User Guidelines
The proposed regulations transpose Commission Delegated Directives (EU) 2021/1978, 2021/1979 and 2021/1980 by amending Schedule IV of the Restriction of Use of Hazardous Substances in Electrical and Electronic Equipment Regulations, 2013 (S.L. 427.57) thereby exempting and allowing the continued use of:
a) 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 till the 21 July 2028;
b) bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils till 1 January 2024; and
c) bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids from till 21 July 2028.
These user guidelines are being published in accordance with article 3 of the Small Business Act (Cap. 512) -