Commission Notice – Application of Regulation (EU) 2024/1849 of the European Parliament and of the Council amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions to and in the United Kingdom in respect of Northern Ireland
Date: 2024-07-19
Institutions: Directorate-General for Environment, European Commission
Subjects: Northern Ireland, United Kingdom, dental medicine, environmental protection, export restriction, import restriction, market approval, mercury, metal pollution, withdrawal from the EU








C_202404675EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/4675


19.7.2024







            COMMISSION NOTICE
         
Application of Regulation (EU) 2024/1849 of the European Parliament and of the Council amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions to and in the United Kingdom in respect of Northern Ireland
(C/2024/4675)

DISCLAIMER
This guidance notice is intended to facilitate the application of Regulation (EU) 2024/1849 of the European Parliament and of the Council amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions (1) to and in the United Kingdom in respect of Northern Ireland. While this Notice seeks to assist authorities and operators, only the Court of Justice of the European Union is competent to authoritatively interpret Union law.
1.   Legal framework and other relevant considerations

On 1 February 2020, the United Kingdom withdrew from the European Union. The Withdrawal Agreement (2) was concluded between the European Union and the European Atomic Energy Community, on the one part, and the United Kingdom, on the other part. It was approved by Council Decision (EU) 2020/135 (3) of 30 January 2020 and entered into force on 1 February 2020. The Withdrawal Agreement provides for a transition period which ended on 31 December 2020.
At the end of the transition period, Union law ceased to apply to the United Kingdom, whilst the Protocol on Ireland/Northern Ireland – now referred to as the Windsor Framework (4), which forms an integral part of the Withdrawal Agreement, became applicable.
In accordance with Article 5(4) of and point 23 of Annex 2 to the Windsor Framework, Regulation (EU) 2017/852 on mercury (5), as well as legal acts of the Union implementing, amending or replacing that legal act, apply to and in the United Kingdom in respect of Northern Ireland.
On 13 June 2024, the European Parliament and the Council adopted Regulation (EU) 2024/1849. In accordance with Article 13(3) of the Windsor Framework, the reference to Regulation (EU) 2017/852 in point 23 of Annex 2 to the Windsor Framework shall therefore now be read as referring to Regulation (EU) 2017/852 as amended by Regulation (EU) 2024/1849.
Regulation (EU) 2024/1849 amends Regulation (EU) 2017/852 to phase out the use of dental amalgam and prohibit the manufacturing, import and export of a number of mercury-added products. Regulation (EU) 2024/1849 addresses the residual remaining uses of mercury in products in the EU, with a view to establishing a mercury-free Europe.
Concerning dental amalgam specifically, Article 1(1) of Regulation (EU) 2024/1849 inserts the following changes in Regulation (EU) 2017/852:






—


From 1 January 2025, a prohibition to use dental amalgam for dental treatment in the Union, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. Furthermore, subject to specific conditions, a derogation is available to continue the use of dental amalgam until 30 June 2026 for those Member States in which dental amalgam is the only publicly reimbursed material at a rate of at least 90 % under national law for patients who are not eligible for other reimbursed materials of dental filling and persons with low income are socio-economically disproportionately affected by the phase-out date of 1 January 2025.










—


From 1 January 2025, a prohibition to export dental amalgam from the Union to a third country.










—


From 1 July 2026, a prohibition to import and manufacture dental amalgam in the Union, except for specific medical needs of the patient.




Following the adoption of the Commission proposal (6) and during the resulting ordinary legislative procedure, the Government of the United Kingdom has informed the Commission of its intention to continue using dental amalgam for patients in the United Kingdom until a phase-out date is agreed under the Minamata Convention on Mercury (7) to which the Union and all its Member States as well as the United Kingdom are Parties. The derogation available for Member States until 30 June 2026 pursuant to the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849 is not in itself sufficient in that regard.
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 of the United Kingdom is prohibited in accordance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849;










—


the manufacturing of dental amalgam in Northern Ireland is prohibited from 1 July 2026 in accordance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849.




