Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)

(a) Short-term (acute) aquatic hazard	(a) Short-term (acute) aquatic hazard	(a) Short-term (acute) aquatic hazard
Category Acute 1:	(Note 1)	(Note 1)
96 hr LC50 (for fish)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
48 hr EC50 (for crustacea)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants)	≤ 1 mg/l.	(Note 2)
(b) Long-term (chronic) aquatic hazard	(b) Long-term (chronic) aquatic hazard	(b) Long-term (chronic) aquatic hazard
(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available	(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available	(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available
Category Chronic 1:	(Note 1)	(Note 1)
Chronic NOEC or ECx (for fish)	≤ 0,1 mg/l and/or	≤ 0,1 mg/l and/or
Chronic NOEC or ECx (for crustacea)	≤ 0,1 mg/l and/or	≤ 0,1 mg/l and/or
Chronic NOEC or ECx (for algae or other aquatic plants)	≤ 0,1 mg/l.	≤ 0,1 mg/l.
Category Chronic 2:	Category Chronic 2:	Category Chronic 2:
Chronic NOEC or ECx (for fish)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
Chronic NOEC or ECx (for crustacea)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
Chronic NOEC or ECx (for algae or other aquatic plants)	≤ 1 mg/l.	≤ 1 mg/l.
(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available	(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available	(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available
Category Chronic 1:	(Note 1)	(Note 1)
Chronic NOEC or ECx (for fish)	≤ 0,01 mg/l and/or	≤ 0,01 mg/l and/or
Chronic NOEC or ECx (for crustacea)	≤ 0,01 mg/l and/or	≤ 0,01 mg/l and/or
Chronic NOEC or ECx (for algae or other aquatic plants)	≤ 0,01 mg/l.	≤ 0,01 mg/l.
Category Chronic 2:	Category Chronic 2:	Category Chronic 2:
Chronic NOEC or ECx (for fish)	≤ 0,1 mg/l and/or	≤ 0,1 mg/l and/or
Chronic NOEC or ECx (for crustacea)	≤ 0,1 mg/l and/or	≤ 0,1 mg/l and/or
Chronic NOEC or ECx (for algae or other aquatic plants)	≤ 0,1 mg/l.	≤ 0,1 mg/l.
Category Chronic 3:	Category Chronic 3:	Category Chronic 3:
Chronic NOEC or ECx (for fish)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
Chronic NOEC or ECx (for crustacea)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
Chronic NOEC or ECx (for algae or other aquatic plants)	≤ 1 mg/l.	≤ 1 mg/l.
(iii) Substances for which adequate chronic toxicity data are not available	(iii) Substances for which adequate chronic toxicity data are not available	(iii) Substances for which adequate chronic toxicity data are not available
Category Chronic 1:	(Note 1)	(Note 1)
96 hr LC50 (for fish)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
48 hr EC50 (for crustacea)	≤ 1 mg/l and/or	≤ 1 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants)	≤ 1 mg/l.	(Note 2)
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500
(or, if absent, the log Kow ≥ 4).	(Note 3).	(Note 3).
Category Chronic 2:	Category Chronic 2:	Category Chronic 2:
96 hr LC50 (for fish)	> 1 to ≤ 10 mg/l and/or	> 1 to ≤ 10 mg/l and/or
48 hr EC50 (for crustacea)	> 1 to ≤ 10 mg/l and/or	> 1 to ≤ 10 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants)	> 1 to ≤ 10 mg/l.	(Note 2)
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500
(or, if absent, the log Kow ≥ 4).	(Note 3).	(Note 3).
Category Chronic 3:	Category Chronic 3:	Category Chronic 3:
96 hr LC50 (for fish)	> 10 to ≤ 100 mg/l and/or	> 10 to ≤ 100 mg/l and/or
48 hr EC50 (for crustacea)	> 10 to ≤ 100 mg/l and/or	> 10 to ≤ 100 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants)	> 10 to ≤ 100 mg/l.	(Note 2)
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500	and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500
(or, if absent, the log Kow ≥ 4).	(Note 3).	(Note 3).
‘Safety net’ classification Category Chronic 4 Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with Section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in Section 4.1.2.9.5.	‘Safety net’ classification Category Chronic 4 Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with Section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in Section 4.1.2.9.5.	‘Safety net’ classification Category Chronic 4 Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with Section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in Section 4.1.2.9.5.

Note 1:

When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at the same time to indicate the appropriate M-factor(s) (see Table 4.1.3).

Note 2:

Classification shall be based on the ErC50 [= EC50 (growth rate)]. In circumstances where the basis of the EC50 is not specified or no ErC50 is recorded, classification shall be based on the lowest EC50 available.

Note 3:

When no useful data on degradability are available, either experimentally determined or estimated data, the substance should be regarded as not rapidly degradable.

Note 4:

‘No acute toxicity’ is taken to mean that the L(E)C50(s) is/are above the water solubility. Also for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the acute test does not provide a true measure of the intrinsic toxicity.

