The following Ph. Eur. Packaging Chapters have been adopted at the November 2017 session of the European Pharmacopoeia Comission:
As reported before in Pharmeuropa Draft Chapters regarding PVC, these chapters had been revised to include four new poly(vinyl chloride) (PVC) plasticizers:
- cyclohexane 1,2-dicarboxylic acid, diisononyl ester;
- butyryl tri-n-hexyl citrate;
- tris(2-ethylhexyl) trimellitate;
- bis(2-ethylhexyl) terephthalate.
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:
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.
For more Information please see Pharmeuropa online.