·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)

	Amalgam use %	2019 (t)	Predicted 2025 (t)	Predicted 2030 (t)
AT	43%	1.291	0.893	0.579
BE	7%	0.427	0.285	0.150
BG	21%	0.379	0.225	0.146
HR	43%	0.110	0.000	0.000
CY	21%	0.008	0.005	0.004
CZ	43%	2.656	1.765	0.100
DK	1.7%	0.065	0.040	0.025
EE	2.5%	0.005	0.004	0.002
FI	1%	0.002	0.001	0.000
FR	25%	18.730	11.444	7.860
DE	6%	3.433	2.310	1.458
EL	43%	0.192	0.112	0.073
HU	7%	0.476	0.305	0.077
IE	20%	0.998	0.657	0.000
IT	2.5%	0.663	0.000	0.000
LV	21%	0.178	0.112	0.078
LT	4.6%	0.105	0.064	0.047
LU	21%	0.009	0.006	0.004
MT	43%	0.006	0.004	0.003
NL	0.5%	0.087	0.048	0.037
PL	43%	7.182	0.000	0.000
PT	10%	0.849	0.444	0.261
RO	7.5%	0.464	0.283	0.149
SK	50%	0.279	0.184	0.146
SI	70%	1.650	1.094	0.000
ES	1%	0.182	0.102	0.000
SE	0%	0.000	0.000	0.000
EU total		40.4 t	20.4 t	11.2 t

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)

Member State	Number of crematoria, 2019 (by capacity band)
	<1,000	1,000 – 2,000	2,000 – 3,000	3,000 – 4,000	4,000 – 5,000	>5,000	Total	% change 2010 - 2019
AT	1	2	4	2	3	1	13	18%
BE	1	3	6	4	4	1	19	58%
BG	1	0	0	0	0	0	1	0%
CY	0	0	0	0	0	0	0	N/A
CZ	2	5	10	4	4	2	27	0%
DE	8	22	50	30	38	11	159	5%
DK	1	10	6	0	0	2	19	-38%
EE	2	0	0	0	0	0	2	0%
EL	1	0	0	0	0	0	1	N/A
ES	434	0	0	0	0	0	434	No 2010 data
FI	3	12	4	0	1	0	20	-9%
FR	88	71	21	3	1	1	185	23%
HR	0	0	0	0	0	1	1	0%
HU	1	1	2	5	5	3	17	42%
IE	5	1	1	0	0	0	7	75%
IT	29	19	26	8	2	1	85	47%
LT	0	0	0	0	1	0	1	N/A
LU	0	0	1	0	0	0	1	0%
LV	0	0	0	1	0	0	1	0%
MT	0	0	0	0	0	0	0	N/A
NL	66	24	6	1	1	1	99	43%
PL	12	13	17	7	2	1	52	300%
PT	1	4	6	3	4	2	20	400%
RO	4	0	0	0	0	0	4	300%
SE	25	24	5	2	0	2	58	-12%
SI	0	0	0	0	0	2	2	0%
SK	0	0	0	0	1	2	3	0%
EU-27	685	211	165	70	67	33	1,231

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

Member State	Number of cremations
	2010	2019	Change
AT	25,553	41,869	64%
BE	51,062	67,794	33%
BG	364	519	43%
CY	0	0	0%
CZ	86,405	88,901	3%
DE	487,135	648,269	33%
DK	42,048	46,134	10%
EE	538	1,967	266%
EL	0	487	N/A
ES	174,649	185,332	6%
FI	21,103	30,956	47%
FR	165,907	239,283	44%
HR	39,258	38,647	-2%
HU	79,217	86,898	10%
IE	3,134	7,025	124%
IT	76,902	194,639	153%
LT	1,425	4,888	243%
LU	2,228	2,810	26%
LV	1,010	3,540	250%
MT	0	0	N/A
NL	77,471	101,687	31%
PL	34,063	132,746	290%
PT	56,632	64,259	13%
RO	857	1,248	46%
SE	69,548	73,631	6%
SI	14,569	17,506	20%
SK	4,810	17,248	259%
EU27	1,517,897	2,100,301	38%

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)

Products

Compact fluorescent lamps (CLFs) for general lighting purposes not already covered by Annex II of the Mercury Regulation

