The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as toxic

7

The following preparations shall be regarded as toxic—

• (a) owing to their acute lethal effects, preparations containing one or more substances classified or regarded as very toxic or toxic in concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or Table IA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) owing to their acute lethal effects, preparations containing more than one substance classified or regarded as very toxic or toxic in individual concentrations not exceeding the limits specified in the approved supply list or in paragraph 1 of Part II of this Schedule (Table I or Table IA) if the sum of the quotients obtained by dividing the percentage weight of each very toxic or toxic substance in the preparation by the toxic limit specified for that substance is 1 or more, i.e.—

$$∑(PT+LT+PTLT)≥1$ where— PT+ the percentage by weight of each very toxic substance in the preparation, PT the percentage by weight of each toxic substance in the preparation, LT the toxic limit specified for each very toxic or toxic substance expressed as a percentage;$

• (c) owing to their non-lethal irreversible effects after a single exposure, preparations containing one or more substances dangerous for supply which produce such effects in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (d) owing to their long term effects after repeated or prolonged exposure, preparations containing one or more substances dangerous for supply which produce such effects in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as harmful

8

The following preparations shall be regarded as harmful—

• (a) owing to their acute lethal effects, preparations containing one or more substances classified or regarded as very toxic, toxic or harmful in concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or Table IA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) owing to their acute lethal effects, preparations containing more than one substance classified or regarded as very toxic, toxic or harmful in individual concentrations not exceeding the limits specified in the approved supply list or in paragraph 1 of Part II of this Schedule (Table I or Table IA) if the sum of the quotients obtained by dividing the percentage weight of each very toxic, toxic or harmful substance in the preparation by the harmful limit specified for that substance is 1 or more, i.e.—

$$∑(PT+LXn+PTLXn+PXnLXn)≥1$ where— PT+ the percentage by weight of each very toxic substance in the preparation, PT the percentage by weight of each toxic substance in the preparation, PXn the percentage by weight of each harmful substance in the preparation, LXn the harmful limit specified for each very toxic, toxic or harmful substance expressed as a percentage;$

• (c) owing to their non-lethal irreversible effects after a single exposure, preparations containing one or more substances dangerous for supply which produce such effects in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (d) owing to their long-term effects after repeated or prolonged exposure, preparations cont` aining one or more substances dangerous for supply that produce such effects in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (e) owing to their sensitizing effects by inhalation, preparations containing at least one substance dangerous for supply to which is assigned the risk phrase R42 (may cause sensitization by inhalation) that produces such effects in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 5 of Part II of this Schedule (Table V or Table VA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as corrosive

9

• (1) In this Schedule a preparation shall be regarded as “very corrosive” if it has been classified as corrosive with the risk phrase R35 (causes severe burns).

• (2) The following preparations shall be regarded as very corrosive—

• (a) preparations containing one or more substances classified or regarded as very corrosive in concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as very corrosive in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each very corrosive substance in the preparation by the corrosive (R35) limit specified for that substance is 1 or more, i.e.—

$$∑(PC.R35LC.R35)≥1$ where— PC.R35 the percentage by weight of each very corrosive substance in the preparation, LC.R35 the corrosive (R35) limit specified for each very corrosive substance expressed as a percentage by weight.$

10

The following preparations shall also be regarded as corrosive—

• (a) preparations containing one or more substances classified or regarded as corrosive to which is assigned the risk phrase R35 or R34 (causes burns) in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as corrosive to which is assigned the risk phrase R35 or R34 in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each corrosive substance in the preparation by the corrosive (R34) limit specified for that substance is 1 or more, i.e.—

$$∑(PC.R35LC.R34+PC.R34LC.R34)≥1$ where— PC.R35 the percentage by weight of each corrosive substance to which is assigned the risk phrase R35 in the preparation, PC.R34 the percentage by weight of each corrosive substance to which is assigned the risk phrase R34 in the preparation, LC.R34 the corrosive (R34) limit specified for each corrosive substance to which is assigned the risk phrase R35 or R34 expressed as a percentage by weight.$

