1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC
1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC
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:
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.
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 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.
1.2.3. 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 differentiation.
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.
1.2.4. 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.