Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

[F1 4. PART 4: ENVIRONMENTAL HAZARDS U.K.

4.1. Hazardous to the aquatic environment U.K.

4.1.1. Definitions and general considerations U.K.

4.1.1.1. Definitions U.K.

(a)

‘ acute aquatic toxicity ’ means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance.

(b)

‘ [F2 short-term (acute) hazard] ’ means for classification purposes the hazard of a substance or mixture caused by its acute toxicity to an organism during short-term aquatic exposure to that substance or mixture.

(c)

‘ availability of a substance ’ means the extent to which this substance becomes a soluble or disaggregate species. For metal availability, the extent to which the metal ion portion of a metal (M°) compound can disaggregate from the rest of the compound (molecule).

(d)

‘ bioavailability ’ or ‘ biological availability ’ means the extent to which a substance is taken up by an organism, and distributed to an area within the organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability.

(e)

‘ bioaccumulation ’ means the net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food).

(f)

‘ bioconcentration ’ means the net result of uptake, transformation and elimination of a substance in an organism due to waterborne exposure.

(g)

‘ chronic aquatic toxicity ’ means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism.

(h)

‘ degradation ’ means the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts.

(i)

‘EC _x ’ means the effect concentration associated with x% response.

(j)

‘ [F2 long-term (chronic) hazard] ’ means for classification purposes the hazard of a substance or mixture caused by its chronic toxicity following long-term exposure in the aquatic environment.

(k)

‘ no observed effect concentration (NOEC) ’ means the test concentration immediately below the lowest tested concentration with statistically significant adverse effect. The NOEC has no statistically significant adverse effect compared to the control.

Textual Amendments

F2 Substituted by Commission Regulation (EU) 2016/918 of 19 May 2016 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

4.1.1.2. Basic elements U.K.

4.1.1.2.0. [F2 Hazardous to the aquatic environment is differentiated into: U.K.

• short-term (acute) aquatic hazard

• long-term (chronic) aquatic hazard.]

4.1.1.2.1. The basic elements used for classification for aquatic environmental hazards are: U.K.

• acute aquatic toxicity,

• chronic aquatic toxicity,

• potential for or actual bioaccumulation, and

• degradation (biotic or abiotic) for organic chemicals.

4.1.1.2.2. Preferably data shall be derived using the standardised test methods referred to in Article 8(3). In practice data from other standardised test methods such as national methods shall also be used where they are considered as equivalent. Where valid data are available from non-standard testing and from non-testing methods, these shall be considered in classification provided they fulfil the requirements specified in section 1 of Annex XI to Regulation (EC) No 1907/2006. In general, both freshwater and marine species toxicity data are considered suitable for use in classification provided the test methods used are equivalent. Where such data are not available classification shall be based on the best available data. See also Part 1 of Annex I to Regulation (EC) No 1272/2008. U.K.

4.1.1.3. Other considerations U.K.

4.1.1.3.1. Classification of substances and mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment. [F2 The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part. The basis, therefore, of the identification of short-term (acute) and long-term (chronic) hazards is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate.] U.K.

4.1.1.3.2. While the classification system applies to all substances and mixtures, it is recognised that for special cases (e.g. metals) the European Chemicals Agency has issued guidance. U.K.

4.1.2. Classification criteria for substances U.K.

4.1.2.1. [F2 The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and chronic toxicity of a substance. For the long-term (chronic) hazard, separate hazard categories are defined representing a gradation in the level of hazard identified.] The lowest of the available toxicity values between and within the different trophic levels (fish, crustacean, algae/aquatic plants) shall normally be used to define the appropriate hazard category(ies). There are circumstances, however, when a weight of evidence approach is appropriate. U.K.

4.1.2.2. [F2 The core classification system for substances consists of one short-term (acute) hazard classification category and three long-term (chronic) hazard classification categories. The short-term (acute) and long-term (chronic) classification categories are applied independently.] U.K.

4.1.2.3. [F2 The criteria for classification of a substance in Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC 50). The criteria for classification of a substance into Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term (chronic) hazard classification. In absence of adequate chronic toxicity data, the subsequent step is to combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data) (see Figure 4.1.1).] U.K.

Figure 4.1.1

[F2 Categories for substances long-term (chronic) hazardous to the aquatic environment]

4.1.2.4. [F2 The system also introduces a ‘ safety net ’ classification (referred to as Chronic 4) for use when the data available do not allow classification under the formal criteria for Acute 1 or Chronic 1 to 3 but there are nevertheless some grounds for concern (see example Table 4.1.0).] U.K.

4.1.2.5. Substances with acute toxicities below 1 mg/l or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute as components of a mixture 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 (see note 1 of Table 4.1.0 and section 4.1.3.5.5). U.K.

