S.I. No. 116/2003 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003

0. Identity of manufacturer and the identity of the notifier: Location of the production site. For substances manufactured outside the Community and for which, for the purpose of notification the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community.

1.

IDENTITY OF THE SUBSTANCE

1.1.

Name

1.1.1.

Name in the IUPAC nomenclature

1.1.2.

Other names (usual name, trade name, abbreviation).

1.1.3.

CAS number and CAS name if available

1.2

Molecular and structural formula

1.2.1

Number average molecular weight

1.2.2

Molecular weight distribution (MWD)

1.2.3.

Identity and concentration of starting monomers and starting substances which will be bound in the polymer

1.2.4.

Indication of end groups and identity and frequency of reactive functional groups

1.3.

Composition of the substance

1.3.1.

Degree of purity (%)

1.3.2.

Nature of impurities, including by-products

1.3.2.1

Identity of non-reacted monomers

1.3.3.

Percentage of (significant) main impurities

1.3.3.1.

Percentage of non-reacted monomers

1.3.4.

If the substances contains a stabilizing agent or an inhibitor or other additives, specify: nature order of magnitude: … ppm, … % 1.3.5. Spectral data (UV, IR, NMR or mass spectrum)

1.3.6.1.

GPC1.

1.4.

Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references. Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans.

2.

INFORMATION ON THE SUBSTANCE

2.0.

Production

Information given in the section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature are not required.

2.0.1.

Technological process in production.

2.0.2.

Exposure estimates related to production

- working environment

- environment

2.1.

Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1.

Types of use: description of the function and the desired effect

2.1.1.1.

Technological process(es) related to the use of the substance (where known)

2.1.1.2.

Exposure estimate(s) related to the use (where known)

- working environment

- environment

2.1.1.3.

Form under which the substance is marketed: substance, preparation, product

2.1.1.4.

Concentration of the substance in marketing preparations and products (where known)

2.1.2.

Fields of application with approximate breakdown

- industries

- farmers and skilled trades

- use by the public at large

2.1.3.

Where known and where appropriate, the identify of the recipients of the substance

2.1.4.

Waste quantities and composition of waste resulting from the proposed uses (where known)

2.2.

Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1.

Overall production and/or imports in tonnes per year

- the first calendar year

- the following calendar years

For the substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section O above.

2.2.2.

Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage: - the first calendar year- the following calendar years

2.3.

Recommended methods and precautions concerning

2.3.1.

Handling

2.3.2.

Storage

2.3.3.

Transport

2.3.4.

Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5.

Other dangers, particularly chemical reaction with water

2.3.6.

If relevant, information concerning the susceptibility of the substance to explode when present in the form of a dust

2.4.

Emergency measures in the case of accidental spillage

2.5

Emergency measures in the case of injury to persons (e. g. poisoning)

2.6.

Packaging

1. For a notification under Regulation 10 (1) (“base set”) (See notes 1 and 2)

€8,380

2. For a re-notification submitted in accordance with Regulation 17 (1) (See notes 1 and 2)

€1,675

3. For a notification of a substance notified at least 10 years previously (Regulation 12) (See notes 1 and 2)

€1,675

4. For additional tests submitted under Regulation 10(3)

(a)

(>10 tonnes per year)

€8,380

5. For additional tests submitted under Regulation 10(3)

(b)

(>100 tonnes per year)

€8,380

6. For additional tests submitted under Regulation 10(3)(c) (>1000 tonnes per year)

€16,760

7. For a notification under Regulation 11 (see note 3)

(a)

quantity of the new substance equal to or more than 100kg (Regulation 11(1))

€1,675

(b)

quantity of the new substance up to 100kg

1

(Regulation 11(3))

€838

8. For a successful application made by a notifier for an exemption relating to him under Regulation 15(3)

€838

Note 1. Additional charge where notification particulars are not provided on an approved diskette -

€304

Note 2. Additional charge where an adequate risk assessment is not included -

€3,809

Note 3. Additional charge where an adequate risk assessment is not included -

€838

GIVEN under my Official Seal,

27 March 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

).

These Regulations transpose for the first time Commission Directive 2001/58/EC amending for the second time Directive 91/155/EEC, relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets) and Commission Directive 2001/59/EC, the 28

th

Adaptation to Technical Progress of Council Directive 67/548/EEC. (The provisions of Commission Directive 2001/58/EC relating to dangerous preparations in implementation of European Parliament and Council Directive 1999/45/EC will be transposed in separate Regulations.)

These Regulations also retranspose Council Directive 92/32/EEC, amending for the 7th time Directive 67/548/EEC, together with Council Directive 96/56/EC and Commission Directives 92/69/EEC (17

th

ATP), 93/21/EEC (18

th

ATP), 93/72/EEC (19

th

ATP), 93/101/EC (20

th

ATP), 94/69/EC (21

st

ATP) 96/54/EC (22

nd

ATP), 97/69/EC (23

rd

ATP), 98/73/EC (24

th

ATP), 98/98/EEC (25

th

ATP), 2000/32/EC (26

th

ATP) and 2000/33/EC (27

th

ATP). Related Commission Directives on Risk Assessment (93/67/EEC), on substances for which equivalent European Community notification or approval systems exist (93/90/EEC), data requirements for polymers (93/105/EC) and requirements for Safety Data Sheets (91/155/EEC, 93/112/EC) are also retransposed.

These Regulations revoke the European Communities (Dangerous Substances) (Classification, Packaging and Labelling) Regulations, 2000 (

S.I. No. 393 of 2000

).

The aim of these Regulations is to protect man and the environment from the harmful effects of both new substances and existing dangerous substances. The Regulations apply to all substances which are intended to be placed on the market either on their own or in a preparation with exceptions for certain categories of substances such as medicinal, cosmetic, pesticide, waste, etc., products which are covered by other Directives.

They require each manufacturer, importer or other person proposing to place any new chemical on the market for the first time to submit to the competent authority a notification dossier containing details of tests to which the substance has been subjected and the proposed classification and labelling of the substance.

The Regulations also require suppliers to put warning labels on containers for dangerous substances and to ensure that the containers are properly designed, constructed and secured to prevent spillage or seepage during normal use. Safety data sheets must be supplied for dangerous substances covered by these Regulations.

Commission Directive 2001/59/EC adapts to technical progress for the 28

th

time Annexes I, III, V, VI VII and VIII of Directive 67/548/EEC.

• The Directive adds a number of additional dangerous substances to Annex I, the list of substances classified and labelled as dangerous in the European Community, amends the classification and labelling of a number of other dangerous substances already included in Annex 1, and deletes a number of existing entries in the Annex.

• In addition, the Foreword to Annex I is updated. It is provided for the first time as Schedule 1 to the Regulations.

• Additional risk phrases are included in Annex III of the Directive and are set out in Schedule 3 to the Regulations.

• Safety advice is set out in Annex VI and is set out in Schedule 5 to the Regulations.

• Additional test methods are incorporated into Annex V.

• Annex VI, the general classification and labelling guide, is set out in Schedule 5 to the Regulations.

• Annex VII is amended to contain details of the reduced test package (RTP) which can be submitted for intermediates with limited exposure and is set out in Schedule 6 to the Regulations.

• Annex VIII is amended to detail additional tests that may be required for intermediates with limited exposure marketed in higher volumes. The Irish Competent Authority shall produce guidelines on this Reduced Test Package.

• Annex IX contains provisions relating to child-proof fastenings and tactile warning devices and is set out in Schedule 7 to the Regulations.

• Schedule 8 to the Regulations sets out the obligatory headings for safety data sheets.

The Fees payable by the notifier are set out in Schedule 9 to the Regulations.

The Hazardous Substances Assessment Unit of the Health and Safety Authority, 10 Hogan Place, Dublin 2. is the competent authority to which notifications under these Regulations should be sent.

1

O.J. L 154, 5.6.1992, p. 1 and O.J. L 154A, 5.6.1992, p.1

2

O.J. L 236, 18.9.1996, p. 35

3

O.J. L 76, 22.3.1991, p.35

4

O.J. L 383, 29.12.1992, p. 113 and O.J. L 383A, 29.12.1992, p. 1

5

O.J. L 110, 4.5.1993, p. 20 and O.J. L 110A, 4.5.1993, p.1

6

O.J. L 227, 8.9.1993, p.9.

7

O.J. L 258, 16.10.1993 p. 29 and O.J. L 258A, 16.10.1993, p.1

8

O.J. L 13, 15.1.1994, p.1

9

O.J. L 294, 30.11.1993, p.21

10

O.J. L 314, 16.12.1993, p.38

11

O.J. L 381, 31.12.1994, p.1

12

O.J. L 248, 30.9.1996, p.1

13

O.J. L 343, 13.12.1997, p.19

14

O.J. l 305, 16.11.1998, p.1 as corrected by Corrigendum to Commission Directive 98/73/EC of 18 September, 1998, O.J. L285, 8.11.1999, p.1

15

O.J. L355, 30.12.1998, p.1 as corrected by Corrigendum to Commission Directive 98/98/EC of 15 December, 1998, O.J. L293, 15.11.1999, p.1 and Commission Decision of 19 May 2000, correcting Commission Directive 98/98/EC of 15 December, 1998, O.J. L136, 8.6.2000, p108

16

O.J. L 136, 8.6.2000, p. 1

17

O.J. L 103, 28.4.2000, p. 70

18

O.J. L 136, 8.6.2000, p. 90

19

O.J. L212, 7.8.2001, p.24

20

O.J. L225, 21.8.2001, p. 1

21

O.J. 196, 16.8.1967, p. 1

22

O.J. L 154, 5.6.1992, p. 1 and O.J. L 154A, 5.6.1992, p. 1

23

O.J. L 236, 18.9.1996, p. 35

24

O.J. L 76, 22.3.1991, p.35

25

O.J. L 383, 29.12.1992, p. 113 and O.J. L 383A, 29.12.1992, p. 1

26

O.J. L 110, 4.5.1993, p. 20 and O.J. L 110A, 4.5.1993, p. 1

27

O.J. L 227, 8.9.1993, p. 9.

28

O.J. L 258, 16.10.1993 p. 29 and O.J. L 258A, 16.10.1993, p.1

29

O.J. L 13, 15.1.1994, p.1

30

O.J. L 294, 30.11.1993, p. 21

31

O.J. L 314, 16.12.1993, p.38

32

O.J. L 381, 31.12.1994, p.1

33

O.J. L 248, 30.9.1996, p.1

34

O.J. L 343, 13.12.1997, p. 19

35

O.J. L305, 16.11.1998, p.1 as corrected by Corrigendum to Commission Directive 98/73/EC of 18 September, 1998, O.J. L285, 8.11.1999, p.1

36

O.J. L355, 30.12.1998, p.1 as corrected by Corrigendum to Commission Directive 98/98/EC of 15 December, 1998, O.J. L293, 15.11.1999, p.1 and Commission Decision of 19 May 2000, correcting Commission Directive 98/98/EC of 15 December, 1998, O.J. L136, 8.6.2000, p108

37

O.J. L 136, 8.6.2000, p. 1

38

O.J. L 103, 28.4.2000, p. 70

39

O.J. L 136, 8.6.2000, p. 90

40

O.J. L212, 7.8.2001, p.24

41

O.J. L225, 21.8.2001, p. 1

42

O.J. C 146A, 15.6.1990, p.1

43

O.J. C 361, 7.12.1994, p.1

44

O.J. 22, 9.2.1965, p. 369

45

O.J. L214, 24.8.1993 p22

46

O.J. L 262, 27.9.1976, p. 169

47

O.J. L253, 15.9.1998, p20

48

O.J. L 194, 15.7.1975 p. 39

49

O.J. L135, 6.6.1996, p32

50

O.J. L377, 31.12.1991, p20

51

O.J. L168, 2.7.1994, p28

52

O.J. L 246, 17.9.1980, p. 1

53

O.J. L 358, 18.12.1986, p. 1

54

O.J. L 15, 17.1.1987, p. 29

55

O.J. L200, 30.7.2000, p.1

56

O.J. L 270, 14.12.1970, p. 1

57

O.J. L 213, 21.7. 1982, p. 8

58

O.J. L 40, 11.2. 1989, p. 27

59

O.J. L 184, 15.7. 1988, P. 61

60

This article corresponds to Regulation 20.

61

This article corresponds to Regulation 2(2).

62

The category of carcinogen, mutagen or toxic for reproduction (i.e. 1, 2 or 3) is shown as appropriate.

62

The category of carcinogen, mutagen or toxic for reproduction (i.e. 1, 2 or 3) is shown as appropriate.

