Hazardous to the aquatic environment
According to 4.1.3.5 of Annex I to CLP, classification of Hazardous to the aquatic environment may be based on two approaches:
1) |
summation method (CLP, Annex I, 4.1.3.5.5) |
2) |
additivity formulas (CLP, Annex I, 4.1.3.5.2) |
M-factor (Multiplying factor)
Specific Concentration Limits (SCLs) conception is not applied for the class Hazardous to the aquatic environment. Instead of this M-factors are applied. M-factors are substance specific and are only applicable to classification categories 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Values of M-factors are available in Table 3 of Annex VI to CLP in column "Specific Conc. Limits, M-factors and ATEs". If value is not provided in Annex VI to CLP, a company that places on the European Economic Area market such a substance should set M-factor.
M-factor is applied to 'Aquatic Acute 1' and 'Aquatic Chronic 1' only. It is not applied to 'Aquatic Chronic 2-4'.
M-factor is used for:
a) |
calculation cut-off limits, |
b) |
in the summation method for classification of a mixture. |
Cut-off limit for 'Aquatic Acute 1' and 'Aquatic Chronic 1' is established as 0.1 % (CLP, Annex I, Table 1.1), but the value may be different depending on M-factor. Cut-off is calculated using the below formula (CLP, Annex I, 4.1.3.1):
For example, if M-factor equals to 1 the cut-off is 0.1 % (0.1/1). If M = 10 then cuf-off = 0.01 % (0.1/10) etc. In turn, cut-off limit for 'Aquatic Chronic 2', 'Aquatic Chronic 3' and 'Aquatic Chronic 4' does not depend from M-factor and equals to 1 % (CLP, Annex I, Table 1.1).
In case if a substance is classified both 'Aquatic Acute 1' and 'Aquatic Chronic 1' and two M-factors are provided in Table 3 of Annex VI to CLP:
− |
the first M is applied to first mentioned category of hazardous to the aquatic environment and second M is applied to second category. |
In below example M = 10 is applied to 'Aquatic Acute 1' and M = 100 to 'Aquatic Chronic 1'.
|
Classification |
|
Specific Conc. |
... |
Hazard Class and Category Code(s) |
Hazard statement Code(s) |
... |
Limits, M-factors and ATEs |
... |
Aquatic Acute 1
Aquatic Acute 1
Aquatic Chronic 1
Aquatic Chronic 1
|
H400
H400
H410
H410
|
...
|
M = 10
M = 10
?
×
M = 100
M = 100
|
In below example M = 10 is applied to 'Aquatic Acute 1' and M = 1 to 'Aquatic Chronic 1'.
|
Classification |
|
Specific Conc. |
... |
Hazard Class and Category Code(s) |
Hazard statement Code(s) |
... |
Limits, M-factors and ATEs |
... |
Skin Corr. 1B
Eye Dam. 1
Aquatic Acute 1
Aquatic Acute 1
Aquatic Chronic 1
Aquatic Chronic 1
|
H314
H318
H400
H400
H410
H410
|
... |
M = 10
M = 10
?
×
M = 1
M = 1
EUH031: C ≥ 5 %
|
In below example the same M = 100 is applied to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.
|
Classification |
|
Specific Conc. |
... |
Hazard Class and Category Code(s) |
Hazard statement Code(s) |
... |
Limits, M-factors and ATEs |
... |
Aquatic Acute 1
Aquatic Acute 1
Aquatic Chronic 1
Aquatic Chronic 1
|
H400
H400
H410
H410
|
... |
M = 100
M = 100
?
×
M = 100
M = 100
|
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.