4.1.2.6. The criteria for classifying and categorising substances as ‘ hazardous to the aquatic environment ’ are summarised in Table 4.1.0. U.K.

[F2 Table 4.1.0

Classification categories for substances hazardous to the aquatic environment

(a) Short-term (acute) aquatic hazard
Category Acute 1:	(Note 1)
96 hr LC 50 (for fish)	≤ 1 mg/l and/or
48 hr EC 50 (for crustacea)	≤ 1 mg/l and/or
72 or 96 hr ErC 50 (for algae or other aquatic plants)	≤ 1 mg/l.	(Note 2)
(b) Long-term (chronic) aquatic hazard
(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available
Category Chronic 1:	(Note 1)
Chronic NOEC or EC x (for fish)	≤ 0,1 mg/l and/or
Chronic NOEC or EC x (for crustacea)	≤ 0,1 mg/l and/or
Chronic NOEC or EC x (for algae or other aquatic plants)	≤ 0,1 mg/l.
Category Chronic 2:
Chronic NOEC or EC x (for fish)	≤ 1 mg/l and/or
Chronic NOEC or EC x (for crustacea)	≤ 1 mg/l and/or
Chronic NOEC or EC x (for algae or other aquatic plants)	≤ 1 mg/l.
(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available
Category Chronic 1:	(Note 1)
Chronic NOEC or EC x (for fish)	≤ 0,01 mg/l and/or
Chronic NOEC or EC x (for crustacea)	≤ 0,01 mg/l and/or
Chronic NOEC or EC x (for algae or other aquatic plants)	≤ 0,01 mg/l.
Category Chronic 2:
Chronic NOEC or EC x (for fish)	≤ 0,1 mg/l and/or
Chronic NOEC or EC x (for crustacea)	≤ 0,1 mg/l and/or
Chronic NOEC or EC x (for algae or other aquatic plants)	≤ 0,1 mg/l.
Category Chronic 3:
Chronic NOEC or EC x (for fish)	≤ 1 mg/l and/or
Chronic NOEC or EC x (for crustacea)	≤ 1 mg/l and/or
Chronic NOEC or EC x (for algae or other aquatic plants)	≤ 1 mg/l.
(iii) Substances for which adequate chronic toxicity data are not available
Category Chronic 1:	(Note 1)
96 hr LC 50 (for fish)	≤ 1 mg/l and/or
48 hr EC 50 (for crustacea)	≤ 1 mg/l and/or
72 or 96 hr ErC 50 (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
(or, if absent, the log K ow ≥ 4).	(Note 3).
Category Chronic 2:
96 hr LC 50 (for fish)	> 1 to ≤ 10 mg/l and/or
48 hr EC 50 (for crustacea)	> 1 to ≤ 10 mg/l and/or
72 or 96 hr ErC 50 (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
(or, if absent, the log K ow ≥ 4).	(Note 3).
Category Chronic 3:
96 hr LC 50 (for fish)	> 10 to ≤ 100 mg/l and/or
48 hr EC 50 (for crustacea)	> 10 to ≤ 100 mg/l and/or
72 or 96 hr ErC 50 (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
(or, if absent, the log K ow ≥ 4).	(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.]

Note 1: U.K.

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: U.K.

Classification shall be based on the ErC ₅₀ [= EC ₅₀ (growth rate)]. In circumstances where the basis of the EC ₅₀ is not specified or no ErC ₅₀ is recorded, classification shall be based on the lowest EC ₅₀ available.

Note 3: U.K.

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: U.K.

‘No acute toxicity’ is taken to mean that the L(E)C ₅₀ (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 U.K.

4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96-hour LC ₅₀ , a crustacea species 48-hour EC ₅₀ and/or an algal species 72- or 96-hour EC ₅₀ . 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 EC ₅₀ s are treated as acute values for classification purposes (see note 2). U.K.

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 EC _x (e.g. EC ₁₀ ) shall be used. U.K.

4.1.2.8. Bioaccumulation U.K.

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 K _ow . The relationship between the log K _ow 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 K _ow ≥ 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. U.K.

4.1.2.9. Rapid degradability of organic substances U.K.

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. U.K.

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. U.K.

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. U.K.

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. U.K.

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

(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 BOD ₅ /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 U.K.

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 (1) . U.K.

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. U.K.

4.1.3. Classification criteria for mixtures U.K.

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: U.K.

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. U.K.

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 ’ .

[F2 Figure 4.1.2 Tiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards] U.K.

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

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). U.K.

4.1.3.3.2. [F2 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. U.K.

4.1.3.3.3. Classification for category Acute 1 U.K.

(a)

When there are adequate acute toxicity test data (LC ₅₀ or EC ₅₀ ) available for the mixture as a whole showing L(E)C ₅₀ ≤ 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 (LC ₅₀ (s) or EC ₅₀ (s)) available for the mixture as a whole showing L(E)C ₅₀ (s) > 1 mg/l for normally all trophic levels:

[F2 No need to classify for short-term (acute) hazard.]

