REGAFFAIRS AI
ANSWERS · 4 OCT 2026

Is DEHP (CAS 117-81-7) on the REACH Authorisation List (Annex XIV), and what latest application date and sunset date apply to its use in medical devices under the MDR and IVDR?

Yes. DEHP (EC 204-211-0, CAS 117-81-7) is entry 4 on the REACH Authorisation List (Annex XIV). For uses in medical devices within the scope of the MDR (EU) 2017/745 and IVDR (EU) 2017/746, the latest application date is 1 January 2029 and the sunset date is 1 July 2030 [1].

Approach: I checked ECHA's Authorisation List and the Annex XIV entry in the current consolidated REACH Regulation (consolidated version of 11 May 2026).

What the entry says

Scope of useLatest application dateSunset date
General (point a)21 August 201321 February 2015
Food contact materials (Reg. (EC) 1935/2004); immediate packaging of medicinal products (Reg. (EC) 726/2004, Dir. 2001/82/EC, Dir. 2001/83/EC); mixtures with 0.1% to under 0.3% w/w DEHP (point b)14 June 202314 December 2024
Medical devices under MDR / IVDR (point c)1 January 20291 July 2030

[1]

  • Reasons for listing: Toxic for reproduction (Cat. 1B), plus endocrine-disrupting properties under Article 57(f) for both human health and the environment [1].
  • Where the dates come from: ECHA's Authorisation List entry only shows the general dates (21 August 2013 and 21 February 2015). The medical-device dates are in the consolidated legal text. ECHA links the entry to two amending regulations: Regulation (EU) 2021/2045 and the original listing, Regulation (EU) No 143/2011 [2].
  • What this means for devices: If you want to keep using DEHP in a device after 1 July 2030, you need an authorisation. To keep supplying while your application is being decided, it must be submitted by 1 January 2029 [1].

I can look up the existing Commission authorisation decisions or RAC/SEAC opinions for DEHP uses next, if that would help.

SOURCES · 2

  1. [1]Bis(2-ethylhexyl) phthalate (entry 4, Entry 4) [REACH 02006R1907-20260511] · p.1REACH
  2. [2]Bis(2-ethylhexyl) phthalate (DEHP) · p.2Annex XIV
Continue this research.
Ask a follow-up; this answer comes along as context.