LegalizeS.I. No. 272/1995 - European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations, 1995
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
2 amending acts · 2004-02-19, S.I. No. 62/2004 - European Communities (Classification, Packaging and Labelling of Dange…
- (ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 5%; or
( b ) it contains at least one substance assigned the risk phrase R41 in a concentration in the preparation—
- (i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit range specified therein for that substance, if it is so specified; or
- (ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, equal to or exceeding 0.5% but less than 5%; or
( c ) it contains more than one substance classified as irritant and assigned the risk phrases R 36 or R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a) or (b), or classified as corrosive and assigned the risk phrases R35 or R34 and the sum of their quotients satisfies the following equation—
where
- (i) Σ means the sum of,
- (ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,
- (iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,
- (iv) PXi, R41 is the concentration in the preparation of each irritant substance assigned the risk phrase R41,
- (v) PXi, R36 is the concentration in the preparation of each irritant substance assigned the risk phrase R36, and
- (vi) LXi, R36 is—
- (A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it so specified, or
- (B) in the case of a corrosive substance assigned the risk phrase R35, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.02%, or
- (C) in the case of a corrosive substance assigned the risk phrase R34, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.5%, or
- (D) in the case of an irritant substance, assigned the risk phrase R41 which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.5%, or
- (E) in the case of an irritant substance, assigned the risk phrase R36 which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.
Subject to the provisions of Part V, a preparation shall be classified as irritant and assigned the risk phrase R41 if—
( a ) it contains at least one irritant substance assigned the risk phrase R41 in a concentration equal to or exceeding—
- (i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or
- (ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 5%; or
( b ) it contains more than one substance classified as irritant and assigned the risk phrase R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), or classified as corrosive and assigned the risk phrases R35 or R34 and the sum of their quotients satisfies the following equation—
where
- (i) Σ means the sum of,
- (ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,
- (iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,
- (iv) PXi, R41 is the concentration in the preparation of each irritant substance assigned the risk phrase R41, and
- (v) PXi, R41 is—
- (A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
- (B) in the case of a corrosive substance assigned the risk phrase R35, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.2%, or
- (C) in the case of a corrosive substance assigned the risk phrase R34, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or
- (D) in the case of an irritant substance assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.
PART VII CARCINOGENIC/MUTAGENIC/TOXIC FOR REPRODUCTION
A preparation shall be classified as carcinogenic and assigned the risk phrase R45 or R49 (as appropriate) if it contains at least one substance assigned one of the risk phrases R45 or R49 in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%.
A preparation shall be classified as suspect for humans owing to its possible carcinogenic effects and shall be assigned the risk phrase R40 if it contains at least one substance assigned the risk phrase R40 (due to the suspicion for humans owing to the possible carcinogenic effects of the substance), in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.
(1) A preparation classified as carcinogenic, in accordance with the provisions of paragraph 1 shall be assigned the "toxic" symbol and "toxic" indication of danger unless the preparation is otherwise classified as very toxic.
- (2) A preparation classified as suspect for humans owing to its possible carcinogenic effects in accordance with provisions of paragraph 2 shall be assigned the "harmful" symbol and "harmful" indication of danger unless the preparation is otherwise classified as very toxic or toxic.
A preparation shall be classified as mutagenic and assigned the risk phrase R46 if it contains at least one substance, assigned the risk phrase R46, in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.1%.
A preparation shall be classified as suspect for humans owing to its possible mutagenic effects and shall be assigned the risk phrase R40 if it contains at least one substance, classified as mutagenic category 3 and assigned the risk phrase R40 (due to the suspicion for humans owing to the possible mutagenic effects of the substance), in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.
(1) A preparation classified as mutagenic in accordance with the provisions of paragraph 4 shall be assigned the "toxic" symbol and "toxic" indication of danger unless the preparation is otherwise classified as very toxic.
- (2) A preparation classified as suspect for humans owing to its possible mutagenic effects in accordance with the provisions of paragraph 5 shall be assigned the "harmful" symbol and "harmful" indication of danger unless the preparation is otherwise classified as very toxic or toxic.
A preparation shall be classified as toxic for reproduction and assigned the risk phrase R60 if it contains at least one substance assigned the risk phrase R60 in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.2%.
A preparation shall be classified as toxic for reproduction and assigned the risk phrase R61 if it contains at least one substance assigned the risk phrase R61 in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.2%.
A preparation shall be classified as having to be regarded as toxic for reproduction and assigned the risk phrase R62 if it contains at least one substance assigned the risk phrase R62 in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.
A preparation shall be classified as having to be regarded as toxic for reproduction and assigned the risk phrase R63 if it contains at least one substance assigned the risk phrase R63 in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or
( b ) in the case of a substance which is not specified in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.