Linear triband phosphor lamps for general lighting purposes not already covered in Annex II of the Mercury Regulation

Halophosphate phosphor lamps for general lighting purposes not already covered in Annex II of the Mercury Regulation

Non-linear tri-band phosphor lamps for general lighting purposes

High Pressure Sodium (vapour) lamps (HPS) for general lighting purposes not exceeding (per burner) in lamps with improved colour rendering index Ra:

a)> 60: P ≤ 155 W

b)> 60: 155 W < P ≤ 405 W

c)> 60: P > 405 W

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)

Product	Mercury content in exported product per year
Dental amalgam (in capsules)	13 – 38 t (2019)
Hot cathode discharge lamps (CFLs, LFLs and other double-capped FLs)	0.46 t (2020)
High Pressure Sodium (vapour) lamps (HPS)	≈ 0.024 t (2020)

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

Product	No. of exported MAPs (Mio. units)	Value of exported MAPs (Mio. €)
Hot cathode discharge lamps (CFLs, LFLs and other double-capped FLs)	156 (2020)	92 (2020)
Dental amalgam (in capsules)	≈ 21-64 (2019)	≈ 21-64 (2019)
High Pressure Sodium (vapour) lamps (HPS)	≈ 1	Not quantified

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)

Fate of Dental Amalgam (DA)		T of Hg per year (2019)	T of Hg per year (2030)
Total DA Inputs
Total DA		40.4	11.2
DA used in restorations		18.6	5.2
DA to waste		21.8	6.0
Total DA Outputs
Emissions to air	1.3		0.4
Emissions to water 66	0.3		0.1
Discharged to wastewater 67	1.1		0.3
Emissions to soil	1.4		0.4
Sequestered or recycled	17.8		4.9

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

Country	Price per restoration (dental amalgam) (EUR)	Price per restoration (alternatives) (EUR)	Price difference (EUR)
AT	97.5	97.5	0
BE	52.5	52.5	0
BG	13.0	13.1	0.1
CY	60.0	60.0	0
CZ	19.2	19.3	0.1
DE	48.2	75.0	26.8
DK	54.2	60.6	6.4
EE	28.3	28.5	0.2
ES	46.1	46.1	0
FI	50.0	50.0	0
FR	40.0	40.0	0
EL	50	60	10
HR	23.0	23.2	0.2
HU	20.4	20.6	0.2
IE	50.0	51.5	1.5
IT	125.0	175.0	50
LT	19.9	20.0	0.1
LU	58.0	71.0	13
LV	15.0	25.0	10
MT	70.0	70.0	0
NL	45.0	67.3	22.3
PL	19.0	19.1	0.1
PT	33.7	33.7	0
RO	13.9	14.0	0.1
SE	N/A	105.0	N/A
SI	26.0	48.5	22.5
SK	22.7	22.9	0.2
UK	42.7	45.8	3.1
EU 28	40.8	50.5	9.7

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

Fate of Dental Amalgam (DA)	T of Hg (PO2a 2025 phase-out)	T of Hg (PO2b 2027 phase-out)	T of Hg (PO2c 2030 phase-out)
Emissions to air 76	3.1	1.3	0.4
Emissions to water 77	0.6	0.3	0.1
Discharged to wastewater 78	2.6	1.1	0.3
Emissions to soil	3.4	1.4	0.4
Sequestered or recycled	42.1	17.9	4.9
Total	51.7	22	6.1

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)

2030 Cremation capacity
	<1,000	1,000 - 2,000	2,000 - 3,000	3,000 - 4,000	4,000 - 5,000	>5,000	Total
Total emission reductions (kg)	1,0	1,6	4,0	2,7	2,7	5,1	17,1
Capital costs (€, one-off)	6.465.662	1.020.366	1.279.049	596.503	515.258	412.179	10.289.017
Operating costs (€, annual)	201.154	31.745	39.793	18.558	16.030	12.823	320.103
Capital and operational costs (€, EAC)	681.444	107.541	134.805	62.868	54.305	43.441	1.084.404
Admin burdens (€, operators and authorities)	Assumed to be zero for PO3
Total annual benefits (€, central)	26.795	33.114	76.565	51.546	51.967	96.277	336.265
Costs per kg mercury abated	682.997	65.879	33.864	23.491	20.045	8.577	63.560
Net costs / benefits	654.649	74.427	58.239	11.322	2.338	-52.836	748.139
Benefit-cost ratios	0,04	0,31	0,57	0,82	0,96	2,22	0,31