62

The category of carcinogen, mutagen or toxic for reproduction (i.e. 1, 2 or 3) is shown as appropriate.

63

This article corresponds to Regulation 9.

64

This article corresponds to Regulation 8

65

This article corresponds to Regulation 9

66

These articles correspond to Regulations 19, 20 and 21

67

This Annex corresponds to Schedule 6

68

This article corresponds to Regulation 2(2)

69

J.R. Young, M.J. How, A.P. Walker and W.M.H. Worth (1988) “Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances, without testing on animals” Toxic. In Vitro 2(1): 19-26.

70

This Annex corresponds to Schedule 2

71

This Annex corresponds to Schedule 3

72

This Annex corresponds to Schedule 4

73

This article corresponds to Regulation 22(2)(b)

74

This article corresponds to Regulation 24

75

O.J. L319, 12.12.1994, p. 7.

76 The type of construction and the technical specifications (e.g. leakproofness) of the closed functional element determines the effectiveness of the containment. To enable the competent authority to make a decision as to whether rigorous containment is achieved or not, it is essential that the noti fier includes details on these aspects. The technical measures must normally fulfil the conditions of the “Criteria for the Assessment of Closed Systems during Handling of Chemical Agents”, which are included for guidance in section 7.5 of these Regulations and Table 1 of Annex VIIA of Directive 67/548/EEC (As set down in Annex VB of Commission Directive 2001/59/EC: O.J. L225, 21.08.2001 p320 - 332

77

This article corresponds to Regulation 10

78

This article corresponds to Regulation 19(a)

1

Including a re-notification submitted in accordance with Regulation 17(1)

9. Obligation to carry out investigation

Manufacturers, distributors and importers of dangerous substances, which appear in the EINECS but which hsve not yet been introduced into Annex 1 shall carry out an investigation to make themselves aware of the relevant and accessible data existing concerning the properties of such substances, and on the basis of this information shall package and provisionally label these substances in accordance with Regulations 19 to 21 and the criteria specified in Annex VI.

10. Full Notification

(1) A notifier intending to place on the European Communities market a substance in quantities of greater than or equal to one tonne per annum per manufacturer shall submit to the competent authority, a notification including -

(a) a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose,

(b) a declaration concerning the unfavourable effects of the substance in relation to the various foreseeable uses,

(c) the proposed classification and labelling of the substance in accordance with these Regulations,

(d) in the case of dangerous substances, a proposal for a safety data sheet in accordance with Regulation 24,

(e) in the case of a manufacturer located outside the European Communities, a statement if appropriate from the manufacturer to the effect that, for the purpose of submitting a notification for the substance in question, he is designated as the manufacturer's sole representative,

(f) if so desired by the notifier, a statement requesting on reasoned grounds that as a first notifier of a substance the notification be exempted from the provisions of Regulation 17(2) for a maximum period which shall not in any case exceed one year following the date of notification,

(g) if so desired by the notifier, a preliminary assessment of the real or potential risk to man and the environment on the basis of the principles adopted in Directive 93/67/EEC.

(2) A dossier required by paragraph (1) (a) shall contain the information and results of the studies referred to in Annex VII.A, together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them.

(3) Notwithstanding anything in Regulation 16, a notifier of a substance already notified shall inform the competent authority -

(a) when the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when the total quantity placed on the market reaches 50 tonnes per manufacturer, and in such case the competent authority may require some or all of the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines;

(b) when the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when the total quantity placed on the market reaches 500 tonnes per manufacturer, and in such case the competent authority shall require the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines, unless the notifier can give good reason why a particular test or study is not appropriate or an alternative scientific test or study would be preferable;

(c) when the quantity of a substance placed on the market reaches 1,000 tonnes per year per manufacturer or when the total quantity placed on the market reaches 5,000 tonnes per manufacturer, and in such case the competent authority shall draw up a programme of tests and studies according to Annex VIII, level 2, to be carried out by the notifier within such period as the competent authority determines.

(4) When additional tests or studies are carried out either in accordance with the requirements of paragraph (3) or voluntarily, the notifier shall provide the competent authority with the results of such tests or studies.

(5) Where a notifier requests the competent authority to grant permission to apply a reduced test package (RTP) for intermediates in accordance with Annex VIIA, section 7, or Annex VIII Level 1, then the notifier shall

(a) at any time at the request of the competent authority provide verification by an independent competent person, chosen in agreement with the competent authority and paid for by the notifier, that the conditions for application of the RTP are being applied on the site, or sites, in question, and

(b) immediately upgrade the dossier to the appropriate level, as if the RTP criteria did not apply, if in the opinion of the competent authority such verification is not demonstrated within such period as the competent authority determines.

(6) Notwithstanding paragraph (5) where the competent authority finds that any of the conditions for application of the RTP are not being applied on the site, or sites, for which a dossier has been accepted it shall so inform the notifier who shall upgrade the dossier to the appropriate level as if the RTP criteria did not apply.

11. Reduced Notification for substances placed on the market in quantities of less than one tonne per annum

(1) Subject to Regulation 15(2), a notifier intending to place on the European Communities market a substance in quantities of less than one tonne per annum per manufacturer shall submit to the competent authority a notification including the information referred to in Regulation 10(1).

(2) A dossier required by paragraph (1) shall contain the information and results of the studies referred to in Annex VII.B, together with a full and detailed description of the studies conducted and of the methods used or a bibliographical reference to them if the competent authority so requires.

(3) When the quantities to be placed on the market are below 100kg per year per manufacturer the notifier may, without prejudice to Regulation 7(3), restrict the information in the technical dossier referred to in paragraph (2) to that provided for in Annex VII.C.

(4) In the case of a notifier who has submitted a reduced notification dossier under paragraph (3), he shall, before the quantity of the substance placed on the market reaches 100 kg per year per manufacturer or before the total quantity placed on the market reaches 500 kg per manufacturer provide the competent authority with the additional information necessary to complete the technical dossier to the level referred to in paragraph (2).

(5) In the case of a notifier who has submitted a reduced notification dossier under paragraph (1) he shall, before the quantity of the substance placed on the market reaches 1 tonne per year per manufacturer, or before the total quantity placed on the market reaches 5 tonnes per manufacturer submit a full notification in accordance with Regulation 10.

(6) The substances notified under paragraphs (1) and (3) shall, in so far as the notifier may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled in accordance with Regulations 19 to 21.

(7) Where it is not possible to label substances in accordance with Regulation 20, because all the results of tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

12. Substances notified at least 10 years previously

Where the information specified in Annex VII.A, VII.B, VII.C or VII.D is required in accordance with these Regulations, a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

13. Notification of Polymers

In the case of polymers, the provisions concerning the technical dossiers contained in the notifications referred to in Regulations 10(2) and 11(2) shall be construed as if the reference to Annex VII.A and Annex VII.B respectively were a reference to Annex VII.D.

14. Pre-marketing Notification Period

(1) (a) Substances notified under Regulation 10 may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 60 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

(b) Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 60 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

(2) (a) Substances notified under Regulation 11(1) or 11(3) may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 30 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

(b) Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 30 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

(c) Notwithstanding subparagraph (a) where the notifier has received notice from the competent authority of the official number which has been allocated to his notification indicating acceptance of the dossier, the substance may be placed on the market no sooner than 15 days after receipt of the dossier by the competent authority.

15. Exemptions from the notification requirements

(1) The following substances shall be exempt from the notification requirements specified in these Regulations —

(a) substances which appear on the EINECS inventory,

(b) additives and substances for exclusive use in animal feeding stuffs and to which Directives 70/524/EEC

56

and 82/471/EEC

57

apply,

(c) substances used exclusively as additives in foodstuffs, to which Directive 89/107/EEC

58

applies, and substances used exclusively as flavourings in foodstuffs to which Directive 88/388/EEC

59

applies,

(d) active ingredients used exclusively in medicinal products for human or veterinary use, as defined in Directive 65/65/EEC as amended by Commission Directive 93/39/EEC,

(e) substances for exclusive use in other product sectors for which European Communities notification or approval procedures exist, as set out in the Annex to Commission Directive 2000/21/EC of 25 April 2000, and for which the requirements for data submission are equivalent to those laid down in these Regulations, and

(f) substances manufactured in the European Communities, which are not included in EINECS or ELINCS but are intended solely for export outside the European Communities, provided the manufacturer notifies such substances to the competent authority, and in relation to which such notification includes the following information -

(i) the identity of the substance in accordance with point 1 of Annex VII.C,

(ii) the quantity of the substance to be exported,

(iii) the country of destination of the substance,

(iv) information on the hazards of the substance, where available,

(v) the proposed labelling of the substance, and

the competent authority may communicate the contents of such notifications to the Commission and the competent authorities of other Member States.

(2) The following substances shall be considered as having been notified within the meaning of these Regulations-

(a) polymers, with the exception of those which contain in combined form 2% or more of any substance which is not on EINECS;

(b) substances placed on the market in quantities of less than 10 kg per year per manufacturer;

(c) substances placed on the market in quantities not exceeding 100 kg per manufacturer per year, and intended solely for purposes of scientific research and development carried out under controlled conditions, provided the manufacturer or importer maintains written records, containing the identity of the substance labelling data, quantities and a list of customers involved, which shall be made available upon request to the competent authorities of each Member State where the manufacture, importation or scientific research and development takes place; and

(d) without prejudice to the provisions of paragraph (3)(a), substances placed on the market for the purposes of process-orientated research and development with a limited number of registered customers in quantities which are limited to the purpose of process-orientated research and development.

3(a) Substances referred to in paragraph (2)(d) shall qualify for an exemption for a period of one year if the manufacturer or importer communicates their identity, labelling data quantity, the justification for the quantity and a list of customers and the research and development programme to the competent authorities of each Member State where the manufacture, importation or process-orientated research and development takes place and complies with any conditions imposed by these authorities or the Member States on such research and development, and the conditions imposed by the competent authorities or the Member States may include information not exceeding that provided for in Annex VII.C for quantities less than 500 kg, Annex VII.B for quantities between 500 kg and less than 1 tonne, and Annex VII.A for other quantities.

(b) The manufacturer or importer shall also give an assurance to the competent authority that the substance or the preparation in which it is incorporated will be handled only by customers' staff in controlled conditions and will not be made available to the general public at any time either on its own or in a preparation.

(c) Where the competent authority considers that there may exist an unacceptable risk for man and the environment, it may restrict any product, containing a new substance which was produced during the process-orientated research and development.

(d) The one-year exemption period referred to in subparagraph (a) may be extended for a further year where the notifier can demonstrate, to the satisfaction of the competent authority that such an extension is justified.

(4) (a) A substance referred to in paragraph (2) shall, where the manufacturer may reasonably be expected to be aware of its dangerous properties, be packaged and provisionally labelled by the manufacturer or his representative in accordance with Regulations 19 to 21.

(b) Where it is not possible to label the substances completely and in accordance with Regulation 20, because the results of all tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

(c) Where a substance referred to in paragraph (2) is labelled as very toxic, toxic carcinogenic, toxic for reproduction, or mutagenic in accordance with Regulation 20, the manufacturer or importer of such a substance shall submit to the competent authority any appropriate information specified in Annex VII.A Sections 2.3, 2.4 and 2.5, including, where available, acute toxicity data.

(5) Where the information specified in Annex VII.A, VII.B, VII.C or VII.D, is required in accordance with these Regulations a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

16. Follow-up Information

(1) Any notifier of a substance already notified in conformity with Regulation 10(1) or Regulation 11(1) shall inform the competent authority in writing of any -

(a) change in the annual or total quantities placed on the market by him or, by him or others as the case may be where he is the sole representative for a substance manufactured outside the European Communities,

(b) new knowledge of the effects of the substance on man of which he may reasonably be expected to have become aware,

(c) new knowledge of the effects of the substance on the environment of which he may reasonably be expected to have become aware,

(d) new uses for which the substance is placed on the market of which he may reasonably be expected to have become aware,

(e) change in the composition of the substance as given in section 1.3 of each of Annexes VII.A, VII.B, VII.C and VII.D,

(f) change in his status as manufacturer or importer.

(2) An importer of a substance produced by a manufacturer established outside the European Communities who imports the substance under a notification previously submitted by a sole representative shall ensure that the sole representative is provided with up-to-date information concerning the quantities of the substance placed on the market by him.

(3) Where the sole representative ceases to act in that capacity the importer shall submit the information required under paragraph (2) to such other sole representative as may exist or, in his absence, to the competent authority.