4.1.3.3.4. Classification for categories Chronic 1, 2 and 3 U.K.

(a)

When there are adequate chronic toxicity data (EC _x x or NOEC) available for the mixture as a whole showing EC _x 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 (EC _x or NOEC) available for the mixture as a whole showing EC _x (s) or NOEC(s) of the tested mixture > 1 mg/l for normally all trophic levels:

[F2 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 U.K.

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 U.K.

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. U.K.

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. U.K.

[F3 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.] U.K.

Textual Amendments

F3 Substituted by Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

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

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. U.K.

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: U.K.

(a)

Based on acute aquatic toxicity:

where:

C _i

=

concentration of component i (weight percentage);

L(E)C _50i

=

(mg/l) LC ₅₀ or EC ₅₀ for component i;

η

=

number of components, and i is running from 1 to n;

L(E)C _50m

=

L(E) C ₅₀ of the part of the mixture with test data.

[F2 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:

where:

C _i

=

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.

[F2 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. U.K.

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. U.K.

4.1.3.5.5. Summation method U.K.

4.1.3.5.5.1. Rationale U.K.

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. U.K.

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. U.K.

4.1.3.5.5.2. Classification procedure U.K.

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. U.K.

4.1.3.5.5.3. Classification for category Acute 1 U.K.

[F4 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.] U.K.

Textual Amendments

F4 Substituted by Commission Regulation (EU) 2019/521 of 27 March 2019 amending, for the purposes of its adaptation to technical and scientific progress Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

4.1.3.5.5.3.2. [F2 The classification of mixtures for short-term (acute) hazards based on this summation of classified components is summarised in Table 4.1.1.] U.K.

Table 4.1.1

[F2 Classification of a mixture for short-term (acute) hazards based on summation of classified components]

a For explanation of the M-factor, see 4.1.3.5.5.5.
Sum of components classified as:	Mixture is classified as:
Acute 1 × M a ≥ 25 %	Acute 1

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

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. U.K.

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. U.K.

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 %. U.K.

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 %. U.K.

4.1.3.5.5.4.5. [F2 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.] U.K.

Table 4.1.2

[F2 Classification of a mixture for long-term (chronic) hazards, based on summation of the concentration of classified components]

a For explanation of the M-factor, see 4.1.3.5.5.5.
Sum of components classified as:	Mixture is classified as:
Chronic 1 × M a ≥ 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

4.1.3.5.5.5. Mixtures with highly toxic components U.K.

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: U.K.

• 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.

[F3 Table 4.1.3

Multiplying factors for highly toxic components of mixtures

a Non-rapidly degradable.
b Rapidly degradable.]
Acute toxicity	M factor	Chronic toxicity	M factor
L(E)C 50 value (mg/l)		NOEC value (mg/l)	NRD a components	RD b components
0,1 < L(E)C 50 ≤ 1	1	0,01 < NOEC ≤ 0,1	1	—
0,01 < L(E)C 50 ≤ 0,1	10	0,001 < NOEC ≤ 0,01	10	1
0,001 < L(E)C 50 ≤ 0,01	100	0,0001 < NOEC ≤ 0,001	100	10
0,0001 < L(E)C 50 ≤ 0,001	1 000	0,00001 < NOEC ≤ 0,0001	1 000	100
0,00001 < L(E)C 50 ≤ 0,0001	10 000	0,000001 < NOEC ≤ 0,00001	10 000	1 000
(continue in factor 10 intervals)		(continue in factor 10 intervals)

4.1.3.6. Classification of mixtures with components without any useable information U.K.

4.1.3.6.1. [F2 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’. U.K.

4.1.4. Hazard communication U.K.

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. U.K.

[F2 Table 4.1.4

Label elements for hazardous to the aquatic environment

SHORT-TERM (ACUTE) AQUATIC HAZARD
	Acute 1
GHS Pictogram
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
	Chronic 1	Chronic 2	Chronic 3	Chronic 4
GHS Pictograms			No pictogram is used	No pictogram is used
Signal Word	Warning	No signal word is used	No signal word is used	No signal word is used
Hazard Statement	H410: Very toxic to aquatic life with long lasting effects	H411: Toxic to aquatic life with long lasting effects	H412: Harmful to aquatic life with long lasting effects	H413: May cause long lasting harmful effects to aquatic life
Precautionary Statement Prevention	P273	P273	P273	P273
Precautionary Statement Response	P391	P391
Precautionary Statement Storage
Precautionary Statement Disposal	P501	P501	P501	P501] ]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

(1)

[F1 Specific guidance has been issued by the European Chemicals Agency on how these data for such substances may be used in meeting the requirements of the classification criteria.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).