• 4.1.2.7. Aquatic toxicity

• 4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacea species 48-hour EC50 and/or an algal species 72- or 96-hour EC50. These species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are normally considered as chronic tests but the EC50s are treated as acute values for classification purposes (see note 2).

• 4.1.2.7.2. For determining chronic aquatic toxicity for classification purposes data generated according to the standardised test methods referred to in Article 8(3) shall be accepted, as well as results obtained from other validated and internationally accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall be used.

• 4.1.2.8. Bioaccumulation

• 4.1.2.8.1. Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales even when actual water concentrations are low. For organic substances the potential for bioaccumulation shall normally be determined by using the octanol/water partition coefficient, usually reported as a log Kow. The relationship between the log Kow of an organic substance and its bioconcentration as measured by the bioconcentration factor (BCF) in fish has considerable scientific literature support. Using a cut-off value of log Kow ≥ 4 is intended to identify only those substances with a real potential to bioconcentrate. While this represents a potential to bioaccumulate, an experimentally determined BCF provides a better measure and shall be used in preference if available. A BCF in fish of ≥ 500 is indicative of the potential to bioconcentrate for classification purposes. Some relationships can be observed between chronic toxicity and bioaccumulation potential, as toxicity is related to the body burden.

• 4.1.2.9. Rapid degradability of organic substances

• 4.1.2.9.1. Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short duration. In the absence of rapid degradation in the environment a substance in the water has the potential to exert toxicity over a wide temporal and spatial scale.

• 4.1.2.9.2. One way of demonstrating rapid degradation utilises the biodegradation screening tests designed to determine whether an organic substance is ‘readily biodegradable’. Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which passes this screening test is considered likely to biodegrade ‘rapidly’ in the aquatic environment, and is thus unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade rapidly in the environment. Other evidence of rapid degradation in the environment may therefore also be considered and are of particular importance where the substances are inhibitory to microbial activity at the concentration levels used in standard testing. Thus, a further classification criterion is included which allows the use of data to show that the substance did actually degrade biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if degradation is demonstrated under environmentally realistic conditions, then the criterion of ‘rapid degradability’ is met.

• 4.1.2.9.3. Many degradation data are available in the form of degradation half-lives and these can be used in defining rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is achieved. Primary biodegradation does not normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do not fulfil the criteria for classification as hazardous to the aquatic environment.

• 4.1.2.9.4. The criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the aquatic environment.

• 4.1.2.9.5. Substances are considered rapidly degradable in the environment if one of the following criteria holds true:

• (a) if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved:
• (i) tests based on dissolved organic carbon: 70 %;
• (ii) tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum. These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar constituents. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days; or

• (b) if, in those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or

• (c) if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period.

• 4.1.2.10. Inorganic compounds and metals

• 4.1.2.10.1. For inorganic compounds and metals, the concept of degradability as applied to organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processes to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccumulation data shall be treated with care ([^E0042]).

• 4.1.2.10.2. Poorly soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic environment depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and amount of this species which enter solution. All evidence must be weighed in a classification decision. This would be especially true for metals showing borderline results in the Transformation/Dissolution Protocol.

4.1.3.   Classification criteria for mixtures

• 4.1.3.1. The classification system for mixtures covers all classification categories which are used for substances, i.e. categories Acute 1 and Chronic 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate:

The ‘relevant components’ of a mixture are those which are classified ‘Acute 1’or ‘Chronic 1’ and present in a concentration of 0,1 % (w/w) or greater, and those which are classified ‘Chronic 2’, ‘Chronic 3’ or ‘Chronic 4’ and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see section 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as ‘Acute 1’ or ‘Chronic 1’ the concentration to be taken into account is (0,1/M) %. (For explanation M-factor see section 4.1.3.5.5.5.)

• 4.1.3.2. The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed.

Elements of the tiered approach include:

• — classification based on tested mixtures,

• — classification based on bridging principles,

• — the use of ‘summation of classified components’ and/or an ‘additivity formula’.

Figure 4.1.2

Tiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards

Image omitted; see official source

Text of image

Apply summation method (see 4.1.3.5.5) using:

·

Percentage of all components classified as "Chronic"

·

Percentage of components classified as "Acute"

·

Percentage of components with acute or chronic toxicity data: apply additivity formulas (see 4.1.3.5.2) and convert the derived L(E)C50 or EqNOECm to the appropriate "Acute" or "Chronic" category

CLASSIFY

for short-term (acute)/long-term chronic hazard

CLASSIFY

for short-term (acute)/long-term (chronic) aquatic hazard

CLASSIFY

for short-term(acute)/long-term (chronic)aquatic hazard (see 4.1.3.3)

Apply bridging principles (see 4.1.3.4.)

