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).
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 ).
There is a mixture:
Ingredient |
Conc. % (w/w) |
Classification |
Does take into account for mixture classification? |
Substance A |
0.8 |
Skin Corr. 1: H314 |
No, because concentration is below the generic cut-off value 1 %. |
Substance B |
15.2 |
− |
− |
Water |
84.0 |
− |
− |
Mixture-product consists of 10 % of mixture-ingredient 1 and 10 % of mixture-ingredient 2.
Mixture 1 contains 8 % of substance A (Skin Corr. 1: H314) and 6 % of substance B (Aquatic Acute 1: H400). Mixture 2 contains 5 % of substance B (Aquatic Acute 1: H400) and 0.7 % of substance C (Acute Tox. 3: H301).
Final concentration of every separate substance is:
Substance A = 0,8 %
Substance B = 0,6 % + 0.5 % = 1.1 %
Substance C = 0,07 %
Ingredient |
Conc. % (w/w) |
Classification |
Does take into account for mixture classification? |
Substance A |
0.8 |
Skin Corr. 1: H314 |
No, because concentration is below the generic cut-off value 1 %. |
Substance B |
1.1 |
Acute Tox. 4: H302 |
Yes, because concentration is above generic cut-off value 1 %. |
Substance C |
0.07 |
Acute Tox. 3: H301 |
No, because concentration is below the generic cut-off value 0.1 %. |
Water |
98.03 |
− |
− |
There is a mixture:
Ingredient |
Conc. % (w/w) |
Classification |
Does take into account for mixture classification? |
Substance A |
0.8 |
Skin Corr. 1: H314 |
No, because concentration is below the generic cut-off value 1 %. |
|
|
Aquatic Acute 1: H400 |
Yes, because concentration is above calculated generic cut-off value 0.1 % (0.1/1).
Because there is no M-factor in Table 3 of Annex VI to CLP, it is decided to use M = 1.
|
Substance B |
2.0 |
Acute Tox. 4: H302 |
Yes, because concentration is above generic cut-off value 1 %. |
Substance C |
0.07 |
Acute Tox. 3: H301 |
No, because concentration is below the generic cut-off value 0.1 %. |
Substance D |
0.06 |
Acute Tox. 3: H311 |
No, because concentration is below the generic cut-off value 0.1 %. |
Substance E |
0.09 |
Acute Tox. 3: H311 |
No, because concentration is below the generic cut-off value 0.1 %. |
Substance F |
0.8 |
Acute Tox. 3: H311 |
Yes, because concentration is above generic cut-off value 0.1 %. |
|
|
Aquatic Chronic 4: H413 |
No, because concentration is below the generic cut-off value 1 %. |
Water |
96.18 |
− |
− |
There is a mixture:
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Does take into account for mixture classification? |
Substance A |
0.08 |
Skin Corr. 1: H314 |
10 |
No, because concentration is below the generic cut-off value 1 %.
M-factor is not applied. |
|
|
Aquatic Acute 1: H400 |
|
Yes, because concentration is above the calculated cut-off value 0.01 % (0.1/10).
M = 10 is applied to Aquatic Acute 1
|
|
|
Aquatic Chronic 1: H410 |
|
Yes, because concentration is above the calculated cut-off value 0.01 % (0.1/10).
M = 10 is applied to Aquatic Chronic 1. |
Substance B |
0.08 |
Aquatic Acute 1: H400 |
− |
No, because concentration is below the calculated generic cut-off value 0.1 % (0.1/1).
Because there is no M-factor for Aquatic Acute 1 in Table 3 of Annex VI to CLP, it is decided to use M = 1. |
|
|
Aquatic Chronic 1: H410 |
|
No, because concentration is below the calculated generic cut-off value 0.1 % (0.1/1).
Because there is no M-factor for Aquatic Chronic 1 in Table 3 of Annex VI to CLP, it is decided to use M = 1. |
Water |
99.84 |
− |
− |
− |
There is a mixture:
Ingredient |
Conc. % (w/w) |
Classification |
Specific Conc. Limit |
Does take into account for mixture classification? |
Substance A |
0.6 |
STOT SE 3: H335 |
STOT SE 3: H335: C ≥ 0.5 % |
Yes, because concentration is above the specific conc. limit
Though the concentration is below the cut-off value 1 % for STOT SE 3 it is above the specific conc. limit 0.5 %.
|
Substance B |
0.9 |
STOT SE 3: H335 |
− |
No, because concentration is below the generic cut-off value 1 %. |
Substance C |
1.2 |
STOT SE 3: H335 |
− |
Yes, because concentration is above generic cut-off value 1 %. |
Water |
97.3 |
− |
− |
|