Endocrine disruption for the environment
From 1 May 2026 at the latest, mixtures shall be classified and labelled as Endocrine disruptors for environment. Mixtures which were placed on the market before 1 May 2026 are not required to be classified and labelled for this category.
Non-additivity approach
The additivity approach is not applicable for calculation of Endocrine disruption for environment.
If a single ingredient classified as endocrine disruptor for environment 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 as an endocrine disruptor for environment if at least one ingredient is classified as a Category 1 or Category 2 endocrine disruptor for environment and is present at or above the appropriate generic concentration limit as shown in Table 4.2.2 for Category 1 and Category 2, respectively.
| Component classified as |
Generic concentration limits triggering classification of a mixture as |
| Component classified as |
ED ENV 1 |
ED ENV 2 |
| ED ENV 1 |
≥ 0.1 % |
|
| ED ENV 2 |
|
≥ 1.0 % (note 1) |
Note.
The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).
Note 1.
If a Category 2 endocrine disruptor for environment is present in the mixture as an ingredient at a concentration ≥ 0.1 % a safety data sheet shall shall be available for the mixture upon request.
Hierarchy of hazard categories
Hazard
➔
| − |
Endocrine disruption for environment, category 1 (ED ENV 1: EUH430) |
| − |
Endocrine disruption for environment, category 2 (ED ENV 2: EUH431) |
A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as endocrine disruptor for environment category 1 (ED ENV 1) and endocrine disruptor for environment category 2 (ED ENV 2) the category 'ED ENV 1' must be selected. EUH (EU hazard) statements EUH430 and EUH431 are function of H statements (main hazard statements).
To select signal word and precautionary statements please refer to Annex I, part 4, Table 4.2.3 of Regulation (EC) no 1272/2008 (CLP). No pictogram is applied.
If mixture is not intended for the general public and is not classified as hazardous but contains ≥ 0.1 % of a substance classified as ED ENV 2 the label on the packaging must bear the statement EUH210 - 'Safety data sheet available on request' (CLP, Annex II, 2.10).
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
0.2 |
ED ENV 1 |
| Substance B |
1.1 |
ED ENV 2 |
| Water |
98.7 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for Endocrine disruption for environment (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account. |
Specific and Generic concentration limits
| − |
Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits. |
Calculation of 'ED ENV 1'
| − |
Concentration of substance A is above the generic concentration limit 0.1 %. This leads to classification ED ENV 1 . |
Calculation of 'ED ENV 2'
| − |
Concentration of substance B is above the generic concentration limit 1.0 %. This leads to classification ED ENV 2 . |
Selection of hazard category
| − |
Classification 'ED ENV 1' is more severe than 'ED ENV 2', therefore, mixture is classified as 'ED ENV 1'. |
Selection of hazard statements
| − |
EUH430 corresponds to 'ED ENV 1'. |
Selection of pictogram and signal word
| − |
No pictogram is applied. Signal word 'Danger' corresponds to 'ED ENV 1'. |
Selection of precautionary statements
| − |
For EUH430 following precautionary statements are applied: P201, P202, P273, P391, P405, P501. |
Classification and labelling of the mixture
| Classification: |
ED ENV 1 |
| Hazard statements: |
EUH430 |
| Pictogram: |
- |
|
|
| Signal word: |
Danger |
| Precautionary statements: |
P201, P202, P273, P391, P405, P501 |
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
0.09 |
ED ENV 1 |
| Substance M |
0.09 |
ED ENV 1 |
| Substance B |
1.1 |
ED ENV 2 |
| Water |
98.91 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for Endocrine disruption for environment (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account. |
Specific and Generic concentration limits
| − |
Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits. |
Calculation of 'ED ENV 1'
| − |
Concentrations of substances A and M are below the generic concentration limit 0.1 %. Because non-additivity approach is applied their concentrations are not summed. This does not lead to classification 'ED ENV 1'. |
Calculation of 'ED ENV 2'
| − |
Concentration of substance B is above the generic concentration limit 1.0 %. This leads to classification ED ENV 2 . |
Selection of hazard category
| − |
The mixture is classified as 'ED ENV 2'. |
Selection of hazard statements
| − |
EUH431 corresponds to 'ED ENV 2'. |
Selection of pictogram and signal word
| − |
No pictogram is applied. Signal word 'Warning' corresponds to 'ED ENV 2'. |
Selection of precautionary statements
| − |
For EUH431 following precautionary statements are applied: P201, P202, P273, P391, P405, P501. |
Classification and labelling of the mixture
| Classification: |
ED ENV 2 |
| Hazard statements: |
EUH431 |
| Pictogram: |
- |
|
|
| Signal word: |
Warning |
| Precautionary statements: |
P201, P202, P273, P391, P405, P501 |
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
0.09 |
ED ENV 1 |
| Substance M |
0.09 |
ED ENV 1 |
| Substance B |
0.1 |
ED ENV 2 |
| Substance C |
0.09 |
ED ENV 2 |
| Substance D |
0.09 |
ED ENV 2 |
| Water |
99.54 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for Endocrine disruption for environment (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account. |
Specific and Generic concentration limits
| − |
Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits. |
Calculation of 'ED ENV 1'
| − |
Concentrations of substances A and M are below the generic concentration limit 0.1 %. Because non-additivity approach is applied their concentrations are not summed. This does not lead to classification 'ED ENV 1'. |
Calculation of 'ED ENV 2'
| − |
Concentrations of substances B, C and D are below the generic concentration limit 1.0 %. Because non-additivity approach is applied their concentrations are not summed. This does not lead to classification 'ED ENV 2'. |
Classification of the mixture
The mixture is not classified.
Additional information on the label
Because,
| − |
mixture contains substance B (ED ENV 2) at concentration ≥ 0.1 % and |
| − |
mixture is intended for the industrial/professional use only (not to general public/consumer use) |
according to section Annex II, 2.10 to CLP label must bear the statement EUH210 - 'Safety data sheet available on request'.