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UK REACH vs EU REACH
UK RoHS vs EU RoHS
Emerging Differences
Presented at: Chemical Watch UK Chemicals
Regulations 2022
Presented by: Steven Andrews & Raj Takhar,
Assent
© Assent 2022 / assent.com
Today’s presenters
Steve Andrews
Subject Matter Expert on
Environmental Stewardship
Assent
Raj Takhar
Senior Subject Matter Expert on
Materials Reporting (Europe)
Assent
© Assent 2022 / assent.com
Agenda
1. UK REACH vs EU REACH.
▸ Candidate List
▸ Authorisation List
▸ Restricted List
▸ Summary of Obligations
▸ Divergences known (today)
2. UK RoHS vs EU RoHS
▸ Scope & List of Substances
▸ Exemptions
▸ Product Marking
▸ Review
3. Q&A.
© Assent 2022 / assent.com
UK REACH vs
EU REACH
Similar in nature … but divergence
is emerging.
© Assent 2022 / assent.com
UK REACH
Independent chemicals regulatory framework
● Applicable since 1st January 2021.
● UK has put in place its own independent
chemicals regulatory framework.
● UK Defra has overall policy oversight.
● UK HSE is UK Agency for UK REACH.
○ Mirrors EU REACH as far as
possible.
○ Minimises disruption to supply
chains for chemicals though our
transitional measures.
● Both UK and EU operate REACH
independently of each other.
● UK REACH obligations cover GB
(England, Scotland and Wales).
● Northern Ireland Protocol requires
companies to comply with EU REACH,
but no SCIP obligations.
● Businesses will need to take steps to
ensure regulatory requirements are
fulfilled in both the UK and EU in order
to maintain continuity of supply chains.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Access to systems.
● IUCLID based.
● Comply with UK REACH
○ Create Defra gov.uk account.
○ Only legal entities which are UK
based can register and transmit
data.
○ Third Party Representative
(TPR).
● IUCLID based.
● EU REACH-IT
○ Create EU REACH-IT account.
○ Multiple subsystems report data
differently for REACH, CLP, BPR
and SCIP.
○ Non-EU locations can register
themselves as actors.
○ Only EU based legal entities / Only
Representative (OR) can transmit
data.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Candidate List of Substances of Very High Concern
● Not Yet Updated!
● Aligns to 16th July 2019 version of EU
REACH Candidate List. 201 entries (373
substances) - available as xlsx file.
● Additional 10 substances on
HSE/DEFRA roadmap - all except for
Resorcinol; 1,3-benzenediol [CAS:
108-46-3].
● Article 7(2) transposed (>1 tn use)
● DUIN / Article 26 register new or
existing substance(s).
● Article 33 (currently under review).
● Updates twice a year.
● January 2022, 223 entries (444
substances).
● Resorcinol; 1,3-benzenediol [CAS:
108-46-3]. is on the Registry of
Intentions to be included on to the
REACH Candidate List.
● EU WFD 2018/851 introduced
additional SVHC reporting obligations
for articles with SVHCs onto the ECHA
SCIP Database.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Annex XIV: Authorisation List of Substances
● 54 Entries (98 Substances)
● UK list has for some substances a longer
sunset date.
● Data must be registered and recorded into
the Comply with UK REACH system by
a UK legal entity or UK based Authorised
Representative (data silo from EU
REACH-IT).
● List of Substances proposed for inclusion
UK Annex XIV (DCHP + Disodium
octaborate)
● List of UK Authorisations being
processed and grandfathered
● 54 Entries (120 substances).
● EU REACH-IT, registrations via EU-27
legal entities or an EU-27 located
Authorised Representative.
● Current Consultations (ending May 2022)
include the addition of Lead (Pb) onto the
Authorisation list + 7 other substances.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Annex XVII: Restricted List of Substances
● 74 Entries (1082 substances displayed
in appendix tables).
