S.I. No. 393/2000 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2000.

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. Evidence of conformity with the above standard may be certified only by laboratories which conform with European Standards Series EN 45 000.

2. Specific cases

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the competent authority may ask the person responsible for putting the product on the market to give him a certificate from a laboratory described in 3.1, stating that either

- the type of closure is such that it is not necessary to test to the ISO and CEN standards referred to above, or

- the closure has been tested and has been found to conform with the standard referred to above.

PART B

Provisions relating to tactile warning devices

The technical specifications for tactile warning devices shall conform with EN ISO standard 11683 (1997 edition) relating to “Packaging - Tactile warnings of danger - Requirements”.

SCHEDULE 7

Regulation 22

Obligatory Headings for Safety Data Sheets

1.

Identification of the substance/preparation and of the company/undertaking;

2.

Composition/information on ingredients;

3.

Hazards identification.

4.

First-aid measures;

5.

Fire-fighting measures;

6.

Accidental release measures;

7.

Handling and storage;

8.

Exposure controls/personal protection;

9.

Physical and chemical properties;

10.

Stability and reactivity;

11.

Toxicological information;

12.

Ecological information;

13.

Disposal considerations;

14.

Transport information;

15.

Regulatory information;

16.

Other information.

SCHEDULE 8

FEES PAYABLE BY NOTIFIER

Regulation 25

Column 1

Column 2

Subject matter

Fee payable

1.

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

£5,500

2.

For a re-notification submitted in accordance with Regulation 16 (1) (See notes 1 and 2)

£1,100

3.

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

£1,100

4.

For additional tests submitted under Regulation 10(3)

(a)

(> 10 tonnes per year)

£3,300

5.

For additional tests submitted under Regulation 10(3)

(b)

(> 100 tonnes per year)

£5,500

6.

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

£11,000

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))

£1,100

(b)

quantity of the new substance up to 100kg

1

(Regulation 11(3))

£550

8.

For a successful application made by a notifier

£550

for an exemption relating to him under Regulation 4(14)

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

£200

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

£2500

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

£550

GIVEN under my Official Seal, this

29

day of

November

2000.

Mary Harney, T.D.,

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 implement Commission Directives 98/98/EEC (the 25

th

Adaptation to Technical Progress (ATP) of Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances), 2000/32/EC (the 26

th

Adaptation to Technical Progress) and 2000/33/EC (the 27

th

Adaptation to Technical Progress). The Regulations additionally replace 4 sets of Regulations, (a) the European Communities (Dangerous Substances) (Classification, Packaging and Labelling) Regulations, 1994 (

S.I. No. 77 of 1994

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

S.I. No. 317 of 1998

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

S.I. No. 513 of 1998

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

S.I. No. 363 of 1999

) with a single consolidated set of Regulations.

The consolidated Regulations thus also implement 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) and 98/73/EC (24

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 and 93/112/EC) are also implemented.

The aim of the 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 98/98/EEC of 15 December, 1998, adapts to technical progress Annexes I, III, IV and VI 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 I, and deletes a number of existing entries in the Annex. Additional risk phrases are included in Annex III of the Directive (provided as Schedule 3 of the Regulations), additional safety phrases in Annex IV (provided as Schedule 4 of the Regulations) and Annex VI, the classification and guide (provided as Schedule 6 of the Regulations) is amended.

Commission Directive 2000/32/EEC of 19 May, 2000, adapts to technical progress Annexes I, IV, V and IX of Directive 67/548/EEC. The Directive adds a number of additional dangerous substances to Annex I and amends the classification and labelling of a number of other dangerous substances already included in the Annex. Additional safety phrases are included in Annex IV, a number of additional testing methods are included in Annex V, the harmonised European Union methods for the testing of chemicals for hazardous properties, and Annex IX, the provisions relating to child-proof fastening is amended.

Commission Directive 2000/33/EEC of 25 April, 2000, adapts to technical progress Annex V of Directive 67/548/EEC. Additional test methods are incorporated into Annex V.

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.

Published by the Stationery Office,

Dublin 8.