In below example substance have no M-factor(s) established in CLP. Person responsible for classification decided to use M = 1 for 'Aquatic Acute 1' and M = 1 for 'Aquatic Chronic 1'.
|
Classification |
|
Specific Conc. |
... |
Hazard Class and Category Code(s) |
Hazard statement Code(s) |
... |
Limits, M-factors and ATEs |
... |
Acute Tox. 3 Aquatic Acute 1 Aquatic Chronic 1 |
H301 H400 H410 |
... |
|
In case if a substance is classified as both 'Aquatic Acute 1' and 'Aquatic Chronic 1' and one M-factor is provided in Table 3 of Annex VI to CLP:
− |
M is applied to both mentioned categories of hazardous to the aquatic environment (CLP, Annex VI, 1.1.2.3). |
In below example M = 10 000 is applied to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.
|
Classification |
|
Specific Conc. |
... |
Hazard Class and Category Code(s) |
Hazard statement Code(s) |
... |
Limits, M-factors and ATEs |
... |
Acute Tox. 3
Acute Tox. 4
Aquatic Acute 1
Aquatic Acute 1
Aquatic Chronic 1
Aquatic Chronic 1
|
H301
H312
H400
H400
H410
H410
|
... |
M = 10 000
M = 10 000
?
×
|
1) Summation method
Calculation of classification Aquatic Acute 1
If the sum of the concentrations of ingredients classified as 'Aquatic Acute 1' multiplied by their corresponding M-factors is ≥ 25 % the whole mixture is classified as 'Aquatic Acute 1' (CLP, Annex I, 4.1.3.5.5.3.1 and Table 4.1.1).
Sum of components classified as: |
Mixture is classified as: |
Aquatic Acute 1 × M ≥ 25 % |
Aquatic Acute 1 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
2.0 |
Aquatic Acute 1: H400 |
10 |
Substance B |
1.0 |
Aquatic Acute 1: H400 |
100 |
Substance C |
0.5 |
Aquatic Acute 1: H400 |
1000 |
Substance D |
0.09 |
Aquatic Acute 1: H400 |
1000 |
Water |
96.41 |
− |
− |
Cut-off limits
Cut-off limits are calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.01 % (0.1/10), therefore, A is taken into account. |
− |
Concentration of substance B is above 0.001 % (0.1/100), therefore, B is taken into account. |
− |
Concentrations of substances C and D are above 0.0001 % (0.1/1000), therefore, C and D are taken into account. |
Calculation of 'Aquatic Acute 1'
− |
Concentration of every ingredient must be multiplied by its M-factor and obtained values must be summed.
(conc. A × M) + (conc. B × M) + (conc. C × M) + (conc. D × M) = (2.0 × 10) + (1.0 × 100) + (0.5 × 1000) + (0.09 × 1000) = 710
The obtained value is above 25 %. This leads to classification Aquatic Acute 1 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Acute 1'. |
Selection of hazard statements
− |
H400 corresponds to 'Aquatic Acute 1'. |
Selection of pictogram and signal word
− |
Pictogram GHS09 and signal word 'Warning' correspond to 'Aquatic Acute 1'. |
Selection of precautionary statements
− |
For H400 following precautionary statements are applied: P273, P391, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Acute 1 |
Hazard statements: |
H400 |
Pictogram: |
|
|
GHS09 |
Signal word: |
Warning |
Precautionary statements: |
P273, P391, P501 P273, P391, P501 P273, P391, P501 P273, P391, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance E |
4.5 |
Aquatic Acute 1: H400 |
1 |
Substance G |
1.7 |
Aquatic Acute 1: H400 |
10 |
Substance H |
0.08 |
Aquatic Acute 1: H400 |
− |
Water |
93.72 |
− |
− |
Cut-off limits
Cut-off limits are calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance E is above 0.1 % (0.1/1), therefore, E is taken into account. |
− |
Concentration of substance G is above 0.01 % (0.1/10), therefore, G is taken into account. |
− |
There is no M-factor in Table 3 of Annex VI to CLP established for substance H. Person responsible for classification decided to use M = 1. Concentration of substance H is below 0.1 % (0.1/1), therefore, H is not taken into account. |
Calculation of 'Aquatic Acute 1'
− |
Concentrations of substances E and G must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. E × M) + (conc. G × M) = (4.5 × 1) + (1.7 × 10) = 21.5
The obtained value is below 25 %. This does not lead to classification 'Aquatic Acute 1'. |
Classification of the mixture
The mixture is not classified.
