Part 1 / INTRODUCTION TO THE LIST OF HARMONISED CLASSIFICATIONS AND LABELLING

PART 1: INTRODUCTION TO THE LIST OF HARMONISED CLASSIFICATIONS AND LABELLING

1.1.   Information listed for each entry

Information listed for each entry

1.1.1.   Numbering of entries and identification of a substance

Numbering of entries and identification of a substance

1.1.1.1.   Index numbers Index numbers

Entries in Part 3 are listed according to the atomic number of the element most characteristic of the properties of the substance. Organic substances, because of their variety, have been placed in classes. The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y. ABC corresponds to the atomic number of the most characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number of the substance in the series ABC. VW denotes the form in which the substance is produced or placed on the market. Y is the check-digit calculated in accordance with the 10-digit ISBN method. This number is indicated in the column entitled ‘Index No’.

1.1.1.2.   EC numbers EC numbers

The EC number, i.e. EINECS, ELINCS or NLP, is the official number of the substance within the European Union. The EINECS number can be obtained from the European Inventory of Existing Commercial Chemical Substance (EINECS) ( 21 ). The ELINCS number can be obtained from the European List of Notified Substances (as amended) (EUR 22543 EN, Office for Official Publications of the European Communities, 2006, ISSN 1018-5593). The NLP number can be obtained from the list of ‘No-longer-polymers’ (as amended) (Document, Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0). The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (EINECS), at 400-010-9 (ELINCS) and at 500-001-0 (NLP). This number is indicated in the column entitled ‘EC No’. 21 21

1.1.1.3.   CAS number CAS number

The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry. It should be noted that the EINECS number includes both anhydrous and hydrated forms of a substance, and there are frequently different CAS numbers for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately as the EINECS number. This number is indicated in the column entitled ‘CAS No’.

1.1.1.4.    ►M18  Chemical name ◄ ►M18  Chemical name ◄ ►M18 ►M18 ►M18  ◄

Wherever possible, hazardous substances are designated by their IUPAC names. Substances listed in EINECS, ELINCS or the list of ‘No-longer-polymers’ are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.

Impurities, additives and minor components are normally not mentioned unless they contribute significantly to the classification of the substance.

Some substances are described with a specific percentage of purity. Substances containing a higher content of active material (e.g. organic peroxide) than this percentage are not included in the entry in Part 3 and may have other hazardous properties (e.g. explosive) and should be classified and labelled accordingly.

Where specific concentration limits are shown, these apply to the substance or substances shown in the entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific percentage of purity, the limits apply to the substance as described in Part 3 and not the pure substance.

Without prejudice to Article 17(2), for substances appearing in Part 3, the name of the substance to be used on the label shall be one of the designations given there. For certain substances, additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.

Certain entries contain a reference to impurities; in these cases the name of the substance is followed by the text: ‘(containing ≥ xx % impurity)’. The reference in brackets is then to be considered as a part of the name, and must be included on the label.

1.1.1.5.   Entries for groups of substances Entries for groups of substances

A number of group entries are included in Part 3. In these cases, the classification and labelling requirements will apply to all substances covered by the description.

In some cases, there are classification and labelling requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 for the substance and the group entry will be annotated with the phrase ‘except those specified elsewhere in this Annex’.

In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification shall be applied.

Entries in Part 3 for salts (under any denomination) cover both anhydrous and hydrous forms, unless specified otherwise.

EC or CAS numbers are not usually included for entries which comprise more than four individual substances.

▼M15 ▼M15

1.1.2.   Information related to the classification and labelling of each entry in Table 3

Information related to the classification and labelling of each entry in Table 3

▼B ▼B

1.1.2.1.   Classification codes Classification codes

1.1.2.1.1.    Hazard class and category codes Hazard class and category codes Hazard class and category codes

The classification for each entry is based on the criteria set out in Annex I, in accordance with Article 13(a) and is presented in the form of a code representing the hazard class and the category or categories/divisions/types within this hazard class.

The Hazard class and category codes used for each of the hazard categories/divisions/types included in a class are shown in Table 1.1.

Table 1.1

Hazard Class

Hazard Class and Category Code

Explosive

Unst. Expl.

