Five new entries added to the EU REACH Authorisation List

September 09, 2022
Table 1. New substances added to Annex XIV on 8 April 2022
Substance name | EC No. | CAS No. | Example trade names | Latest application date | Sunset Date | Intrinsic property |
Tetraethyllead | 201-075-4 | 78-00-2 | Avgas 100LL | 01-Nov-2023 | 01-May-2025 | Toxic for reproduction (Article 57c) |
4,4′-bis(dimethylamino)-4′-(methylamino)trityl alcohol (with u2265 0,1 % of Michler’s ketone (EC No 202-027-5) or Michler’s base (EC No 202-959-2)) | 209-218-2 | 561-41-1 | Solvent violet 8 | 01-Nov-2023 | 01-May-2025 | Carcinogenic (Article 57a) |
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with u22650.1% w/w 4-heptylphenol, branched and linear (4-HPbl)Formaldehyde, reaction products with phenol heptyl derivs. and 1,3,4-thiadiazolidine-2,5-dithioneFormaldehyde, reaction products with branched and linear heptylphenol, carbon disulfide and hydrazine | -939-460-0300-298-5 | -1471311-26-893925-00-9 | MASLO G-TRUCK LS 80W-90 | 01-Nov-2023 | 01-May-2025 | Endocrine disrupting properties (Article 57(f) – environment) |
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) | 239-622-4 | 15571-58-1 | EVICOM IR69, Thermolite 890 | 01-Nov-2023 | 01-May-2025 | Toxic for reproduction (Article 57c) |
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) | 915-270-3 | – | 01-Nov-2023 | 01-May-2025 | Toxic for reproduction (Article 57c) |
Sagentia Regulatory can help you to:
- Determine how and when these new entries to Annex XIV impact you and your supply chain
- Prepare a practical roadmap so you can navigate authorisation, meet your compliance obligations and effectively manage your business risks, including evaluating opportunities to avoid the need for authorisation through substitution
- Prepare and submit an application for authorisation if the path to successful substitution is not clear or timely, and/or use is required after the Sunset date
Preparing a robust application dossier takes many months and beginning work as early as possible is advisable to minimise business continuity risks. The Commission will grant an authorisation with a time-bound review period if an application is successful. There may be an option to extend the review period if required.Sagentia Regulatory helps organisations around the world manage their authorisation obligations and, when needed, submit applications under EU and UK REACH. Get in contact today at [email protected] to discuss how REACH authorisation requirements affect your business.