EU - Amending Annex XIV to RoHS Directive Regarding the Use of Phthalates in Spare Parts in Medical Devices

​Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex IV to that Directive.

Delegated Directive (EU) 2015/863 provides that the restriction of DEHP, BBP, DBP and DIBP is not to apply to spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, including in vitro medical devices, placed on the market before July 22, 2021.

On July 17, 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of DEHP, BBP, DBP and DIBP in spare parts recovered from and used for the repair or refurbishment of medical devices, including in-vitro diagnostic medical devices.

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, and reuse of spare parts should be notified to the customer.

Furthermore, the exemption is consistent with REACH Regulation and thus does not weaken the environmental and health protection afforded by it.

Therefore, a new exemption entry (47) regarding spare parts containing DEHP, BBP, DBP and DIBP recovered from and used for the repair or refurbishment of medical devices and their accessories is added to Annex XIV to RoHS Directive with an expiry date July 21, 2028.​