17. Re-notification of the same substance and avoidance of duplicate testing on vertebrate animals

(1) In the case of a substance which has already been notified in accordance with Regulation 10(1) or 11(1), the competent authority may agree that the subsequent notifier of that substance may, for the purposes of sections 3, 4 and 5 of each of Annexes VII.A, VII.B and VII.D and sections 3 and 4 of Annex VII.C, refer to the results of the tests and studies forwarded by the first notifier, in so far as the subsequent notifier can provide evidence that the substance renotified is the same as the one previously notified, including the degree of purity and the nature of impurities, but the first notifier shall give his agreement in writing to the references to the results of the tests and studies he has forwarded before such reference can be made.

(2) Before carrying out testing on vertebrate animals for the purpose of submitting a notification under Regulations 10(1) or 11(1) and notwithstanding paragraph (1), prospective notifiers shall enquire of the competent authority as to -

(a) whether or not the substance they intend to notify has already been notified;

(b) the name and address of the first notifier, and

this enquiry shall be supported by evidence that the prospective notifier intends to place the substance on the market and, specify the quantities involved.

(3) Where a substance has been previously notified and the competent authority is satisfied with the evidence provided under paragraph (2), it shall supply the prospective notifier with the name and address of the first notifier and shall inform the first notifier of the name and address of the prospective notifier except where the first notifier has requested and been granted a temporary exemption from the provisions of this paragraph.

(4) The first notifier and the prospective notifier shall take all reasonable steps to reach an agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(5) Notifiers of the same substance who have agreed to share information relating to Annex VII.A VII.B, VII.C or VII.D in accordance with paragraphs (1) and (4) shall take all necessary steps to reach an agreement on the sharing of information derived from testing on vertebrate animals submitted in conformity with Regulation 10(3).

(6) Where notifiers and prospective notifiers of the same substance cannot reach an agreement on the sharing of data, the competent authority may require notifiers and prospective notifiers to share the data with a view to avoiding duplicative testing on vertebrate animals and may determine the procedure for utilizing information.

18. Confidentiality of data

(1) A notifier may, in a submission made under Regulations 10, 11 or 17, indicate the information required by these Regulations which the notifier considers to be commercially sensitive and disclosure of which could cause industrial or commercial damage to that notifier, and in respect of which that notifier requires to be kept secret from all persons other than the competent authority and the Commission, and shall give full justification in such cases.

(2) Industrial and commercial secrecy shall not apply to -

(a) the trade name of the substance,

(b) the name of the manufacturer and the notifier,

(c) physico-chemical data concerning the substance in connection with section 3 of each of Annexes VII.A, VII.B, VII.C, and VII.D,

(d) the possible ways of rendering the substance harmless,

(e) the summary results of the toxicological and ecotoxicological tests,

(f) the degree of purity of the substance or the identity of impurities or additives which are known to be dangerous within the meaning of these Regulations, if essential to classification and labelling for the purpose of introducing the substance into Annex I,

(g) the recommended methods and precautions referred to in Annexes VII.A, VII.B, VII.C and VII.D, section 2.3, and the emergency measures referred to in Annex VII.A, VII.B VII.C and VII.D, sections 2.4 and 2.5,

(h) the information contained in the safety data sheet,

(i) in the case of substances in Annex I, analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

(3) Where the notifier, manufacturer or importer himself subsequently discloses previously confidential information, he shall inform the competent authority accordingly.

(4) The competent authority, on receipt of information under Regulation 10, 11 or 17 shall decide at its discretion which information is covered by industrial and commercial secrecy in accordance with paragraph (1).

(5) Confidential information brought to the attention of the competent authority shall be kept secret by it.

(6) In all cases such confidential information -

(a) may be brought to the attention only of the Commission and the competent authority of another Member State,

(b) may, when administrative or legal proceedings involving sanctions are undertaken for the purpose of controlling substances placed on the market, be divulged to persons directly involved in such proceedings,

(c) may be divulged to persons directly involved in providing medical information in the case of exposure or likely exposure of persons to the substance, especially in emergencies, and such information may only be used to formulate preventative and curative measures in relation to exposure of persons to the substance.

(7) For a substance appearing in ELINCS which is not classified as dangerous for the purpose of these Regulations, its name may be included in the form of its trade name when requested by the competent authority.

(8) Substances referred to in paragraph (7) may be included in ELINCS in the form of their trade name for a maximum of three years unless the competent authority considers that the publication of the chemical name in the International Union of Pure and Applied Chemistry (IUPAC nomenclature itself could reveal information concerning commercial exploitation or manufacture in which case the name of the substance may be recorded under its trade name alone for as long as the competent authority sees fit.

(9) Dangerous substances to which these Regulations apply may, at the request of the competent authority, be entered on ELINCS in the form of their trade names alone until such time as they are introduced into Annex I.

(10) “Industrial and commercial secrecy” shall be construed in accordance with paragraph (1).

19. Packaging

A dangerous substance to which these Regulations apply shall not be placed on the market unless its packaging satisfies the following requirements -

(a) it is so designed and constructed that its contents cannot escape, except in a case where special safety devices are prescribed by Regulations made by the Minister,

(b) the materials constituting the packaging and fastening are not susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents,

(c) the packaging and fastenings are sufficiently strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling,

(d) containers fitted with replaceable fastening devices can be repeatedly refastened without the contents escaping,

(e) containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “very toxic”, “toxic” or “corrosive” as defined in these Regulations must have a child resistant fastening and bear a tactile warning of danger,

(f) containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “harmful”, “extremely flammable” or “highly flammable” as defined in these Regulations must bear a tactile warning of danger.

20. Labelling

(1) A dangerous substance to which these Regulations apply shall not be placed on the market unless the labelling on its packaging shows clearly and indelibly the following -

(a) the name of the substance under one of the designations given in Annex I, or, if the substance is not yet listed in Annex I, a name using an internationally recognised designation for that substance,

(b) the name and full address, including the telephone number, of the person established in the European Communities who is responsible for placing the substance on the market,

(c) danger symbols, if required, and an indication of the danger involved in the use of the substance,

(d) standard phrases (risk phrases) indicating the special risks arising from the dangers involved in using the substance,

(e) standard phrases (safety phrases) relating to the safe use of the substance,

(f) the EC number, if allocated, and

(g) for substances listed in Annex I, the words “EC label”.

(2) Subject to paragraphs (3) and (5) -

(a) the design of danger symbols and the wording of the indications of danger shall comply with those laid down in Annex II;

(b) the danger symbol shall be printed in black on an orange-yellow background; and

(c) the danger symbols and indications of danger to be used for each substance shall —

(i) for substances listed in Annex I, be those indicated in that Annex; and

(ii) for substances not listed in Annex I, be assigned according to the rules laid down in Annex VI.

(3) When more than one danger symbol is assigned to a substance, the following requirements apply-

(a) the obligation to indicate the symbol T makes the symbols X and C optional, unless Annex I provides otherwise;

(b) the obligation to indicate the symbol C makes the symbol X optional; and

(c) the obligation to indicate the symbol E makes the symbol F and O optional.

(4) Subject to paragraph (8) -

(a) the wording of risk phrases shall comply with that laid down in Annex III,

(b) the risk phrases to be used for each substance shall -

(i) be as indicated in Annex I, and

(ii) for dangerous substances not yet appearing in Annex I the risk phrases to be used shall be assigned according to the rules laid down in Annex VI.

(5) The requirement to label with the symbol “Xn”, the indication of danger “Harmful” and the risk phrase R65 “Harmful: may cause lung damage if swallowed” shall not apply to substances which are placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

(6) Subject to paragraph (8) -

(a) the wording of safety phrases shall comply with that laid down in Annex IV, and

(b) the safety phrases to be used for each dangerous substance shall —

(i) be as indicated in Annex I,

(ii) for dangerous substances not yet appearing in Annex I, the safety phrase to be used shall be as assigned according to the rules laid down in Annex VI.

(7) The EC number shall be obtained from the EINECS or from the ELINCS.

(8) An indication of risk phrases and safety phrases need not be given if the package contains 125 millilitres or less of -

(a) an irritant, highly flammable, flammable or oxidising substance, or

(b) a harmful substance that is not retailed to the general public.

(9) Indications such as “non-toxic”, “non-harmful” or any other similar indications shall not appear on the label or packaging of substances to which these Regulations apply.

(10) The information referred to in paragraph (1) shall be shown on the packaging in the English language or in both the English and Irish languages.

(11) Subject to Regulation 22(2)(b), gas cylinders placed on the market and intended for propane butane or liquefied petroleum gas shall be labelled in accordance with the requirements of these Regulations.

(12) Information regarding effects on human health is not required on the label of gas containers intended for propane, butane or liquefied petroleum gas if —

(a) the propane, butane or liquefied petroleum gas is placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of ISEN 417 1993 as fuel gases which are only released for combustion,

(b) the information regarding effects on human health is transmitted, in the format required by Regulation 24, to professional or industrial users, distributors, wholesalers, retailers and consumers by the person placing the propane, butane or liquefied petroleum gas on the market, and

(c) sufficient information regarding effects on human health is transmitted to consumers to enable them to take all necessary measures for health and safety as indicated in Article 1 paragraph 3 of Commission Directive 91/155/EEC of 5 March, 1991, as modified by Commission Directive 93/112/EEC of 10 December, 1993 and Commission Directive 2001/58/EC of 27 July 2001.

(13) For the purpose of paragraph 12 (a), “ISEN 417 1993” means Irish Standard ISEN 417 1993 of the National Standards Authority of Ireland.

21. Implementation of labelling

(1) Where the particulars required by Regulation 20 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that these particulars can be read horizontally when the package is set down normally.

(2) The dimensions of such a label shall be as follows -

Capacity of the package

Dimensions

(in millimetres)

- Not exceeding three litres

if possible at least 52 × 74

- Greater than three litres but not exceeding 50 litres

at least 74 × 105

- Greater than 50 litres but not exceeding 500 litres

at least 105 × 148

- Greater than 500 litres

at least 148 × 210

(3) Each symbol required by Regulation 20 shall cover at least one-tenth of the surface area of the label but not be less than one square centimetre (1 cm

2

), and the entire surface of the label shall adhere to the package immediately containing the substance.

(4) A label shall not be required where the particulars are clearly shown on the package itself in accordance with this Regulation.

(5) The colour and presentation of the label (or, in the case of paragraph (3), of the package) shall be such that the danger symbol and its background stand out clearly from the label or package.

(6) The information required on a label by Regulation 20 shall stand out clearly from its background and shall be of such size and spacing as to be easily read and shall be in accordance with the provisions of Annex VI.

22. Exemptions from labelling and packaging requirements

(1) The packaging and labelling requirements of Regulations 19 to 21 shall not apply to munitions and explosives placed on the market with a view to producing a practical effect by explosion or a pyrotechnic effect.

(2) For the purpose of these Regulations, labelling requirements shall be deemed to be satisfied -

(a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous substances and the inner package or packages are labelled in accordance with Regulations 20 and 21; and

(b) in the case of a single package if such a package is labelled in accordance with international rules on the transport of dangerous substances and with Regulations 20(1)(a), (b), (d), (e) and (f), and where appropriate, for particular types of packaging such as mobile gas cylinders, in accordance with the specific requirements referred to in Annex VI.

(3) The packaging of dangerous substances which are not explosive, very toxic or toxic may be unlabelled or may be labelled in such other way as may be approved by the competent authority if they contain such small quantities that there is no reason to fear any danger to persons handling such substances or to other persons.

(4) The packaging of dangerous substances which are explosive, very toxic or toxic may be labelled in such other way as may be approved by the competent authority if they are too small for labelling in accordance with Regulations 20 and 21 and there is no reason to fear any danger to persons handling such substances or to other persons.

(5) The labelling required on packages which are either too small or otherwise unsuitable for labelling in accordance with Regulations 20 and 21 may be applied on packages in such other appropriate manner as may be approved by the competent authority.

(6) A derogation under paragraph (3), (4), or (5) shall not permit the use of symbols, indications of danger, risk phrases or safety phrases different from those required by these Regulations.

(7) Where dangerous substances do not leave the State, the competent authority may permit labelling that complies with national rules relating to the transport of dangerous substances.

23. Advertising

A person shall not publish any advertisement for a substance which belongs to one or more of the categories referred to in Regulation 8(1)(a) to (o) unless mention is made in the advertisement of the category or categories concerned.

24. Safety Data Sheet

(1) A person placing a dangerous substance to which these Regulations apply on the market shall prepare a safety data sheet giving information on that substance.

