4.4. Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties
4.4. Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties
4.4.1.1. For the purposes of Section 4.4 the following definitions shall apply:
‘PMT’ means a persistent, mobile and toxic substance or mixture that meets the classification criteria set out in Section 4.4.2.1.
‘vPvM’ means a very persistent and very mobile substance or mixture that meets the classification criteria set out in Section 4.4.2.2.
‘log Koc ’ means the common logarithm of the organic carbon-water partition coefficient (i.e. Koc).
4.4.1.2 The hazard class Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties is differentiated into:
4.4.2. Classification criteria for substances
4.4.2.1. Classification criteria for PMT
A substance shall be considered a PMT substance when it fulfils the persistence, mobility and toxicity criteria set out in Sections 4.4.2.1.1, 4.4.2.1.2 and 4.4.2.1.3. and assessed according to Section 4.4.2.3.
4.4.2.1.1. Persistence
A substance shall be considered to fulfil the persistence criterion (P) in any of the following situations:
the degradation half-life in marine water is higher than 60 days;
the degradation half-life in fresh or estuarine water is higher than 40 days;
the degradation half-life in marine sediment is higher than 180 days;
the degradation half-life in fresh or estuarine water sediment is higher than 120 days;
the degradation half-life in soil is higher than 120 days.
4.4.2.1.2. Mobility
A substance shall be considered to fulfil the mobility criterion (M) when the log Koc is less than 3. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 3.
4.4.2.1.3. Toxicity
A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations:
the long-term no-observed effect concentration (NOEC) or ECx (e.g. EC10) for marine or freshwater organisms is less than 0,01 mg/l;
the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Sections 3.5, 3.6 or 3.7;
there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Section 3.9;
the substance meets the criteria for classification as endocrine disruptor (category 1) for human health or the environment according to Sections 3.11 or 4.2.
4.4.2.2. Classification criteria for vPvM
A substance shall be considered a vPvM substance when it fulfils the persistence and mobility criteria set out in Sections 4.4.2.2.1 and 4.4.2.2.2 and assessed according to Section 4.4.2.3.
4.4.2.2.1. Persistence
A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) in any of the following situations:
the degradation half-life in marine, fresh or estuarine water is higher than 60 days;
the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;
the degradation half-life in soil is higher than 180 days.
4.4.2.2.2. Mobility
A substance shall be considered to fulfil the ‘very mobile’ criterion (vM) when the log Koc is less than 2. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 2.
4.4.2.3. Basis of classification
For the classification of PMT substances and vPvM substances, a weight of evidence determination using expert judgment shall be applied, by comparing all relevant and available information listed in Section 4.4.2.3 with the criteria set out in Sections 4.4.2.1 and 4.4.2.2. That weight of evidence shall be applied in particular where the criteria set out in Sections 4.4.2.1 and 4.4.2.2 cannot be applied directly to the available information.
The information used for the purposes of assessment of the PMT/vPvM properties shall be based on data obtained under relevant conditions.
The identification shall also take account of the PMT/vPvM properties of relevant constituents, additives or impurities of a substance and relevant transformation or degradation products.
This hazard class (PMT and vPvM properties) shall apply to all organic substances, including organo-metals.
The information set out in Sections 4.4.2.3.1, 4.4.2.3.2 and 4.4.2.3.3 shall be considered for the assessment of P, vP, M, vM and T properties.