(1) A preparation classified as toxic for reproduction in accordance with the provisions of paragraphs 7 and/or 8 shall be assigned the "toxic" symbol and "toxic" indication of danger unless the preparation is otherwise classified as very toxic.
- (2) A preparation classified as having to be regarded as toxic for reproduction in accordance with the provisions of paragraphs 9 and/or 10 shall be assigned the "harmful" symbol and "harmful" indication of danger unless the preparation is otherwise classified as very toxic or toxic.
Notwithstanding the provisions of paragraphs 2, 5, 9 and 10 and Table VIA of Annex I to Council Directive 88/379/EEC,
( a ) the provisions of paragraph 2 shall not apply to a preparation to which the provisions of paragraph 1 apply,
( b ) the provisions of paragraph 5 shall not apply to a preparation to which the provisions of paragraph 4 apply,
( c ) the provisions of paragraph 9 shall not apply to a preparation to which the provisions of paragraph 7 apply, and
( d ) the provisions of paragraph 10 shall not apply to a preparation to which the provisions of paragraph 8 apply.
PART VIII SENSITIZING CLASSIFICATION
A preparation shall be classified as sensitizing and assigned the risk phrase R42 if it contains at least one substance, assigned the single risk phrase R42, in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.2%.
A preparation shall be classified as sensitizing and assigned the combined risk phrase R42/43 if it contains at least one substance, assigned the combined risk phrase R42/43, in a concentration equal to or exceeding—
( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or
( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.2%.
A preparation, classified as sensitizing and assigned the risk phrase R42 or R42/43 in accordance with paragraphs 1 or 2 shall be assigned the "harmful" symbol and "harmful" indication of danger unless the preparation is otherwise classified as very toxic or toxic.
Regulation 22.
SCHEDULE 4
DANGER SYMBOLS AND INDICATIONS OF DANGER
Any danger symbol or symbols and indication or indications of danger to be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of Regulations 17 (d) and 22 shall, subject to paragraph 3, be those assigned to the dangerous preparation in accordance with the provisions of paragraph 2.
( a ) Any danger symbol or symbols and indication or indications of danger assigned to a dangerous preparation shall be that or those specified in the Table below, according to the classification or classifications of the dangerous preparation, determined in accordance with the provisions of Regulations 5, 6 and 7;
( b ) Each such danger symbol and indication of danger shall be that specified, in columns 2 and 3 respectively of the Table below, for each classification in column 1 of the Table below of the dangerous preparation.
( a ) In the case where more than one danger symbol has been assigned to a dangerous preparation, in accordance with the provisions of paragraph 2 and Regulation 5 (5)—
- (i) the obligation to apply the symbol T shall make the symbols C and X optional,
- (ii) the obligation to apply the symbol C shall make the symbol X optional,
- (iii) the obligation to apply the symbol E shall make the symbols F and O optional.
( b ) For the purposes of this paragraph, the reference characters specified in column 4 are those respectively for the danger symbols in column 2 of the Table below.
The danger symbols shall conform to those contained in Annex II to Directive 67/548/EEC and shall be printed in black on an orange-yellow background.
TABLE
| Classification of Danger | Danger Symbol | Indication of Danger | Characters Reference |
| Explosive | E | Explosive | E |
| [image omitted] | |||
| Oxidising | O | Oxidising | O |
| [image omitted] | |||
| Extremely flammable | F+ | Extremely flammable | F+ |
| [image omitted] | |||
| Highly flammable | F | Highly flammable | F |
| [image omitted] | |||
| Flammable | NONE | NONE | NONE |
| Very Toxic | T+ | Very Toxic | T+ |
| [image omitted] |
Note: The letters E, O, F, F+, T, T+, C, Xn, Xi, N do not form part of the Danger Symbol.
| Classification of Danger | Danger Symbol | Indication of Danger | Characters Reference |
| Toxic | T | Toxic | T |
| [image omitted] | |||
| Harmful | Xn | Harmful | Xn |
| [image omitted] | |||
| Corrosive | C | Corrosive | C |
| [image omitted] | |||
| Irritant | Xi | Irritant | Xi |
| [image omitted] | |||
| Dangerous for the Environment | N | Dangerous for the Environment | N |
| [image omitted] |
Note: The letters E, O, F, F+, T, T+, C, Xn, Xi, N do not form part of the Danger Symbol.
Regulation 23.
SCHEDULE 5
RISK PHRASES
The risk phrase or phrases to be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of Regulations 17 (e) and 23 shall be selected from those assigned to the dangerous preparation in accordance with the provisions of Regulations 5, 6 and 7 and Schedules 1, 2 and 3.