Classification by the conventional method as irritant

11

The following preparations shall be regarded as liable to cause serious eye damage—

• (a) preparations containing one or more substances classified or regarded as irritant to which is assigned the risk phrase R41 (risk of serious damage to eyes) in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as corrosive, to which is assigned the risk phrase R35 or R34, or irritant, to which is assigned the risk phrase R41, in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant (R41) limit specified for that substance is 1 or more, i.e.—

$$∑(PC.R35LXi.R41+PC.R34LXi.R41+PXi.R41LXi.R41)≥1$ where— PC.R35 the percentage by weight of each corrosive substance to which is assigned the risk phrase R35 in the preparation, PC.R34 the percentage by weight of each corrosive substance to which is assigned the risk phrase R34 in the preparation, PXi.R41 the percentage by weight of each irritant substance to which is assigned the risk phrase R41 in the preparation, LXi.R41 the irritant (R41) limit specified for each irritant substance expressed as a percentage by weight to which is assigned the risk phrase R 41 in the preparation.$

12

The following preparations shall be regarded as skin irritants—

• (a) preparations containing one or more substances classified or regarded as corrosive, to which is assigned the risk phrase R35 or R34, or irritant, to which is assigned the risk phrase R38 (irritating to skin) in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as corrosive, to which is assigned the risk phrase R35 or R34, or irritant, to which is assigned the risk phrase R38, in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each substance in the preparation by the irritant (R38) limit specified for that substance is 1 or more, i.e.—

$$∑(PC.R34LXi.R38+PC.R35LXi.R38+PXi.R38LXi.R38)≥1$ where— PC.R35 the percentage by weight of each corrosive substance to which is assigned the risk phrase R35 in the preparation, PC.R34 the percentage by weight of each corrosive substance to which is assigned the risk phrase R34 in the preparation, PXi.R38 the percentage by weight of each irritant substance to which is assigned the risk phrase R38 in the preparation, LXi.R38 the irritant (R38) limit specified for each corrosive or irritant substance expressed as a percentage by weight to which is assigned the risk phrase R35, R34 or R38 in the preparation;$

• (c) owing to their sensitizing effects by skin contact preparations containing at least one substance dangerous for supply to which is assigned phrase R43 (may cause sensitization by skin contact) that produces such effects in individual concentrations exceeding:

• either the concentration specified in the approved supply list for the substance under consideration, or

• the concentration specified in paragraph 5 of Part II of this Schedule (Table V or Table VA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

13

The following preparations shall be regarded as eye irritants—

• (a) preparations containing one or more substances classified or regarded as irritant to which is assigned the risk phrase R41 (risk of serious damage to eyes) or R36 (irritating to eyes) in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as irritant to which is assigned the risk phrase R41 or R36 in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant (R36) limit specified for that substance is 1 or more, i.e.—

$$∑(PXi.R41LXi.R36+PXi.R36LXi.R36)≥1$ where— PXi.R41 the percentage by weight of each irritant substance to which is assigned the risk phrase R41 in the preparation, PXi.R36 the percentage by weight of each irritant substance to which is assigned the risk phrase R36 in the preparation, LXi.R36 the irritant (R36) limit specified for each irritant substance expressed as a percentage by weight to which is assigned the risk phrase R41 or R36 in the preparation.$

14

The following preparations shall be regarded as irritants for the respiratory system—

• (a) preparations containing one or more substances classified or regarded as irritant to which is assigned the risk phrase R37 (irritating to the respiratory system) in individual concentrations exceeding—

• (i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (b) preparations containing more than one substance classified or regarded as irritant to which is assigned the risk phrase R37 in individual concentrations not exceeding the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant (R37) limit specified for that substance is 1 or more, i.e.—

$$∑(PXi.R37LXi.R37)≥1$ where— PXi.R37 the percentage by weight of each irritant substance to which is assigned the risk phrase R37 in the preparation, LXi.R37 the irritant (R37) limit specified for each irritant substance expressed as a percentage by weight to which is assigned the risk phrase R37 in the preparation.$