CLASSIFY

for short-term (acute)/long-term (chronic) hazard

Apply summation method and/or additivity formula (see 4.1.3.5) and apply 4.1.3.6

Use available hazard data of known components

Either aquatic toxicity or classification data available for all relevant components

Sufficient data available on similar mixtures to estimate hazards

No

No

Yes

Yes

Yes

No

Aquatic toxicity test data available on the mixture as a whole

• 4.1.3.3. Classification of mixtures when toxicity data are available for the complete mixture

• 4.1.3.3.1. When the mixture as a whole has been tested to determine its aquatic toxicity, this information can be used for classifying the mixture according to the criteria that have been agreed for substances. The classification is normally based on the data for fish, crustacea and algae/plants (see sections 4.1.2.7.1 and 4.1.2.7.2). When adequate acute or chronic toxicity data for the mixture as a whole are lacking, ‘bridging principles’ or ‘summation method’ should be applied (see sections 4.1.3.4 and 4.1.3.5).

• 4.1.3.3.2. The long-term (chronic) hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation. Degradability and bioaccumulation tests for mixtures are not used as they are usually difficult to interpret, and such tests may be meaningful only for single substances.

• 4.1.3.3.3. Classification for category Acute 1

• (a) When there are adequate acute toxicity test data (LC50 or EC50) available for the mixture as a whole showing L(E)C50 ≤ 1 mg/l: Classify mixture as Acute 1 in accordance with point (a) of Table 4.1.0.

• (b) When there are acute toxicity test data (LC50(s) or EC50(s)) available for the mixture as a whole showing L(E)C50(s) > 1 mg/l for normally all trophic levels: No need to classify for short-term (acute) hazard.

• 4.1.3.3.4. Classification for categories Chronic 1, 2 and 3

• (a) When there are adequate chronic toxicity data (ECxx or NOEC) available for the mixture as a whole showing ECx or NOEC of the tested mixture ≤ 1mg/l:
• (i) Classify the mixture as Chronic 1, 2 or 3 in accordance with point (b)(ii) of Table 4.1.0 as rapidly degradable if the available information allows the conclusion that all relevant components of the mixture are rapidly degradable;
• (ii) Classify the mixture as Chronic 1 or 2 in all other cases in accordance with point (b)(i) of Table 4.1.0 as non-rapidly degradable;

• (b) When there are adequate chronic toxicity data (ECx or NOEC) available for the mixture as a whole showing ECx(s) or NOEC(s) of the tested mixture > 1 mg/l for normally all trophic levels: No need to classify for long-term (chronic) hazard in categories Chronic 1, 2 or 3.

• 4.1.3.3.5. Classification for category Chronic 4

If there are nevertheless reasons for concern:

Classify the mixture as Chronic 4 (safety net classification) in accordance with Table 4.1.0.

• 4.1.3.4. Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles

• 4.1.3.4.1. Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterise the hazards of the mixture, this data shall be used in accordance with the bridging rules set out in section 1.1.3. However, in relation to application of the bridging rule for dilution, sections 4.1.3.4.2 and 4.1.3.4.3 shall be used.

• 4.1.3.4.2. Dilution: if a mixture is formed by diluting another tested mixture or a substance classified for its aquatic environmental hazard with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the resulting mixture may be classified as equivalent to the original tested mixture or substance. Alternatively, the method explained in section 4.1.3.5 may be applied.

• 4.1.3.4.3. If a mixture is formed by diluting another tested mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance.

• 4.1.3.5. Classification of mixtures when toxicity data are available for some or all components of the mixture

• 4.1.3.5.1. The classification of a mixture is based on summation of the concentration of its classified components. The percentage of components classified as ‘Acute’ or ‘Chronic’ is fed straight in to the summation method. Details of the summation method are described in section 4.1.3.5.5.

• 4.1.3.5.2. Mixtures can be made of a combination of both components that are classified (as Acute 1 and/or Chronic 1, 2, 3, 4) and others for which adequate toxicity test data is available. When adequate toxicity data are available for more than one component in the mixture, the combined toxicity of those components is calculated using the following additivity formulas (a) or (b), depending on the nature of the toxicity data:

• (a) Based on acute aquatic toxicity: Image omitted; see official source where: Ci = concentration of component i (weight percentage); L(E)C50i = (mg/l) LC50 or EC50 for component i; η = 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. The calculated toxicity may be used to assign that portion of the mixture a short-term (acute) hazard category which is then subsequently used in applying the summation method;

• (b) Based on chronic aquatic toxicity: Image omitted; see official source where: Ci = concentration of component i (weight percentage) covering the rapidly degradable components; Cj = concentration of component j (weight percentage) covering the non- rapidly degradable components; NOECi = NOEC (or other recognised measures for chronic toxicity) for component i covering the rapidly degradable components, in mg/l; NOECj = NOEC (or other recognised measures for chronic toxicity) for component j covering the non-rapidly degradable components, in mg/l; n = number of components, and i and j are running from 1 to n; EqNOECm = Equivalent NOEC of the part of the mixture with test data. The equivalent toxicity thus reflects the fact that non-rapidly degrading substances are classified one hazard category level more ‘severe’ than rapidly degrading substances. The calculated equivalent toxicity may be used to assign that portion of the mixture a long-term (chronic) hazard category, in accordance with the criteria for rapidly degradable substances (point (b)(ii) of Table 4.1.0), which is then subsequently used in applying the summation method.

