(1)

The title of Section 1.1.3.4 is replaced by the following:

‘1.1.3.4   Interpolation within one hazard category’

(2)

Section 1.3.6 is replaced by the following:

‘1.3.6    Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)

Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05.’

(1)

Section 2.1.3 is replaced by the following:

‘2.1.3    Hazard Communication

Label elements shall be used for substances, mixtures or articles meeting the criteria for classification in this hazard class in accordance with Table 2.1.2.

Table 2.1.2

Label elements for explosives

NOTE 1: Unpackaged explosives or explosives repackaged in packaging other than the original or similar packaging shall include all of the following label elements:

unless the hazard is shown to correspond to one of the hazard categories in Table 2.1.2, in which case the corresponding symbol, the signal word and/or the hazard statement shall be assigned.

NOTE 2: Substances and mixtures, as supplied, with a positive result in Test Series 2 in Part I, Section 12, of the UN RTDG, Manual of Tests and Criteria, which are exempted from classification as explosives (based on a negative result in Test Series 6 in Part I, Section 16 of the UN RTDG, Manual of Tests and Criteria) still have explosive properties. The user shall be informed of these intrinsic explosive properties because they have to be considered for handling — especially if the substance or mixture is removed from its packaging or is repackaged — and for storage. For this reason, the explosive properties of the substance or mixture shall be communicated in Section 2 (Hazards identification) and Section 9 (Physical and chemical properties) of the Safety Data Sheet and other sections of the Safety Data Sheet, as appropriate.’

(2)

In Section 2.1.4, Figure 2.1.3 is replaced by the following:

‘Figure 2.1.3

Procedure for assignment to a division in the class of explosives (Class 1 for transport)

(3)

In Section 2.2.3, Table 2.2.3 is replaced by the following:

‘Table 2.2.3

Label elements for flammable gases (including chemically unstable gases)

(4)

Section 2.3.2.1 is replaced by the following:

2.3.2.1.   Aerosols shall be classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:

or if their heat of combustion is at least 20 kJ/g.

NOTE 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.

NOTE 2: Aerosols do not fall additionally within the scope of Sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements.’

(5)

In Section 2.3.2, Figure 2.3.1(a) is replaced by the following:

‘Figure 2.3.1(a) for aerosols

(6)

In Section 2.3.3, the heading of Table 2.3.1 is replaced by the following:

‘Label elements for aerosols’

(7)

In Section 2.5.3, Table 2.5.2 is replaced by the following:

‘Table 2.5.2

Label elements for gases under pressure

(8)

In Section 2.8.3, Table 2.8.1 is replaced by the following:

‘Table 2.8.1

Label elements for self-reactive substances and mixtures

(9)

In Section 2.8.4, Figure 2.8.1 is replaced by the following:

‘Figure 2.8.1

Self-reactive substances and mixtures

(10)

In Section 2.9.3, Table 2.9.2 is replaced by the following:

‘Table 2.9.2

Label elements for pyrophoric liquids

(11)

In Section 2.10.3, Table 2.10.2 is replaced by the following:

‘Table 2.10.2

Label elements for pyrophoric solids

(12)

In Section 2.11.3, Table 2.11.2 is replaced by the following:

‘Table 2.11.2

Label elements for self-heating substances and mixtures

(13)

In Section 2.12.3, Table 2.12.2 is replaced by the following:

‘Table 2.12.2

Label elements for substances and mixtures which in contact with water emit flammable gases

(14)

In Section 2.13.3, Table 2.13.2 is replaced by the following:

‘Table 2.13.2

Label elements for oxidising liquids

(15)

In Section 2.14.2.1, the introductory sentence is replaced by the following:

‘An oxidising solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 or test O.3 in Part III, sub-section 34.4 3 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.14.1:’

(16)

In Section 2.14.2.1, Table 2.14.1 is replaced by the following:

‘Table 2.14.1

Criteria for oxidising solids

(17)

In Section 2.14.2.1, in Note 1 to Table 2.14.1, ‘(BC Code, Annex 3, Test 5)’ is replaced by ‘(IMSBC Code (International Maritime Solid Bulk Cargoes Code, IMO), Appendix 2, Section 5)’.

(18)

In Section 2.14.3, Table 2.14.2 is replaced by the following:

‘Table 2.14.2

Label elements for oxidising solids

(19)

In Section 2.15.3, Table 2.15.1 is replaced by the following:

‘Table 2.15.1

Label elements for organic peroxides

(20)

In Section 2.15.4, Figure 2.15.1 is replaced by the following:

‘Figure 2.15.1

Organic Peroxides

(1)

In Section 3.1.2.1, the first sentence is replaced by the following:

‘Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1.’