Expl. 1.1

Expl. 1.2

Expl. 1.3

Expl. 1.4

Expl. 1.5

Expl. 1.6

▼M19

Flammable gases

Flam. Gas 1A

Flam. Gas 1B

Flam. Gas 2

Pyr. Gas

Chem. Unst. Gas A

Chem. Unst. Gas B

▼M4

Aerosol

Aerosol 1

Aerosol 2

Aerosol 3

▼B

Oxidising gas

Ox. Gas 1

Gases under pressure

Press. Gas (*1)

Flammable liquid

Flam. Liq. 1

Flam. Liq. 2

Flam. Liq. 3

Flammable solid

Flam. Sol. 1

Flam. Sol. 2

Self-reactive substance or mixture

Self-react. A

Self-react. B

Self-react. CD

Self-react. EF

Self-react. G

Pyrophoric liquid

Pyr. Liq. 1

Pyrophoric solid

Pyr. Sol. 1

Self-heating substance or mixture

Self-heat. 1

Self-heat. 2

Substance or mixture which in contact with water emits flammable gas

Water-react. 1

Water-react. 2

Water-react. 3

Oxidising liquid

Ox. Liq. 1

Ox. Liq. 2

Ox. Liq. 3

Oxidising solid

Ox. Sol. 1

Ox. Sol. 2

Ox. Sol. 3

Organic peroxide

Org. Perox. A

Org. Perox. B

Org. Perox. CD

Org. Perox. EF

Org. Perox. G

Substance or mixture corrosive to metals

Met. Corr. 1

▼M19

Desensitised explosives

Desen. Expl. 1

Desen. Expl. 2

Desen. Expl. 3

Desen. Expl. 4

▼B

Acute toxicity

Acute Tox. 1

Acute Tox. 2

Acute Tox. 3

Acute Tox. 4

▼M12

Skin corrosion/irritation

Skin Corr. 1

Skin Corr. 1A

Skin Corr. 1B

Skin Corr. 1C

Skin Irrit. 2

▼B

Serious eye damage/eye irritation

Eye Dam. 1

Eye Irrit. 2

Respiratory/skin sensitization

►M2  Resp. Sens. 1, 1A, 1B ◄

►M2  Skin. Sens. 1, 1A, 1B ◄

Germ cell mutagenicity

Muta. 1A

Muta. 1B

Muta. 2

Carcinogenicity

Carc. 1A

Carc. 1B

Carc. 2

Reproductive toxicity

Repr. 1A

Repr. 1B

Repr. 2

Lact.

Specific target organ toxicity — single exposure

STOT SE 1

STOT SE 2

STOT SE 3

Specific target organ toxicity — repeated exposure

STOT RE 1

STOT RE 2

Aspiration hazard

Asp. Tox. 1

▼M32

Endocrine disruptor for human health

ED HH 1

ED HH 2

▼B

Hazardous to the aquatic environment

Aquatic Acute 1

Aquatic Chronic 1

Aquatic Chronic 2

Aquatic Chronic 3

Aquatic Chronic 4

▼M32

Endocrine disruptor for the environment

ED ENV 1

ED ENV 2

Persistent, bioaccumulative and toxic

Very persistent and very bioaccumulative

PBT

vPvB

Persistent, mobile and toxic

Very persistent and very mobile

PMT

vPvM

▼B

Hazardous for the ozone layer

►M2  Ozone 1 ◄

Hazard Class

Hazard Class and Category Code

Hazard Class

Hazard Class

Hazard Class and Category Code

Hazard Class and Category Code

Explosive

Unst. Expl.

Expl. 1.1

Expl. 1.2

Expl. 1.3

Expl. 1.4

Expl. 1.5

Expl. 1.6

Explosive

Explosive

Unst. Expl.

Expl. 1.1

Expl. 1.2

Expl. 1.3

Expl. 1.4

Expl. 1.5

Expl. 1.6

Unst. Expl.

Expl. 1.1

Expl. 1.2

Expl. 1.3

Expl. 1.4

Expl. 1.5

Expl. 1.6

▼M19

▼M19

▼M19 ▼M19

Flammable gases

Flam. Gas 1A

Flam. Gas 1B

Flam. Gas 2

Pyr. Gas

Chem. Unst. Gas A

Chem. Unst. Gas B

Flammable gases

Flammable gases

Flam. Gas 1A

Flam. Gas 1B

Flam. Gas 2

Pyr. Gas

Chem. Unst. Gas A

Chem. Unst. Gas B

Flam. Gas 1A

Flam. Gas 1B

Flam. Gas 2

Pyr. Gas

Chem. Unst. Gas A

Chem. Unst. Gas B

▼M4

▼M4

▼M4 ▼M4

Aerosol

Aerosol 1

Aerosol 2

Aerosol 3

Aerosol

Aerosol

Aerosol 1

Aerosol 2

Aerosol 3

Aerosol 1

Aerosol 2

Aerosol 3

▼B

▼B

▼B ▼B

Oxidising gas

Ox. Gas 1

Oxidising gas

Oxidising gas

Ox. Gas 1

Ox. Gas 1

Gases under pressure

Press. Gas (*1)