The risk phrase or phrases required to be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of paragraph 1 shall conform to those contained in Annex III to Council Directive 67/548/EEC, as set out in the Table below.
In the case of a dangerous preparation assigned two or more single risk phrases contained in Part I of the Table below in accordance with the provisions of paragraph 1, and which can be combined in a combined risk phrase contained in Part II of the Table below, that combined risk phrase shall be assigned to the dangerous preparation in place of the single phrase assigned.
TABLE
PART I SINGLE RISK PHRASES
| Risk Phrase Reference No. | Risk Phrase | Risk Phrase |
| R1 | Explosive when dry | Explosive when dry |
| R2 | Risk of explosion by shock, friction, fire or other sources of ignition | Risk of explosion by shock, friction, fire or other sources of ignition |
| R3 | Extreme risk of explosion by shock, friction, fire or other sources of ignition | Extreme risk of explosion by shock, friction, fire or other sources of ignition |
| R4 | Forms very sensitive explosive metallic compounds | Forms very sensitive explosive metallic compounds |
| R5 | Heating may cause an explosion | Heating may cause an explosion |
| R6 | Explosive with or without contact with air | Explosive with or without contact with air |
| R7 | May cause fire | May cause fire |
| R8 | Contact with combustible material may cause fire | Contact with combustible material may cause fire |
| R9 | Explosive when mixed with combustible material | Explosive when mixed with combustible material |
| R10 | Flammable | Flammable |
| R11 | Highly flammable | Highly flammable |
| R12 | Extremely flammable | Extremely flammable |
| R14 | Reacts violently with water | Reacts violently with water |
| R15 | Contact with water liberates extremely flammable gases | Contact with water liberates extremely flammable gases |
| R16 | Explosive when mixed with oxidizing substances | Explosive when mixed with oxidizing substances |
| R17 | Spontaneously flammable in air | Spontaneously flammable in air |
| R18 | In use, may form flammable/explosive vapour-air mixture | In use, may form flammable/explosive vapour-air mixture |
| R19 | May form explosive peroxides | May form explosive peroxides |
| R20 | Harmful by inhalation | Harmful by inhalation |
| R21 | Harmful in contact with skin | Harmful in contact with skin |
| R22 | Harmful if swallowed | Harmful if swallowed |
| R23 | Toxic by inhalation | Toxic by inhalation |
| R24 | Toxic in contact with skin | Toxic in contact with skin |
| R25 | Toxic if swallowed | Toxic if swallowed |
| R26 | Very toxic by inhalation | Very toxic by inhalation |
| R27 | Very toxic in contact with skin | Very toxic in contact with skin |
| R28 | Very toxic if swallowed | Very toxic if swallowed |
| R29 | Contact with water liberates toxic gas | Contact with water liberates toxic gas |
| R30 | Can become highly flammable in use | Can become highly flammable in use |
| R31 | Contact with acids liberates toxic gas | Contact with acids liberates toxic gas |
| R32 | Contact with acids liberates very toxic gas | Contact with acids liberates very toxic gas |
| R33 | Danger of cumulative effects | Danger of cumulative effects |
| R34 | Causes burns | Causes burns |
| R35 | Causes severe burns | Causes severe burns |
| R36 | Irritating to eyes | Irritating to eyes |
| R37 | Irritating to respiratory system | Irritating to respiratory system |
| R38 | Irritating to skin | Irritating to skin |
| R39 | Danger of very serious irreversible effects | Danger of very serious irreversible effects |
| R40 | Possible risks of irreversible effects | Possible risks of irreversible effects |
| R41 | Risk of serious damage to eyes | Risk of serious damage to eyes |
| R42 | May cause sensitisation by inhalation | May cause sensitisation by inhalation |
| R43 | May cause sensitisation by skin contact | May cause sensitisation by skin contact |
| R44 | Risk of explosion if heated under confinement | Risk of explosion if heated under confinement |
| R45 | May cause cancer | May cause cancer |
| R46 | May cause heritable genetic damage | May cause heritable genetic damage |
| R48 | Danger of serious damage to health by prolonged exposure | Danger of serious damage to health by prolonged exposure |
| R49 | May cause cancer by inhalation | May cause cancer by inhalation |
| R50 | Very toxic to aquatic organisms | Very toxic to aquatic organisms |
| R51 | Toxic to aquatic organisms | Toxic to aquatic organisms |
| R52 | Harmful to aquatic organisms | Harmful to aquatic organisms |
| R53 | May cause long-term adverse effects in the aquatic environment | May cause long-term adverse effects in the aquatic environment |
| R54 | Toxic to flora | Toxic to flora |
| R55 | Toxic to fauna | Toxic to fauna |
| R56 | Toxic to soil organisms | Toxic to soil organisms |
| R57 | Toxic to bees | Toxic to bees |
| R58 | May cause long-term adverse effects in the environment | May cause long-term adverse effects in the environment |