Classification by the conventional method as carcinogenic

15

• (1) Preparations shall be regarded as carcinogenic and assigned at least the symbol and indication of danger “toxic” if they contain a substance producing such effects to which is assigned either the risk phrase R45 (may cause cancer) or R49 (may cause cancer by inhalation) which denotes carcinogenic substances in category 1 or category 2 in a concentration equal to or exceeding—

• (a) either the concentration specified in t he approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA in the case of gases) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

• (2) Preparations shall be regarded as suspect for humans owing to their possible carcinogenic effects and assigned at least the symbol and indication of danger “harmful” if they contain a substance producing such effects to which is assigned the risk phrase R40 (possible risk of irreversible effects) which denotes carcinogenic substances in category 3 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as mutagenic

16

• (1) Preparations shall be regarded as mutagenic and assigned at least the symbol and indication of danger “toxic” if they contain a substance producing such effects to which is assigned the risk phrase R46 (may cause heritable genetic damage) which denotes mutagenic substances in category 1 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

• (2) Preparations shall be regarded as mutagenic and assigned at least the symbol and indication of danger “toxic” if they contain a substance producing such effects to which is assigned the risk phrase R46 (may cause heritable genetic damage) which denotes mutagenic substances in category 2 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

• (3) Preparations shall be regarded as suspect for humans because of their possible mutagenic effects and assigned at least the symbol and indication of danger “harmful” if they contain a substance producing such effects to which is assigned the risk phrase R40 (possible risk of irreversible effects) which denotes mutagenic substances in category 3 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as toxic for reproduction

17

• (1) Preparations shall be regarded as toxic for reproduction and assigned at least the symbol and indication of danger “toxic” if they contain a substance producing such effects to which is assigned the appropriate risk phrase as ascertained from the approved classification and labelling guide which denotes substances toxic for reproduction in category 1 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

• (2) Preparations shall be regarded as having to be treated as toxic for reproduction and assigned at least the symbol and indication of danger “toxic” if they contain a substance producing such effects to which is assigned the appropriate risk phrase as ascertained from the approved classification and labelling guide which denotes substances toxic for reproduction in category 2 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

• (3) Preparations shall be regarded as having to be treated as toxic for reproduction and assigned at least the symbol and indication of danger “harmful” if they contain a substance producing such effects to which is assigned the appropriate risk phrase as ascertained from the approved classification and labelling guide which denotes substances toxic for reproduction in category 3 in a concentration equal to or exceeding—

• (a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

• (b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Lower limits of concentration

18

• (1) For preparations to which this Schedule applies, no account shall be taken of substances, whether or not listed in the approved supply list, whether existing as impurities or as additives, if their concentration by weight is less than—

• (a) 0.1% for substances classified as very toxic, toxic, carcinogenic (category 1 or 2) or mutagenic (category 1 or 2);

• (b) 0.5% for substances classified as toxic for reproduction (category 1 or 2);

• (c) 1% for substances classified as harmful, corrosive, irritant, sensitizing, carcinogenic (category 3) or mutagenic (category 3); or

• (d) 5% for substances classified as toxic to reproduction (category 3),

unless lower limits are referred to in Part V of the approved supply list, or in the case of gases in Part II of this Schedule.

• (2) Some substances may have more than one health effect and each of these properties shall be characterised by its specific concentration limit.

PART II — CONCENTRATION LIMITS TO BE USED IN APPLYING THE CONVENTIONAL METHOD OF ASSESSING HEALTH EFFECTS IN ACCORDANCE WITH PART I OF THIS SCHEDULE WHERE NO SUCH LIMITS ARE GIVEN IN THE APPROVED SUPPLY LIST

An assessment must 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:

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 effects

1

Other than gaseous preparations

1.1

The concentration limits fixed in Table 1 determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Classification of the substance	Classification of the preparation	Classification of the preparation	Classification of the preparation
T+	T	Xn
The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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 R20, R21, R22			concentration > 25% —

Gaseous preparations

1.2

The concentration limits expressed as a volume/volume percentage in Table 1A below determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown.