Calculation of classification Aquatic Chronic 1
If the sum of the concentrations of ingredients classified as 'Aquatic Chronic 1' multiplied by their corresponding M-factors is ≥ 25 % the whole mixture is classified as 'Aquatic Chronic 1' (CLP, Annex I, 4.1.3.5.5.4.1 and Table 4.1.2).
Sum of components classified as: |
Mixture is classified as: |
Aquatic Chronic 1 × M ≥ 25 % |
Aquatic Chronic 1 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
1.5 |
Aquatic Chronic 1: H410 |
10 |
Substance B |
2.3 |
Aquatic Chronic 1: H410 |
100 |
Substance C |
0.5 |
Aquatic Chronic 1: H410 |
1000 |
Substance D |
0.09 |
Aquatic Chronic 1: H410 |
1000 |
Water |
95.61 |
− |
− |
Cut-off limits
Cut-off limits are calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.01 % (0.1/10), therefore, A is taken into account. |
− |
Concentration of substance B is above 0.001 % (0.1/100), therefore, B is taken into account. |
− |
Concentrations of substances C and D are above 0.0001 % (0.1/1000), therefore, C and D are taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentration of every ingredient must be multiplied by its M-factor and obtained values must be summed.
(conc. A × M) + (conc. B × M) + (conc. C × M) + (conc. D × M) = (1.5 × 10) + (2.3 × 100) + (0.5 × 1000) + (0.09 × 1000) = 835
The obtained value is above 25 %. This leads to classification Aquatic Chronic 1 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Chronic 1'. |
Selection of hazard statements
− |
H410 corresponds to 'Aquatic Chronic 1'. |
Selection of pictogram and signal word
− |
Pictogram GHS09 and signal word 'Warning' correspond to 'Aquatic Chronic 1'. |
Selection of precautionary statements
− |
For H410 following precautionary statements are applied: P273, P391, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Chronic 1 |
Hazard statements: |
H410 |
Pictogram: |
|
|
GHS09 |
Signal word: |
Warning |
Precautionary statements: |
P273, P391, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance E |
3.7 |
Aquatic Chronic 1: H410 |
1 |
Substance G |
2.1 |
Aquatic Chronic 1: H410 |
10 |
Substance H |
0.08 |
Aquatic Chronic 1: H410 |
− |
Water |
94.12 |
− |
− |
Cut-off limits
Cut-off limits are calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance E is above 0.1 % (0.1/1), therefore, E is taken into account. |
− |
Concentration of substance G is above 0.01 % (0.1/10), therefore, G is taken into account. |
− |
There is no M-factor in Table 3 of Annex VI to CLP established for substance H. Person responsible for classification decided to use M = 1. Concentration of substance H is below 0.1 % (0.1/1), therefore, H is not taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentrations of substances E and G must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. E × M) + (conc. G × M) = (3.7 × 1) + (2.1 × 10) = 24.7
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 1'. |
Classification of the mixture
The mixture is not classified as 'Aquatic Chronic 1', but is classified as 'Aquatic Chronic 2' (see explanation below).
Calculation of classification Aquatic Chronic 2
A mixture is classified as 'Aquatic Chronic 2' if 10 times the sum of the concentrations of all components classified as 'Aquatic Chronic 1' multiplied by their corresponding M-factors plus the sum of the concentrations of all components classified as 'Aquatic Chronic 2' is ≥ 25 % (CLP, Annex I, 4.1.3.5.5.4.2 and Table 4.1.2).
Sum of components classified as: |
Mixture is classified as: |
(M × 10 × Aquatic Chronic 1) + Aquatic Chronic 2 ≥ 25 % |
Aquatic Chronic 2 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
0.05 |
Aquatic Chronic 1: H410 |
100 |
Substance B |
0.7 |
Aquatic Chronic 1: H410 |
10 |
Substance C |
3.1 |
Aquatic Chronic 2: H411 |
− |
Substance D |
0.9 |
Aquatic Chronic 2: H411 |
− |
Water |
95.25 |
− |
− |
Cut-off limits
For Aquatic Chronic 1 cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.001 % (0.1/100), therefore, A is taken into account. |
− |
Concentration of substance B is above 0.01 % (0.1/10), therefore, B is taken into account. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentration of substance C is above 1 %, therefore, C is taken into account. |
− |
Concentration of substance D is below 1 %, therefore, D is not taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentrations of substances A and B must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. A × M) + (conc. B × M) = (0.05 × 100) + (0.7 × 10) = 12
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 1'. |
Calculation of 'Aquatic Chronic 2'
− |
Concentrations of substances A and B must be multiplied by their corresponding M-factors and multiplied by 10. Obtained values must later be summed with concentration of substance C.