Gases under pressure

Gases under pressure

Press. Gas (*1)

Press. Gas (*1) (*1) *1

Flammable liquid

Flam. Liq. 1

Flam. Liq. 2

Flam. Liq. 3

Flammable liquid

Flammable liquid

Flam. Liq. 1

Flam. Liq. 2

Flam. Liq. 3

Flam. Liq. 1

Flam. Liq. 2

Flam. Liq. 3

Flammable solid

Flam. Sol. 1

Flam. Sol. 2

Flammable solid

Flammable solid

Flam. Sol. 1

Flam. Sol. 2

Flam. Sol. 1

Flam. Sol. 2

Self-reactive substance or mixture

Self-react. A

Self-react. B

Self-react. CD

Self-react. EF

Self-react. G

Self-reactive substance or mixture

Self-reactive substance or mixture

Self-react. A

Self-react. B

Self-react. CD

Self-react. EF

Self-react. G

Self-react. A

Self-react. B

Self-react. CD

Self-react. EF

Self-react. G

Pyrophoric liquid

Pyr. Liq. 1

Pyrophoric liquid

Pyrophoric liquid

Pyr. Liq. 1

Pyr. Liq. 1

Pyrophoric solid

Pyr. Sol. 1

Pyrophoric solid

Pyrophoric solid

Pyr. Sol. 1

Pyr. Sol. 1

Self-heating substance or mixture

Self-heat. 1

Self-heat. 2

Self-heating substance or mixture

Self-heating substance or mixture

Self-heat. 1

Self-heat. 2

Self-heat. 1

Self-heat. 2

Substance or mixture which in contact with water emits flammable gas

Water-react. 1

Water-react. 2

Water-react. 3

Substance or mixture which in contact with water emits flammable gas

Substance or mixture which in contact with water emits flammable gas

Water-react. 1

Water-react. 2

Water-react. 3

Water-react. 1

Water-react. 2

Water-react. 3

Oxidising liquid

Ox. Liq. 1

Ox. Liq. 2

Ox. Liq. 3

Oxidising liquid

Oxidising liquid

Ox. Liq. 1

Ox. Liq. 2

Ox. Liq. 3

Ox. Liq. 1

Ox. Liq. 2

Ox. Liq. 3

Oxidising solid

Ox. Sol. 1

Ox. Sol. 2

Ox. Sol. 3

Oxidising solid

Oxidising solid

Ox. Sol. 1

Ox. Sol. 2

Ox. Sol. 3

Ox. Sol. 1

Ox. Sol. 2

Ox. Sol. 3

Organic peroxide

Org. Perox. A

Org. Perox. B

Org. Perox. CD

Org. Perox. EF

Org. Perox. G

Organic peroxide

Organic peroxide

Org. Perox. A

Org. Perox. B

Org. Perox. CD

Org. Perox. EF

Org. Perox. G

Org. Perox. A

Org. Perox. B

Org. Perox. CD

Org. Perox. EF

Org. Perox. G

Substance or mixture corrosive to metals

Met. Corr. 1

Substance or mixture corrosive to metals

Substance or mixture corrosive to metals

Met. Corr. 1

Met. Corr. 1

▼M19

▼M19

▼M19 ▼M19

Desensitised explosives

Desen. Expl. 1

Desen. Expl. 2

Desen. Expl. 3

Desen. Expl. 4

Desensitised explosives

Desensitised explosives

Desen. Expl. 1

Desen. Expl. 2

Desen. Expl. 3

Desen. Expl. 4

Desen. Expl. 1

Desen. Expl. 2

Desen. Expl. 3

Desen. Expl. 4

▼B

▼B

▼B ▼B

Acute toxicity

Acute Tox. 1

Acute Tox. 2

Acute Tox. 3

Acute Tox. 4

Acute toxicity

Acute toxicity

Acute Tox. 1

Acute Tox. 2

Acute Tox. 3

Acute Tox. 4

Acute Tox. 1

Acute Tox. 2

Acute Tox. 3

Acute Tox. 4

▼M12

▼M12

▼M12 ▼M12

Skin corrosion/irritation

Skin Corr. 1

Skin Corr. 1A

Skin Corr. 1B

Skin Corr. 1C

Skin Irrit. 2

Skin corrosion/irritation

Skin corrosion/irritation

Skin Corr. 1

Skin Corr. 1A

Skin Corr. 1B

Skin Corr. 1C

Skin Irrit. 2

Skin Corr. 1

Skin Corr. 1A

Skin Corr. 1B

Skin Corr. 1C

