Ph. Eur. Survey for DEHP Plasticiser Alternatives

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

Due to a change in the REACH Regulation, the European Pharmacopoeia (Ph. Eur.) is considering to replace the plasticiser DEHP (bis(2-ethylhexyl)phthalate), described as plastic additive 01 in Ph. Eur. general chapter 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion.

The Ph. Eur. would like to receive information from manufacturers on the availability and use of containers that include alternative plasticisers to DEHP in their composition.

The following Information is requested in the Ph. Eur. survey for the availability of alternative plasticisers in containers in authorized medicinal products. The deadline for replies is 30 September 2022. Supporting data can be sent to epd@edqm.eu.

• Name of the Company / Site / Contact details.
• Information about any containers for aqueous solutions for intravenous infusion made from materials based on plasticised PVC that are used for licensed medicinal products in Europe and that contain a plasticiser other than DEHP.
• Information about ongoing regulatory submissions or studies concerning the replacement of DEHP in plasticised PVC bags for intravenous infusions (if available).
• Available data (typically, control procedures and validation data) that would make it possible to introduce new plasticisers in the Ph. Eur.
  Data shared may be kept confidential (if requested) and only shared within the group of Ph. Eur. experts responsible for the specified chapter.

More information is available in the EDQM Newsroom.