S.I. No. 62/2004 - European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations 2004

1.2. Preparations should be classified as dangerous for the environment and assigned the risk phrase R59 if they contain one or more substances classified as dangerous to the environment and to which is assigned R59 in individual concentrations equal to or greater than:

• (a) either the concentration specified in Annex I for the substance or substances under consideration, or

• (b) the concentration specified in Part B of this Schedule (Table 5) where the substance or substances do not appear in Annex I or appear in it without concentration limits;

• (2) TERRESTRIAL ENVIRONMENT

1. Evaluation of preparations dangerous for the terrestrial environment

Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI.

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.

PART B — Concentration limits to be used for the evaluation of environmental hazards

I. For the aquatic environment

The concentration limits fixed in the following tables, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1

Acute aquatic toxicity and long-term adverse effects

Classification of the substance	Classification of the preparation	Classification of the preparation	Classification of the preparation
Classification of the substance	N, R50-53	N, R51-53	R52-53
N, R50-53	Cn > = 25%	2.5% = < Cn < 25%1	0.25% = < Cn < 2.5%
N, R51-53		Cn > = 25%	2.5% = < Cn < 25%
R52-53			Cn > = 25%

Table 2

Acute aquatic toxicity

Classification of the substance	Classification of the preparation N, R50
N, R50	Cn > = 25%
N, R50-53	Cn > = 25%

Table 3

Aquatic toxicity

Classification of the substance	Classification of the preparation N, R52
R52	Cn > = 25%

Table 4

Long-term adverse effects

Classification of the substance	Classification of the preparation N, R53
R53	Cn > = 25%
N, R50-53	Cn > = 25%
N, R51-53	Cn > = □ 25%
R52-53	Cn > = 25%

II. For the non-aquatic environment

The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 5

Dangerous for the ozone layer

Classification of the substance	Classification of the preparation N, R59
N with R59	Cn > = 0.1%
R59	Cn > = 0.1%

PART C — Test methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation.

The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method, i.e. cannot be used to modify long term toxicity effects.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C of Annex V have been complied with.

Furthermore, the tests are to be carried out on all three species in conformity with the criteria of Annex VI (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species or a test result was already available before the Directive entered into force.

SCHEDULE 5 SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE PUBLIC

Regulations 3 and 13

PART A Containers to be fitted with child-resistant fastenings

No.	Identification o e substance	Identification o e substance	Identification o e substance	Concentration limit
No.	CAS-Reg No	Name	Einecs No.	Concentration limit
1	67-56-1	Methanol	2006596	≥3%
2	75-09-2	Dichloromethane	2008389	≥1%

which are offered or sold to the general public are to be fitted with child-resistant fastenings.

PART B Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Regulation 14 and under the conditions laid down in Regulations 8 and 9, are to carry a tactile warning of danger.

This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable.

PART C Provisions relating to child-proof fastenings

Reclosable packages

Child-proof fastenings used on reclosable packages shall comply with ISO standard 8317 (1 July 1989 edition) relating to ‘Child-resistant packages — Requirements and methods of testing for reclosable packages’ adopted by the International Standard Organisation (ISO).

Non-reclosable packages

Child-proof fastenings used on non-reclosable packages shall comply with CEN standard EN 862 (March 1997 edition) relating to ‘Packaging — Child-resistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

Notes

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

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 Note 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 D 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 6 NAMING OF SUBSTANCES IN A PREPARATION

Regulation 14

• (a) in the case of a preparation classified as very toxic, (T^+), toxic, (T), or harmful (Xn) in accordance with Regulation 9 only those substances classified as very toxic, (T^+), toxic, (T) or harmful (Xn) present in concentrations equal to or greater than the lowest limit (limit Xn) specified in Annex I or, if no such limit is specified, Part B of Schedule 3 have to be taken into consideration,

• (b) in the case of a preparation classified in accordance with Regulation 9 as corrosive, (C), only corrosive substances present in concentrations equal to or greater than the lowest limit (limit Xi) specified in Annex I or, if no such limit is specified, Part B of Schedule 3 have to be taken into account,

• (c) the name of the substances which have given rise to the classification in one or more of the following danger categories—

• (i) carcinogen category 1, 2 or 3,

• (ii) mutagen category 1, 2, or 3,

• (iii) toxic for reproduction category 1, 2 or 3,

• (iv) very toxic, toxic or harmful due to non-lethal effects after a single exposure,

• (v) toxic or harmful due to severe effects after repeated or prolonged exposure,

• (vi) sensitising,

shall be mentioned on the label.

