Windsor Framework Democratic Scrutiny Committee

Ordered by the Windsor Framework Democratic Scrutiny Committee to be published 15 August 2024

Report: NIA 46/22-27 Windsor Framework Democratic Scrutiny Committee

Contents

• Purpose and Membership
• Introduction
• The Replacement EU Act
• The Committee’s Examination of the Proposed Replacement EU Act
• The Committee’s Decision on Whether to Hold an Inquiry
• The Inquiry Process
• The Committee’s Conclusions
• Next Steps
• Links to Appendices
  • Appendix A: Minutes of Proceedings
  • Appendix B: Memoranda and Other Papers
  • Appendix C: Minutes of Evidence
  • Appendix D: Consultation Responses

 

Purpose and Membership

Purpose

The Windsor Framework Democratic Scrutiny Committee is a standing committee of the Northern Ireland Assembly established under Schedule 6B to the Northern Ireland Act 1998.

The purpose of the Committee is to assist with the observation and implementation of Article 13(3a) and Article 13(4) of the Windsor Framework.

The functions of the Committee include:

1. the examination and consideration of new EU acts and replacement EU acts;
2. the conduct of inquiries and publication of reports in relation to replacement EU acts;
3. engagement with businesses, civil society and others as appropriate in relation to replacement EU acts;
4. engagement with the UK Government in relation to replacement EU acts;
5. engagement with Ministers and Northern Ireland departments in relation to replacement EU acts;
6. the collation and publication of evidence collected as part of its other activities; and
7. dealing with other matters (including legislative proposals which may become new EU acts or replacement EU acts) which the Committee considers to be connected with its purpose or other functions.

A replacement EU act means an EU law which updates, by amending or replacing, any of the relevant [1] EU laws which already apply in Northern Ireland, as listed under Annex 2 of the Windsor Framework.Areas of EU law that apply in Northern Ireland include legislation on goods, animal and plant health rules, rules on agricultural production, VAT and excise on goods, and state aid rules.The EU’s Customs Code also applies to goods entering Northern Ireland.There is a procedure by which members of the Assembly may seek to prevent the application of a replacement EU act (an emergency brake mechanism known as the Stormont Brake). Further information on the Stormont Brake can be found here.

A new EU act means a new EU law which falls within the scope of the Windsor Framework, but which neither amends nor replaces an EU act listed in the Annexes. The Northern Ireland Assembly has a role, by means of an “applicability motion”, in setting out its position on whether a new EU act should be added to the list of EU laws applicable in Northern Ireland. Further information on Applicability Motions can be found here.

Membership

The Committee has 9 members, including a Chairperson and Deputy Chairperson, and a quorum of five members. The membership of the Committee is as follows:

• Mr Philip McGuigan MLA (Chairperson) [2]
• Mr David Brooks MLA (Deputy Chairperson)
• Mr Eóin Tennyson MLA [3]
• Ms Connie Egan MLA [4]
• Ms Joanne Bunting MLA
• Mr Stephen Dunne MLA [5]
• Mr Declan Kearney MLA
• Ms Emma Sheerin MLA
• Dr Steve Aiken OBE MLA

 

Introduction

1. This report sets out the conclusions of an inquiry by the Windsor Framework Democratic Scrutiny Committee (‘the Committee’) into a published replacement EU act: Regulation (EU) 2024/1849 of the European Parliament and of the Council of 13 June 2024 amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions.

2. The Regulation is a replacement EU act because it amends Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repeals Regulation (EC) No 1102/2008, as listed in the Windsor Framework at Article 5(4), Annex 2, indent 23.

3. The replacement EU act applies in Northern Ireland under Article 13(3) of the Windsor Framework but is subject to the mechanism set out in Article 13(3a) of the Windsor Framework. This mechanism provides for a replacement EU act, or relevant parts of a replacement EU act, not to apply in Northern Ireland if the United Kingdom Government (‘UK Government’) notifies the EU within two months of the act’s publication in the EU Official Journal.