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

2030 Cremation capacity
	<1,000	1,000 - 2,000	2,000 - 3,000	3,000 - 4,000	4,000 - 5,000	>5,000	Total
Total emission reductions (kg)	16,8	31,3	75,4	49,3	47,4	93,9	314,1
Capital costs (€, one-off)	118.677.895	14.954.038	23.816.566	10.039.199	8.396.870	6.481.619	182.366.188
Operating costs (€, annual)	3.692.201	465.237	740.960	312.331	261.236	201.650	5.673.615
Capital and operational costs (€, EAC)	12.507.980	1.576.071	2.510.132	1.058.075	884.983	683.126	19.220.367
Admin burdens (€, operators and authorities)	564.276	123.601	115.909	44.193	27.425	23.293	898.698
Total annual benefits (€, central)	465.515	618.902	1.450.451	944.566	902.607	1.765.889	6.147.930
Costs per kg mercury abated	776.883	54.321	34.840	22.357	19.257	7.525	61.201
Net costs / benefits	12.606.741	1.080.771	1.175.590	157.702	9.801	-1.059.470	13.971.135
Benefit-cost ratios	0,04	0.36	0.55	0.86	0.99	2.50	0.31

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

2030 Cremation capacity
	<1,000	1,000 – 2,000	2,000 – 3,000	3,000 – 4,000	4,000 – 5,000	>5,000	Total
Total emission reductions (kg)	15,7	29,2	68,2	43,0	37,8	75,0	268,9
Capital costs (€, one-off)	118.677.895	14.954.038	23.816.566	10.039.199	8.396.870	6.481.619	182.366.188
Operating costs (€, annual)	3.692.201	465.237	740.960	312.331	261.236	201.650	5.673.615
Capital and operational costs (€, EAC)	12.507.980	1.576.071	2.510.132	1.058.075	884.983	683.126	19.220.367
Admin burdens (€, operators and authorities)	564.276	123.601	115.909	44.193	27.425	23.293	898.698
Total annual benefits (€, central)	444.895	581.988	1.324.683	834.310	733.157	1.433.862	5.352.895
Costs per kg mercury abated	835.032	58.225	38.490	25.612	24.168	9.417	71.485
Net costs / benefits	12.627.361	1.117.684	1.301.358	267.958	179.252	-727.443	14.766.170
Benefit-cost ratios	0,03	0,34	0,50	0,76	0,80	2,03	0,27

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).

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.

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

XXX	XX	X	O	✓	✓✓	✓✓✓
Extremely negative	Strongly negative	Weakly negative	Zero i.e., no or limited impact	Weakly positive	Strongly positive	Extremely positive

The coding provided in the summary tables below for each policy option are based on the detailed assessment of impacts (see Annex 8) for each measure and option. Quantitative information on the likely impacts of each option was not always available and, where it was, it was not always comparable across options e.g., compliance costs compared to potential loss of revenue. Therefore, expert judgement has been applied for the overall coding and comparison.

Table 14: Summary of impacts for PO1 to PO4 (Problems 1 and 2)