(2)

In Section 3.1.2.3.2, the first sentence is replaced by the following:

‘Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the highest hazard categories for dusts and mists.’

(3)

In Section 3.1.3.6.1, point (a) is replaced by the following:

‘include ingredients with a known acute toxicity, which fall into any of the acute hazard categories shown in Table 3.1.1;’

(4)

Chapter 3.2 is replaced by the following:

‘3.2.   Skin corrosion/irritation

3.2.1.    Definitions and general considerations

3.2.1.2.   In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data and then other sources of information. Classification results directly when the data satisfy the criteria. In some cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5).

3.2.2.    Classification criteria for substances

Substances shall be allocated to one of the following two categories within this hazard class:

3.2.2.1.   Classification based on standard animal test data

3.2.2.1.1.   Skin corrosion

3.2.2.1.2.   Skin irritation

3.2.2.2   Classification in a tiered approach

3.2.2.2.1.   A tiered approach to the evaluation of initial information shall be considered, where applicable, recognising that not all elements may be relevant.

3.2.2.2.2.   Existing human and animal data including information from single or repeated exposure shall be the first line of evaluation, as they give information directly relevant to effects on the skin.

3.2.2.2.3.   Acute dermal toxicity data may be used for classification. If a substance is highly toxic by the dermal route, a skin corrosion/irritation study is not practicable since the amount of test substance to be applied considerably exceeds the toxic dose and, consequently, results in the death of the animals. When observations are made of skin corrosion/irritation in acute toxicity studies and are observed up through the limit dose, these data may be used for classification, provided that the dilutions used and species tested are equivalent. Solid substances (powders) may become corrosive or irritant when moistened or in contact with moist skin or mucous membranes.

3.2.2.2.4.   In vitro alternatives that have been validated and accepted shall be used to make classification decisions.

3.2.2.2.5.   Likewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the potential to cause skin effects, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally, such substances are expected to produce significant effects on the skin. In the absence of any other information, a substance is considered as corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

3.2.2.2.6.   In some cases, sufficient information may be available from structurally related substances to make classification decisions.

3.2.2.2.7.   The tiered approach provides guidance on how to organize existing information on a substance and to make a weight of evidence decision about hazard assessment and hazard classification.

Although information might be gained from the evaluation of single parameters within a tier (see Section 3.2.2.2.1.), consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.

3.2.3.    Classification criteria for mixtures

3.2.3.1.   Classification of mixtures when data are available for the complete mixture

3.2.3.1.1.   The mixture shall be classified using the criteria for substances, taking into account the tiered approach to evaluate data for this hazard class.

3.2.3.1.2.   When considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and irritation (Sections 3.2.1.2 and 3.2.2.2), to help ensure an accurate classification as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the mixture may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

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

3.2.3.2.1.   Where the mixture itself has not been tested to determine its skin corrosion/irritation potential, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.

3.2.3.3.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.2.3.3.1.   In order to make use of all available data for purposes of classifying the skin corrosion/irritation hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

The “relevant ingredients” of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g., in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for skin corrosion/irritation.

3.2.3.3.2.   In general, the approach to classification of mixtures as corrosive or irritant to skin when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or skin irritant ingredient contributes to the overall skin corrosive or skin irritant properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as skin irritant. The mixture is classified as corrosive or irritant to skin when the sum of the concentrations of such ingredients exceeds a concentration limit.

3.2.3.3.3.   Table 3.2.3 provides the generic concentration limits to be used to determine if the mixture is considered to be corrosive or irritant to the skin.

3.2.3.3.4.1.   Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.2.3.3.1 and 3.2.3.3.2 may not be applicable given that many such substances are corrosive or irritant to the skin at concentrations < 1 %.

3.2.3.3.4.2.   For mixtures containing strong acids or bases the pH shall be used as a classification criterion (see Section 3.2.3.1.2) since pH is a better indicator of skin corrosion than the concentration limits in Table 3.2.3.

3.2.3.3.4.3.   A mixture containing ingredients that are corrosive or irritant to the skin and that cannot be classified on the basis of the additivity approach (Table 3.2.3), due to chemical characteristics that make this approach unworkable, shall be classified as Skin Corrosion Category 1 if it contains ≥ 1 % of an ingredient classified as Skin Corrosion or as Skin Irritation (Category 2) when it contains ≥ 3 % of an skin irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.2.3 does not apply is summarised in Table 3.2.4.

3.2.3.3.5.   On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4 in Section 3.2.3.3.6. In these cases the mixture shall be classified according to that data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered. In those cases the tiered weight of evidence approach shall be applied, as described in Section 3.2.2.2.

3.2.3.3.6.   If there are data showing that (an) ingredient(s) is/are corrosive or irritant to skin at a concentration of < 1 % (skin corrosive) or < 3 % (skin irritant), the mixture shall be classified accordingly.