Skin Irrit. 2

▼B

▼B

▼B ▼B

Serious eye damage/eye irritation

Eye Dam. 1

Eye Irrit. 2

Serious eye damage/eye irritation

Serious eye damage/eye irritation

Eye Dam. 1

Eye Irrit. 2

Eye Dam. 1

Eye Irrit. 2

Respiratory/skin sensitization

►M2  Resp. Sens. 1, 1A, 1B ◄

►M2  Skin. Sens. 1, 1A, 1B ◄

Respiratory/skin sensitization

Respiratory/skin sensitization

►M2  Resp. Sens. 1, 1A, 1B ◄

►M2  Skin. Sens. 1, 1A, 1B ◄

►M2  Resp. Sens. 1, 1A, 1B ◄ ►M2 ►M2 ►M2  ◄

►M2  Skin. Sens. 1, 1A, 1B ◄ ►M2 ►M2 ►M2  ◄

Germ cell mutagenicity

Muta. 1A

Muta. 1B

Muta. 2

Germ cell mutagenicity

Germ cell mutagenicity

Muta. 1A

Muta. 1B

Muta. 2

Muta. 1A

Muta. 1B

Muta. 2

Carcinogenicity

Carc. 1A

Carc. 1B

Carc. 2

Carcinogenicity

Carcinogenicity

Carc. 1A

Carc. 1B

Carc. 2

Carc. 1A

Carc. 1B

Carc. 2

Reproductive toxicity

Repr. 1A

Repr. 1B

Repr. 2

Lact.

Reproductive toxicity

Reproductive toxicity

Repr. 1A

Repr. 1B

Repr. 2

Lact.

Repr. 1A

Repr. 1B

Repr. 2

Lact.

Specific target organ toxicity — single exposure

STOT SE 1

STOT SE 2

STOT SE 3

Specific target organ toxicity — single exposure

Specific target organ toxicity — single exposure

STOT SE 1

STOT SE 2

STOT SE 3

STOT SE 1

STOT SE 2

STOT SE 3

Specific target organ toxicity — repeated exposure

STOT RE 1

STOT RE 2

Specific target organ toxicity — repeated exposure

Specific target organ toxicity — repeated exposure

STOT RE 1

STOT RE 2

STOT RE 1

STOT RE 2

Aspiration hazard

Asp. Tox. 1

Aspiration hazard

Aspiration hazard

Asp. Tox. 1

Asp. Tox. 1

▼M32

▼M32

▼M32 ▼M32

Endocrine disruptor for human health

ED HH 1

ED HH 2

Endocrine disruptor for human health

Endocrine disruptor for human health

ED HH 1

ED HH 2

ED HH 1

ED HH 2

▼B

▼B

▼B ▼B

Hazardous to the aquatic environment

Aquatic Acute 1

Aquatic Chronic 1

Aquatic Chronic 2

Aquatic Chronic 3

Aquatic Chronic 4

Hazardous to the aquatic environment

Hazardous to the aquatic environment

Aquatic Acute 1

Aquatic Chronic 1

Aquatic Chronic 2

Aquatic Chronic 3

Aquatic Chronic 4

Aquatic Acute 1

Aquatic Chronic 1

Aquatic Chronic 2

Aquatic Chronic 3

Aquatic Chronic 4

▼M32

▼M32

▼M32 ▼M32

Endocrine disruptor for the environment

ED ENV 1

ED ENV 2

Endocrine disruptor for the environment

Endocrine disruptor for the environment

ED ENV 1

ED ENV 2

ED ENV 1

ED ENV 2

Persistent, bioaccumulative and toxic

Very persistent and very bioaccumulative

PBT

vPvB

Persistent, bioaccumulative and toxic

Very persistent and very bioaccumulative

Persistent, bioaccumulative and toxic

Very persistent and very bioaccumulative

PBT

vPvB

PBT

vPvB

Persistent, mobile and toxic

Very persistent and very mobile

PMT

vPvM

Persistent, mobile and toxic

Very persistent and very mobile

Persistent, mobile and toxic

Very persistent and very mobile

PMT

vPvM

PMT

vPvM

▼B

▼B

▼B ▼B

Hazardous for the ozone layer

►M2  Ozone 1 ◄

Hazardous for the ozone layer

Hazardous for the ozone layer

►M2  Ozone 1 ◄

►M2  Ozone 1 ◄ ►M2 ►M2 ►M2  ◄

(*1)    *1

see Note U in 1.1.3.

