PVC | PLASTICISERS
Right: A new regulation that will further restrict use of DEHP in medical
devices has been delayed due to the Covid-19 pandemic
Medical moves A new medical device regulation — Regulation (EU) 2017/745) — that will further restrict use of DEHP was scheduled to come into effect in 2020, but due to the pandemic, has been postponed until 26 May, 2021. In June 2019, the EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued guidelines for the use of DEHP in medical devices as included in the new regulation, says Mastrantonio. In December 2019, EFSA also updated its risk assessment of DBP, BBP, DEHP, diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) for use in food-contact materials (FCM). Although EFSA reported they were not a concern for public health, it proposed a tolerable daily intake (TDI) limit, on a temporary basis, of 50 μg/kg of body weight (bw) per day for the combined total intake of DBP, BBP, DEHP, DINP, and confirmed a TDI of 150 μg/kg of bw per day for DIDP. “It is important to note that the EFSA opinion is not supported by scientific evidence or ECHA’s Risk Assessment Committee’s assessment of DINP [which said DINP did not warrant classification for reprotoxic effects]. The opinion acknowledges the uncertainties related to the outcome of an assessment that, due to time constraints, could not be performed in a thorough manner,” Mastrantonio says. “The European Commission is currently working on a new mandate for EFSA to further assess phthalates in FCM. European Plasticisers provided input in the EFSA public consultation in April 2019 and it is ready to support any further assessment of substances in food-contact materials as appropriate, consistently ensuring a robust scientific weight of evidence approach.”
Phthalate research Recent research aims to provide more scientific data on phthalate plasticisers, says the trade association. For example, the University of Edinburgh in the UK is preparing to publish a study comparing DBP and DINP that confirms DINP does not cause adverse reproductive effects and is not an endocrine disruptor. European Plasticisers and VinylPlus say they are are supporting “scientifically solid risk assessments, compared to those which use simple in-vitro studies which are not representative of the complex metabolism in whole organisms” by developing and publishing physiologically based pharmacokinetic (PBPK) models. The group reports that a PBPK model for DINCH has been published in a peer-reviewed journal, and the model for DINP was submitted for publication in 2020. Others are being developed. In the US, the Environmental Protection Agency
(EPA) began assessments for phthalates that were identified as high priority chemicals, including BBP, DBP, DIBP, DEHP, and dicyclohexyl phthalate. EPA also began evaluations of DINP and DIDP as requested by their manufacturers — Evonik, ExxonMobil Chemical, and Teknor Apex had requested an evaluation of DINP uses and ExxonMobil had also requested evaluation of DIDP through the American Chemistry Council’s High Phthalates Panel. The assessments are expected to take three years and the manufacturers say they are confident tests will show that these high molecular weight phthalates are safe for use.
Figure 1: Elatur DPT can boost gelation of Elatur CH to near DINP (Vestinol 9) levels or further speed gelation of DINP Source: Evonik
40 COMPOUNDING WORLD | August 2020
Alternative plasticisers Evonik produces and sells DINP under the brand name Vestinol 9 and says that in Europe it is an important general-purpose plasticiser for soft PVC because of its broad processing window and beneficial cost/performance ratio. The company also produces alternative plasticisers: cyclohexanoate under the brandname Elatur CH;
www.compoundingworld.com
IMAGE: SHUTTERSTOCK
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