Anexo VI ao Regulamento CRE
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
ON CLASSIFICATION, LABELLING AND PACKAGING
OF SUBSTANCES AND MIXTURES,
AMENDING AND REPEALING DIRECTIVES 67/548/EEC AND 1999/45/EC,
AND AMENDING REGULATION (EC) No 1907/2006
Harmonised classification and labelling for certain hazardous substances
Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3.1, subject to certain considerations arising from translating the classifications listed in Annex I to Directive 67/548/EEC.
Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Community level.
Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Community level. In Table 3.1 the classification and labelling are based on the criteria in Annex I to this Regulation. In Table 3.2 classification and labelling are based on the criteria in Annex VI to Directive 67/548/EEC.
1. PART 1: INTRODUCTION TO THE LIST OF HARMONISED CLASSIFICATIONS AND LABELLING
1.1. INFORMATION LISTED FOR EACH ENTRY
1.1.1. Numbering of entries and identification of a substance
126.96.36.199. 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".
188.8.131.52. 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). 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".
184.108.40.206. 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".
220.127.116.11. International Chemical Identification
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 ³ xx % impurity)". The reference in brackets is then to be considered as a part of the name, and must be included on the label.
18.104.22.168. 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.
1.1.2. Information related to the classification and labelling of each entry in Table 3.1
22.214.171.124. Classification codes
126.96.36.199.1. 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.
Hazard Class and Category Code
Flam. Gas 1
Flam. Gas 2
Flam. Aerosol 1
Flam. Aerosol 2
Ox. Gas 1
Gases under pressure
Flam. Liq. 1
Flam. Liq. 2
Flam. Liq. 3
Flam. Sol. 1
Flam. Sol. 2
Self-reactive substance or mixture
Pyr. Liq. 1
Pyr. Sol. 1
Self-heating substance or mixture
Substance or mixture which in contact with water emits flammable gas
Ox. Liq. 1
Ox. Liq. 2
Ox. Liq. 3
Ox. Sol. 1
Ox. Sol. 2
Ox. Sol. 3
Org. Perox. A
Org. Perox. B
Org. Perox. CD
Org. Perox. EF
Org. Perox. G
Substance or mixture corrosive to metals
Met. Corr. 1
Acute Tox. 1
Acute Tox. 2
Acute Tox. 3
Acute Tox. 4
Skin Corr. 1A
Skin Corr. 1B
Skin Corr. 1C
Skin Irrit. 2
Serious eye damage/eye irritation
Eye Dam. 1
Eye Irrit. 2
Resp. Sens. 1
Skin Sens. 1
Germ cell mutagenicity
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
Asp. Tox. 1
Hazardous to the aquatic environment
Aquatic Acute 1
Aquatic Chronic 1
Aquatic Chronic 2
Aquatic Chronic 3
Aquatic Chronic 4
Hazardous for the ozone layer
* see Note U in 1.1.3.
188.8.131.52.2. Hazard statement codes
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 code. The following additional codes are used:
May cause cancer by inhalation.
May damage fertility.
May damage the unborn child.
Suspected of damaging fertility.
Suspected of damaging the unborn child.
May damage fertility. May damage the unborn child.
Suspected of damaging fertility. Suspected of damaging the unborn child.
May damage fertility. Suspected of damaging the unborn child.
May damage the unborn child. Suspected of damaging fertility.
184.108.40.206. 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.
220.127.116.11. Specific concentration limits and M-factors
Specific concentration limits, 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 18.104.22.168.1. 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. An asterisk (*) in this column indicates that the entry has specific concentration limits for acute toxicity under Directive 67/548/EEC (Table 3.2): see also section 1.2.1.
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, this M-factor is given in the same column as the specific concentration limits. Where an M-factor is not given in Table 3.1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used. For the setting of M-factors, see paragraph22.214.171.124.5.5 of Annex I.
1.1.3. 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:
126.96.36.199. Notes relating to the identification, classification and labelling of substances
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 188.8.131.52.
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.
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.
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".
Note E (Table 3.2):
Substances with specific effects on human health (see Chapter 4 of Annex VI to Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word "Also".
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.
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.
Note H (Table 3.1):
The classification and labelling shown for this substance applies to the hazardous property(ies) indicated by the hazard statement(s) in combination with the hazard class(es) and category(ies) shown. The requirements of Article 4 for manufacturers, importers or downstream users of this substance apply to all other hazard classes and categories. For hazard classes where the route of exposure or the nature of the effects leads to a differentiation of the classification of the hazard class, the manufacturer, importer or downstream user is required to consider the routes of exposure or the nature of the effects not already considered.
The final label shall follow the requirements of Article 17 and of section 1.2 of Annex I.
Note H (Table 3.2):
The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. Manufacturers, importers and downstream users of this substance shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exists for all other properties to classify and label the substance. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC.
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Part 3.
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 (Table 3.1) or the S-phrases (2-)9-16 (Table 3.2) should apply. This note applies only to certain complex oil-derived substances in Part 3.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO 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. This note applies only to certain complex oil-derived substances in Part 3.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,.005 % w/w benzo[a]-pyrene (EINECS No 200-028-5). This note applies only to certain complex coal-derived substances in Part 3.
The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil‑derived substances in Part 3.
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7).
When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 (Table 3.1) or the S-phrases (2-)23-24-62 (Table 3.2) shall apply.
