SCHEDULE 3PROVISIONS FOR CLASSIFYING DANGEROUS PREPARATIONS

Regulations 4(7) and 8(3)

PART IGENERAL PROVISIONS

Application1

The provisions of this Schedule shall apply for the classification of preparations.

Interpretation and application2

1

In this Schedule, for the purposes of classification—

  • “physico-chemcial properities” means the properties to be applied for the classifications “explosive”, “oxidising”, “extremely flammable”, “highly flammable” or “flammable”;

  • “health effects” means the effects to be assessed for the classifications “very toxic”, “toxic”, “harmful”, “corrosive”, “irritant”, “sensitising”, “carcinogenic”, “mutagenic” or “toxic for reproduction”; and

  • “environmental hazards” means the hazards to be assessed for the classification “dangerous for the environment”.

2

In its application to preparations that are gases, this Part shall be modified so that reference to concentrations expressed as percentage by weight are to concentrations expressed as the same percentage by volume.

Classification of preparations by physico-chemical properties3

1

The requisite physico-chemical properties for the classification of preparations shall be determined in accordance with the criteria set out in the approved classification and labelling guide.

2

Subject to sub-paragraph (3), preparations shall be classified as explosive, oxidising, extremely flammable, highly flammable or flammable when they satisfy the criteria referred to in sub-paragraph (1) for the category of danger.

3

The determination of explosive, oxidising, extremely flammable, highly flammable or flammable properties is not necessary provided that—

a

none of the constituents possess such properties and that, on the basis of information available to the manufacturer, the preparation is unlikely to present dangers of this kind;

b

in the event of a change in composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification; and

c

in the case of a preparation supplied in the form of an aerosol, that preparation satisfies the provisions of article 9a of Council Directive 75/324/EEC39.

Classification of preparations by health effects4

1

The health effects of a preparation shall be assessed by one or more of the following methods—

a

by the conventional method described in the following paragraphs using concentration limits; or

b

by the criteria set out in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

2

Any one or more of the health effects of the preparation which are not assessed by the method set out in sub-paragraph (1)(b) shall be assessed in accordance with the conventional method.

3

Where the health effects have been established by both methods, the results of the method set out in sub-paragraph (1)(b shall be used for classifying the preparation except in the case of carcinogenic and mutagenic effects and toxic effects for reproduction, when the conventional method set out in sub-paragraph (1)(a) shall always be used.

4

Where it can be demonstrated—

a

by epidemiological studies, by scientifically valid case studies as specified in the approved classification and labelling guide or by statistically backed experience (such as the assessment of data from poison information units or concerning occupational diseases) that toxicological effects on man differ from those suggested by the application of the methods set out in paragraph (1), then the preparation shall be classified according to its effects on man;

b

that owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation; or

c

that owing to effects such antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.

5

Subject to sub-paragraph (6), for preparations of a known composition, with the exception of plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b), a new health effect assessment shall be performed either by the method set out in sub-paragraph (1)(a) or (1)(b) whenever—

a

changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table—

Initial concentration range of the constituent

Permitted variation in actual concentration of the constituent

≤2.5%

±30%

>2.5

≤10%

±20%

>10

≤25%

±10%

>25

≤100%

±5%

b

changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.

6

The revised assessment required by paragraph (5) shall not be required where there is a valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Classification for health effects by the conventional method5

1

In accordance with paragraph 4(1)(a), the health effects shall be assessed by the conventional method described below using concentration limits.

2

Where the substances concerned are dangerous substances and are listed as dangerous substances in the approved supply list and are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits shall be used.

3

Where the substances concerned are dangerous substances and do not appear in the approved supply list as dangerous substances or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with Part II of this Schedule.

4

Where a preparation contains at least one substance which, in accordance with regulation 6(7) of the NONS Regulations bears the warning “Caution—Substance not yet fully tested”, the label of the preparation must bear the words “Warning—This preparation contains a substance not yet tested completely” if the substance is present in a concentration equal to or in excess of 1% by weight.

5

A substance referred to in sub-paragraph (4) must, whatever its concentration level, be treated on the same basis as the other substances present in the preparation when applying the method of evaluation by calculation, if its labelling gives at least an indication of the health effect.