● Registry of intentions - 2 substances
Lead (Pb) and Substances in Tattoos
(already restricted under EU REACH.
● Evolving process (RMOA)
● 76 Entries (>2100 substances)
● Established process
● Includes updates via REACH
consultations & updates via EU CLP
Delegated Acts.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Summary of Obligations
● Candidate List:
○ Article 7(2) reporting.
○ Article 33 (being developed)
○ Contains all substances on EU
REACH Candidate List (except for
Resorcinol which has not yet been
added).
● Authorisation List:
○ Apply for authorisation where
identified.
● Restricted List:
○ Identify use and understand terms of
restriction.
● Candidate List:
○ Article 7(2) reporting.
○ Article 33 reporting.
○ EU WfD SCIP Database reporting.
● Authorisation List:
○ Apply for authorisation where
identified.
● Restricted List:
○ Identify use and understand terms of
restriction.
© Assent 2022 / assent.com
UK REACH vs EU REACH
Future Misalignment Ahead!!
● Evolving process.
● Regulatory Management Options
Analysis (RMOA announced similar to EU
REACH announced.
● Following Brexit, the Comply with UK
REACH system has similarities with the
EU system, but will be UK specific.
● Pharmaceutical sector is the biggest
exporting sector for products (63K
employees, Revenues >£21 Billion).
● EU Green Deal established EU Chemical
Sustainability Strategy (EU CSS)
● EU CSS proposed overhaul of EU REACH,
which is expected to be released as a
public draft in Q4, 2022:
○ Wider scope of criteria for SVHCs.
○ EU Criteria for Essential Use (Q2,
2022).
○ EU Criteria for Safe Use (2023).
○ New EU Chemical Audit Agency.
○ Professional uses.
○ ‘one substance, one assessment’
○ More SCIP Data fields!!
UK government policy is looking at
reforming sectors and reducing burden of
reporting. EU More Reporting More Circularity
© Assent 2022 / assent.com
UK RoHS vs
EU RoHS
Misalignment Already Evident & More
Ahead!!
© Assent 2022 / assent.com
UK RoHS
The Restriction of the use of certain Hazardous Substances in EEE
● Applicable since 1st July 2006 (RoHS
1), then 2 January 2013 (RoHS 2).
● UK Regulations prior to Brexit mirrored
the EU Directives.
● Originally 6 substances, now 10.
● Defra has had overall policy oversight in
the UK since 2016, prior to that it was
DTI/BERR/BIS.
● The Office for Product Safety &
Standards is the UK enforcement
agency for UK RoHS.
● Both UK and EU now operate RoHS
independently of each other.
● UK RoHS obligations cover GB
(England, Scotland and Wales).
● Northern Ireland Protocol requires
companies to comply with EU RoHS.
● Businesses will need to take steps to
ensure regulatory requirements are
fulfilled in both in the UK and EU in
order to maintain continuity of supply
chains.
© Assent 2022 / assent.com
UK RoHS vs EU RoHS
Scope & Lists of Substances
● The UK RoHS Regulations 2012 (SI 2012
No. 3032) mirrored the RoHS 2 Directive,
but they have already been amended by
five subsequent SIs and another on the
way!
● Time lags already evident
● The application of the four phthalates
restrictions to most Categories came into
force on 21 July 2019, but will only apply
to Categories 8 and 9 from 1 July 2022
● The RoHS 2 Directive (2011/65/EU) was
amended by (EU) 2015/863 to add the four
phthalates to Annex II
● The new phthalate restrictions applied to
most Categories from 21 July 2019
● The new phthalate restrictions applied to
Categories 8 and 9 from 21 July 2021
© Assent 2022 / assent.com
UK RoHS vs EU RoHS
Exemptions
● The UK Regulations had ‘ambulatory’
provisions - RoHS exemptions updated as
and when they appeared in the EC Official
Journal.
● This ceased to happen when the Brexit
transition period ended on 31 December
2020.
● UK lists effectively frozen on that date &
new numbering.
