EUROPEAN COMMISSION

Brussels, 14.7.2023

SWD(2023) 396 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT REPORT

IMPACT ASSESSMENT

Accompanying the document

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury as regards dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions

{COM(2023) 395 final} - {SEC(2023) 395 final} - {SWD(2023) 395 final} - {SWD(2023) 397 final}

Table of Contents

1.Introduction: Political and legal context

1.1.Policy context of the initiative

1.2.Legal context of the initiative

2.Problem definition

2.1.Problem 1 – Dental amalgam

2.2.Problem 2 – Mercury emissions from crematoria

2.3.Problem 3 – Manufacture of MAPs for export to third countries

2.4.Overview of problems and drivers

2.5.Stakeholder views

3.Why should the EU act?

3.1.Legal basis

3.2.Subsidiarity: Necessity of EU action

3.3.Subsidiarity: Added value of EU action

4.Objectives: What is to be achieved?

4.1.General objectives

4.2.Specific objectives

5.What are the available policy options?

5.1.What is the baseline from which options are assessed?

5.1.1.    Dental Amalgam    

5.1.2.    Emissions from crematoria    

5.1.3.    Mercury-added products for export to third countries    

5.2.Description of the policy options

6.What are the impacts of the policy options?

6.1.Problem 1 – dental amalgam use

6.1.1.    Analysis of Policy Option 1 – Dental health communication campaigns    

6.1.2.    Analysis of Policy Option 2 – Establish a legally binding end date for the use of dental amalgam in the EU    

6.2.Problem 2 – Emissions of mercury from crematoria

6.2.1.    Analysis of Policy Option 3 – Publication of EU guidance on emissions abatement in crematoria    

6.2.2.    Analysis of Policy Option 4 – Mandatory application of emissions abatement in crematoria    

6.3.Problem 3 – Mercury-added products for export to third countries

6.3.1.    Analysis of Policy Option 5 – Global agreement to ban the manufacture and trade of mercury-containing lamps    

6.3.2.    Analysis of Policy Option 6 – EU ban on the manufacture and export of MAPs    

7.How do the options compare?

8.Preferred option

8.1.1 Preferred Policy Option for Problem 1

8.1.2 Preferred Policy Option for Problem 2

8.1.3 Preferred Policy Option for Problem 3

8.1.4 Overall preferred policy package

8.2.1.REFIT

8.2.2One-in-one-out

8.2.3. Preferred instrument

9.How will actual impacts be monitored and evaluated?

9.1.Identification of monitoring needs

9.2.Identification of key indicators

Annex 1: Procedural Information

Annex 2: Stakeholder Consultation

Annex 3: Who is affected and how?

Annex 4: Analytical methods

Annex 5: Detailed Baseline

Annex 6: Problems and Drivers

Annex 7: Impacts of shortlisted measures

ANNEX 8: EU and International law on Mercury in respect of dental amalgam and mercury-added products

Table of acronyms

1.1.    Introduction: Political and legal context

This initiative addresses three specific issues in accordance with Article 19(1) of Regulation (EU) 2017/852 on mercury (hereinafter, ‘the Mercury Regulation’) 1 , i.e. (i) the feasibility to completely phase out dental amalgam in the Union; (ii) the potential need to regulate at EU level emissions of mercury and mercury compounds from crematoria; and (iii) the environmental benefits and feasibility to prohibit the manufacture, import and export of certain mercury-added products (hereinafter, ‘MAPs’) 2  already banned from being placed on the market. In light of the assessment carried out by the Commission and in accordance with Article 19(3) of this Regulation, the Commission intends to present a legislative proposal. This initiative is part of a wider EU and global policy and legal context.

1.1.1.1.    Policy context of the initiative

This initiative is firstly shaped by the 2019 European Green Deal (EGD) 3 as well as by the 2020 EU Chemicals Strategy for Sustainability 4 and the 2021 EU Zero Pollution Action Plan (ZPAP) 5 adopted under it.

Under those policy documents, the Commission calls for banning the most harmful chemicals in consumer products and has pledged to revise EU instruments to reduce air, water and soil pollution to levels no longer considered harmful to health and natural ecosystems, thus creating a toxic-free environment. The Commission has therefore committed to revise, for instance, the CLP Regulation 6 by introducing new hazard classes (including for bio-accumulative and toxic substances) 7   and the REACH Regulation 8  by updating registration requirements and adapting the processes for authorisation and restriction, hence increasing the protection of humans and the environment from the most harmful substances, including mercury. Hence, this initiative clearly fits into this context.  

Another key policy objective of high significance for this initiative concerns the commitment by the EU under the EU Chemicals Strategy for Sustainability to ‘lead by example, and, in line with international commitments, ensure that hazardous chemicals banned in the European Union are not produced for export, including by amending relevant legislation if and as needed’, hence reducing its external pollution footprint.

Secondly, this initiative contributes to the development of a new Union framework for sustainable products 9 , which aims at complementing existing Union product ecodesign requirements 10 . It is expected that current requirements concerning, for instance, product energy efficiency, be supplemented by ecodesign rules on the presence of substances that inhibit circularity, such as mercury. Hence, whilst this initiative addresses, among others, the phasing-out of the manufacturing and international trade in some mercury-containing lamps, the proposed new ecodesign requirements aim at ensuring, simultaneously, a shift towards more durable and energy efficient products. Light-emitting diode (LED) lamps are more energy efficiency compared to mercury-containing lamps as LED bulbs waste very little energy on heat, concentrating electricity on the production of light.

The third main component of the EU policy context of this initiative is the 2005 Mercury Strategy 11 as reviewed in 2010 12 . Considering the risk posed by mercury to both human health and the environment, the EU developed a dedicated strategy setting six general policy objectives and defining twenty actions on the reduction of mercury emissions, supply and demand and on the promotion of international action on mercury. Consequently, several non-regulatory and regulatory initiatives were undertaken by the EU, including the adoption of Regulation (EC) 1102/2008 on mercury exports and storage 13 , as the first EU legal instrument devoted to mercury. As an initial step, this Regulation addressed only a select number of issues, including the phase-out of the export of mercury and of several mercury compounds and the obligation to make certain mercury waste subject to final disposal. The 2010 reviewed Mercury Strategy called for further initiatives and actions concerning notably dental amalgam, other MAPs and EU’s efforts to promote the development of an international legal framework on mercury. As a result, not only was a new legislative framework, i.e., the Mercury Regulation adopted in May 2017 addressing, inter alia, intentional uses of mercury in products, but the key role played by the EU together with other major economies in promoting the development a multilateral environmental agreement resulted also in the adoption in 2013 of the Minamata Convention on Mercury (hereinafter ‘Minamata Convention’) 14 .

The 2010 reviewed Mercury Strategy was subsequently endorsed by Council conclusions 15 that called for phasing out all mercury uses, including MAPs as follows:

‘Mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstances and the needs for scientific research and development.’

The global policy context of this initiative is first and foremost characterised by the aforementioned Minamata Convention. This Convention, which has been ratified to date by the EU 16  and 138 countries, including all Member States and other major economies (e.g., US, China, Japan and Brazil), aims at protecting human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. To assist Parties in achieving this objective, the Minamata Convention addresses, amongst others, intentional uses of mercury in products, i.e., including in dental amalgam and other products such as lamps. As documented in this Impact Assessment Report (see sections addressing problem 3 and Annex 8), this initiative is developed on the basis of the existing and strong interplay between Union legislation on MAPs and the relevant Minamata Convention’s provisions on products. 

Additionally, this initiative contributes to the implementation within the EU of two Sustainable Development Goals (SDGs) i.e., good health and well-being ensuring healthy lives and promoting well-being for all at all ages (Goal 3) and responsible consumption and production ensuring sustainable consumption and production patterns (Goal 12) 17 , as well as to the EU decarbonisation agenda 18 by promoting the substitution of mercury-containing lamps with more energy-efficient lighting alternatives, i.e. LED lamps (see Section 6.3.1 below).

1.2.1.2.    Legal context of the initiative

Whereas mercury and mercury compounds are addressed in numerous EU instruments, the Union legal context of this initiative is primarily concerned with the Mercury Regulation as the current dedicated EU legal instrument covering the entire life cycle of mercury, from primary mining to its final disposal. This Regulation regulates, inter alia, the manufacture, import and export of MAPs and implements the Minamata Convention.

As mentioned above, whilst this initiative is specifically triggered by the review clause established in Article 19 of the Mercury Regulation, the Commission presented the outcome of this review in its Report on the use of mercury in dental amalgam and products adopted in August 2020 (hereinafter ‘the Commission Review Report’) 19 . A summary can be found in Annex 8. This impact assessment takes forward the results to inform on the possible revision of the Mercury Regulation as far as dental amalgam, other MAPs and mercury emissions from crematoria are concerned.

Regarding dental amalgam, Article 10(2) of the Mercury Regulation sets an EU-wide prohibition to use dental amalgam since 1 July 2018 for dental treatment (i) of deciduous teeth and (ii) of vulnerable population (children below the age of 15, pregnant and breastfeeding women). Thanks to the ambition of the Union to achieve a mercury-free society both at EU and global level and to the key role played in this respect by the EU under the Minamata Convention, the fourth Conference of the Parties to that Convention (COP4) adopted in March 2022 Decision MC-4/3 amending Annex A (Part II) to the Convention by establishing therein a similar prohibition on the use of dental amalgam for vulnerable population. 20  

As far as mercury emissions from crematoria are concerned, EU law currently sets no legally binding requirements or standards. Such emissions are only addressed at international level in the form of non-legally binding recommendations on the use of Best Available Techniques (BAT) adopted under both OSPAR 21 and HELCOM 22 Regional Seas Conventions to which the EU and some Member States are Parties.

Concerning MAPs (other than dental amalgam), the legal context of this initiative consists of both EU and international law. Under Union legislation, the manufacture, placing on the market, import and export of MAPs, specifically mercury-containing lamps, is regulated by several instruments. On the one hand, the Mercury Regulation establishes an EU-wide prohibition since 1 January 2019 and 2021 on the manufacture, import and export of MAPs listed in its Annex II. This list includes batteries, pesticides, biocides and topical antiseptics and certain switches and relays, cosmetics, lamps (e.g., high pressure mercury vapour lamps for general lighting purposes) and non-electronic measuring devices (e.g., barometers and thermometers) 23 and mirrors the list of MAPs contained in Annex A (Part I) to the Minamata Convention subject to a similar prohibition at global level. On the other hand, restrictions on the placing on the market and import of those MAPs are also set out in other instruments, including REACH and the RoHS Directive 24 . 

De jure, MAPs that are already banned from being placed on the market and imported under REACH, the Cosmetics Regulation 25  and the Batteries Directive 26 , are also listed in Annex II (Part A) to the Mercury Regulation, hence also subject to a manufacturing, export and import prohibition under that Regulation. Inversely, the alignment of the Mercury Regulation with the existing prohibition set out under the RoHS Directive to place on the market and import certain mercury-containing lamps is not yet complete as some of those lamps (see Table 3 below) are not to date referred to in the above-mentioned Annex II (Part A) and can therefore still be manufactured in the Union and exported from the EU.

By addressing the feasibility to further align EU law on mercury-containing lamps between the Mercury Regulation and the RoHS Directive, the Union must not only consider the difference in scope of application of both those instruments but must also take full account of the following developments that have taken place under the Minamata Convention.