Lower limits of concentration6

1

For preparations to which this Schedule applies, account shall be taken of dangerous substances which are classified as dangerous on the basis of their health or environmental effects (whether they are present as additives or impurities) when their concentrations are equal to or greater than those defined in the following table unless lower limits are given in the approved supply list or in Part II of this Schedule—

Category of danger of the substance

Concentration to take into consideration for

gaseous preparations % vol/vol

other preparations % w/w

Very toxic

≥0.02

≥0.1

Toxic

≥0.02

≥0.1

Carcinogenic Category 1 or 2

≥0.02

≥0.1

Mutagenic Category 1 or 2

≥0.02

≥0.1

Toxic for reproduction Category 1 or 2

≥0.02

≥0.1

Harmful

≥0.2

≥1

Corrosive

≥0.02

≥1

Irritant

≥0.2

≥1

Sensitising

≥0.2

≥1

Carcinogenic Category 3

≥0.2

≥1

Mutagenic Category 3

≥0.2

≥1

Toxic for reproduction Category 3

≥0.2

≥1

Dangerous for the environment N

≥0.1

Dangerous for the environment ozone

≥0.1

≥0.1

Dangerous for the environment

≥1

2

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

Classification by the conventional method as very toxic7

1

The following preparations shall be classified as very toxic owing to their acute lethal effects and assigned the symbol “T+”, the indication of danger “very toxic” and the risk phrase R26, R27 or R28—

a

preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or 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

preparations containing more than one substance classified as very toxic in lower individual concentrations than 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 substance in the preparation by the very toxic limit specified for that substance is 1 or more, i.e.—

(PT+LT+)1math

where—

PT+

is the percentage by weight of each very toxic substance in the preparation,

LT+

is the very toxic limit specified for each very toxic substance expressed as a percentage by weight or by volume.

2

The following preparations shall be classified as very toxic owing to their non-lethal irreversible effects after a single exposure and assigned the symbol “T+”, the indication of danger “very toxic” and the risk phrase R39/route of exposure—

  • Preparations containing one or more dangerous substances which produce such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. 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.

Classification by the conventional method as toxic8

1

The following preparations shall be classified as toxic owing to their acute lethal effects and assigned the symbol “T”, the indication of danger “toxic” and the risk phrase R23, R24 or R25—

a

preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or 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

preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than 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)1math

where—

PT+

is the percentage by weight or by volume of each very toxic substance in the preparation,

PT

is the percentage by weight or by volume of each toxic substance in the preparation,

LT

is the respective toxic limit specified for each very toxic or toxic substance expressed as a percentage by weight or by volume.

2

The following preparations shall be classified as toxic owing to their non-lethal irreversible effects after a single exposure and assigned the symbol “T”, the indication of danger “toxic” and the risk phrase R39/route of exposure—

Preparations containing one or more dangerous substances classified as very toxic or toxic which produce such effects in individual concentrations equal to or 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.

3

The following preparations shall be classified as toxic owing to their long-term effects and assigned the symbol “T”, the indication of danger “toxic” and the risk phrase R48/route of exposure—

  • Preparations containing one or more dangerous substances which produce such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. ii

      the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA) 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 harmful9

1

The following preparations shall be classified as harmful owing to their acute lethal effects and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R20, R21 or R22—

a

preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or 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

preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than 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)1math

where—

PT+

is the percentage by weight or by volume of each very toxic substance in the preparation,

PT

is the percentage by weight or by volume of each toxic substance in the preparation,

PXn

is the percentage by weight or by volume of each harmful substance in the preparation,

LXn

is the respective harmful limit specified for each very toxic, toxic or harmful substance expressed as a percentage by weight or by volume.

2

The following preparations shall be classified as harmful owing to their acute effects to the lungs if swallowed and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R65—

  • Preparations classified as harmful according to the criteria specified in the approved classification and labelling guide.

  • In applying the conventional method according to sub-paragraph (1), no account shall be taken of the classification of a substance as R65.

3

The following preparations shall be classified as harmful owing to their non-lethal irreversible effects after a single exposure and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R68/route of exposure—

  • Preparations containing one or more dangerous substances classified as very toxic, toxic or harmful which produce such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. 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;

4

The following preparations shall be classified as harmful owing to their long-term effects and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R48/route of exposure—

  • Preparations containing one or more dangerous substances classified as toxic or harmful that produce such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. ii

      the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA) 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 corrosive10

1

The following preparations shall be classified as corrosive and assigned the symbol “C”, the indication of danger “corrosive” and the risk phrase R35—

a

preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 in individual concentrations equal to or 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 as corrosive to which is assigned the risk phrase R35 in lower individual concentrations than 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 limit R35 specified for that substance is 1 or more, i.e.—

(PC.R35LC.R35)1math

where—

PC.R35

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phase R35 in the preparation,

LC.R35

is the corrosive limit R35 specified for each corrosive substance to which is assigned the risk phase R35 expressed as a percentage by weight or by volume.