| R59 | Dangerous for the ozone layer | Dangerous for the ozone layer |
| R60 | May impair fertility | May impair fertility |
| R61 | May cause harm to the unborn child | May cause harm to the unborn child |
| R62 | Possible risk of impaired fertility | Possible risk of impaired fertility |
| R63 | Possible risk of harm to the unborn child | Possible risk of harm to the unborn child |
| R64 | May cause harm to breastfed babies | May cause harm to breastfed babies |
PART II COMBINED RISK PHRASES
| Risk Phrase Reference No. | Risk Phrase |
| R14/15 | Reacts violently with water, liberating extremely flammable gases |
| R15/29 | Contact with water liberates toxic, extremely flammable gas |
| R20/21 | Harmful by inhalation and in contact with skin |
| R20/21/22 | Harmful by inhalation, in contact with skin and if swallowed |
| R20/22 | Harmful by inhalation and if swallowed |
| R21/22 | Harmful in contact with skin and if swallowed |
| R23/24 | Toxic by inhalation and in contact with skin |
| R23/24/25 | Toxic by inhalation, in contact with skin and if swallowed |
| R23/25 | Toxic by inhalation and if swallowed |
| R24/25 | Toxic in contact with skin and if swallowed |
| R26/27 | Very toxic by inhalation and in contact with skin |
| R26/27/28 | Very toxic by inhalation, in contact with skin and if swallowed |
| R26/28 | Very toxic by inhalation and if swallowed |
| R27/28 | Very toxic in contact with skin and if swallowed |
| R36/37 | Irritating to eyes and respiratory system |
| R36/37/38 | Irritating to eyes, respiratory system and skin |
| R36/38 | Irritating to eyes and skin |
| R37/38 | Irritating to respiratory system and skin |
| R39/23 | Toxic: danger of very serious irreversible effects through inhalation |
| R39/23/24 | Toxic: danger of very serious irreversible effects through inhalation and in contact with skin |
| R39/23/24/25 | Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed |
| R39/23/25 | Toxic: danger of very serious irreversible effects through inhalation and if swallowed |
| R39/24 | Toxic: danger of very serious irreversible effects in contact with skin |
| R39/24/25 | Toxic: danger of very serious irreversible effects in contact with skin and if swallowed |
| R39/25 | Toxic: danger of very serious irreversible effects if swallowed |
| R39/26 | Very toxic: danger of very serious irreversible effects through inhalation |
| R39/26/27 | Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin |
| R39/26/27/28 | Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed |
| R39/26/28 | Very toxic: danger of very serious irreversible effects through inhalation and if swallowed |
| R39/27 | Very toxic: danger of very serious irreversible effects in contact with skin |
| R39/27/28 | Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed |
| R39/28 | Very toxic: danger of very serious irreversible effects if swallowed |
| R40/20 | Harmful: possible risk of irreversible effects through inhalation |
| R40/20/21 | Harmful: possible risk of irreversible effects through inhalation and in contact with skin |
| R40/20/21/22 | Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed |
| R40/20/22 | Harmful: possible risk of irreversible effects through inhalation and if swallowed |
| R40/21 | Harmful: possible risk of irreversible effects in contact with skin |
| R40/21/22 | Harmful: possible risk of irreversible effects in contact with skin and if swallowed |
| R40/22 | Harmful: possible risk of irreversible effects if swallowed |
| R42/43 | May cause sensitization by inhalation and skin contact |
| R48/20 | Harmful: danger of serious damage to health by prolonged exposure through inhalation |
| R48/20/21 | Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin |
| R48/20/21/22 | Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed |
| R48/20/22 | Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed |
| R48/21 | Harmful: danger of serious damage to health by prolonged exposure in contact with skin |
| R48/21/22 | Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed |
| R48/22 | Harmful: danger of serious damage to health by prolonged exposure if swallowed |
| R48/23 | Toxic: danger of serious damage to health by prolonged exposure through inhalation |
| R48/23/24 | Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin |
| R48/23/24/25 | Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed |
| R48/23/25 | Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed |
| R48/24 | Toxic: danger of serious damage to health by prolonged exposure in contact with skin |
| R48/24/25 | Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed |
| R48/25 | Toxic: danger of serious damage to health by prolonged exposure 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 |
Regulation 24.
SCHEDULE 6
SAFETY PHRASES
The safety phrase or phrases to be marked on the package of a dangerous preparation or contained in the label shall be selected in accordance with the provisions of Annex VI to Directive 67/548/EEC.
