On February 5, 2018, the European Chemicals Agency (ECHA) published its eighth recommendation to the European Commission (EC) regarding substances of very high concern (SVHCs) for authorization under REACH. ECHA prioritized seven SVHCs from the Candidate List to be added to the Authorisation List due to “their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment.” The draft recommendation on these seven substances was published in March 2017 and a public consultation was open until June 2017 (FPF reported).

The substances are: 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, no CAS number available); 2) 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328, CAS 25973-55-4); 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 3846-71-1); 6) 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2- benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (CAS 68515-51-5); and 7) 1-methyl-2-pyrrolidone (NMP, CAS 872-50-4).

Substances 2) to 5) are UV filters and are included in the FACET inventory of food contact materials (FCMs). Additionally, UV-327 is authorized as an additive under the EU Plastics Regulation (EU) 10/2011. NMP is also authorized as an additive under the Plastics Regulation and the phthalate (substance 6)) is listed in the FACET database. ECHA noted that “some of these substances are currently not used in the EU but could replace other substances recommended for or already on the Authorisation List.” The substances were prioritized “to avoid regrettable substitution,” ECHA reasoned. The EC, together with EU Member States and the European Parliament, will take the final decision regarding the inclusion of the substances in the Authorisation List.

Read more

ECHA (February 5, 2018). “ECHA proposes seven substances for authorization.

ECHA (February 5, 2018). “Annex to press release ECHA/PR/18/03.(pdf)

ECHA (February 5, 2018). “Recommendation of the European Chemicals Agency of 5 February 2018 for the inclusion of substances in Annex XIV to REACH (list of substances subject to authorization).(pdf)

Chemical Watch (February 7, 2018). “ECHA MSC backs proposal to add seven SVHCs to authorization list.