PART IIN.I.CONCENTRATION LIMITS TO BE USED IN THE EVALUATION OF HEALTH HAZARDS
An assessment shall be made of the health effects that the use of a substance or a preparation might entail. For that purpose the dangerous health effects have been subdivided into:
1. acute lethal effects;N.I.
2. non-lethal irreversible effects after a single exposure;N.I.
3. severe effects after repeated or prolonged exposure;N.I.
4. corrosive effects, irritant effects;N.I.
5. sensitising effects;N.I.
6. carcinogenic effects, mutagenic effects, toxic effects for reproduction.N.I.
The systematic assessment of the dangerous health effects is expressed by means of concentration limits, expressed as weight/weight percentage except for gaseous preparations (Tables A) where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance.
The classification of the substance is expressed either by a symbol and one or more risk phrases or by categories (category 1, category 2 or category 3) also expressed by risk phrases when substances are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.
Acute lethal effectsN.I.
Other than gaseous preparationsN.I.
1.1 The concentration limits fixed in Table I determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.
Table I
Classification of the substance | Classification of the preparation |
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| T+ | T | Xn |
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The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria—
(i) the label shall include one or more of the above mentioned R phrases according to the classification used,
(ii) in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.
|
T+ with R26, R27, R28 | concentration ≥ 7% | 1% ≤ concentration < 7% | 0.1% ≤ concentration < 1% |
T with R23, R24, R25 | | concentration ≥ 25% | 3% ≤ concentration < 25% |
Xn with R20, R21, R22 | | | concentration ≥ 25% |
Gaseous preparationsN.I.
1.2 The concentration limits expressed as a volume/volume percentage in Table IA determine the classification of the gaseous preparations in relation to the individual concentrations of the gas(es) present whose classification is also shown.
Table IA
Classification of the substance | Classification of the preparation |
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| T+ | T | Xn |
---|
The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria—
(i) the label shall include one or more of the above mentioned R phrases according to the classification used,
(ii) in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.
|
T+ with R26, R27, R28 | concentration ≥ 1% | 0.2% ≤ concentration <1% | 0.02% ≤ concentration < 0.2% |
T with R23, R24, R25 | | concentration ≥ 5% | 0.5% ≤ concentration < 5% |
Xn with R20, R21, R22 | | | concentration ≥ 5% |
Non-lethal irreversible effects after a single exposureN.I.
Other than gaseous preparationsN.I.
2.1 For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R68/route of exposure), the individual concentration limits specified in Table II determine, when appropriate, the classification of the preparation.
Table II
Classification of the substance | Classification of the preparation |
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| T+ | T | Xn |
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|
|
T+ with R39/ route of exposure | concentration ≥ 10% R39 obligatory | 1% ≤ concentration < 10% R39 obligatory | 0.1% ≤ concentration < 1% R68 obligatory |
T with R39/ route of exposure | | concentration ≥ 10% R39 obligatory | 1% ≤ concentration < 10% R68 obligatory |
Xn with R68/ route of exposure | | | concentration ≥ 10% R68 obligatory |
Gaseous preparationsN.I.
2.2 For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R68/route of exposure), the individual concentration limits specified in Table IIA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.
Table IIA
Classification of the substance (gas) | Classification of the preparation |
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| T+ | T | Xn |
---|
|
|
T+ with R39/ route of exposure | concentration ≥ 1% R39 obligatory | 0.2% ≤ concentration < 1% R39 obligatory | 0.02% ≤ concentration < 0.2% R68 obligatory |
T with R39/ route of exposure | | concentration ≥ 5% R39 obligatory | 0.5% ≤ concentration < 5% R68 obligatory |
Xn with R68/ route of exposure | | | concentration ≥ 5% R68 obligatory |
Severe effects after repeated or prolonged exposureN.I.
Other than gaseous preparationsN.I.
3.1 For substances that produce severe effects after repeated exposure (R48/route of exposure), the individual concentration limits specified in Table III determine, when appropriate, the classification of the preparation.