2

The following preparations shall be classified as corrosive and assigned the symbol “C”, the indication of danger “corrosive” and the risk phrase R34—

a

preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 or R34 in individual concentrations equal to or 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 as corrosive to which is assigned the risk phrase R35 or R34 in lower individual concentrations than 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 limit R34 specified for that substance is 1 or more, i.e.—

(PC.R35LC.R34+PC.R34LC.R34)1math

where—

PC.R35

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phase R35 in the preparation,

PC.R34

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phase R34 in the preparation,

LC.R34

is the respective corrosive limit R34 specified for each corrosive substance to which is assigned the risk phase R35 or R34 expressed as a percentage by weight or by volume.

Classification by the conventional method as irritant11

1

The following preparations shall be classified as irritants liable to cause serious eye damage and assigned the symbol “Xi”, the indication of danger “irritant” and the risk phrase R41—

a

preparations containing one or more substances classified as irritant to which is assigned the risk phrase R41 in individual concentrations equal to or 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 as irritant to which is assigned the risk phrase R41, or classified as corrosive and to which is assigned the risk phrase R35 or R34, in lower individual concentrations than 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 limit R41 specified for that substance is 1 or more, i.e.—

(PC.R35LXi.R41+PC.R34LXi.R41+PXi.R41LXi.R41)1math

where—

PC.R35

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R35 in the preparation,

PC.R34

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R34 in the preparation,

PXi.R41

is the percentage by weight or by volume of each irritant substance to which is assigned the risk phrase R41 in the preparation,

LXi.R41

is the respective irritant limit R41 specified for each corrosive substance to which is assigned the risk phrase R35 or R34 or irritant substance to which is assigned the risk phrase R41, expressed as a percentage by weight or by volume.

2

The following preparations shall be classified as irritant to eyes and assigned the symbol “Xi”, the indication of danger “irritant” and the risk phrase R36—

a

preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 or R34 or as irritant to which is assigned the risk phrase R41 or R36 in individual concentrations equal to or 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 as irritant to which is assigned the risk phrase R41 or R36 or as corrosive and to which is assigned the risk phrase R35 or R34, in lower individual concentrations than 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 limit R36 specified for that substance is 1 or more, i.e.—

(PC.R35LXi.36+PC.R34LXi.R36+PXi.R41LXi.R36+PXi.R36LXi.R36)1math

where—

PC. R35

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R35 in the preparation,

PC. R34

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R34 in the preparation,

PXi. R41

is the percentage by weight or by volume of each irritant substance to which is assigned the risk phrase R41 in the preparation,

PXi.R36

is the percentage by weight or by volume of each irritant substance to which is assigned the risk phrase R36 in the preparation,

LXi. R36

is the respective irritant limit R36 specified for each corrosive substance to which is assigned the risk phrase R35 or R34 or irritant substance to which is assigned the risk phrase R41 or R36, expressed as a percentage by weight or by volume.

3

The following preparations shall be classified as irritant to skin and assigned the symbol “Xi”, the indication of danger “irritant” and the risk phrase R38—

a

preparations containing one or more substances classified as irritant and to which is assigned the risk phrase R38 or as corrosive and to which is assigned the risk phrase R35 or R34, in individual concentrations equal to or 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 as irritant and to which is assigned the risk phrase R38, or as corrosive and to which is assigned the risk phrase R35 or R34 in lower individual concentrations than 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 limit R38 specified for that substance is 1 or more, i.e.—

(PC.R35LXi.R38+PC.R34LXi.R38+PXi.R38LXi.R38)1math

where—

PC. R35

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R35 in the preparation,

PC. R34

is the percentage by weight or by volume of each corrosive substance to which is assigned the risk phrase R34 in the preparation,

PXi. R38

is the percentage by weight or by volume of each irritant substance to which is assigned the risk phrase R38 in the preparation,

LXi. R38

is the respective irritant limit R38 specified for each corrosive substance to which is assigned the risk phrase R35 or R34 or irritant substance to which is assigned risk phrase R38, expressed as a percentage by weight or by volume.

