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Document 32011R0286
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
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
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
OJ L 83, 30.3.2011, p. 1–53
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) This document has been published in a special edition(s)
(HR)
In force: This act has been changed. Current consolidated version: 01/07/2013
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Modifies | 32008R1272 | Amendment | annex V | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex IV | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex VII | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex I | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex II | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex VI | 19/04/2011 | |
Modifies | 32008R1272 | Addition | article 26 .1.E | 19/04/2011 | |
Modifies | 32008R1272 | Amendment | annex III | 19/04/2011 | |
Modifies | 32008R1272 | abolition | article 25 .5 | 19/04/2011 |
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Corrected by | 32011R0286R(01) | (BG, CS, DA, DE, EL, EN, ES, ET, FI, FR, HU, IT, LT, LV, MT, NL, PL, PT, RO, SK, SL, SV) | |||
Corrected by | 32011R0286R(02) | (HU, NL, RO, MT, LV, SK, LT, EL, DE, ES, IT) | |||
Corrected by | 32011R0286R(03) | (DA, FR, HU) | |||
Corrected by | 32011R0286R(04) | (FR) | |||
Corrected by | 32011R0286R(05) | (RO) | |||
Corrected by | 32011R0286R(06) | (SL) | |||
Modified by | 32013R0519 | Addition | annex XIII PT 3.2 | 01/07/2013 | |
Modified by | 32013R0519 | Completion | annex III.1 point D)i) | 01/07/2013 | |
Modified by | 32013R0519 | Completion | annex III.1 point C)iii) | 01/07/2013 | |
Modified by | 32013R0519 | Completion | annex IV.1 point C).2 | 01/07/2013 |
30.3.2011 |
EN |
Official Journal of the European Union |
L 83/1 |
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 53 thereof,
Whereas:
(1) |
Regulation (EC) No 1272/2008 harmonises the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the European Union. |
(2) |
That Regulation takes into account the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as ‘the GHS’) of the United Nations (UN). |
(3) |
The classification criteria and labelling rules of the GHS are periodically reviewed at UN level. The third revised edition of the GHS was adopted in December 2008 by the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals (UNCETDG/GHS). It contains amendments concerning, inter alia, the provisions for the allocation of hazard statements and for the labelling of small packaging, new sub-categories for respiratory and skin sensitisation, the revision of the classification criteria for long-term hazards (chronic toxicity) to the aquatic environment and a new hazard class for substances and mixtures hazardous to the ozone layer. It is therefore necessary to adapt the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the third revised edition of the GHS. |
(4) |
The GHS allows authorities to adopt supplemental labelling provisions to protect individuals already sensitised to a specific chemical that may elicit a response at very low concentration. Requirements should be introduced to add the name of such chemical on the label even if present at very low concentration in a mixture. |
(5) |
The terminology of different provisions in the Annexes and certain technical criteria should also be amended to facilitate implementation by operators and enforcement authorities, to improve consistency of the legal text and to enhance clarity. |
(6) |
To ensure that suppliers of substances can adapt to the new classification, labelling and packaging provisions introduced by this Regulation, a transitional period should be foreseen and the application of this Regulation should be deferred. This should allow for the possibility to apply the provisions laid down in this Regulation on a voluntary basis before the transitional period is over. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established pursuant to Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2), |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 1272/2008 is amended as follows:
(1) |
Article 25(5) is deleted; |
(2) |
the following new section (e) is inserted in Article 26(1):
|
(3) |
Annex I is amended in accordance with Annex I to this Regulation; |
(4) |
Annex II is amended in accordance with Annex II to this Regulation; |
(5) |
Annex III is amended in accordance with Annex III to this Regulation; |
(6) |
Annex IV is amended in accordance with Annex IV to this Regulation; |
(7) |
Annex V is amended in accordance with Annex V to this Regulation; |
(8) |
Annex VI is amended in accordance with Annex VI to this Regulation; |
(9) |
Annex VII is amended in accordance with Annex VII to this Regulation. |
Article 2
Transitional provisions
1. By way of derogation from the second paragraph of Article 3, substances and mixtures may, before 1 December 2012 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.