Classification of the substance (gas)	Classification of the preparation	Classification of the preparation	Classification of the preparation
T+	T	Xn
The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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.	The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the above mentioned R phrases according to the classification used, 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 exposure

2

Other than gaseous preparations

2.1

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route of exposure), the individual concentration limits specified in Table II determine, when appropriate, the classification of the preparation.

Classification of the substance	Classification of the preparation	Classification of the preparation	Classification of the preparation
T+	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.
(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.
T+ with R39/route of exposure	concentration > 10% R39[^f01000] obligatory	1% < concentration < 10% R39[^f01000] obligatory	0.1% < concentration < 1% R40[^f01000][^f01001] obligatory
T with R39/route of exposure		concentration > 10% R39[^f01000] obligatory	1% < concentration < 10% R40[^f01000][^f01001] obligatory
Xn with R40/route of exposure			concentration > 10% R40[^f01000][^f01001] obligatory

Gaseous preparations

2.2

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/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.

Classification of the substance (gas)	Classification of the preparation	Classification of the preparation	Classification of the preparation
T+	T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.
(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.	(†) R40 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R40 but classified as carcinogenic or mutagenic are given in Table VI.
T+ with R39/route of exposure	concentration > 1% R39[^f01002] obligatory	0.2% < concentration < 1% R39[^f01002] obligatory	0.02% < concentration < 0.2% R40[^f01002][^f01003] obligatory
T with R39/route of exposure		concentration > 5% R39[^f01002] obligatory	0.5% < concentration < 5% R40[^f01002][^f01003] obligatory
Xn with R40/route of exposure			concentration > 5% R40[^f01002][^f01003] obligatory

Severe effects after repeated or prolonged exposure

3

Other than gaseous preparations

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.

Classification of the substance	Classification of the preparation	Classification of the preparation
T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.
T + with R48/route of exposure	concentration > 10% R48[^f01004] obligatory	1% < concentration < 10% R48[^f01004] obligatory
Xn with R48/route of exposure		concentration > 10% R48[^f01004] obligatory

Gaseous preparations

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 below, e⅔ xpressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Classification of the substance (gas)	Classification of the preparation	Classification of the preparation
T	Xn
(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.	(*) In order to indicate the route of administration/exposure the combined R phrases listed in paragraphs 44, 45 and 46 of the approved classification and labelling guide shall be used.
T + with R48/route of exposure	concentration > 5% R48[^f01005] obligatory	0.5% < concentration < 5% R48[^f01005] obligatory
Xn with R48/route of exposure		concentration > 5% R48[^f01005] obligatory

Corrosive and irritant effects including serious damage to eye

4

Other than gaseous preparations

4.1

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table IV determine, when appropriate, the classification of the preparation.

Gaseous preparations

4.2

For gases that produce such effects (R34, R35 — or R36, R37, R38, R41), the individual concentration limits specified in Table IVA below, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.

Classification of the substance	Classification of the preparation	Classification of the preparation	Classification of the preparation	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 (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.
C with R35	concentration > 10% R35 obligatory	5% < concentration < 10% R34 obligatory	[^f01006]	1% < concentration < 5% R36/38 obligatory
C with R34		concentration > 10% R34 obligatory	[^f01006]	5% < concentration < 10% R36/38 obligatory
Xi with R41			concentration > 10% R41 obligatory	5% < concentration < 10%
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
Classification of the substance (gas)	Classification of the preparation	Classification of the preparation	Classification of the preparation	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 (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.	(*) According to the approved classification and labelling guide (paragraph 57) when a substance or preparation is classified as corrosive and assigned the risk phrase R34 or R35, the risk phrase R41 does not need to be included. 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). Therefore when the formulae of paragraphs 11(b) and 13(b) of Part I of this Schedule are applied the following concentration limits must be used, unless different values are fixed in the approved supply list. when formula 11(b) is applied the limit values for LXiR41 are: 10% for the substances XiR41, 10% for the substances C R34, 5% for the substances C R35; when the formula 13(b) is applied the limit values for LXiR36 are: 20% for the substances Xi R36, 5% for the substances Xi R41, 5% for the substances C R34, 1% for the substances C R35.
C with R35	concentration > 1% R35 obligatory	0.2% < concentration < 1% R34 obligatory	[^f01007]	0.02% < concentration < 0.2% R37 obligatory
C with R34		concentration > 5% R34 obligatory	[^f01007]	0.5% < concentration < 5% R37 obligatory
Xi with R41			concentration > 5% R41 obligatory	0.5% < concentration < 5% R36 obligatory
Xi with R36, R37, R38			concentration < 5% R41 obligatory	concentration < 5% R36, R37, R38 obligatory as appropriate