4.4.2.3.1. Assessment of P or vP properties
The following information shall be considered for the assessment of P or vP properties:
results from simulation testing on degradation in surface water;
results from simulation testing on degradation in soil;
results from simulation testing on degradation in sediment;
other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.3.2. Assessment of M or vM properties
The following information shall be considered for the assessment of M or vM properties:
results from adsorption/desorption testing;
other information, such as information from leaching, modelling or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.3.3. Assessment of T properties
The following information shall be considered for the assessment of T properties:
results from long-term toxicity testing on aquatic invertebrates;
results from long-term toxicity testing on fish;
results from growth inhibition study on algae or aquatic plants;
the substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard statements: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard statement: H340), toxic for reproduction in Category 1A, 1B or 2 (assigned hazard statements: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard statements: H372 or H373);
the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);
results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;
results from long-term toxicity testing on sediment organisms;
results from long-term or reproductive toxicity testing on birds;
other information provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.4. Weight of evidence and expert judgment
4.4.2.4.1. In applying the weight of evidence determination using expert judgment as referred to in Section 1.1.1, all available relevant scientific data shall be considered together, such as:
in vivo studies or other studies (e.g. in vitro, in silico studies);
information from the application of the category approach (grouping, read-across);
data from analogue substances using structure-activity relationships (SAR), informing about P, vP, M, vM and T properties;
results of monitoring and modelling;
human experience such as occupational data and data from accident databases;
epidemiological and clinical studies;
well documented case reports, peer-reviewed published studies and observations;
any additional acceptable data.
The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight of evidence determination.
4.4.2.4.2. In applying the weight of evidence determination, the following information, in addition to the information referred to in Sections 4.4.2.3.1, 4.4.2.3.2 and 4.4.2.3.3 shall be considered as part of the scientific assessment of the information relevant for the P, vP, M, vM and T properties:
Indication of P or vP properties:
Results from tests on ready biodegradation;
Results from other degradation screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
Results obtained from well-developed and reliable biodegradation (Q)SAR models;
Other information, provided that its suitability and reliability can be reasonably demonstrated.
Information relevant for the M or vM properties:
Organic carbon to water partition coefficient (Koc) estimated by well-developed and reliable (Q)SAR models;
Other information, provided that its suitability and reliability can be reasonably demonstrated.
Information relevant for the T properties:
Short-term aquatic toxicity (e.g. results from acute toxicity testing on invertebrates, algae or aquatic plants or fish, in vitro acute toxicity testing on fish cell line);
Other information provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.5. Application in time
From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 4.4.2.1 to 4.4.2.4.
However, substances which were placed on the market before 1 May 2025 are not required to be classified in accordance with the criteria laid down in Sections 4.4.2.1 to 4.4.2.4 until 1 November 2026.
4.4.3.
Classification criteria for mixtures
4.4.3.1 A mixture shall be classified as a PMT or vPvM where at least one of its components has been classified as a PMT or vPvM and is present at or above 0,1 % (weight/weight).
4.4.3.1 A mixture shall be classified as a PMT or vPvM where at least one of its components has been classified as a PMT or vPvM and is present at or above 0,1 % (weight/weight).
4.4.3.2 Application in time
From 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Section 4.4.3.1.
However, mixtures which were placed on the market before 1 May 2026 are not required to be classified in accordance with the criteria laid down in Section 4.4.3.1 until 1 May 2028.
4.4.4.
Hazard communication
4.4.4.1. Label elements shall be used in accordance with Table 4.4.1 for substances or mixtures meeting the criteria for classification in this hazard class (PMT and vPvM properties).
4.4.4.1. Label elements shall be used in accordance with Table 4.4.1 for substances or mixtures meeting the criteria for classification in this hazard class (PMT and vPvM properties).
Table 4.4.1.
Label elements for PMT and vPvM properties
|
|
PMT |
vPvM |
|
Symbol/pictogram |
|
|
|
Signal word |
Danger |
Danger |
|
Hazard Statement |
EUH450: Can cause long-lasting and diffuse contamination of water resources |
EUH451: Can cause very long-lasting and diffuse contamination of water resources |
|
Precautionary Statement Prevention |
P201 P202 P273 |
P201 P202 P273 |
|
Precautionary Statement Response |
P391 |
P391 |
|
Precautionary Statement Disposal |
P501 |
P501 |
4.4.4.2. Application in time for substances
From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.4.4.1.
However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.4.4.1 until 1 November 2026.
4.4.4.3. Application in time for mixtures
From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 4.4.4.1.
However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.4.4.1 until 1 May 2028.