This note applies only to certain complex oil-derived substances in Part 3.
The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions:
- a short term biopersistence test by inhalation has shown that the fibres longer than 20 µm have a weighted half‑life less than 10 days;, or
- a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 µm have a weighted half-life less than 40 days; or
- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or
- absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 µm.
This substance may not require a label according to Article 17 (see section 1.3 of Annex I) (Table 3.1).
This substance may not require a label according to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI to that Directive) (Table 3.2).
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.
Note U (Table 3.1):
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.
184.108.40.206. Notes relating to the classification and labelling of mixtures
The concentration stated or, in the absence of such concentrations, the generic concentrations of this Regulation (Table 3.1) or the generic concentrations of Directive 1999/45/EC (Table 3.2), are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.
The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.
The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.
The concentration limits for gaseous mixtures are expressed as volume per volume percentage.
Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5 mg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded.
1.1.4. Information related to the classification and labelling of each entry in Table 3.2
220.127.116.11. Classification codes
The classification for each category of danger (as defined in Article 2(2) of Directive 67/548/EEC) is normally presented in the form of an abbreviation representing the category of danger together with the appropriate risk phrase or phrases. However, in some cases (i.e. substances classified as flammable, sensitising and some substances classified as dangerous for the environment) the risk phrase alone is used;
The abbreviation for each of the categories of danger is shown below:
- explosive: E
- oxidising: O
- extremely flammable: F+
- highly flammable: F
- flammable: R10
- very toxic: T+
- Toxic: T
- harmful: Xn
- corrosive: C
- irritant: Xi
- sensitising: R42 and/or R43
- carcinogenic: Carc. Cat. (1, 2 or 3)
- mutagenic: Muta. Cat. (1, 2 or 3)
- toxic for reproduction: Repr. Cat. (1, 2 or 3)
- dangerous for the environment: N or R52 and/or R53;
18.104.22.168. Labelling codes
(i) the letter assigned to the substance in accordance with Annex II to Directive 67/548/EEC (see Article 23(2)(c) Directive 67/548/EEC). This acts as an abbreviation for the symbol and for the indication of danger (if these are assigned);
(ii) the risk phrases, denoted as a series of numbers preceded by the letter R indicating the nature of the special risks, in accordance with Annex III to Directive 67/548/EEC (see Article 23(2)(d) Directive 67/548/EEC). The numbers are separated by either a dash (-) to denote separate statements concerning special risks (R), or an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks as set out in Annex III to Directive 67/548/EEC;
(iii) the safety phrases denoted as a series of numbers preceded by the letter S indicating the recommended safety precautions, in accordance with Annex IV to Directive 67/548/EEC (see Article 23(2)(e) Directive 67/548/EEC). Again the numbers are separated by either a dash or an oblique stroke; the significance of recommended safety precautions is set out in Annex IV to Directive 67/548/EEC. The safety phrases shown apply only to substances; for mixtures, phrases are selected according to the usual rules.
Note that for certain dangerous substances and mixtures sold to the general public certain S-phrases are mandatory.
S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and mixtures sold to the general public.
S2 and S46 are obligatory for all other dangerous substances and mixtures sold to the general public other than those that have only been classified as dangerous for the environment.
Safety phrases S1 and S2 are shown in brackets in Annex I and can only be omitted from the label when the substance or mixture is sold for industrial use only.
22.214.171.124. Specific Concentration Limits
The concentration limits and associated classifications are necessary to classify dangerous mixtures containing the substance in accordance with Directive 1999/45/EC.
Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.
Where no concentration limits are given, the concentration limits to be used when applying the conventional method of assessing health hazards are those in Annex II, and when applying the conventional method of assessing environmental hazards are those in Annex III to Directive 1999/45/EC.
126.96.36.199. Non-conformity with Table 3.1 for physical hazards
It is recommended to update the physical hazards of some entries in Table 3.2 in a forthcoming adaptation to technical progress.
Until these entries are updated, the physical hazards of the corresponding entries in both tables will not be in conformity. These entries are indicated with reference Ä in Table 3.2.
1.2. CLASSIFICATIONS AND HAZARD STATEMENTS IN TABLE 3.1 ARISING FROM TRANSLATION OF CLASSIFICATIONS LISTED IN ANNEX I TO DIRECTIVE 67/548/EEC
1.2.1. 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:
- the manufacturer or importer has access to data or other information as specified in Part 1 of Annex I that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied;
- the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in this Annex if it differs from it.
Minimum classification for a category is indicated by the reference * in the column "Classification" in Table 3.1.
The reference * can also be found in the column 'Specific concentration Limits and M-factors' where it indicates that the entry concerned has specific concentration limits under Directive 67/548/EEC (Table 3.2) 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
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 is 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.
1.2.3. Hazard statements for reproductive toxicity
Hazard statements H360 and H361 indicate a general concern for effects on both fertility and 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 only the property of concern, where either fertility or developmental effects are proven to be not relevant.
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.
1.2.4. 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 3.1.
2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING
This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling.
The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier.
For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.
A dossier for harmonised classification and labelling shall contain the following:
The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed.
- Justification for the proposed harmonised classification and labelling
A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006.
- Justification for other effects at Community level
For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.
3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLES
Table 3.1: List of harmonised classification and labelling of hazardous substances is listed in the separate Volume IIIa.
Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC is listed in the separate Volume IIIb.