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Annex IV, Ex. 31a

“Bis (ethylhexyl) phthalate, Dibutyl phthalate, Di-isobutyl phthalate and Benzyl butyl phthalate 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 customer”

This section includes a questionnaire for a renewal RoHS exemption request. Stakeholders are requested to base their submissions on this questionnaire including as much comprehensive information as possible.

Applicants document

> Original exemption request (PDF)

Additional information provided with exemption Request:

> Annex 1: Assessment of reuse of parts containing phthalates life cycle assessment (PDF)

Additional information provided after first questions for clarification: 

> Answers to clarification questions (PDF)

> Annex 2: Remanufacturing approach of end-of-life electronics by MRI&X-Ray scanners (PDF)


Results from previous evaluations

> Oeko Institute Final Report RoHS Pack 10 – exemption evaluation (PDF)

> Excerpt from Oeko-Institut Final Report RoHS Pack 5 – scope review (PDF)



> Specific questions to RoHS Request Annex IV, Ex. 31a (PDF)


Contributions to the consultation

> Contribution of MedTech Europe, submitted on 13.05.2019: PDF