(2) A safety data sheet shall be amended by the person who provides it when any new information of a significant nature so requires.

(3) At, or before the first delivery, following the commencement of these Regulations, the manufacturer, importer or distributor of a dangerous substance to which these Regulations apply shall communicate the safety data sheet to any recipient who is a professional or industrial user distributor, wholesaler or retailer of the substance.

(4) The safety data sheet referred to in paragraph (3) shall be provided free of charge to the recipient and may be communicated on paper or electronically.

(5) An amended safety data sheet referred to in paragraph (2) shall be provided forthwith free of charge to all industrial or professional users, distributors, wholesalers and retailers who were supplied with the particular dangerous substance within the 12 months preceding the publication date of the amended safety data sheet.

(6) Without prejudice to paragraphs (3) and (4), recipients or users of a dangerous substance shall on request be provided with the safety data sheet by the supplier of the substance to them.

(7) The safety data sheet referred to in paragraph (1) shall contain such information necessary for the protection of man and the environment as the manufacturer, importer or distributor may reasonably be expected to be aware of.

(8) A safety data sheet referred to in paragraph (1) shall be clearly written in the English language or in both the English and Irish languages.

(9) (a) A safety data sheet required to be provided in accordance with this Regulation shall contain information on the dangerous substance under the headings set out in Schedule 8 and shall contain those headings.

(b) The information required to be contained in the safety data sheet in accordance with subparagraph (a) shall be compiled in accordance with the guidelines laid down in the Annex to Directive 2001/58/EC.

(c) The information required under subparagraph (a) shall include -

(i) the name of the person responsible for providing the safety data sheet,

(ii) the date of publication or the date of preparation of the safety data sheet, and

(iii) for an amended safety data sheet, a notice of revision together with the revision date.

25. Supply of Substances

A notifier shall supply to the competent authority on request such quantities of a notified substance as the competent authority deems necessary for the carrying out of verification tests.

26. Restriction on Sale

Where the competent authority is of opinion that a substance, although satisfying the requirements of these Regulations, constitutes a hazard for man or the environment by reason of its classification, packaging or labelling, the competent authority may, by notice in writing to the person who placed the substance on the market, prohibit the sale of that substance or subject its placing on the market to special conditions.

27. Fees Payable by Notifier

The fee specified in column 2 of Schedule 9 shall be payable in advance by a notifier to the competent authority in relation to any matter referred to in the corresponding entry in column 1 of that Schedule.

28. Taking and Detention of Substances

(1) An inspector may, seize and retain, or seize, remove and retain any substance which he believes is a substance to which these Regulations apply and in relation to which he has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

(2) An inspector may, by a notice in writing given to the owner or to the person in apparent charge or control of a substance which has been seized under this Regulation -

(a) require things specified in the notice to be done in relation to the substance before it is released by an inspector, and

(b) may -

(i) require the disposal of the substance by the person to whom the notice is given in a manner specified in the notice and at the expense of the owner, or

(ii) indicate the inspector's intention of disposing of the substance at the expense of the owner,

and such disposal to be, in either case, such as will prevent the substance from being again placed on the market, and, where a notice given under this paragraph requires specified things to be done in relation to a substance, the inspector shall retain control of the substance to which the notice relates until the requirements of the notice have been complied with.

(3) Where a notice is given under this Regulation, a person shall not, without the consent of an inspector sell, move, dispose of or otherwise interfere with the substance in any way pending compliance with the requirements of the notice.

(4) Any person who is aggrieved by a notice given under paragraph (2) of this Regulation which either requires the substance to which it relates to be disposed of or indicates an intention to dispose of such substances may, not later than the expiration of the period of seven days beginning on the date of the notice, appeal to the appropriate court against the notice.

(5) (a) Where an appeal is made to the appropriate court under paragraph (4) the court, if it is satisfied that -

(i) the substance to which the relevant notice under this Regulation relates is one to which these Regulations apply,

(ii) if such substance were released, it might be placed on the market, and

(iii) there has been a failure to comply with the provisions of these Regulations,

may order that the substance be disposed of in the manner specified in the notice, or in such other manner as may be specified by the court which, in the opinion of the court will prevent the substance from being placed on the market.

(b) Where an order made by a court under this paragraph requires the substance to which it relates to be disposed of by an inspector, the cost of such disposal shall be recoverable by the competent authority as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the product at the time of its seizure under this Regulation.

(6) A notice under this Regulation shall not come into force unless -

(a) where an appeal is taken against the notice, the appeal is withdrawn; and

(b) in any other case, the period within which such an appeal may be taken has expired.

(7) In this Regulation ‘appropriate court’ means in relation to an appeal made under this Regulation against a notice given under paragraph (2) -

(a) in case the estimated value of the substance and cost of complying with the order to which the appeal relates does not exceed €6,348.69, the District Court for the district in which the goods were seized;

(b) in case the estimated amounts aforesaid does not exceed €38,092.14, the judge of the Circuit Court for the circuit in which the goods were seized;

(c) in any other case, the High Court.

(8) (a) If, in relation to an appeal under this Regulation to the District Court, that court becomes of the opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed €6,348.69, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to the estimated amounts aforesaid.

(b) If, in relation to an appeal under this regulation to the Circuit Court, that court becomes of opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed €38,092.14, it may, if it so thinks fit, by order transfer the appeal to the High Court.

29. Offences

(1) A person shall be guilty of an offence if the person -

(a) contravenes Regulation 6, 9, 10, 11, 16, 17 (2), 19, 20, 21, 23, 24, 25 or 28 (3),

(b) places on the market a substance to which these Regulations apply and which has not been tested and classified in accordance with these Regulations,

(c) places on the market a substance referred to in Regulation 14(1) or (2) before the expiry of the relevant period specified in that Regulation,

(d) fails to comply with a requirement imposed on that person under Regulation 17(6), or

(e) contravenes a prohibition, or fails to comply with a condition, imposed on that person under Regulation 26.

(2) Where an offence under these Regulations has been committed by a body corporate and is proved to have been so committed with the consent, or connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first mentioned offence.

(3) A person guilty of an offence under these regulations shall be liable on summary conviction to a fine not exceeding €1,904.61 or imprisonment for a term not exceeding 6 months or both.

30. Revocations

The-

(a) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 (

S.I. No. 77 of 1994

),

(b) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1998 (

S.I. No. 317 of 1998

),

(c) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) (No. 2) Regulations, 1998 (

S.I. No. 513 of 1998

),

(d) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1999 (

S.I. No. 363 of 1999

), and

(e) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2000 (

S.I. No. 393 of 2000

),

are revoked.

SCHEDULE 1

FOREWORD TO ANNEX I

Introduction

Annex I is an index of dangerous substances for which harmonised classification and labelling have been agreed at Community level in accordance with the procedure laid down in Article 4(3) of Directive 67/548/EEC.

Numbering of entries

Entries in Annex I are listed according to the atomic number of the element most characteristic of the substance's properties. A list of the chemical elements, arranged according to atomic number is shown in Table A. Organic substances, because of their variety, have been placed in the usual classes, as shown in Table B.

The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y, where

- ABC is either the atomic number of the most characteristic chemical element (preceded by one or two zeros to make up the sequence) or the usual class number for organic substances,

- RST is the consecutive number of the substance in the series ABC,

- VW denotes the form in which the substance is produced or placed on the market,

- Y is the check-digit calculated in accordance with the ISBN (International Standard Book Number) method.

As an example, the Index number for sodium chlorate is 017-005-00-9.

For dangerous substances in the European Inventory of Existing Commercial Chemical Substance (Einecs, OJ No. C 146A, 15.6.1990) the Einecs number is included. This number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8.

For dangerous substances notified under the provisions of this Directive, the number of the substance in the European List of Notified Substance (ELINCS) is included. This number is a seven-digit system of the type XXX-XXX-X which starts at 400-010-9.

For dangerous substances in the list of “No-longer-polymers” (Document, Office for Official Publications of the European Communities, 1997. ISBN 92-827-8995-0) the “No-longer-polymer” number is included. This number is a seven-digit system of the type XXX-XXX-X which starts at 500-001-0.

The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry. It should be noted that the Einecs number includes both anhydrous and hydrated forms of a substance, and there are frequently different CAS numbers for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately as the Einecs number.

Einecs, ELINCS, “No-longer-polymer” or CAS numbers are not usually included for entries which comprise more than four individual substances.

Nomenclature

Wherever possible, dangerous substances are designated by their Einecs, ELINCS or “No-longer-polymer” names. Other substances not listed in Einecs, ELINCS or the list of “No-longer-polymers” are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.

Impurities, additives and minor components are normally not mentioned unless they contribute significantly to the classification of the substance.

Some substances are described as a mixture of A and B. These entries refer to one specific mixture. In some cases where it is necessary to characterise the substance put on the market, the proportions of the main substances in the mixture are specified.

Some substances are described with a specific percentage purity. Substances containing a higher content of active material (e.g. an organic peroxide) are not included in the Annex I entry and may have other hazardous properties (e.g. explosive). Where specific concentration limits are shown, these apply to the substance or substances shown in the entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific percentage purity, the limits apply to the substance as described in Annex I and not the pure substance.

Article 23(2)(a) of Directive 67/548/EEC

60

requires that for substances appearing in Annex I, the name of the substance to be used on the label should be one of the designations given in the Annex. For certain substances additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.

Certain entries contain a reference to impurities. An example is Index No. 607-190-00-X: methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamide). In these cases the reference in brackets forms part of the name, and must be included on the label.

Certain entries refer to groups of substances. An example is Index No. 006-007-00-5: “hydrogen cyanide (salts of …) with exception of complex cyanides such as ferrocyanides, ferricyanides and mercuric oxycyanide”. For individual substances covered by these entries, the Einecs name or another internationally recognised name must be used.

Format of entries

The following information is given for each substance in Annex I

(a)

the classification

(i) the process of classification consists of placing a substance in one or more categories of danger (as defined in Article 2(2) of Directive 92/32/EEC

61

) and assigning the qualifying risk phrase or phrases. The classification has consequences not only for labelling but also for other legislation and regulatory measures on dangerous substances;

(ii) the classification for each category of danger is normally presented in the form of an abbreviation representing the category of danger together with the appropriate risk phrase or phrases. However, in some cases (i.e. substances classified as flammable, sensitising and some substances classified as dangerous for the environment) the risk phrase alone is used;

(iii) the abbreviation for each of the categories of danger is shown below

- explosive: E

- oxidising: O

- extremely flammable: F+

- highly Flammable: F

- flammable: R10

- very toxic: T+

- toxic: T

- harmful: Xn

- corrosive: C

- irritant: Xi

- sensitising: R42 and/or R43

- carcinogenic: Carc. Cat.

62

- mutagenic: Muta. Cat.

62

- toxic for reproduction: Repr. Cat.

62

- dangerous for the environment: N or/and R52, R53, R59;

(iv) Additional risk phrases which have been assigned to describe other properties (see sections 2.2.6 and 3.2.8 of the labelling guide) are shown although they are not formally part of the classification.

(b)

the label

, including

(i) the letter assigned to the substance in accordance with Annex II (see Article 23(2)(c) of Directive 67/548/EEC). This acts as an abbreviation for the symbol and for the indication of danger (if these are assigned);

(ii) the risk phrases, denoted as a series of numbers preceded by the letter R indicating the nature of the special risks, in accordance with Annex III (see Article 23(2)(d) of Directive 67/548/EEC). The numbers are separated by either

- a dash (-) to denote separate statements concerning special risks (R), or

- an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks as set out in Annex III;

(iii) the safety phrases denoted as a series of numbers preceded by the letter S indicating the recommended safety precautions, in accordance with Annex IV (see Article 23(2)(e) of Directive 67/548/EEC). Again the numbers are separated by either a dash or an oblique stroke; the significance of recommended safety precautions are set out in Annex IV. The safety phrases shown apply only to substances; for preparations, phrases are selected according to the usual rules.

Note that for certain dangerous substances and preparations sold to the general public certain S-phrases are mandatory.

S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and preparations sold to the general public.

S2 and S46 are obligatory for all other dangerous substances and preparations sold to the general public other than those that have only been classified as dangerous for the environment.

Safety phrases S1 and S2 are shown in brackets in Annex I and can only be omitted from the label when the substance or preparation is sold for industrial use only.

(c)

the concentration limits

and associated classifications necessary to classify dangerous preparations containing the substance in accordance with Directive 1999/45/EC.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the preparation.

