EUROPEAN UNIONTHE EUROPEAN PARLIAMENT

THE COUNCIL
Brussels, 22 May 2024
(OR. en)2023/0272 (COD)

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ENV 210
COMER 37
MI 208
ONU 24
SAN 102
IND 103
CODEC 581
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:

REGULATION 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

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REGULATION (EU) 2024/…
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of …
amending Regulation (EU) 2017/852 on mercury
as regards dental amalgam and other mercury-added products
subject to export, import and manufacturing restrictions(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 192(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee1,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure2,

1
2

OJ C, C/2024/894, 6.2.2024, ELI: http://data.europa.eu/eli/C/2024/894/oj.
Position of the European Parliament of 10 April 2024 (not yet published in the Official
Journal) and decision of the Council of ….

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1ENWhereas:(1)

In accordance with Article 19(1) and (2) of Regulation (EU) 2017/852 of the European
Parliament and of the Council3, the Commission was to assess and report on the need for
the Union to regulate emissions of mercury and mercury compounds from crematoria, thefeasibility of phasing out the use of dental amalgam in the Union in the long term, andpreferably by 2030, and the environmental benefits and the feasibility of banning the
manufacturing and export of other mercury-added products which are prohibited frombeing placed on the Union market and imported into the Union.

(2)

Mercury is a chemical of global concern for the environment owing to its long-range
atmospheric transport, its persistence following its anthropogenic introduction into theenvironment and its ability to bioaccumulate in ecosystems. Mercury also has significant
negative effects on human health and is passed from mothers to children via the placenta or
through breastfeeding. Mercury pollution of the environment can result fromanthropogenic activities, including insufficient management of mercury waste, cremation
or improper implementation of mandatory separators in dental practices.

3

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).

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(3)

The Commission, following the conclusion reached in its report of 17 August 2020 on thereviews required under Article 19(1) of Regulation (EU) 2017/852 on the use of mercury
in dental amalgam and products, presented a legislative proposal, in accordance with
Article 19(3) of that Regulation, on the phasing out of the use of dental amalgam and theprohibition of the manufacturing and export of dental amalgam and certain
mercury-containing lamps.

(4)

The use of mercury-added products, including the use of dental amalgam and of
mercury-containing lamps, represents the largest remaining intentional use of mercury in
the Union. However, mercury-free alternatives have become economically and technicallyfeasible and are readily available.

(5)

Considering that the Union and its Member States have ratified the Minamata Convention
on Mercury4 of 2013 (‘the Convention’) and given that measures should be taken byParties to the Convention to encourage dental caries prevention and health promotion,
thereby minimising the need for dental restoration as an additional measure to support thephase-out of the use of dental amalgam, and considering the availability and affordabilityof, and the current transition to, mercury-free alternatives in many Member States, it isappropriate to prohibit the use of dental amalgam for dental treatment in the Union, while
maintaining the possibility of using dental amalgam for patients with specific medical
needs when deemed strictly necessary by the dental practitioner.

4

Council Decision (EU) 2017/939 of 11 May 2017 on the conclusion on behalf of theEuropean Union of the Minamata Convention on Mercury (OJ L 142, 2.6.2017, p. 4).

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(6)

While fully respecting Member States’ competence for the organisation and delivery ofhealth services and medical care, in order to limit the socio-economic impact of thephase-out of dental amalgam, in particular on low-income patients, Member States inwhich dental amalgam is the only publicly reimbursed material at a rate of at least 90 %under national law, and in which such reimbursement is not yet possible for mercury-freealternatives as of 1 January 2025, should, by way of derogation from the requirement
provided for in this Regulation to phase out dental amalgam by that date, have more time
to find appropriate solutions to adapt their healthcare system and should therefore beallowed to have a later phase-out date for dental amalgam. The phase-out of dental
amalgam should be accompanied by professional training for dentists, where appropriate,
in order to adjust to new techniques.

(7)

Member States that benefit from the derogation from the phase-out provided for in thisRegulation should be able to allow the use of dental amalgam in very specificcircumstances until 30 June 2026. Accordingly, the import and manufacturing of dental
amalgam should be prohibited only from 1 July 2026. However, from 1 July 2026, importand manufacturing of dental amalgam should continue to be possible only if the use ofsuch amalgam is necessary to cover specific medical needs.

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(8)

In order to assess the continuing need for use of dental amalgam in relation to specificmedical needs, importers and manufacturers should inform the competent authorities every
year of the quantities imported or manufactured for such medical needs. Moreover, by
31 December 2029, the Commission should assess if it is still necessary to maintain the
derogation for the import and manufacturing of dental amalgam used for patients withspecific medical needs, taking into account the availability of mercury-free alternatives forthe relevant patient groups.