• 4.1.3.5.3. When applying the additivity formula for part of the mixture, it is preferable to calculate the toxicity of this part of the mixture using for each substance toxicity values that relate to the same taxonomic group (i.e. fish, crustacean, algae or equivalent) and then to use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each component is selected in the same manner that toxicity values are selected for the classification of substances, i.e. the higher toxicity (from the most sensitive test organism) is used. The calculated acute and chronic toxicity is then used to assess whether this part of the mixture shall be classified as Acute 1 and/or Chronic 1, 2 or 3 using the same criteria described for substances.

• 4.1.3.5.4. If a mixture is classified in more than one way, the method yielding the more conservative result shall be used.

• 4.1.3.5.5. Summation method

4.1.3.5.5.1.   Rationale

• 4.1.3.5.5.1.1. In case of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of any substance classified as Chronic 1, 2 or 3.

• 4.1.3.5.5.1.2. When a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l and/or chronic toxicity is below 0,1 mg/l (if non rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an ‘under-classification’ of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in section 4.1.3.5.5.5.

4.1.3.5.5.2.   Classification procedure

• 4.1.3.5.5.2.1. In general a more severe classification for mixtures overrides a less severe classification, e.g. a classification with Chronic 1 overrides a classification with Chronic 2. As a consequence, in this example, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible. Therefore it is not necessary to undergo the further classification procedure.

4.1.3.5.5.3.   Classification for category Acute 1

• 4.1.3.5.5.3.1. First, all components classified as Acute 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is ≥ 25 % the whole mixture is classified as Acute 1.

• 4.1.3.5.5.3.2. The classification of mixtures for short-term (acute) hazards based on this summation of classified components is summarised in Table 4.1.1.

Table 4.1.1

Classification of a mixture for short-term (acute) hazards based on summation of classified components

Sum of components classified as:	Mixture is classified as:
Acute 1 × M [^E0043] ≥ 25 %	Acute 1

For explanation of the M-factor, see 4.1.3.5.5.5.

4.1.3.5.5.4.   Classification for the categories Chronic 1, 2, 3 and 4

• 4.1.3.5.5.4.1. First all components classified as Chronic 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is equal to or greater than 25 %, the mixture is classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1, the classification procedure is completed.

• 4.1.3.5.5.4.2. In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if 10 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus the sum of the concentrations (in %) of all components classified as Chronic 2 is equal to or greater than 25 %. If the result of the calculation is classification of the mixture as Chronic 2, the classification process is completed.

• 4.1.3.5.5.4.3. In cases where the mixture is not classified either as Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus 10 times the sum of the concentrations (in %) of all components classified with Chronic 2 plus the sum of the concentrations (in %) of all components classified as Chronic 3 is ≥ 25 %.

• 4.1.3.5.5.4.4. If the mixture is still not classified in Chronic 1, 2 or 3, classification of the mixture as Chronic 4 shall be considered. A mixture is classified as Chronic 4 if the sum of the concentrations (in %) of components classified as Chronic 1, 2, 3 and 4 is equal to or greater than 25 %.

• 4.1.3.5.5.4.5. The classification of mixtures for long-term (chronic) hazards, based on this summation of the concentrations of classified components, is summarised in Table 4.1.2.

Table 4.1.2

Classification of a mixture for long-term (chronic) hazards, based on summation of the concentration of classified components

Sum of components classified as:	Mixture is classified as:
Chronic 1 × M [^E0044] ≥ 25 %	Chronic 1
(M × 10 × Chronic 1) + Chronic 2 ≥ 25 %	Chronic 2
(M × 100 × Chronic 1) + (10 × Chronic 2) + Chronic 3 ≥ 25 %	Chronic 3
Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25 %	Chronic 4

For explanation of the M-factor, see 4.1.3.5.5.5.

4.1.3.5.5.5.   Mixtures with highly toxic components

• 4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg/l and/or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic 1, one of the following shall be applied:

• — the tiered approach described in sections 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute 1 and Chronic 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of ‘Acute 1’ in the left column of Table 4.1.1 and the concentration of ‘Chronic 1’ in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic 1 components, the classifier needs to be informed of the value of the M-factor in order to apply the summation method,

• — the additivity formula (see section 4.1.3.5.2) provided that toxicity data are available for all highly toxic components in the mixture and there is convincing evidence that all other components, including those for which specific acute and/or chronic toxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture.

Table 4.1.3

Multiplying factors for highly toxic components of mixtures

Acute toxicity	M factor	Chronic toxicity	M factor	M factor
L(E)C50 value (mg/l)		NOEC value (mg/l)	NRD [^E0045] components	RD [^E0046] components
0,1 < L(E)C50 ≤ 1	1	0,01 < NOEC ≤ 0,1	1	—
0,01 < L(E)C50 ≤ 0,1	10	0,001 < NOEC ≤ 0,01	10	1
0,001 < L(E)C50 ≤ 0,01	100	0,0001 < NOEC ≤ 0,001	100	10
0,0001 < L(E)C50 ≤ 0,001	1 000	0,00001 < NOEC ≤ 0,0001	1 000	100
0,00001 < L(E)C50 ≤ 0,0001	10 000	0,000001 < NOEC ≤ 0,00001	10 000	1 000
(continue in factor 10 intervals)	(continue in factor 10 intervals)	(continue in factor 10 intervals)	(continue in factor 10 intervals)	(continue in factor 10 intervals)

Non-rapidly degradable.