(M × 10 × conc. A) + (M × 10 × conc. B) + conc. C = (100 × 10 × 0.05) + (10 × 10 × 0.7) + 3.1 = 123.1
The obtained value is above 25 %. This leads to classification Aquatic Chronic 2 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Chronic 2'. |
Selection of hazard statements
− |
H411 corresponds to 'Aquatic Chronic 2'. |
Selection of pictogram and signal word
− |
Pictogram GHS09 corresponds to 'Aquatic Chronic 2'. No signal word applies. |
Selection of precautionary statements
− |
For H411 following precautionary statements are applied: P273, P391, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Chronic 2 |
Hazard statements: |
H411 |
Pictogram: |
|
|
GHS09 |
Signal word: |
− |
Precautionary statements: |
P273, P391, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance E |
0.09 |
Aquatic Chronic 1: H410 |
10 |
Substance G |
7.0 |
Aquatic Chronic 2: H411 |
− |
Substance H |
8.0 |
Aquatic Chronic 2: H411 |
− |
Water |
84.91 |
− |
− |
Cut-off limits
For Aquatic Chronic 1 cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance E is above 0.01 % (0.1/10), therefore, E is taken into account. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentrations of substances G and H are above 1 %, therefore, they are taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentration of substance E must be multiplied by its M-factor.
conc. E × M = 0.09 × 10 = 0.9
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 1'. |
Calculation of 'Aquatic Chronic 2'
− |
Concentration of substance E must be multiplied by its M-factor and multiplied by 10. Obtained value must later be summed with concentrations of substances G and H.
(M × 10 × conc. E) + conc. G + conc. H = (10 × 10 × 0.09) + 7.0 + 8.0 = 24
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 2'. |
Classification of the mixture
The mixture is not classified as 'Aquatic Chronic 2', but is classified as 'Aquatic Chronic 3' (see explanation below).
Calculation of classification Aquatic Chronic 3
A mixture is classified as 'Aquatic Chronic 3' if 100 times the sum of the concentrations of all components classified as 'Aquatic Chronic 1' multiplied by their corresponding M-factors plus 10 times the sum of the concentrations of all components classified as 'Aquatic Chronic 2' plus the sum of the concentrations of all components classified as 'Aquatic Chronic 2' is ≥ 25 % (CLP, Annex I, 4.1.3.5.5.4.3 and Table 4.1.2).
Sum of components classified as: |
Mixture is classified as: |
(M × 100 × Aquatic Chronic 1) + (10 × Aquatic Chronic 2) + Aquatic Chronic 3 ≥ 25 % |
Aquatic Chronic 3 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
0.2 |
Aquatic Chronic 1: H410 |
10 |
Substance B |
1.7 |
Aquatic Chronic 2: H411 |
− |
Substance C |
2.8 |
Aquatic Chronic 2: H411 |
− |
Substance D |
9.0 |
Aquatic Chronic 3: H412 |
− |
Water |
86.3 |
− |
− |
Cut-off limits
For Aquatic Chronic 1 cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.01 % (0.1/10), therefore, A is taken into account. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentrations of substances B, C and D are above 1 %, therefore, they are taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentration of substance A must be multiplied by its M-factor.
conc. A × M = 0.2 × 10 = 2
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 1'. |
Calculation of 'Aquatic Chronic 2'
− |
Concentration of substance A must be multiplied by its M-factor and multiplied by 10. Obtained values must later be summed with concentrations of substances B and C.
