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1.1.2.: Specific concentration limits, M-factors and generic cut-off values

1.1.2.1. Specific concentration limits or M-factors shall be applied in accordance with Article 10.
1.1.2.2. Cut-off values
1.1.2.2.1. Cut-off values indicate when the presence of a substance needs to be taken into account for the purposes of classification of a substance or a mixture containing that hazardous substance, whether as an identified impurity, additive, or individual constituent (see Article 11).
1.1.2.2.2. The cut-off values referred to in Article 11 shall be the following:
(a) For health and environmental hazards in Parts 3, 4 and 5 of this Annex:
(i) for substances where a specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is mentioned in Table 1.1, the lower of the specific concentration limit and the relevant generic cut-off value in Table 1.1; or
(ii) for substances where a specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is not mentioned in Table 1.1, the specific concentration limit set either in Part 3 of Annex VI or in the classification and labelling inventory; or
(iii) for substances where no specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is mentioned in Table 1.1, the relevant generic cut-off value set out in that table; or
(iv) for substances where no specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is not mentioned in Table 1.1, the generic concentration limit for classification in the relevant sections of Parts 3, 4 and 5 of this Annex.
(b) For aquatic environmental hazards in section 4.1 of this Annex:
(i) for substances where an M-factor has been set for the relevant hazard category either in Part 3 of Annex VI, or in the classification and labelling inventory referred to in Article 42, the generic cut-off value in Table 1.1 adjusted using the calculation set out in section 4.1 of this Annex; or
(ii) for substances where no M-factor is set for the relevant hazard category either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, the relevant generic cut-off value set out in Table 1.1.


Table 1.1

Generic cut-off values

Hazard class

Generic cut-off values to be taken into account

Acute Toxicity:

 

— Category 1-3

0,1 %

— Category 4

1 %

Skin corrosion/Irritation

1 % ()

Serious damage to eyes/eye irritation

1 % ()

Hazardous to Aquatic Environment

 

— Acute Category 1

0,1 % ()

— Chronic Category 1

0,1 % ()

— Chronic Category 2-4

1 %

(1)   Or < 1 % where relevant, see 3.2.3.3.1.

(2)   Or < 1 % where relevant, see 3.3.3.3.1.

(3)   Or < 0,1 % where relevant, see 4.1.3.1.
▼M2

Note:
Generic cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the generic cut-off values may be best described in volume percentages.
▼B