Regulation 2018/1480 - Commission Regulation 2018/1480 amending, for the purposes of its adaptation to technical and scientific progress, Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2017/776 - Main contents

EN

Official Journal of the European Union

L 251/1

Table 3.1 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions on those proposals issued by the Committee for Risk Assessment of the Agency (RAC), as well as on the comments received from the parties concerned, it is appropriate to introduce, update or delete harmonised classification and labelling of certain substances.

Council Directive 67/548/EEC (2) and Directive 1999/45/EC of the European Parliament and of the Council (3) were repealed with effect from 1 June 2015. As a result, Part 3 of Annex VI to Regulation (EC) No 1272/2008 was amended by Commission Regulation (EU) 2016/1179 (4) to remove Table 3.2. That amendment took effect on 1 June 2017. Annex VI to Regulation (EC) No 1272/2008 was further amended by Commission Regulation (EU) 2017/776 (5) to delete references to Table 3.2, to convert references to Table 3.1 into references to Table 3 and to delete references to the repealed Directives. Under Article 2(2) of Regulation (EU) 2017/776, the majority of those amendments were to apply from 1 June 2017, while the remaining amendments were stated to apply from 1 December 2018. However, due to an oversight, Article 2(2) failed to list two further amendments that should have applied from 1 June 2017, including in particular the amendment changing the name of the Table from ‘Table 3.1’ to ‘Table 3’. The second subparagraph of Article 2(2) of Regulation (EU) 2017/776 should therefore be corrected to include reference to those two amendments. This correction, although it has the effect of applying the two amendments retroactively, does not affect the rights and obligations of manufacturers, importers, downstream users or suppliers.

Regulation (EU) 2017/776 also amended Annex VI to Regulation (EC) No 1272/2008 to add harmonised ‘Acute Toxicity Estimate’ (ATE) values in Table 3.1 as part of the information relating to the classification and labelling of certain substances for the purposes of the classification of mixtures. The ATE introduced for nicotine was expressed in mg/kg. In order to clarify how mixtures containing nicotine should be classified, the ATE for the oral and the dermal routes for nicotine should instead be expressed in ‘mg/kg bw’ (6). The ATEs for three other substances, namely colecalciferol, 1,2-dihydroxybenzene and pinoxaden should also be expressed in the same way. In addition, in the title of the penultimate column of Table 3.1, a footnote should be added indicating what the abbreviation ‘mg/kg bw’ stands...