4. The UK Government may only make this notification if it is satisfied that the conditions in Article 13(3a) of the Windsor Framework have been met and that the procedures set out in its Unilateral Declaration on the involvement of the institutions of the 1998 Agreement have been followed. These procedures provide, amongst other things, that 30 MLAs from at least two parties (and excluding the Speaker and Deputy Speakers) will need to notify the UK Government of their wish that the emergency brake mechanism should be applied.[6]

5. If the UK Government is satisfied that the necessary conditions have been met, it will notify the EU in the Joint Committee. The EU law will not apply in Northern Ireland in its new form two weeks later. The older version of the EU law will still apply. The relevant law would then be discussed in the EU-UK Joint Committee under the process for new EU laws - Article 13(4). The UK Government must not agree (apart from in exceptional circumstances) to adopt the new law unless the Assembly has passed a motion with cross-community support, known as an applicability motion.

6. The replacement EU act in question - Regulation (EU) 2024/1849 - was published in the EU Official Journal on 10 July 2024. The UK Government formally notified the Committee of the act’s publication on 11 July 2024.

7. Under paragraph 8(1) of Schedule 6B to the Northern Ireland Act 1998, the Committee must decide no later than five working days after the day on which it was notified of the replacement Regulation whether it wishes to hold an inquiry. In reaching a decision, paragraph 8(2) of Schedule 6B requires the Committee to have regard to whether it appears likely that the replacement EU act:

• significantly differs (in whole or in part) from the content or scope of the EU instrument which it amends or replaces; and
• would have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist.

8. The Committee may also have regard to any other matters it considers appropriate.

 

The Replacement EU Act

9. The replacement EU act amends Regulation (EU) 2017/852 on mercury ‘the Mercury Regulation’ as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions. It delivers on recommendations included in the European Commission’s 2020 report on the use of mercury in dental amalgam and products. The amendments will also align the EU Mercury Regulation with wider EU law on the Restriction of Hazardous Substances.

10. Specifically, the amendments will:

• prohibit the use of dental amalgam in the EU from 1 January 2025, whilst retaining dental practitioners’ discretion to still use it when dental amalgam is deemed strictly necessary for addressing the specific medical needs of an individual patient;
• provide a derogation until 30 June 2026 for the use of dental amalgam in Member States where dental amalgam is the only reimbursed dental restoration material and this is reimbursed at a rate of at least 90%;
• prohibit the export of dental amalgam from the EU from 1 January 2025 and prohibit the import and manufacturing of dental amalgam from 1 July 2026 (the import and manufacturing of dental amalgam will be permitted for specific medical needs); and
• prohibit the manufacture, import and export of six additional mercury-added products (MAPs) by listing them in Annex II to the EU Mercury Regulation. [7]

11. The EU act also repeals Regulation (EC) No 1102/2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury.

 

The Committee's Examination of the Proposed Replacement EU Act

12. At its meeting on 7 March 2024, the Committee considered correspondenceincluding a position paper from the British Dental Association, Northern Ireland (BDA) in relation to COM (2023)395: a proposal to amend Regulation (EU) 2017/852 on mercury. The Committee noted that it was likely to receive a notification from the Cabinet Office when the European Union published the final EU act, and agreed to commence an evidence gathering exercise. The Committee agreed to invite the BDA to give oral evidence on 14 March 2024.

13. The correspondence and position paper from the BDA dated 5 March 2024, and supplementary papers provided by the BDA dated 14 and 19 March 2024, can be found at Appendix B. The official report (‘Hansard’) of the evidence session with the BDA can be found at Appendix C.

14. Having agreed to commence evidence gathering, the Committee wrote to request views, via the Executive Office (TEO), from the Department of Health (DoH) and Department of Agriculture, Environment and Rural Affairs (DAERA) on the impact of the proposed EU act. A copy of the response from TEO, dated 20 March 2024, can be found at Appendix B.

15. The Committee also wrote to the UK Government for its views, including the position in the other jurisdictions. A copy of the response from the UK Government, dated 28 March 2024, can be found at Appendix B.