Sensitizing effects

5

Other than gaseous preparations

5.1

Substances that produce such effects are classified as sensitizing 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 symbol Xn and phrase R42/43 if this effect can be produced by inhalation and through contact with the skin.

Gaseous preparations

5.2

Gases that produce such effects are classified as sensitizing and assigned:

• the symbol Xn and phrase R42 if this effect can be produced by inhafilation,

• the symbol Xn and phrase R 42/43 if this effect can be produced by inhalation and through contact with the skin.

Carcinogenic/mutagenic/toxic effects for reproduction

6

Other than gaseous preparations

6.1

For substances which produce such effects and for which specific concentration limits do not yet appear in the approved supply list, concentration limits laid down in Table VI shall determine, where appropriate, the classification of the preparation.

Classification of the substance	Classification of the preparation	Classification of the preparation
Categories 1 and 2	Category 3
(*) R40 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R40 but classified as harmful are given in Table II.	(*) R40 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R40 but classified as harmful are given in Table II.	(*) R40 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R40 but classified as harmful are given in Table II.
Carcinogenic substances of category 1 or 2 with R45 or R49	> 0.1% carcinogenic R45, R49 obligatory as appropriate
Carcinogenic substances of category 3 with R40[^f01008]		> 1% carcinogenic R40[^f01008] obligatory
Mutagenic substances of category 1 or 2 with R46	> 0.1% mutagenic R46 obligatory
Mutagenic substances of category 3 with R40[^f01008]		> 1% mutagenic R40[^f01008] obligatory
Substances “toxic for reproduction” of category 1 or 2 with R60 (fertility)	> 0.5% toxic for reproduction (fertility) R60 obligatory
Substances “toxic for reproduction” of category 3 with R62 (fertility)		> 5% toxic for reproduction (fertility) R62 obligatory
Substances “toxic for reproduction” of category 1 or 2 with R61 (development)	> 0.5% toxic for reproduction (development) R61 obligatory
Substances “toxic for reproduction” of category 3 with R63 (development)		> 5% toxic for reproduction (development) R63 obligatory

Gaseous preparations

6.2

For gases which produce such effects and for which specific concentration limits do not yet appear in the approved supply list, concentration limits laid down in Table VIA, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation.

Classification of the substance (gas)	Classification of the preparation
Categories 1 and 2	Category 3
(*) R40 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R40 but classified as harmful are given in Table IIA.	(*) R40 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R40 but classified as harmful are given in Table IIA.
Carcinogenic substances of category 1 or 2 with R45 or R49	> 0.1% carcinogenic R45, R49 obligatory as appropriate
Carcinogenic substances of category 3 with R40[^f01009]	> 1% carcinogenic R40[^f01009] obligatory
Mutagenic substances of category 1 or 2 with R46	> 0.1% mutagenic R46 obligatory
Mutagenic substances of category 3 with R40[^f01009]	> 1% mutagenic R40[^f01009] obligatory
Substances “toxic for reproduction” of category 1 or 2 with R60 (fertility)	> 0.2% toxic for reproduction (fertility) R60 obligatory
Substances “toxic for reproduction” of category 3 with R62 (fertility)	> 1% toxic for reproduction (fertility) R62 obligatory
Substances “toxic for reproduction” of category 1 or 2 with R61 (development)	> 0.2% toxic for reproduction (development) R61 obligatory
Substances “toxic for reproduction” of category 3 with R63 (development)	> 1% toxic for reproduction (development) R63 obligatory

