G/TBT/N/GBR/43  
24 September 2021  
(21-7133) Page: 1/4 
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):  N/A 
2. Agency responsible:   
UK TBT Enquiry Point  
Trade Policy Group  
Department for International Trade  
Old Admiralty Building  
London  
SW1A 2DY  
TBTEnquiriesUK@trade.gov.uk  
Name and address (including telephone and fax numbers , email and w ebsite 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 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) and corresponding EU legislation. HS code 
9018 for medical devices, and HS code 36 for civil explosives.; EXPLOSIVES; 
PYROTECHNIC PRODUCTS; MATCHES; PYRO PHORIC ALLOYS; CERTAIN COMBUSTIBLE 
PREPARATIONS (HS 36); Instruments and appliances used in medical, surgical, dental or 
veterinary sciences, incl. scintigraphic apparatus, other electro -medical apparatus and 
sight-testing instruments, n.e.s (HS 9018)  
5. Title, number of pages and language(s) of the notified document:  Draft Statutory 
Instrument: The Restriction of The Use of Certain Hazardous Substances in Electrical and 
Electronic Equipment (Amendment) Regulations 2021 (2 page(s), in English)  
6. Descript ion of content:  These measures will amend 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(2) will ame nd the list of restricted substances in Schedule A1 to extend the 
restriction on the use of four restricted substances (Bis(2 -ethylhexyl) phthalate (DEHP), 
Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Disobutyl phthalate (DIBP)) to 
medical dev ices and monitoring and control instruments.  
Regulation 2(3) will renew the exemption for mercury to be used in electric rotating 
connectors used in ultrasound imaging systems in entry No. 93 of Table 1 in Schedule A2 
to the RoHS Regulations for a period of 5 years.    G/TBT/N/GBR/43  
 
- 2 - 
 
  Regulation 2(3)(b) will grant a new exemption from the list of restricted substances in 
Schedule A1 to the RoHS Regulations by adding certain lead compounds and one 
hexavalent form of chromium (barium) to be used in the supply of electric and electronic 
initiators of explosives for civil  explosives to the list in Table 1 in Schedule A2 of 
applications exempted from the restriction in regulation 3(1) of the RoHS Regulations. 
The exemption will be granted for a period ending on 20th April 2026.  
7. Objective and rationale, including the nat ure 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 impa cts on human health and the environment, 
while granting economic operators adequate transition time for compliance.  ; Protection 
of human health or safety; Protection of the environment  
8. Relevant documents:   
These measures were pre -notified to the WTO by the European Commission at a time 
when the UK was a member of the EU.   The relevant notifications are:  
G/TBT/N/EU/256  
G/TBT/N/EU/725  
G/TBT/N/EU/726  
Relev ant UK documentation  
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic 
Equipment Re gulations 2012 (The RoHS Regulations)  
https://www.legislation.gov.uk/uksi/2012/3032/made  
The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU 
Exit) Regulations2 020 (SI 2020 No 1647) provides powers to amend, by regulation, the 
list of restricted substances (Schedule A1) and exemptions (Table 1 of schedule A2)  
https://www.legislation.gov.u k/uksi/2020/1647/contents/made  
Review of the inclusion of phthalates in the RoHS Regulations in medical devices and 
monitoring and control instruments.  (Annex B)  
Consultation on amendments to the Restriction of the Use of Certain Hazardous 
Substances in E lectrical and Electronic Equipment Regulations. The inclusion of 
restrictions on phthalates in medical devices and monitoring and control instruments.  
Restriction of phthalates medical devices, monitoring and control instruments - GOV.UK 
(www.gov.uk)  
Relevant Documentation: Extension of the 4 phthalates to medical devices and control 
and instrumentation equipment:  
Directiv e 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on 
the restriction of the use of certain hazardous substances in electrical and electronic 
equipment (recast). https://www.legislation.gov.uk/eudr/2011/65  
Direct links to substance evaluation and recommendations:  
Study for the review of the list of restricted substances under RoHS2  
https://op.europa.eu/en/publication -detail/ -/publication/39eb0f95 -27a8-4ae6-8ec3-
627c7336ae65 . 
24th Meeting of the Committee for Risk Assessment 2013   
https://echa.europa.eu/documents/10162/21961120/rac_24_dne l_dehp_comments_en.
pdf/e0506f6b -35f7-433e-99da-
35464a26e2df#:~:text=Derivation%20of%20reference%20DNELs%20for%20DEHP&te
xt=As%20the%20DNELs%20are%20based,most%20sensitive%20endpoint%20for%20
DEHP..#  G/TBT/N/GBR/43  
 