Firstly, besides the establishment of a partial ban on the use of dental amalgam, aforementioned Decision MC-4/3 has also extended the list of prohibited MAPs referred to in Annex A (Part I) to that Convention. More specifically, Parties agreed to prohibit at global level the manufacturing, import and export, as from 1 January 2026, of seven additional MAPs including: (i) compact fluorescent lamps with an integrated ballast (CFL.i) for general lighting purposes that are ≤ 30 watts with a mercury content not exceeding 2.5 mg per lamp burner, (ii) cold cathode fluorescent lamps (CCFL) and external electrode fluorescent lamps (EEFL) of all lengths for electronic displays, that are not yet included in Annex A (Part I), (iii) melt pressure transducers, transmitters and pressure sensors, (iv) mercury vacuum pumps, (v) tire balancers and wheel weights, (vi) photographic film and paper and (vii) propellant for satellites and spacecraft.

Considering that such an extension of the list of prohibited MAPs under the Minamata Convention is in line with the formal proposal made by the Union ahead of COP4 27  and with the relevant negotiating mandate provided by the Member States to the Commission 28 , those MAPs will be added to Annex II (Part A) to the Mercury Regulation via a Delegated Act in accordance with Article 20 of this Regulation. In doing so, the addition of those MAPs is not subject to this impact assessment considering that the Union has, in this respect, no ‘room for manoeuvre’ within the meaning of the ‘Better Regulation’ toolbox 29 that complements the 2021 EU Better Regulation Guidelines 30 .

Secondly, by means of Decision MC-4/3, Parties agreed also to consider at the fifth meeting of the Conference of the Parties to the Minamata Convention (COP5, November 2023) a further extension of the list of MAPs contained in Annex A (Part I) to the Convention. The potential supplementary MAPs include the following linear fluorescent lamps (LFLs) for general lighting purposes not already covered by the Convention: (i) halophosphate phosphor lamps and (ii) triband phosphor lamps < 60 watts. In particular, whilst Parties reached an agreement at COP4 on the principle of phasing-out those LFLs, consensus on the phase-out dates (1st January 2026, 2028 or 2031) is still to be reached and the outcome remains uncertain. As those LFLs are already prohibited from being placed on the market and imported since 24 February 2023 in accordance with the RoHS Directive, this initiative endeavours to address the manufacture and export of those lamps at EU level.

In conclusion, from the policy and legal context perspective, this initiative aims to contribute to increased coherence of the EU regulatory framework on MAPs and implement the international pillar of the ZPAP, reducing the EU pollution footprint in third countries and thereby safeguarding the EU’s credibility ahead of future Minamata Conferences of the Parties, including at COP5.

2.2.    Problem definition

Mercury is a highly toxic element and a major risk to the environment and human health. It is a potent neurotoxin inducing permanent brain and kidney damage in adults and affecting foetal and early childhood development. Hence, mercury has been classified under EU law as being toxic for reproduction, fatal if inhaled, causing damage to all organs through prolonged or repeated exposure and very toxic for aquatic life with long lasting adverse effects 31 . It is bio-accumulative and, via food-webs and transboundary transport of air pollution, travels around the globe. Mercury in the air deposits on land and water bodies. Due to its toxicity for aquatic life, mercury also classifies as a priority hazardous substance under Union water legislation, which implies that mercury releases into water bodies must cease at a certain point in time 32 . For this reason and considering the toxicity of mercury to human health, the EU has set maximum limit values for mercury content in fish for consumption (most large predatory fish) 33 . 

Mercury can be released to the environment by natural sources (earth’s crust, volcanic emissions, geothermal activities, or forest fires) as well as anthropogenic sources resulting either from activities whereby mercury is added intentionally (dental amalgam and other MAPs) or where mercury is emitted non-intentionally as a side-product (coal-fired power plants, residential coal-burning for heating and cooking or waste incinerators) 34 . A general problem definition of mercury can be found in Annex 6.

At global level and based on the latest UNEP global mercury assessment 35 , the largest anthropogenic mercury emissions to the environment occur from fossil fuel combustion (533 t/year), industrial processes (614 t/year) and artisanal small-scale gold mining (838 t/year). Annual world-wide emissions to air were estimated to amount to 2.200 t of which the EU(28) is responsible for 77.2 t i.e., 3.5% (2015). Regarding more specifically the use and disposal of MAPs, including dental amalgam and mercury-containing lamps, global emissions to water were estimated to amount to 99.4 t/year, i.e., about 17% of all mercury emissions (2015).

In the EU, the total quantity of anthropogenic mercury emissions has been steadily and significantly decreasing over the past 20 years, largely thanks to a dedicated Community strategy on Mercury (2005 and 2010) and related EU legislation (e.g., RoHS Directive), determined action at global level having led to the creation, in 2017, of the Minamata Convention, the decarbonisation agenda as well as the Mercury Regulation, which has prohibited since 2018 most intentional uses of mercury (including for manufacturing processes, artisanal and small-scale gold mining and dental amalgam for vulnerable populations).

The objective of this initiative is to address the continued intentional use of mercury in dentistry and products, as the largest remaining intentional uses of mercury in the EU, with a view to minimising the EU’s contribution to the global build-up of mercury.

It is estimated that this initiative would cover between 52.9 and 87.9 t/year of mercury stemming from such MAPs. Such amounts can be broken down as follows:

·40.4 t/year of mercury in dental amalgam for use in the EU

·13-38 t/year 36  of mercury in dental amalgam exported from the EU

·0.5 t/year of mercury used for fluorescent lamps exported from the EU

·1 t/year of mercury emissions from crematoria

This section describes the three elements linked to the review of the Mercury Regulation. Dental amalgam (use) is considered as Problem 1, emissions from crematoria as Problem 2 and MAPs (manufacture and export of dental amalgam and of certain mercury-containing lamps) are addressed under Problem 3. Each of the three problems is treated with its own set of policy options that respond directly to the identified problem drivers and specific objectives. The three problems are obviously interlinked as for example the phase-out of the use of dental amalgam in the EU will automatically lead to a reduction of mercury emissions from crematoria in the longer term.

2.1.2.1.    Problem 1 – Dental amalgam 

The first problem concerns the risks for health and the environment associated with the use of dental amalgam.

Dental amalgam has been used as a dental filling material for centuries to fill dental cavities caused by tooth decay and to restore tooth surfaces. It is a product composed of metallic powders like copper, silver, tin, etc. mixed with mercury, where mercury represents 42% to 53% of the amalgam’s mass 37 , 38 , 39 .

Whilst EU policy and law on mercury aims explicitly at eliminating mercury use and associated pollution, especially when mercury-free alternatives are feasible and available, dental amalgam still represents the largest remaining intentional use of mercury in the EU. This leads to adverse human health effects and mercury emissions, in particular during placement by dental practitioners and via excretion 40 , cremation or burial of people fitted with dental amalgam 41 . The continued use of dental amalgam is therefore a practice that contributes to the continuous build-up of mercury in the environment and excessive and unsustainable amounts of mercury in fauna, flora and habitats.  

Regarding the EU dimension of the problem, the mean total mercury used in dental amalgam in the EU is estimated to be 40.4 t in 2019 (18.6 t in teeth and 21.8 t as waste) with the lower estimate being 31.6 t and the upper estimate being 50.3 t. The use of dental amalgam for the treatment of dental cavities varies across Member States ( Table 1 ).

Whereas SE is to-date the only Member State having completely phased out the use of dental amalgam, many other Member States have made significant progress in phasing down its use. Yet, eight Member States (AT, HR, CZ, EL, MT, PL, SK, SI) in 2019 still conducted close to or over 50% of their dental treatments using dental amalgam, although several of them have since phased-out or announced their intention to progressively phase-out dental amalgam use before 2030. Yet, Table 1  below shows that, in the absence of EU regulatory intervention, dental amalgam would continue to be used, in some Member States with rather high quantities, well beyond 2025.

Table 1: Dental amalgam use per Member State (2019, 2025 and 2030)

The continued use of dental amalgam notwithstanding the availability of mercury-free alternatives is mainly motivated by:

·lack of communication to and awareness of mercury-free alternatives among relevant patients,

·lack of training of dental practitioners to use such alternatives,

·higher costs incurred by patients in some EU Member States (e.g., DE, IT) when seeking the reimbursement of mercury-free versus mercury-added dental amalgam from national social security services or private insurances, creating an uneven level of health insurance coverage across the EU.

Additionally, limited continued use of dental amalgam across the EU results from the specific medical conditions of some patients (allergies to some components of the mercury-free amalgams, excessive saliva production, acute anxiety) for whom dental amalgam is the only appropriate dental treatment technique due to either its chemical properties or its reportedly faster application time.

In addition to the environment being directly affected by mercury emissions associated with the use of dental amalgam, specifically via emissions from crematoria, the main exposure to mercury in individuals with amalgam restorations occurs during placement or removal of the fillings 42 , if not handled properly. Furthermore, low levels of exposure may also occur through the lifetime of a restoration.

In terms of evolution of the problem, the advantages that have historically been associated with the use of dental amalgam were that it was cheaper than its mercury-free counterpart and easier and quicker to place. However, the alternatives are now as cost-effective as dental amalgam and practitioners are increasingly replacing dental amalgam with these alternatives. It is therefore expected that the use of dental amalgam will decrease to 11.2 t by 2030 (with a lower estimate of 7.2 t and an upper estimate of 16.8 t). This is due to increased patient awareness with regards to mercury’s negative health and environmental impacts and increased reliability of mercury-free alternatives and their aesthetic advantages. Nevertheless, the remaining amount will still represent the largest remaining intentional use of mercury in the EU and continue to circulate through environmental media (air, water and soil). Furthermore, with no policy intervention at EU level, a phase-out is predicted to take place at a much slower pace and at different times across the EU.

Problem drivers for Problem 1

Driver 1 – Market failure: Across the EU, whilst mercury-free alternatives have become as cost-effective as dental amalgam, an uneven level of health insurance coverage between dental amalgam and alternatives creates higher costs for patients choosing mercury-free alternatives. Furthermore, although the price of dental amalgam varies among Member States, its price often does not reflect the damage costs of mercury.

Driver 2 – Regulatory failure: The use of dental amalgam is only partially prohibited for vulnerable populations (i.e., children below the age of 15 years, pregnant and breastfeeding women) at EU level. The level to which this prohibition extends or will extend to other members of the population varies a lot between the EU Member States.

Driver 3 – Behavioural biases: In the EU, despite dental health improving over recent years, several problem drivers, including improper dental hygiene and poor eating habits continue to cause cavities, which require treatment and continue to do so as cavities cannot be eradicated completely. This is particularly important for vulnerable and socially excluded groups in society who experience significantly poorer oral health and access to dental services than the mainstream population 43 .

2.2.2.2.    Problem 2 – Mercury emissions from crematoria

Crematoria continue to be an important source of mercury emissions in the EU 44 , 45 . These emissions originate mainly from mercury amalgam fillings in human remains. 

In 2019, the EU had over 1.200 crematoria (see Table 2 below and Annex 5) and experienced between 2010 and 2019 a 38% increase in annual cremation numbers (from 1.5 million to over 2.1 million) (see Table 3 ).

Table 2: Number of crematoria by capacity band by Member State (2019)

Crematoria numbers are estimated to steadily increase across the EU (to 1,482 crematoria in EU27 in 2030), based on an extrapolation of trends over the past 10 years and supported by feedback from stakeholders as part of the consultation activities.

Table 3: Change in number of cremations (2010, 2019) per Member State

Regarding mercury emissions from crematoria, this represents a 14% increase (from 821 kg to 934 kg) as shown in Figure 1 based on Member State reporting under CLRTAP 46 . The wider public is impacted through exposure to mercury emissions from crematoria. Applying EEA damage cost functions for mercury 47 (which take into account mortality and IQ loss), the impacts of these emissions are valued at approximately €16 million 48 per year.