SCHEDULE 4 — CLASSIFICATION PROVISIONS FOR PREPARATIONS INTENDED TO BE USED AS PESTICIDES

Interpretation

1

A pesticide means a preparation designed—

• (a) to destroy organisms harmful to plants or to plant products or to protect plants and plant products from such organisms;

• (b) to improve or regulate plant production, with the exception of a fertiliser and a soil conditioner;

• (c) to preserve plant products except—

• (i) a wood preservative which does not contain preservatives which penetrate into the wood, or

• (ii) a food preservative to which the Preservatives in Food Regulations 1979[^f00050] apply;

• (d) to destroy undesired plants;

• (e) to destroy parts of plants or to prevent undesired growth; or

• (f) to render harmless or to destroy, or to give protection against, any nuisance or harmful animals or insect pests and to control organisms with harmful or unwanted effects on water systems, buildings or other structures, or manufactured products.

Classification as very toxic, toxic or harmful

2

• (1) A preparation intended for use as a pesticide shall be classified as very toxic, toxic or harmful if its toxicity as determined by an internationally recognised test method in accordance with sub-paragraph (2) below is within the range for that classification in the table set out at the end of this sub-paragraph.

Classification	LD₅₀ absorbed orally in rat, mg/kg	LD₅₀ absorbed orally in rat, mg/kg	LD₅₀ absorbed percutaneously in rat or rabbit, mg/kg	LD₅₀ absorbed percutaneously in rat or rabbit, mg/kg	LC₅₀ absorbed by inhalation in rat, mg/litre (4 hours)
	Solids other than baits and tablets	Liquids and bait preparations and pesticides in tablet form	Solids other than baits and tablets	Liquids and bait preparations and pesticides in tablet form	Gases, liquified gases, fumigants and aerosols, in powders having particle size < 50 microns
Very Toxic	< 5	< 25	< 10	< 50	< 0.5
Toxic	&;gt 5 to 50	> 25 to 200	> 10 to 100	> 50 to 400	> 0.5 to 2
Harmful	> 50 to 500	> 200 to 2,000	> 100 to 1,000	> 400 to 4,000	>2 to 20

• (2) Subject to sub-paragraphs (3) and (4) below, pesticides shall be classified as very toxic, toxic or harmful by carrying out toxicity tests on the pesticide in the form in which it is intended to be used and these tests shall be suitable having regard to the naturfi e and intended method of use of the pesticide and in particular—

• (a) in the case of pesticides which can be absorbed through the skin, the percutaneous LD50value shall be used where it is such that it would place a pesticide in a more restrictive class than the oral LD₅₀ value or the inhalation LC₅₀ value; and

• (b) in the case of gases, liquefied gases, fumigants and aerosols and powders in which the diameter of the particles does not exceed 50 microns, the inhalation LC₅₀ value shall be used.

• (3) In a case where a preparation to which this Schedule applies—

• (a) contains only one active ingredient;

• (b) the toxicity of that active ingredient is known; and

• (c) there are valid grounds for believing that the toxicity determined on the basis of a calculation carried out in accordance with this sub-paragraph would not differ substantially from the toxicity determined by biological testing carried out in accordance with sub-paragraphs (1) and (2) above, the toxicity of the preparation may be calculated in accordance with the formula—

$$L×100C$ where L is the oral toxicity (LD₅₀) of the active ingredient and C its concentration as a percentage by weight and in this sub-paragraph where the active ingredient is listed in column 1 of Part VI of the approved supply list, its toxicity shall be taken as the conventional LD50 value given in the corresponding entry in column 2 of that Part.$

• (4) Account shall also be taken of any fact which suggests that—

• (a) the preparation in normal use involves a risk to human health;

• (b) the preparation is less toxic or harmful than its ingredients seem to indicate; or

• (c) in relation to a particular preparation, the rat is not the most suitable animal for testing.

• (5) Classification for properties other than very toxic, toxic or harmful shall be carried out in accordance with the provisions of regulation 5(5).

