On 16 October 2015, the European Union submitted Circular G/TBT/N/EU/320 to the World Trade Organisation (WTO) to amend the exemption for lead, cadmium and hexavalent chromium in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes and set new validity of in-vitro diagnostic medical devices as well as electron microscopes and their accessories. Meanwhile, PBDE is also added in the exemption.

The proposal replaced the previous Point 31 with Point 31a. The comparison is as the following:

No.	Exemption	Validity
31.	Lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer.	Expires on 21 July 2021.
31(a).	Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes 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.	(a) 21 July 2021 for the use in medical devices other than in-vitro diagnostic medical devices; (b) 21 July 2023 for the use in in-vitro diagnostic medical devices; (c) 21 July 2024 for the use in electron microscopes and their accessories.

The draft is expected to be passed in January 2016.

Reminder: Clauses for RoHS exemption is on continuous update along with the progressive technology. Manufacturers should track the list of exemption and look for green alternatives to ensure their products that intended for export on the EU market in line with the latest requirements.