2. By way of derogation from the second paragraph of Article 3, substances classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before 1 December 2012, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2014.
3. By way of derogation from the second paragraph of Article 3, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC of the European Parliament and of the Council (3) or Regulation (EC) No 1272/2008 and placed on the market before 1 June 2015, are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply in respect of substances from 1 December 2012 and in respect of mixtures from 1 June 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 March 2011.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 353, 31.12.2008, p. 1.
ANNEX I
A. |
Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:
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B. |
Part 2 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:
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C. |
Part 3 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:
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D. |
Part 4 of Annex I to Regulation (EC) No 1272/2008 is replaced by the following text: ‘4. PART 4: ENVIRONMENTAL HAZARDS 4.1. Hazardous to the aquatic environment 4.1.1. Definitions and general considerations 4.1.1.1. Definitions
4.1.1.2. Basic elements 4.1.1.2.0. Hazardous to the aquatic environment is differentiated into:
4.1.1.2.1. The basic elements used for classification for aquatic environmental hazards are:
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. 4.1.1.3. Other considerations 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. 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 acute (short-term) and long-term 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. 4.1.1.3.2. 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. 4.1.2. Classification criteria for substances 4.1.2.1. The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and long-term hazard of a substance. For the long-term 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. 4.1.2.2. The core classification system for substances consists of one acute hazard classification category and three long-term hazard classification categories. The acute and the long-term hazard classification categories are applied independently. The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50). The criteria for classification of a substance into the categories Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term 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). Figure 4.1.1 Categories for substances long-term hazardous to the aquatic environment Are there adequate chronic toxicity data available for all three trophic levels? Yes Classify according to the criteria given in Table 4.1.0(b) (i) or 4.1.0(b)(ii) depending on information on rapid degradation No Are there adequate chronic toxicity data available for one or two trophic levels? Yes Assess both: (a) according to the criteria given in Table 4.1.0(b)(i) or 4.1.0(b)(ii) (depending on information on rapid degradation), and (b) (if for the other trophic level(s) adequate acute toxicity data are available) according to the criteria given in Table 4.1.0(b) (iii), and classify according to the most stringent outcome No Are there adequate acute toxicity data available? Yes Classify according to the criteria given in Table 4.1.0(b) (iii) 4.1.2.4. The system also introduces a “safety net” classification (referred to as category 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 in Table 4.1.0). 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). 4.1.2.6. The criteria for classifying and categorising substances as “hazardous to the aquatic environment” are summarised in Table 4.1.0. Table 4.1.0 Classification categories for hazardous to the aquatic environment
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:
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 (*8). 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.) 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:
Figure 4.1.2 Tiered approach to classification of mixtures for acute and long-term aquatic environmental hazards Aquatic toxicity test data available on the mixture as a whole No Yes CLASSIFY for acute/long-term aquatic hazard (see 4.1.3.3) Sufficient data available on similar mixtures to estimate hazards Yes Apply bridging principles (see 4.1.3.4.) CLASSIFY for acute/long-term aquatic hazard No Either aquatic toxicity or classification data available for all relevant components Yes 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 acute/long-term aquatic hazard No Use available hazard data of known components Apply summation method and/or additivity formula (see 4.1.3.5) and apply 4.1.3.6 CLASSIFY for acute/long-term aquatic hazard 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 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
4.1.3.3.4. Classification for categories Chronic 1, 2 and 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 classified 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:
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 greater than 25 % the whole mixture is classified as Acute 1. 4.1.3.5.5.3.2. The classification of mixtures for 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 acute hazards, based on summation of classified components
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 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 hazards, based on summation of the concentrations of classified components
