null Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products

EDQM Strasbourg, France 23/08/2022
Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products

Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have been considering replacing 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.

To help with this reflexion, the experts of the Ph. Eur. would like to gather information from manufacturers on the availability on the market and use for medicinal products of containers for aqueous solutions for intravenous infusion that include alternative plasticisers to DEHP in their composition.

We would like to ask our industry stakeholders for their support in gathering information on this subject, by responding to this survey. We understand that the kind of information requested may be confidential, but we would be most grateful for your help. 

Supporting data can be sent to epd@edqm.eu.

Thank you in advance for your efforts in helping us ensure that the general chapter remains fit for purpose.