• (i) explosive,

• (ii) oxidising,

• (iii) extremely flammable,

• (iv) highly flammable,

• (v) flammable,

• (vi) irritant,

• (vii) dangerous for the environment,

need not be mentioned on the label unless the substance has to be mentioned pursuant to paragraph (1)(a), paragraph (1)(b) or paragraph (1)(c).

• (b) Notwithstanding subparagraph (a), in certain circumstances more than 4 chemical names may be necessary to identify such substance.

SCHEDULE 7 SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS

Regulations 3 and 14

A. For preparations classified as dangerous as defined under Regulation 3(2)

1.1 The labels on packages containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI.

1.2 When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.

2. Preparations intended for use by spraying

The package label containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI.

3. Preparations containing a substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one substance assigned the phrase R33, the label of the preparation must carry the wording of this phrase as set out in Annex III, when the concentration of this substance present in the preparation is equal to or higher than 1%, unless different values are set in Annex I.

4. Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one substance assigned phrase R64, the label of the preparation must carry the wording of this phrase as set out in Annex III, when the concentration of this substance present in the preparation is equal to or higher than 1%, unless different values are set in Annex I.

B. For preparations irrespective of their classification as defined under Regulation 3(3)

1. Preparations containing lead

1.1. Paint and varnishes

Labels of packages of paints and varnishes containing lead in quantities exceeding 0.15% (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars:

“Contains lead. Should not be used on surfaces liable to be chewed or sucked by children”.

In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:

“Warning! Contains lead”.

2. Preparations containing cyanoacryl

2.1. Adhesives

The immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:

“Cyanoacrylate

Danger

Bonds skin and eyes in seconds

Keep out of the reach of children.”

Appropriate advice on safety must accompany the package.

3. Preparations containing isocyanates

The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:

“Contains isocyanates.

See information supplied by the manufacturer.”

4. Preparations containing epoxy constituents with an average molecular weight ≤ 700

The package labels of preparations containing epoxy constituents with an average molecular weight ≤ 700 must bear the following inscriptions:

“Contains epoxy constituents.

See information supplied by the manufacturer.”

5. Preparations sold to the general public which contain active chlorine

The packaging of preparations containing more than 1% of active chlorine must bear the following particular inscriptions:

“Warning! Do not use together with other products.

May release dangerous gases (chlorine).”

6. Preparations containing cadmium (alloys) and intended to be used for brazing or soldering

The packaging of the abovementioned preparations must bear the following inscription printed in clearly legible and indelible characters:

“Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions.”

7. Preparations available as aerosols

Without prejudice to these Regulations, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Council Directive 75/324/EEC of 20 May 1975³¹ as last amended by Commission Directive 94/1/EC of 6 January 1994³² .

8. Preparations containing substances not yet tested completely

Where a preparation contains at least one substance which, in accordance with Article 13.3 of Directive 67/548/EEC, bears the inscription “Warning — substance not fully tested", the label of the preparation must bear the inscription “Warning — this preparation contains a substance not yet fully tested” if this substance is present in a concentration ≥ 1%.

9. Preparations not classified as sensitising but containing at least one sensitising substance

The packaging of preparations containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0.1% or in a concentration equal to or greater than that specified under a specific note for the substance in Annex I must bear the inscription:

“Contains (name of sensitising substance). May produce an allergic reaction.”

10. Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55°C and contain a halogenated hydrocarbon and more than 5% flammable or highly flammable substances, the packaging must bear the following inscription as appropriate:

“Can become highly flammable in use” or “Can become flammable in use".

11. Preparations containing a substance assigned phrase R67: Vapours may cause drowsiness and dizziness

When a preparation contains one or more substances assigned the phrase R67, the label of the preparation must carry the wording of this phrase as set out in Annex III, when the total concentration of these substances present in the preparation is equal to or higher than 15%, unless:

— the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26

— or the preparation is in a package not exceeding 125ml.

12. Cements and cement preparations

The packaging of cements and cement preparations containing more than 0.0002% soluble chromium (VI) of the total dry weight of the cement must bear the inscription:

“Contains chromium (VI). May produce an allergic reaction"

unless the preparation is already classified and labelled as a sensitiser with phrase R43.

C. For preparations not classified within the meaning of Regulation 3(2), but containing at least one dangerous substance

1. Preparations not intended for the general public

The label on the packaging of the preparations referred to in Regulation 18(1)(b) must bear the following inscription:

“Safety data sheet available for professional user on request".

