EUR-Lex - 32017D1210 - EN - EUR-Lex - Europa
Commission Implementing Decision (EU) 2017/1210 of 4 July 2017 on the identification of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) as substances of very high concern according to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (notified under document C(2017) 4462) (Text
Authorisation - Internal Market, Industry, Entrepreneurship
Between 5 June - 6 August 2018, the European Chemicals Agency conducted, on behalf of the European Commission, a public consultation on the inclusion of additional intrinsic properties of the substances bis (2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in Annex XIV to
Court of Justice of the European Union PRESS RELEASE No 26/20
ClientEarth v Commission In the opinion of Advocate General Juliane Kokott, the Commission’s decision refusing to review the authorisation of the plasticiser DEHP (bis(2-ethylhexyl) phthalate) should be annulled The Commission should not have disregarded the endocrine-disrupting risks posed by DEHP
Exporting dual-use items - Trade
On 20 May 2025, the European Parliament and the Council adopted Regulation (EU) 2025/821. The new Export Control Regulation upgrades and strengthens the EU's export control toolbox to respond effectively to evolving security risks and emerging technologies, and allows the EU to effectively protect its interests and values.
Adequacy decisions | European Commission
the adoption of the decision by the European Commission At any time, the European Parliament and the Council may request the European Commission to maintain, amend or withdraw the adequacy decision on the grounds that its act exceeds the implementing powers provided for in the regulation.
- What is the new EU Regulation on phthalate in medical devices?
- The European Commission has recently revised Regulation (EC) No 1907/2006, extending the use of bis (2-ethylhexyl) phthalate (DEHP) in medical devices. Originally, the use of DEHP was to be subject to authorisation requirements after May 2025, but the new regulation, EC 2023/2482, issued on November 13, 2023, postpones this deadline.
- Is a final decision by the European Commission required?
- final decision by the European Commission is required. On page 4 of this factsheet we provide a provisional timeline for the final do
- What does Annex XIV to Regulation (EC) No 1907/2006 include for DEHP?
- Furthermore, Regulation (EC) No 726/2004 and Directives 2001/82/EC and 2001/83/EC lay down requirements related to the protection of human health only, while, as regards DEHP, intrinsic properties relating to hazards for the environment have been included in the entry for that substance in Annex XIV to Regulation (EC) No 1907/2006.
- What is the new deadline for the use of DEHP in medical devices?
- The new deadline for the use of DEHP in medical devices is 1 July 2030, extended from the original deadline of May 2025. This extension allows more time for a gradual shift to DEHP-free medical devices, aligning with the transitional periods for medical device regulations (EU) 2017/745 and (EU) 2017/746.
- What properties of DEHP are identified in Article 57?
- 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.
- 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.