(M × 10 × conc. A) + conc. B + conc. C = (10 × 10 × 0.2) + 1.7 + 2.8 = 24.5
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 2'. |
Calculation of 'Aquatic Chronic 3'
− |
Concentration of substance A must be multiplied by its M-factor and multiplied by 100. Concentrations of substances B and C must be multiplied by 10. Obtained values must later be summed with concentration of substance D.
(M × 100 × conc. A) + (10 × conc. B) + (10 × conc. C) + conc. D = (10 × 100 × 0.2) + (10 × 1.7) + (10 × 2.8) + 9.0 = 254
The obtained value is above 25 %. This leads to classification Aquatic Chronic 3 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Chronic 3'. |
Selection of hazard statements
− |
H412 corresponds to 'Aquatic Chronic 3'. |
Selection of pictogram and signal word
− |
Neither pictogram nor signal word are required for 'Aquatic Chronic 3'. |
Selection of precautionary statements
− |
For H412 following precautionary statements are applied: P273, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Chronic 3 |
Hazard statements: |
H412 |
Pictogram: |
− |
Signal word: |
− |
Precautionary statements: |
P273, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance E |
12.0 |
Aquatic Chronic 2: H411 |
− |
Substance G |
10.0 |
Aquatic Chronic 2: H411 |
− |
Substance H |
0.8 |
Aquatic Chronic 3: H412 |
− |
Water |
77.2 |
− |
− |
Cut-off limits
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentrations of substances E and G are above 1 %, therefore, they are taken into account. |
− |
Concentration of substance H is below 1 %, therefore, H is not taken into account. |
Calculation of 'Aquatic Chronic 1'
This category is not calculated, because no ingredient is classified as 'Aquatic Chronic 1'.
Calculation of 'Aquatic Chronic 2'
− |
Concentrations of substances E and G must be summed.
conc. E + conc. G = 12.0 + 10.0 = 22.0
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 2'. |
Calculation of 'Aquatic Chronic 3'
− |
Concentrations of substances E and G must be multiplied by 10.
(10 × conc. E) + (10 × conc. G)= (10 × 12.0) + (10 × 10.0) = 220
The obtained value is above 25 %. This leads to classification Aquatic Chronic 3 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Chronic 3'. |
Selection of hazard statements
− |
H412 corresponds to 'Aquatic Chronic 3'. |
Selection of pictogram and signal word
− |
Neither pictogram nor signal word are required for 'Aquatic Chronic 3'. |
Selection of precautionary statements
− |
For H412 following precautionary statements are applied: P273, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Chronic 3 |
Hazard statements: |
H412 |
Pictogram: |
− |
Signal word: |
− |
Precautionary statements: |
P273, P501 |
Calculation of classification Aquatic Chronic 4
A mixture is classified as 'Aquatic Chronic 4' if the sum of the concentrations of components classified as 'Aquatic Chronic 1', 'Aquatic Chronic 2', 'Aquatic Chronic 3' and 'Aquatic Chronic 4' is ≥ 25 % (CLP, Annex I, 4.1.3.5.5.4.4 and Table 4.1.2).
Sum of components classified as: |
Mixture is classified as: |
Aquatic Chronic 1 + Aquatic Chronic 2 + Aquatic Chronic 3 + Aquatic Chronic 4 ≥ 25 % |
Aquatic Chronic 4 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
0.2 |
Aquatic Chronic 1: H410 |
1 |
Substance B |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance C |
4.5 |
Aquatic Chronic 3: H412 |
− |
Substance D |
22.0 |
Aquatic Chronic 4: H413 |
− |
Water |
72.4 |
− |
− |
Cut-off limits
For Aquatic Chronic 1 cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.1 % (0.1/1), therefore, A is taken into account. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentration of substance B is below 1 %, therefore, B is not taken into account. |
− |
Concentrations of substances C and D are above 1 %, therefore, they are taken into account. |
Calculation of 'Aquatic Chronic 1'
− |
Concentration of substance A must be multiplied by its M-factor.
conc. A × 1 = 0.2 × 1 = 0.2
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 1'. |
Calculation of 'Aquatic Chronic 2'
− |
Concentration of substance A must be multiplied by its M-factor and multiplied by 10.
