The European Chemicals Agency (ECHA) has issued a draft regulation that proposes the addition of new substances of very high concern (SVHCs) to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Authorisation List.

When the regulation is adopted, the 12 substances will increase the REACH Authorisation List from 43 to 55 substances. The European Union Notification to World Trade Organisation has proposed an October 2019 implementation date for the new substances.

Substances proposed under “toxic for reproduction category 1B” are:

  1. 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (CAS number: 68515-50-4)
  2. dihexyl phthalate (CAS number: 84-75-3)
  3. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl, hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (CAS numbers: 68515-51-5; 68648-93-1)
  4. trixylyl phosphate (CAS number: 25155-23-1)
  5. sodium perborate, perboric acid, sodium salt (EC number: 239-172-9; 234-390-0)
  6. sodium peroxometaborate (CAS number: 7632-04-4)

Learn more about REACH and how to manage SVHC data in our ebook, The REACH Handbook: Your Guide to SVHC Compliance.

Substances proposed as “persistent, bioaccumulative and toxic (PBT), and/or very persistent and very bioaccumulative (vPvB)” and “vPVB” are:

  1. 5-sec-butyl-2-(2,4-dimethylcyclohex3-en-1-yl)-5-methyl-1,3-dioxane [1],
    5-sec-butyl-2-(4,6-dimethylcyclohex3-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 number: 25973-55-1)
  3. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) (CAS number: 3864-99-1)
  4. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) (CAS number: 36437-37-3)
  5. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) octyl diesters with ≥ 0.3% of dihexyl phthalate (CAS number: 3846-71-7)

The lone substance classified as a “respiratory sensitiser category 1” is diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA) (CAS number: 123-77-3).

The update is the first amendment to the Authorisation List since June 2017.

Monitoring the use of SVHCs and future SVHCs in products is essential to maintaining compliance and market access. By collecting full material disclosures (FMDs), companies can quickly search for the proposed SVHC additions and, if necessary, take the appropriate action before they come into force.

The Assent Platform supports SVHC and FMD data collection. To learn more, contact us today.

Dr. Raj Takhar
Regulatory & Sustainability Expert, Product Sustainability

Raj helps companies meet their product compliance challenges in an ever-changing regulatory landscape. He specializes in product compliance, chemical reporting, and program implementation in Europe.

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