● Now new amending SIs need to be agreed
& laid before Parliament.
● Time lags already evident, eg exemption
Annex III, 45 - January 2020 (EU); January
2021 (UK)
● RoHS exemptions - the use of any of the
restricted substances above the maximum
concentration values is permitted in certain
clearly specified & limited technical
applications - has been a feature of the
Directive since 2006.
● Separate lists for Categories 8 and 9
appeared as part of RoHS 2 in 2013.
● Each time an exemption is approved,
amended or extended a Delegated
Directive amends either Annex III or IV.
© Assent 2022 / assent.com
UK RoHS vs EU RoHS
Product Marking
● The UK has introduced its own version of
the CE Mark - the UKCA Mark
● This will be required on most products
placed on the GB (English, Scottish &
Welsh) market from 1 January 2023
● But goods placed on the Northern Ireland
market will still require the CE mark
● Medical Device sector has a longer date - 1
July 2023
● The EU CE Mark has been the visible sign
of a producer’s compliance with most ‘new
approach’ legislation since the 1990s
● The first RoHS Directive did not require the
CE Mark
● This was introduced as a part of the RoHS
2 obligations in 2013
© Assent 2022 / assent.com
UK RoHS vs EU RoHS
Review - RoHS 3?
● Following Brexit, the UK will not be a party
to or bound by any outcome from the EC’s
review of RoHS
● UK Government has not announced any
plans to undertake or implement a RoHS
review.
● Article 24 of RoHS 2 had a review
provision
● Consultants Evaluation Report on RoHS
published in March 2021
● EC Call for Evidence - February 2022,
deadline March 2022
● EC open public consultation - March 2022,
deadline June 2022
● Commission proposals expected before
end of year
● Negotiations likely throughout 2023
© Assent 2022 / assent.com

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UK REACH vs EU REACH, UK RoHS vs EU RoHS: Emerging Differences

  • 1. © Assent 2022 / assent.com UK REACH vs EU REACH UK RoHS vs EU RoHS Emerging Differences Presented at: Chemical Watch UK Chemicals Regulations 2022 Presented by: Steven Andrews & Raj Takhar, Assent
  • 2. © Assent 2022 / assent.com Today’s presenters Steve Andrews Subject Matter Expert on Environmental Stewardship Assent Raj Takhar Senior Subject Matter Expert on Materials Reporting (Europe) Assent
  • 3. © Assent 2022 / assent.com Agenda 1. UK REACH vs EU REACH. ▸ Candidate List ▸ Authorisation List ▸ Restricted List ▸ Summary of Obligations ▸ Divergences known (today) 2. UK RoHS vs EU RoHS ▸ Scope & List of Substances ▸ Exemptions ▸ Product Marking ▸ Review 3. Q&A.
  • 4. © Assent 2022 / assent.com UK REACH vs EU REACH Similar in nature … but divergence is emerging.
  • 5. © Assent 2022 / assent.com UK REACH Independent chemicals regulatory framework ● Applicable since 1st January 2021. ● UK has put in place its own independent chemicals regulatory framework. ● UK Defra has overall policy oversight. ● UK HSE is UK Agency for UK REACH. ○ Mirrors EU REACH as far as possible. ○ Minimises disruption to supply chains for chemicals though our transitional measures. ● Both UK and EU operate REACH independently of each other. ● UK REACH obligations cover GB (England, Scotland and Wales). ● Northern Ireland Protocol requires companies to comply with EU REACH, but no SCIP obligations. ● Businesses will need to take steps to ensure regulatory requirements are fulfilled in both the UK and EU in order to maintain continuity of supply chains.
  • 6. © Assent 2022 / assent.com UK REACH vs EU REACH Access to systems. ● IUCLID based. ● Comply with UK REACH ○ Create Defra gov.uk account. ○ Only legal entities which are UK based can register and transmit data. ○ Third Party Representative (TPR). ● IUCLID based. ● EU REACH-IT ○ Create EU REACH-IT account. ○ Multiple subsystems report data differently for REACH, CLP, BPR and SCIP. ○ Non-EU locations can register themselves as actors. ○ Only EU based legal entities / Only Representative (OR) can transmit data.