Figure 1: Annual crematoria mercury emissions to air for the EU 27 as reported by the Member States under CLRTAP (2000-2019)

Data from EMEP (2022) 49

Crematoria operators do not fall under the scope of application of the 2010/75/EU Industrial Emissions Directive 50 : hence, they are not subject to an obligation under EU law to make use of best available techniques (BAT).

The size of crematoria and businesses that operate crematoria varies significantly across the EU. For example, ES has the highest number of crematoria in Europe, but most crematoria are estimated to carry out less than 350 cremations a year 51 . In contrast, the average crematorium in HR carries out over 5,000 cremations per year. It is estimated that more than half of all crematoria in the EU are small (less than 1,000 cremations per year) as presented in Table 2  (see Annex 5 for number of crematoria and cremations per Member State). 

Emissions of mercury from crematoria can be avoided through the application of abatement technologies. The most used technologies include Injection of Absorbent or Solid Bed Filtration using Absorbent. A list of Member States applying abatement technologies can be found in Annex 5. Uptake of emissions abatement technologies in crematoria is anticipated to increase in future years, at least in some Member States, although this is highly uncertain. In case of no EU-wide policy intervention, any prolonged use of dental amalgam will therefore entail continued mercury emissions from crematoria. The phase-out of dental amalgam would lead over time, taking into account legacy dental amalgam (the average life expectancy of a dental amalgam filling is 15 to 20 years), to a cessation of mercury emissions from crematoria and their associated environmental risks.

Problem drivers for Problem 2

The evidence points out to only two drivers for this problem as there is no indication for a market failure. The fact that environmental requirements are different in the various Member States might lead to marginally different costs for the cremation as usually, operators transfer these costs to the consumers via the application of an environmental levy. The cost of the cremation itself as a proportion of total funeral cost is low (around 10-20%) and the potential additional costs for abatement would not significantly change the overall cost.

However, the evidence points quite clearly towards no market distortion amongst Member States when it comes to cremation, not even in transboundary areas. In general, the cross-border transportation of deceased people occurs in cases of repatriation, where the main factor driving the transportation is social rather than financial (returning the body to hold a cremation or funeral where they or their loved ones live). As costs for repatriation are quoted to be in the order of thousands of euros, it is unlikely that small financial differences between cremation costs in neighbouring Member States are causing transboundary effects.

Driver 1 – Regulatory failure: There is no provision in EU law requiring Member States to control mercury emissions from crematoria. At international level, recommendations for the use of abatement technologies using BAT have been adopted by both the OSPAR and HELCOM Commissions. These Recommendations are non-legally binding and only 15 Member States are signatories to the OSPAR and/or HELCOM Conventions. In this context, what is most apparent from available data is that the use of mercury emission abatement technologies across the EU varies significantly, with very high levels of uptake in some Member States (BE, DE, LU, NL, DK), and much lower uptake in others (PT, ES).

Driver 2 – Behavioural biases: Regarding mercury emissions from crematoria, the number of cremations conducted annually in the EU is increasing. Beyond the spike in numbers linked to the tragic loss of life due to the COVID-19 pandemic, the average increase, but also the variations in cremation rates across the EU is linked to social factors (i.e., costs of services, personal preferences for cremation over burial) and cultural preferences (i.e., religious practices).

2.3.2.3.     Problem 3 – Manufacture of MAPs for export to third countries

The third problem that this initiative addresses are the adverse impacts of EU exported MAPs on third countries. For the purpose of this initiative, the expression ‘MAPs’ under problem 3 concerns dental amalgam and certain mercury-containing lamps (see also Section 1.2 and Annex 8).

Those exports highlight the current inconsistencies affecting Union law on MAPs. Various EU legal provisions have been developed and implemented to prohibit the placing on the EU market and import into the EU of MAPs, including under REACH, RoHS and Ecodesign 52 . The Mercury Regulation complements those provisions by additionally prohibiting the manufacture and export of those MAPs (see Figure 2 ). This, in turn, weakens the EU’s position and reputation as a leading player within the international community and jeopardising the objectives set out in the ZPAP on the reduction of the EU’s external pollution footprint. Furthermore, at an EU-level, such inconsistencies can cause regulatory uncertainty for industry.

Figure 2: Interaction between EU legal instruments concerning the manufacture and trade of MAPs

As a result, there are MAPs that are prohibited for placing on the EU market and import into the Union whilst still being manufactured in the Union for export to third countries. An overview of relevant MAPs currently or soon no longer allowed to be placed on the EU market but allowed for manufacture and export can be found in Table   4  below.

Table 4: Mercury-containing lamps addressed by this impact assessment (as they are not or will soon no longer be allowed on the internal market but continue to be manufactured and exported)

The continued export of concerned MAPs is a significant cause of mercury pollution, especially in third countries where EU-made products add to the national burden of hazardous products and increase the risk for local retailers, end-users, and inhabitants. In most low to medium-income third countries, few if any options exist for environmentally sound disposal of mercury-containing end-of-life products 53 , 54 . In the 2018 Global Mercury assessment 55 , it was assumed that in many countries over 95% of MAPs were not separately collected and recycled but ended up in landfills and (much less frequently) in uncontrolled waste incinerators. This causes emissions to the environment and adverse health impacts for those populations that handle waste or live or work near disposal sites. Due to mercury’s transboundary nature and accumulation in food chains, mercury that is released anywhere in the world 56 in turn poses a risk to European citizens.

Regarding the size of the identified problem, dental amalgam and mercury-containing lamps are the key MAPs in terms of volume, export values and mercury content. Accordingly, this initiative addresses those products specifically. Considering that a ban on the use of dental amalgam is assessed in this impact assessment (PO2a), problem area 3 also addresses the manufacture and export of dental amalgam in order to align the prohibition of manufacture and export with the ban on use.

Based on previous information on the relative ratio of EU demand, import, and export, it was estimated that with respect to mercury content, dental amalgam is the most relevant exported MAP ( Table 5 ). The amount of mercury in exported dental amalgam is in the order of 13 to 38 t in 2018. 

Table 5: Estimated mercury content in exported MAPs (only those for which quantitative data is available are listed)

Regarding export value, lamps (CFLs, LFLs and other double-capped FLs, HPS) are much more important. According to published export data (EU PRODCOM 57 and UN COMTRADE 58 ), in 2020 the EU exported about 156 million hot cathode discharge lamps (CFLs, LFLs and other double-capped FLs) with a value of about €92 million. This corresponds to a mercury content in the order of 460 kg.

Table 6: Estimated value of exported MAPs

A significant share of these lamps exported from the EU are destined for countries with very low collection and recycling rates for electronic waste i.e., 0.4% in UAE 59 and 2.5% in the Russian Federation. Furthermore, as opposed to the EU which requires the installation of amalgam separators in dental practices, dental amalgam waste is often not collected separately in developing countries, but instead ends up in the normal waste stream 60 , 61 , 62 . Often, amalgam waste is disposed of in landfills without further treatment or incinerated together with other medical waste. It can therefore be assumed that most of the mercury waste from dental practices is released into the environment.

Following declining demand and global competition, many production lines in the Union for fluorescent lamps have already been closed in recent years. According to available information, the Impact Assessment identified only the four following factories in the EU that still produce fluorescent lamps for general lighting purposes 63 :

·Signify / Philips (PL)

·Feilo Sylvania (DE)

·Tungsram, announced to be closed by the end of 2022 (HU)

·Ledvance / Osram (IT)

Available information shows that, until recently, there were 23 companies located within the EU that produced dental amalgam. 19 of them have stopped amalgam production in Europe or announced to do so by the end of 2024. The Impact Assessment identified only the following four EU companies producing encapsulated dental amalgam:

·Cavex (NL)

·Madespa S.A. (ES)

·Global Dental Trade (CZ)

·World Work Srl (IT)

Although a trend cannot be predicted for every single product type, a general trend of continuously decreasing EU export of MAPs can be observed. The increasing awareness about mercury-related risks, strengthened national and global legal regulation, and the availability of effective and affordable mercury-free alternatives are the main driving forces to further push MAPs out of the market. An increasing ambition towards eliminating MAPs at international level has led (at COP4) to decisions being adopted at global level. However, the continued level of ambition at future COPs, will still depend on Parties domestic regulatory regime and interests and thus remains uncertain.

In the absence of alignment between the Mercury Regulation and RoHS, inconsistencies within the EU acquis will lead to continued contribution by the Union to the availability of MAPs on the global market.

Problem drivers from Problem 3

Driver 1 – Market failure: Although for many MAPs the transition to mercury-free alternatives is technically feasible, the cost and availability of such alternatives influences the external market choice. Lower product prices that do not reflect environmental and human health costs and mask higher energy costs sustain demand for MAPs. European manufacturers of MAPs are sometimes reluctant to voluntarily leave the MAP market and forego revenues. In addition, the ongoing supply from EU manufacturers slows down the transition process and keeps mercury in circulation globally.

Driver 2 – Regulatory failure: Inconsistencies within EU law on MAPs (placing on the market and import prohibition vs. manufacture and export allowed) entitles the EU to manufacture and export certain MAPs, for which mercury-free alternatives exist. In doing so, the EU supplies the global market with mercury which in turn disincentives the shift towards mercury-free alternatives and harms the EU’s reputation in the light of the EGD implementation.

Driver 3 – Behavioural biases: On one hand, there is still a global demand for MAPs affecting a complete transition to mercury-free alternative. Although the switch is usually economically attractive in the medium term, users shy away from the possible high short-term investment costs.

2.4.2.4.    Overview of problems and drivers

Figure 3  below represents the problem tree for the review of the Mercury Regulation.

Figure 3: The problem tree for the review of the Mercury Regulation

2.5.2.5.    Stakeholder views

Problem 1: Almost two-thirds of the consulted stakeholder believe that an EU-wide discontinuation of dental amalgam would require a general phase-out, while 28% believe a gradual phase-down to be chosen by each Member State according to national priorities and conditions would be appropriate. Citizens, civil society organisations, environmental non-governmental organisations (NGOs) and associations of environmental dental practitioners broadly support the elimination of dental amalgam from the market by 2025. Business associations and dental practitioners pointed out several conditions for an efficient phase-out: ensuring that the lower-income population has access to alternative solutions including a full range of dental hygiene prevention measures, promoting research and innovation in chemistry with the aim to find trustworthy and sustainable alternatives to dental amalgam and taking due account of specific medical needs of patients. A handful of organisations voiced concerns about an early phase-out, indicating that trends in oral health prevention and campaigning may suffice to naturally reduce dental amalgam use.

Problem 2: As regards mercury emissions from crematoria, there is a general understanding among stakeholders that they are directly linked to the continued use of dental amalgam and the majority of respondents to the online public consultation (OPC) and targeted survey supported EU-wide policy to control mercury emissions from crematoria. One environmental NGO strongly supported setting mercury emission limit values for all crematoria, while one business association recommended a flexible approach to addressing industrial emissions of mercury, i.e., to identify these specific activities in which mercury remains essential in the manufacturing process while promoting the use of BAT within the industrial sector to minimise them. As part of the targeted consultation, some stakeholders supported EU limits for all crematoria whereas other stakeholders expressed concerns about impacts on smaller crematoria if EU-wide limits were to be established and indicated that less stringent limits could be applied, or they could be excluded entirely.

Problem 3: Business associations, Member State authorities and NGOs agree that, within the context of the Minamata Convention, the EU has a responsibility to continue showing global leadership in phasing out anthropogenic sources of mercury. In this respect, restrictions on the manufacture and international trade of MAPs are a key element, in particular when alternatives are economically and technically feasible. All NGOs voiced a strong opinion that the EU should stop producing and exporting MAPs, which are already banned on the internal market, as this is a practice that directly contradicts the objectives of the EGD. Business associations supported globally harmonised actions but raised doubts about the effectiveness of unilateral EU measures, especially in foreign markets with persistent demand in and supply by third countries.