16. At its meeting on 14 March, the Committee considered the ExplanatoryMemorandum (EM) from the UK Department for Environment, Food and Rural Affairs, dated 1 November 2023, on the proposed EU act; and, a report published by the House of Commons European Scrutiny Committee. The EM and the European Scrutiny Committee report can be found at Appendix B.

17. Following oral evidence from the BDA on 14 March 2024, the Committee agreed to request legal advice on whether it appeared likely that the proposed replacement EU act differed significantly (in whole or in part) from the content or scope of the old Regulation which it seeks to amend or replace. The Committee noted that the legal advice indicated that the proposed replacement EU act significantly differs, in part, from the content or scope of the Mercury Regulation.

18. In addition, the Committee agreed to write to the Joint Consultative Working Group, via the Cabinet Office, to inform them of the significant issues raised during the oral evidence session with the BDA. A copy of the correspondence, dated 15 March 2024, is at Appendix B.

19. The Committee also agreed to request an initial departmental assessment of impact on the proposed EU act, to consider whether it appeared likely that the replacement EU act would have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist; and, to schedule an oral evidence session with departmental officials on 18 April 2024.

20. The departmental assessment of impact can be found at Appendix B. The Hansard of the evidence session with the Department of Health can be found at Appendix C.

21. At its meeting on 21 March 2024, the Committee considered correspondence from the World Alliance for Mercury-Free Dentistry (WAFMFD) on the proposed EU act and agreed, as part of its evidence gathering exercise, to invite representatives to give oral evidence on 18 April 2024.

22. The correspondence from the WAFMFD dated 15 March 2024, and additional correspondence and papers provided by the WAFMFD dated 19 March 2024 and 15 April 2024, are at Appendix B. The Hansard of the evidence session with the WAFMFD can be found at Appendix C.

23. Between 4 and 10 April 2024, the Committee received fifty-five emails from members of the public regarding the proposed EU act. Twenty-five of the emails were identical in content. All fifty-five respondents were in favour of banning the use of amalgam in dentistry. A copy of the emails is at Appendix B.

24. The Committee received further correspondence from the WAFMFD dated 26 April 2024, querying information provided by the DoH during its oral evidence session, regarding the cost for transitioning the reimbursement from amalgam to composite fillings. The Committee wrote to the DoH for its views on the issues raised by the WAFMFD. The correspondence from the WAFMFD and the response from the DoH, dated 17 June 2024, can be found at Appendix B.

25. At its meeting on 11 July 2024, the Committee considered correspondence and a costings paper from the BDA, dated 20 June 2024, outlining the anticipated financial impact of introducing a ban on dental amalgam. A copy of the correspondence and costings paper from the BDA is at Appendix B.

 

The Committee’s Decision on Whether to Hold an Inquiry

26. The Committee met on 18 July 2024 to decide whether or not to conduct an inquiry into Regulation EU) 2024/1849.

27. To assist it in reaching a decision, the Committee considered legal advice on whether it appeared likely that the replacement EU act differed significantly (in whole or in part) from the content or scope of the old Regulations which it seeks to amend or replace. The Committee noted that the legal advice indicated that the published replacement act significantly differs, in part, from the content or scope of the EU instrument which it amends or replaces.

28. The Committee also considered whether it appeared likely that the replacement EU act would have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist. It did this by: examining all the evidence gathered as part of its consideration of the proposed EU act; considering an initial assessment of impact provided by the DoH and DAERA; listening to evidence from DoH and DAERA officials; and considering the Cabinet Office Mercury Regulation Information Note on the published EU act, dated July 2024.

29. The evidence gathered as part of the Committee’s consideration of the proposed EU act, the assessment of impact and the Cabinet Office Information Note can be found at Appendix B. The Official Report of the evidence session can be found at Appendix C.

30. Having had regard to whether it appears likely that Regulation (EU) 2024/1849:

• significantly differs (in whole or in part) from the content or scope of the EU instrument which it amends or replaces; and
• would have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist,

the Committee decided to hold an inquiry into that act. This decision was published on the Committee’s webpage.

