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EU Proposed Commission Regulation to Add Five New Substances in Annex XIV to REACH Regulation

In June 2021, the European Commission has proposed Commission Regulation to amend Annex XIV to REACH Regulation (EC) No 1907/2006. Five new substances shall be newly added to Annex XIV, as following:

Entries 55-59 shall be added in the table in Annex XIV:

Entry No. Substance Intrinsic property(ies) referred to in Article 57
55 Tetraethyllead
EC No: 201-075-4
CAS No: 78-00-2
Toxic for reproduction (category 1A)
56 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol (with ≥ 0.1% of Michler's ketone (EC No 202-027-5) or Michler's base (EC No 202-959-2))
EC No: 209-218-2
CAS No: 561-41-1
Carcinogenic (category 1B)
57 Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) (with ≥ 0.1% w/w 4-heptylphenol, branched and linear)
EC No: -
CAS No: -
Endocrine disrupting properties (Article 57, point (f) - environment)
58 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
EC No: 239-622-4
CAS No: 15571-58-1
Toxic for reproduction (category 1B)
59 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)
EC No: -
CAS No: -
Toxic for reproduction (category 1B)

The latest application date shall be 18 months after this amending regulation enters into force, while the sunset date shall be 36 months after this amending regulation enters into force.

Once the regulation is adopted and enters into force, the placing on the market and the use of those substances in the EU will only be possible, after sunset date, for those operators who have been granted an authorisation, and for those who have submitted an application for authorisation before the latest application date but a decision has not yet been adopted.

Note: Annex XIV - List of substances subject to authorization

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