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Explanation of the Notes for the Annex VI to CLP Regulation

By Little Pro on 2017-03-03 Views:  Update:2017-03-03

Annex VI to the CLP Regulation contains a list of harmonized classification and labelling for around 7,000 hazardous substances. It is mandatory for the suppliers of the respective substances or mixture to apply harmonized classification and labelling to prepare their GHS labels and safety data sheets. In this article, we will explain the factors to consider when using harmonized classification with a focus on the notes for the annex VI to the CLP regulation.

Example of Harmonized Classifications in Annex VI

The table below is an example of several entries in the Annex VI. Using harmonized classification will greatly simplify your SDSs and label preparation work. You can click here to download the complete table. 

Notes Annex VI CLP Regulation

Factors to Consider

Applying harmonized classification in the Annex VI without considering the following factors is wrong!

  • For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification in the Annex shall be considered as a minimum classification;
  • If a manufacturer or importer has access to data or other information that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied;
  • For some entries (indicated by the reference ****), harmonized classification has not included physical hazards due to insufficient data. In this case, the correct classification for physical hazards shall be confirmed by testing;
  • Please do pay attention to specific concentration limits and M-factors;
  • Please do read notes (i.e., A, B, H, L, U) for each Annex VI entry  which contain conditions for the harmonized classifications to apply;

Example 1:Natural Gasoline

Let's assume that you need to prepare a SDS for a very common solvent: natural gasoline (CAS 8006-61-9). If you search the CLP annex VI table, you will know the given classification is H304 (Asp. Tox. 1), H340 (Muta. 1B), and H350 (Carc. 1B).  However, if you use this classification, you might have over-classified your product without checking the content of benzene in your product first since you did not pay attention to note P.

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).

Notes for the CLP Annex VI

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 BSome 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 CSome 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 DCertain 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 FThis 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 GThis 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 JThe 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 KThe 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 LThe 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 MThe 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 NThe 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 PThe 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 QThe 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 RThe 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 SThis 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 TThis 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.

Notes relating to the classification and labelling of mixtures

Note 1The 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.

Note 2The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.

Note 3The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.

Note 5The concentration limits for gaseous mixtures are expressed as volume per volume percentage.

Note 7Alloys 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.

Reference

 

 

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