4

the following preparations shall be classified as irritant to the respiratory system and assigned the symbol “Xi”, the indication of danger “irritant” and the risk phrase R37—

a

preparations containing one or more substances classified as irritant to which is assigned the risk phrase R37 in individual concentrations equal to or 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 as irritant to which is assigned the risk phrase R37 in lower individual concentrations than 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 limit R37 specified for that substance is 1 or more, i.e.—

(PXi.R37LXi.R37)1math

where—

PXi. R37

is the percentage by weight or by volume of each irritant substance to which is assigned the risk phrase R37 in the preparation,

LXi. R37

is the irritant limit R37 specified for each irritant substance to which is assigned the risk phrase R37, expressed as a percentage by weight or by volume.

c

gaseous preparations containing more than one substance classified as irritant and to which is assigned the risk phrase R37 or as corrosive and to which is assigned the risk phrase R35 or R34 in lower individual concentrations than 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 limit R37 specified for that substance is 1 or more, i.e.—

(PC.R35LXi.R37+PC.R34LXi.R37+PXi.R38LXi.R37)1math

where—

PC.R35

is the percentage by volume of each corrosive substance to which is assigned the risk phrase R35 in the preparation,

PC.R.34

is the percentage by volume of each corrosive substance to which is assigned the risk phrase R34 in the preparation,

PXi.R37

is the percentage by volume of each irritant substance to which is assigned the risk phrase R37 in the preparation,

LXi.R37

is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned the risk phrase R35 of R34 or gaseous irritant substance to which is assigned risk phrase R37, expressed as a percentage by weight or by volume.

Classification by the conventional method as sensitising12

1

The following preparations shall be classified as sensitising by skin contact and assigned the symbol “Xi”, the indication of danger “irritant” and the risk phrase R43—

  • Preparations containing one or more substances classified as sensitising and to which is assigned risk phrase R43 that produces such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. ii

      the concentration specified in paragraph 5 of Part II of this Schedule (Table V or Table VA) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits.

2

The following preparations shall be classified as sensitising by inhalation and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R42—

  • Preparations containing one or more substances classified as sensitising and to which is assigned risk phrase R42 that produces such effects in individual concentrations equal to or exceeding—

    1. i

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

    2. ii

      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.

Classification by the conventional method as carcinogenic13

1

Preparations shall be classified as carcinogenic category 1 or 2 and assigned the symbol “T” and the risk phrase R45 or R49 if they contain one or more substances producing such effects to which is assigned the risk phrase R45 of R49 which denotes carcinogenic substances in category 1 and category 2 in individual concentrations 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 classified as carcinogenic category 3 and assigned the symbol “Xn” and the risk phrase R40 if they contain one or more substances producing such effects to which is assigned the risk phrase R40 which denotes carcinogenic substances in category 3 in individual concentrations 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 mutagenic14

1

Preparations shall be classified as mutagenic category 1 or 2 and assigned the symbol “T” and the risk phrase R46 if they contain one or more substances producing such effects to which is assigned the risk phrase R46 which denotes mutagenic substances in category 1 and category 2 in individual concentrations 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 classified as mutagenic category 3 and assigned the symbol “Xn” and the risk phrase R68 if they contain one or more substances producing such effects to which is assigned the risk phrase R68 which denotes mutagenic substances in category 2 in individual concentrations 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 reproduction15

1

Preparations shall be classified as toxic for reproduction category 1 or 2 and assigned the symbol “T” and the risk phrase R60 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R60 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations 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 classified as toxic for reproduction category 3 and assigned the symbol “Xn” and the risk phrase R62 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R62 which denotes substances toxic for reproduction in category 3 in individual concentrations 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 classified as toxic for reproduction category 1 or 2 and assigned the symbol “T” and the risk phrase R61 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R61 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations 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;

4

Preparations shall be classified as toxic for reproduction category 3 and assigned the symbol “Xn” and the risk phrase R63 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R63 which denotes substances toxic for reproduction in category 3 in individual concentrations 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 of preparations by environmental hazards16

1

The environmental hazards of a preparation shall be assessed by one or more of the following methods—

a

by the conventional method described in the following paragraphs using concentration limits; or

b

by the criteria set out in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

2

Where the environmental hazards have been established by both methods, the results of the method set out in sub-paragraph (1)(b) shall be used for classifying the preparation.

3

Subject to sub-paragraph (4), for preparations of a known composition, with the exception of plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b), a new assessment of the environmental hazards shall be performed either by the method set out in sub-paragraph (1)(a) or (1)(b) whenever—

a

changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table—

Initial concentration range of the constituent

Permitted variation in actual concentration of the constituent

≤2.5%

±30%

>2.5

≤10%

±20%

>10

≤25%

±10%

>25

≤100%

±5%

b

changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.