The safety phrase or phrases, required to be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of paragraph 1 shall conform to those contained in Annex VI to Directive 67/548/EEC, as set out in the Table below.
Where two or more single safety phrases contained in Part I of the Table below are selected, in accordance with the provisions of paragraph 1, and which can be combined in a combined safety phrase contained in Part II of the Table below, that combined safety phrase shall be assigned to the dangerous preparation in place of the single ones selected.
TABLE
PART I SINGLE SAFETY PHRASE
| Safety Phrase Reference No. | Safety Phrase |
| S1 | Keep locked up |
| S2 | Keep out of reach of children |
| S3 | Keep in a cool place |
| S4 | Keep away from living quarters |
| S5 | Keep contents under .... (appropriate liquid to be specified by the manufacturer) |
| S6 | Keep under ... (inert gas to be specified by the manufacturer) |
| S7 | Keep container tightly closed |
| S8 | Keep container dry |
| S9 | Keep container in a well ventilated place |
| S12 | Do not keep the container sealed |
| S13 | Keep away from food, drink and animal feeding stuffs |
| S14 | Keep away from ... (incompatible materials to be indicated by the manufacturer) |
| S15 | Keep away from heat |
| S16 | Keep away from sources of ignition — No Smoking |
| S17 | Keep away from combustible material |
| S18 | Handle and open container with care |
| S20 | When using do not eat or drink |
| S21 | When using do not smoke |
| S22 | Do not breathe dust |
| S23 | Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer) |
| S24 | Avoid contact with skin |
| S25 | Avoid contact with eyes |
| S26 | In case of contact with eyes, rinse immediately with plenty of water and seek medical advice |
| S27 | Take off immediately all contaminated clothing |
| S28 | After contact with skin, wash immediately with plenty of .. (to be specified by the manufacturer) |
| S29 | Do not empty into drains |
| S30 | Never add water to this product |
| S33 | Take precautionary measures against static discharges |
| S35 | This material and its container must be disposed of in a safe way |
| S36 | Wear suitable protective clothing |
| S37 | Wear suitable gloves |
| S38 | In case of insufficient ventilation, wear suitable respiratory equipment |
| S39 | Wear eye/face protection |
| S40 | To clean the floor and all objects contaminated by this material, use ... (to be specified by the manufacturer) |
| S41 | In case of fire and/or explosion do not breathe fumes |
| S42 | During fumigation/spraying wear suitable respiratory equipment (Appropriate wording to be specified by the manufacturer) |
| S43 | In case of fire, use .... (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add — Never use water) |
| S45 | In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) |
| S46 | If swallowed, seek medical advice immediately and show this container or label |
| S47 | Keep at temperature not exceeding .... °C (to be specified by the manufacturer) |
| S48 | Keep wetted with ... (appropriate material to be specified by the manufacturer) |
| S49 | Keep only in the original container |
| S50 | Do not mix with .... (to be specified by the manufacturer) |
| S51 | Use only in well ventilated areas |
| S52 | Not recommended for interior use on large surface areas |
| S53 | Avoid exposure — obtain special instructions before use |
| S56 | Dispose of this material and its container to hazardous or special waste collection point |
| S57 | Use appropriate containment to avoid environmental contamination |
| S59 | Refer to manufacture/supplier for information on recovery/recycling |
| S60 | This material and its container must be disposed of as hazardous waste |
| S61 | Avoid release to the environment. Refer to special instructions/safety data sheets |
| S62 | If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label |
PART II COMBINED SAFETY PHRASES
| Safety Phrase Reference No. | Safety Phrase |
| S1/2 | Keep locked up and out of the reach of children |
| S3/7 | Keep container tightly closed in a cool place |
| S3/9/14 | Keep in a cool, well ventilated place away from ... (incompatible materials to be indicated by the manufacturer) |
| S3/9/14/49 | Keep only in the original container in a cool, well ventilated place away from... (incompatible materials to be indicated by the manufacturer) |
| S3/9/49 | Keep only in the original container in a cool, well ventilated place |
| S3/14 | Keep in a cool place away from ... (incompatible materials to be indicated by the manufacturer) |
| S7/8 | Keep container tightly closed and dry |
| S7/9 | Keep container tightly closed and in a well ventilated place |
| S7/47 | Keep container tightly closed and at a temperature not exceeding ..... °C (to be specified by the manufacturer) |
| S20/21 | When using do not eat, drink or smoke |
| S24/25 | Avoid contact with skin and eyes |
| S29/56 | Do not empty into drains, dispose of this material and its container to hazardous or special waste collection point |
| S36/37 | Wear suitable protective clothing and gloves |
| S36/37/39 | Wear suitable protective clothing, gloves and eye/face protection |
| S36/39 | Wear suitable protective clothing and eye/face protection |
| S37/39 | Wear suitable gloves and eye/face protection |
| S47/49 | Keep only in the original container at temperature not exceeding .... °C (to be specified by the manufacturer)". |
Regulation 15.
