ECHA raises its sights: Several recent additions to the REACH Candidate List set precedents

Alissa Sasso is a Chemicals Policy Fellow.

The European Union is maintaining a steady pace as it works to address chemicals of concern: Last month, the European Chemicals Agency (ECHA) added 54 Substances of Very High Concern (SVHCs) to the Candidate List for Authorisation under its REACH Regulation, bringing the total number of substances on the list to 138. ECHA posted a press release listing the new SVHCs and describing some of the more interesting additions, which we’ve highlighted below.

For 23 of the additions, REACH’s Member State Committee (MSC) reviewed public comments during the comment period on draft SVHC proposals before voting unanimously to add all of them onto the Candidate List. The other 31 new additions were not challenged during the public comment period, and hence moved directly onto the candidate list without MSC consultation.

The majority of the new SVHCs, like most substances already on the list, are classified as carcinogen, mutagenic and/or toxic to reproduction (CMRs).  But it’s with the other new listings that it gets really interesting. 

Noteworthy additions to the Candidate List under the “equivalent level of concern” designation

  • For the first time, three respiratory sensitizers were identified as SVHCs: diazene-1,2-dicarboxamide (ADCA), hexahydro-2-benzofuran-1,3-dione (HHPA) and hexahydromethylphthalic anhydride (MHHPA).
  • Two more endocrine-disrupting chemicals were added to accompany the one already on the list ((1,1,3,3-tetramethylbutyl)phenol, first listed in December 2011):
    • 4-nonylphenol; and
    • Octylphenol ethoxylate, which was added because of the endocrine-disrupting properties of its degradation product(1,1,3,3-tetramethylbutyl)phenol, mentioned above.

Other precedents

Another chemical also made the list due to the properties of its degradation products:  DecaBDE is classified as both persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB), based on the PBT/vPvB properties of the lower-brominated BDE substance(s) it degrades into.

Finally, four perfluorinated chemicals were added to the list based on “read-across” – a process by which hazard data on one or more chemicals that have been tested and are structurally related to chemicals under consideration are used to “estimate” the latter chemicals’ hazards.  In this case, perfluorinated chemicals with 11, 12, 13 and 14 carbon atoms in their backbone chains (C11-14) were classified as vPvB substances based primarily on the known vPvB properties of their shorter-chain analogs (C8-9).

The identification of these chemicals as SVHCs sets important precedents for broadening the scope of chemicals that may be included on the Candidate List under REACH. Geert Dancet, Executive Director of ECHA, believes “that through the recent work on respiratory sensitisers, PBTs and endocrine disruptors [ECHA] has created a solid foundation for the inclusion of all types of substances of concern” in the future.

And, as with all substances on the Candidate List, these chemicals may be added to the Authorisation List, which ultimately leads to bans or limits on the use of such substances.

ECHA’s most recent move draws an even starker contrast with the badly outmoded U.S. system, where exceedingly few substances of high concern have been identified, let alone restricted, in the nearly four decades since adoption of the Toxic Substances Control Act in 1976.

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