Table III
Classification of the substance | Classification of the preparation |
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| T | Xn |
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|
T with R48/ route of exposure | concentration ≥ 10% R48 obligatory | 1% ≤ concentration < 10% R48 obligatory |
Xn with R48/ route of exposure | | concentration ≥ 10% R48obligatory |
Gaseous preparationsN.I.
3.2 For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table IIIA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.
Table IIIA
Classification of the substance (gas) | Classification of the preparation |
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| T | Xn |
---|
|
T with R48/ route of exposure | concentration ≥ 5% R48 obligatory | 0.5% ≤ concentration < 5% R48 obligatory |
Xn with R48/ route of exposure | | concentration ≥ 5% R48 obligatory |
Corrosive and irritant effects including serious damage to eyeN.I.
Other than gaseous preparationsN.I.
4.1 For substances that produce corrosive effects (R34, R35) or irritant effect (R36, R37, R38, R41), the individual concentration limits specified in Table IV determine, when appropriate, the classification of the preparation.
Table IV
Classification of the substance | Classification of the preparation |
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| C with R35 | C with R34 | Xi with R41 | Xi with R36, R37 R38 |
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|
Note
Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity consider the advice given in the approved classification and labelling guide regarding classification as corrosive and paragraph 4(4)(b) and (c) of Part I of this Schedule.
|
C with R35 | concentration ≥ 10% R35 obligatory | 5% ≤ concentration < 10% R34 obligatory | 5% | 1% ≤ concentration < 5% R36/38 obligatory |
C with R34 | | concentration ≥ 10% R34 obligatory | 10% | 5% ≤ concentration < 10% R36/38 obligatory |
Xi with R41 | | | concentration ≥ 10% R41 obligatory | 5% ≤ concentration < 10% R36 obligatory |
Xi with R36, R37, R38 | | | | concentration ≥ 20% R36, R37, R38 are obligatory in the light of the concentration present if they apply to the substances under consideration |
Gaseous preparationsN.I.
4.2 For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table IVA, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.
Table IVA
Classification of the substance (gas) | Classification of the preparation |
---|
| C with R35 | C with R34 | Xi with R41 | Xi with R36, R37 R38 |
---|
|
Note
Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in approved classification and labelling guide regarding classification as corrosive and paragraph 4(4)(b) and (c) of Part I of this Schedule.
|
C with R35 | concentration ≥ 1% R35 obligatory | 0.2% ≤ concentration < 1% R34 obligatory | 0.2% | 0.02% ≤ concentration < 0.2% R36/37/38 obligatory |
C with R34 | | concentration ≥ 5% R34 obligatory | 5% | 0.5% ≤ concentration < 5% R36/37/38 obligatory |
Xi with R41 | | | concentration ≥ 5% R41 obligatory | 0.5% ≤ concentration < 5% R36 obligatory |
Xi with R36, R37, R38 | | | | concentration ≥ 5% R36, R37, R38 are obligatory as appropriate |
Sensitising effectsN.I.
Other than gaseous preparationsN.I.
5.1 Preparations that produce such effects are classified as sensitising and assigned:
the symbol Xn and phrase R42 if this effect can be produced by inhalation,
the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.
The individual concentration limits specified in Table V determine, when appropriate, the classification of the preparation.
Table V
Classification of the substance | Classification of the preparation |
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| Sensitising with R42 | Sensitising with R43 |
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Sensitising with R42 | concentration ≥ 1% R42 obligatory | |
Sensitising with R43 | | concentration ≥ 1% R43 obligatory |
Gaseous preparationsN.I.
5.2 Gases that produce such effects are classified as sensitising and assigned:
the symbol Xn and phrase R42 if this effect can be produced by inhalation,
the symbol Xi and phrase R43 if this effect can be produced by inhalation and through contact with the skin.
The individual concentration limits specified in Table VA expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.
Table VA
Classification of the substance (gas) | Classification of the gaseous preparation |
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| Sensitising with R42 | Sensitising with R43 |
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Sensitising with R42 | concentration ≥ 0.2% R42 obligatory | |
Sensitising with R43 | | concentration ≥ 0.2% R43 obligatory |
Carcinogenic/mutagenic/toxic effects for reproductionN.I.