SCHEDULE 7
CHILD-RESISTANT FASTENINGS AND TACTILE WARNINGS OF DANGER
PART I Categories requiring child-resistant fastenings to be fitted to containers
When offered or sold to the general public, the container of a dangerous preparation having a classification listed in paragraph 2 shall be fitted with a child-resistant fastening in accordance with the provisions of Regulation 15 (2).
(1) The provisions of paragraph 1 shall apply to a dangerous preparation—
( a ) classified as very toxic, toxic and/or corrosive;
or
( b ) being a liquid preparation having a kinematic viscosity, measured by rotative viscosity in accordance with ISO 3219: 1977, of less than 7 x 10-^6 m^2 per second at a temperature of 40° celsius and containing aliphatic and/or aromatic hydrocarbons in a total concentration in the preparation equal to or exceeding 10%;
or
( c ) containing—
- (i) methanol (CAS Reg. No. 67-56-1, EINECS No. 2006596) in the preparation in a concentration equal to or exceeding 3%, or
- (ii) Dichloromethane (CAS Reg. No. 75-09-2, EINECS No. 2008389) in the preparation in a concentration equal to or exceeding 1%.
- (2) For the purposes of subparagraph (1)—
( a ) "ISO 3219: 1977" means the International Standard ISO 3219: 1977 (edition of 15 December, 1977) of the International Organisation for Standardisation;
( b ) "CAS Reg No." means the CAS Registration Number, for a substance, of the Chemical Abstracts Service of the American Chemical Society of the United States of America; and
( c ) "EINECS No." means the number allotted to a substance in the European Inventory of Existing Commercial Chemical Substances of the Commission of the European Community.
The provisions of paragraph 1 shall apply to containers of all capacities.
PART II Categories Required to Carry Tactile Warnings of Danger on the Containers
When offered or sold to the general public, the container of a dangerous preparation having a classification listed in paragraph 2 shall carry a tactile warning of danger in accordance with the provisions of Regulation 15 (3).
The provisions of paragraph 1 shall apply to dangerous preparations classified as very toxic, toxic, corrosive, harmful, extremely flammable and/or highly flammable.
The provisions of paragraph 1 shall apply to containers of all capacities.
PART III Aerosols
Except for subparagraph (1) (b) of paragraph 2 of Part I, the provisions of Parts I and II shall apply to preparations offered or sold to the general public in aerosol dispensers.
Regulation 16.
SCHEDULE 8
DIMENSIONS OF LABELS
The label required by Regulation 16 (1) (a) or the area specified in Regulation 16 (1) (a) (ii) (as the case may be) shall conform with the dimensions specified for each capacity category of package (containing a preparation to which these Regulations apply), set out in the Table below.
Any danger symbol required to be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of Regulations 17 (d) and 22 shall cover at least one-tenth of the surface area, referred to in paragraph 1, of the label or specified in Regulation 16 (1) (a) (ii) (as the case may be) and shall not in any case be less than 1 square centimetre in area.
TABLE
| Capacity Category of Package | Dimension (in millimetres) |
| Not exceeding 3 litres | if possible at least 52 x 74 |
| Greater than 3 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 |
Regulation 30.
SCHEDULE 9
MATERIAL SAFETY DATA SHEETS
The safety data sheet required to be provided in accordance with the provisions of Regulation 30 shall comply with the provisions of this Schedule.
Every person who is responsible for placing a dangerous preparation on the market (whether that person is a manufacturer, importer, distributor, wholesaler or a retailer) shall provide an industrial user (including a distributor, wholesaler or retailer) with a safety data sheet.
( a ) The safety data sheet, required to be provided in accordance with the provisions of paragraph 2 shall be provided free of charge and shall be provided at or before the time when the dangerous preparation is first supplied.
( b ) For the purposes of this paragraph, the time specified in subparagraph (a) when the safety data sheet is to be provided shall be the period beginning at the commencement of these Regulations.
( c ) Notwithstanding the provisions of subparagraph (b) but subject to the provisions of paragraph 7, any industrial user (including a distributor, wholesaler or retailer) who was supplied with a dangerous preparation within 12 months preceding the commencement of these Regulations, shall be provided with the safety data sheet required to be provided in accordance with the provisions of paragraph 2.
