11/12 March 2020
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of di(2-ethylhexyl)phthalate as a substance of very high concern (SvHC) according to the criteria of Article 57 of regulation (EC) 1907/2006 (REACH). Di(2-ethylhexyl)phthalate is currently used as a plasticiser in most poly(vinyl chloride) (PVC) materials and containers for pharmaceutical use. In this context, the European Pharmacopoeia proposes to include descriptions of the following four additional plasticisers in order to provide manufacturers with alternatives to di(2-ethylhexyl)phthalate (plastic additive 01) whenever possible:
Furthermore the sections "Definition and General requirements" have been added to provide additional information regarding the quality of plastic additives to be used for materials and containers for pharmaceutical use. To avoid duplicating reference numbers for each substance, it is proposed to delete the plastic material registration numbers (PM RN) from the list of additives.
The changes proposed in this general chapter are to be considered in conjunction with the proposed changes in the following general chapters, which are also published in Pharmeuropa 29.2:
Additional proposed changes to 22.214.171.124, 126.96.36.199, 3.1.14, 3.2.4, and 3.2.5 are:
3.1.14: The four plasticisers have not been included in this chapter due to the lack of information regarding the use of these plasticisers in containers for aqueous solutions for intravenous infusion. In order to consider the addition of these additional plasticisers in the future, authorities and manufacturers are invited to send information on plasticisers other than di(2-ethylhexyl)phthalate with regard to the typical amount used, suitable specifications and analytical procedures for testing additives, and complete information on relevant authorised medicinal products or certified medical devices.
The deadline for comment is June 30, 2017. Following your registration on the Pharmeuropa website you will have access to the complete drafts of the Ph. Eur. general chapters covering PVC materials and containers for pharmaceutical use.