Rapidly degradable.

• 4.1.3.6. Classification of mixtures with components without any useable information

• 4.1.3.6.1. In the event that 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 shall be classified based on the known components only, with the additional statement on the label and in the SDS that: ‘Contains x % of components with unknown hazards to the aquatic environment’.

4.1.4.   Hazard communication

• 4.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 4.1.4.

Table 4.1.4

Label elements for hazardous to the aquatic environment

SHORT-TERM (ACUTE) AQUATIC HAZARD	SHORT-TERM (ACUTE) AQUATIC HAZARD
	Acute 1
GHS Pictogram	Image omitted; see official source
Signal Word	Warning
Hazard Statement	H400: Very toxic to aquatic life
Precautionary Statement Prevention	P273
Precautionary Statement Response	P391
Precautionary Statement Storage
Precautionary Statement Disposal	P501
---	---
LONG-TERM (CHRONIC) AQUATIC HAZARD	LONG-TERM (CHRONIC) AQUATIC HAZARD
	Chronic 1
GHS Pictograms	Image omitted; see official source
Signal Word	Warning
Hazard Statement	H410: Very toxic to aquatic life with long lasting effects
Precautionary Statement Prevention	P273
Precautionary Statement Response	P391
Precautionary Statement Storage
Precautionary Statement Disposal	P501

4.2.   Endocrine disruption for the environment

4.2.1.   Definitions and general considerations

4.2.1.1.   Definitions

For the purposes of Section 4.2., the following definitions shall apply:

• (a) ‘endocrine disruptor’ means a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations;

• (b) ‘endocrine disruption’ means the alteration of one or more functions of the endocrine system caused by an endocrine disruptor;

• (c) ‘endocrine activity’ means an interaction with the endocrine system that may result in a response of that system, of target organs or target tissues and that confers on a substance or mixture the potential to alter one or more functions of the endocrine system;

• (d) ‘adverse effect’ means a change in morphology, physiology, growth, development, reproduction or lifespan of an organism, system, population or subpopulation that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;

• (e) ‘biologically plausible link’ means the correlation between an endocrine activity and an adverse effect, based on biological processes, where the correlation is consistent with existing scientific knowledge.

4.2.1.2.   General considerations

• 4.2.1.2.1Substances and mixtures fulfilling the criteria of endocrine disruptors for the environment based on evidence referred to in Table 4.2.1 shall be considered to be known, presumed or suspected endocrine disruptors for the environment unless there is evidence conclusively demonstrating that the adverse effects identified are not relevant at the population or subpopulation level.

• 4.2.1.2.2Evidence that is to be considered for classification of substances in accordance with other Sections of this Annex may also be used for classification of substances as an endocrine disruptor for the environment where the criteria provided in this Section are met.

4.2.2   Classification criteria for substances

4.2.2.1   Hazard categories

For the purpose of classification for endocrine disruption for the environment, substances shall be allocated to one of two categories.

Table 4.2.1.

Hazard categories for endocrine disruptors for the environment

Categories	Criteria
CATEGORY 1	Known or presumed endocrine disruptors for the environment The classification in Category 1 shall be largely based on evidence from at least one of the following: a) animal data; b) non-animal data providing an equivalent predictive capacity as data in point a. Such data shall provide evidence that the substance meets all the following criteria: (a) endocrine activity; (b) an adverse effect in an intact organism or its offspring or future generations; (c) a biologically plausible link between the endocrine activity and the adverse effect. However, where there is information that raises serious doubt about the relevance of the adverse effects identified at population or subpopulation level, classification in Category 2 may be more appropriate.
CATEGORY 2	Suspected endocrine disruptors for the environment A substance shall be classified in Category 2 where all the following criteria are met: (a) there is evidence of: i. an endocrine activity; and ii. an adverse effect in an intact organism or its offspring or future generations; (b) the evidence referred to in point (a) is not sufficiently convincing to classify the substance in Category 1; (c) there is evidence of a biologically plausible link between the endocrine activity and the adverse effect.

Where there is evidence conclusively demonstrating that the adverse effects identified are not relevant at the population or subpopulation level, the substance shall not be considered an endocrine disruptor for the environment.

4.2.2.2.   Basis of classification

• 4.2.2.2.1Classification shall be made on the basis of the appropriate criteria outlined above, and a weight of evidence determination of each of the criteria (see Section 4.2.2.3) and an overall weight of evidence determination (see Section 1.1.1). Classification as an endocrine disruptor for the environment is intended to be used for substances which cause or may cause an endocrine-related adverse effect at population or subpopulation level.

• 4.2.2.2.2Adverse effects that are solely non-specific consequences of other toxic effects shall not be considered for the identification of a substance as endocrine disruptor for the environment.