 

The Inquiry Process

31. In conducting an inquiry, paragraph 9(2) of Schedule 6B to the Northern Ireland Act 1998, requires the Committee to “seek substantive discussion and engagement” with the UK Government, the relevant Northern Ireland Minister or department, and, to the extent that the Committee considers appropriate, representatives of businesses and civil society affected by the replacement EU act, or who would be affected, if the act was to apply in Northern Ireland. The Committee may also consider any matters it deems appropriate.

32. The Committee had to conclude its inquiry and publish a report setting out its conclusions no later than 15 working days before the end of the two-month scrutiny period. The scrutiny period started when the replacement Regulation was published in the EU Official Journal on 10 July 2024, and therefore ends on 10 September 2024.

33. The Committee considered matters relating to its inquiry, including making a decision on whether to conduct an inquiry, at four meetings. The Minutes of Proceedings can be found at Appendix A.

34. At its meeting on 18 July 2024, the Committee agreed to seek substantive discussion and engagement with the UK Government. It therefore wrote to the UK Government to seek its views on whether applying, or not applying, the replacement EU act would have an impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist. In considering the matter of divergence, details of the position in England, Scotland and Wales was also requested. A copy of the Committee’s correspondence dated 19 July 2024, and the UK Government response dated 24 July 2024, can be found at Appendix B.

35. At this meeting, the Committee also agreed to seek substantive discussion and engagement with the relevant Northern Ireland departments - DoH and DAERA. Therefore, it requested that departmental officials attend the Committee meeting on 25 July 2024, to give oral evidence.

36. Further, the Committee agreed to seek substantive discussion and engagement with representatives of business and civil society. It opted to use Citizen Space as a platform to facilitate this engagement. A survey asking for views on the impact of the replacement EU act was launched on 19 July 2024.

37. At its meeting on 18 July 2024, the Committee agreed to write directly to key representatives of business and civil society, identified by the Assembly’s Research and Information Service, as being affected, or who would be affected, if the replacement EU act was to apply in Northern Ireland. The survey, which was publicised widely, was also open for response by any other representatives of business and civil society as well as members of the public.

38. On 19 July 2024, the European Commission published Commission Notice C/2024/4675 concerning the application of Regulation (EU) 2024/1849 in respect of Northern Ireland. A copy of the Notice can be found at Appendix B.

39. The key provisions of the Notice were as follows:

“The use of dental amalgam in dental treatment in Northern Ireland for patients residing in the United Kingdom does not pose a risk to the integrity of the Union’s internal market nor to the protection of public health and the environment within the Union when the following conditions are met:

• • The import of dental amalgam from third countries into Northern Ireland for the use in dental treatment for patients residing in the
    United Kingdom is done in accordance with the specific
    conditions in Section 2 of this Notice.
  • The export of dental amalgam from Northern Ireland to outside
    the United Kingdom is prohibited.
  • The manufacturing of dental amalgam in Northern Ireland is
    prohibited from 1 July 2026.

For that reason, and as long as the United Kingdom in respect of Northern Ireland complies with these conditions, the Commission takes the view that dental amalgam may be used in Northern Ireland for the purpose of dental treatment for patients residing in the United Kingdom, and continue importing dental amalgam from outside the Union for that purpose until 31 December 2034 or until the date agreed under the framework of the Minamata Convention on Mercury, whichever is earlier.”

40. The Committee noted that, assuming ongoing compliance by the United Kingdom with the conditions specified in the Commission Notice in respect of Northern Ireland, this will effectively extend the period for the phase out of dental amalgam in Northern Ireland until December 2034, unless an earlier date for the international phase out of Mercury is not first agreed under the framework of the Minamata Convention.

41. In light of the material change in circumstances brought about by Commission Notice C/2024/4675, legal advice on the effect of the Commission Notice on an inquiry commenced by the Committee under Schedule 6B of the Northern Ireland Act 1998, was commissioned. At its meeting on 25 July 2024, the Committee considered the legal advice, and whether to re-take its decision of 18 July 2024 to conduct an inquiry into the EU act. The Committee agreed not to re-take its decision and therefore the inquiry continued.