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.
The Commission will monitor on an ongoing basis the application of the amendments introduced by Regulation (EU) 2024/1849 in Northern Ireland, including in view of this Notice, and on the basis of that monitoring decide whether to maintain this Notice.
2.   Specific conditions

In order for the Commission to assess whether the conditions of this Notice continue to be met, in particular that the use of dental amalgam in Northern Ireland for the purpose of dental treatment 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 or the environment within the Union, the authorities of the United Kingdom shall further observe the following specific conditions:






a)


Take the necessary measures to ensure regular and consistent progress towards full compliance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849 at the latest by 31 December 2034 or until the date agreed by the Parties to the Minamata Convention on Mercury for phasing out the use of dental amalgam, whichever is earlier.










b)


Ensure that until a ban on the use of dental amalgam applies in Northern Ireland in accordance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849 taking into account section 2(a), dental amalgam can only be used for dental treatment in Northern Ireland if the patient resides in the United Kingdom and if the treatment is carried out by a dental practitioner registered for that purpose in Northern Ireland.










c)


Implement and enforce a system to penalise operators who do not comply with the conditions of this Notice, including when registered dental practitioners in Northern Ireland use dental amalgam for residents outside of the United Kingdom or any operator would resell dental amalgam to Union operators.










d)


Ensure that the imports of dental amalgam destined to dental practitioners in Northern Ireland are commensurate to their use of such material.










e)


Ensure that after 1 July 2026, imports of dental amalgam in Northern Ireland comply with the customs formalities applicable to importers of dental amalgam for specific medical needs in accordance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1)(b) of Regulation (EU) 2024/1849. In this regard, it is noted that after 1 July 2026, for the import of dental amalgam into Northern Ireland from other parts of the United Kingdom, dental amalgam is considered as ‘category 1 goods’ in accordance with Annex IV of Decision No 1/2023 (8) laying down arrangements relating to the Windsor Framework.










f)


In accordance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(2) of Regulation (EU) 2024/1849, the competent authorities in the United Kingdom in respect of Northern Ireland shall by 31 December of each calendar year submit a written report to the European Commission, based inter alia on information received from importers of dental amalgam on the amount of dental amalgam they imported. In addition to the information required in the amendments introduced to Regulation (EU) 2017/852 by Article 1(2) of Regulation (EU) 2024/1849, the report shall contain the following information:






i.


The amount of dental amalgam imported into Northern Ireland and the amount of dental amalgam used in dental treatments. In this regard, the competent authorities in the United Kingdom in respect of Northern Ireland shall also estimate the available stock of dental amalgam present in Northern Ireland, including in view of the requirement in section 2(d).










ii.


The number and percentage of dental amalgam treatments in Northern Ireland as well as of the number and percentage of alternative dental treatments.










iii.


Any relevant actions undertaken by the competent authorities in the United Kingdom in respect of Northern Ireland to reduce the use of dental amalgam in dental treatments and promote the transition to mercury-free alternatives, with a view to ensuring full compliance with the amendments introduced to Regulation (EU) 2017/852 by Article 1(1) of Regulation (EU) 2024/1849 as well as an update of the ‘Northern Ireland Plan to phase down the use of dental amalgam’ shared with the Commission in 2019 in the context of Article 10(3) of Regulation (EU) 2017/852.










(1)  Regulation (EU) 2024/1849 of the European Parliament and of the Council amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions (OJ L, 2024/1849, 10.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1849/oj).

(2)  Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 7) (‘Withdrawal Agreement’).

(3)  
            OJ L 29, 31.1.2020, p. 1.

(4)  The Windsor Framework is the new way in which the Protocol on Ireland / Northern Ireland, as amended by the Withdrawal Agreement Joint Committee Decision No 1/2023, is referred to in accordance with Joint Declaration No 1/2023 of the Union and the United Kingdom (
OJ L 102, 17.4.2023, p. 87).

(5)  Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1).

(6)  COM(2023)395, 14.7.2024.

(7)  Minamata Convention on Mercury, 10 October 2023, as latest amended by the Conference of the Parties to the Minamata Convention on Mercury.

(8)  Decision No 1/2023 of the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023 laying down arrangements relating to the Windsor Framework (OJ L 102, 17.4.2023, p. 61).


ELI: http://data.europa.eu/eli/C/2024/4675/oj
ISSN 1977-091X (electronic edition)