Other than gaseous preparationsN.I.
6.1 For substances that produce such effects and for which specific concentration limits do not yet appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation, concentration limits laid down in Table VI shall determine, where appropriate, the classification of the preparation.
The following symbol and risk phrases are assigned:
Carcinogenic categories 1 and 2: | T; R45 or R49 |
Carcinogenic category 3: | Xn; R40 |
Mutagenic categories 1 and 2: | T; R46 |
Mutagenic category 3: | Xn R68 |
Toxic for reproduction fertility categories 1 and 2: | T; R60 |
Toxic for reproduction development categories 1 and 2: | T; R61 |
Toxic for reproduction fertility category 3: | Xn; R62 |
Toxic for reproduction development category 3: | Xn; R63 |
Table VI
Classification of the substance | Classification of the preparation |
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| Categories 1 and 2 | Category 3 |
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|
|
carcinogenic substances of category 1 or 2 with R45 or R49 | concentration ≥ 0.1% carcinogenic R45, R49 obligatory as appropriate | |
carcinogenic substances of category 3 with R40 | | concentration ≥ 1% carcinogenic R40 obligatory (unless already assigned R45) |
mutagenic substances of category 1 or 2 with R46 | concentration ≥ 0.1% mutagenic R46 obligatory | |
mutagenic substances of category 3 with R68 | | concentration ≥ 1% mutagenic R68 obligatory (unless already assigned R46) |
substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) | concentration ≥ 0.5% toxic for reproduction (fertility) R60 obligatory | |
substances “toxic for reproduction” of category 3 with R62 (fertility) | | concentration ≥ 5% toxic for reproduction (fertility) R62 obligatory (unless already assigned R60) |
substances “toxic for reproduction” of category 1 or 2 with R61 (development) | concentration ≥ 0.5% toxic for reproduction (development) R61 obligatory | |
substances “toxic for reproduction” of category 3 with R63 (development) | | concentration ≥ 5% toxic for reproduction (development) R63 obligatory (unless already assigned R61) |
Gaseous preparationsN.I.
6.2 For gases which produce such effects and for which specific concentration limits do not yet appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation, concentration limits laid down in Table VIA, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation.
The following symbol and risk phrases are assigned:
Carcinogenic categories 1 and 2: | T; R45 or R49 |
Carcinogenic category 3: | Xn; R40 |
Mutagenic categories 1 and 2: | T; R46 |
Mutagenic category 3: | Xn R68 |
Toxic for reproduction fertility categories 1 and 2: | T; R60 |
Toxic for reproduction development categories 1 and 2: | T; R61 |
Toxic for reproduction fertility category 3: | Xn; R62 |
Toxic for reproduction development category 3: | Xn; R63 |
Table VIA
Classification of the substance (gas) | Classification of the gaseous preparation |
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| Categories 1 and 2 | Category 3 |
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|
|
carcinogenic substances of category 1 or 2 with R45 or R49 | concentration ≥ 0.1% carcinogenic R45, R49 obligatory as appropriate | |
carcinogenic substances of category 3 with R40 | | concentration ≥ 1% carcinogenic R40 obligatory (unless already assigned R45) |
mutagenic substances of category 1 or 2 with R46 | concentration ≥ 0.1% mutagenic R46 obligatory | |
mutagenic substances of category 3 with R68 | | concentration ≥ 1% mutagenic R68 obligatory (unless already assigned R46) |
substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) | concentration ≥ 0.2% toxic for reproduction (fertility) R60 obligatory | |
substances “toxic for reproduction” of category 3 with R62 (fertility) | | concentration ≥ 1% toxic for reproduction (fertility) R62 obligatory (unless already assigned R60) |
substances “toxic for reproduction” of category 1 or 2 with R61 (development) | concentration ≥ 0.2% toxic for reproduction (development) R61 obligatory | |
substances “toxic for reproduction” of category 3 with R63 (development) | | concentration ≥ 1% toxic for reproduction (development) R63 obligatory (unless already assigned R61) |