A full summary of stakeholder activities can be found in Annex 2.

3.3.    Why should the EU act?

3.1.3.1.    Legal basis

Articles 191 and 192 of the Treaty on the Functioning of the European Union (TFEU) 64 empower the EU to act inter alia to: preserve, protect and improve the quality of the environment; protect human health and promote measures at the international level to deal with regional or worldwide environmental problems.

3.2.3.2.    Subsidiarity: Necessity of EU action

This initiative stems directly from Article 19 of the Mercury Regulation. Paragraph 3 of this provision stipulates that the Commission shall, if appropriate, present a legislative proposal together with its report referred to in paragraph 1. In that respect, the Commission Review Report has concluded on the necessity of EU action to, inter alia, establish a complete EU phase-out of the use of dental amalgam and to align Union legislation on MAPs, for the purpose of protecting the environment and human health from mercury pollution (see Annex 6). This can be achieved by Member States, but by reason of the nature of the measures to be taken (i.e., uniform prohibition on the use of dental amalgam, alignment of EU law on MAPs), be better achieved at Union level.

3.3.3.3.    Subsidiarity: Added value of EU action

Mercury pollution is transboundary, travelling across national borders, both between Member States and across the frontiers of the EU. Hence appropriate and effective pollution control can be achieved more quickly and efficiently at Union level compared to Member States acting alone in an uncoordinated manner. Furthermore, as explained in sub-section 1.1 of this document, this initiative will contribute to the meeting of the objectives of the EGD and, in particular, of the ZPAP.

Additionally, action at Union level would allow establishing a more consistent and clearer legal framework by addressing all sides of the issue from manufacturing to export. Clear and precise EU-wide rules would enable concerned individuals and legal persons to ascertain the full extent of their rights and obligations.

The EU has always been an instrumental player at global level, advocating the gradual and rapid phase-out of all mercury production, use and trade. EU action, law and policy that is coherent with this policy will therefore strengthen the credibility of the EU and generate a positive impact on health and environment at international level and in third countries.

4.4.    Objectives: What is to be achieved?

4.1.4.1.    General objectives

The general objective of this initiative is to close remaining gaps in EU mercury legislation to further contribute to the objectives of (i) the Minamata Convention by protecting human health and the environment from mercury pollution, (ii) the G7 decarbonisation agenda by ensuring more energy efficient lighting products and (iii) the EGD aiming for a non-toxic environment and protecting natural ecosystems and public health from the adverse effects of mercury pollution at EU and global level.

4.2.4.2.    Specific objectives

The initiative aims to address the harmful impacts on health and the environment from mercury pollution currently not regulated or insufficiently regulated by the Mercury Regulation, to prevent, or at least minimise, the emissions of mercury and its compounds from dentistry, crematoria and the production and use of MAPs. There are three specific objectives logically linked to the two problem areas and their respective drivers:

Objective 1 (Dental amalgam use): Phase-out the use of dental amalgam in the EU whilst ensuring access of individuals to affordable mercury-free alternatives in relation to oral health and consumer rights, in order to eliminate exposure and risks associated with dental amalgam.

Objective 2 (crematoria emissions): Reduce emissions from crematoria to levels no longer considered harmful to human health and natural ecosystems, taking full account of the subsidiarity and proportionality principles.

Objective 3 (mercury-added products for export to third countries): Eliminate the manufacture and export of a variety of MAPs, with a view to reducing global mercury consumption and ensuring that the EU leads by example and align the EU acquis on the placing on the market, import, export and manufacturing of MAPs, thereby simplifying Union legislation and providing greater legal certainty for all stakeholders, including relevant industrial sectors.

5.5.    What are the available policy options?

5.1.5.1.    What is the baseline from which options are assessed?

This section summarises the detailed description and discussion of the baseline provided in Annex 5. The baseline implies the continuation of the existing legal framework and scope. An assessment was made to evaluate whether and to what extent the baseline is dynamic for each of the three problem areas, taking full account of the increased awareness of mercury and its associated environmental and health risks. The key parameters of the baseline are depicted, by problem area, in the following sub-sections.

5.1.1.5.1.1.    Dental Amalgam

Decayed, Missing and Filled Teeth (DMFT) index

To develop a baseline for dental amalgam use in the EU, the DMFT epidemiologic index was used as the predominant population-based measure of caries experience worldwide. This index gives the sum of an individual’s decayed, missing and filled permanent teeth for different age groups and for specific years (2000, 2005, 2015, and 2030). Thanks to this model (outlined in Annex 5), the state of dental health in the EU in 2019 was calculated and the DMFT index for all ages for all Member States was determined. To further develop the baseline, three sets of data were necessary to estimate the quantity of mercury used for the treatment of dental cavities:

Mercury content of dental amalgam capsules

Since 1 January 2019, dental amalgam is only allowed to be used in the EU in pre-dosed encapsulated from and the use of bulk mercury is prohibited. Dental amalgam capsules are round-ended plastic cylinder containing amalgam alloy and mercury. The content of mercury in dental amalgam capsules was identified for different types of capsules. The baseline assumes a total mercury content of amalgam capsules of ~590 ± 110 mg.

Share of dental amalgam use

The share of dental amalgam use per Member State was approximated using a variety of data sources. The data clearly shows the difference in the share of dental amalgam use across Member States ranging from 0% to over 50%. The share of dental amalgam use per Member State is available in Annex 5 and includes baseline projections for 2030.

Share of dental amalgam capsules placed in the tooth

The share of dental amalgam capsule content put in patients’ teeth was estimated to range from 26% to 66% 65 which would represent a range of 125 mg to 462 mg per filling.

Using the above information in combination with the population data from Eurostat for 2019 with projections to 2030 and the DMFT estimates for all Member States for 2019 and 2030, it was possible to estimate the quantities of mercury used in the EU due to dental amalgam use in 2019 and 2030.

The mean total mercury used in dental amalgam in the EU ( Figure 4 ) is estimated to be 40.4 t in 2019 (of which 18.6 t are placed in teeth and 21.8 t are wasted) (with the lower estimate being 31.6 t and the upper estimate being 50.3 t). Mercury use is expected to decrease to 11.2 t by 2030 (with the lower estimate being 7.1 t and the upper estimate being 16.8 t). The use of dental amalgam is projected to be nearly totally phased out (reduced to 0.16 t) by 2035, subject to Member States continuing to reduce such use at a similar rate to the previous 10 years (which is not guaranteed). This reduction is mirrored by a decline in the number of manufacturers producing dental amalgam. In the EU, only four (out of nine) dental amalgam manufacturers (NL, ES, CZ, IT) remain to date, who also produce a variety of mercury-free dental filling materials.

Figure 4: Baseline projections for dental amalgam use (EU27)

The figures obtained for mercury use in dental amalgam in the different Member States in 2019, 2025 and 2030 can be found in Table 1 above (uncertainties and assumptions made during the quantification of mercury use in the EU are available in Annex 5).

Emissions from dental amalgam

Dental amalgam use (including wasted amalgam) in 2019 and 2030 (as part of the baseline) as well as their estimated emissions are presented in Table 7 below.

Table 7: Total dental amalgam inputs and outputs (2019 and 2030)

Any mercury used in dental amalgam will, in the short, medium or long-term, enter the environment via various pathways (see Figure 5 ).

Figure 5: Fate of mercury and flows into the environment resulting from dental amalgam use (2019)

Additionally, the releases of mercury to the environment in 2019 as a result of dental amalgam in deceased people’ mouths are displayed in  Figure 6 . These emissions are displayed separately from the releases from dental use, as the former account for legacy mercury (i.e., mercury in dental amalgam restorations fitted in patients’ teeth in 2019 as well as previous years), while the latter only account for releases in 2019 (i.e., mercury used in restorations fitted in patients’ teeth in 2019 only).

Figure 6: Fate of mercury and flows into the environment resulting from dental amalgam in deceased people (2019)

The three phase-out scenarios assessed within this Policy Option would reduce these environmental releases to zero as the underlying source, continued dental amalgam use, is eliminated, except in the few cases where such a use will remain justified to address specific medical conditions.

5.1.2.5.1.2.    Emissions from crematoria

Estimated emissions for individual Member States in 2019 and in 2030 are presented in Annex 5. Total mercury emissions are estimated at 0.69 t in 2019. Emissions in 2030 are estimated at 0.36 t. All Member States are predicted to see a decline in emissions over this period as a result of declining use of dental amalgam in the baseline.  Figure 7 displays the predicted evolution of mercury emissions from crematoria under the baseline scenario. 

Figure 7: Baseline projections for mercury emissions from crematoria (EU27)

These figures (for 2019) are lower than those reported by the Member States under the CLRTAP as set out in Section 2.2 and Figure 1 . It is likely that the emissions inventory data reported under the CLRTAP are largely derived using a top-down approach based on a simplified approach. In defining the baseline for this assessment, a bottom-up approach to quantifying emissions has been adopted which is considered more representative. This involved exploring trends and activity levels in the underlying drivers in order to build up to an estimate of crematoria emissions as well as considering existing controls already applied in some Member States.

In constructing a baseline, four underlying drivers were considered separately before they were drawn together to estimate crematoria emissions. The framework for combining these separate factors into a quantified reference scenario of mercury emissions from crematoria is set out in Annex 5. In addition, for the analysis of impacts of different policy options, a dynamic baseline has been developed with or without a phase-out of dental amalgam (being considered as part of Problem 1).

Note: All impacts of Policy Options addressing mercury emissions from crematoria in subsequent sections are assessed relative to a baseline assuming no phase-out of dental amalgam. However, such a phase-out would have significant impacts on the effectiveness and efficiency of PO3 and PO4a and b, i.e., considering that the average lifetime of dental amalgam fillings is 15 to 20 years, a phase-out in 2025 would mean that most dental amalgam will be removed from people’s mouths by 2045, hence decreasing the amount of mercury reaching crematoria. The combined impact of PO3 or PO4a and b and a phase-out of dental amalgam are therefore considered in the assessment (Section 6) and comparison of options (Section 7).

Annual cremation rates per Member State

Data for each Member State were obtained from the Cremation Society for the period 2010 to 2019 where available. These were used to extrapolate historical trends to a future baseline year of 2030 using a linear regression (see Annex 5). The projected cremation rates from 2019 to 2030 show an overall increased trend across the EU with some Member States expected to experience a significant rise in cremation rates e.g., Germany’s cremation rates rising to above 97% in 2030 and Poland’s cremation rate doubling to reach 61% in 2030. Targeted stakeholder feedback also confirmed an overall increasing trend in numbers of cremations.

Complete data are available only up to the year 2019 and therefore do not reflect the very sad and sudden increase in mortality rates brought about by the COVID-19 pandemic. Limited data on 2020 cremation rates in some Member States were accessed during targeted stakeholder consultation. 68  Although most cremation rates had increased in 2020 in comparison to 2019 rates, the amount by which they increased varied greatly, and some Member States even saw modest decreases in cremation rates (NL and SE). Large increases between 2010 and 2019 were seen in BE (58% increase), IE (75% increase) and IT (47% increase). Most other Member States for which data is available saw an increase closer to 5-7% from 2019 rates. However, it is expected that as the pandemic diminishes, cremation rates will return to pre-pandemic trends. Consequently, future projections are based solely on pre-pandemic trends.

Total corpse mercury content

The mercury content for corpses in different age bands was calculated for each Member State. This was based on (i) the mean number of decayed, missing and filled teeth (DMFT) for each age group; (ii) the relative share of amalgam use in dental restorations and (iii) the typical mercury content of a dental amalgam filling. Details on this methodology are set out in Annex 5, which links the baseline for crematoria with the one on dental amalgam.

