Classification, Labelling and Packaging Regulation

02008R1272-20170101 → 02008R1272-20170601

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ANNEX I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met. … 1,225 unchanged lines … (b) not more than 0,5 % available oxygen from the organic peroxides when containing more than 1,0 % but not more than 7,0 % hydrogen peroxide. Note The available oxygen content ( %) of an organic peroxide mixture is given by the formula: 16nininjmi 16ninicimi where: ni number of peroxygen groups per molecule of organic peroxide i; … 1,629 unchanged lines … Symbol/pictogram Signal word Warning Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere Precautionary statements P502

02008R1272-20170101 → 02008R1272-20170601

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ANNEX VI Harmonised classification and labelling for certain hazardous substances Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3.1, subject to certain considerations arising from translating the classifications listed in Annex I to Directive 67/548/EEC. Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Community level. Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Community level. In Table 3.1 the classification and labelling are based on the criteria in Annex I to this Regulation. In Table 3.2 classification and labelling are based on the criteria in Annex VI to Directive 67/548/EEC. Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3. Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Union level. Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Union level. In Table 3 the classification and labelling are based on the criteria in Annex I to this Regulation. 1. PART 1: INTRODUCTION TO THE LIST OF HARMONISED CLASSIFICATIONS AND LABELLING 1.1. Information listed for each entry 1.1.1. Numbering of entries and identification of a substance … 16 unchanged lines … In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification shall be applied. Entries in Part 3 for salts (under any denomination) cover both anhydrous and hydrous forms, unless specified otherwise. EC or CAS numbers are not usually included for entries which comprise more than four individual substances. 1.1.2. Information related to the classification and labelling of each entry in Table 3.1 1.1.2. Information related to the classification and labelling of each entry in Table 3 1.1.2.1. Classification codes 1.1.2.1.1. Hazard class and category codes The classification for each entry is based on the criteria set out in Annex I, in accordance with Article 13(a) and is presented in the form of a code representing the hazard class and the category or categories/divisions/types within this hazard class. … 97 unchanged lines … (ii) the signal word code Dgr for Dangeror Wng for Warning, in accordance with the precedence rule in Article 20(3); (iii) the hazard statement codes as specified in Annex III, in accordance with the classification; (iv) the codes for the supplemental statements assigned in accordance with Article 25(1) and the rules specified in Annex II, part 1. 1.1.2.3. Specific concentration limits and M-factors Specific concentration limits, where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. An asterisk (*) in this column indicates that the entry has specific concentration limits for acute toxicity under Directive 67/548/EEC (Table 3.2): see also section 1.2.1. 1.1.2.3. Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE) Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of table 3. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data. Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture. In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, this M-factor is given in Table 3.1 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3.1 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, this M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3.1, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see section 4.1.3.5.5.5 of Annex I. In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, that M-factor is given in Table 3 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see Section 4.1.3.5.5.5 of Annex I. 1.1.3. Notes assigned to an entry The note(s) assigned to an entry are listed in the column entitled Notes. The meaning of the notes is as follows: 1.1.3.1. Notes relating to the identification, classification and labelling of substances … 52 unchanged lines … When put on the market gases have to be classified as Gases under pressure, in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. 1.1.3.2. Notes relating to the classification and labelling of mixtures Note 1: The concentration stated or, in the absence of such concentrations, the generic concentrations of this Regulation (Table 3.1) or the generic concentrations of Directive 1999/45/EC (Table 3.2), are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. Note 2: The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture. Note 3: The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture. Note 5: The concentration limits for gaseous mixtures are expressed as volume per volume percentage. Note 7: Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5 μg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded. Note 8: The classification as a carcinogen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %. Note 9: The classification as a mutagen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %. 1.1.4. Information related to the classification and labelling of each entry in Table 3.2 1.1.4.1. Classification codes The classification for each category of danger (as defined in Article 2(2) of Directive 67/548/EEC) is normally presented in the form of an abbreviation representing the category of danger together with the appropriate risk phrase or phrases. However, in some cases (i.e. substances classified as flammable, sensitising and some substances classified as dangerous for the environment) the risk phrase alone is used; … 28 unchanged lines … 1.1.4.4. Non-conformity with Table 3.1 for physical hazards It is recommended to update the physical hazards of some entries in Table 3.2 in a forthcoming adaptation to technical progress. Until these entries are updated, the physical hazards of the corresponding entries in both tables will not be in conformity. These entries are indicated with reference in Table 3.2. 1.2. Classifications and hazard statements in table 3.1 arising from translation of classifications listed in Annex i to directive 67/548/EEC 1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC 1.2.1. Minimum classification For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled: the manufacturer or importer has access to data or other information as specified in Part 1 of Annex I that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied; the manufacturer or importer has access to data or other information, as specified in Part 1 of Annex I, that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied, the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in this Annex if it differs from it. Minimum classification for a category is indicated by the reference * in the column Classification in Table 3.1. The reference * can also be found in the column Specific concentration Limits and M-factors where it indicates that the entry concerned has specific concentration limits under Directive 67/548/EEC (Table 3.2) for acute toxicity. These concentration limits cannot be translated into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern. Minimum classification for a category is indicated by the reference * in the column Classification in Table 3. The reference * can also be found in the column Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE) where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be translated into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern. 1.2.2. Route of exposure cannot be excluded For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure is indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available. These hazard statements are indicated by the reference ** in Table 3.1. For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available. These hazard statements are indicated by the reference ** in Table 3. 1.2.3. Hazard statements for reproductive toxicity Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: May damage/Suspected of damaging fertility or the unborn child. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation. Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: May damage/Suspected of damaging fertility or the unborn child. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation. In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive. These hazard statements are indicated by the reference *** in Table 3.1. These hazard statements are indicated by the reference *** in Table 3. 1.2.4. Correct classification for physical hazards could not be established For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing. The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.1. The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3. 2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC. 3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLES 3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE Table 3.1: List of harmonised classification and labelling of hazardous substances. Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC. Table 3.1 … 56,226 unchanged lines … S: 61 650-055-00-5 silver sodium zirconium hydrogenphosphate 422-570-3 155925-27-2 N; R50-53 N R: 50/53 S: 60-61