Where no concentration limits are given, the concentration limits to be used when applying the conventional method of assessing health hazards are those in Annex II, and when applying the conventional method of assessing environmental hazards are those in Annex III of Directive 1999/45/EC.

General Explanatory Notes

Groups of substances

A number of group entries are included in Annex I. In these cases, the classification and labelling requirements will apply to all substances covered by the description if they are placed on the market, insofar as they are listed in Einecs or ELINCS. Where a substance that is covered by a group entry occurs as an impurity in another substance, the classification and labelling requirements described in the group entry shall be taken into account in the labelling of the substance.

In some cases, there are classification and labelling requirements for specific substances that would be covered by the group entry. In such cases a specific Annex I entry will be present for the substance and the group entry will be annotated with the phrase “except those specified elsewhere in this Annex”.

In some cases, individual substances may be covered by more than one group entry. Lead oxalate (Einecs No 212-413-5) is for instance covered by the entry for lead compounds (Index No 082-001-00-6) as well as for salts of oxalic acid (607-007-00-3). In these cases, the labelling of the substance reflects the labelling for each of the two group entries. In cases where different classifications for the same hazard are given, the classification leading to the more severe classification is used for the label of the particular substance (see section on Note A below).

Entries in Annex I for salts (under any denomination) cover both anhydrous and hydrous forms unless specifically specified otherwise.

Substances with an ELINCS number

In Annex I, substances with an ELINCS number have been notified under the provisions of this Directive. A producer or importer who has not previously notified these substances must refer to the provisions of this Directive if he intends to place these substances on the market.

Explanation of the notes relating to the identification, classification and labelling of substances

Note A

The name of the substance must appear on the label in the form of one of the designations given in Annex I (see Article 23(2)(a)).

In Annex I, use is sometimes made of a general description such as “… compounds” or “… salts”. In this case the manufacturer or any other person who markets such a substance is required to state on the label the correct name, due account being taken of the chapter entitled “Nomenclature” of the Foreword

Example: for BeC12 (Einecs No 232-116-4): beryllium chloride.

The Directive also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in Annex I (Article 23(2)(c), (d) and (e)).

For substances belonging to one particular group of substances included in Annex I, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in Annex I.

For substances belonging to more than one group of substances included in Annex I, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in Annex I. In cases where two different classifications are given in the two entries for the same hazard the classification reflecting the more severe hazard classification is used.

Example

for substance AB - no individual entry in Annex I

Annex I group entry for compounds of A

Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R20/22 R33 N; R50-53

Annex I group entry for compounds of B

Carc. Cat. 1; R45 T; R23/25 N; R51-53

Classification of substance AB thus becomes

Carc. Cat. 1; R45 Repr. Cat. 1; R61 Repr. Cat. 3; R62 T; R23/25 R33 N; R50-53

Note B

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and therefore, these solutions require different labelling since the hazards vary at different concentrations.

In Annex I entries with Note B have a general designation of the following type: “nitric acid …%”.

In this case the manufacturer or any other person who markets such a substance in aqueous solution must state the percentage concentration of the solution on the label.

Example: nitric acid 45%.

Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

The use of additional data (e.g. specific gravity, degrees Baumé) or descriptive phrases (e.g. fuming or glacial is permissible.

Note C

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

In Annex I, a 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) 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 F

This substance may contain a stabiliser. If the stabiliser changes the dangerous properties of the substance, as indicated by the label in Annex I, a label should be provided in accordance with the rules for the labelling of dangerous preparations.

Note G

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods and a label should be provided reflecting its explosive property.

Note H

The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6

63

of Directive 67/548/EEC on manufacturers, distributors and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI of this Directive.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I.

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 in Annex I.

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 in Annex I.

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 in Annex I.

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 in Annex I.

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 in Annex I.

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 shall apply.

This note applies only to certain complex oil-derived substances in Annex I.

Note Q

The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions

- a short term biopersistence test by inhalation has shown that the fibres longer than 20 µm have a weighted half-life less than 10 days, or

- a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 µm have a weighted half-life less than 40 days, or

- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, or

- absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.

Note R

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

Note S

This substance may not require a label according to Article 23 (see Section 8 of Annex VI).

Explanation of the notes relating to the labelling of preparations

The significance of the notes that appear to the right of the concentration limits is as follows

Note 1

The concentration stated or, in the absence of such concentrations, the general concentrations of Directive 1999/45/EC are the percentages by weight of the metallic element calculated with reference to the total weight of the preparation.

Note 2

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the preparation.

Note 3

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the preparation.

Note 4

Preparations containing these substances have to be classified as harmful with R65 if they meet the criteria in Section 3.2.3 in Annex VI.

Note 5

The concentration limits for gaseous preparations are expressed as volume per volume percentage.

Note 6

Preparations containing these substances have to be assigned R67 if they meet the criteria in Section 3.2.8 in Annex VI.

This Note will no longer apply from the date on which the criteria for the use of R67 provided for in Directive 1999/45/EC enter into force.

TABLE A

List of chemical elements listed according to their atomic number [Z]

Z

Symbol

Element

Z

Symbol

Element

Z

Symbol

Element

1

H

Hydrogen

19

K

Potassium

37

Rb

Rubidium

2

He

Helium

20

Ca

Calcium

38

Sr

Strontium

3

Li

Lithium

21

Sc

Scandium

39

Y

Yttrium

4

Be

Berllium

22

Ti

Titanium

40

Zr

Zirconium

5

B

Boron

23

V

Vanadium

41

Nb

Nicobium

6

C

Carbon

24

Cr

Chromium

42

Mo

Molybdenum

7

N

Nitrogen

25

Mn

Manganese

43

Tc

Technetium

8

O

Oxygen

26

Fe

Iron

44

Ru

Ruthenium

9

F

Fluoride

27

Co

Cobalt

45

Rh

Rhodium

10

Ne

Neon

28

Ni

Nickel

46

Pd

Palladium

11

Na

Sodium

29

Cu

Copper

47

Ag

Silver

12

Mg

Magnesium

30

Zn

Zinc

48

Cd

Cadmium

13

Al

Aluminium

31

Ga

Gallium

49

In

Indium

14

Si

Silicon

32

Ge

Germanium

50

Sn

Tin

15

P

Phosphorus

33

As

Arsenic

51

Sb

Antimony

16

S

Sulphur

34

Se

Selenium

52

Te

Tellurium

17

Cl

Chlorine

35

Br

Bromine

53

I

Iodine

18

Ar

Argon

36

Kr

Krypton

54

Xe

Xenon

55

Cs

Caesium

72

Hf

Hafnium

89

Ac

Actinium

56

Ba

Barium

73

Ta

Tantalum

90

Th

Thorium

57

La

Lanthanum

74

W

Tungsten

91

Pa

Protactinium

58

Ce

Cerium

75

Re

Rhenium

92

U

Uranium

59

Pr

Praseodymium

76

Os

Osmium

93

Np

Neptunium

60

Nd

Neodymium

77

Ir

Iridium

94

Pu

Plutonium

61

Pm

Promethium

78

Pt

Platinum

95

Am

Americium

62

Sm

Samarium

79

Au

Gold

96

Cm

Curium

63

Eu

Europium

80

Hg

Mercury

97

Bk

Berkelium

64

Gd

Gadolinium

81

Tl

Thallium

98

Cf

Californium

65

Tb

Terbium

82

Pb

Lead

99

Es

Einsteinium

66

Dy

Dysprosium

83

Bi

Bismuth

100

Fm

Fermium

67

Ho

Holmium

84

Po

Polonium

101

Md

Mendelevium

68

Er

Erbium

85

At

Astatine

102

No

Nobelium

69

Tm

Thulium

86

Rn

Radon

103

Lw

Lawrencium

70

Yb

Ytterbium

87

Fr

Francium

71

Lu

Lutetium

88

Ra

Radium

TABLE B

SPECIAL CLASSIFICATION FOR ORGANIC SUBSTANCES

601

Hydrocarbons

606

Ketones and their derivatives

602

Halogenated hydrocarbons

607

Organic acids and their derivatives

603

Alcohols and their derivatives

608

Nitriles

604

Phenols and their derivatives

609

Nitro compounds

605

Aldehydes and their derivatives

610

Chloronitro compounds

611

Azoxy-and azo compounds

616

Amides and their derivatives

612

Amine compounds

617

Organic Peroxides

613

Heterocyclic bases and their derivatives

647

Enzymes

614

Glycosides and alkaloids

648

Complex substances derived from coal

615

Cyanates and isocyanates

649

Complex substances derived from petroleum

650

Miscellandous substances

SCHEDULE 2

ANNEX II

SYMBOLS AND INDICATIONS OF DANGER FOR DANGEROUS SUBSTANCES AND PREPARATIONS

Note: The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.

E

Explosive

O

Oxidizing

F

Highly flammable

F+

Extremely flammable

T

Toxic

T+

Very Toxic

C

Corrosive

Xn

Harmful

Xi

Irritant

N

Dangerous for the environment

SCHEDULE 3

ANNEX III

NATURE OF SPECIAL RISKS ATTRIBUTED TO DANGEROUS SUBSTANCES AND PREPARATIONS

R1

Explosive when dry

R2

Risk of explosion by shock, fire or other sources of ignition

R3

Extreme risk of explosion by shock, friction, fire or other sources of ignition

R4

Forms very sensitive explosive metallic compounds

R5

Heating may cause an explosion

R6

Explosive with or without contact with air

R7

May cause fire

R8

Contact with combustible material may cause fire

R9

Explosive when mixed with combustible materials

R10

Flammable

R11

Highly flammable

R12

Extremely flammable

R14

Reacts violently with water

R15

Contact with water liberates highly flammable gases

R16

Explosive when mixed with oxidizing substances

R17

Spontaneously flammable in air

R18

In use, may form flammable/explosive vapour-air mixture

R19

May form explosive peroxides

R20

Harmful by inhalation

R21

Harmful in contact with skin

R22

Harmful if swallowed

R23

Toxic by inhalation

R24

Toxic in contact with skin

R25

Toxic if swallowed

R26

Very toxic by inhalation

R27

Very toxic in contact with skin

R28

Very toxic if swallowed

R29

Contact with water liberates toxic gas

R30

Can become highly flammable in use

R31

Contact with acids liberates toxic gas

R32

Contact with acids liberates very toxic gas

R33

Danger of cumulative effects

R34

Causes burns

R35

Causes severe burns

R36

Irritating to eyes

R37

Irritating to respiratory system

R38

Irritating to skin.

R39

Danger of very serious irreversible effects

R40

Limited evidence of a carcinogenic effect

R41

Risk of serious damage to eyes

R42

May cause sensitisation by inhalation

R43

May cause sensitisation by skin contact

R44

Risk of explosion if heated under confinement

R45

May cause cancer

R46

May cause heritable genetic damage

R48

Danger of serious damage to health by prolonged exposure

R49

May cause cancer by inhalation

R50

Very toxic to aquatic organisms

R51

Toxic to aquatic organisms

R52

Harmful to aquatic organisms

R53

May cause long-term adverse effects in the aquatic environment

R54

Toxic to flora

R55

Toxic to fauna

R56

Toxic to soil organisms

R57

Toxic to bees

R58

May cause long-term adverse effects in the environment

R59

Dangerous for the ozone layer

R60

May impair fertility

R61

May cause harm to the unborn child

R62

Possible risk of impaired fertility

R63

Possible risk of harm to the unborn child

R64

May cause harm to breastfed babies

R65

Harmful: May cause lung damage if swallowed

R66

Repeated exposure may cause skin dryness or cracking

R67

Vapours may cause drowsiness and dizziness

R68

Possible risk of irreversible effects

COMBINATION OF R-PHRASES

R14/15

Reacts violently with water, liberating highly flammable gases

R15/29

Contact with water liberates toxic, highly flammable gas

R20/21

Harmful by inhalation and in contact with skin

R20/22

Harmful by inhalation and if swallowed

R20/21/22

Harmful by inhalation, in contact with skin and if swallowed

R21/22

Harmful in contact with skin and if swallowed

R23/24

Toxic by inhalation and in contact with skin

R23/25

Toxic by inhalation and if swallowed

R23/24/25

Toxic by inhalation, in contact with skin and if swallowed

R24/25

Toxic in contact with skin and if swallowed

R26/27

Very toxic by inhalation and in contact with skin

R26/28

Very toxic by inhalation and if swallowed

R26/27/28

Very toxic by inhalation and in contact with skin and if swallowed

R27/28

Very toxic in contact with skin and if swallowed

R36/37

Irritating to eyes and respiratory system

R36/38

Irritating to eyes and skin

R36/37/38

Irritating to eyes, respiratory system and skin

R37/38

Irritating to respiratory system and skin

R39/23

Toxic: danger of very serious irreversible effects through inhalation

R39/24

Toxic: danger of very serious irreversible effects in contact with skin

R39/25

Toxic: danger of very serious irreversible effects if swallowed

R39/23/24

Toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/23/25

Toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/24/25

Toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/23/24/25

Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R39/26

Very toxic: danger of very serious irreversible effects through inhalation

R39/27

Very toxic: danger of very serious irreversible effects in contact with skin

R39/28

Very toxic: danger of very serious irreversible effects if swallowed

R39/26/27

Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/26/28

Very toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/27/28

Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/26/27/28

Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R68/20

Harmful: possible risk of irreversible effects through inhalation

R68/21

Harmful: possible risk of irreversible effects in contact with skin

R68/22

Harmful: possible risk of irreversible effects if swallowed

R68/20/21

Harmful: possible risk of irreversible effects through inhalation and in contact with skin