Uptake of emissions abatement technologies

Historical data on uptake of emissions abatement systems at crematoria are limited and it was not possible to obtain any further information through the stakeholder survey; it was therefore not possible to robustly project uptake trends into the future. It was therefore assumed that, under a business-as-usual baseline scenario, future uptake of abatement systems would remain at the same level as current levels (presented in Annex 5).

Mercury removal efficiency of abatement systems

For this assessment, it has been assumed that 100% of mercury reaching crematoria in corpses is emitted to air during cremation. This assumption is considered an accurate approximation of operating conditions 69 . Data collated from the literature on mercury removal efficiencies for the most widely used abatement technologies are presented in Annex 5.

Where no further country-specific removal efficiency could be obtained, an upper value of 99.9% was assumed along with a lower value of 90% and a central value of 95%. This is based on reported removal efficiencies for carbon injection and solid bed filtration, the most widely used abatement technologies.

5.1.3.5.1.3.    Mercury-added products for export to third countries

Based on the problem description, three groups of MAPs have been selected as they constitute the vast majority of MAPs both in number and value currently being manufactured and exported from the EU.

·Dental amalgam

·CFLs for general lighting purposes

·Double capped hot cathode fluorescent lamps for general lighting purposes (mainly LFLs)

The baseline scenario aims to provide a reference point against which the potential impacts of an EU-wide manufacture and export prohibition can be assessed. This requires a reasonable estimation of the current manufacture in the Union and export from the EU of MAPs. Third countries’ legal regimes, national programmes and initiatives that will lead to a change in demand of products exported from the EU were analysed and taken into account.

A baseline scenario was developed, which assumes:

·No further legal actions in the EU beyond those already agreed or planned to take place,

·The impact of national measures in importing third countries in response to restrictions already laid down in EU law. 

The baseline does not include the additional mercury-containing lamps (triband phosphor lamps and halophosphate lamps), for which Parties decided to defer to COP5 the possible decisions on their phase-out dates (2025, 2027 or 2030), since it entails a relatively high level of uncertainty in terms of outcome. COP Decisions to determine if, when and to what extent a specific MAP will be restricted under the Minamata Convention are not in the hands of the EU alone. In practice, consensus needs to be reached among all 139 Parties whose national interests in this matter may vary significantly and where major economies can show strong resistance.

For the baseline scenario, future exports of relevant MAPs in terms of number, value, and mercury content were estimated based on identified current and past trends.

Predicted export volumes for 2025 and 2030

Regarding dental amalgam and considering the expectations expressed in a WHO study 70 (75% of participants foresaw a phase-out by 2030) and data on declining use in the USA and Canada, it is expected that the demand for EU-made encapsulated amalgam will decrease and that exports will decrease by 25% to 75% of the current levels by 2030. The already large uncertainty concerning current dental amalgam exports only allows a rough calculation of the order of future export volumes. The mercury content of these exports is estimated to range from 13-55 million capsules with a total mercury content of 7-32 t in 2025 and 5-48 million capsules with a total mercury content of 3-28 t in 2030.

Regarding other MAPs (more specifically, mercury-containing lamps), the projected exports (in terms of units) for the baseline is summarised in Annex 5. For the baseline, it is expected that, by 2025, export volumes for all CFLs and LFLs would fall to around 83-141 million units. By 2030, the numbers would fall to between 49 and 83 million units. The calculated decrease is stronger for CFL lamps. In comparison to 2020, exports are predicted to decrease by 47-68%.

The value of all above-mentioned exported lamps decreases from €92.2 million (2020) to approx. €59 million by 2025 and to approx. €29 million by 2030.

Due to an increased shift towards LED lamps, in the EU, there are only four remaining manufacturers (the two largest are located in DE and PL) that continue to produce mercury-containing lamps, although even their production lines are increasingly focused on the production of LEDs. One of the four plants (located in HU) has already announced its closure by the end of 2022. The amount of mercury exported via CFLs and LFLs is estimated at 450-501 kg in 2020 71 . This quantity would decrease to about 245-414 kg by 2025 and to about 146-246 kg by 2030. The wide range follows from the uncertainty of the average mercury content of the exported lamps.

5.2.5.2.    Description of the policy options

The policy options have been developed from the list of potential policy measures, which were identified based on the findings of Commission Review Report and input from Member States and stakeholders. These measures were screened to identify those that should be retained for further analysis.

The screening process resulted in a list of 13 measures retained for impact assessment, including three for dental amalgam, six for crematoria emissions and four for MAPs. After impact assessing all policy options, six were retained (two for dental amalgam, two for crematoria emissions and two for MAPs). Whilst most are relatively independent from each other, some of them contribute to several specific objectives. Others are mainly relevant for a single objective. Annex 7 contains the list of measures which were screened out, as well as the rationale for not retaining them.

Problem 1: Health and environmental risks associated with the use of dental amalgam

Policy Options for Problem 1 are mapped below in Figure 8 .

Policy Option 1 (PO1) – Dental health communication campaigns: It may provide for several information campaigns to improve the knowledge and understanding of patients and healthcare practitioners, such as:

·A patient awareness campaign on the current knowledge of the risks associated with amalgam and the indications for the removal of old amalgam

·A campaign to evaluate current professional practices in relation to monitoring of urinary mercury in health professionals

·The continuation of training for future practitioners on the risks associated with removal of dental amalgam and related waste management beyond 2030

Policy Option 2 (PO2) – Establish a legally binding end date for the use of dental amalgam in the EU: This option foresees an amendment of the Mercury Regulation establishing a legally binding phase-out of dental amalgam use in the EU. The exact impacts of PO2 would depend on the timelines of the EU-wide ban, and the following scenarios have been assessed:

·PO2a: a phase-out with a 2025 deadline

·PO2b: a phase-out with a 2027 deadline

·PO2c: a phase-out with a 2030 deadline

Note: This Policy Option would not affect the existing derogation set out under Article 10(2) of the Mercury Regulation allowing continued use of dental amalgam in the very few cases where the dental practitioner deems it strictly necessary to treat specific medical conditions (e.g., allergies). Considering that this option would prohibit the use (PO2) and manufacture and export of dental amalgam (PO6 below) in the Union, dental amalgam required to address those limited specific cases would either be imported and/or sourced from existing stocks in the EU.

Figure 8: Mapping of policy options addressing the continued use of dental amalgam

Problem 2: Health and environmental risks associated with mercury emissions from crematoria

Policy Options for Problem 2 are mapped below in Figure 9 .

Policy Option 3 (PO3) – Guidance on abatement technology: It provides for EU guidance on abatement technology for controlling mercury emissions from crematoria, including adsorption techniques. Such guidance could describe various available abatement techniques and the costs associated with installing, operating and maintaining these, taking into account the existing OSPAR and HELCOM recommendations.

Policy Option 4 (PO4) - Mandatory abatement of mercury emissions: provides for EU-wide mandatory application of abatement technology using BAT. A number of routes to delivering PO4 have been assessed 72 :

·PO4a – Abatement for all crematoria: assumed to deliver a 100% uptake in emissions abatement systems in all crematoria across the EU.

·PO4b – Abatement for large crematoria: only crematoria above a certain number of cremations per year would be required to install abatement. The threshold is set at ≥4,000 based on Table 9 (below) that shows that below this threshold the benefits to cost-ratio falls rapidly under breakeven point.

·PO4c – Abatement for large crematoria: only crematoria above a certain number of cremations per year would be required to install abatement. The threshold is set at ≥ 3,000 based on Table 9 (below).

Figure 9: Mapping of policy options addressing mercury emissions from crematoria

Problem 3: Health and environmental risks associated with MAPs manufactured in and exported from the EU

Policy Options for Problem 3 are mapped below in

Figure 10 10.

Policy Option 5 (PO5) - Global agreement: It addresses the continued manufacture in and export from the EU of dental amalgam and concerned mercury-containing lamps by seeking international agreement, under the Minamata Convention, to prohibit it. The EU would need to negotiate and achieve global agreement on amendments to Annex A of the Convention, which lists MAPs and sets deadlines after which the manufacture, export and import of the concerned MAPs is no longer allowed. Implementation of such a global agreement into EU law could then be done by amending the Mercury Regulation via Delegated Acts (in line with its Article 20).

Policy Option 6 (PO6): EU ban on MAPs: It assesses the possibility of introducing an EU-wide ban on manufacturing and exporting dental amalgam and concerned mercury-containing lamps. Two timeframes were considered by which such EU-wide ban could enter into force:

·PO6a: 2025 

·PO6b: 2026/2028 based on the earliest phase-out dates retained for negotiations at the next Conference of the Parties to the Minamata Convention (COP5) (further described in Annex 8, 2026 for halophosphate LFLs and 2028 for all other considered lamp types)

Figure 10: Mapping of policy options addressing the manufacture and export of MAPs

6.6.    What are the impacts of the policy options?

This section presents an assessment of the impacts of all options against the baseline. As options and sub-options are packages of measures, the impact assessment builds on the assessment of the impacts of the individual measures, which is available in Annex 8.

6.1.6.1.    Problem 1 – dental amalgam use 

6.1.1.6.1.1.    Analysis of Policy Option 1 – Dental health communication campaigns

Economic impacts

The impact of the measures taken by Member States under PO1 is expected to be positive regarding employment. Jobs may first be created for organising awareness-raising activities, although these jobs may use the existing personnel or temporary ones created only for a short period. Jobs may also be created to train dentists in mercury-free restoration techniques. Finally, as this option is expected to foster innovation in mercury-free filling materials, it may also generate new employment opportunities in R&D activities within the dental industry.

Environmental impacts

The non-mandatory nature of this option makes it difficult to quantify the potential human health impacts. Any reduction in the use of dental amalgam would result in direct health benefits from reduced patient exposure to mercury. It would also result in reduced emissions of mercury to the environment from both direct (dental practices) and indirect sources (including crematoria emissions) and would reduce public environmental exposure to mercury. The voluntary character of the option however means that there is no certainty regarding environmental and health benefits.

Social impacts

The impact of health improvement campaigns cannot be measured in absolute magnitude but on the degree of their effectiveness. For such campaigns, studies have highlighted various aspects of socio-economic inequality, which will impact their effectiveness, including coverage of state social security, patient income disparities, and dependence on public versus private dental insurance.

Stakeholder views

About 89% of the stakeholders who responded to the OPC, including almost all companies and business associations, believe that dental health in the EU could still be improved. Such improvement can be achieved by a continuous/further expansion of prevention measures at the national level, in which communication campaigns play a significant role. Stakeholders also believed corresponding developments can already be seen in Member States that have increased their focus on prevention.

6.1.2.6.1.2.    Analysis of Policy Option 2 – Establish a legally binding end date for the use of dental amalgam in the EU 

Economic impacts

Conduct of business: Considering that six out of the nine manufacturers have already (or will soon) discontinue the production of dental amalgam, the impact of a dental amalgam phase-out would be limited to those few remaining manufacturers (SME’s). For some of these remaining manufacturers, existing certificates issued under the previous Medical Device Directive 93/42/EEC 73  were due to expire on 31 December 2028 in accordance with the new Medical Device Regulation EU 2017/745 74 . No information on whether any of these manufacturers have sought to apply for new certificates under this Regulation has been identified.