SCHEDULE 8 SYMBOLS AND INDICATIONS OF DANGER

Regulations 2 and 14

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

E [image omitted]	Explosive	O [image omitted]	Oxidizing
F [image omitted]	Highly flammable	F+ [image omitted]	Extremely flammable
T [image omitted]	Toxic	T+ [image omitted]	Very Toxic
C [image omitted]	Corrosive	Xn [image omitted]	Harmful
Xi [image omitted]	Irritant	N [image omitted]	Dangerous for the environ

SCHEDULE 9 RISKS PHRASES

NATURE OF SPECIAL RISKS ATTRIBUTED TO DANGEROUS SUBSTANCES AND PREPARATIONS

PART I SINGLE R-PHRASES

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 the 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

PART II 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

39/26/27

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 10 SAFETY PHRASES

Regulations 2 and 14

PART I SINGLE SAFETY PHRASES

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 manufactuer).

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 specifed 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 protective 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).

PART II COMBINATION SAFETY 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 ..... (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 11 SPECIAL LABELLING PROVISIONS FOR SINGLE PACKAGES

Regulation 15

Labelling of Mobile Gas Cylinders

For mobile gas containers the requirements concerning labelling are considered to be satisfied when they are in agreement with Regulation 15(7).

However, by way of derogation from Regulation 15(1) to (4), 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 (1994 edition) relating to ‘Gas cylinders — Precautionary labels’. In this case, the label can bear the generic name or industrial/commercial name of the preparation where 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 Regulation 14 may be provided on a durable information disc or label held captive on the containers.

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 Regulations 10 to 12, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or non-refillable cartridges within the scope on EN 417 as fuel gases which are only released for combustion (EN 417, September 1992 edition, relating to ‘Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve, for use with portable appliances; construction, inspection, testing and marking’).

These cylinders and 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 Regulation 18. For the consumer, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety as foreseen in Article 1(3) of Directive 91/155/EEC.

Alloys, preparations containing polymers, preparations containing elastomers

These preparations shall be classified according to Regulations 10 to 12, and labelled according to Regulation 14.

However some of these preparations although classified in accordance with Regulations 11 and 12 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 Regulation 14 or according to Schedule 7, B.9. 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 Regulation 18.

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 fitted with a sealed spray attachment.

SCHEDULE 12 OBLIGATORY HEADINGS FOR SAFETY DATA SHEETS

Regulation 18

SCHEDULE 13 Labelling of a plant protection product

Regulation 14(2)

The following wording shall be printed on the label of a plant protection product referred to in Regulation 14(2):

“To avoid risks to man and the environment, comply with the instructions for use."

	GIVEN under my Official Seal, this 19th day of February, 2004.
	MARY HARNEY,
	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 Directive 1999/45/EC of the European Parliament and of the Council of 31 May, 1999 on the classification, packaging and labelling of dangerous preparations placed on the market of the E.C. This Directive replaces Council Directive 88/379/EEC. The Regulations also transpose the first adaptation to technical progress (ATP) of Directive 1999/45/EC — Commission Directive 2001/60/EC of 7 August 2001.

The Regulations apply to all dangerous preparations with exceptions for certain categories of preparations such as medicines, cosmetics etc., which are covered by other Council Directives. The Regulations require persons placing a dangerous preparation on the market, to classify and label it according to the inherent hazards including, for the first time, the danger to the environment hazard category. Certain preparations that would not be classified as dangerous by the Directive and these Regulations are nevertheless subject to specific labelling requirements if the particular preparations are listed in the Annex V to Directive 1999/45/EC, as amended by Commission Directive 2001/60/EC. The classification, labelling and packaging requirements of these Regulations have also been extended to include plant protection products from 30 July 2004. (Biocides, within the meaning of Council Directive 98/8/EC are covered in the same way as dangerous preparations within the Regulations.)

The requirements for classification and provision of Safety Data Sheets have been extended to explosive and pyrotechnic preparations for the first time.

The Regulations also transpose Commission Directive 2001/58/EC of 27 July 2001, which amends Commission Directive 91/155/EEC of 5 March 1991 concerning the provision of specific information relating to dangerous preparations in the form of Safety Data Sheets, requiring the provision of safety data sheets on request to professional users of certain preparations not classified as dangerous.

The Regulations revoke and replace the European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations, 1995 ( S.I. No. 272 of 1995 ) and the European Communities (Classification, Packaging and Labelling of Dangerous Preparations) (Amendment) Regulations, 1998 ( S.I. No. 354 of 1998 ).

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