1.1.2.1.2.    Hazard statement codes Hazard statement codes Hazard statement codes

▼M4 ▼M4

The hazard statements assigned in accordance with Article 13(b) are indicated in accordance with Annex III. In addition, for certain hazard statements, letters are added to the 3-digit hazard statement code for further differentiations. The following additional codes are used:

▼B ▼B

H350i

May cause cancer by inhalation.

H360F

May damage fertility.

H360D

May damage the unborn child.

H361f

Suspected of damaging fertility.

H361d

Suspected of damaging the unborn child.

H360FD

May damage fertility. May damage the unborn child.

H361fd

Suspected of damaging fertility. Suspected of damaging the unborn child.

H360Fd

May damage fertility. Suspected of damaging the unborn child.

H360Df

May damage the unborn child. Suspected of damaging fertility.

H350i

May cause cancer by inhalation.

H350i

H350i

May cause cancer by inhalation.

May cause cancer by inhalation.

H360F

May damage fertility.

H360F

H360F

May damage fertility.

May damage fertility.

H360D

May damage the unborn child.

H360D

H360D

May damage the unborn child.

May damage the unborn child.

H361f

Suspected of damaging fertility.

H361f

H361f

Suspected of damaging fertility.

Suspected of damaging fertility.

H361d

Suspected of damaging the unborn child.

H361d

H361d

Suspected of damaging the unborn child.

Suspected of damaging the unborn child.

H360FD

May damage fertility. May damage the unborn child.

H360FD

H360FD

May damage fertility. May damage the unborn child.

May damage fertility. May damage the unborn child.

H361fd

Suspected of damaging fertility. Suspected of damaging the unborn child.

H361fd

H361fd

Suspected of damaging fertility. Suspected of damaging the unborn child.

Suspected of damaging fertility. Suspected of damaging the unborn child.

H360Fd

May damage fertility. Suspected of damaging the unborn child.

H360Fd

H360Fd

May damage fertility. Suspected of damaging the unborn child.

May damage fertility. Suspected of damaging the unborn child.

H360Df

May damage the unborn child. Suspected of damaging fertility.

H360Df

H360Df

May damage the unborn child. Suspected of damaging fertility.

May damage the unborn child. Suspected of damaging fertility.

1.1.2.2.   Labelling codes Labelling codes

In the labelling column, the following elements are listed:

(i) 

the hazard pictogram codes as specified in Annex V, in accordance with the precedence rules in Article 26;

(ii) 

the signal word code ‘Dgr’ for ‘Danger’or ‘Wng’ for ‘Warning’, in accordance with the precedence rule in Article 20(3);

(iii) 

the hazard statement codes as specified in Annex III, in accordance with the classification;

(iv) 

the codes for the supplemental statements assigned in accordance with Article 25(1) and the rules specified in Annex II, part 1.

▼M15 ▼M15

1.1.2.3.   Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE) Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE)

Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of table 3. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.

In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, that M-factor is given in Table 3 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see Section 4.1.3.5.5.5 of Annex I.

▼B ▼B

1.1.3.   Notes assigned to an entry

Notes assigned to an entry

The note(s) assigned to an entry are listed in the column entitled ‘Notes’. The meaning of the notes is as follows:

1.1.3.1.   Notes relating to the identification, classification and labelling of substances Notes relating to the identification, classification and labelling of substances

Note A: Note A:

Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in Part 3.

In Part 3, use is sometimes made of a general description such as ‘... compounds’ or ‘... salts’. In this case, the supplier is required to state on the label the correct name, due account being taken of section 1.1.1.4.

Note B: Note B:

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations.

In Part 3 entries with Note B have a general designation of the following type: ‘nitric acid … %’.

In this case the supplier must state the percentage concentration of the solution on the label. Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

Note C: Note C:

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In this case the supplier must state on the label whether the substance is a specific isomer or a mixture of isomers.

Note D: Note D:

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier must state on the label the name of the substance followed by the words ‘non-stabilised’.