The extent of potential adverse effects on those manufacturers will therefore depend on the share of dental amalgam in their overall production and the capacity to switch production lines to mercury-free alternatives. Although the four remaining EU dental amalgam manufacturers are considered SMEs, available information suggests that they do not rely solely on the production of dental amalgam but also produce mercury-free alternatives and other medical devices. Although information is limited for this sector, the small number of remaining EU manufacturers and their capacity to shift to other product lines implies a limited economic impact of a manufacture and export ban. Companies with a high share of mercury-free materials in their production will gain an even more significant competitive advantage.

Although dental practices are considered micro-enterprises, the associated costs of a phase-out of the use of dental amalgam are considered negligible for dentists as the costs are passed on to patients (or in some Member States, the re-imbursement schemes). Costs incurred by dentists due to the maintenance of amalgam separators and the collection and treatment of amalgam waste as hazardous waste will not change as legacy dental amalgam will need to be treated. In the short-term, a phase-out scenario may put pressure on the few remaining dentists who have limited experience in carrying out mercury-free restorations. On the other hand, a phase-out will generate a competitive advantage for dentists already fully skilled in mercury-free restoration techniques.

Consumers and households: Currently, the use of dental amalgam affects EU citizens mainly through their tax contributions to the costs of managing mercury-contaminated urban wastewater and municipal waste (usually included in local taxes). If the installation of separators has not already led to sufficiently low levels of mercury in sewage sludge, an amalgam phase-out would ultimately (in the long-term) result in an even lower input of mercury into the wastewater system. Overall, this will have a positive economic impact on municipalities and taxpayers, as it will reduce the environmental costs associated with managing mercury pollution from dental amalgam.

Dental restoration costs borne by the patients depend on four main factors, i.e. (i) the cost of the filling material (negligible difference between dental amalgam and alternatives), (ii) reimbursement by the social security and/or private medical insurance, (iii) the longevity of restorations and (iv) labour cost for the treatment. The difference in cost of restorations can vary across the EU (see Table 8 although the data is from 2018 and cost differentials are expected to have further narrowed as more Member States phase out dental amalgam use and experience with use of alternatives increases). In DK (a Member State with long-term experience with dental amalgam phase-out), dental amalgam use decreased to 1.7% by 2017, and the cost difference associated with this shift to mercury-free alternatives has been estimated to be about €6 per treatment. This figure is therefore considered most representative of the cost differential if a full EU phase-out were to be applied.

Table 8: Price difference between dental amalgam and its alternatives per Member State

Based on this information, the additional annual costs to EU consumers (i.e., national care health systems) using alternatives in the first year of the phase-out of dental amalgam (i.e., 2025, 2027 or 2030) are estimated as follows:

·€208 million in 2025 (with a phase-out in 2025 i.e., PO2a)

·€170 million in 2027 (with a phase-out in 2027 i.e., PO2b)

·€114 million in 2030 (with a phase-out in 2030 i.e., PO2c)

The cost of a dental amalgam phase-out per Member State is available in Annex 7. Considering the difference in the use of dental amalgam across the EU, the distribution of these costs will affect Member States differently. However, the economic impact of a phase-out of the use of dental amalgam is expected to be minimal compared to Member States national healthcare budgets.

Figure 11  illustrates that the greatest burden of a dental amalgam phase-out on the national healthcare budget may be incurred by SI, SK, BU, and the CZ (between 0.4% and 0.7% of their national healthcare budgets). This is based on the assumption that all costs associated with a shift towards mercury-free alternatives are covered by national insurance schemes. However, it is likely that this will not be the case for all Member States where costs may be shared over national or private insurance schemes or transferred to patients (see Figure 12 ).

Figure 11: Cost to Member States associated with dental amalgam phase-out (2025, 2027 and 2030), expressed as a % of national healthcare budgets

Environmental impacts

A phase-out of dental amalgam would lead to a sudden drop to zero of its use in the deadline year. Small amounts of mercury may however still be used to treat patients with specific medical conditions.

The cumulative reductions in mercury used in dental restorations up until the year 2035 are given below for each of the three phase-out scenarios:

·PO2a (2025 phase-out): a reduction in mercury use of 114.4 t by 2035 

·PO2b (2027 phase-out): a reduction in mercury use of 75.9 t by 2035 

·PO2c (2030 phase-out): a reduction in mercury use of 29.8 t by 2035 

Previous assessments estimated the total mass of mercury in people’s mouths in the EU-27 (excluding Croatia but including the UK) at over 1,000 t 75 . The total population mercury load will be declining as a result of existing actions taken by the Member States to eliminate or reduce the use of dental amalgam. The phase-out scenarios would facilitate a quicker reduction in the population mercury load, although it is not possible to reliably quantify this change in reduction.

The cumulative reductions in environmental releases of mercury up until the year 2030 resulting from the phase-out scenarios, considering the mass flows set out in Figure 5 , are displayed in Table 9 . 

Table 9: Cumulative reductions in environmental mercury releases resulting from phase-out scenarios

In addition, a phase-out of dental amalgam would result in indirect environmental benefits through reduced mercury emissions from crematoria, although the continued arrival of mercury to crematoria in ‘legacy’ restorations means that emissions reductions would be delayed and would not follow dental amalgam use in immediately dropping to zero. Relative to a baseline assuming no EU-level phase-out of dental amalgam, the PO2 scenarios are anticipated to have the following impacts in terms of mercury emissions from crematoria in 2030 (relative to baseline emissions of 355 kg). The below figures represent a snapshot of changes in emissions in 2030, and not cumulative emissions savings over a set period of time. They take account of emissions from ‘legacy’ amalgam in old dental restorations, hence continued crematoria emissions even after the phase-out of dental amalgam. The figures highlight that an earlier dental amalgam phase-out would deliver much greater crematoria emissions reductions sooner (both in 2030 and cumulatively from the date of a ban).

·PO2a (2025 phase-out): a reduction in mercury emissions of 54 kg

·PO2b (2027 phase-out): a reduction in mercury emissions of 31 kg

·PO2c (2030 phase-out): a reduction in mercury emissions of 3 kg

Social impacts

It is expected that new jobs will be created to train the dentists who did not receive training for using alternatives or haven’t practiced it much, some of which will need to improve their skills or acquire new skills in mercury-free restoration techniques within a short timeframe. New jobs would also be expected to support R&D activities in the dental fillings industry due to the need for companies to maintain a high level of innovation in mercury-free materials.

A phase-out of dental amalgam is expected to have both direct and indirect health benefits for EU society. Benefits will be observed for the general population as mercury exposure reduction will likely lead to lower mercury levels in the blood, especially for practitioners, and reduction of associated health risks. In particular, the greatest direct benefits will be for dental practitioners as they are directly exposed to mercury vapours. These benefits are expected to be higher under PO2a as the exposure will cease sooner. The reduction of releases to water (e.g., via deposition from the atmosphere and emissions from crematoria) is likely to reduce mercury content in the marine food chain and, ultimately in fish, which is directly linked to human exposure to mercury.

Figure 12 provides an overview of the existing financing structures in the dental sectors of a number of Member States, which will likely influence the way in which the costs of switching to mercury-free alternatives will be distributed. FR and DE have the greatest share of public expenditure in their total dental expenditure (>60%), followed by HR, BG, LU and SK. Dental care expenditure in EL, ES and CY is dominated by private financing, while voluntary health insurance schemes make up the majority (>60%) of expenditure in the NL. The distribution of costs for dental amalgam and mercury-free alternatives per Member State is available in Annex 7.

Figure 12: Government, voluntary and out-of-pocket spending for dental care as % of total dental outpatient curative care expenditure

Data from the OECD Health Statistics 2022 database. Data for 2020, except for Denmark and the Netherlands (2021 data), and Malta (2019 data). No data for Portugal, Italy or Ireland.

Stakeholder views

Overall, 58% of the consulted stakeholders believe a phase-out could be achieved by 2025 and 22% indicated a phase-out being achievable by 2030, while 20% think that a phase-out is not needed, or the proposed years are not appropriate. Among companies or business associations, 65% and 20% respectively believed that a phase-out was achievable by 2025 and 2030 respectively. Of both EU and non-EU citizens’ responses, 50% and 29% respectively believed a phase-out could be achieved by 2025 and 2030 respectively. Four responses were received from public authorities, two of which responded by indicating 2025 with the other two supporting a 2030 phase-out. From Civil Society stakeholders, 62% and 10% were in favour of a 2025 or 2030 phase-out of dental amalgam respectively.

6.2.6.2.    Problem 2 – Emissions of mercury from crematoria 

6.2.1.6.2.1.    Analysis of Policy Option 3 – Publication of EU guidance on emissions abatement in crematoria

Economic impacts

Operating costs and the conduct of business: The introduction of EU guidance on emissions abatement in crematoria, is not anticipated to have a significant impact on abatement uptake in the absence of supporting legislation. Nonetheless, crematoria operators choosing to implement the non-legally binding guidance on information for abatement would face additional operational and capital costs. These vary according to the cremation capacity of the installation.

·For PO3 a 5% increase in abatement uptake (compared to baseline levels) is assumed to occur, with no impact assumed to occur in Member States where guidance or legislation is already in effect. Costs to operators in 2030 relative to a baseline assuming no phase-out of dental amalgam are estimated as total one-off capital costs of €10.3 million and annual operating costs of €0.32 million (equivalent annual costs of €1.08 million).

Administrative burden on businesses and public authorities: The cremation sector is not anticipated to incur any administrative burdens from the introduction of sector-specific guidance. EU institutions producing the guidance and Member States’ competent authorities disseminating these are likely to face some level of cost (albeit relatively limited) in doing so; this would vary depending on the scope of the guidance.

Position of SMEs: Although more than half of EU crematoria are considered SMEs, the associated costs of application of BAT are considered to be passed on to consumers. According to available information this is done in most Member States by using environmental premiums/fees. Given the voluntary nature of the option, it is not anticipated that issuing EU guidance will present significant impacts for SMEs.

Consumers and households: Given the voluntary uptake of the guidance, it is difficult to estimate the additional costs by consumers and households, albeit it can be assumed the associated costs of application of BAT would be passed on to them.

Table 10: PO3 cost-benefit summary table (assuming 5% increase in abatement uptake)

Environmental impacts

Quality of natural resources: PO3 is estimated to result in a reduction in mercury emissions in 2030 of around 17 kg (compared to 2030 baseline emissions of 355 kg). Any reduction in mercury emissions would result in an improvement in the quality of natural resources. Most directly, it would result in improved air quality, which would indirectly result in reduced mercury deposition to soil and waterbodies. In turn, the improved environmental quality would result in further indirect human health benefits; seafood is the primary source of human exposure to mercury, and reduced presence of mercury in environmental media would lead to reduced mercury in seafood consumed by populations.

Social impacts

Public health & safety and health systems: Mercury exposure is linked with health outcomes including cardiovascular mortality, IQ loss in younger age groups, and anemia. Based on EEA damage costs, the health benefits of the mercury emission reductions outlined in the previous section for 2030 are estimated at around €0.30 million, if applied across all crematoria, with the greatest benefit gained through emission reductions among crematoria operating at capacities of above 5,000 cremations annually.

Abatement technology used to reduce mercury emissions also capture a number of other pollutants. In light of this, human health benefits would also be experienced through reductions in PM2.5 emissions and other pollutants (including lead, cadmium, arsenic, chromium, nickel and dioxins and furans) estimated at €36,000 (2030).

Stakeholder views

Whilst no explicit feedback was received from stakeholders on a possible option involving the development of EU guidance, the majority of respondents to the OPC and targeted survey supported EU-wide policy to control mercury emissions from crematoria although this related more to the establishment of specific limits and application of BAT.