R68/20/22

Harmful: possible risk of irreversible effects through inhalation and if swallowed

R68/21/22

Harmful: possible risk of irreversible effects in contact with skin and if swallowed

R68/20/21/22

Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed

R42/43

May cause sensitisation by inhalation and skin contact

R48/20

Harmful: danger of serious damage to health by prolonged exposure through inhalation

R48/21

Harmful: danger of serious damage to health by prolonged exposure in contact with skin

R48/22

Harmful: danger of serious damage to health by prolonged exposure if swallowed

R48/20/21

Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/20/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/21/22

Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/20/21/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R48/23

Toxic: danger of serious damage to health by prolonged exposure through inhalation

R48/24

Toxic: danger of serious damage to health by prolonged exposure in contact with skin

R48/25

Toxic: danger of serious damage to health by prolonged exposure if swallowed

R48/23/24

Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/23/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/24/25

Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/23/24/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R50/53

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R52/53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment

SCHEDULE 4

ANNEX IV

SAFETY ADVICE CONCERNING DANGEROUS SUBSTANCES AND PREPARATIONS

S 1

Keep locked up.

S 2

Keep out of the reach of children.

S 3

Keep in a cool place.

S 4

Keep away from living quarters.

S 5

Keep contents under … (appropriate liquid to be specified by the manufacturer).

S 6

Keep under … (inert gas to be specified by the manufacturer).

S 7

Keep container tightly closed.

S 8

Keep container dry.

S 9

Keep container in a well-ventilated place.

S 12

Do not keep the container sealed.

S 13

Keep away from food, drink and animal feedingstuffs.

S 14

Keep away from … (incompatible materials to be indicated by the manufacturer).

S 15

Keep away from heat.

S 16

Keep away from sources of ignition - No smoking.

S 17

Keep away from combustible material.

S 18

Handle and open container with care.

S 20

When using do not eat or drink.

S 21

When using do not smoke.

S 22

Do not breathe dust.

S 23

Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).

S 24

Avoid contact with skin.

S 25

Avoid contact with eyes.

S 26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

S 27

Take off immediately all contaminated clothing.

S 28

After contact with skin, wash immediately with plenty of … (to be specified by the manufacturer).

S 29

Do not empty into drains.

S 30

Never add water to this product.

S 33

Take precautionary measures against static discharges.

S 35

This material and its container must be disposed of in a safe way.

S 36

Wear suitable protective clothing.

S 37

Wear suitable gloves.

S 38

In case of insufficient ventilation, wear suitable respiratory equipment.

S 39

Wear eye/face protection.

S 40

To clean the floor and all objects contaminated by this material, use … (to be specified by the manufacturer).

S 41

In case of fire and/or explosion do not breathe fumes.

S 42

During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).

S 43

In case of fire, use … (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add - ‘Never use water’).

S 45

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

S 46

If swallowed, seek medical advice immediately and show this container or label.

S 47

Keep at temperature not exceeding … °C (to be specified by the manufacturer).

S 48

Keep wetted with … (appropriate material to be specified by the manufacturer).

S 49

Keep only in the original container.

S 50

Do not mix with … (to be specified by the manufacturer).

S 51

Use only in well-ventilated areas.

S 52

Not recommended for interior use on large surface areas.

S 53

Avoid exposure - obtain special instructions before use.

S 56

Dispose of this material and its container at hazardous or special waste collection point.

S 57

Use appropriate containment to avoid environmental contamination.

S 59

Refer to manufacturer/supplier for information on recovery/recycling.

S 60

This material and its container must be disposed of as hazardous waste.

S 61

Avoid release to the environment. Refer to special instructions/Safety data sheets.

S 62

If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.

S 63

In case of accident by inhalation: remove casualty to fresh air and keep at rest.

S 64

If swallowed, rinse mouth with water (only if the person is conscious).

Combination of S-phrases

S 1/2

Keep locked up and out of reach of children.

S 3/7

Keep container tightly closed in a cool place.

S 3/9/14

Keep in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/14/49

Keep only in the original container in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/49

Keep only in the original container in a cool, well-ventilated place.

S 3/14

Keep in a cool place away from … (incompatible materials to be indicated by the manufacturer).

S 7/8

Keep container tightly closed and dry.

S 7/9

Keep container tightly closed and in a well-ventilated place.

S 7/47

Keep container tightly closed and at a temperature not exceeding … °C (to be specified by the manufacturer).

S 20/21

When using do not eat, drink or smoke.

S 24/25

Avoid contact with skin and eyes.

S 27/28

After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of … (

to be specified by the manufacturer

).

S 29/35

Do not empty into drains; dispose of this material and its container in a safe way.

S 29/56

Do not empty into drains, dispose of this material and its container to hazardous or special waste collection point.

S 36/37

Wear suitable protective clothing and gloves.

S 36/37/39

Wear suitable protective clothing, gloves and eye/face protection.

S 36/39

Wear suitable protective clothing and eye/face protection.

S 37/39

Wear suitable gloves and eye/face protection.

S 47/49

Keep only in the original container at a temperature not exceeding … °C (to be specified by the manufacturer).

SCHEDULE 5

ANNEX VI

GENERAL CLASSIFICATION AND LABELLING REQUIREMENTS FOR DANGEROUS SUBSTANCES AND PREPARATIONS

CONTENTS

1.

GENERAL INTRODUCTION

2.

CLASSIFICATION ON THE BASIS OF PHYSICOCHEMICAL PROPERTIES

2.1.

Introduction

2.2.

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

2.2.1.

Explosive

2.2.2.

Oxidising

2.2.3.

Extremely flammable

2.2.4.

Highly flammable

2.2.5.

Flammable

2.2.6.

Other physicochemical properties

3.

CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

3.1.

Introduction

3.2.

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

3.2.1.

Very toxic

3.2.2.

Toxic

3.2.3.

Harmful

3.2.4.

Comments regarding the use of R48

3.2.5.

Corrosive

3.2.6.

Irritant

3.2.7.

Sensitisation

3.2.8.

Other toxicological properties

4.

CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

4.1.

Introduction

4.2.

Criteria for classification, indication of danger, choice of risk phrases

4.2.1.

Carcinogenic substances

4.2.2.

Mutagenic substances

4.2.3.

Substances toxic to reproduction

4.2.4.

Procedure for the classification of preparations concerning specific effects on health

5.

CLASSIFICATION ON THE BASIS OF ENVIRONMENTAL EFFECTS

5.1.

Introduction

5.2.

Criteria for classification, indication of danger, choice of risk phrases

5.2.1.

Aquatic environment

5.2.2.

Non-aquatic environment

6.

CHOICE OF SAFETY ADVICE PHRASES

6.1.

Introduction

6.2.

Safety phrases for substances and preparations

7.

LABELLING

8.

SPECIAL CASES: Substances

8.1.

Mobile gas cylinders

8.2.

Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

8.3.

Metals in massive form

8.4.

Substances classified with R65

9.

SPECIAL CASES: Preparations

9.1.

Gaseous preparations (gas mixtures)

9.2.

Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum gas (LPG)

9.3.

Alloys, preparations containing polymers, preparations containing elastomers

9.4.

Preparations classified with R65

9.5.

Organic peroxides

9.6.

Additional labelling requirements for certain preparations

COMMISSION STATEMENT

1.

GENERAL INTRODUCTION

1.1. The object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances and preparations which may constitute a risk during normal handling or use. Having identified any hazardous properties the substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment.

1.2. This Annex sets out the general principles governing the classification and labelling of substances and preparations referred to in Article 4

64

of Directive 67/548/EEC and in Article 4 of Directive 1999/45/EC and other relevant Directives on dangerous preparations.

It is addressed to all those concerned (manufacturers, importers, national authorities) with methods of classifying and labelling dangerous substances and preparations.

1.3. The requirements of Directive 67/548/EEC and of Directive 1999/45/EC are intended to provide a primary means by which the general public and persons at work are given essential information about dangerous substances and preparations. The label draws the attention of persons handling or using substances and preparations to the inherent danger of certain such materials.

The label may also serve to draw attention to more comprehensive product information on safety and use available in other forms.

1.4. The label takes account of all potential hazards which are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which they are placed on the market, but not necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are highlighted by symbols, such hazards and those arising from other dangerous properties are specified in standard risk phrases, and safety phrases give advice on necessary precautions.

In the case of substances, the information is completed by the name of the substance under an internationally recognised chemical nomenclature, the preferred name being the one used in the European Inventory of Existing Commercial Chemical Substances (Einecs), or in the European List of Notified Chemical Substances (ELINCS), the EC number and the name address and telephone number of the person established in the Community who is responsible for placing the substance on the market.

In the case of preparations, the information in accordance with Article 10.2. of Directive 1999/45/EC, is completed by

- the trade name or the designation of the preparation;

- the chemical name of the substance or substances present in the preparation; and

- the name, full address and telephone number of the person established in the Community who is responsible for placing the preparation on the market.

1.5. Article 6

65

of Directive 67/548/EEC requires that manufacturers, distributors and importers of dangerous substances which appear in the Einecs but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances according to the rules laid down in Articles 22 to 25

66

and the criteria in this Annex.

1.6.

Data required for classification and labelling

1.6.1. For substances the data required for classification and labelling may be obtained

(a) as regards substances for which the information specified in Annex VII

67

, is required most of the necessary data for classification and labelling appear in the ‘base set’. This classification and labelling must be reviewed, if necessary, when further information is available (Annex VIII);

(b) as regards other substances (e.g. those referred to in section 1.5 above), the data required for classification and labelling may, if necessary, be obtained from a number of different sources, for example

- the results of previous tests;

- information required by international rules on the transport of dangerous substances;

- information taken from reference works and the literature; or

- information derived from practical experience.

The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.

1.6.2. For preparations, normally the data required for classification and labelling may be obtained

(a) if it concerns physicochemical data, by the application of the methods specified in Annex V. This applies also to preparations covered by Directive 91/414/EEC unless other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 5. 5. of Directive 1999/45/EC). For gaseous preparations a calculation method may be used for flammable and oxidising properties (see 9.1.1.1 and 9.1.1.2). For non-gaseous preparations containing organic peroxides a calculation method may be used for oxidising properties (see 2.2.2.1).

(b) if it concerns data on health effects

- by the application of the methods specified in Annex V, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 6. 1. (b) of Directive 1999/45/EC),

- and/or by the application of a conventional method referred to in Article 6 and Annex II, Parts A 1 - 6 and B 1 - 5 of Directive 1999/45/EC, or,

- in the case of R65, by the application of the rules under 3.2.3

- however, if it concerns the evaluation of the carcinogenic, mutagenic and reproductive toxicity properties, by the application of a conventional method referred to in Article 6 and Annex II, Parts A 7 - 9 and B 6 of Directive 1999/45/EC.

(c) if it concerns data on ecotoxicological properties

(i) for aquatic toxicity only

- by the application of the methods specified in Annex V, subject to the conditions referred to in Annex III Part C of Directive 1999/45/EC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 7. 1. (b) of Directive 1999/45/EC), or

- by application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.

(ii) for the evaluation of the potential for (or actual) bioaccumulation through the determination of log Pow (or BCF), or the evaluation of degradability, by application of a conventional method referred to in Article 7 and Annex III Parts A and B, of Directive 1999/45/EC.

(iii) for dangers of the ozone layer by application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.

Note concerning the performance of animal tests

The performance of animal tests to establish experimental data is subject to the provisions of Directive 86/609/EEC regarding the protection of animals used for experimental purposes.

