(2)

Part 1 is amended as follows: (a) the title of Section 1.1.2 is replaced by the following: ‘1.1.2. Information related to the classification and labelling of each entry in Table 3’; (b) Section 1.1.2.3 is replaced by the following: ‘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, 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.’; (c) Section 1.1.3.1 is amended as follows: (i) Note E is deleted; (ii) Note K is replaced by the following: ‘Note K: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3.’; (iii) Note P is replaced by the following: ‘Note P: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7). When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply. This note applies only to certain complex oil-derived substances in Part 3.’; (iv) Note S is replaced by the following: ‘Note S: This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).’; (v) in Note U, the title is replaced by the following: ‘Note U (Table 3):’; (d) Section 1.1.3.2 is amended as follows: (i) Note 1 is replaced by the following: ‘Note 1: 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.’; (ii) Note 8 is added as follows: ‘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 %.’; (iii) Note 9 is added as follows: ‘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 %.’; (e) Section 1.1.4 is deleted; (f) The Title of Section 1.2 is replaced by the following: ‘1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC’; (g) Section 1.2.1 is replaced by the following: ‘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 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. 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.’; (h) Section 1.2.2 is replaced by the following: ‘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 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.’; (i) Section 1.2.3 is replaced by the following: ‘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. 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.’; (j) Section 1.2.4 is replaced by the following: ‘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.’;