6.2.2.6.2.2.    Analysis of Policy Option 4 – Mandatory application of emissions abatement in crematoria 

Economic impacts

Operating costs and the conduct of business: Mandatory application of best available mercury emission abatement techniques would entail additional capital costs to crematoria operators from installing abatement systems, and additional operational costs from their continued maintenance and use. These vary according to the cremation capacity of the installation. Additional costs to operators in 2030 relative to a baseline assuming no phase-out of dental amalgam are estimated as follows:

·Where PO4a is expected to deliver a 100% uptake of emissions abatement across all crematoria in the EU, it is estimated to result in total one-off capital costs of €182 million, and annual operating costs of €6 million

·PO4b is expected to deliver a 100% uptake of emissions abatement across crematoria operating at a capacity of ≥ 4000 cremations per year and is estimated to result in total one-off capital costs of €15 million and annual operating costs of €0.46 million (see Table 11 ).

·PO4c is expected to deliver a 100% uptake of emissions abatement across crematoria operating at a capacity of ≥ 3000 cremations per year and is estimated to result in total one-off capital costs of €25 million and annual operating costs of €0.78 million (see Table 11).

Table 11: PO4 cost-benefit summary table

The greatest costs are incurred among low-capacity crematoria, (below 1,000 cremations per year), where the cost per unit of mercury emissions abated is highest. By implementing PO4b with an activity threshold exempting installations below a capacity of 4000 cremations per year, the capital and operating costs to business can be significantly reduced. By implementing PO4c, the capital and operating costs can only be slightly reduced.

A phase-out of dental amalgam (PO2a) in 2025 will lead to a significant reduction in mercury emissions from crematoria, decreasing the cost-benefit ratio of PO4 to 0.27 (see Table 12 ). The long-term positive economic effect stemming from a dental amalgam phase-out will ultimately result in the non-necessity to install mercury abatement techniques in new EU crematoria (as only small quantities of dental amalgam would still be used within the EU). These benefits will materialize following a delay due to legacy dental amalgam (the lag in dental restorations reaching crematoria).

By combining a dental amalgam phase-out (in 2025) with mandatory abatement of mercury emissions from crematoria:

·PO4a is expected to result in total one-off capital costs of €182 million, and annual operating costs of €6 million

·PO4b is expected to be cost-beneficial in crematoria operating at a capacity of ≥ 4000 cremations per year and is estimated to result in total one-off capital costs of €15 million and annual operating costs of €0.46 million (see Table 12 ), covering crematoria in 17 Member States (100 crematoria).

·PO4c is expected to be only marginally cost-beneficial in crematoria operating at a capacity of ≥ 3000 cremations per year and is estimated to result in total one-off capital costs of €25 million and annual operating costs of €0.78 million (see Table 12), covering crematoria in 18 Member States (170 crematoria).

Table 12: PO4 cost-benefit summary table assuming a dental amalgam phase-out in 2025

Position of SMEs: Implementing the measure with no, or a low, activity threshold would incur substantial costs to smaller installations. Some stakeholders indicated that there is potential movement away from significant public sector involvement in operation of crematoria to greater involvement from private enterprises. Limited data are available on the structure of the sector across the EU, but there are likely to be SMEs involved, especially in Member States dominated by smaller crematoria (including ES and FR). The implementation of no activity threshold is likely to have greater implications for SMEs within the sector, who would bear higher costs. However, according to available information, these costs are passed on (in full or in part) to consumers by using environmental premiums/fees and thus impacts on crematoria are expected to be limited.

Administrative burden on businesses and public authorities: In addition to the costs of implementing and operating mercury emissions abatement systems at their installations, crematoria operators would face added administrative burdens. This would arise from the need to submit information on their abatement systems and any periodic emissions monitoring and reporting to Member States’ competent authorities, who would also encounter a new administrative burden in processing such information. It is assumed that costs to both operators and authorities would be comparable to administrative burdens incurred by the smallest medium combustion plants (1-5 MWth) under Directive (EU) 2015/2193 on medium combustion plants 79 . Administrative costs are estimated to amount to €400,000 to operators and €500,000 to authorities for PO4a (all crematoria), €23.000 to operators and €28.000 to authorities for PO4b (crematoria greater than 4,000 cremations per year) and €42.000 to operators and €53.000 to authorities for PO4c (crematoria greater than 3,000 cremations per year) in 2030. 

Consumers and households: Crematoria operators implementing abatement technologies are likely to pass some or all of the capital and operational costs on to consumers, who would ultimately pay more for the same services. The degree to which costs would be passed on is not known.

Environmental impacts

Quality of natural resources: PO4a is anticipated to result in emissions abatement uptake of 100% across EU crematoria, mercury emissions reductions are estimated at 314 kg (compared to a baseline of 355 kg), assuming no activity threshold (PO4a), 141 kg (compared to a baseline of 355 kg) with an activity threshold of 4,000 cremations per year (PO4b) and 191 kg (compared to a baseline of 355 kg) with an activity threshold of 3,000 cremations per year (PO4c).

If PO4 is combined with a dental amalgam phase-out in 2025 (PO2a), its efficiency would decrease. It is anticipated that resulting emission reductions would be 269 kg (compared to a baseline of 301 kg) assuming no activities threshold (PO4a), 113 kg (compared to a baseline of 301 kg) with an activity threshold of 4,000 cremations per year (PO4b) and 156 kg (compared to a baseline of 301 kg) with an activity threshold of 3,000 cremations per year (PO4c).

Any reduction in mercury emissions would result in an improvement in the quality of natural resources through improved air quality and subsequently reduced deposition to soil and waterbodies. Reduced emissions to air from crematoria can be quantified and valued using damage cost functions. For other releases / sources (e.g., to water) there is no robust way of quantifying and valuing such changes in releases. Following decreasing mercury use in dentistry, extra operational costs will decrease with time, albeit slowly due to the lifetime of dental amalgam restorations and time it takes for it to be removed from circulation e.g., during replacement of restorations.

Social impacts

Public health & safety and health systems: Mercury exposure is linked with health outcomes including cardiovascular mortality, IQ loss in younger age groups, and anemia. Based on EEA damage costs, the health benefits of the mercury emissions reductions outlined in the previous section for 2030 are estimated at around €6 million, for PO4a, with the greatest benefit gained through emissions reductions among crematoria operating at capacities of above 4,000 cremations annually (PO4b) estimated at €2 million and €3 million for PO4c (3,000 cremations annually and above).

Abatement technology used to reduce mercury emissions also capture a number of other pollutants. In light of this, human health benefits would also be experienced through reductions in PM2.5 emissions and other pollutants (including lead, cadmium, arsenic, chromium, nickel and dioxins and furans) estimated at €0.62 million (PO4a, 2030), €0.18 million (PO4b, 2030) or €0.26 million (PO4c, 2030).

Stakeholder views

Overall, 86% (115/133) of respondents to the OPC believed that there should be an EU wide policy to limit mercury emissions from crematoria. This picture was consistent across all stakeholder groups that responded to the OPC (i.e., civil society, EU & non-EU citizens, companies & business associations and public authorities). As part of the targeted consultation, some stakeholders supported EU limits for all crematoria whereas other stakeholders expressed concerns about impacts on smaller crematoria if EU-wide limits were to be established and indicated that less stringent limits could be applied, or they could be excluded entirely. Some of the experts consulted indicated that crematoria should be treated similarly to other emission points, such as through Best Available Techniques (BAT) and associated emission levels (similar to the Industrial Emissions Directive) whereas others felt that the use of minimum emission limit values and a simpler regulatory approach would be more appropriate (e.g., similar to the Medium Combustion Plant Directive).

6.3.6.3.    Problem 3 – Mercury-added products for export to third countries

6.3.1.6.3.1.    Analysis of Policy Option 5 – Global agreement to ban the manufacture and trade of mercury-containing lamps 

Economic impacts

Conduct of business: Under a global ban scenario, EU exports of FLs would stepwise decrease to zero between 2026 and 2030. The accumulated number of exported FLs would be 167 million to 308 million units in comparison to 412 million to 693 million in the baseline scenario. The calculated accumulated loss of export value would be €97 to €190 million between 2025 and 2030. Jobs in the order of 500 may be affected by an export ban. Demand for lighting products in general will not be affected by a global ban of mercury-containing lamps but instead is expected to increase (by about 4% annually). Thus, manufacturers have opportunities to compensate for losses in the conventional lighting sector, e.g., by selling LED lamps/luminaries and smart lighting systems. For other lamp types, the impact is considered small (about €25 million per year, or less than 10% of annual export volume) because many applications still fall under exemptions within the EU. The economic impact for other MAPs e.g., certain types of rheometers, electrodes, seam-welding machines could not be quantified but is considered small in comparison to lamps.

Position of SMEs: In the case of FLs, SMEs would not be affected by an export ban since both remaining EU manufacturers belong to large company groups. This does not necessarily apply to SMEs that are producing other lamp types (HID lamps, other low pressure discharge lamps for special purposes). Manufacturers of aforementioned other MAPs are typically SMEs, but the impacts are considered minor as MAPs are only a small part of their portfolio.

Administrative burden on businesses and public authorities: The administrative impact of a ban is considered small to negligible as the cessation of manufacture and exports is not related to specific administrative burdens.

Environmental impacts

A global ban on FLs for general lighting purposes would primarily result in less mercury being needed within the EU to produce discharge lamps. To the same extent, the mercury content of exported lamps would decrease. With a ban taking effect in two steps by in 2026 and 2028, this would affect a quantity of 0.9 to 1.5 t of mercury in the period 2026-2030. Stopping the export could prevent some 0.8 to 1.3 t from entering the general waste stream and contributing to a contamination of soil and emissions to air in third countries, as currently only about 15% of lamps are recycled.

The magnitude of energy savings due to the switch from FLs to LEDs was estimated to be in the order of 10 to 28 TWh. Considering a carbon intensity of electricity of about 475 g CO2/ kWh, this would result in a lifetime saving of about 5 to 13 Mt CO2, constituting an important contribution to the fight against climate change and to the objectives under the EU decarbonisation agenda.

Social impacts

For citizens in importing third countries, the phase-out of mercury-containing fluorescent lamps would eliminate the most important source of product-related mercury exposure. New input of mercury into general waste would be avoided, so that populations working with waste (e.g., waste pickers) or living near waste dump sites have a lower risk of getting in contact with mercury. Social impacts in the EU are considered negligible.

Stakeholder views

During the stakeholder consultation, both NGOs and business associations supported a global agreement as it would effectively reduce access to and supply of MAPs, reduce mercury demand and at the same time contribute to energy savings. At the same time, it provides equal conditions for all market participants. However, industry stressed the necessity of a gradual and manageable transition to LED-based lighting in order to avoid disruptions of the supply chain and to improve the availability of compatible LED plug-and play solutions.

6.3.2.6.3.2.    Analysis of Policy Option 6 – EU ban on the manufacture and export of MAPs

Economic impacts

Conduct of business: 

·PO6a would ensure that all exports of would end from 2025, so that 412 million to 693 million FLs would no longer be exported. Their accumulated export value in the period 2025 to 2030 is €191 to €347 million. Jobs in the order of 500 may be affected by an export ban. If it is assumed that around 8% of the current HID lamp exports would be affected by an export ban, about 6 million units of HID lamps could no longer be exported within 2025 to 2030. Their value is at approximately €55 million. For dental amalgam, an export ban would affect predicted sales with a total retail value of about €50 to €300 million in the period 2025-2030. Because of the costs in the intermediate trade, the manufacturers’ sales value is considerably smaller. The number of affected jobs is considered to be significantly below 200.