Note concerning physicochemical properties

For organic peroxides and organic peroxide preparations data may be derived from the calculation method set out in Chapter 9.5. For gaseous preparations a calculation method may be used for flammable and oxidising properties (see chapter 9).

1.7.

Application of the guide criteria

Classification must cover the physicochemical, toxicological and ecotoxicological properties of substances and preparations.

Classification of substances and preparations is made according to Chapter 1.6, on the basis of the criteria in Chapters 2 to 5 (substances) and Chapters 2, 3, 4.2.4 and 5 of this Annex. All types of hazard must be considered. For instance, classification under 3.2.1 does not imply that the sections such as 3.2.2 or 3.2.4 can be ignored.

The choice of symbol(s) and risk phrase(s) is made on the basis of the classification in order to ensure that the specific nature of the potential dangers identified in classification is expressed on the label.

Notwithstanding the criteria given under 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of aerosols shall be subject to the provisions of Directive 75/324/EEC as amended and adapted to technical progress.

1.7.1. Definitions

‘Substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product, and any impurity deriving from the production process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents have been identified.

‘Preparations’ means mixtures or solutions composed of two or more substances.

1.7.2. Application of the guide criteria for substances

The guidance criteria set out in this Annex are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and labelling.

In some cases there may be doubt over the application of the relevant criteria, especially where these require the use of expert judgement. In such cases the manufacturer, distributor or importer should provisionally classify and label the substance on the basis of an assessment of the evidence by a competent person.

Without prejudice to Article 6, where the above procedure has been followed and there is concern over possible inconsistencies then a proposal may be submitted for the entry of the provisional classification into Annex I. The proposal should be made to one of the Member States and should be accompanied by appropriate scientific data (see also section 4.1).

A similar procedure may be followed when information is identified which gives cause for concern over the accuracy of an existing entry in Annex I.

1.7.2.1.

Classification of substances containing impurities, additives or individual constituents

Where impurities, additives or individual constituents of substances have been identified, they shall be taken into account if their concentration is greater than or equal to the limits specified

- 0,1 % for substances classified as very toxic, toxic, carcinogenic (category 1 or 2) mutagenic (category 1 or 2), toxic to reproduction (category 1 or 2), or dangerous for the environment (assigned the symbol ‘N’ for the aquatic environment, dangerous for the ozone layer)

- 1% for substances classified as harmful, corrosive, irritant sensitising, carcinogenic (category 3), mutagenic (category 3), toxic to reproduction (category 3), or dangerous for the environment (not assigned the symbol ‘N’, i.e. harmful to aquatic organisms, may cause long-term adverse effects)

unless lower values have been specified in Annex I.

With the exception of substances listed specifically in Annex I, classification should be carried out according to the requirements of Articles 5, 6 and 7 of Council Directive 1999/45/EC.

In the case of asbestos (650-013-00-6) this general rule does not apply until a concentration limit has been fixed in Annex I. Substances in which asbestos is present must be classified and labelled according to the principles in Article 6.

1.7.3. Application of the guide criteria for preparations

The guidance criteria set out in this Annex are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V with the exception of the criteria of Chapter 4 for which only the conventional method is applicable. A conventional method is also applicable in relation to the criteria of Chapter 5, with the exception of aquatic toxicity, subject to the conditions referred to in Annex III Part C of Directive 1999/45/EC. For preparations covered by Directive 91/414/EEC data for classification and labelling are also acceptable from other internationally recognised methods (see special provisions in Section 1.6 of this Annex). In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and labelling.

Where the health and environmental hazards are assessed by applying a conventional method referred to in Articles 6 and 7 and Annexes II and III of Directive 1999/45/EC the individual concentration limits to be used are those set out either

- in Annex I to Directive 67/548/EEC, or

- in Annex II Part B and/or Annex III Part B of Directive 1999/45/EC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

In the case of preparations containing mixtures of gases, classification with respect to the health and environmental effects will be established by the calculation method on the basis of the individual concentration limits from Annex I to Directive 67/548/EEC or when these limits are not in Annex I on the basis of the criteria of Annexes II and III of Directive 1999/45/EC.

1.7.3.1.

Preparations or substances described in Section 1.7.2.1 used as constituents of another preparation

The labelling of such preparations must be in conformity with the provisions of Article 10 according to the principles set out in Articles 3 and 4 of Directive 1999/45/EC. However, in certain cases, the information on the label of the preparation or substance described in Section 1.7.2.1 is insufficient to enable other manufacturers who wish to use it as a constituent of their own preparation(s) to carry out the classification and labelling of their preparation(s correctly.

In these cases, the person established within the Community responsible for placing the original preparation or substance described in Section 1.7.2.1 on the market, whether it be the manufacturer, the importer or the distributor shall supply upon justified request and as soon as possible all necessary data concerning the dangerous substances present to enable correct classification and labelling of the new preparation. This data is also necessary to enable the person responsible for placing the new preparation on the market to comply with other requirements of Directive 1999/45/EC.

2.

CLASSIFICATION ON THE BASIS OF PHYSICOCHEMICAL PROPERTIES

2.1.

Introduction

The test methods relating to explosive, oxidising and flammable properties included in Annex V serve to give specific meaning to the general definitions given in Article 2 (2) (a) to (e) of Directive 67/548/EEC

68

. Criteria follow directly from the test methods in Annex V as far as they are mentioned.

If adequate information is available to demonstrate in practice that the physicochemical properties of substances and preparations (apart from organic peroxides) are different from those revealed by the test methods given in Annex V, then such substances and preparations should be classified according to the hazard they present, if any, to those handling the substances and preparations or to other persons.

2.2.

Criteria for classification, choice of symbols, indication of danger and choice of risk phrases

In the case of preparations, the criteria referred to in Article 5 of Directive 1999/45/EC need to be taken into consideration.

2.2.1. Explosive

Substances and preparations shall be classified as explosive and assigned the symbol ‘E’ and the indication of danger ‘explosive’ in accordance with the results of the tests given in Annex V and in so far as the substances and preparations are explosive as placed on the market. One risk phrase is obligatory, it is to be specified on the basis of the following

R2 Risk of explosion by shock, friction, fire or other sources of ignition

- substances and preparations except those set out below.

R3 Extreme risk of explosion by shock, friction, fire or other source of ignition

- substances and preparations which are particularly sensitive such as picric acid salts or PETN.

2.2.2. Oxidising

Substances and preparations shall be classified as oxidising and assigned the symbol ‘O’ and the indication of danger ‘oxidising’ in accordance with the results of the tests given in Annex V. One risk phrase is obligatory, it is to be specified on the basis of the test results but subject to the following

R7 May cause fire

- organic peroxides which have flammable properties even when not in contact with other combustible material.

R8 Contact with combustible material may cause fire

- other oxidising substances and preparations, including inorganic peroxides, which may cause fire or enhance the risk of fire when in contact with combustible material.

R9 Explosive when mixed with combustible material

- other substances and preparations, including inorganic peroxides, which become explosive when mixed with combustible materials, e.g. certain chlorates.

2.2.2.1.

Remarks concerning peroxides

For the explosive properties, an organic peroxide or preparation thereof in the form in which it is placed on the market is classified according to the criteria in section 2.2.1. on the basis of tests carried out in accordance with the methods given in Annex V.

For the oxidising properties the existing methods in Annex V cannot be applied to organic peroxides.

For substances, organic peroxides not already classified as explosive are classified as dangerous on the basis of their structure (e.g. R-O-O-H; R

1

-O-O-R

2

).

Preparations not already classified as explosive shall be classified using the calculation method based on the percentage of active oxygen shown in Section 9.5.

Any organic peroxide or preparation thereof not already classified as explosive is classified as oxidising, if the peroxide or its formulation contains

- more than 5 % of organic peroxides, or

- more than 0.5 % available oxygen from the organic peroxides, and more than 5 % hydrogen peroxide.

2.2.3. Extremely flammable

Substances and preparations shall be classified as extremely flammable and assigned the symbol ‘F+’ and the indication of danger ‘extremely flammable’ in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the following criteria

R12 Extremely flammable

- Liquid substances and preparations which have a flash point lower than 0 °C and a boiling point (or in case of a boiling range the initial boiling point) lower than or equal to 35 °C.

- Gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure.

2.2.4. Highly flammable

Substances and preparations shall be classified as highly flammable and assigned the symbol ‘F’ and the indication of danger ‘highly flammable’ in accordance with the results of the tests given in Annex V. Risk phrases shall be assigned in accordance with the following criteria

R11 Highly flammable

- Solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition.

- Liquid substances and preparations having a flash point below 21 °C but which are not extremely flammable.

R15 Contact with water liberates extremely flammable gases

- Substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities, at a minimum rate of one litre per kilogram per hour.

R17 Spontaneously flammable in air

- Substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any input of energy.

2.2.5. Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

R10 Flammable

- Liquid substances and preparations having a flash point equal to or greater than 21 °C, and less than or equal to 55 °C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21 °C and less than or equal to 55 °C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons.

2.2.6. Other physicochemical properties

Additional risk phrases shall be assigned to substances and preparations which have been classified by virtue of Sections 2.2.1 to 2.2.5 above or by Chapter 3, 4 and 5 below, in accordance with the following criteria (based on experience obtained during compilation of Annex I)

R1 Explosive when dry

For explosive substances and preparations put on the market in solution or in a wetted form e.g. nitrocellulose with more than 12.6% nitrogen.

R4 Forms very sensitive explosive metallic compounds

For substances and preparations which may form sensitive explosive metallic derivatives e.g. picric acid, styphnic acid.

R5 Heating may cause an explosion

For thermally unstable substances and preparations not classified as explosive, e.g. perchloric acid > 50%.

R6 Explosive with or without contact with air

For substances and preparations which are unstable at ambient temperatures, e.g. acetylene.

R7 May cause fire

For reactive substances and preparations, e.g. fluorine, sodium hydrosulphite.

R14 Reacts violently with water

For substances and preparations which react violently with water, e.g. acetyl chloride alkali metals, titanium tetrachloride.

R16 Explosive when mixed with oxidising substances

For substances and preparations which react explosively with an oxidising agent, e.g. red phosphorus.

R18 In use, may form flammable/explosive vapour-air mixture

For preparations not in themselves classified as flammable, which contain volatile components which are flammable in air.

R19 May form explosive peroxides

For substances and preparations which may form explosive peroxides during storage e.g. diethyl ether, 1,4-dioxan.

R30 Can become highly flammable in use

For preparations not in themselves classified as flammable, which may become flammable due to the loss of non-flammable volatile components.

R44 Risk of explosion if heated under confinement

For substances and preparations not in themselves classified as explosive in accordance with Section 2.2.1 above but which may nevertheless display explosive properties in practice if heated under sufficient confinement. For example, certain substances which would decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

For other additional risk phrases see Section 3.2.8.

3.

CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

3.1.

Introduction

3.1.1. Classification is concerned with both the acute and long-term effects of substances and preparations, whether resulting from a single instance of exposure or repeated or prolonged exposure.

Where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified in this Annex or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in Section 1.6 of this Annex, then the substance or preparation shall be classified according to its effects on man. However, tests on man should be discouraged and should not normally be used to negate positive animal data.

Directive 86/609/EEC seeks to protect animals used for experimental and other scientific purposes. For several endpoints there are validated

in vitro

test methods in Annex V of Directive 67/548/EEC and these tests should be used where appropriate.

3.1.2. The classification of substances must be made on the basis of the experimental data available in accordance with the following criteria which take into account the magnitude of these effects

(a) for acute toxicity (lethal and irreversible effects after a single exposure), the criteria under Sections 3.2.1 to 3.2.3 are to be used,

(b) for sub-acute, sub-chronic or chronic toxicity the criteria under Sections 3.2.2 to 3.2.4 are to be used,

(c) for corrosive and irritant effects the criteria under Sections 3.2.5 and 3.2.6 are to be used,

(d) for sensitising effects the criteria under Section 3.2.7 are to be used,

(e) for specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity) the criteria in Chapter 4 are to be used.

3.1.3. For preparations, the classification relating to dangerous for health is carried out

(a) on the basis of a conventional method referred to in Article 6 and Annex II of Directive 1999/45/EC in the absence of experimental data. In this case, the classification is based on the individual concentration limits

- either taken from Annex I to Directive 67/548/EEC, or

- from Annex II, Part B of Directive 1999/45/EC where the substance or substances do not appear in Annex I of Directive 67/548/EEC or appear in it without concentration limits.