4.2.2.3.   Weight of evidence and expert judgment

• 4.2.2.3.1.Classification as an endocrine disruptor for the environment is made on the basis of an assessment of the total weight of evidence using expert judgment (see Section 1.1.1). This means that all available information that bears on the determination of endocrine disruption for the environment is considered together, such as:

• (a) in vivo studies or other studies (e.g. in vitro, in silico studies) predictive of adverse effects, endocrine activity or biologically plausible link in animals;

• (b) data from analogue substances using structure-activity relationships (SAR),

• (c) evaluation of substances chemically related to the substance under study may also be included (grouping, read-across), particularly when information on the substance is scarce;

• (d) any additional relevant and acceptable scientific data.

• 4.2.2.3.2.In applying the weight of evidence determination and expert judgement, the assessment of the scientific evidence referred to in Section 4.2.2.3.1 shall, in particular, consider all of the following factors:

• (a) both positive and negative results;

• (b) the relevance of the study design for the assessment of adverse effects and its relevance at the population or subpopulation level, and for the assessment of the endocrine activity;

• (c) the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on populations or subpopulations;

• (d) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;

• (e) the route of exposure, toxicokinetic and metabolism studies;

• (f) the concept of the limit dose (concentration), and international guidelines on maximum recommended doses (concentrations) and for assessing confounding effects of excessive toxicity;

• (g) where available, adequate, reliable and representative field or monitoring data or results from population models.

• 4.2.2.3.3.Using a weight of evidence determination, the link between the endocrine activity and the adverse effects shall be established based on biological plausibility, which shall be determined in light of available scientific knowledge. The biologically plausible link does not need to be demonstrated with substance specific data.

• 4.2.2.3.4.Using a weight of evidence determination, evidence considered for the classification of a substance as an endocrine disruptor for human health referred to in Section 3.11 shall be considered when assessing the classification of the substance as an endocrine disruptor for the environment under Section 4.2.

4.2.2.4.   Application in time

From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 4.2.2.1 to 4.2.2.3.

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 4.2.2.1 to 4.2.2.3 until 1 November 2026.

4.2.3.   Classification criteria for mixtures

4.2.3.1.   Classification of mixtures where data are available for all components or only for some components of the mixture

• 4.2.3.1.1.A mixture shall be classified as an endocrine disruptor for the environment where at least one component has been classified as a Category 1 or Category 2 endocrine disruptor for the 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.

Table 4.2.2.

Generic concentration limits of components of a mixture classified as endocrine disruptor for the environment that trigger classification of the mixture

Component classified as:	Generic concentration limits triggering classification of a mixture as:	Generic concentration limits triggering classification of a mixture as:
Component classified as:	Category 1 endocrine disruptor for the environment	Category 2 endocrine disruptor for the environment
Category 1 endocrine disruptor for the environment	≥ 0,1  %
Category 2 endocrine disruptor for the environment		≥ 1  % [Note 1 ]

• Note:The concentration limits in this Table apply to solids and liquids (w/w units) as well as gases (v/v units).

• Note 1:If a Category 2 endocrine disruptor for the environment is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request.

4.2.3.2.   Classification of mixtures where data are available for the complete mixture

4.2.3.2.1.

Classification of mixtures shall be based on the available test data for the individual components of the mixture using concentration limits for the components classified as endocrine disruptor for the environment. On a case-by-case basis, test data on the mixture as a whole may be used for classification when demonstrating endocrine disruption for the environment that has not been established from the evaluation based on the individual components. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose (concentration) and other factors such as duration, observations, sensitivity and statistical analysis of the test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.

4.2.3.3.   Classification of mixtures where data are not available for the complete mixture: bridging principles

• 4.2.3.3.1.Where the mixture itself has not been tested to determine its endocrine disruption for the environment, but there are sufficient data on the individual components and similar tested mixtures (subject to paragraph 4.2.3.2.1) to adequately characterise the hazards of the mixture, those data shall be used in accordance with the applicable bridging principles set out in Section 1.1.3.

4.2.3.4.   Application in time

From 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Sections 4.2.3.1 to 4.2.3.3.

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 Sections 4.2.3.1, 4.2.3.2 and 4.2.3.3 until 1 May 2028.

4.2.4.   Hazard Communication

• 4.2.4.1.Label elements shall be used in accordance with Table 4.2.3 for substances and mixtures meeting the criteria for classification in this hazard class (Endocrine disruption for the environment).

Table 4.2.3.

Label elements of endocrine disruption for the environment

Classification	Category 1	Category 2
Symbol/pictogram
Signal Word	Danger	Warning
Hazard Statement	EUH430: May cause endocrine disruption in the environment	EUH431: Suspected of causing endocrine disruption in the environment
Precautionary Statement Prevention	P201 P202 P273	P201 P202 P273
Precautionary Statement Response	P391	P391
Precautionary Statement Storage	P405	P405
Precautionary Statement Disposal	P501	P501

4.2.4.2.   Application in time for substances

From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.2.4.1.