42. Departmental officials attended the Committee meeting on 25 July 2024, to give oral evidence as requested. The Hansard of the oral evidence can be found at Appendix C. On the day of the meeting, a revised assessment of impact, which took account of Commission Notice C/2024/4675 was submitted. A copy of the revised assessment can be found at Appendix B. At the same meeting, the Committee considered correspondence from WAFMFD on the financial impact of phasing out dental amalgam in Northern Ireland. A copy of the correspondence, dated 17 July 2024, can be found at Appendix B.

43. During the evidence session, officials agreed to provide confirmation of the legal effect and status of the Commission Notice. Correspondence relating to this matter, dated 6 August, can also be found at Appendix B.

44. At its meeting on 1 August, the Committee considered the responses to its Citizen Space survey. Eleven responses were received and these can be found at Appendix D.

45. The Committee also considered a response from the UK Government regarding its assessment of the Commission Notice. A copy of the UK Government Response, dated 24 July 2024, can be found at Appendix B.

46. The Committee agreed to write to the BDA to seek clarity in relation to its views on the implications of Regulation (EU) 2024/1849 and the Commission Notice. A copy of the BDA response can be found at Appendix B.

47. The Committee deliberated on the evidence received at its meeting on 15 August 2024. The evidence received is not rehearsed in this report; a complete picture of the written and oral evidence can be found in the Appendices. At this meeting, the Committee also agreed its Inquiry report and that it should be published.

 

The Committee’s Conclusions

48. In reaching its conclusions, the Committee has carefully considered all the evidence provided to it. The Committee has focused in particular on the two conditions that must be satisfied if the Stormont Brake is to be pulled.

49. In relation to the legal question of whether the replacement EU act significantly differs (in whole or in part) from the content or scope of the EU instrument which it amends or replaces, the Committee noted the legal advice it commissioned on the act, and considered on 18 July 2024, which indicated that the replacement EU act significantly differs, in part, from the content or scope of the EU instrument which it amends or replaces.

50. The legal advice was provided before the publication of Commission Notice C/2024/4675 on 19 July 2024, which provides for the use and importation of dental amalgam in Northern Ireland for dental treatment until 31 December 2034 if certain conditions are met. While the Commission Notice does not, strictly, modify the legal effect of the Mercury Regulation in Northern Ireland, it does provide important guidance on the application of Regulation (EU) 2024/1849 in Northern Ireland. The Committee noted that, had such provision been included in Regulation (EU) 2024/1849, it is unlikely that the legal text would have significantly differed from the Mercury Regulation as enacted, which had contemplated a phase-out of dental amalgam by 2030.

51. Having considered its commissioned legal advice, the Committee concluded that the replacement EU act significantly differed, in part, from the content or scope of the EU instrument which it amended. However, it noted that the European Commission has taken the view that as long as the United Kingdom in respect of Northern Ireland complies with the conditions specified in the Commission Notice, dental amalgam may be used in Northern Ireland for the purpose of dental treatment for patients residing in the United Kingdom, and dental amalgam can be imported from outside the Union for that purpose until 31 December 2034, or until the date agreed under the framework of the Minamata Convention on Mercury, whichever is earlier.

52. In relation to the question of whether the replacement EU actwould have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist, the Committee considered the UK Government’s views as outlined in the Cabinet Office Information Note dated 17 July 2024 (received on 18 July 2024), and its response dated 24 July 2024, the written and oral evidence it received from DoH and DAERA officials, the written and oral evidence it received from the BDA and WAFMFD, the emails received from members of the public and the responses to its Citizen Space survey.

53. The Committee also considered Commission Notice C/2024/4675 which set out the European Commission’s view that as long as the United Kingdom in respect of Northern Ireland complies with the conditions specified, dental amalgam may be used in Northern Ireland for the purpose of dental treatment for patients residing in the United Kingdom, and dental amalgam can be imported from outside the Union for that purpose until 31 December 2034, or until the date agreed under the framework of the Minamata Convention on Mercury, whichever is earlier.

