not be used in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity, such as:
- clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary items, sleeping bags,
- footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair covers, purses worn round the neck,
- textile or leather toys and toys which include textile or leather garments,
- yarn and fabrics intended for use by the final consumer.
2. Furthermore, the textile and leather articles referred to in point 1 above may not be placed on the market unless they conform to the requirements set out in that point.
By way of derogation, until 1 January 2005, this provision shall not apply to textile articles made of recycled fibres if the amines are released by residues deriving from previous dyeing of the same fibres and if the listed amines are released in concentrations below 70 ppm.
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.
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”.
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Schedule C
|
| |
Regulation 3
(1)(c)
|
| | |
“
|
|
|
|
44. Directive No. 2003/11/EC of the European Parliament and of the Council
|
diphenylether, pentabromo derivative C12H5Br5O
|
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.
|
|
45. Directive No. 2003/11/EC of the European Parliament and of the Council
|
diphenylether, octabromo derivative C12H2Br8O
|
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.
|
|
|
|
”.
|
|
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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
|
|
|
|
|
”.
|
|
|
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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 C39H23ClCrN7O12S.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: C46H30CrN10O20S2.3Na
|
|
|
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 |