However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.2.4.1 until 1 November 2026.

4.2.4.3.   Application in time for mixtures

From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 4.2.4.1.

However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.2.4.1 until 1 May 2028.

4.3.   Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties

4.3.1.   Definitions and general considerations

• 4.3.1.1.For the purposes of Section 4.3 the following definitions shall apply:

• ‘PBT’ means a persistent, bioaccumulative and toxic substance or mixture that meets the classification criteria set out in Section 4.3.2.1.

• ‘vPvB’ means a very persistent and very bioaccumulative substance or mixture that meets the classification criteria set out in Section 4.3.2.2.

• 4.3.1.2.The hazard class Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties is differentiated into:

• — PBT properties and,

• — vPvB properties.

4.3.2.   Classification criteria for substances

4.3.2.1.   Classification criteria for PBT

A substance shall be considered a PBT substance when it fulfils the persistence, bioaccumulation and toxicity criteria set out in Sections 4.3.2.1.1 to 4.3.2.1.3 and assessed according to Section 4.3.2.3.

4.3.2.1.1.   Persistence

A substance shall be considered to fulfil the persistence criterion (P) where any of the following conditions is met:

• (a) the degradation half-life in marine water is higher than 60 days;

• (b) the degradation half-life in fresh or estuarine water is higher than 40 days;

• (c) the degradation half-life in marine sediment is higher than 180 days;

• (d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

• (e) the degradation half-life in soil is higher than 120 days.

4.3.2.1.2.   Bioaccumulation

A substance shall be considered to fulfil the bioaccumulation criterion (B) where the bioconcentration factor in aquatic species is higher than 2 000 .

4.3.2.1.3.   Toxicity

A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations:

• (a) 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;

• (b) 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;

• (c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Section 3.9;

• (d) the substance meets the criteria for classification as endocrine disruptor (category 1) for humans or the environment according to Sections 3.11 or 4.2.

4.3.2.2.   Classification criteria for vPvB

A substance shall be considered a vPvB substance when it fulfils the persistence and bioaccumulation criteria set out in Sections 4.3.2.2.1 and 4.3.2.2.2 and assessed according to Section 4.3.2.3.

4.3.2.2.1.   Persistence

A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) where any of the following conditions is met:

• (a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days;

• (b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;

• (c) the degradation half-life in soil is higher than 180 days.

4.3.2.2.2.   Bioaccumulation

A substance shall be considered to fulfil the ‘very bioaccumulative’ criterion (vB) where the bioconcentration factor in aquatic species is higher than 5 000 .

4.3.2.3.   Basis of classification

For the classification of PBT substances and vPvB substances, a weight of evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 4.3.2.3 with the criteria set out in Sections 4.3.2.1 and 4.3.2.2. That weight of evidence shall be applied in particular where the criteria set out in Sections 4.3.2.1 and 4.3.2.2 cannot be applied directly to the available information.

The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.

The identification shall also take account of the PBT/vPvB properties of relevant constituents, additives or impurities of a substance and relevant transformation or degradation products.

This hazard class (Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) properties) shall apply to all organic substances, including organo-metals.

The information set out in Sections 4.3.2.3.1, 4.3.2.3.2 and 4.3.2.3.3 shall be considered for the assessment of P, vP, B, vB and T properties.

4.3.2.3.1.   Assessment of P or vP properties

The following information shall be considered for the assessment of P or vP properties:

• (a) results from simulation testing on degradation in surface water;

• (b) results from simulation testing on degradation in soil;

• (c) results from simulation testing on degradation in sediment;

• (d) other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.

4.3.2.3.2.   Assessment of B or vB properties

The following information shall be considered for the assessment of B or vB properties:

• (a) results from a bioconcentration or bioaccumulation study in aquatic species;

• (b) other information on the bioaccumulation potential, provided that its suitability and reliability can be reasonably demonstrated, such as:
• (i) results from a bioaccumulation study in terrestrial species;
• (ii) data from scientific analysis of human body fluids or tissues, such as blood, milk or fat;
• (iii) detection of elevated levels in biota, in particular in endangered species or in vulnerable populations or subpopulations, compared to levels in their surrounding environment;
• (iv) results from a chronic toxicity study on animals;
• (v) assessment of the toxicokinetic behaviour of the substance.

• (c) information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.

4.3.2.3.3.   Assessment of T properties

The following information shall be considered for the assessment of T properties:

• (a) results from long-term toxicity testing on aquatic invertebrates;

• (b) results from long-term toxicity testing on fish;

• (c) results from growth inhibition study on algae or aquatic plants;

• (d) 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);

• (e) the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);

• (f) results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;

• (g) results from long-term toxicity testing on sediment organisms;

• (h) results from long-term or reproductive toxicity testing with birds;

• (i) other information, provided that its suitability and reliability can be reasonably demonstrated.

