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:

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

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’.

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▼B

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.

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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:

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:

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:

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:

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:

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:

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

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 ).

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Note S:

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

▼B

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):

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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

1.1.3.2.   Notes relating to the classification and labelling of mixtures

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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.

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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.

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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:

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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