On 24 September 2014, the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has adopted a preliminary Opinion on “The safety of medical devices containing DEHP-plasticised PVC or other plasticisers on neonates and other groups possibly at risk”.
SCENIHR states that while new scientific data has been made available since its 2008 Opinion, the conclusions of the latter remain largely valid. It should also be emphasised that a number of recent alarmist epidemiological studies investigating DEHP exposure were found to be “inconclusive or inconsistent” by the SCENIHR working group.
The SCENIHR recognises that “DEHP-containing plasticised PVC devices are important for many treatments “ and that they are “justified because of the benefits of these procedures”. They form a complex family of products that have been used for many years. While the Opinion enables their continuous use, it provides a strong basis for stakeholders in the medical value chain to collaborate to ensure progress towards transition out of DEHP to alternative plasticisers.
Since over a decade, the PVC medical value chain has been actively working to develop alternative plasticisers. These are increasingly being used in a wide array of medical applications allowing healthcare professionals and medical equipment purchasers to benefit from PVC’s unique properties in high quality healthcare solutions, providing for patient comfort, performance, affordability and hospital hygiene.
In this context, as part of their commitment to innovation and continuous improvement of safety, the PVCMed Alliance member companies have contributed to the report “Alternatives to classified phthalates in medical devices” prepared by the Danish Environmental Protection Agency and Health and Medicines Authority by providing data to these authorities. PVCMed encourages the value chain to continuously research into alternative plasticisers in order to develop innovative products for all PVC healthcare applications.
The PVCMed Alliance, however, believes that some elements of this Preliminary Opinion require more work and that a more accurate and precise analysis of the available data is needed to ensure higher scientific quality. As an example, it seems that given the data available in the ECHA database, substances that are currently evaluated under CoRAP are not well depicted in the Preliminary Opinion. The PVCMed Alliance is committed to actively cooperate with European scientific and legislative authorities and welcomes any new scientific evidence and assessment of the use of plasticisers for flexible PVC in medical applications.
A public consultation on this Preliminary Opinion has been launched by the European Commission and the SCENIHR in view of gathering scientific comments, suggestions, explanations and contributions. All interested parties are encouraged to participate in the public consultation and submit written comments on the preliminary opinion by 30 November.