Policy option	Main impacts			Benefits	Costs	Admin burden	Key aspects
	Econ.	Env.	Social.
PO1 Communication campaign	O / X	O / ✓	O / ✓	·Benefits not feasible to quantify due to high uncertainties and overlaps with existing dental health campaigns. ·Increased employment in organizing awareness-raising activities, training dentists in mercury-free restoration, and R&D of mercury-free alternatives. ·Potential resulting reductions in mercury emissions to air, soil, and water.	·Limited costs anticipated for developing and running communication campaigns (existing campaigns already in place for improving dental hygiene). ·Potential loss of business to amalgam producers depending on several factors (e.g., content and extent of the campaign).	Limited	Many MSs already implement such communication campaigns so limited additional impacts anticipated from further awareness raising campaigns.
PO2 Establish legally binding end date for use dental amalgam	X	✓✓✓	✓	Cumulative reductions in mercury used in dental restorations of: ·PO2a (2025 phase-out): 114.4 t by 2035 ·PO2b (2027 phase-out): 75.9 t by 2035 ·PO2c (2030 phase-out): 29.8 t by 2035 Estimated cumulative reductions in direct mercury emissions from dental amalgam phase-out by 2030 of: ·PO2a: 3.1 t to air, 3.4 t to soil, 0.6 t to waterbodies, and 2.6 t to wastewater. ·PO2b: 1.3 t to air, 1.4 t to soil, 0.3 t to waterbodies, and 1.1 t to wastewater ·PO2c: 0.4 t to air, 0.4 t to soil, 0.1 t to waterbodies, and 0.3 t to wastewater. Estimated reductions in mercury emissions from crematoria by 2030 of: · PO2a: 54 kg · PO2b: 31 kg · PO2c: 3 kg. Human health benefits from reductions in mercury emissions from crematoria valued at: · PO2a: €900,000 · PO2b: €500,000 · PO2c: €50,000 Anticipated social benefits resulting from PO2 combine: I.improved health thanks to reduced mercury pollution exposure, II.positive impacts of improved dental aesthetics, especially for modest income households, III.R&I promotion potentially leading to slight increases in employment, but also slight increases of expenses for national healthcare systems	·Loss of business to manufacturers of amalgam fillings, dentists using amalgam products estimated to be limited. ·Anticipated that they would quickly adapt in case of a phase-out in light of on-going decreasing trend in dental amalgam use. Estimated increased short-term costs of dental treatment (for citizens, social security and./or private healthcare depending on systems in place in each MS) as a result of use of mercury-free alternatives: · PO2a: €208 million · PO2b: €170 million · PO2c: €114 million	·Business 0 ·Public authorities <1	Scale and timing of impacts depend on sub-options PO2a, PO2b and PO2c. Unlike for the reductions of mercury emissions from crematoria, it has not been possible to value/monetize robustly the benefits associated with PO2. Therefore, the valued benefits are significantly underestimated, and it is not feasible or appropriate to present a cost-benefit ratio as for PO3 and PO4. .
PO3 Issue guidance on emissions abatement in crematoria	X	✓	✓	·PO3: estimated mercury emissions reductions of 17 kg in 2030, delivering human health benefits valued at €300,000. Associated cost-benefit ratio: 0.31 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO3 combined with PO2a: estimated emissions reductions of 14 kg in 2030, delivering human health benefits valued at €280,000. Associated cost-benefit ratio: 0.27 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO3: estimated reductions in emissions of PM2.5 and other pollutants delivering human health benefits valued at €36,000.	·Total capital and operational costs of €1.1 million (EAC) in 2030 (with or without PO2).	·Business 0 ·Public authorities – limited costs for EU institutions to prepare guidance	Non-legally binding guidance will be helpful for those MSs that do not currently address mercury emissions from crematoria.
PO4a Mandatory application of best available abatement techniques for all crematoria	XXX	✓✓	✓✓	·PO4a: estimated mercury emissions reductions of 314 kg in 2030, delivering human health benefits valued at €5.5 million. Associated cost-benefit ratio: 0.31 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4a combined with PO2a: estimated emissions reductions of 269 kg in 2030, delivering human health benefits valued at €4.7 million. Associated cost-benefit ratio: 0.27 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4a: estimated reductions in emissions of PM2.5 and other pollutants delivering human health benefits valued at €621,000.	·Total capital and operational costs of €19.2 million (EAC) in 2030.	·Business €400,000 ·Public authorities €500,000	The mandatory application of BAT for crematoria in the EU will require the development and implementation of associated requirements, including in terms of permit/registration, monitoring, reporting, inspections etc.
PO4b Mandatory application of best available abatement techniques only for crematoria above 4000 cremations per year	X	✓	✓	·PO4b: estimated mercury emissions reductions of 141 kg in 2030, delivering human health benefits valued at €2.5 million. Associated cost-benefit ratio: 1.65 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4b combined with PO2a: estimated emissions reductions of 113 kg in 2030, delivering human health benefits valued at €2.0 million. Associated cost-benefit ratio: 1.34 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4b: estimated reductions in emissions of PM2.5 and other pollutants delivering human health benefits valued at €183,000.	·Total capital and operational costs of €1.6 million (EAC) in 2030.	·Business €23,000 ·Public authorities €28,000	The mandatory application of BAT for crematoria in the EU will require the development and implementation of associated requirements, including in terms of permit/registration, monitoring, reporting, inspections etc.
PO4c Mandatory application of best available abatement techniques only for crematoria above 3000 cremations per year	X	✓	✓	·PO4c: estimated mercury emissions reductions of 191 kg in 2030, delivering human health benefits valued at €3.4 million. Associated cost-benefit ratio: 1.33 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4c combined with PO2a: estimated emissions reductions of 155 kg in 2030, delivering human health benefits valued at €3 million. Associated cost-benefit ratio: 1.10 (when benefits from other pollutant reductions, described below, are also accounted for). ·PO4c: estimated reductions in emissions of PM2.5 and other pollutants delivering human health benefits valued at €260,000.	·Total capital and operations costs of €2.6 million (EAC) in 2030.	·Business €42,000 ·Public authorities €53,000	The mandatory application of BAT for crematoria in the EU will require the development and implementation of associated requirements, including in terms of permit/registration, monitoring, reporting, inspections etc.