▼M15 ————— ▼M15

▼B ▼B

Note F: Note F:

This substance may contain a stabiliser. If the stabiliser changes the hazardous properties of the substance, as indicated by the classification in Part 3, classification and labelling should be provided in accordance with the rules for classification and labelling of hazardous mixtures.

Note G: Note G:

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods. The classification and labelling provided shall reflect the explosive properties.

▼M2 ————— ▼M2

▼M27 ▼M27

Note J: Note J:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1  % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes.

Note K: Note K:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w 1,3- butadiene (Einecs No 203-450-8), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 shall apply.

Note L: Note L:

The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 3 % of dimethyl sulphoxide extract as measured by IP 346 (‘Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions – Dimethyl sulphoxide extraction refractive index method’ Institute of Petroleum, London), in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

Note M: Note M:

The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 0,005  % w/w benzo[a]-pyrene (Einecs No 200-028-5), in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

Note N: Note N:

The harmonised classification as a carcinogen applies unless the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen, in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

Note P: Note P:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes.

Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

Note Q: Note Q:

The harmonised classification as a carcinogen applies unless one of the following conditions is fulfilled:

—  —  —  — 

Note R: Note R:

The harmonised classification as a carcinogen applies except in the case of fibres with a Length Weighted Geometric Mean Diameter (LWGMD) minus two geometric standard errors greater than 6 μm, as measured in accordance with Test method A.22 in the Annex to Commission Regulation (EC) No 440/2008 ( *4 ). *4 *4

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Note S: Note S:

This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).

▼B ▼B

Note T: Note T:

This substance may be marketed in a form which does not have the physical hazards as indicated by the classification in the entry in Part 3. If the results of the relevant method or methods in accordance with Part 2 of Annex I of this Regulation show that the specific form of substance marketed does not exhibit this physical property or these physical hazards, the substance shall be classified in accordance with the result or results of this test or these tests. Relevant information, including reference to the relevant test method(s) shall be included in the safety data sheet.

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Note U (Table 3): Note U (Table 3):

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When put on the market gases have to be classified as ‘Gases under pressure’, in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. The following codes are assigned:

Aerosols shall not be classified as gases under pressure (See Annex I, Part 2, Section 2.3.2.1, Note 2).

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Note V:

If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.

Note W:

It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.

This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.

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Note X:

The classification for the hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is common to all substances in the entry. The hazardous properties of any substances in the entry also depend on the properties of the part of the substance which is not common to all substances in the group. The latter must be evaluated to assess whether more severe classification(s) (i.e. a higher category) or a broader scope of the same classification (additional differentiation, target organs and/or hazard statements) might apply for the hazard class(es) in the entry.

▼B ▼B

1.1.3.2.   Notes relating to the classification and labelling of mixtures Notes relating to the classification and labelling of mixtures

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Note 1: Note 1:

The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.

▼B ▼B

Note 2: Note 2:

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.

Note 3: Note 3:

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.

Note 5: Note 5:

The concentration limits for gaseous mixtures are expressed as volume per volume percentage.

Note 7: Note 7:

Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5  μg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded. 2

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Note 8: Note 8:

The classification as a carcinogen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.

Note 9: Note 9:

The classification as a mutagen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.

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Note 10:

The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.

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Note 11:

The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual boron compounds that are classified as reproductive toxicant in the mixture as placed on the market is ≥ 0,3 %.

Note 12:

The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual substances covered by this entry in the mixture as placed on the market is equal to, or above, the applicable generic concentration limit for the assigned category, or a specific concentration limit given in this entry.

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1.2.   Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC

Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC

1.2.1.    Minimum classification

Minimum classification Minimum classification Minimum classification

For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled:

—  — 

Minimum classification for a category is indicated by the reference * in the column ‘Classification’ in Table 3.

The reference * can also be found in the column ‘Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE)’ where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be ‘translated’ into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern.

1.2.2.   Route of exposure cannot be excluded

Route of exposure cannot be excluded

For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available.

These hazard statements are indicated by the reference ** in Table 3.

1.2.3.   Hazard statements for reproductive toxicity

Hazard statements for reproductive toxicity

Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: ‘May damage/Suspected of damaging fertility or the unborn child’. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation.

In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive.

These hazard statements are indicated by the reference *** in Table 3.

1.2.4.   Correct classification for physical hazards could not be established

Correct classification for physical hazards could not be established

For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing.

The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.

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