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Release Time:2021-11-18 On November 15, 2021, the European Union issued Directives (EU) 2021/1978, (EU) 2021/1979 and (EU) 2021/1980 Directives in its official gazette
On November 15, 2021, the European Union issued Directives (EU) 2021/1978, (EU) 2021/1979 and (EU) 2021/1980 Directives in its official gazette, updating the list of RoHS Annex IV exemptions, adding Articles 45 and 46 And 47 exemptions. This time, the exemption for phthalate esters of category 8 medical equipment and monitoring and control equipment has been added.
In Annex IV to Directive 2011/65/EU, the following exemption clauses are added:
Exemption | Scope and dates of applicability | |
45 | Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids | Applies to category 8 and expires on 21 July 2028 |
46 | Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils. | Applies to category 8 and expires on 1 January 2024 |
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 customer. | Applies to category 8 and expires on 21 July 2028 |
AGC reminds companies to focus on RoHS exemption updates to ensure product compliance.
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