S.I. No. 852/2004 - European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2004

Type Statutory Instrument
Publication 2004-12-15
Last updated 2010-12-31
State Repealed superseded text
Text As published
articles 4

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

1 amending act · 2010-12-31, S.I. No. 633/2010 - European Communities (Dangerous Substances and Preparations) (Marketi…

Reform history JSON API

I, MICHEÁL MARTIN, 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 2003/3/EC of 6 January 20032 , Directive 2003/53/EC of the European Parliament and of the Council of 18 June 20033 , Commission Directive 2004/21/EC of 24 February 20044 , Commission Directive 2004/96/EC of 27 September 20045 and Commission Directive 2004/98/EC of 30 September 20046 , hereby make the following regulations:

1.

1.

(1) These Regulations may be cited as the European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2004.

2.

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 ) as amended by the European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2003 ( S.I. No. 503 of 2003 );

“Regulations of 2003” means the European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2003 ( S.I. No. 503 of 2003 ).

3.

3.

(1) Schedule 1 to the Principal Regulations is amended—

4.

4.

Notwithstanding Regulation 3(1)(c), the validity of any existing national authorisations of pesticides or biocidal products containing nonylphenol ethoxylate (NPE) as a coformulant, which have been granted before 17 July 2003, shall not be affected by these Regulations until such authorisations expire.

SCHEDULE A

Regulation 3 (1)(a)

28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 The provisions at points 1, 2 and 3 below shall apply as follows:—
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 (a) From 20 July 2000 no manufacturer or importer may place on the market products which fail to comply with those provisions, and
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 (b) From 20 July 2001 products which fail to comply with those provisions may not be sold or made available to the final consumer unless they have been placed on the market before 20 January 2000.
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 Nickel and its compounds may not be used:
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 1. in all post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0.2 μg/cm2/week (migration limit).
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 2. in products intended to come into direct and prolonged contact with the skin such as:
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 — earrings,
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 — necklaces, bracelets and chains, anklets, finger rings,
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 — wrist-watch cases, watch straps and tighteners,
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 — rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 if the rate of nickel release from the parts of these products coming into direct and prolonged contact with the skin is greater than 0.5μg/cm2/week; (as measured by the method laid down in the harmonised CEN standard EN 1811:1998 “Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin”, as published in Commission Communication 1999/C 205/05 of 20 July 1999).
28. Directive No. 94/27/EC of the European Parliament and of the Council and Commission Directive 2004/96/EC Nickel and its compounds CAS No. 7440-0-20 EINECS No. 231-111-4 3. in products such as those listed in point 2 where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such products coming into direct and prolonged contact with the skin will not exceed 0.5μg/cm2/week for a period of at least two years of normal use of the product (as measured by the method laid down in the harmonised CEN standard EN 12472:1998 “Method for the simulation of wear and corrosion for the detection of nickel release from coated items”, as published in Commission Communication 1999/C 205/05 of 20 July 1999).

SCHEDULE B

Regulation 3 (1)(b)

43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D 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 3, in detectable concentrations, i.e. above 30 ppm in the finished articles or in the dyed parts thereof, according to the testing methods listed in Schedule 3, 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:
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) — clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary items, sleeping bags,
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) — footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair covers, purses worn round the neck,
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) — textile or leather toys and toys which include textile or leather garments,
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) — yarn and fabrics intended for use by the final consumer.
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) 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.
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) 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.
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) 3. Azodyes, which are contained in the “List of azodyes” set out in Schedule 3, 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.
43. Commission Directive No. 2003/3/EC and Commission Directive No. 2004/21/EC Azocolourants (See lists of aromatic amines and azodyes in Schedule D to these Regulations.) 4. Not later than 11 September 2005, the Commission shall, in the light of new scientific knowledge, review the provisions on azocolourants.
44. Directive No. 2003/11/EC of the European Parliament and of the Council and Commission Directive 2004/98/EC 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
44. Directive No. 2003/11/EC of the European Parliament and of the Council and Commission Directive 2004/98/EC diphenylether, pentabromo derivative C12H5Br5O 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.
44. Directive No. 2003/11/EC of the European Parliament and of the Council and Commission Directive 2004/98/EC diphenylether, pentabromo derivative C12H5Br5O 3. By way of derogation, until 31 March 2006 paragraphs 1 and 2 shall not apply to aircraft emergency evacuation systems.
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.
45. Directive No. 2003/11/EC of the European Parliament and of the Council diphenylether, octabromo derivative C12H2Br8O 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 C

Regulation 3 (1)(c)

