EU to Add 12 Substances to REACH Authorization List

On February 15, 2019, the European Commission’s (EC) notified the WTO of a draft regulation to add additional 12 substances of very high concern (SVHCs) to the REACH Authorization List (Annex XIV). The substances are proposed to be added in October 2019.

Six of the substances (or substance groups) are included based on their toxicity for reproduction category 1B and include:

  1. 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (CAS 68515-50-4, );
  2. 2)dihexyl phthalate (CAS 84-75-3);
  3. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters (CAS 68515-51-5); 1,2-benzenedicarboxylic acid, mixed decyl, hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (CAS 68648-93-1);
  4. trixylyl phosphate (CAS 25155-23-1);
  5. sodium perborate, perboric acid, sodium salt;
  6. sodium peroxometaborate

Four of the substances are persistent, bioaccumative and toxic (PBT), and/or very persistent and very bioaccumulative (vPvB), and one is included as just vPVB. These include:

  1. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] (covering any of the individual stereoisomers of [1] and [2] or any combination thereof) (‘karanal group’);
  2. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328, CAS 25973-55-1);
  3. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327, CAS 3864-99-1);
  4. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350, CAS 36437-37-3);
  5. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320, CAS 3846-71-7).

One other substance is included as a respiratory sensitizer category 1: 12) diazene-1,2-dicarboxamide (C,C’-azodi (formamide)) (ADCA, CAS 123-77-3). Substances 3) and 9) to 12) are included in the FACET inventory of food contact materials (FCMs).

The EC has proposed to adopt the draft regulation in October 2019 based on a World Trade Organization (WTO) notification.