54. In considering this evidence the Committee took the view that for an act to have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist, that significant impact must be negative.

55. Having considered the evidence received from the UK Government, theevidence received from the DoH and DAERA, the evidence received from the BDA and WAFMFD, the emails received from members of the public, the responses to its Citizen Space survey and Commission Notice C/2024/4675, the Committee concluded that the replacement EU act would not have a significant impact specific to everyday life of communities in Northern Ireland in a way that is liable to persist.

 

Next Steps

56. Having reached its conclusions, the Committee’s Inquiry report will be issued to all Members of the Legislative Assembly for further consideration.

 

Links to Appendices

Appendix A: Minutes of Proceedings

View Minutes of Proceedings from evidence sessions related to the report

• 14 March 2024 (niassembly.gov.uk)
• 18 April 2024 (niassembly.gov.uk)
• 18 July 2024 (niassembly.gov.uk)
• 25 July 2024 (niassembly.gov.uk)
• 01 August 2024 (niassembly.gov.uk)
• 15 August 2024 (niassembly.gov.uk)
• Windsor Framework Democratic Scrutiny Committee - Minutes of Proceedings (niassembly.gov.uk) 

Appendix B: Memoranda and Other Papers

View Memoranda and Other Papers considered by the Committee:

Consideration of the proposed EU act

• Correspondence from the British Dental Association (Northern Ireland) - 5 March 2024
• British Dental Association (Northern Ireland) Assessment of Impact: Views received from dentists in Northern Ireland - 14 March 2024
• Correspondence from the British Dental Association (Northern Ireland) in respect of the United Nations Minamata Convention on Mercury - 19 March 2024
• Correspondence from the Executive Office - 20 March 2024
• Correspondence from the UK Government - 28 March 2024
• Department for Environment, Food and Rural Affairs Explanatory Memorandum - 1 November 2023
• Extract from the House of Commons European Scrutiny Committee, Third Report of Session 2023-24 - 19 December 2023
• Correspondence from the Clerk to the Joint Consultative Working Group (via the Cabinet Office) - 15 March 2024
• Departmental Initial Assessment of Impact
• Correspondence from the World Alliance for Mercury-Free Dentistry - 15 March 2024
• Correspondence from Charles G Brown, President, World Alliance for Mercury-Free Dentistry - 19 March 2024
• Written submission from Dr Graeme Munro-Hall, Chief Dental Officer, World Alliance for Mercury-Free Dentistry - 15 April 2024
• A copy of emails received from members of the public regarding the proposed EU Act - 4 to 10 April 2024
• Correspondence from the World Alliance for Mercury-Free Dentistry - 26 April 2024
• A response from the Department of Health in relation to costs - 17 June 2024
• Correspondence from the British Dental Association (Northern Ireland) - 20 June 2024

Consideration of the published EU act

• Departmental Initial Impact of Assessment - 10 July 2024
• Information note by the Cabinet Office - July 2024
• Response to the Chairperson from the Cabinet Office - 24 July 2024
• Commission Notice C/2024/4675 - 19 July 2024
• Revised Departmental Initial Assessment of Impact - 25 July 2024
• Correspondence from the World Alliance for Mercury-free Dentistry - 17 July 2024
• Correspondence from the Department – 6 August 2024
• Response from the British Dental Association (Northern Ireland) – 5 August 2024

Appendix C: Minutes of Evidence

View Minutes of Evidence of Committee meetings related to the report:

• Minutes of Evidence - 14 March 2024
• Minutes of Evidence - 18 April 2024 (Department of Health)
• Minutes of Evidence - 18 April 2024 (World Alliance for Mercury-Free Dentistry)
• Minutes of Evidence - 25 July 2024 (Department of Agriculture, Environment and Rural Affairs and Department of Health)

Appendix D: Consultation Responses

View responses to the Committee’s consultation:

• Consultation Responses