SCHEDULE 5 — HEADINGS UNDER WHICH PARTICULARS ARE TO BE PROVIDED IN SAFETY DATA SHEETS

The safety data sheet referred to in regulation 6 shall contain the following obligatory headings:

SCHEDULE 6 — PARTICULARS TO BE SHOWN ON LABELS FOR SUBSTANCES AND PREPARATIONS DANGEROUS FOR SUPPLY AND CERTAIN OTHER PREPARATIONS

PART I — GENERAL PROVISIONS RELATING TO LABELS

Labelling particulars for substances dangerous for supply

1

• (1) In the case of a substance dangerous for supply which is listed in Part I of the approved supply list, the particulars to be shown on the label in accordance with regulation 9(2) (c) shall be the particulars specified for the substance in the relevant entry in column 3 of Part V of that list.

• (2) Subject to paragraph 4, in the case of a substance dangerous for supply which is not listed in Part I of the approved supply list the particulars required to be shown on the label in accordance with regulation 9(2)(c) shall be determined from the classification of the substance in accordance with regulation 5 in conjunction with the approved classification and labelling guide.

Labelling particulars for preparations dangerous for supply

2

• (1) Subject to paragraphs 3, 4 and 5, the provisions of this paragraph shall have effect in relation to the labelling of preparations dangerous for supply.

• (2) Subject to sub-paragraph (4) below, the chemical names of the substances dangerous for supply present in the preparation shall be shown in accordance with the following rules—

• (a) in the case of a preparation classified as requiring the indication of danger T+, T or Xn, only substances requiring those indications of danger present in the preparation in concentrations exceeding the lowest limit (Xn limit) for the substance laid down in column 4 of Part V of the approved supply list, or if no such limit is laid down the relevant limit laid down in Part II of Schedule 3 need be referred to;

• (b) in the case of a preparation classified as requiring the indication of danger C, only substances requiring that indication of danger present in the preparation in concentrations exceeding the lowest limit (Xi limit) for the substance laid down in column 4 of Part V of the approved supply list, or if no such limit is laid down the relevant limit laid down in Part II of Schedule 3 need be referred to; and

• (c) if the preparation is assigned one or more of the standard risk phrases R39, R40, R42, R43, R42/43, R45, R46, R48, R49, R60, R61 or R62, the name of any substance causing the preparation to be so assigned shall be referred to.

• (3) The chemical name referred to in sub-paragraph (2) above shall be—

• (a) in the case of a substance listed in Part I of the approved supply list, the name or one of the names under which it is listed; or

• (b) in the case of a substance not so listed, an internationally recognised name.

• (4) For the purposes of labelling, no account shall be taken of any substance in the preparation if its concentration is less than the concentration referred to in paragraph 18(1) of Part I of Schedule 3.

• (5) Subject to sub-paragraph (4) above, the particulars to be shown on the label in accordance with regulation 9(3)(c)(ii), (iii) and (iv) shall be determined from the classification of the preparation made in accordance with regulation 5 in conjunction with the approved classification and labelling guide.

Derogation for naming the ingredients of certain preparations containing harmful substances.

3

• (1) Where a person can demonstrate to the Executive that the disclosure of the chemical identity of a substance required to show the indication of danger Xn (not being a substance which would cause the preparation to be assigned one of the risk phrases referred to in paragraph 2(2)(c)) on the label will put at risk the confidential nature of his property, he shall be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups of the substance or by means of an alternative name giving equivalent information.

• (2) In such a case the manufacturer shall notify the Executive of his intention so to label the preparation.

• (3) Regulation 18 of the Notification of New Substances Regulations 1993[^f00051] (which relates to confidentiality of information notified) shall apply to information notified under sub-paragraph (2) above as it applies to information notified under those Regulations.

Indications of danger and symbols for substances and preparations dangerous for supply

4

• (1) Except in the case of a substance dangerous for supply which is listed in Part I of the approved supply list, where a substance or preparation is required to have more than one indication of danger in either of the following groups listed in decreasing order of severity, namely—

• (a) explosive, oxidizing, extremely flammable and highly flammable; or

• (b) very toxic, toxic, corrosive, harmful and irritant,

only one of the indications of danger with its symbol from each group corresponding to the most severe indication of danger in that group needs be shown.

