EU - Draft Amendment on RoHS Exemption Regarding the Use of Certain Phthalates in Spare Parts of Medical Devices

​This draft Commission Delegated Directive amends Annex IV to Directive 2011/65/EU (RoHS 2 Directive) regarding an exemption for the use of the following phthalates in spare parts recovered from and used for the repair or refurbishment of medical devices:

- Bis(2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)​

The Commission received a request for a new exemption in Annex IV in July 2018 to allow the continued placing on the market of spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, containing > 0.1% DEHP, BBP, DBP and DIBP by weight in homogeneous materials. According to the application request, the reuse of spare parts containing these phthalates would take place in auditable closed-loop business-to-business return systems and each reuse would be notified to the consumer.

After the technical and scientific assessment, the Commission concluded in 2020 that the total negative environmental and health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new substance-free refurbished parts are likely to outweigh the total environmental and health benefits. In order to ensure a high level of protection for the environment, health and consumer safety, reuse should take place in auditable closed-loop business-to-business return systems. Together with other reasons, the Commission proposed to add a new exemption in Annex IV to RoHS 2 Directive as stated below:

47) Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the consumer, expires 7 years after the adoption.

Final date for comment: July 14, 2021