Article 9
Evaluation of hazard information for substances and mixtures
1.
Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class or differentiation in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.
2.
In evaluating available test data for a substance or a mixture which have been obtained from test methods other than those referred to in Article 8(3), manufacturers, importers and downstream users shall compare the test methods employed with those indicated in that Article in order to determine whether the use of those test methods affects the evaluation referred to in paragraph 1 of this Article.
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3.
Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.
4.
When evaluating hazard information for mixtures, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3 of Annex I and in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation.
If more than one similar tested mixture is available when applying the bridging principles, manufacturers, importers and downstream users shall apply a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006, to select the most suitable similar tested mixtures in accordance with Article 6(5) of this Regulation for their decision on classification.
When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods set out in Parts 3 and 4 of Annex I.
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5.
When evaluating the available information for the purposes of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