M × 10 × conc. A = 1 × 10 × 0.2 = 2.0
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 2'. |
Calculation of 'Aquatic Chronic 3'
− |
Concentration of substance A must be multiplied by its M-factor and multiplied by 100. Obtained values must later be summed with concentration of substance C.
(M × 100 × conc. A) + conc. C = (1 × 100 × 0.2) + 4.5 = 24.5
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 3'. |
Calculation of 'Aquatic Chronic 4'
− |
Concentrations of substances A, C and D must be summed.
conc. A + conc. C + conc. D = 0.2 + 4.5 + 22.0 = 26.7
The obtained value is above 25 %. This leads to classification Aquatic Chronic 4 . |
Selection of hazard category
− |
The mixture is classified as 'Aquatic Chronic 4'. |
Selection of hazard statements
− |
H413 corresponds to 'Aquatic Chronic 4'. |
Selection of pictogram and signal word
− |
Neither pictogram nor signal word are required for 'Aquatic Chronic 4'. |
Selection of precautionary statements
− |
For H413 following precautionary statements are applied: P273, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Chronic 4 |
Hazard statements: |
H413 |
Pictogram: |
− |
Signal word: |
− |
Precautionary statements: |
P273, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance E |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance G |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance H |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance J |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance K |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance L |
0.9 |
Aquatic Chronic 2: H411 |
− |
Substance N |
21.0 |
Aquatic Chronic 3: H412 |
− |
Substance P |
3.7 |
Aquatic Chronic 4: H413 |
− |
Water |
69.9 |
− |
− |
Cut-off limits
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentrations of substances E, G, H, J, K and L are below 1 %, therefore, they are not taken into account. |
− |
Concentrations of substances N and P are above 1 %, therefore, they are taken into account. |
Calculation of 'Aquatic Chronic 1'
This category is not calculated, because no ingredient is classified as 'Aquatic Chronic 1'.
Calculation of 'Aquatic Chronic 2'
This category is not calculated, because mixture does not contain ingredient classified as 'Aquatic Chronic 2' at concentration above cut-off limit.
Calculation of 'Aquatic Chronic 3'
− |
Concentration of substance N is taken into account only.
conc. N = 21.0
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 3'. |
Calculation of 'Aquatic Chronic 4'
− |
Concentrations of substances N and P must be summed.
conc. N + conc. P = 21.0 + 3.7 = 24.7
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 4'. |
Classification of the mixture
The mixture is not classified.
2) Additivity formulas
If for components of a mixture only toxicity data are available with no information on hazard categories to the aquatic environment the additivity formulas are applied.
Acute aquatic toxicity is calculated based on following formula (CLP, Annex I, 4.1.3.5.2(a)):
where:
C i |
− |
concentration of component i (%, w/w), |
L(E)C50i |
− |
(mg/l) LC50 or EC50 for component i, |
n |
− |
number of components, and i is running from 1 to n, |
L(E)C50m |
− |
L(E)C50 of the part of the mixture with test data. |
Chronic aquatic toxicity is calculated based on following formula (CLP, Annex I, 4.1.3.5.2(b)):
where:
C i |
− |
concentration of component i (%, w/w) covering the rapidly degradable components, |
C j |
− |
concentration of component j (%, w/w) covering the non-rapidly degradable components, |
NOECi |
− |
NOEC (or other recognized measures for chronic toxicity) for component i covering the rapidly degradable components, in mg/l, |
NOECj |
− |
NOEC (or other recognized measures for chronic toxicity) for component j covering the non-rapidly degradable components, in mg/l, |
n |
− |
number of components, and i and j is running from 1 to n, |
EqNOECm |
− |
equivalent NOEC of the part of the mixture with test data. |
If a mixture contains one component with no information on aquatic toxicity category, but toxicity data are available, the aquatic toxicity category of such component and an M-factor for aquatic acute 1 and/or aquatic chronic 1 should be defined (CLP, Annex I, 4.1.2) and then be used in the summation method.
