Persistent, bioaccumulative and toxic (PBT)
very Persistent and very Bioaccumulative (vPvB)
From 1 May 2026 at the latest, mixtures shall be classified and labelled as PBT or vPvB. Mixtures which were placed on the market before 1 May 2026 are not required to be classified and labelled for these categories.
Non-additivity approach
The additivity approach is not applicable for calculation of neither PBT nor vPvB.
If a single ingredient classified respectively as a PBT or vPvB is present in the mixture above the generic or specific concentration limit the mixture must be classified for that hazard. Other hand, if the mixture contains two or more ingredients each below the generic or specific concentration limit, even if the sum of their concentrations is above generic concentration limit, the mixture will not be classified.
A mixture is classified respectively as a PBT or vPvB when at least one ingredient contained in the mixture has been classified respectively as a PBT or vPvB and is present at or above 0.1 % (weight/weight) in accordance with section 4.3.3.1 of Annex I to CLP.
| Component classified as |
Generic concentration limits triggering classification of a mixture |
| PBT |
C ≥ 0.1 % |
| vPvB |
C ≥ 0.1 % |
To select signal word and precautionary statements please refer to Annex I, part 4, Table 4.3.1 of Regulation (EC) no 1272/2008 (CLP). No pictograms are applied.
In accordance to Article 27 and Part 1 of Annex III to CLP, if the hazard statement EUH441 'Strongly accumulates in the environment and living organisms including in humans' is assigned, the statement EUH440 'Accumulates in the environment and living organisms including in humans' does not need to be indicated in hazard communication (label, section 2.2 of safety data sheet).
Mixtures are classified for either or both PBT and vPvB independently.
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
0.2 |
PBT: EUH440 |
| Substance B |
0.09 |
PBT: EUH440 |
| Substance C |
0.1 |
vPvB: EUH441 |
| Substance D |
0.09 |
vPvB: EUH441 |
| Water |
99.52 |
− |
Cut-off limits
| − |
There is no generic cut-off limits for both PBT and vPvB (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with one of such classification is taken into account. |
Specific and Generic concentration limits
| − |
Because no specific concentration limits are applied for A, B, C and D their concentrations must be compared to generic concentration limit. |
Calculation of 'PBT'
| − |
Concentration of substance A is above the generic concentration limit 0.1 %. This leads to classification PBT . |
| − |
Concentration of substance B is below the generic concentration limit 0.1 %. This does not lead to classification 'PBT'. |
Calculation of 'vPvB'
| − |
Concentration of substance C equals to generic concentration limit 0.1 %. This leads to classification vPvB . |
| − |
Concentration of substance D is below the generic concentration limit 0.1 %. This does not lead to classification 'vPvB'. |
Selection of hazard category
| − |
The mixture is classified as both 'PBT' and 'vPvB'. |
Selection of hazard statements
| − |
EUH440 corresponds to 'PBT'. |
| − |
EUH441 corresponds to 'vPvB'. |
| − |
EUH440 may be omitted on the label if EUH441 is assigned. |
Selection of pictogram and signal word
| − |
Signal word 'Danger' corresponds to both 'PBT' and 'vPvB'. No pictogram is applied. |
Selection of precautionary statements
| − |
For EUH441 following precautionary statements are applied: P201, P202, P273, P391, P501. |
Classification and labelling of the mixture
| Classification: |
PBT, vPvB |
| Hazard statements: |
EUH441 |
| Pictogram: |
- |
| Signal word: |
Danger |
| Precautionary statements: |
P201, P202, P273, P391, P501. |
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
0.2 |
PBT: EUH440 |
| Substance B |
0.09 |
PBT: EUH440 |
| Substance C |
0.09 |
vPvB: EUH441 |
| Substance D |
0.09 |
vPvB: EUH441 |
| Water |
99.53 |
− |
Cut-off limits
| − |
There is no generic cut-off limits for both PBT and vPvB (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with one of such classification is taken into account. |
Specific and Generic concentration limits
| − |
Because no specific concentration limits are applied for A, B, C and D their concentrations must be compared to generic concentration limit. |
Calculation of 'PBT'
| − |
Concentration of substance A is above the generic concentration limit 0.1 %. This leads to classification PBT . |
| − |
Concentration of substance B is below the generic concentration limit 0.1 %. This does not lead to classification 'PBT'. |
Calculation of 'vPvB'
| − |
Concentration of substance C is below the generic concentration limit 0.1 %. This does not lead to classification 'vPvB'. |
| − |
Concentration of substance D is below the generic concentration limit 0.1 %. This does not lead to classification 'vPvB'. |
Selection of hazard category
| − |
The mixture is classified as 'PBT'. |
Selection of hazard statements
| − |
EUH440 corresponds to 'PBT'. |
Selection of pictogram and signal word
| − |
Signal word 'Danger' corresponds to 'PBT'. No pictogram is applied. |
Selection of precautionary statements
| − |
For EUH440 following precautionary statements are applied: P201, P202, P273, P391, P501. |
Classification and labelling of the mixture
| Classification: |
PBT |
| Hazard statements: |
EUH440 |
| Pictogram: |
- |
| Signal word: |
Danger |
| Precautionary statements: |
P201, P202, P273, P391, P501. |