G/TBT/N/GBR/46  
16 March 2022  
(22-2327) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED KINGDOM   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Department for Environment, Food and Rural Affairs (Defra)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
UK TBT Enquiry Point  
Trade Policy Group  
Department for International Trade  
Old Admiralty Building  
London  
SW1A 2DY  
TBTEnquiriesUK@trade.gov.uk  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Electrical 
and electronic equipment (EEE). More detail on product coverage can be found in 
Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic 
Equipment Regulations 2012 (SI 2012/3032) 
(https://www.legislation.gov.uk/uksi/2012/3032/made ). HS code 9018 for medical 
devices. Electronic Components in general (ICS 31.020); Electronic components in 
general (ICS 31.020)  
5. Title, number of pages and language(s) of the notified document:  Draft statutory 
instrument on the Restriction of the Use of Certain Hazardous Substances in Electrical 
and Electronic Equipment (Amendment) Regulations 2022 (2 page(s), in English)  
6. Description of content:  These measures will amen d the Restriction of the Use of Certain 
Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 ("the 
RoHS Regulations") as they apply in England and Wales and Scotland.  
Regulation 2 will grant new specific and temporary exemptions wh ich will be added as 
entries 97 to 99 of Table 1 in Schedule A2 of the RoHS Regulations. The exemptions apply 
to:  
(1) 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. This 
exemption will expire on 21 July 2028.  
(2) Bis(2 -ethylhexyl)  phthalate  (DEHP) in plastic components in MRI detector coils. This 
exemption will expire on 1 January 2024.  
(3) Bis(2 -ethylhexyl) phthalate (DEH P), butyl benzyl phthalate (BBP), dibutyl phthalate 
(DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the G/TBT/N/GBR/46  
 
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  repair or refurbishment of medical devices, including in vitro  diagnostic medical devices, 
and their accessories, provi ded 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 exemption will expire on 21 July 2028.  
These regulations will also make minor incidental amendments t o Schedule A2 of the 
RoHS Regulations to clarify the descriptions of the tables containing the exemptions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Adaptation of existing legislation to scientific and technical  progress; phase -
out of substances of very high concern (SVHC) in electrical equipment in order to facilitate 
recycling and reduce possible negative impacts on human health and the environment, 
while granting economic operators adequate transition time for  compliance. A shorter 
entry into force period for the Amendment is necessary to avoid potential negative 
impacts on the supply of medical devices/spare parts.  A longer delay may have a 
consequential impact on human health because of potential delays in di agnoses and 
treatment.; Protection of human health or safety; Protection of the environment  
8. Relevant documents:   
Relevent UK documentation  
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic 
Equipment Regulations 2012 (The RoHS Regulations)  
https://www.legislation.gov.uk/uksi/2012/3032/made  
The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU 
Exit) Regulations 2020 (SI 2020 No 1647) provides powers to amend, by regulation, the 
list of   exemptions (Table 1 of Schedule A2)  
https://www.legislation.gov.uk/uksi/2020/1647/contents/made  
Consultation on amendments to the Restriction of the Use of Certain Hazardous 
Substances in Electrical and Electronic Equipment Regulations. The inclusion of 
restrictions on phthalates in medical devices and monitoring and control instruments.  
Restriction of phthalates medical devi ces, monitoring and control instruments - GOV.UK 
(www.gov.uk)  
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic 
Equipment (Amendment) No 2 Regulations 2021, which introduces restriction on the 
use of phthalates in medi cal devices and monitoring and control instruments from 1 July 
2022. See notification G/TBT/N/GBR/43 . 
https://www.legislation.gov.uk/uksi/2021/1395/made  
Technical and scientific analysis reports of the exemptions (see attachments).  
9. Proposed date of adoption:  June 2022  
Proposed date of entry into force:  The relevant provisions in the draft instrument will 
come into force on 1 July 2022  
10. Final date for comments:  60 days from notification  G/TBT/N/GBR/46  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
UK TBT Enquiry Point  
Trade Policy Group  
Department for International Trade  
Old Admiralty Building  
London  
SW1A 2DY  
TBTEnquiriesUK@trade.gov.uk  
 
Draft statutory instrument on the Restriction of the Use of Certain Hazardous 
Substances in Electrical and Electronic Equipment (Amendment) Regulations 2022 (see 
attachment).  
https://members.wto.org/crnattachments/2022/TBT/GBR/22_2264_00_e.pdf  
https://members.wto. org/crnattachments/2022/TBT/GBR/22_2264_01_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/GBR/22_2264_02_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/GBR/22_2264_03_e.pdf