PVC | PLASTICISERS
Plasticisers – sticking to the facts
European Plasticisers, the trade association representing around 85% of European plasticiser production capacity, has provided this update on regulations within the Euro- pean Union and on new scientific moves its hopes will back up safety claims for PVC plasticisers. It says that although an opinion from the European Food Safety Authority (EFSA) on the use of phthalates in food contact materials (FCM), published in Decem- ber 2019, concluded that “current exposure to these five phthalates [DBP, BBP, DEHP, DINP and DIDP] from food is not a concern for public health”, a new mandate has been given to EFSA to assess phthalates, structurally similar substances and replacement substances. European Plasticisers has already contributed to calls for data published in the context of this new mandate. It will provide input to the currently open consultations on the “Call for collection of data on phthalates, structurally similar substances and replacement substances migrating from or occurring in food contact
the risks may take place as part of the Restriction Roadmap exercise on ortho-phthalates. European Plasticisers will contribute to consultations on this regard with data and information as appropriate. Turning to plasticiser safety,
a project aimed at developing a physiologically-based pharmacokinetic (PBPK) model for plasticisers was initiated in
materials (Plasticisers_FCM_2022)” and the “Call for continuous collection of chemical contaminants occurrence data in food and feed,” the latter being part of a separate mandate (EFSA M-2010-0374). European Plasticisers also contrib- uted to a call for evidence in December 2021 for ten “Annex XIV” phthalates, aiming at assessing if they are ad- equately controlled after their sunset date. For seven phthalates (entries 33 to 39), the sunset date has passed. For three more phthalates (44 to 46), no applications for authorisations were submitted before their latest applica- tion date of 27 August 2021. ECHA has said there is no need to
submit restriction dossiers at this stage, although further examination of
Also new from Valtris is Santicizer Platinum
P-1700. Based on benzyl cyclohexanoate technol- ogy, it is claimed to combine high solvating ability with ultra-low volatility and excellent migration resistance. It has a high molecular weight and branched structure. Valtris says Santicizer Platinum P-1700 can be used in a variety of applications and contributes to the permanence and processing of acrylic/PVC screen inks, automotive sealants and high performance polysulphide sealants. “We have seen a lot of customer success using Santicizer Platinum P-1700 in plastisol screen inks for its excellent permanence, low bleed through, and favourable water wash characteristics,” says Megan Kravec, New Business Development Polymer Modifiers at Valtris. “When using Santi- cizer Platinum P-1700 in combination with general purpose plasticisers, manufacturers will see
20 COMPOUNDING WORLD | August 2022
2017 by European Plasticisers and co-funded by VinylPlus, the sustain- ability initiative of the wider PVC value chain. Its aim was to assess the safe use of plasticised PVC and support scientifically solid risk assessments, rather than those using simple in-vitro studies that may not be representative of the complex metabolism in whole organisms. A first PBPK model for DINCH was published in a peer reviewed journal in 2019, the model for DINP was pub- lished in August 2020, and one on DPHP in September 2021. PBPK models for DEHTP, DEHA, DINA and DBA are also being developed and the respective studies will be submitted for publication in scientific journals. �
https://www.europeanplasticisers.eu/
improved efficiency and processing speed without sacrificing emissions or migration.”
DEHP alternative Citroflex B-6, from Vertellus, is partially derived from bio-based raw materials and is said to demonstrate biodegradability. It is marketed as a phthalate-free plasticiser solution for flexible PVC blood storage and transfusion systems that can provide an alternative to di-2-ethylhexyl phthalate (DEHP). The company says DEHP has long been the predominant plasticiser used in PVC medical devices. While questions about its safety in blood bag systems have been raised since the 1970s, it says it has only recently been labelled as a repro- ductive toxin. “With the recent changes in the European Union’s Medical Device Regulation (MDR; EU
www.compoundingworld.com
IMAGE: SHUTTERSTOCK
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