  • 7. © Assent 2022 / assent.com UK REACH vs EU REACH Candidate List of Substances of Very High Concern ● Not Yet Updated! ● Aligns to 16th July 2019 version of EU REACH Candidate List. 201 entries (373 substances) - available as xlsx file. ● Additional 10 substances on HSE/DEFRA roadmap - all except for Resorcinol; 1,3-benzenediol [CAS: 108-46-3]. ● Article 7(2) transposed (>1 tn use) ● DUIN / Article 26 register new or existing substance(s). ● Article 33 (currently under review). ● Updates twice a year. ● January 2022, 223 entries (444 substances). ● Resorcinol; 1,3-benzenediol [CAS: 108-46-3]. is on the Registry of Intentions to be included on to the REACH Candidate List. ● EU WFD 2018/851 introduced additional SVHC reporting obligations for articles with SVHCs onto the ECHA SCIP Database.
  • 8. © Assent 2022 / assent.com UK REACH vs EU REACH Annex XIV: Authorisation List of Substances ● 54 Entries (98 Substances) ● UK list has for some substances a longer sunset date. ● Data must be registered and recorded into the Comply with UK REACH system by a UK legal entity or UK based Authorised Representative (data silo from EU REACH-IT). ● List of Substances proposed for inclusion UK Annex XIV (DCHP + Disodium octaborate) ● List of UK Authorisations being processed and grandfathered ● 54 Entries (120 substances). ● EU REACH-IT, registrations via EU-27 legal entities or an EU-27 located Authorised Representative. ● Current Consultations (ending May 2022) include the addition of Lead (Pb) onto the Authorisation list + 7 other substances.
  • 9. © Assent 2022 / assent.com UK REACH vs EU REACH Annex XVII: Restricted List of Substances ● 74 Entries (1082 substances displayed in appendix tables). ● Registry of intentions - 2 substances Lead (Pb) and Substances in Tattoos (already restricted under EU REACH. ● Evolving process (RMOA) ● 76 Entries (>2100 substances) ● Established process ● Includes updates via REACH consultations & updates via EU CLP Delegated Acts.
  • 10. © Assent 2022 / assent.com UK REACH vs EU REACH Summary of Obligations ● Candidate List: ○ Article 7(2) reporting. ○ Article 33 (being developed) ○ Contains all substances on EU REACH Candidate List (except for Resorcinol which has not yet been added). ● Authorisation List: ○ Apply for authorisation where identified. ● Restricted List: ○ Identify use and understand terms of restriction. ● Candidate List: ○ Article 7(2) reporting. ○ Article 33 reporting. ○ EU WfD SCIP Database reporting. ● Authorisation List: ○ Apply for authorisation where identified. ● Restricted List: ○ Identify use and understand terms of restriction.
  • 11. © Assent 2022 / assent.com UK REACH vs EU REACH Future Misalignment Ahead!! ● Evolving process. ● Regulatory Management Options Analysis (RMOA announced similar to EU REACH announced. ● Following Brexit, the Comply with UK REACH system has similarities with the EU system, but will be UK specific. ● Pharmaceutical sector is the biggest exporting sector for products (63K employees, Revenues >£21 Billion). ● EU Green Deal established EU Chemical Sustainability Strategy (EU CSS) ● EU CSS proposed overhaul of EU REACH, which is expected to be released as a public draft in Q4, 2022: ○ Wider scope of criteria for SVHCs. ○ EU Criteria for Essential Use (Q2, 2022). ○ EU Criteria for Safe Use (2023). ○ New EU Chemical Audit Agency. ○ Professional uses. ○ ‘one substance, one assessment’ ○ More SCIP Data fields!! UK government policy is looking at reforming sectors and reducing burden of reporting. EU More Reporting More Circularity
  • 12. © Assent 2022 / assent.com UK RoHS vs EU RoHS Misalignment Already Evident & More Ahead!!
