PVC | PLASTICISERS
Figure 3:
Haemolysis and morphology results from blood stored in bags of PVC plasticised with DEHP and DEHT (AS-1 and PAGGSM are preservative solutions)
Haemolysis
RBC morphology score
Source: Eastman
plasticiser market “has already adapted to the regulatory and market pressures with an important major shift from the use of these classified LMW phthalates to the use of non-classified high molecular weight (HMW) phthalates and other plasticisers.
One close observer of the industry says that the major move away from LMW phthalates to non- classified HMW phthalates – and more recently to non-phthalate plasticisers – has been a 25-year process requiring an investment that probably amounts to more than €6bn by the industry in manufacturing process and plant, applications support for customer conversion, as well as investment in toxicology and environmental testing, regulatory and expert evaluations of the data, not forgetting conduct of LCA studies and extensive support for recycling via the VinylPlus sustainability initiative. European Plasticisers does point out though
that, “given that the four LMW phthalates are already regulated and Authorisation as well as Restriction procedures are ongoing, we believe that their double listing for the same adverse health effects in animals and inclusion in the Authorisation List for their ED [endocrine disrup- tion] properties is unnecessary overregulation, and puts excessive burdens on the industry, weakens policy predictability and hence undermines the European industry from investing and staying competitive in a global market. “Due to the fact that some uses of DEHP (for
example in food contact materials or medical devices) will as a result no longer fall under the generic exemptions from the authorisation require- ment, the update of the Annex XIV list will oblige DEHP producers, medical devices producers and recyclers of flexible PVC to face a new challenge regarding the Authorisation process.”
20 COMPOUNDING WORLD | August 2018
Medical moves In the medical sector, DEHP remains the plasticiser of choice in many applications. And the reason is simple – it provides a property set that is nigh-on unbeatable. That position may not be unassailable, however. Speaking at Compounding World publisher AMI’s Medical Fluid Bags 2018 confer- ence in Cologne in June, Dr Angelika Langsch, Senior Manager of Regulatory Affairs at BASF, said regulators increasingly believe there is a lack of justification for exposing sensitive new-born children to DEHP. French law already prohibits the use of tubes containing DEHP in paediatrics, neonatology and maternity. Countries in the Arabian Gulf also recently notified the WTO of their intention to essentially ban DEHP in all medical devices from 22 July 2021. And a ban on DEHP in blood transfusion products came into effect in South Korea this June. “Medical device producers need a competitive and technically suitable alternative plasticiser,” said Langsch. In addition, European Medical Device Regulation 2017/745 – which came into force in May 2017 and has a three-year transition period – says medical devices “need a specific justification if containing substances above 0.1% (w/w) with the following properties: CMR Cat 1A or 1B (carcinogenic, mutagenic or toxic to reproduction); or endocrine disrupting properties for which there is scientific evidence of serious effects to human health.” For a long time, the European Pharmacopoeia has listed only DEHP as a suitable PVC plasticiser for medical devices. That changed on 18 January this year, when four more plasticisers – DINCH, BTHC, TOTM and DEHT – were added. BASF produces DINCH, which (like DEHT)
exceeds REACH requirements. Langsch cited studies that demonstrate its suitability for use in various medical devices, such as bags for infusion
www.compoundingworld.com
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