The Chemicals (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 2009

PART II N.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.

Commencement Information

I1 Sch. 3 Pt. II para. 1n2 in operation at 27.7.2009, see reg. 1

2.  non-lethal irreversible effects after a single exposure; N.I.

Commencement Information

I2 Sch. 3 Pt. II para. 2n2 in operation at 27.7.2009, see reg. 1

3.  severe effects after repeated or prolonged exposure; N.I.

Commencement Information

I3 Sch. 3 Pt. II para. 3n2 in operation at 27.7.2009, see reg. 1

4.  corrosive effects, irritant effects; N.I.

Commencement Information

I4 Sch. 3 Pt. II para. 4n2 in operation at 27.7.2009, see reg. 1

5.  sensitising effects; N.I.

Commencement Information

I5 Sch. 3 Pt. II para. 5n2 in operation at 27.7.2009, see reg. 1

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.

Commencement Information

I6 Sch. 3 Pt. II para. 6n2 in operation at 27.7.2009, see reg. 1

Acute lethal effects N.I.

Commencement Information

I7 Sch. 3 Pt. II para. 1n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	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 ≥ 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%

Commencement Information

I8 Sch. 3 para. 1.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
	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%

Commencement Information

I9 Sch. 3 para. 1.2 in operation at 27.7.2009, see reg. 1

Non-lethal irreversible effects after a single exposure N.I.

Commencement Information

I10 Sch. 3 Pt. II para. 2n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	T+	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in Annex III of the Council Directive 67/548/EEC shall be used.
(†) R68 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R68 but classified mutagenic are given in Table VI.
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

Commencement Information

I11 Sch. 3 para. 2.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
	T+	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in Annex III of Council Directive 67/548/EEC shall be used.
(†) R68 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R68 but classified mutagenic are given in Table VI.
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

Commencement Information

I12 Sch. 3 para. 2.2 in operation at 27.7.2009, see reg. 1

Severe effects after repeated or prolonged exposure N.I.

Commencement Information

I13 Sch. 3 Pt. II para. 3n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in Annex III of Council Directive 67/548/EEC shall be used.
T with R48/ route of exposure	concentration ≥ 10% R48(*) obligatory	1% ≤ concentration < 10% R48(*) obligatory
Xn with R48/ route of exposure		concentration ≥ 10% R48(*)obligatory

Commencement Information

I14 Sch. 3 para. 3.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in Annex III of Council Directive 67/548/EEC shall be used.
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

Commencement Information

I15 Sch. 3 para. 3.2 in operation at 27.7.2009, see reg. 1

Corrosive and irritant effects including serious damage to eye N.I.

Commencement Information

I16 Sch. 3 Pt. II para. 4n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	C with R35	C with R34	Xi with R41	Xi with R36, R37 R38
(*) According to the approved classification and labelling guide, when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk of severe damage to the eyes is considered implicit and the risk phrase R41 is not included on the label. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant (R41) or irritant (R36).
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

Commencement Information

I17 Sch. 3 para. 4.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
(*) According to the approved classification and labelling guide, when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk of severe damage to the eyes is considered implicit and the risk phrase R41 is not included on the label. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant (R41) or irritant (R36).
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

Commencement Information

I18 Sch. 3 para. 4.2 in operation at 27.7.2009, see reg. 1

Sensitising effects N.I.

Commencement Information

I19 Sch. 3 Pt. II para. 5n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	Sensitising with R42	Sensitising with R43
Sensitising with R42	concentration ≥ 1% R42 obligatory
Sensitising with R43		concentration ≥ 1% R43 obligatory

Commencement Information

I20 Sch. 3 para. 5.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
	Sensitising with R42	Sensitising with R43
Sensitising with R42	concentration ≥ 0.2% R42 obligatory
Sensitising with R43		concentration ≥ 0.2% R43 obligatory

Commencement Information

I21 Sch. 3 para. 5.2 in operation at 27.7.2009, see reg. 1

Carcinogenic/mutagenic/toxic effects for reproduction N.I.

Commencement Information

I22 Sch. 3 Pt. II para. 6n3 in operation at 27.7.2009, see reg. 1

Other than gaseous preparations N.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
	Categories 1 and 2	Category 3
a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.
b R68 here refers to substances classified as mutagenic. Concentration limits for substances required to be labelled R68 but classified as harmful are given in Table II.
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 R45a)
mutagenic substances of category 1 or 2 with R46	concentration ≥ 0.1% mutagenic R46 obligatory
mutagenic substances of category 3 with R68b		concentration ≥ 1% mutagenic R68b 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)

Commencement Information

I23 Sch. 3 para. 6.1 in operation at 27.7.2009, see reg. 1

Gaseous preparations N.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
	Categories 1 and 2	Category 3
a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.
b R68 here refers to substances classified as mutagenic. Concentration limits for substances required to be labelled R68 but classified as harmful are given in Table IIA.
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 R45a)
mutagenic substances of category 1 or 2 with R46	concentration ≥ 0.1% mutagenic R46 obligatory
mutagenic substances of category 3 with R68b		concentration ≥ 1% mutagenic R68b 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)

Commencement Information

I24 Sch. 3 para. 6.2 in operation at 27.7.2009, see reg. 1