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 use | Latest application date | Sunset date |
|---|---|---|
| General (point a) | 21 August 2013 | 21 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 2023 | 14 December 2024 |
| Medical devices under MDR / IVDR (point c) | 1 January 2029 | 1 July 2030 |
- 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]Bis(2-ethylhexyl) phthalate (entry 4, Entry 4) [REACH 02006R1907-20260511] · p.1REACH
- [2]Bis(2-ethylhexyl) phthalate (DEHP) · p.2Annex XIV
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