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:
Table 4.1.3 Multiplying factors for highly toxic components of mixtures
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 acute and/or long-term 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
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E. |
Part 5 of Annex I to Regulation (EC) No 1272/2008 is replaced by the following text: ‘5. PART 5: ADDITIONAL HAZARDS 5.1. Hazardous to the ozone layer 5.1.1. Definitions and general considerations 5.1.1.1. Ozone depleting potential (ODP) is an integrative quantity, distinct for each halocarbon source species, that represents the extent of ozone depletion in the stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11. Substance hazardous to the ozone layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (*9). 5.1.2. Classification criteria for substances 5.1.2.1. A substance shall be classified as hazardous to the ozone layer (Category 1) if the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer. 5.1.3. Classification criteria for mixtures 5.1.3.1. Mixtures shall be classified as hazardous to the ozone layer (Category 1) on the basis of the individual concentration of the substance(s) contained therein that are also classified as hazardous to the ozone layer (Category 1), in accordance with Table 5.1. Table 5.1 Generic concentration limits for substances (in a mixture), classified as hazardous to the ozone layer (Category 1), that trigger classification of the mixture as hazardous to the ozone layer (Category 1)
5.1.4. Hazard communication 5.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2. Table 5.2 Label elements for hazardous to the ozone layer
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(*1) To date, the calculation method has been validated for mixtures containing up to 6 volatile components. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except acrylates), and water. It is however not yet validated for mixtures containing halogenated sulphurous, and/or phosphoric compounds as well as reactive acrylates.
(*2) If the calculated flash point is less than 5 °C greater than the relevant classification criterion, the calculation method may not be used and the flash point should be determined experimentally.’;
(*6) At present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment.
(*7) The mechanisms by which substances induce symptoms of asthma are not yet fully known. For preventative measures, these substances are considered respiratory sensitisers. However, if on the basis of the evidence, it can be demonstrated that these substances induce symptoms of asthma by irritation only in people with bronchial hyper reactivity, they should not be considered as respiratory sensitisers.’;
(*9) OJ L 286, 31.10.2009, p. 1.’.’
(*3) OJ L 142, 31.5.2008, p. 1.’
(*4) Gas concentrations are expressed in parts per million per volume (ppmV).
(*5) At present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment.
(*8) 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.
(1) For explanation of the M-factor, see 4.1.3.5.5.5.
(2) For explanation of the M-factor, see 4.1.3.5.5.5.
(3) Non-rapidly degradable.
(4) Rapidly degradable.
ANNEX II
Annex II to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
Part 2 is amended as follows:
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(2) |
in Part 3, section 3.2.2.1, is replaced by the following:
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ANNEX III
Annex III to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
Part 1 shall be amended as follows:
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(2) |
in Part 2, Table 2.3 is deleted; |
(3) |
Part 3 is amended as follows:
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ANNEX IV
Annex IV to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
Part 1 is amended as follows:
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(2) |
in Part 2, Table 1.5, the following precautionary statement is added after Code P501:
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ANNEX V
Annex V to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
the first sentence is replaced by the following: ‘The hazard pictograms for each hazard class, differentiation of a hazard class and hazard category shall satisfy the provisions of this Annex and Annex I, section 1.2 and conform in terms of symbols and general format, to the specimens shown.’; |
(2) |
Part 2, section 2.3 is amended as follows:
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(3) |
in Part 2, section 2.4, column 2, the words ‘Respiratory sensitisation, hazard category 1’ are replaced by ‘Respiratory sensitisation, hazard categories 1, 1A, 1B’; |
(4) |
in Part 3, the pictogram GHS09 is replaced by the following pictogram: ‘GHS09
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(5) |
the following new Part 4 is added: ‘4. PART 4: ADDITIONAL HAZARDS 4.1. Symbol: exclamation mark
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ANNEX VI
Annex VI to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
Part 1 is amended as follows:
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(2) |
Part 3, is amended as follows:
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ANNEX VII
Annex VII to Regulation (EC) No 1272/2008 is amended as follows:
in Table 1.1, last row, the hazard statement ‘EUH059’ is replaced by ‘H420’.