  • 13. © Assent 2022 / assent.com UK RoHS The Restriction of the use of certain Hazardous Substances in EEE ● Applicable since 1st July 2006 (RoHS 1), then 2 January 2013 (RoHS 2). ● UK Regulations prior to Brexit mirrored the EU Directives. ● Originally 6 substances, now 10. ● Defra has had overall policy oversight in the UK since 2016, prior to that it was DTI/BERR/BIS. ● The Office for Product Safety & Standards is the UK enforcement agency for UK RoHS. ● Both UK and EU now operate RoHS independently of each other. ● UK RoHS obligations cover GB (England, Scotland and Wales). ● Northern Ireland Protocol requires companies to comply with EU RoHS. ● Businesses will need to take steps to ensure regulatory requirements are fulfilled in both in the UK and EU in order to maintain continuity of supply chains.
  • 14. © Assent 2022 / assent.com UK RoHS vs EU RoHS Scope & Lists of Substances ● The UK RoHS Regulations 2012 (SI 2012 No. 3032) mirrored the RoHS 2 Directive, but they have already been amended by five subsequent SIs and another on the way! ● Time lags already evident ● The application of the four phthalates restrictions to most Categories came into force on 21 July 2019, but will only apply to Categories 8 and 9 from 1 July 2022 ● The RoHS 2 Directive (2011/65/EU) was amended by (EU) 2015/863 to add the four phthalates to Annex II ● The new phthalate restrictions applied to most Categories from 21 July 2019 ● The new phthalate restrictions applied to Categories 8 and 9 from 21 July 2021
  • 15. © Assent 2022 / assent.com UK RoHS vs EU RoHS Exemptions ● The UK Regulations had ‘ambulatory’ provisions - RoHS exemptions updated as and when they appeared in the EC Official Journal. ● This ceased to happen when the Brexit transition period ended on 31 December 2020. ● UK lists effectively frozen on that date & new numbering. ● Now new amending SIs need to be agreed & laid before Parliament. ● Time lags already evident, eg exemption Annex III, 45 - January 2020 (EU); January 2021 (UK) ● RoHS exemptions - the use of any of the restricted substances above the maximum concentration values is permitted in certain clearly specified & limited technical applications - has been a feature of the Directive since 2006. ● Separate lists for Categories 8 and 9 appeared as part of RoHS 2 in 2013. ● Each time an exemption is approved, amended or extended a Delegated Directive amends either Annex III or IV.
  • 16. © Assent 2022 / assent.com UK RoHS vs EU RoHS Product Marking ● The UK has introduced its own version of the CE Mark - the UKCA Mark ● This will be required on most products placed on the GB (English, Scottish & Welsh) market from 1 January 2023 ● But goods placed on the Northern Ireland market will still require the CE mark ● Medical Device sector has a longer date - 1 July 2023 ● The EU CE Mark has been the visible sign of a producer’s compliance with most ‘new approach’ legislation since the 1990s ● The first RoHS Directive did not require the CE Mark ● This was introduced as a part of the RoHS 2 obligations in 2013
  • 17. © Assent 2022 / assent.com UK RoHS vs EU RoHS Review - RoHS 3? ● Following Brexit, the UK will not be a party to or bound by any outcome from the EC’s review of RoHS ● UK Government has not announced any plans to undertake or implement a RoHS review. ● Article 24 of RoHS 2 had a review provision ● Consultants Evaluation Report on RoHS published in March 2021 ● EC Call for Evidence - February 2022, deadline March 2022 ● EC open public consultation - March 2022, deadline June 2022 ● Commission proposals expected before end of year ● Negotiations likely throughout 2023
  • 18. © Assent 2022 / assent.com