4

The revised assessment required by paragraph (3) shall not be required where there is a valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Classification for environmental hazards by the conventional method17

1

In accordance with paragraph 16(1)(a), the environmental hazards shall be assessed by the conventional method described below using concentration limits.

2

Where the substances concerned are dangerous substances and are listed as dangerous substances in the approved supply list and are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits shall be used.

3

where the substances concerned are dangerous substances and do not appear in the approved supply list as dangerous substances or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with Part III of this Schedule.

Conventional method for the evaluation of hazards to the aquatic environment18

1

The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrases R50 and R53 (R50-R53)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 1) 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 as dangerous to the environment and to which is assigned phrases R50-R53 in lower individual concentrations than the limits specified under paragraph (a) if—

(PN.R50-53LN.R50-53)1math

where—

PN. R50—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN. R50—53

is the limit R50-53 for each substance dangerous for the environment to which is assigned phrases R50-53 expressed as a percentage by weight.

2

The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrases R51 and R53 (R51-R53) unless the preparation is already classified according to sub-paragraph (1)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits;

b

preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 in lower individual concentrations than the limits specified under paragraph (a) if—

(PN.R50-53LN.R51-53+PN.R51-53LN.R51-53)1math

where—

PN. R50—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN. R51—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

LN. R51—53

is the respective limit R51-53 for each substance dangerous for the environment to which is assigned phrases R50-53 or R51-53 expressed as a percentage of weight.

3

The following preparations shall be classified as dangerous for the environment and assigned the risk phrases R52 and R53 (R52-R53) unless the preparation is already classified according to sub-paragraph (1) or (2)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 or R52-53 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 1) 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 as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 or R52-53 in lower individual concentrations that the limits specified under paragraph (a) if—

(PN.R50-53LR 52-53+PN.R51-53LR52-53+PR 52-53LR 52-53)1math

where—

PN. R50—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN. R51—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

P R52—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52-53 in the preparation,

L R52—53

is the respective limit R52-53 for each substance dangerous for the environment to which is assigned phrases R50-53, R51-53 or R52-53 expressed as a percentage by weight.

4

The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrase R50 unless the preparation is already classified according to sub-paragraph (1)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 2) 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 as dangerous to the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified under paragraph (a) if—

(PN.R50LN.R50)1math

where—

PN. R50

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

LN. R50

is the limit R50 for each substance dangerous for the environment to which is assigned phrase R50 expressed as a percentage by weight

c

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R50 not meeting the criteria under paragraph (a) or (b) and containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 if—

(PN.R50LN.R50+PN.R50-53LN.R50)1math

where—

PN. R50

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

PN. R50—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN. R50

is the respective limit R50 for each substance dangerous for the environment to which is assigned phrases R50 or R50-53 expressed as a percentage by weight.

5

The following preparations shall be classified as dangerous for the environment and assigned the risk phrase R52 unless the preparation is already classified according to sub-paragraph (1), (2), (3) or (4)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 3) 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 as dangerous to the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified under paragraph (a) if—

(PR52LR52)1math

where—

P R52

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,

L R52

is the limit R52 for each substance dangerous for the environment to which is assigned phrase R52 expressed as a percentage by weight.

6

The following preparations shall be classified as dangerous for the environment and assigned the risk phrase R53 unless the preparation is already classified according to sub-paragraph (1), (2) or (3)—

a

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 4) 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 as dangerous to the environment and to which is assigned phrase R53 in lower individual concentrations than the limits specified under paragraph (a) if—

(PR53LR53)1math

where—

P R53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

L R53

is the limit R53 for each substance dangerous for the environment to which is assigned phrase R53 expressed as a percentage by weight.

c

preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R53 not meeting the criteria under paragraph (b) and containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53, R51-53 or R52-53 if—

(PR53LR53+PN.R50-53LR53+PN.R51-53LR53+PR52-53LR53)1math

where—

P R53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

PN. R50—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN. R51—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

P R52—53

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52-53 in the preparation,

L R53

is the respective limit R53 for each substance dangerous for the environment to which is assigned phrases R53, R50-53, R51-53 or R52-53 expressed as a percentage by weight.

Conventional method for the evaluation of hazards to the ozone layer19

1

Preparations containing one or more substances classified as dangerous to the environment and to which is assigned the symbol “N” and the risk phrase R59 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 5) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits,

shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrase R59.

