Version in force 10 May 2021

Previous version, in force 14 November 2020 02008R1272-20201114 → this version, in force 10 May 2021 02008R1272-20210510

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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. … 165 unchanged lines … Note H (Table 3.2): The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. Manufacturers, importers and downstream users of this substance shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exists for all other properties to classify and label the substance. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC. Note J: 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). This note applies only to certain complex coal- and oil-derived substances in Part 3. The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. 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. The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w 1,3- butadiene (Einecs No 203-450-8), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 shall apply. Note L: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346 Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in Part 3. The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 3 % of dimethyl sulphoxide extract as measured by IP 346 (Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions – Dimethyl sulphoxide extraction refractive index method Institute of Petroleum, London), in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class. Note M: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (EINECS No 200-028-5). This note applies only to certain complex coal-derived substances in Part 3. The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5), in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class. Note N: The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances in Part 3. The harmonised classification as a carcinogen applies unless the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen, in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class. 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. The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply. Note Q: The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions: a short term biopersistence test by inhalation has shown that the fibres longer than 20 μm have a weighted half-life less than 10 days; or a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted half-life less than 40 days; or an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test. The harmonised classification as a carcinogen applies unless one of the following conditions is fulfilled: a short term biopersistence test by inhalation has shown that fibres longer than 20 μm have a weighted half-life less than 10 days; or a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted half-life less than 40 days; or an appropriate intra-peritoneal test has provided no evidence of excess carcinogenicity; or no relevant pathogenicity or neoplastic changes are noted in a suitable long term inhalation test Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 μm. The harmonised classification as a carcinogen applies except in the case of fibres with a Length Weighted Geometric Mean Diameter (LWGMD) minus two geometric standard errors greater than 6 μm, as measured in accordance with Test method A.22 in the Annex to Commission Regulation (EC) No 440/2008 Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).. Note S: This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3). Note T: … 17 unchanged lines … 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 %. The classification as a carcinogen shall apply unless 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 %. The classification as a mutagen shall apply unless 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; … 55,159 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