Plasticisers for medical applicationsSoftness and flexibility are key properties for medical devices. This is, for example, crucial for tubing that goes inside the body, which must be as soft as possible for optimum patient treatment and comfort. In order to make PVC medical devices soft and flexible, a plasticiser (US: plasticizer) is added to the PVC compound.
A wide range of plasticisers for medical applications are now included in the European Pharmacopoeia, which sets Europe’s legal and scientific standards to delivering high quality medicines in Europe and beyond. This broad range of plasticisers allows medical devices manufacturers to develop high performance medical PVC solutions to best serve patients and medical professionals.
Alternatives to DEHP now in the European PharmacopoeiaThe phthalate DEHP used to be the main plasticizer in medical PVC due to its technical properties and low cost. The substance has been under increasing scrutiny by regulatory and medical authorities, and in the EU its continued use in medical devices after 2020 will require robust justification.
As part of their commitment to innovation, continuous improvement of safety, performance and cost-efficiency, companies within the medical PVC value chain have progressively made available a wide range of alternatives to DEHP plasticiser for medical applications, which are approved by the European Pharmacopeia. These include:
DEHP regulatory status in the EU
The use of DEHP in the EU is regulated by different pieces of legislation, including REACH Regulation, RoHS Directive and by the Medical Device Regulation. To date, medical devices have been exempted from restrictions. This is due to change in the coming years, as follows:
Medical Device Regulation
According to the Regulation (EU) 2017/745 (Medical Device Regulation) as published on the Official Journal on 5 April 2017, from 26 May 2020 medical devices containing DEHP in quantity above 0.1% w/w will need specific justification. The justification for the presence of Carcinogenic, Mutagenic and Reprotoxic Category 1A and 1B and endocrine disrupting substances – including DEHP – shall be based upon:
- An analysis and estimation of potential patient or user exposure to the substance
- An analysis of possible alternative substances, materials or designs
- Argumentation as to why possible substance and/or material substitutes or design changes are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product
- Latest relevant scientific committee “Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine disrupting (ED) properties”
- On 10 July 2019, ECHA’s Member State Committee adopted the “Recommendation to amend the Annex XIV (Authorisation) entries to DEHP, BBP, DBP and DIBP”. This is ECHA’s last step on the process started in December 2014 and July 2017, when DEHP was added on the Candidate List for Authorisation under REACH respectively for its endocrine disrupting properties to the environment and human health
- The European Commission is now expected to include DEHP in Annex XIV during the second half of 2020 (approximately)
- The latest application date for authorisation will be 18 months after entry into force (approximately during the first half of 2021)
- The sunset date will be 36 months after entry into force (likely by the end of 2022) and no exemptions are foreseen, meaning that medical devices containing DEHP will need to undergo the Authorisation process to be placed on the market after that date (to be confirmed)
- According to the EU Directive 2015/863 (RoHS 3) as published on the Official Journal on 4 June 2015, electronic and electrical equipment containing DEHP in medical devices will be restricted starting from 22 July 2021
- Please note that the restriction shall not apply to medical devices placed on the market before 22 July 2021
PVCMed Alliance’s commitment
The Alliance is planning to continue to contribute in the future.