EU Commission Adopts Decisions on Authorisations for DEHP and DBP Hungary

  • EU Commission Adopts Decisions on Authorisations for DEHP and DBP Hungary
  • EU Commission Adopts Decisions on Authorisations for DEHP and DBP Hungary
  • EU Commission Adopts Decisions on Authorisations for DEHP and DBP Hungary
  • What is the latest application date for bis(2-ethylhexyl phthalate (DEHP)?
  • Commission Regulation (EU) 2021/2045 (2) amending Annex XIV to Regulation (EC) No 1907/2006 sets 27 May 2025 as sunset date and 27 November 2023 as latest application date for uses of the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices.
  • What is the EU Regulation 2021/2045 of 23 November 2021?
  • 1. Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 418, 24.11.2021, p. 6).
  • What does EU 2023/607 mean for medical devices and in vitro diagnostics?
  • (9) (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (OJ L 80, 20.3.2023, p. 24).
  • When did DNELs for DEHP and DBP come out?
  • Reference DNELs for DEHP and DBP were derived in 2013 for reproductive toxicity and thus pre-date RAC’s opinion of 201711 on the restriction proposal from ECHA and Denmark on these phthalates as well as the opinion of EFSA on several phthalates (EFSA 2019)12.
  • Is DEHP used as a food contact material?
  • DEHP is a substance for which the exemption for use in food contact materials within the scope of Regulation (EC) No 1935/2004 has been removed [for which it is used]. Applications for authorization must be submitted by 14.06.2023, and the ban on use under Art. 56 (1) REACH will take effect from 14.12.2024.
  • Is DEHP endocrine disrupting?
  • In accordance with Article 59 of Regulation (EC) No 1907/2006, DEHP has subsequently been additionally identified as meeting the criteria set out in point (f) Article 57 of that Regulation, namely as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment (2).

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