- 3 - 
 
  Adopted opinions and previous consultations on applications  for exemptions  
https://echa. europa.eu/applications -for-authorisation -previous -
consultations?diss=true&search_criteria_ecnumber=204 -211-
0&search_criteria_casnumber=117 -81-7&search_criteria_name=Bis%282 -
ethylhexyl%29+phthalate . 
Analysis of alternatives non -confidential report -DEHP Use  3  
https://echa.europa.eu/home?p_p_state=maximized&p_p_mode=view&saveLastPath=f
alse&_com_liferay_login_web_portlet_LoginPortlet_mvcRenderCommandName=%2Fl ogi
n%2Flogin&p_p_id=com_liferay_login_web_portlet_LoginPortlet&p_p_lifecycle=0&_com
_liferay_login_web_portlet_LoginPortlet_redirect=%2Fdocuments%2F10162%2Fa85d2e
25-5cef-41be-9089-cd83cc3d6718 . 
REACH Authorisation for DEHP in Medical Devices Factsheet  
https://www.osservatoriobiomedicaleveneto.it/wp -
content/uploads/2020/09/200921_MTE_DEHP -factsheet_FINAL -DRAFT.pdf  
Study to assess three (3) exemption requests relating to Annex IV to Directive 
2011/65/EU: request for amendment of existing exemption 31a; request for a new 
exemption for bis - (ethylhexyl) phthalate (DEHP) in ion selective electrodes for point of 
care an. May 2020 . 
https://op.europa.eu/en/publication -detail/ -/publication/df0ab036 -8b52-11ea-812f-
01aa75ed71a1/language -en/format -PDF/source -146143357  
Study to assess one (1) request for a new exemption to Annex IV of Directive 2011/65/EU 
for bis -(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils (Pack 
20) – Draft final Report. June 2020.  
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_20/RoHS_Pack -
20_final_30062020.pdf  
ECHA. Recommendation of the European Chemicals Ag ency of 10 July 2019 to amend the 
Annex XIV entries to REACH of DEHP, BBP, DBP and DIBP. [Online] 10 July 2019.  
https://echa.europa.eu/documents/10162/13640/axiv_amend_recommendation_phthal
ates_july2019_en.pdf/1889866a -bec3-fe16-6322-67c16a13b09d  
ECHA. SCIP  
https://echa.europa.eu/scip  
Study for the Review of the list of Restricted Substances under RoHS2: 
https://op.europa.eu/en/publication -detail/ -/publication/39eb0f95 -27a8-4ae6-8ec3-
627c7336ae65 . 
DelegatedDirective(EU) 2015/863:  
Delegated Directive (EU) 2015/863 "RoHS III"  
Study for the Review of the list of Restricted Substances under RoHS2. 
https://op.europa.eu/en/publication -detail/ -/publication/39eb0f95 -27a8-4ae6-8ec3-
627c7336ae65 . 
DelegatedDirective(EU) 2015/863  
Delegated Directive (EU) 2015/863 "RoHS III " 
Relevant Documentation: Exemption for lead and hexavalent chromium compounds in 
electric and electronic initiators of explosives for civil (professional) use  
Documentation Scientific background studies  
https://op.europa.eu/en/publication -detail/ -/publication/7e6bf135 -f0b9-11e9-a32c-
01aa75ed71a1/language -en/format -PDF/source -120742148  
Commission Del egated Directive (EU) 2021/647  
EUR-Lex – 32021L0647 – EN – EUR-Lex  G/TBT/N/GBR/43  
 
- 4 - 
 
  Relevant Documentation: Extension of the validity period for the exemption for for the 
use of mercury in electric rotating connectors used in intravascular ultrasoun d imaging 
systems  
Scientific background studies  
https://op.europa.eu/en/publication -detail/ -/publication/ 7e6bf135 -f0b9-11e9-a32c-
01aa75ed71a1/language -en/format -PDF/source -120742148  
Delegated Directive EU 21/884 https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32021L0884#:~:text=Commission%20Delegated%20
Directive%20%28EU%29%202021%2F884%20of%2 08%20March,intravascular%20ultr
asound%20imaging%20systems%20%28Text%20with%20EEA%20relevance%29  
9. Proposed date of adoption:  December 2021  
Proposed date of entry into force:  1 July 2022  
10. Final date for comments:  23 November 2021  
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 2 DY 
TBTEnquiriesUK@trade.gov.uk  
https://members.wto.org/crnattachments/2021/TBT/GBR/21_6085_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/GBR/21_6085_01_e.pdf