( a ) Whenever a safety data sheet required to be provided in accordance with the provisions of paragraph 2 is amended in accordance with the provisions of Regulation 30 (6), the amended safety data sheet shall be identified as such and shall bear, in a conspicuous place in it the term "Revision" together with the date of the publication of it.
( b ) The amended safety data sheet referred to in subparagraph (a) shall be provided free of charge to all industrial users (including distributors, wholesalers and retailers) who were supplied with the particular dangerous preparation within 12 months preceding the publication date of the amended safety data sheet.
The safety data sheet required to be provided in accordance with the provisions of paragraph 2 shall be clearly written in the Irish and English languages or in the English language.
( a ) The safety data sheet required to be provided in accordance with the provisions of paragraph 2 shall contain information on the dangerous preparation under the headings set out in the Table below and shall contain those headings.
( b ) The information required to be contained in the safety data sheet in accordance with the provisions of subparagraph (a) shall be in accordance with the principles of the guidelines laid down in the Annex to Commission Directive 91/155/EEC of 5 March, 1991, as amended by Commission Directive 93/112/EC of 10 December, 1993..
( a ) Notwithstanding their provisions but subject to subparagraph (b), the requirements of paragraphs 2 and 3 do not apply in the case of a dangerous preparation which is offered or sold to the general public', provided the user is furnished with sufficient information to enable him to take the necessary measures as regards the protection of health and safety.
( b ) Notwithstanding the provisions of subparagraph (a), a safety data sheet, required to be provided in accordance with paragraph 2, shall, when requested, be provided to an industrial user.
TABLE
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 |
Regulation 25.
SCHEDULE 10
SPECIAL PROVISIONS ON THE LABELLING OF CERTAIN PREPARATIONS
PART I Dangerous Preparations
Preparations on sale to general public.
( a ) In accordance with the provisions of Regulation 17 (g) and 25 and subject to subparagraph (b), a dangerous preparation which is offered or sold to the general public shall have marked on the package or on the label (as the case may be)
- (i) the safety phrases S1 and S2, and
- (ii) one of the safety phrases S45 or S46
in accordance with the criteria fixed in Annex VI to Council Directive 67/548/EEC.
( b ) Notwithstanding the provisions of subparagraph (a) and Regulation 24 (2), the requirements of subparagraph (a) shall not apply in the case of a preparation classified as very toxic, toxic or corrosive where it is physically impossible to mark the safety phrases (required by subparagraph (a)) on the package or on the label provided the dangerous preparation is accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.
Preparations intended for spraying.
In accordance with the provisions of Regulations 17 (g) and 25, a dangerous preparation intended for use by spraying shall have marked on the package or on the label (as the case may be)
- (i) the safety phrase S23, and
- (ii) one of the safety phrases S38 or S51
in accordance with the criteria fixed in Annex VI to Council Directive 67/548/EEC.
Preparations with R33 substances.
In accordance with the provisions of Regulations 17 (g) and 25, the risk phrase R33 shall be marked on the package or on the label (as the case may be) of a dangerous preparation when it contains at least one substance, assigned the risk phrase R33, in a concentration equal to or exceeding
- (i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the relevant limit specified therein for that substance, if it is so specified, or
- (ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%.
Preparations with R64 substances.
In accordance with the provisions of Regulations 17 (g) and 25, the risk phrase R64 shall be marked on the package or on the label (as the case may be) of a dangerous preparation when it contains at least one substance, assigned the risk phrase R64, in a concentration equal to or exceeding
- (i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the relevant limit specified therein for that substance, if it is so specified, or
- (ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%.
( a ) Subject to the provisions of subparagraph (b), the provisions of paragraphs 1,2,3 and 4 of this Part are in addition to the other provisions of these Regulations.
( b ) In any case where one or more of the risk or safety phrases required by paragraphs 1, 2, 3 and 4 of this Part are already marked on the package or on the label, they need not be repeated.
For the purposes of this Part a reference to concentration is a reference to a concentration expressed
- (i) on a volume/volume basis in the case of gas preparations,
and
- (ii) on a mass/mass basis in the case of preparations which are not gas preparations.
PART II Preparations whether or not Dangerous
The provisions of this Part shall apply to all preparations, to which the other provisions of this Part apply, whether or not the preparations are dangerous within the meaning of these Regulations.
Preparations containing lead (paints and varnishes).
( a ) In accordance with the provisions of Regulations 17 (g) and 25 and subject to subparagraph (c), the following phrases shall be marked on the package or on the label (as the case may be) of a preparation consisting of paint or varnish which contains lead in accordance with the provisions of subparagraph (b):
"Contains lead. Should not be used on surfaces liable to be chewed or sucked by children".