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. 196. 16.8.1967, p. 1

20

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

21

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

22

O.J. 22, 9.2.1965, p. 369

23

O.J. L214, 24.8.1993 p22

24

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

25

O.J. L253, 15.9.1998, p20

26

O.J. L 194, 15.7.1975 p. 39

27

O.J. L135, 6.6.1996, p32

28

O.J. L377, 31.12.1991, p20

29

O.J. L168, 2.7.1994, p28

30

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

31

O.J. L 270. 14.12. 1970. p. 1

32

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

33

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

34

O.J. L 184. 15.7. 1988. p. 61

35

O.J. L 15. 17.1. 1987, p. 29

36

O.J. L 398. 18.12. 1986. p. 1

37

O.J. L187, 16.7. 1988. p. 14

38

This article corresponds to Regulations 8 and 19.

39

This article corresponds to Regulation 9

40

These articles correspond to Regulations 18, 19 and 20.

41

These articles correspond to Regulation 2(2).

42

This Annex corresponds to Schedule 1

43

This Annex corresponds to Schedule 2

44

This Annex corresponds to Schedule 3

45

This article corresponds to Regulation 4(6)b

46

This article corresponds to Regulation 2

47

This article corresponds to Regulation 22

48

This article corresponds to Regulation 18(a)

1

Including a re-notification submitted in accordance with Regulation 16 (1)

3. Notes

4. TOXICOLOGICAL STUDIES

On a case by case basis and without delaying in acceptance of the notification, the competent authorities may, on the basis of the presence of reactive groups, structural/physical characteristics, knowledge concerning the properties of low molecular weight components of the polymer or exposure potential, require certain tests to be carried out. In particular tests for inhalation toxicity (e. g. 4.1.2 or 4.2.1), may be required if exposure by the inhalatory route is considered possible.

5. ECOTOXICOLOGICAL STUDIES

On a case-by-case basis and without delaying the acceptance of the notification, the competent authorities may on the basis of the presence of reactive groups, structural/physical characteristics, knowledge concerning the properties of low molecular weight components of the polymer or exposure potential, require certain tests to be carried out. In particular, the following additional tests may be required

- light-stability, if the polymer is not specifically light-stabilized

- - long-term extextactivity (leachate test). Depending on the results of this test, any appropriate test on the leachate may be requested on a case by case basis

6. POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS

6.1. For industry/skilled trades

6.1.1. Possibility of recycling

6.1.2. Possibility of neutralization of unfavourable effects

6.1.3. Possibility of destruction

- controlled discharge

- incineration

- water purification station

- others

6.2. For the public at large

6.2.1. Possibility of recycling

6.2.2. Possibility of neutralization of unfavourable effects

6.2.3. Possibility of destruction

- controlled discharge

- incineration

- water purification station

- others

C.2.2. Polymers placed on the Community market in quantities of < t/a or total quantities of < 5 t

7. Testing and Assessment

(1) For the purposes of these Regulations -

(a) tests on substances shall as a general principle be conducted according to the methods laid down in Annex V,

(b) the physico-chemical properties of substances shall be determined according to the methods specified in Annex V (A),

(c) the toxicity of substances shall be determined according to the methods specified in Annex V (B),

(d) the ecotoxicity of substances shall be determined according to the methods specified in Annex V (C),

(e) laboratory tests on substances shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 87/18/EE C

35

and in Directive 86/609/EEC

36

,

(f) for substances on the EINECS the adequacy of the data for the purposes of classification and labelling and the need to conduct new tests shall be decided on a case-by-case basis taking into account the need to minimise testing on vertebrate animals.

(2) (a) Where more than one notification exists for a substance manufactured by the same manufacturer outside the European Communities, the obligation to carry out supplementary testing required under these Regulations will fall collectively on all notifiers placing that substance on the market;

(b) For substances referred to in subparagraph (a), if the quantities detailed in Regulation 10(3) are attained, the competent authority shall contact each notifier and inform him of the identity of the other notifiers and shall draw his attention to the provisions of subparagraph (a).

(3) Where it is necessary in the opinion of the competent authority for the purposes of carrying out the evaluation of the risks which may be caused by a substance in accordance with Directive 93/67/EEC, the competent authority may ask for further information, verification or confirmatory tests concerning the substances or their transformation products of which they have been notified or have received information under these Regulations and may also request information referred to in Annex VIII earlier than provided for in Regulation 10(3).