The situation is possible when mixture may contains components with known aquatic toxocity (e.g. A = 15 % and B = 17 %) and several components (e.g. C = 22 % and D = 24 %) with no information on aquatic toxicity category, but their toxicity data are available. Additivity formula(s) should be used to calculate aquatic toxicity of part of a mixture consistion of C and D (46 %) and then, in a second step, be used in the summation method of three ingredients: A (15 %), B (17 %) and CD (46 %).
Hierarchy of hazard categories
− |
Hazardous to the aquatic environment (short-term (acute)), category 1 (Aquatic Acute 1: H400) |
Hazard
➔
− |
Hazardous to the aquatic environment (long-term (chronic)), category 1 (Aquatic Chronic 1: H410) |
− |
Hazardous to the aquatic environment (long-term (chronic)), category 2 (Aquatic Chronic 2: H411) |
− |
Hazardous to the aquatic environment (long-term (chronic)), category 3 (Aquatic Chronic 3: H412) |
− |
Hazardous to the aquatic environment (long-term (chronic)), category 4 (Aquatic Chronic 4: H413) |
A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as hazardous to the aquatic environment (long-term (chronic)) category 1 (Aquatic Chronic 1) and category 2 (Aquatic Chronic 2) the category 'Aquatic Chronic 1' must be selected.
In case if a mixture is classified as both hazardous to the aquatic environment (short-term (acute)) category 1 (Aquatic Acute 1) and one of the categories hazardous to the aquatic environment (long-term (chronic)) category 1 or 2 or 3 or 4, and because both belong to different modes of exposure (short- and long-term) both classifications must be indicated in hazard communication (label, section 2.2 of safety data sheet). For example, if ingredients of a mixture lead to classification both as 'Aquatic Acute 1' and 'Aquatic Chronic 2' both must be indicated.
In accordance with Article 27 and Part 1 of Annex III to CLP, if the hazard statement H410 'Very toxic to aquatic life with long lasting effects' is assigned, the hazard statement H400 'Very toxic to aquatic life' does not need to be indicated in hazard communication (label, section 2.2 of safety data sheet). Furthermore, where a mixture is classified both in acute and long-term hazard categories, it is possible to use only hazard statement H410 in hazard communication (Guidance on the Application of the CLP Criteria, Version 5.0, section 4.1.6. Hazard communication for hazards to the aquatic environment).
Aquatic hazard classification |
Statement that could appear in the hazard communication |
Acute 1: H400 |
Acute 1: H400 |
Acute 1: H400 and Aquatic Chronic 1: H410 |
Aquatic Chronic 1: H410 |
Acute 1: H400 and Aquatic Chronic 2: H411 |
Aquatic Chronic 1: H410 |
Acute 1: H400 and Aquatic Chronic 3: H412 |
Aquatic Chronic 1: H410 |
Acute 1: H400 and Aquatic Chronic 4: H413 |
Aquatic Chronic 1: H410 |
Aquatic Chronic 1: H410 |
Aquatic Chronic 1: H410 |
Aquatic Chronic 2: H411 |
Aquatic Chronic 2: H411 |
Aquatic Chronic 3: H412 |
Aquatic Chronic 3: H412 |
Aquatic Chronic 4: H413 |
Aquatic Chronic 4: H413 |
To select pictogram, signal word, hazard and precautionary statements please refer to Annex I, part 4, Table 4.1.1 of Regulation (EC) no 1272/2008 (CLP).
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
0.9 |
Aquatic Acute 1: H400 |
100 |
Substance B |
12.0 |
Aquatic Chronic 2: H411 |
− |
Substance C |
10.0 |
Aquatic Chronic 2: H411 |
− |
Water |
77.1 |
− |
− |
Cut-off limits
For Aquatic Acute 1 cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentration of substance A is above 0.001 % (0.1/100), therefore, A is taken into account. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− |
Concentrations of substances B and C are above 1 %, therefore, they are taken into account. |
Calculation of 'Aquatic Acute 1'
− |
Concentration of substance A must be multiplied by its M-factor.
conc. A × M = 0.9 × 100 = 90
The obtained value is above 25 %. This leads to classification Aquatic Acute 1 . |
Calculation of 'Aquatic Chronic 1'
This category is not calculated, because no ingredient is classified as 'Aquatic Chronic 1'.