Table 3.2.3

Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C)/skin irritation (Category 2) that trigger classification of the mixture as skin corrosion/skin irritation where the additivity approach applies

Note:

The sum of all ingredients of a mixture classified as Skin Corrosion Sub-Category 1A, 1B, or 1C respectively, shall each be ≥ 5 % in order to classify the mixture as either Skin Corrosion Sub-Category 1A, 1B or 1C. If the sum of the ingredients classified as Skin Corrosion Sub-Category 1A is < 5 % but the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B is ≥ 5 %, the mixture shall be classified as Skin Corrosion Sub-Category 1B. Similarly, if the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B ingredients is < 5 % but the sum of ingredients classified as Sub-Category 1A + 1B + 1C is ≥ 5 % the mixture shall be classified as Skin Corrosion Sub-Category 1C. Where at least one relevant ingredient in a mixture is classified as Category 1 without sub-categorisation, the mixture shall be classified as Category 1 without sub-categorisation if the sum of all ingredients corrosive to skin is ≥ 5 %.

Table 3.2.4

Generic concentration limits of ingredients that trigger classification of the mixture as skin corrosion/skin irritation, where the additivity approach does not apply

3.2.4.    Hazard Communication

3.2.4.1.   Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.2.5.

Table 3.2.5

Label elements for skin corrosion/irritation

(5)

Chapter 3.3 is replaced by the following:

‘3.3.   Serious eye damage/eye irritation

3.3.1.    Definitions and general considerations

3.3.1.2.   In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data, and then other sources of information. Classification results directly when the data satisfy the criteria. In other cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Section 1.1.1.3).

3.3.2.    Classification criteria for substances

Substances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows:

3.3.2.1.   Classification based on standard animal test data

3.3.2.1.1.   Serious eye damage (Category 1)

Table 3.3.1

Serious eye damage  (2)

3.3.2.1.2.   Eye irritation (Category 2)

Table 3.3.2

Eye irritation  (3)

3.3.2.2.   Classification in a tiered approach

3.3.2.2.1.   A tiered approach to the evaluation of initial information shall be considered where applicable, recognizing that not all elements may be relevant.

3.3.2.2.2.   Existing human and animal data shall be the first line of evaluation as they give information directly relevant to effects on the eye. Possible skin corrosion has to be evaluated prior to consideration of any testing for serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. Skin corrosive substances shall be considered as leading to serious eye damage (Category 1) as well, while skin irritant substances may be considered as leading to eye irritation (Category 2).

3.3.2.2.3.   In vitro alternatives that have been validated and accepted shall be used to make classification decisions.

3.3.2.2.4.   Likewise, pH extremes like ≤ 2 and ≥ 11,5, may indicate serious eye damage, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally such substances are expected to produce significant effects on the eyes. In the absence of any other information, a substance is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

3.3.2.2.5.   In some cases sufficient information may be available from structurally related substances to make classification decisions.

3.3.2.2.6.   The tiered approach provides guidance on how to organize existing information and to make a weight-of-evidence decision about hazard assessment and hazard classification. Animal testing with corrosive substances shall be avoided whenever possible. Although information might be gained from the evaluation of single parameters within a tier (see 3.3.2.1.1) consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.

3.3.3.    Classification criteria for mixtures

3.3.3.1.   Classification of mixtures when data are available for the complete mixture

3.3.3.1.1.   The mixture shall be classified using the criteria for substances, and taking into account the tiered approach to evaluate data for this hazard class.

3.3.3.1.2.   When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and serious eye damage/eye irritation to help ensure an accurate classification, as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkali reserve suggests the mixture may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably data from an appropriate validated in vitro test.

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

3.3.3.2.1.   Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage/eye irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.

3.3.3.3.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.3.3.3.1.   In order to make use of all available data for purposes of classifying the serious eye damage/eye irritation properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

The “relevant ingredients” of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g. in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for serious eye damage/eye irritation.

3.3.3.3.2.   In general, the approach to classification of mixtures as seriously damaging to the eye/eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or serious eye damaging/eye irritant ingredient contributes to the overall serious eye damage/eye irritation properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive and serious eye damaging ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as eye irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a concentration limit.

3.3.3.3.3.   Table 3.3.3 provides the generic concentration limits to be used to determine if the mixture shall be classified as seriously damaging to the eye or as eye irritant.

3.3.3.3.4.1.   Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.3.3.3.1 and 3.3.3.3.2 might not work given that many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %.

3.3.3.3.4.2.   For mixtures containing strong acids or bases the pH shall be used as classification criterion (see Section 3.3.3.1.2) since pH will be a better indicator of serious eye damage (subject to consideration of acid/alkali reserve) than the generic concentration limits in Table 3.3.3.