• (2) The risk phrases R 12 (extremely flammable) and R 11 (highly flammable) need not be used if they repeat the indication of danger shown on the label.

Designation of pesticides to which Schedule 4 applies

5

• (1) A preparation which is a pesticide shall be designated by—

• (a) the trade name or trade designation of the preparation;

• (b) the name and concentration of each active ingredient in the preparation and the concentration thereof shall be expressed—

• (i) in the case of pesticides which are supplied as solids, in aerosol dispensers, or as volatile or viscous liquids, as percentage by weight,

• (ii) for other liquids as percentage by weight or as grams per litre, or

• (iii) for gases, as percentage by volume;

• (c) the name of each other ingredient which is—

• (i) required to have the indication of danger T+ or T, if the concentration thereof exceeds 0.2 per cent by weight,

• (ii) required to have the indication of danger C or Xn, if the concentration thereof exceeds 5 per cent by weight.

• (2) the label shall also show—

• (a) the net quantity of the preparation;

• (b) the batch number; and

• (c) in the case of preparations which are required to have the indication of danger T+, T or Xn, an indication that the container must not be re-used except in the case of containers that are specifically designed for re-use, recharging or refilling by the supplier of the pesticide.

PART II — PARTICULAR PROVISIONS CONCERNING CERTAIN PREPARATIONS

A — Special provisions for preparations dangerous for supply

Preparations to be supplied to the general public

1

• (1) The labels on packages of preparations dangerous for supply intended to be supplied to the general public must bear relevant safety phrase S1, S2, S45 or S46 in accordance with the approved classification and labelling guide.

• (2) When such preparations are classified as very toxic, toxic, or corrosive and where it is physically impossible to give the 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.

Preparations intended for use by spraying

2

The labels on packages containing preparations dangerous for supply intended to be used for spraying shall bear the safety phrase S23 and safety phrase S38 or S51 assigned in accordance with the approved classification and labelling guide.

Preparations containing a substance affected by the risk phrase R33 (danger of cumulative effects)

3

When a preparation dangerous for supply contains at least one substance required to show the risk phrase R33, that phrase must be shown on the label of the preparation when the concentration of that substance is equal to or higher than 1% unless a different value for that substance is shown in Part V of the approved supply list.

Preparations containing a substance affected by the risk phrase R64 (may cause harm to breast-fed babies)

4

When a preparation dangerous for supply contains at least one substance required to show the risk phrase R64, that phrase must be shown on the label of the preparation when the concentration of that substance is equal to or higher than 1% unless a different value for that substance is shown in Part V of the approved supply list.

B — Special provisions for preparations whether or not dangerous for supply

Paints and varnishes containing lead

1

• (1) 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, shall show the following particulars—

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

• (2) In the case of packages containing less than 125 millilitres of such preparations the particulars may be—

Warning. Contains lead.

Cyanoacrylate based adhesives

2

• (1) The immediate packages of glues based on cyanoacrylates shall bear the following inscription—

Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children.

• (2) Appropriate safety advice shall accompany the package.

Preparations containing isocyanates

3

The package labels of preparations containing isocyanates (whether as monomers, oligomers, prepolymers etc or as mixtures thereof) shall bear the following inscriptions—

Contains isocyanates. See information supplied by the manufacuter.

Certain preparations containing epoxy constituents

4

The package labels of preparations containing epoxy constituents with an average molecular weight < 700 shall bear the following inscriptions—

Contains epoxy constituents. See information supplied by the manufacturer.

Preparations intended to be sold to the general public that contain active chlorine

5

The package labels of preparations containing more than 1% of active chlorine which are intended to be sold to the general public shall bear the following inscription—

Warning! Do not use with other products. May release dangerous gases (chlorine).

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

6

The package labels of preparations containing cadmium (alloys) intended to be used for brazing or soldering shall bear the following inscription—

Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions.

SCHEDULE 7 — PROVISIONS RELATING TO CHILD RESISTANT CLOSURES AND TACTILE WARNING DEVICES