8. SPECIAL CASES: SUBSTANCES

8.1. Mobile gas cylinders

For mobile gas cylinders the requirements concerning labelling are considered to be satisfied when they are in agreement with Article 23 or Article 24(6)b

45

of Directive 67/548/EEC

However, by way of derogation from Article 24(1) and (2) of Directive 67/548/EEC one of the following alternatives can be used for gas cylinders with a water capacity of less than or equal to 150 litres

- the format and dimensions of the label can follow the prescriptions of the ISO Standard ISO/DP 7225

- the information specified in Article 23(2) of Directive 67/548/EEC may be provided on a durable information disc or label held captive on the cylinder.

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

These substances are classified in Annex I. Although classified in accordance with Article 2

46

of Directive 67/548/EEC, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of EN 417 as fuel gases which are only released for combustion.

These cylinders or cartridges must be labelled with the appropriate symbol and the risk and safety phrases concerning flammability. No information concerning the effects on human health is required on the label. However, the information concerning effects on human health which should have appeared on the label shall be transmitted to the professional user by the person responsible for placing the substance on the market in the format foreseen in Article 27

47

of Directive 67/548/EEC. For the consumer, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety as foreseen in Article I paragraph 3 of Directive 91/155/EEC, as modified by Directive 93/112/EEC.

8.3 Metals in massive form

These substances are classified in Annex I or shall be classified in accordance with Article 6 of Directive 67/548/EEC. However, some of these substances, although classified in accordance with Article 2 Of Directive 67/548/EEC do not present a danger to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market. Such substances do not require a label according to Article 23 of Directive 67/548/EEC. However, all the information which should have appeared on the label shall be transmitted to the user by the person responsible for placing the metal on the market, in a format foreseen in Article 30 of Directive 67/548/EEC.

8.4. Substances classified with R65

Substances classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9 SPECIAL CASES: PREPARATIONS

9.1. Gaseous preparations (gas mixtures)

For gaseous preparations, consideration must be given to

- the evaluation of the physico-chemical properties,

- the evaluation of health hazards.

9.1.1. Evaluation of physico-chemical properties

9.1.1.1. Flammability

The flammable properties of these preparations are determined in accordance with Article 3(2) of Directive 88/379/EEC according to the methods specified in Part A of Annex V to Directive 67/548/EEC.

These preparations will be classified according to the results of the tests carried out and with respect to the criteria of Annex V and to the criteria of the labelling guide.

However, by derogation, in the case where gaseous preparations are produced to order in small amounts, the flammability of these gaseous mixtures can be evaluated by the following calculation method

the expression of the gaseous mixture

A

l

F

l

+ … + A

i

F

i

+ … A

n

F

n

+ … + B

i

I

i

+ … + B

p

I

i

+ … B

p

I

p

where: Ai and Bi are the molar fractions

F

i

flammable gas

I

i

inert gas

n number of flammable gases

p number of inert gases

can be transformed in a form where all the I

i

(inert gases) are expressed by a nitrogen equivalent using a coefficient K

i

and where the equivalent content of inflammable gas A'

i

is expressed as follows

A'

i

=A

i

x ( 100/ (A

i

+K

i

B

i

))

By using the value of the maximum content of flammable gas which, in a mixture with nitrogen, gives a composition which is not flammable in air (Tci), the following expression can be obtained

Σ

i

A'

i

/ Tci ≤ 1

The gas mixture is flammable if the value of the above expression is greater than one. The preparation is classified extremely flammable and, the phrase R12 is assigned.

Coefficients of equivalency (K

i

)

The values of the coefficients of equivalency K

i

, between the inert gases and nitrogen and the values of the maximum contents of flammable gas (Tci) may be found in tables 1 and 2 of the ISO Standard ISO 10156 edition 15. 12. 1990

Maximum content of flammable gas (Tci)

The value of the maximum content of flammable gas (Tci) may be found in table 2 of the ISO Standard ISO 10156 edition 15. 12. 1990

When a Tci value for a flammable gas does not appear in the above standard, the corresponding lower explosivity limit (LEL) will be used. If no LEL value exists, the value of Tci will be set at 1 % by volume.

Remarks

- The expression above can be used to allow an appropriate labelling of gaseous preparations, however, it should not be regarded as a method for replacing experimentation for the determination of technical safety parameters.

- Furthermore, this expression gives no information as to whether a mixture containing oxidizing gases can be prepared safely. When estimating flammability these oxidizing gases a are not taken into account.

