The revision follows the REACH identification of DEHP (diethylhexyl phthalate) as a substance of very high concern (SvHC). DEHP is currently used as a plasticizer in most PVC materials and containers for pharmaceutical use.
The following two general chapters were also indirectly impacted by the revision:
3.1.13. Plastic additives (the list of additives has been updated with the four plasticizers mentioned above),
3.1.14. Materials based on plasticized poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion (the quantification of plasticizers (including DEHP) is now performed by GC-MS).
Additionally, the following two packaging chapters have been revised:
These monographs are expected to be published in June/July 2018 in the online version of Ph. Eur. Supplement 9.6. They will be implemented on January 1, 2019.