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Risk Notes
 
 

Risk Notes


Note 1: The concentration stated or, in the absence of such concentrations, the general concentrations of Directive 88/379/EEC are the percentages by weight of the metallic element calculated with reference to the total weight of the preparation.

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 preparation.

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 preparation.

Note 4: Preparations containing these substances have to be classified as harmful with R 65 if they meet the criteria in section 3.2.3 in Annex VI to Commission Directive 98/98/EC.

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

Note 6: Preparations containing these substances have to be assigned R 67 if they meet the criteria in section 3.2.8 in Annex VI to Commission Directive 98/98/EC.

Note A: The name of the substance must appear on the label in the form of one of the designations given in Annex I to Commission Directive 98/98/EC (see Article 23(2)(a)).

The Directive also requires that the symbols, indications of danger, R and S phrases to be used for each substance shall be those shown in Annex I (Article 23(2)(c), (d) and (e)).

For substances belonging to more than one group of substances included in Annex I, the symbols, indications of danger, R and S phrases to be used for each substance shall be those shown in both the appropriate entries given in Annex I. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification is used.


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

In this case the manufacturer or any other person who markets such a substance 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.

The use of additional data (e.g. specific gravity, degrees Baum~) or descriptive phrases (e.g. fuming or glacial) is permissible.


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 manufacturer or any other person who markets such a substance must state on the label whether the substance is a specific isomer (a) or a mixture of isomers (b).

Example a) 2,4-dimethylphenol

Example b) xylenol (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 Annex I to Commission Directive 98/98/EC.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words "non-stabilised".


Note E: Substances with specific effects on human health (see Chapter 4 of Annex VI to Commission Directive 98/98/EC) 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 RØ20, RØ21, RØ22, RØ23, RØ24, RØ25, RØ26, RØ27, RØ28, RØ39, RØ40, RØ48 and RØ65 and all combinations of these risk phrases shall be preceded by the word "Also''.

Example: R 45-23 "May cause cancer. Also toxic by inhalation''


Note F: This substance may contain a stabiliser. If the stabiliser changes the dangerous properties of the substance, as indicated by the label in Annex I to Commission Directive 98/98/EC, a label should be provided in accordance with the rules for the labelling of dangerous preparations.

Note G: This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods and a label should be provided reflecting its explosive property.

Note H: 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. The requirements of Article 6 of Commission Directive 98/98/EC on manufacturers, distributors and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI of Commission Directive 98/98/EC.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I.


Note J: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1Ø% w/w benzene (Einecs No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Annex I to Commission Directive 98/98/EC.

Note K: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1Ø% w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen, at least the S phrases (2-)9-16 should apply. This note applies only to certain complex oil-derived substances in Annex I to Commission Directive 98/98/EC.

Note L: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3Ø% DMSO extract as measured by IP 346. This note applies only to certain complex oil-derived substances in Annex I to Commission Directive 98/98/EC.

Note M: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005Ø% w/w benzo[a]-pyrene (Einecs No 200-028-5). This note applies only to certain complex coal-derived substances in Annex I to Commission Directive 98/98/EC.

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 Annex I to Commission Directive 98/98/EC.

Note P: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1Ø% w/w benzene (Einecs No 200-753-7).

When the substance is classified as a carcinogen, Note E shall also apply.

When the substance is not classified as a carcinogen at least the S phrases (2-)23-24-62 shall apply.

This note applies only to certain complex oil-derived substances in Annex I to Commission Directive 98/98/EC.


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 mm have a weighted half-life of less than 10 days, or
  • a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 mm have a weighted half-life of 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 errors greater than 6 mm.

Note S: This substance may not require a label according to Article 23 (see section 8 of Annex VI to Commission Directive 98/98/EC).