- The expression above will give reliable results only if the flammable gases do not influence each other as far as their flammability is concerned. This has to be considered, e.g. with halogenated hydrocarbons.

9.1.1.2. Oxidizing properties

Given the fact that Annex V to Directive 67/548/EEC does not contain a method to determine the oxidizing properties of gaseous mixtures, the evaluation of these properties must be realised according to the following estimation method.

The principle of the method is comparison of the oxidizing potential of gases in a mixture with that of the oxidizing potential of oxygen in air. The concentrations of gases in the mixture are expressed in % vol.

It is considered that the gas mixture is as oxidant as or more oxidant than air, if the following condition is verified

Σ

i

X

i

C

i

≥ 21

where: x

i

is the concentration of gas i in % vol,

Ci is the coefficient of oxygen equivalency.

In this case, the preparation is classified as oxidizing and the phrase R8 will be assigned.

Coefficients of equivalency between oxidizing gases and oxygen

The coefficients used in the calculation to determine the oxidizing capacity of certain gases in a mixture with respect to the oxidizing capacity of oxygen in air, listed under 5.2. in the ISO Standard ISO 10156 edition 15. 12. 1990, are the following.

O

2

1

N

2

O 0,6

When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this coefficient.

9.1.2. Evaluation of the health effects

This evaluation of the dangers of a preparation for health is made according to Article 3(3) of Directive 88/379/EEC.

When the evaluation of the health hazards is made according to the conventional method described in Article 3(5) of Directive 88/379/EEC by reference to individual concentration limits, the individual concentration limits to be used are expressed in percent by volume and appear

- either in Annex I to Directive 67/548/EEC for the gas (es) considered,

- or in Annex I to Directive 88/379/EEC, tables IA to VIA when the gas (es) considered are not in Annex I, or appear there without concentration limits.

9.1.3. Labelling

For mobile gas containers the requirements concerning labelling are considered to be satisfied when they are in agreement with Article 8(5) (b) of Directive 88/379/EEC.

However, by way of derogation from Articles 8(1). and 8(2)., for gas containers with a water capacity of less than or equal to 150 litres, the format and dimensions of the label can follow the prescriptions of the ISO Standard 7225. In this case, the label can bear the generic name or industrial/commercial name of the preparation provided that the dangerous component substances of the preparation are shown on the body of the gas cylinder in a clear and indelible way. The information specified in Article 7 may be provided on a durable information disc or label held captive on the containers.

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

Propane, butane and liquefied petroleum gas are classified in Annex I. Although preparations containing these substances are classified in accordance with Article 3 of Directive 88/379/EEC, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope on EN417 as fuel gases which are only released for combustion. These cylinders and cartridges must be labelled with the appropriate symbol and the R- and S-phrases concerning flammability. No information concerning effects on human health is required on the label. However, the information concerning the effects on human health which should have appeared on the label shall be transmitted to the professional user by the person responsible for placing the substance on the market in the format foreseen in Article 10 of Directive 88/379/EEC. For the consumer, sufficient information shall be transmitted to enable them to take all the necessary measures for health and safety as foreseen in Article I paragraph 3 of Directive 91/55/EEC.

9.3 Alloys, preparations containing polymers, preparations containing elastomers

These preparations shall be classified according to the requirements of Articles 3 and labelled according to the requirements of Article 7 of Directive 88/379/EEC.

However some of these preparations although classified in accordance with Articles 3(3) do not present a danger to human health by inhalation, ingestion or contact with the skin or to the aquatic environment in the form in which they are placed on the market. Such preparations do not require a label according to Article 7. However, all the information which would have appeared on the label shall be transmitted to the professional user by means of an information system in a format foreseen in Article 10 of the above-mentioned Directive.

9.4 Preparations classified with R65

Preparations classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers with a sealed spray attachment.

9.5 Organic peroxides

Organic peroxides combine the properties of an oxidizer and a combustible substance in one molecule: when an organic peroxide decomposes, the oxidizing part of the molecule reacts exothermically with the combustible (oxidisable) part. For the oxidizing properties the existing methods in Annex V cannot be applied to the organic peroxides.

The following calculation method based on the presence of active oxygen must be used.

The available oxygen content (%) of an organic peroxide preparation is given by the formula

16 x (ni x ci/mi)

where

ni=number of peroxygen groups per molecule of organic peroxide i,

ci=concentration (mass %) of organic peroxide i,

mi=molecular mass of organic peroxide i.

