EU - Draft of a New Exemption to Annex IV of RoHS 2 Directive (DEHP in Plastic Components in MRI Detector Coils) (Pack 20)

A consortium led by Oeko-Institut was requested by DG Environment of the European Commission to provide technical and scientific support for the evaluation of exemption requests under the RoHS 2 regime. The work has been undertaken by Oeko-Institut and has been peer reviewed by Fraunhofer Institute IZM.

COCIR (2019b) requests an exemption for the plasticiser bis-(ethylhexyl) phthalate (DEHP) applied in flexible polymers used in plastic components in MRI detector coils, which comprise bushing, cable covers (sheathing and insulation), fixing belt components and mattresses including their coverings in MRI detector coils for a duration of the exemption of two years thus ending July 2023 (COCIR 2020).

Magnetic Resonance Imaging (MRI) is a medical imaging technique used to examine the human soft tissue. In MRI, the patient is exposed to a strong magnetic field and radio waves. The human tissue then emits weak radio frequency signals that are received by antennas - the coils – located in close proximity to the part of the human body that is examined. The received signal is used to generate detailed three dimensional images of the human body, including e.g. muscles, blood vessels and internal organs. There are a number of different coils depending on the specific part of the body that is scanned e.g. shoulder, head, hand, knee, foot, breast etc.

One of the essential characteristics of the coils and the electronic circuitry that is connected to each coil is that the materials used must be non-magnetic because any magnetic materials degrade the weak RF signals emitted by the human tissue resulting in distorted MRI images.

COCIR (2019b) and GE Healthcare (2018) argue that there will be a negative impact on the EU healthcare if the exemption will not be granted: Particularly MRI coils cannot be purchased by EU hospitals because approved substitutes are not available​.

The exemption request covered in this project is summarised as follows. 

Exemption Request No.: 2019-4
Requested exemption wording: Bis-(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils
Applicant: COCIR
Recommendation: DEHP in plastic components in MRI detector coils
Expiry date and scope: 21 July 2023