( b ) The provisions of subparagraph (a) shall apply to a preparation, consisting of paint or varnish which contains lead in quantities exceeding 0.15%, expressed as weight of metal, of the total weight of the preparation as determined in accordance with ISO 6503:1984.
( c ) Notwithstanding its provisions, the requirements of subparagraph (a) shall be deemed to be satisfied in the case of a preparation in a package of which the contents are less than 125 millilitres if the following phrases are marked on the package or on the label (as the case may be) of the preparation:
"Warning. Contains lead."
( d ) For the purposes of subparagraph (b), "ISO 6503:1984" means the International Standard ISO 6503: 1984 of the International Organisation for Standardisation.
Preparations containing cyanoacrylates (adhesives).
( a ) In accordance with the provisions of Regulations 17(g) and 25, the following phrases shall be marked on the package or on the label (as the case may be) of a preparation consisting of an adhesive based on cyanoacrylate:
"Cyanoacrylate.
Danger.
Bonds skin and eyes in seconds.
Keep out of the reach of children."
( b ) Appropriate advice on safety shall accompany the package of a preparation to which the provisions of subparagraph (a) apply.
Preparations containing isocyanates.
( a ) In accordance with the provisions of Regulations 17 (g) and 25, the following phrases shall be marked on the package or on the label (as the case may be) of a preparation containing isocyanates:—
"Contains isocyanates.
See information supplied by the manufacturer."
( b ) For the purposes of subparagraph (a) isocyanates shall include isocyanates as monomers, oligomers, prepolymers, etc., and as mixtures thereof.
Preparations containing epoxy constituents.
In accordance with the provisions of Regulations 17 (g) and 25, the following phrases shall be marked on the package or on the label (as the case may be) of a preparation containing epoxy constituents, with an average molecular weight equal to or less than 700:
"Contains epoxy constituents.
See information supplied by the manufacturer."
Preparations containing active chlorine on sale to the general public.
( a ) In accordance with the provisions of Regulations 17 (g) and 25, and subject to subparagraph (b), the following phrases shall be marked on the package or on the label (as the case may be) of a preparation containing more than 1% active chlorine:
"Warning! Do not use with other products.
May release dangerous gases (chlorine)."
( b ) The provisions of subparagraph (a) shall apply to preparations offered or sold to the general public.
Preparations containing cadmium (alloys) intended for brazing or soldering.
( a ) In accordance with the provisions of Regulations 17 (g) and 25 and subject to subparagraph (b), the following phrases shall be printed in clearly legible and indelible characters on the package or on the label (as the case may be) of a preparation containing cadmium (alloys):
"Warning! Contains cadmium.
Dangerous fumes are formed during use.
See information supplied by the manufacturer.
Comply with the safety instructions."
( b ) The provisions of subparagraph (a) shall apply to preparations intended to be used for brazing or soldering.
( a ) Subject to subparagraph (b), the provisions of paragraphs 2, 3, 4, 5, 6 and 7 of this Part are in addition to the other provisions of these Regulations.
( b ) In any case where the safety phrase S2 is already marked on the package or on the label of the preparation, the phrase, "Keep out of the reach of children" (required by paragraph 3 of this Part) need not be repeated.
GIVEN under my Official Seal, this 9th day of October, 1995.
RICHARD BRUTON,
Minister for Enterprise and Employment.
EXPLANATORY NOTE
These Regulations implement Council Directive 88/379/EEC of 7th June, 1988 on the classification, packaging and labelling of dangerous preparations placed on the market of the E.U. They apply to all dangerous preparations with exceptions for certain categories of preparations such as pesticides, cosmetics etc. which are covered by other Council Directives. Certain preparations which 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 Annex II of the Directive.
These Regulations also implement Commission Directives which adapt to technical progress the Annexes to or which expand some of the provisions of Directive 88/379/EEC. These Directives are
— Commission Directives 89/178/EEC of 22 February, 1989, 90/492/EEC of 5 September, 1990 and 93/18/EEC of 5 April, 1993 which adapt to technical progress Annexes I and II,
— Commission Directives 90/35/EEC of 19 December, 1989 and 91/442/EEC of 23 July, 1991 which define the categories of preparations requiring child-resistant fastenings and tactile warnings of danger, and
— Commission Directive 91/155/EEC of 5 March, 1991 and 93/112/EEC of 10 December, 1993 which contain the format for safety data sheets.
They also give effect to those parts of Council Directive 92/32/EEC of 30 April, 1992 and Commission Directive 93/21/EEC of 27 April, 1993 which are relevant for Dangerous Preparations.
These Regulations revoke the European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations, 1992 ( S.I. No. 393 of 1992 ).
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