4.3.2.4.   Weight of evidence and expert judgment

• 4.3.2.4.1.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:

• (a) in vivo studies or other studies (e.g. in vitro, in silico studies);

• (b) information from the application of the category approach (grouping, read-across);

• (c) data from analogue substances using structure-activity relationships (SAR), informing about P, vP, B, vB and T properties;

• (d) results of monitoring and modelling;

• (e) human experience such as occupational data and data from accident databases;

• (f) epidemiological and clinical studies;

• (g) well documented case reports, peer-reviewed published studies and observations;

• (h) 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.

• 4.3.2.4.2.In applying the weight of evidence determination, the following information, in addition to the information referred to in Sections 4.3.2.3.1, 4.3.2.3.2 and 4.3.2.3.3, shall be considered as part of the scientific assessment of the information relevant for the P, vP, B, vB and T properties:

• (a) Indication of P or vP properties:
• (i) Results from tests on ready biodegradation;
• (ii) Results from other degradation screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
• (iii) Results obtained from well-developed and reliable biodegradation (Q)SAR models;
• (iv) Other information provided that its suitability and reliability can be reasonably demonstrated.

• (b) Indication of B or vB properties:
• (i) Octanol-water partitioning coefficient experimentally determined or estimated by well-developed and reliable (Q)SAR models;
• (ii) Other information provided that its suitability and reliability can be reasonably demonstrated.

• (c) Indication of T properties:
• (i) 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);
• (ii) Other information provided that its suitability and reliability can be reasonably demonstrated.

4.3.2.5.   Application in time

From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 4.3.2.1 to 4.3.2.4.

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 4.3.2.1 to 4.3.2.4 until 1 November 2026.

4.3.3.   Classification criteria for mixtures

• 4.3.3.1.A mixture shall be classified respectively as a PBT or vPvB when at least one component contained in the mixture has been classified respectively as a PBT or vPvB and is present at or above 0,1 % (weight/weight).

• 4.3.3.2. Application in time

• From 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Section 4.3.3.1.

• 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 4.3.3.1 until 1 May 2028.

4.3.4.   Hazard communication

• 4.3.4.1.Label elements shall be used in accordance with Table 4.3.1 for substances or mixtures meeting the criteria for classification in this hazard class.

Table 4.3.1.

Label elements for PBT and vPvB properties

	PBT	vPvB
Symbol/pictogram
Signal word	Danger	Danger
Hazard Statement	EUH440: Accumulates in the environment and living organisms including in humans	EUH441: Strongly accumulates in the environment and living organisms including in humans
Precautionary Statement Prevention	P201 P202 P273	P201 P202 P273
Precautionary Statement Response	P391	P391
Precautionary Statement Disposal	P501	P501

4.3.4.2.   Application in time for substances

From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.3.4.1.

However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.3.4.1 until 1 November 2026.

4.3.4.3.   Application in time for mixtures

From 1 May 2026 at the latest, mixtures shall be labelled in accordance with the provisions laid down in Section 4.3.4.1.

However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.3.4.1 until 1 May 2028.

4.4.   Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties

4.4.1.   Definitions and general considerations

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:

• — PMT properties and,

• — vPvM properties.

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:

• (a) the degradation half-life in marine water is higher than 60 days;

• (b) the degradation half-life in fresh or estuarine water is higher than 40 days;

• (c) the degradation half-life in marine sediment is higher than 180 days;

• (d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

• (e) 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:

• (a) 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;

• (b) 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;

• (c) 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;

• (d) 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:

• (a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days;

• (b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;

• (c) 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:

• (a) results from simulation testing on degradation in surface water;

• (b) results from simulation testing on degradation in soil;

• (c) results from simulation testing on degradation in sediment;

• (d) 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:

• (a) results from adsorption/desorption testing;

• (b) 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:

• (a) results from long-term toxicity testing on aquatic invertebrates;

• (b) results from long-term toxicity testing on fish;

• (c) results from growth inhibition study on algae or aquatic plants;

• (d) 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);

• (e) the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);

• (f) results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;

• (g) results from long-term toxicity testing on sediment organisms;

• (h) results from long-term or reproductive toxicity testing on birds;

• (i) 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:

• (a) in vivo studies or other studies (e.g. in vitro, in silico studies);

• (b) information from the application of the category approach (grouping, read-across);

• (c) data from analogue substances using structure-activity relationships (SAR), informing about P, vP, M, vM and T properties;

• (d) results of monitoring and modelling;

• (e) human experience such as occupational data and data from accident databases;

• (f) epidemiological and clinical studies;

• (g) well documented case reports, peer-reviewed published studies and observations;

• (h) 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:

• (a) Indication of P or vP properties:
• (i) Results from tests on ready biodegradation;
• (ii) Results from other degradation screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
• (iii) Results obtained from well-developed and reliable biodegradation (Q)SAR models;
• (iv) Other information, provided that its suitability and reliability can be reasonably demonstrated.

• (b) Information relevant for the M or vM properties:
• (i) Organic carbon to water partition coefficient (Koc) estimated by well-developed and reliable (Q)SAR models;
• (ii) Other information, provided that its suitability and reliability can be reasonably demonstrated.

• (c) Information relevant for the T properties:
• (i) 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);
• (ii) 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

• 4.4.3.1A 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.