(9)

Crematoria are a significant source of mercury emissions into the atmosphere and,notwithstanding the phase-out of dental amalgam provided for in this Regulation,crematoria will continue to contribute to mercury pollution of air, water, and soil. It isnecessary to develop guidance on abatement technologies for emissions of mercury andmercury compounds from crematoria and to collect information on the measures
implemented on the basis of that guidance in Member States, in order to achieve
appropriate pollution prevention and to mitigate the impact on human health and theenvironment.

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(10)

The illegal use of mercury and mercury compounds in cosmetic products persists at global
level. The fifth meeting of the Conference of the Parties to the Convention (‘Conference of
the Parties’) therefore decided in Decision MC-5/5 to collect information from Parties to
the Convention on the challenges they face in preventing the export, import andmanufacturing of cosmetics listed in Part I of Annex A to the Convention. In light of the
detrimental effects of mercury and mercury compounds on human health and theenvironment, exposure and emissions should be further minimised as much as possible.
Recent reports show that companies operating in the Union are manufacturing andexporting mercury compounds, resulting in illegal mercury use, in particular, in cosmetics.
Therefore, the Commission should report on the developments under the Convention as
regards the phase-out of illegal mercury use in cosmetic products, taking into accountinformation provided by Parties to the Convention in line with Decision MC-5/5. The
Commission should, furthermore, assess the remaining uses of mercury and mercury
compounds, such as its use in porosimetry, lighthouses and vaccines, as well as the need to
expand the list of large waste sources, and, where appropriate, suggest measures to phaseout such uses and to regulate export, import and manufacturing for such purposes.

(11)

Member States are to ensure proper collection systems for mercury-added products in
non-electronic and electronic waste and to collect such products separately and in anenvironmentally sound manner, in accordance with Directive 2012/19/EU of the European
Parliament and of the Council5.

5Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 onwaste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38).

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(12)

Article 4(1) of Directive 2011/65/EU of the European Parliament and of the Council6
prohibits the placing on the Union market and import into the Union of certain electricaland electronic equipment containing mercury. Annex III to that Directive lists, inter alia,
certain mercury-added lamps which are exempt from that prohibition until the dates set out
therein. That exemption expired on 13 April 2016 for non-linear halophosphate lamps, on
24 February 2023 for certain compact fluorescent lamps, and on 24 August 2023 for linear
fluorescent lamps for general lighting purposes. For non-linear tri-band phosphor
fluorescent lamps, the exemption expires on 24 February 2025. The exemption for mosthigh pressure sodium (vapour) lamps for general lighting purposes that have an improved
colouring index expired on 24 February 2023, whereas for the remaining high pressure
sodium (vapour) lamps for general lighting purposes listed in entry 4 of Annex III to
Directive 2011/65/EU, the exemption expires on 24 February 2027.

6

Directive 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(OJ L 174, 1.7.2011, p. 88).

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(13)

In addition, certain linear fluorescent lamps for general lighting purposes were listed, witha view to them being prohibited, in Decision MC-4/3, adopted at the fourth meeting of theConference of the Parties, held from 21 to 25 March 2022, and phase-out dates were set forthem in Decision MC-5/4 adopted at the fifth meeting of the Conference of the Parties,
held from 30 October to 3 November 2023. Those Decisions were supported by the Union
by means of Council Decisions (EU) 2022/5497 and (EU) 2023/24178.

(14)

As it is appropriate to prohibit the export from the Union of the remaining mercury-added
lamps as soon as possible, and since some of those lamps are currently not covered byPart A of Annex II to Regulation (EU) 2017/852, they should, for the purposes ofconsistency, be included therein to prohibit their manufacturing and export as from thedates set out in Annex III to Directive 2011/65/EU and no later than the most ambitious
dates included in Decision MC-4/3. Moreover, significant co-benefits can be achieved byphasing out the export of mercury-added lamps as soon as possible, given that
mercury-free alternatives are more energy-efficient and would therefore prevent tonnes of
CO2 emissions from being released.

7

8

Council Decision (EU) 2022/549 of 17 March 2022 on the position to be taken on behalf ofthe European Union at the second segment of the fourth meeting of the Conference of theParties to the Minamata Convention on Mercury as regards the adoption of a Decision toamend Annexes A and B to that Convention (OJ L 107, 6.4.2022, p. 78).
Council Decision (EU) 2023/2417 of 23 October 2023 on the position to be taken on behalfof the European Union at the fifth meeting of the Conference of the Parties to the Minamata
Convention on Mercury as regards the adoption of a decision to amend Annexes A and B tothat Convention (OJ L, 2023/2417, 6.11.2023, ELI:
http://data.europa.eu/eli/dec/2023/2417/oj).

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(15)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member
States but can rather, by reason of their scale and effects, be better achieved at Union level,
the Union may adopt measures, in accordance with the principle of subsidiarity as set out
in Article 5 of the Treaty on European Union. In accordance with the principle ofproportionality as set out in that Article, this Regulation does not go beyond what isnecessary in order to achieve those objectives.

