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Physical Hazards Health Hazards Environmental Hazards
Generic cut-off values,
M-factor
Specific and Generic concentration limits Additivity and non-additivity of hazards Labelling
Acute toxicity Skin corrosion / Irritation Serious damage to eyes / Eye irritation Respiratory / Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration Endocrine disruption for human health
Hazardous to the aquatic environment Endocrine disruption for the environment PBT and vPvB PMT and vPvM Hazardous to the ozone layer
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Classification

Generic cut-off values

Cut-off value means a threshold of any classified impurity, additive or individual constituent in ... a mixture, above which threshold these shall be taken into account for determining if ... the mixture ... shall be classified (CLP, Article 2(31)). Cut-off value indicates if the presence of a substance in mixture needs to be taken into account for the purposes of appropriate classification.

The generic cut-off values are listed in Table 1.1 of Annex I to CLP.

Hazard class Generic cut-off values to be taken into account
Acute Toxicity:
 -  Category 1-3:
    Acute Tox. 1
    Acute Tox. 2
    Acute Tox. 3
0.1 %
 -  Category 4:
    Acute Tox. 4
1 %
Skin corrosion/Irritation:
    Skin Corr. 1A
    Skin Corr. 1B
    Skin Corr. 1C
    Skin Corr. 1
    Skin Irrit. 2
1 %
or < 1 % where relevant
Serious damage to eyes/Eye irritation:
    Eye Dam. 1
    Eye Irrit. 2
1 %
or < 1 % where relevant
Specific target organ toxicity,
single exposure, Category 3:
    STOT SE 3
1 %
or < 1 % where relevant
Aspiration toxicity:
    Asp. Tox. 1
1 %
Hazardous to Aquatic Environment:
 -  Acute Category 1:
    Aquatic Acute 1
0.1 %
or < 0.1 % where relevant
 -  Chronic Category 1:
    Aquatic Chronic 1
0.1 %
or < 0.1 % where relevant
 -  Chronic Category 2-4:
    Aquatic Chronic 2
    Aquatic Chronic 3
    Aquatic Chronic 4
1 %

If mixture consists of substances each present at a concentration below the cut-off limit and even if the sum of their concentrations is above this limit the mixture will not be classified for this category.

Other hand, if ingredient has a specific concentration limit (SCL) below cut-off value, at the same time ingredient's concentration in a mixture is below cut-off value but above SCL, such ingredient is taken into account and a mixture will be classified in such category.

M-factor

For substances where M-factor (Multiplying factor) has been set for 'Aquatic Acute 1: H400' and/or 'Aquatic Chronic 1: H410' the cut-off value is calculated using the below formula (CLP, Annex I, 4.1.3.1).

Cut-off   =
0.1
M
%

For example, if substance is classified both as 'Aquatic Acute 1: H400' with M = 100 and as 'Aquatic Chronic 1: H410' with M = 1, the cut-off for 'Aquatic Acute 1: H400' equals to 0.001 % (0.1/100) and for 'Aquatic Chronic 1: H410' equals to 0.1 % (0.1/1).

The entity which places on the European Economic Area market substances as such, in mixture or in article is obliged to classify all substances, as well as to set M-factors for those classified as 'Aquatic Acute 1' and/or 'Aquatic Chronic 1'. As a consequence, if substance have no M-factor in Table 3 of Annex VI to CLP, it should be set to calculate classification.

M-factor is also used for calculation of Aquatic Acute and Aquatic Chronic classification in summation method (see section Hazardous to the aquatic environment  ).

Example 1
Example 2
Example 3
Example 4
Example 5