3.3.3.3.4.3.   A mixture containing skin corrosive or serious eye damaging/eye irritating ingredients that cannot be classified based on the additivity approach (Table 3.3.3) due to chemical characteristics that make this approach unworkable, shall be classified as Serious Eye Damage (Category 1) if it contains ≥ 1 % of a skin corrosive or serious eye damaging ingredient and as Eye Irritation (Category 2) when it contains ≥ 3 % of an eye irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.3.3 does not apply is summarised in Table 3.3.4.

3.3.3.3.5.   On occasion, reliable data may show that the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in Section 3.3.3.3.6. In these cases the mixture shall be classified according to those data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazards or the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence approach shall be applied.

3.3.3.3.6.   If there are data showing that (an) ingredient(s) may be corrosive to the skin or seriously damaging to the eye/eye irritating at a concentration of < 1 % (corrosive to the skin or seriously damaging to the eye) or < 3 % (eye irritant), the mixture shall be classified accordingly.

Table 3.3.3

Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C) and/or serious eye damage (Category 1) or eye irritation (Category 2) that trigger classification of the mixture as serious eye damage/eye irritation where the additivity approach applies

Table 3.3.4

Generic concentration limits of ingredients that trigger classification of the mixture as serious eye damage (Category 1) or eye irritation (Category 2), where the additivity approach does not apply

3.3.4.    Hazard Communication

3.3.4.1.   Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.3.5.

Table 3.3.5

Label elements for serious eye damage/eye irritation  (5)

(6)

In Section 3.5.2.3.5, the second indent is deleted.

(1)

Section 4.1.1.1 is amended as follows:

(2)

Section 4.1.1.2.0 is replaced by the following:

‘Hazardous to the aquatic environment is differentiated into:

(3)

In Section 4.1.1.3.1, the second and third sentences are replaced by the following:

‘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.’

(4)

In Section 4.1.2.1, the first and second sentences are replaced by the following:

‘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.’

(5)

Section 4.1.2.2 is replaced by the following:

‘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.’

(6)

Section 4.1.2.3 is replaced by the following:

‘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).’

(7)

The title of Figure 4.1.1 is replaced by:

‘Categories for substances long-term (chronic) hazardous to the aquatic environment’.

(8)

Section 4.1.2.4. is replaced by the following:

‘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).’

(9)

Table 4.1.0 is replaced by the following:

‘Table 4.1.0

Classification categories for substances hazardous to the aquatic environment

(10)

In Section 4.1.3.2, Figure 4.1.2 is replaced by the following:

‘Figure 4.1.2

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

(11)

In Section 4.1.3.3.2, the first sentence is replaced by the following:

‘The long-term (chronic) hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation.’

(12)

In Section 4.1.3.3.3, ‘No need to classify for acute hazard’ is replaced by the following:

‘No need to classify for short-term (acute) hazard.’

(13)

In Section 4.1.3.3.4, ‘No need to classify for long-term hazard in categories Chronic 1, 2 or 3’ is replaced by the following:

‘No need to classify for long-term (chronic) hazard in categories Chronic 1, 2 or 3.’

(14)

In Section 4.1.3.5.2, point (a), the last sentence is replaced by the following:

‘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.’

(15)

In Section 4.1.3.5.2, point (b), the last sentence is replaced by the following:

‘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.’

(16)

Section 4.1.3.5.5.3.2 is replaced by the following:

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

(17)

In Section 4.1.3.5.5.3.2 the title of Table 4.1.1 is replaced by the following:

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

(18)

Section 4.1.3.5.5.4.5 is replaced by the following:

‘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.’

(19)

The title of Table 4.1.2 is replaced by the following:

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

(20)

In Section 4.1.3.6.1, the first sentence is replaced by the following:

‘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).’

(21)

In Section 4.1.4, Table 4.1.4 is replaced by the following:

‘Table 4.1.4

Label elements for hazardous to the aquatic environment

‘(b)

if the statement H314 “Causes severe skin burns and eye damage” is assigned, the statement H318 “Causes serious eye damage” may be omitted.’

(2)

The third paragraph is replaced by the following:

‘When a forward slash or diagonal mark [/] appears in a precautionary statement text in column (2), this indicates that a choice has to be made between the phrases they separate in accordance with the indications provided in column (5).’

(a)

Table 6.2 is amended as follows:

(b)

Table 6.3 is amended as follows:

(c)

Table 6.4 is amended as follows:

(d)

Table 6.5 is amended as follows:

The entries concerning codes P501 and P502 are replaced by the following:

(a)

Table 1.2 is amended as follows: