1.Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.
3.Manufacturers, importers and downstream users shall establish acute toxicity estimates for substances classified as acutely toxic for human health.
6.By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.
10.Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.
11.Where a mixture contains another mixture, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.
Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when thatthe substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.
Manufacturers,In importersexceptional and downstream users may set acircumstances specific concentration limitlimits formay abe substanceset inby exceptionalthe circumstancesmanufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information shows that thea hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.
2.Manufacturers, importers and downstream users shall establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1.1, shall be established by manufacturers, importers and downstream users.
3.4. By way of derogation fromNotwithstanding paragraph 1, second and third subparagraphs, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
4.5. By way of derogation fromNotwithstanding paragraph 2, M-factors shall not be establishedset for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.
However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, the manufacturer, importer or downstream user shall set an M-factor based on available data for the substance.substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, thatthis M-factor shall be used.
5.7. WhenIn setting the specific concentration limit, M-factorlimit or acute toxicity estimate,M-factor manufacturers, importers and downstream users shall take into account any specific concentration limits, M-factorslimits or acute toxicity estimateM-factors for that substance which have been included in the classification and labelling inventory.
6.8. Specific concentration limits set in accordance with paragraph 1, second and third subparagraphs,1 shall take precedence over the concentration limits set outconcentrations in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of thatAnnex Annex.I.
7.9. The Agency shall provide further guidance for the application of paragraphs 1, 21 and 3.2.