The European Commission recently announced a postponement of the ban on the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices (MDs).
Bis (2-ethylhexyl) phthalate, or DEHP
DEHP belongs to the family of phthalates, chemical substances frequently used to increase the flexibility of plastics such as PVC (polyvinyl chloride). These phthalates are commonly used in the formulation of medical devices such as blood bags, tubing, catheters and disposable gloves, to improve their flexibility and workability.
Although DEHP has interesting properties, it nevertheless raises concerns in terms of public health. DEHP can migrate into the device in which it is incorporated. Thus, patients undergoing medical treatment may be exposed to DEHP released by PVC medical devices. It can also come into contact with the skin, particularly when wearing gloves. These situations give rise to concerns about possible adverse health effects.
Studies to determine DEHP's effects on the reproductive system led to its classification as a category 1B reproductive toxicant. The substance was then alternately identified as an endocrine disruptor for the environment (inclusion in the SVHC-Substance of very High Concern-list under this heading in 2014), then an endocrine disruptor for human health (inclusion in the SVHC-list under this heading in 2017).
Due to its properties of concern (classified as a reproductive toxicant and endocrine disruptor), DEHP was one of the first substances to be included in the REACH Annex XIV list of substances banned for use in the European Union. First, in 2011, for its reproductive toxicity, then more recently, in 2021, for its endocrine-disrupting properties for human health and the environment.
Regulation of DEHP in medical devices
Published on November 23, 2021, EU Regulation No. 2021/2045 extended the scope of DEHP uses prohibited by entry No. 4 in REACH Annex XIV.
Since this modification of entry n°4 of the REACH authorization list to include DEHP's endocrine disrupting properties, the following uses, previously exempt from the ban, are now subject to an authorization requirement if they wish to continue in the European Union:
- medical devices and materials in contact with food containing DEHP
- mixtures containing DEHP in concentrations greater than or equal to 0.1% by weight
- primary packaging for medicines containing DEHP
Under these provisions, the use of DEHP in medical devices was subject to two main dates:
- November 27, 2023 for the deadline for filing a request for authorization ("LAD").
- May 27, 2025 for the substance use expiration date ("SD").
The expiry date and the deadline for submitting applications for DEHP authorization were aligned with the transitional provisions set out in Regulations (EU) 2017/745 and (EU) 2017/746.
Following a postponement of the dates laid down in the aforementioned regulations on medical devices, it was therefore appropriate to align the two regulations once again with the same deadlines. The Commission's stated aim in making these regulatory adjustments is to encourage the transition to alternatives to DEHP that meet public health and patient safety standards. While the Commission recognizes the need to progressively replace DEHP, it also wishes to avoid any major disruption in the supply of medical devices, thus underlining the balance between innovation and safety.
This has now been achieved with the publication on November 13 of Regulation (EU) 2023/2482 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards DEHP in medical devices.
Under the new regulation (EU) 2023/2482, from November 13, users of DEHP in medical devices will note that they will no longer be able to use DEHP from July 1, 2030, unless they apply for authorization before January 1, 2029.