·PO6b would ensure that all exports would end with a later ban on 1st January 2026 (halophosphate LFLs) and 1st January 2028 (all other considered lamp types), so that 167 million to 308 million FL units could still be exported until then, and the foregone revenue would decrease to €97 to €190 million, the majority of which (78%) can be attributed to double-capped FLs. For dental amalgam sales with a retail value of €30 to €200 million in the period 2027 to 2030 would be affected. The number of affected jobs is considered to be slightly below the values of option PO6a as exports and thus employment linked to these exports are expected to decrease even without a ban.

The ability to compensate losses in FL sales by increased LED sales would depend on the extent these markets switch to LED solutions. Stakeholders agreed that a significant part of the FL market currently supplied by EU exports will shift to FLs manufactured in third countries (especially mainstream lamp types). However, there are different opinions on the extent of this shift and how long it will last. In this assessment, they are expressed by assuming that the substitution rate is 50-90% of EU exports (see Annex 07).

The effect on employment for FL production would be similar to PO5 (global ban). The major difference between PO5 and PO6 (a and b) would be that FL exports from third countries may persist under PO6 until a global ban comes into force and/or the full transition to LED.

All four identified manufacturers that have not yet ceased dental amalgam production belong to SMEs. Two of these companies specialize to a large extent in dental amalgam. Depending on the relevance of the amalgam business, an export ban could result in a reduction in sales if not replaced by the export of mercury-free filling materials or other dental products to third countries.

Administrative burden on businesses and public authorities: The administrative impact of a ban is considered small to negligible as the cessation of manufacture and exports is not related to specific administrative burdens.

Environmental impacts

An EU export ban from 2025 would avoid the use of about 1.21 t to 2.17 t of mercury in European lamp products between 2025 and 2030. About 85% of this amount or 1 t to 1.9 t would not enter the general waste stream in importing countries. With an export ban from 2026/2028, the mercury content in exports would decrease by 0.8 t to 1.5 t and the mercury input into general waste by 0.7 t to 1.3 t. However, this is countered by the amount of mercury contained in FLs that are imported instead of European lamps. The assessment considers a level of substituting imports in the range of 50% to 90%. In addition, non-European FLs have a significantly higher average mercury content. While the difference for CFL.ni lamps is often only small and amounts to only a few tenths of a milligram, the difference is higher for the economically more important FL lamps and there especially for halophosphate lamps (3 to 5 mg per lamp).

For the scenario of an export ban from 2025, the substitute FLs would have a mercury content that is 0.53 t lower but can also be 1.59 t higher. The low values of this range are only realised when low substitution rates and low mercury contents in substituting imports coincide. The range is smaller if an export ban is considered from 2026/2028 (‑0.32 t to 1.12 t). For HID lamps the environmental impact is expected to be limited.

An EU decision by the EU is not detached from further negotiations at the international level. If an EU export ban and a global ban coincide in 2026/2028, the effect is equally positive as if there had only been a global ban (-1.50 t to -0.97 t). Should the global ban occur two years later (2028/2030), the net effect is still positive (-0.57 t to -0.24 t), as substitute imports could only occur for a maximum period of two years.

In the case of an export ban in 2025, the mercury content of exported dental amalgam would decrease by approximately 30 t to 180 t in the years 2025 to 2030. A later phase-out (2027) would result in a decrease of 20 t – 120 t. The reduced exports, if not substituted by dental amalgam supply from other third countries would result in reduced mercury releases to air and soil in the same order of magnitude.

Social impacts

An EU ban on the manufacture and export of MAPs will contribute to a decrease of mercury input into the society, thus reducing the risk of exposure and contamination. However, should third country markets replace EU made MAPs by imported MAPs from other countries, this could lead to continued mercury pollution. However, such negative impacts are limited to a couple of years until the predicted general decrease of FL sales compensates a possible short-term effects or measures.

In case of an EU ban on dental amalgam export, access of practitioners in third countries could become more difficult in the short-term. However, in the context of the Minamata Convention, the African Region has already highlighted its capacity to “leap-frog” dental amalgam and provide patients with mercury-free alternatives. Consequently, an EU export ban of dental amalgam may incentivize the accelerated transition from dental amalgam to mercury-free alternatives in third countries in the long-term, depending on their health systems and self-defined priorities.

Stakeholder views

NGO’s supported unilateral measures and expected an overall positive environmental impact caused by reduced supply from the EU in combination with national measures that follow the EU example. They preferred an early phase-out of exports as it would avoid a higher amount of mercury used in lamps. On the other hand, businesses expressed concerns that cutting supply to the global market from the EU could be compensated to a large extend by increased imports from third countries. In case of lamps, they expect a neutral or even negative effect because persistent demand could be met by imports of lamps (e.g., from Asia) with a higher mercury content. Businesses expressed caution over unilateral measures and preferred a global agreement on MAPs. In addition, businesses stressed the need for sufficient transition periods as short-term phase-outs pose serious challenges for users who may need to make significant investments to replace existing luminaires. Also, time is needed to re-export legally imported lamps that are currently in European distribution centers. Concerning dental amalgam, only one amalgam manufacturer submitted an opinion, stressing that European exports mainly go to low-income countries where many clinics don’t have the technical equipment for mercury-free fillings.

7.7.    How do the options compare?

The legal basis for this initiative is Article 19 of the Mercury Regulation, which requires the Commission to address three distinct issues, different in nature addressing the largest remaining intentional use of mercury in the EU (problem area 1), mercury emissions to air (problem area 2) and the alignment of EU law on MAPs (problem area 3).

Regardless of differences in scope and objectives, this initiative seeks to provide for a single policy package with an overall objective towards a non-toxic environment. In doing so, for the purpose of developing an effective, efficient and proportionate policy package, this initiative makes comparisons across problem areas, where feasible.

This section highlights the key aspects of the impact assessment relevant for supporting decision-making on the choice of options and sub-options to include in the preferred package. It identifies which sub-options have a favourable cost-benefit profile. Furthermore, where sub-options include alternatives, their impacts are compared ( Table 13 , Table 14 and Table 15 ).

Problem area 1 - Dental amalgam: Comparison between PO1 and PO2

Regarding PO1, as a ‘soft’ policy option, the assessment of the economic, environmental and social impacts of the implementation of communication campaigns shows that it would not deliver strong positive outcomes across the EU. Whilst the foreseen impacts are likely to be minimal in terms of costs, they would yield only limited environmental and social benefits. Due to uncertainties regarding the type, extent, content and potential overlaps with existing national campaigns, it not possible to robustly quantity the impacts of PO1.

Concerning PO2, as a ‘hard’ policy option, the assessment of the economic, environmental and social impacts of the implementation of a legally binding phase-out on the use of dental amalgam shows that significant environmental and human health benefits are associated with that option compared to PO1. Yet, due to the very nature of PO2 as a legally binding measure and its associated implementation (compulsory substitution of dental amalgam with mercury-free alternatives), that option incurs more costs compared to PO1.

The extent to which PO2 yields environmental and human health benefits depends on the date when the obligation to phase-out the use of dental amalgam enters into force. In particular, the cumulative reductions of mercury emissions by 2030 are significantly higher with an early phase-out date: 51.7 t for PO2a (2025), 21.9 t for PO2b (2027) and 6.0 t for PO2c (2030) (see Table 9 ). In parallel, human health benefits as a result of reduced mercury emissions to air from crematoria will also be significantly higher with an earlier phase-out date (2025), valued at €900,000 in 2030 compared to €50,000 with a 2030 phase-out date.

Problem area 2 – Emissions from crematoria: Comparison between PO3 and PO4

As PO2 addresses the reduction of mercury use at source resulting de facto in significantly reduced mercury emissions from crematoria, it decreases the effectiveness and cost-benefit ratio of PO3 and PO4. Hence, with PO2 in place, operators of crematoria will only have to abate mercury emissions from legacy dental amalgam.

Regarding PO3, as a ‘soft’ policy option, the assessment of the economic, environmental and social impacts of the development of a non-legally binding guidance on abatement technologies to control and reduce mercury emissions from crematoria shows some environmental and human health benefits. Estimated mercury emissions reductions of 17 kg in 2030 have been estimated assuming no phase-out of dental amalgam, delivering human health benefits valued at just over €300,000. Costs to operators in 2030 assuming no phase-out of dental amalgam are estimated as total one-off capital costs of €10.3 million and annual operating costs of €0.32 million.

Concerning PO4a, PO4b or PO4c, as a ‘hard’ policy option, the assessment of the economic, environmental and social impacts of an EU-wide obligation to install mercury emission abatement technologies in crematoria shows higher environmental and human health benefits compared to PO3, but significantly higher associated costs.

Under PO4a, estimated mercury emissions reductions amount to 314 kg in 2030, delivering human health benefits valued at €6.1 million. However, when combined with PO2a, estimated emissions reductions amount to 269 kg in 2030, delivering human health benefits valued at €5.3 million. PO4a is expected to deliver a 100% uptake of emissions abatement across all crematoria in the EU and is estimated to result in total one-off capital costs of €182 million, and annual operating costs of €6 million.

Under PO4b, estimated mercury emissions reductions amount to 141 kg in 2030, delivering human health benefits valued at €2.7 million. However, when combined with PO2a, emissions reductions amount to 113 kg in 2030, delivering human health benefits valued at €2.2 million. PO4b is expected to deliver a 100% uptake of emissions abatement across crematoria operating at a capacity of ≥ 4000 cremations per year and is estimated to result in total capital costs of €15 million and annual operating costs of €0.46 million. 

Under PO4c, estimated mercury emissions reductions amount to 191 kg in 2030, delivering human health benefits valued at €3.4 million. However, when combined with PO2a, emissions reductions amount to 156 kg in 2030, delivering human health benefits valued at €2.7 million. PO4c is expected to deliver 100% uptake of emissions abatement across all crematoria operating at a capacity of ≥ 3000 cremations per year and is estimated to result in total capital costs of €25 million and annual operating costs of €0.78 million.

Problem area 3 – Mercury-added products: Comparison between PO5 and PO6

Regarding PO5, as an option based on potential developments at international level, the assessment of the economic, environmental and social impact shows that the estimated decreased demand for mercury in the EU to be used for producing the concerned mercury-containing lamps (relevant LFLs) amount to 0.8-1.5 t (2026-2030) and the cumulative foregone revenues to EU businesses amount to €144 million (€97-190 million) (2026-2030). PO5 is characterised by a high level of uncertainty as Parties to the Minamata Convention may fail to reach an agreement at COP5 or at subsequent COPs on the phase-out dates for relevant MAPs 80 .

Concerning PO6, as an option based on a unilateral prohibition, the assessment of the economic, environmental and social impact shows that the decreased demand for mercury in the EU to be used for producing the concerned mercury-containing lamps (relevant LFLs, CFLs and HPS) amounts to 1.2-2.2 t (export ban in 2025 under PO6a) and to 0.8-1.5 t (export ban in 2026/2028 under PO6b). Both PO6a and PO6b would lead to cumulative foregone revenues to EU businesses amounting to €191-347 million (PO6a; 2025-2030) or to € 144 million (PO6b; 2026-2030). 

The assessment of the economic, environmental and social impact shows that PO6a applied only to dental amalgam would reduce the EU export of mercury in the range of 13-38 t and affect predicted sales with a total retail value of about €50 to €300 million in the period 2025-2030.

It is to be noted that both PO5 and PO6b are assumed to result in similar environmental benefits and foregone revenues, should the international community agree, based on Minamata Decision MC-4/6, on the most ambitious proposed phase-out date (2026) to be considered by Parties to the Minamata Convention at COP5. However, considering the uncertainty linked to PO5, PO6b provides for certainty across the EU on the applicable regulatory regime to MAPs.

Colour coding is used to summarise the assessment of impacts referring to the direction (positive or negative) and magnitude (small or large) of any expected impacts (see Table 13 ).

Table 13: Coding used to present expected impacts