On 15 December 2020, REACH Annex XVII Entry 3, Entry 28/Entry 29/Entry 30, and Entry 46, restricting the placing on the market and use of liquid substances or mixtures regarded as dangerous, substances which are classified as carcinogen, germ cell mutagen, or reproductive toxicant category 1A or 1B, and nonylphenol and nonylphenol ethoxylates respectively, were amended as per Commission Regulation (EU) 2020/2096.
In addition, Entry 22, Entry 67, and Entry 68, restricting the placing on the market and use of pentachlorophenol and its salts and esters, bis(pentabromophenyl)ether, and perfluorooctanoic acid and its salts respectively, were deleted.
Entry 3 contains several references to labelling with R65, which is one of the standard ‘R-phrases’, indicating special risks arising from the dangers associated with using the substance that were set out in Council Directive 67/548/EEC. As that Directive has been repealed, the references to R65 have been deleted from entry 3.
Pursuant to paragraph 6 of Entry 3, on 8 July 2015 the European Chemicals Agency prepared a dossier in accordance with Article 69 of Regulation (EC) No 1907/2006 and concluded that there is no need to propose an amendment of the restriction set out in that entry. Accordingly, paragraphs 6 and 7 of entry 3 have become superfluous and have been deleted.
Regulation (EU) 2017/745 of the European Parliament and of the Council lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use, accessories for such devices and certain groups of products without an intended medical purpose. As Regulation (EU) 2017/745 contains provisions on CMR substances, and to avoid double regulation, devices within the scope of Regulation (EU) 2017/745 should be exempted from the restrictions laid down in entries 28-30 of Annex XVII to Regulation (EC) No 1907/2006.
Entry 46, as first included in Regulation (EC) No 1907/2006, contained no CAS or EC numbers for nonylphenol. Commission Regulation (EC) No 552/2009 added a CAS number and an EC number to that entry, with the intention of clarifying it and allowing operators and enforcement authorities to apply it correctly. That addition however had the unintended effect that not all isomers of nonylphenol are now covered by entry 46. The intention of the legislator at the time of adoption of the restriction is now reflected by deleting those numbers.
As more severe restrictions are laid down for Entry 22, Entry 67, and Entry 68 in Regulation (EU) 2019/1021, these substances have been deleted from REACH Annex XVII.
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