Notes assigned to an entry in CLP Annex VI

* 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. 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.

**: 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.

***: 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 differenti ation. 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 clas sified under that Directive. These hazard statements are indicated by the reference *** in Table 3.

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:

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:

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:

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’.

 

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:

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 J:

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.

 

Note K:

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.

 

Note L:

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.

 

Note M:

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.

 

Note N:

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.

 

Note P:

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.

Note Q:

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.

Note R:

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.

Note S:

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).

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.

 

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. The following codes are assigned:

  • Press. Gas (Comp.)

  • Press. Gas (Liq.)

  • Press. Gas (Ref. Liq.)

  • Press. Gas (Diss.)

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

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.

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.

Notes relating to the classification and labelling of mixtures

 

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.

 

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:

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:

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

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.

 

Note 8:

The classification as a carcinogen need not apply if 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:

The classification as a mutagen need not apply if 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 %.

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.

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.