Table 15: Summary of impacts for PO5 and PO6 (Problem 3)

Policy option	Main impacts			Benefits	Compliance costs	Admin costs €million/y	Key aspects
	Econ.	Env.	Social.
PO5 Seek change to international agreement	X	✓✓✓	✓✓	·Decreased demand for mercury for mercury-containing lamps production in the order of 0.8-1.5 t (2026-2030) ·Decreased demand for mercury for dental amalgam production in the order of 30-180 t (2025-2030).	·Foregone revenues to EU businesses of €144 million (€97-190 million) (2026-2030) for mercury-containing lamps. ·Foregone revenues to EU businesses of €50-300 million for dental amalgam (2025-2030)	·Business 0 ·Public authorities 0	On the one hand, the analysis has quantified the potential reduction in demand for mercury for production of MAPs. Yet, on the other hand and unlike for PO3 and PO4, it has not been feasible to further quantify or value the benefits (e.g. impacts for the environment and human health) due to the significant uncertainties associated with the fate of such MAPs in third countries. Overall, a positive environmental impact is expected but this strongly depends on willingness of Parties to the Minamata Convention to agree on a global ban at COP5 or at subsequent COPs.
PO6 EU export ban	XX	✓✓	X / ✓	Decreased demand for mercury for mercury-containing lamps production of: ·PO6a: 1.2-2.2 t ·PO6b: 0.8-1.5 t Lower release of mercury to general waste and resulting reduced human exposure.	Foregone revenues to EU businesses of: ·PO6a: €191-347 million (2025-2030) ·PO6b: €97-190 million (2026-2030)	·Business 0 ·Public authorities 0	As set out above for PO5, whilst the analysis has quantified the potential reduction in demand for mercury for production of MAPs, it has not been feasible to further quantify or value the benefits (e.g., impacts for the environment and human health) due to the significant uncertainties associated with the fate of such MAPs in third countries. The ultimate benefits will depend upon the resources and regulatory measures for such MAPs in third countries. As a result, it has not been feasible to present a cost benefit ratio similar to PO3 and PO4. Overall impacts will depend on rate of FL substitution in importing third countries and mercury content of lamps produced outside the EU. Economic operators may better adapt the longer the transition phase, i.e. if more time is given between the adoption of the manufacture and export ban decision and its entry into force.

8.8. Preferred option

Table 16 summarises the broad rationale for selecting or discarding (sub-)options. Retained (sub-) options appear in bold. The preferred Policy Option for problem area 2 will require a political choice.

Table 16: (Sub-) options included in and discarded from the preferred policy package

Policy option

Broad rationale for retaining or discarding the option/sub-option

1 – Reducing the health and environmental risks associated with mercury exposure during the use and disposal of mercury containing dental amalgam.

PO1: Communication campaign to raise awareness and change behaviour of dental patients (discarded)

Several such campaigns are already organised by MSs and the consultation responses show that most people are aware of impacts of mercury and availability of alternatives. Whereas some sectoral stakeholders consider the above-mentioned initiatives of high relevance, in terms of pollution control, they are not expected to have much impact.

PO2: Establish legally binding end date for the use of mercury-containing dental amalgam in the EU.