SCHEDULE 5

ANNEX VII. A

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 7 (1)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

9. Obligation to carry out investigation

Manufacturers, distributors and importers of dangerous substances, which appear in the EINECS but which have not yet been introduced into Annex I, 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 21 to 20.

10. Full Notification

(1) Subject to Regulation 4, 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 22,

(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 16(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 15, 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.

11. Reduced Notification

(1) Subject to Regulation 4, 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 21 to 20.

(7) Where it is not possible to label substances in accordance with Regulation 19, 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, V.II.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. 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 Regulation 15(2) to such other sole representative as may exist or, in his absence, to the competent authority.

16. Re-notification

(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.

17. Confidentiality of data

(1) In the case of submissions made under Regulations 10, 11 or 15 the notifier may indicate the information required by these Regulations which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he wishes 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 15 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.

18. 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.

19. 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,

(g) for substances listed in Annex I, the words “EC label”, but until 31 December 2000 the words “EEC label” shall be deemed to satisfy this requirement.

(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;

(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

(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

(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 4 (6) (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 22, 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.

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

20. Implementation of labelling

(1) Where the particulars required by Regulation 19 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 x 74

-

Greater than three litres but not exceeding 50 litres

at least 74 x 105

-

Greater than 50 litres but not exceeding 500 litres

at least 105 x 148

-

Greater than 500 litres

at least 148 x 210

(3) Each symbol required by Regulation 19 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 19 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.

21. 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.

22. 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 7 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 93/112/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.

23. 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.

24. 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.

25. Fees Payable by Notifier

The fee fixed by column 2 of Schedule 8 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.

26. 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;

(b) either -

(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) indictate the inspector's intention of disposing of the substance at the expense of the owner.

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, and

(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;

(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 £5,000, the District Court for the district in which the goods were seized;

(b) in case the estimated amounts aforesaid does not exceed £30,000, 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 £5,000, 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 £30,000, it may, if it so thinks fit, by order transfer the appeal to the High Court.

27. Offences

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

(a) contravenes Regulation 6, 9, 10, 11, 15, 16 (2), 21, 22, 23 or 26 (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 16 (6), or

(e) contravenes a prohibition, or fails to comply with a condition, imposed on that person under Regulation 24.

(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 £1,500 or imprisonment for a term not exceeding 6 months or both.

28. Revocations

The following are hereby revoked:-

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

S.I. No. 77 of 1994

),

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

S.I. No. 317 of 1998

),

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

S.I. No. 513 of 1998

) and

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

S.I. No. 363 of 1999

).

SCHEDULE 1

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

O

Explosive

Oxidizing

F

F+

Highly flammable

Extremely flammable

T

T+

Toxic

Very Toxic

C

Xn

Corrosive

Harmful

Xi

N

Irritant

Dangerous for the environment

SCHEDULE 2

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

Possible risk of irreversible effects

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

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

R40/20

Harmful: possible risk of irreversible effects through inhalation

R40/21

Harmful: possible risk of irreversible effects in contact with skin

R40/22

Harmful: possible risk of irreversible effects if swallowed

R40/20/21

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

R40/20/22

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

R40/21/22

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

R40/20/21/22

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 3

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 feeding stuffs.

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 4

ANNEX VI

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 physico-chemical 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

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

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

12.

Substances Notified 10 years

13.

Notification of Polymers

14.

Pre-marketing Notification Period

15.

Follow-up Information

16.

Re-notification

17.

Confidentiality of Data

18.

Packaging

19.

Labelling

20.

Implementation of Labelling

21.

Advertising

22.

Safety Data Sheets

23.

Supply of Substances

24.

Restriction on Sale

25.

Fees payable by notifier

26.

Taking and Detention of Substances

27.

Offences

28.

Revocations

Schedule 1.

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

Schedule 2.

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

Schedule 3.

Annex IV: Safety Advice concerning dangerous substances and preparations.

Schedule 4.

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

Schedule 5.

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

Schedule 6.

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

Schedule 7.

Obligatory Headings for Safety Data Sheets.

Schedule 8.

Fees Payable by Notifier

S.I. No. 393 of 2000.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS, 2000.

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

and 96/56/EC 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

, and 2000/33/EEC of 25 April 2000

18

hereby make the following Regulations