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…
