1. Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. When a manufacturer, importer or downstream user becomes aware of such information which he considers to be adequate and reliable, that manufacturer, importer or downstream user shall without undue delay carry out a new evaluation in accordance with this Chapter.
(a)a change in the composition of the initial concentration of one or more of the hazardous constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex I;
(b)a change in the composition involving the substitution or addition of one or more constituents in concentrations at or above the cut-off value referred to in Article 11(3).
3. A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there is valid scientific justification that this will not result in a change of classification.
4. Manufacturers, importers and downstream users shall adapt the classification of the substance or the mixture in accordance with the results of the new evaluation except where there are harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
5. For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is within the scope of Directive 91/414/EEC or Directive 98/8/EC, the requirements of those Directives shall also apply.