(b) or when experimental data are available, according to the criteria described under Sections 3.1.2 excluding the carcinogenic, mutagenic and toxic to reproduction properties referred to under 3.1.2 (e) which must be evaluated by a conventional method referred to in Article 6 and Annex II, Parts A 7 - 9 and B 6 of Directive 1999/45/EC.

Note: Without prejudice to requirements of Directive 91/414/EEC, only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in paragraph 3.1.3 (a), or on the basis of existing test results on animals, the methods outlined in paragraph 3.1.3 (b) may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.

Whichever method is used for the evaluation of the danger of a preparation, all the dangerous effects on health as defined in Annex II, Part B of Directive 1999/45/EC must be taken into consideration.

3.1.4. When the classification is to be established from experimental results obtained in animal tests the results should have validity for man in that the tests reflect, in an appropriate way, the risks to man.

3.1.5. The acute oral toxicity of substances or preparations placed on the market may be established either by a method permitting assessment of the LD

50

value, or by determining the discriminating dose (the fixed dose method), or by determining the range of exposure where lethality is expected (the acute toxic class method).

3.1.5.1. The discriminating dose is the dose which causes evident toxicity but not mortality and must be one of the four dosage levels specified in Annex V (5, 50, 500 or 2 000 mg per kg body weight).

The concept ‘evident toxicity’ is used to designate toxic effects, after exposure to the substance tested, which are so severe that exposure to the next highest fixed dose would probably lead to mortality.

The results of testing at a particular dose following the fixed dose method may be either

- less than 100 % survival,

- 100 % survival, but evident toxicity,

- 100 % survival, but no evident toxicity.

In the criteria in sections 3.2.1, 3.2.2 and 3.2.3 only the final test result is shown. The 2 000 mg/kg dose should be used primarily to obtain information on the toxic effects of substances which are of low acute toxicity and which are not classified on the basis of acute toxicity.

The fixed dose method requires in some cases testing at higher or lower doses, if not already tested at the relevant dose level. Refer also to the evaluation table in test method B.1

bis

.

3.1.5.1. The range of exposure where lethality is expected is derived from the observed absence or presence of substance related mortality following the acute toxic class method. For initial testing one of three fixed starting doses (25, 200 or 2 000 mg per kg body weight) is used.

The acute toxic class method requires in some cases testing at higher or lower doses, if not already tested at the relevant dose level. Refer also to the test procedure flow charts in test method B.1

tris

of Annex V.

3.2.

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

3.2.1. Very toxic

Substances and preparations shall be classified as very toxic, and assigned the symbol ‘T+’ and indication of danger ‘very toxic’ in accordance with the criteria specified below.

Risk phrases shall be assigned in accordance with the following criteria

R28 Very toxic if swallowed

Acute toxicity results

- LD

50

oral, rat ≤ 25 mg/kg,

- less than 100 % survival at 5 mg/kg oral, rat by the fixed dose procedure, or

- high mortality at doses ≤ 25 mg/kg oral, rat, by the acute toxic class method (for test result interpretation see flow charts in Annex 2 of test method B.1

tris

of Annex V).

R27 Very toxic in contact with skin

Acute toxicity results

- LD

50

dermal, rat or rabbit: ≤ 50 mg/kg.

R26 Very toxic by inhalation

Acute toxicity results

- LC

50

inhalation, rat, for aerosols or particulates: ≤ 0.25 mg/litre/4hr,

- LC

50

inhalation, rat, for gases and vapours: ≤ 0.5 mg/litre/4hr.

R39 Danger of very serious irreversible effects

- Strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/26, R39/27, R39/28, R39/26/27, R39/26/28, R39/27/28, R39/26/27/28.

3.2.2. Toxic

Substances and preparations shall be classified as toxic and assigned the symbol ‘T’ and the indication of danger ‘toxic’ in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria.

R25 Toxic if swallowed

Acute toxicity results

- LD

50

oral, rat: 25 < LD

50

≤ 200 mg/kg,

- Discriminating dose, oral, rat, 5 mg/kg: 100 % survival but evident toxicity, or

- high mortality in the dose range > 25 to ≤ 200 mg/kg oral, rat, by the acute toxic class method (for test result interpretation see flow charts in Annex 2 of test method B.1 tris of Annex V).

R24 Toxic in contact with skin

Acute toxicity results

- LD

50

dermal, rat or rabbit: 50 < LD

50

≤ 400 mg/kg.

R23 Toxic by inhalation

Acute toxicity results

- LC

50

inhalation, rat, for aerosols or particulates: 0.25 < LC

50

≤ 1 mg/litre/4hr,

- LC

50

inhalation, rat, for gases and vapours: 0.5 < LC

50

≤ 2 mg/litre/4hr.

R39 Danger of very serious irreversible effects

- strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/23, R39/24, R39/25, R39/23/24, R39/23/25, R39/24/25, R39/23/24/25.

R48 Danger of serious damage to health by prolonged exposure

- serious damage (clear functional disturbance or morphological change which have toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as toxic when these effects are observed at levels of one order of magnitude lower (i.e. 10-fold) than those set out for R48 in Section 3.2.3.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R48/23, R48/24, R48/25, R48/23/24, R48/23/25, R48/24/25, R48/23/24/25.

3.2.3. Harmful

Substances and preparations shall be classified as harmful and assigned the symbol ‘Xn’ and the indication of danger ‘harmful’ in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria

R22 Harmful if swallowed

Acute toxicity results

- LD

50

per oral, rat: 200 < LD

50

≤ 2000 mg/kg,

- discriminating dose, oral, rat, 50 mg/kg: 100 % survival but evident toxicity,

- less than 100 % survival at 500 mg/kg, rat oral by the fixed dose procedure. Refer to the evaluation table in the test method B.1

bis

of Annex V, or

- high mortality in the dose range > 200 to ≤ 2 000 mg/kg oral, rat, by the acute toxic class method (for test result interpretation see flow charts in Annex 2 of test method B.1

tris

of Annex V).

R21 Harmful in contact with skin

Acute toxicity results

- LD

50

dermal, rat or rabbit: 400 < LD

50

≤ 2 000 mg/kg.

R20 Harmful by inhalation

Acute toxicity results

- LC

50

inhalation, rat, for aerosols or particulates: 1 < LC

50

≤ 5 mg/litre/4hr,

- LC

50

inhalation, rat, for gases or vapours: 2 < LC

50

≤ 20 mg/litre/4hr.

R65 Harmful: may cause lung damage if swallowed

Liquid substances and preparations presenting an aspiration hazard in humans because of their low viscosity

(a) For substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total concentration equal to or greater than 10 % and having either

- a flow time of less than 30 sec. in a 3 mm ISO cup according to ISO 2431 (April 1996 / July 1999 edition) relating to ‘Paints and varnishes - Determination of flow time by use of flow cups’,

- a kinematic viscosity measured by a calibrated glass capillary viscometer in accordance with ISO 3104/3105 of less than 7 × 10

-6

m

2

/sec at 40° C (ISO 3104 1994 edition, relating to ‘Petroleum products - Transparent and opaque liquids - Determination of kinematic viscosity and calculation of dynamic viscosity’; ISO 3105, 1994 edition, relating to ‘Glass capillary kinematic viscometers - Specifications and operating instructions’), or

- a kinematic viscosity derived from measurements of rotational viscometry in accordance with ISO 3219 of less than 7 × 10

-6

m

2

/sec at 40° C (ISO 3219, 1993 edition, relating to ‘Plastics - Polymers/resins in the liquid state or as emulsions or dispersions - Determination of viscosity using a rotational viscometer with defined shear rate’).

Note that substances and preparations meeting these criteria need not be classified if they have a mean surface tension greater than 33mN/m at 25° C as measured by the du Nouy tensiometer or by the test methods shown in Annex V Part A.5.

(b) For substances and preparations, based on practical experience in humans.

R68 Possible risk of irreversible effects

- strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate route of administration/exposure one of the following combinations shall be used: R68/20, R68/21, R68/22, R68/20/21, R68/20/22, R68/21/22, R68/20/21/22.

R48 Danger of serious damage to health by prolonged exposure

- serious damage (clear functional disturbance or morphological change which has toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as harmful when these effects are observed at levels of the order of

- oral, rat ≤ 50 mg/kg (bodyweight)/day,

- dermal, rat or rabbit ≤ 100 mg/kg (bodyweight)/day,

- inhalation, rat ≤ 0.25 mg/l, 6h/day.

These guide values can apply directly when severe lesions have been observed in a sub-chronic (90 days) toxicity test. When interpreting the results of a sub-acute (28 days) toxicity test these figures should be increased approximately three fold. If a chronic (two years toxicity test is available it should be evaluated on a case-by-case basis. If results of studies of more than one duration are available, then those from the study of the longest duration should normally be used.

In order to indicate route of administration/exposure one of the following combinations shall be used: R48/20, R48/21, R48/22, R48/20/21, R48/20/22, R48/21/22, R48/20/21/22.

3.2.3.1.

Comments regarding volatile substances

For certain substances with a high-saturated vapour concentration evidence may be available to indicate effects that give cause for concern. Such substances may not be classified under the criteria for health effects in this guide (3.2.3) or not covered by Section 3.2.8. However, where there is appropriate evidence that such substances may present a risk in normal handling and use then classification on a case-by-case basis in Annex I may be necessary.

3.2.4. Comments regarding the use of R48

Use of this risk phrase refers to the specific range of biological effects within the terms described below. For application of this risk phrase serious damage to health is to be considered to include death, clear functional disturbance or morphological changes which are toxicologically significant. It is particularly important when these changes are irreversible. It is also important to consider not only specific severe changes in a single organ or biological system but also generalised changes of a less severe nature involving several organs, or severe changes in general health status.

When assessing whether there is evidence for these types of effects reference should be made to the following guidelines

ARRANGEMENT OF REGULATIONS

REGULATION.

1.

Citation

2.

Interpretation

3.

Construction and Application

4.

Exemptions

5.

Competent Authority

6.

Placing on the Market

7.

Testing and assessment

8.

Classification

9.

Obligation to carry out investigations

10.

Full Notification

11.

Reduced Notification for substances placed on the market in quantities of less than one tonne per annum

12.

Substances Notified at least 10 years previously

13.

Notification of Polymers

14.

Pre-marketing Notification Period

15.

Exemptions from the notification requirements

16.

Follow up Information

17.

Re-notification of the same substance and avoidance of duplicate testing in vertebrate animals

18.

Confidentiality of data

19.

Packaging

20.

Labelling

21.

Implementation of labelling

22.

Exemptions from labelling and packaging requirements

23.

Advertising

24.

Safety Data Sheet

25.

Supply of Substances

26.

Restriction on Sale

27.

Fees Payable by Notifier

28.

Taking and Detention of Substances

29.

Offences

30.

Revocations

Schedule 1

Foreword to Annex I

Schedule 2

Annex II: Symbols and Indications of Danger for dangerous substances and preparations

Schedule 3

Annex III: Nature of special risks attributed to dangerous substances and preparations

Schedule 4

Annex IV: Safety Advice concerning dangerous substances and preparations

Schedule 5

Annex VI: General Classification and Labelling Requirements for dangerous substances and preparations

Schedule 6

Annex VIIA, Annex VIIB, Annex VIIC, Annex VIID and Annex VIII: Information required for the Technical dossier

Schedule 7

Annex IX: Provisions relating to child-proof fastenings and tactile warning devices

Schedule 8

Obligatory Headings for Safety Data Sheets

Schedule 9

Fees Payable by Notifier

S.I. No. 116 of 2003

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS 2003

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 effect to Council Directives 92/32/EEC of 30 April 1992

1

, Directive 96/56/EC of the European Parliament and the Council of 3 September 1996

2

, Commission Directives 91/155/EEC of 5 March 1991

3

, 92/69/EEC of 31 July 1992

4

, 93/21/EEC of 27 April 1993

5

, 93/67/EEC of 20 July 1993

6

, 93/72/EEC of 1 September 1993

7

, 93/101/EC of 11 November 1993

8

, 93/105/EC of 25 November 1993

9

, 93/112/EC of 10 December 1993

10

, 94/69/EC of 19 December 1994

11

96/54/EC of 30 July 1996

12

, 97/69/EC of 5 December 1997

13

, 98/73/EC of 18 September 1998

14

, 98/98/EC of 15 December 1998

15

, 2000/32/EC of 19 May 2000

16

, 2000/21/EC of 25 April 2000

17

, 2000/33/EC of 25 April 2000

18

, 2001/58/EC of 27 July 2001

19

and 2001/59/EC of 6 August 2001

20

hereby make the following regulations