Calculation of 'Aquatic Chronic 2'
− |
Concentrations of substances B and C must be summed.
conc. B + conc. C = 12.0 + 10.0 = 22.0
The obtained value is below 25 %. This does not lead to classification 'Aquatic Chronic 2'. |
Calculation of 'Aquatic Chronic 3'
− |
Concentrations of substances B and C must be multiplied by 10.
(10 × conc. B) + (10 × conc. C) = (10 × 12.0) + (10 × 10.0) = 220
The obtained value is above 25 %. This leads to classification Aquatic Chronic 3 . |
Selection of hazard category
− |
The mixture is classified both as 'Aquatic Acute 1' and 'Aquatic Chronic 3'. |
Selection of hazard statements
− |
H400 corresponds to 'Aquatic Acute 1'. |
− |
H412 corresponds to 'Aquatic Chronic 3'. |
Selection of pictogram and signal word
− |
Pictogram GHS09 and signal word 'Warning' correspond to 'Aquatic Acute 1'. |
− |
Neither pictogram nor signal word are required for 'Aquatic Chronic 3'. |
Selection of precautionary statements
− |
For H400 following precautionary statements are applied: P273, P391, P501. |
− |
For H412 following precautionary statements are applied: P273, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Acute 1, Aquatic Chronic 3 |
Hazard statements: |
H400, H412 |
Pictogram: |
|
|
GHS09 |
Signal word: |
Warning |
Precautionary statements: |
P273, P391, P501 |
There is a mixture.
Ingredient |
Conc. % (w/w) |
Classification |
M-factor |
Substance A |
0.9 |
Aquatic Acute 1: H400 |
100 |
Substance B |
2.3 |
Aquatic Chronic 1: H410 |
100 |
Substance C |
0.5 |
Aquatic Chronic 1: H410 |
1000 |
Water |
96.3 |
− |
− |
Cut-off limits
For 'Aquatic Acute 1' and 'Aquatic Chronic 1' cut-off limits are calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− |
Concentrations of substances A and B are above 0.001 % (0.1/100), therefore, they are taken into account. |
− |
Concentration of substance C is above 0.0001 % (0.1/1000), therefore, C is taken into account. |
Calculation of 'Aquatic Acute 1'
− |
Concentration of substance A must be multiplied by its M-factor.
conc. A × M = 0.9 × 100 = 90
The obtained value is above 25 %. This leads to classification Aquatic Acute 1 . |
Calculation of 'Aquatic Chronic 1'
− |
Concentrations of substances B and C must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. B × M) + (conc. C × M) = (2.3 × 100) + (0.5 × 1000) = 730
The obtained value is above 25 %. This leads to classification Aquatic Chronic 1 . |
Selection of hazard category
− |
The mixture is classified both as 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
Selection of hazard statements
− |
H400 corresponds to 'Aquatic Acute 1'. |
− |
H410 corresponds to 'Aquatic Chronic 1'. Because H410 is applied, the statement H400 don't have to be used (Article 27 and Part 1 of Annex III to CLP). |
Selection of pictogram and signal word
− |
Pictogram GHS09 and signal word 'Warning' correspond to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
Selection of precautionary statements
− |
For H410 following precautionary statements are applied: P273, P391, P501. |
Classification and labelling of the mixture
Classification: |
Aquatic Acute 1, Aquatic Chronic 1 |
Hazard statements: |
H410 |
Pictogram: |
|
|
GHS09 |
Signal word: |
Warning |
Precautionary statements: |
P273, P391, P501 |
See also Example 8 and Example 10 in section Examples.
Additional labelling provisions
In case if no useable information on short-term (acute) and/or long-term (chronic) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies). In this situation the mixture is classified based on the known components only, with the additional statement on the label and in the safety data sheet that: "Contains x % of components with unknown hazards to the aquatic environment" (CLP, Annex I, 4.1.3.6.1).