(16)

Regulation (EU) 2017/852 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

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Article 1
Regulation (EU) 2017/852 is amended as follows:(1)

Article 10 is amended as follows:(a)the following paragraph is inserted:‘2a. From 1 January 2025, dental amalgam shall not be used for dental treatment in
the Union, except when deemed strictly necessary by the dental practitioner
based on the specific medical needs of the patient.
Fully respecting Member States’ competence for the organisation and deliveryof health services and medical care, and by way of derogation from the firstsubparagraph, in 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 thephase-out date of 1 January 2025, dental amalgam may be used for dental
treatment until 30 June 2026. Member States shall provide, and make publicly
available, reasoned explanations for making use of the derogation, including
the appropriate measures to be implemented by 30 June 2026, and notify themto the Commission by … [1 month from the date of the entry into force of thisRegulation].’;PE-CONS 53/24

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(b)

the following paragraph is added:‘7.

From 1 January 2025, the export of dental amalgam shall be prohibited.
From 1 July 2026, the import and manufacturing of dental amalgam shall be
prohibited.
By way of derogation from the second subparagraph of this paragraph, theimport and manufacturing of dental amalgam shall be allowed for specificmedical needs as referred to in paragraph 2a, first subparagraph.’;(2)

Article 18 is amended as follows:(a)in paragraph 1, first subparagraph, the following points are added:‘(f)a summary of the information gathered in accordance with paragraph 1a of this
Article as well as the information on the amounts of mercury used for specificmedical needs as referred to in Article 10(2a);(g)

information on the measures implemented on the basis of the Commission
guidance on abatement technologies for emissions of mercury and mercury
compounds from crematoria referred to in Article 19(2a), point (a).’;PE-CONS 53/24

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(b)

the following paragraph is inserted:‘1a. By 31 May of a given calendar year, importers and manufacturers of dental
amalgam shall report to their competent authority for the preceding calendar
year the amount of dental amalgam they imported or manufactured pursuant to
Article 10(7), third subparagraph.’;(3)

Article 19 is amended as follows:(a)in paragraph 2, the date ‘31 December 2024’ is replaced by ‘31 December 2029’;(b)

the following paragraph is inserted:‘2a. By 31 December 2029, the Commission shall report to the European
Parliament and to the Council on:(a)the implementation and impact of the guidance, developed by theCommission by 31 December 2025, on abatement technologies foremissions of mercury and mercury compounds from crematoria appliedin Member States;

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(b)

the need to maintain the exemption from the prohibition on the use of
dental amalgam referred to in Article 10(2a), first subparagraph, taking
into account the impact on the health of patients generally and of patientsdependent on amalgam fillings, and the need to maintain the derogation
for the import and manufacturing of dental amalgam as referred to in
Article 10(7), third subparagraph;(c)the developments under the Convention as regards the phase-out ofillegal mercury use in cosmetics, taking into account information
provided by Parties to the Convention in line with Decision MC-5/5 of
the Conference of the Parties on the preparation of a report on cosmetics;(d)the need to phase out remaining mercury uses;(e)the need to expand the list of mercury waste sources set out in Article 11;(f)

the need to expand the list of mercury compounds set out in Annex I, byadding, for example, mercuric azanide chloride (HgNH2Cl).’;(c)paragraph 3 is replaced by the following:‘3.

The Commission shall, if appropriate, present a legislative proposal together
with the reports referred to in this Article.’;(4)

Annex II is amended in accordance with the Annex to this Regulation.

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Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …,

For the European Parliament

For the Council

The President

The President

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ANNEXPart A of Annex II is amended as follows:(1)

the following entry is inserted:

Mercury-added products‘3b. All other compact fluorescent lamps (CFLs) for generallighting purposes that are not included in entries 3 and 3a(2)

Date from which the export,
import and manufacturing of
the mercury-added products
are prohibited
31.12.2025’;

the following entries are inserted:

Mercury-added products

Date from which the export,
import and manufacturing of
the mercury-added products
are prohibited‘4a. Tri-band phosphor lamps for general lighting purposes thatare not included in entry 4, point (a).

31.12.2026

4b.

Halophosphate phosphor lamps for general lighting purposesthat are not included in entry 4, point (b).

31.12.20254c.

Non-linear tri-band phosphor lamps.

31.12.2026

4d.

Non-linear halophosphate phosphor lamps.

31.12.2025’;

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(3)

the following entry is inserted:

Mercury-added products‘5a. High pressure sodium (vapour) lamps (HPS) for generallighting purposes with:(a)P ≤ 105 W exceeding 16 mg Hg;(b)

105 W < P ≤ 155 W exceeding 20 mg Hg;(c)

P > 155 W exceeding 25 mg Hg.

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ANNEX

Date from which the export,
import and manufacturing of
the mercury-added products
are prohibited
31.12.2025’.

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