2

Preparations containing one or more substances classified as dangerous to the environment and to which is assigned the risk phrase R59 in individual concentrations equal to or greater than—

i

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

ii

the concentration specified in Part III of this Schedule (Table 5) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits,

shall be classified as dangerous for the environment and assigned the risk phrase R59.

PART IICONCENTRATION 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:

1

acute lethal effects;

2

non-lethal irreversible effects after a single exposure;

3

severe effects after repeated or prolonged exposure;

4

corrosive effects, irritant effects;

5

sensitising effects;

6

carcinogenic effects, mutagenic effects, toxic effects for reproduction.

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

1.1

Other than gaseous preparations

  • 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.

  • Table I

    Classification of the substance

    Classification of the preparation

    T+

    T

    Xn

    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%

  • The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria—

    1. i

      the label shall include one or more of the above mentioned R phrases according to the classification used,

    2. 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.

Gaseous preparations1.2

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

Table IA

Classification of the substance (gas)

Classification of the preparation

T+

T

Xn

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%

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.

Non-lethal irreversible effects after a single exposure2

Other than gaseous preparations2.1

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

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

(*)

In order to indicate the route of administration/exposure the combined R phrases listed in Part V of the approved supply list shall be used.

(†)

R68 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R68 but classified as carcinogenic or mutagenic are given in Table VI.

Gaseous preparations2.2

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

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

(*)

In order to indicate the route of administration/exposure the combined R phrases listed in Part V of the approved supply list shall be used.

(†)

R68 here refers to substances classified as harmful. Concentration limits for substances required to be labelled R68 but classified as carcinogenic or mutagenic are given in Table VI.

Severe effects after repeated or prolonged exposure3

Other than gaseous preparations3.1

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

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

(*)

In order to indicate the route of administration/exposure the combined R phrases listed in Part V of the approved supply list shall be used.

Gaseous preparations3.2

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

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

(*)

In order to indicate the route of administration/exposure the combined R phrases listed in Part V of the approved supply list shall be used.

Corrosive and irritant effects including serious damage to eye4

Other than gaseous preparations4.1

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.

Table IV

Classification of the substance

Classification of the preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

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

(*)

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.

Gaseous preparations4.2

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

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 obligatory as appropriate

(*)

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.

Sensitising effects5

Other than gaseous preparations5.1

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

Gaseous preparations5.2

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

Carcinogenic/mutagenic/toxic effects for reproduction6

Other than gaseous preparations6.1

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.

The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2:

T; R45 or R49

Carcinogenic category 3:

Xsubn;; 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

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

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

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

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

(*)

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.

Gaseous preparations6.2

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.

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

Carcinogenic substances of category 1 or 2 with R45 or R49

concentration ≥0.% carcinogenic R45, R49 obligatory as appropriate

Carcinogenic substances of category 3 with R40

concentration ≥1% carcinogenic R40 obligatory

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

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

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

(*)

R68 here refers to substances classified as carcinogenic or mutagenic. Concentration limits for substances required to be labelled R68 but classified as harmful are given in Table IIA

PART IIICONCENTRATION LIMITS TO BE USED FOR THE EVALUATION OF ENVIRONMENT HAZARDS

The aquatic environment1

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

Table 1:Acute aquatic toxicity and long-term adverse effects

Classification of the substance

Classification of the preparation

N, R50-53

N, R51-53

R52-53

N, R50-53

Cn≥25%

2.5%≤ Cn<25%

0.25%≤Cn<2.5%

N, R51-53

Cn≥25%

2.5%≤Cn<25%

R52-53

Cn≥25%

Table 2Acute aquatic toxicity

Classification of the substance

Classification of the preparation N, R50

N, R50

Cn ≥ 25%

N, R50-53

Cn ≥ 25%

Table 3Aquatic toxicity

Classification of the substance

Classification of the preparation R52

R52

Cn ≥ 25%

Table 4Long-term adverse effects

Classification of the substance

Classification of the preparation R53

R53

Cn ≥ 25%

N, R50-53

Cn ≥ 25%

N, R51-53

Cn ≥ 25%

R52-53

Cn ≥ 25%

The non-aquatic environment2

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

Table 5Dangerous for the ozone layer

Classification of the substance

Classification of the preparation N, R59

N with R59

Cn ≥ 0.1%

Classification of the substance

Classification of the preparation R59

R59

Cn ≥ 0.1%