Sub-option phase-out by 2025 (retained)

Sub-options phase-out by 2027 or 2030 (discarded)

A number of MSs have already phased out dental amalgam use or are planning to in the coming years demonstrating that it is technically feasible to do so. Although the baseline shows significant reductions in usage for all MSs over the assessment period, an EU wide phase-out of the use of dental amalgam would ensure a uniform phase-out across all MSs and place the EU in a first-move leadership role in relation to future international negotiations within the context of the Minamata Convention. 2025 is the preferred option for phase-out as it would lead to the greatest environmental and health benefits and is considered feasible to implement within this time frame.

2 – Reducing the health and environmental risks associated with mercury emissions from crematoria.

PO3: EU guidance on BAT for crematoria

Non-legally binding EU guidance on abatement technology for mercury emissions from crematoria should provide a valuable reference guide for the MSs to be able to implement controls at national (or local or regional) level. This should be of most value to those MSs that do not currently regulate mercury emissions from crematoria and choose to do so voluntarily e.g., for a crematorium located near residential areas or for pollution control of other substances. Documents on BAT have been developed by the European Commission for other sectors under, in particular, the Industrial Emissions Directive 81 and the Mining Waste Directive 82 . A supporting voluntary agreement with the sector has been discarded as it is not considered feasible to broker such an agreement at EU level and should be left to the MSs to determine how best to engage with the sector.

PO4: Mandatory application of best available abatement techniques to reduce mercury emissions from crematoria.

Sub-option: for all crematoria

Sub-option: only for crematoria with capacity ≥ 4000

Sub-option: only for crematoria with capacity ≥ 3000

Whilst mandatory application of abatement technology would guarantee a uniform application of abatement across the EU, the potential costs relative to benefits are high, particularly for the smaller, more numerous crematoria, many of which are SMEs. In addition, if dental amalgam is phased out in 2025 (PO2a) then emissions from crematoria will be even lower by 2030 so the cost effectiveness of this option reduces. When the obligation to operate crematoria with abatement techniques applies only to larger crematoria (more than 4000 cremations/year), the cost-benefit ratio becomes slightly positive. This would capture around 30% of mercury emissions from all EU crematoria of all sizes while keeping the administrative costs for the authorities and the economic costs for the operators reasonable. However, only a few Member States would be concerned (in particular DE, HU), i.e., this raises questions about the EU added value. When the obligation to operate crematoria with abatement techniques applies to crematoria with a capacity ≥ 3000 cremations per year, the cost-benefit ratio is reduced.

3 – Reducing the health and environmental risks associated with mercury contained in products intended for export from the EU (but banned in the EU).

PO5: Seek change to international agreement to prevent (manufacture and) export of mercury containing products which would then be transposed into EU law (retained)

This option is considered an effective approach to achieve a maximum reduction of product-related mercury use and emissions. If agreed upon by Parties to the Minamata Convention, it provides for an international phase-out of MAPs. The instrument would close most, if not all, loopholes for third country manufacturers (other than an EU ban). Due to its consensual character, interests and priorities of third countries, especially developing countries are explicitly considered. However, the outcome of international negotiations on the prohibition of additional MAPs is undoubtedly uncertain regarding both its content and timing.

PO6: Introduce an EU ban on the export of mercury containing products already prevented from being placed on the market in the EU

Sub-option by 2025 (retained for dental amalgam)

Sub-option by 2026/28 (retained for relevant mercury-containing lamps

An EU ban would allow the EU to take immediate action and to further decrease export of MAPs independently form the outcome of future negotiations at the international level (Minamata Convention). Thereby, the EU could lower its external pollution footprint. Such an action is a political signal to other countries that may wish to follow this path and prohibit the sale/export of MAPs as well. However, the EU cannot restrict the import to third countries of MAPs produced outside the EU. Part of EU-made products may be substituted by products with a possibly higher mercury level. The risk for net negative impacts decreases if more time is planned between adoption of the initiative and entry into force of a manufacture and export ban. This would also give third countries more time to adjust their national legislation. If closely followed by a global ban (PO5) no negative impacts are to be expected. This is the reason why a ban on the manufacture and export of FLs in 2026/2028 is preferred whereas a similar prohibition on the manufacture and export of dental amalgam in 2025 is preferred.

Overall, the preferred policy package would likely generate significant and positive environmental impacts and incur limited negative economic impacts. Where it has not been possible to systematically quantify and monetise all impacts for all measures, quantification has been supplemented with qualitative data based on expert judgement.