46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O May not be placed on the market or used as a substance or constituent of preparations in concentrations equal or higher than 0.1 % by mass for the following purposes:
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (1) industrial and institutional cleaning except:
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — controlled closed dry cleaning systems where the washing liquid is recycled or incinerated,
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — cleaning systems with special treatment where the washing liquid is recycled or incinerated;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (2) domestic cleaning;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (3) textiles and leather processing except:
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — processing with no release into waste water,
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — systems with special treatment where the process water is pretreated to remove the organic fraction completely prior to biological waste water treatment (degreasing of sheepskin);
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (4) emulsifier in agricultural teat dips;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (5) metal working except:
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — uses in controlled closed systems where the washing liquid is recycled or incinerated;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (6) manufacturing of pulp and paper;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (7) cosmetic products;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (8) other personal care products except:
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O — spermicides;
46. Directive No. 2003/53/EC of the European Parliament and of the Council (1) Nonylphenol C6H4(OH)C9H19 (2) Nonylphenol ethoxylate (C2H4O)nC15H24O (9) co-formulants in pesticides and biocides.
47. Directive No. 2003/53/EC of the European Parliament and of the Council Cement (1) Cement and cement-containing preparations may not be used or placed on the market, if they contain, when hydrated, more than 0.0002 % soluble chromium VI of the total dry weight of the cement.
47. Directive No. 2003/53/EC of the European Parliament and of the Council Cement (2) If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of cement or cement-containing preparations shall be legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below the limit indicated in paragraph (1).
47. Directive No. 2003/53/EC of the European Parliament and of the Council Cement (3) By way of derogation, paragraphs (1) and (2) shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing preparations are handled solely by machines and in which there is no possibility of contact with the skin.

SCHEDULE D

Regulation 3(2)

Point 43 (of Schedule 1) — Azocolourants

List of aromatic names

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 C39H23CICrN7O12S.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-)

List of testing methods

European Standardisation Organisation (*) Reference and title of the standard Reference document Reference of the superseded standard
CEN Leather — Chemical tests — Determination of certain azo colourants in dyed leathers CEN ISO/TS 17234:2003 NONE
CEN Textiles — Methods for the determination of certain aromatic amines derived from azo colourants — Part 1: Detection of the use of certain azo colourants accessible without extraction EN 14362-1:2003 NONE
CEN Textiles — Methods for determination of certain aromatic amines derived from azo colourants — Part 2: Detection of the use of certain azo colourants accessible by extracting the fibres EN 14362-2:2003 NONE
(*) ESO: European Standardisation Organisations: CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax: (32-2) 550 08 19. http://www.cenorm.be CENELEC: rue de Stassart 35, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax: (32-2) 519 69 19. http://www.cenelec.org ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax: (33) 493 65 47 16. http://www.etsi.org' (*) ESO: European Standardisation Organisations: CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax: (32-2) 550 08 19. http://www.cenorm.be CENELEC: rue de Stassart 35, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax: (32-2) 519 69 19. http://www.cenelec.org ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax: (33) 493 65 47 16. http://www.etsi.org' (*) ESO: European Standardisation Organisations: CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax: (32-2) 550 08 19. http://www.cenorm.be CENELEC: rue de Stassart 35, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax: (32-2) 519 69 19. http://www.cenelec.org ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax: (33) 493 65 47 16. http://www.etsi.org' (*) ESO: European Standardisation Organisations: CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax: (32-2) 550 08 19. http://www.cenorm.be CENELEC: rue de Stassart 35, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax: (32-2) 519 69 19. http://www.cenelec.org ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax: (33) 493 65 47 16. http://www.etsi.org'
--- ---
GIVEN under my Official Seal, 15th December 2004.
MICHEÁL MARTIN 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).

These Regulations amend Schedules 1 and 3 to the European Communities (Dangerous Substances and Preparations) (Marketing and Use) Regulations, 2003 ( S.I. No. 220 of 2003 ), as previously amended by the European Communities (Dangerous Substances and Preparations) (Marketing and Use) (Amendment) Regulations 2003 ( S.I. No. 503 of 2003 ).

The new Regulations transpose—

Directive 2004/96/EC is transposed through Regulation 3(1)(a) and Schedule A to these Regulations, which come into operation from 1 September 2005.

Directive 2004/21/EC is transposed through Regulation 3(1)(b) and (2), Schedule B, reference number 43, third column, point 1, and Schedule D, “Listing of testing methods”, to these Regulations, which come into operation on 31 December 2004.

Directive 2003/53/EC is transposed through Regulation 3(1)(c) and Schedule C, to these Regulations, which come into operation on 17 January 2005.

The other provisions of Schedule B (third column, points 2 to 4) and Schedule D (“List of aromatic amines” and “List of azodyes”), to these Regulations, retranspose relevant provisions of Directive 2003/3/EC, which were first transposed through S.I. No. 503 of 2003 .

Directive 2004/98/EC is transposed through Regulation 3(1)(b) and Schedule B to these Regulations, reference number 44, third column, point 3, which come into operation from 31 December 2004. Points 1 and 2 of the third column at reference number 44 retranspose relevant provisions of Directive 2003/11/EC, which were first transposed through S.I. No. 503 of 2003 .

Reference number 45 of Schedule B to these Regulations retransposes relevant provisions of Directive 2003/11/EC, which were first transposed through S.I. No. 503 of 2003 .

Footnotes

1

O.J. No. L 262, 27.9.1976, p.201

2

O.J. No. L 4, 9.1.2003, p.12

3

O.J. No. L 178, 17.7.2003, p.24

4

O.J. No. L 57, 25.2.2004, p.4

5

O.J. No. L 301, 28.9.2004, p. 51

6

O.J. No. L 305, 1.10.2004, p.63

7

O.J. No. L 262, 27.9.1976, p. 201

8

O.J. No. L 4, 9.1.2003, p. 12

9

O.J. No. L 178, 17.7.2003, p. 24

10

O.J. No. L 57, 25.2.2004, p. 4

11

O.J. No. L 305, 1.10.2004, p. 63

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