8.1.1 Preferred Policy Option for Problem 1

The preferred policy option for Problem Area 1 tackles the issue of continued dental amalgam use at source through the earliest possible phase-out (2025) (PO2a). An EU wide phase-out of the use of dental amalgam would ensure a uniform phase-out across all Member States and place the EU in a first-mover leadership role in relation to future international negotiations within the Minamata Convention. Absence of such action could result in global criticism and risks reduced credibility of the EGD and EU Chemicals policy at global level.

Whilst this will lead to some additional costs due to the current cost difference between dental amalgam and mercury-free alternatives, many Member States are already planning phase-outs so additional impacts of EU action are relatively limited. These additional costs decline over time as the cost difference between dental amalgam and mercury-free alternatives is expected to narrow with greater demand and innovation. The year 2025 is the preferred option for a phase-out as it would lead to the greatest environmental and health benefits and is considered feasible to implement within a short timeframe (as demonstrated by some Member States already having phased out, or planning to phase out, dental amalgam use by then).

The phase-out of dental amalgam use in the EU will lead to significant benefits for the environment and health. In addition, it will lead to reductions in mercury emissions from crematoria, which will continue to steadily decline over time.

8.1.2 Preferred Policy Option for Problem 2

The policy options concerning mercury emissions from crematoria will require a political choice. The outcome of this choice will have environmental and economic impacts. There are advantages and disadvantages associated with each policy option identified for Problem 2.

Regarding PO4a or PO4b, on the one hand, it would ensure the implementation of a uniform and legally certain obligation to install mercury emission abatement technologies in crematoria across the EU at a time where cremation rates are increasing. On the other hand, whereas for PO4a, in practice, all EU crematoria (25 Member States) would be covered under PO4a, this proves not to be cost-beneficial with a very low cost-benefit ratio of 0.31. Furthermore, PO4a would prove to place considerable economic pressure on SMEs operating crematoria with low capacity (noting that the sector is dominated by SMEs) as well as significant administrative burden on operators and competent authorities (e.g., compliance and enforcement). Whilst a slightly positive cost-benefit ratio (between 1.34 or 1.65, depending on the implementation of PO2a) can be achieved under PO4b, the legal obligation would apply in practice to very few crematoria (around 100 out of 1.200) located mainly in two Member States (DE, HU) and abate less than 40% of mercury emissions from EU crematoria. Under PO4c, a cost-benefit ratio between 1.10 or 1.33 (depending on the implementation of PO2a) can be achieved, but the legal application would only apply, in practice, to an additional 70 crematoria compared to PO4b. Hence, above-mentioned disadvantages may put into question in particular the proportionality principle, especially when considering a dental amalgam phase-out (PO2a).

An alternative to PO4 is PO3 whereby the European Commission develops a non-legally binding guidance on BAT for the abatement of mercury emissions from crematoria. The advantage of PO3 provides room for manoeuvre for operators to make an informed choice on whether economic and administrative burden is feasible, dependent on their capacity.

In choosing the preferred option, account should be taken also of the time needed to implement abatement technology in crematoria across the EU (typically, around 2-3 years for developing appropriate BATs and then at least 1-2 years for Member States to implement them).

8.1.3 Preferred Policy Option for Problem 3

The preferred policy options for Problem Area 3 includes both the introduction in the Mercury Regulation of an EU-wide prohibition of the manufacture and export of mercury-containing lamps which are already prohibited from being placed on the internal market, by 2026 and 2028 and a manufacture and export ban of dental amalgam aligned with the phase-out of its use in 2025 (PO6b) as well as the promotion of a ban under the Minamata Convention (PO5). It is to be noted that this manufacture and export ban, once implemented into the Mercury Regulation by this initiative, will also be transposed into Annex V (Part 2) to the PIC Regulation, as has been done with the full list of MAPs under Annex II to the Mercury Regulation.

An EU ban (PO6) would allow the EU to take immediate action and to further decrease export of MAPs independently from the unpredictable outcome of future negotiations at the international level (Minamata Convention). Such an action is a signal to third countries that may wish to follow this approach and prohibit the sale/export of MAPs as well. It also sets an example for future negotiations under the Convention. Furthermore, such action would ensure upholding the EU’s credibility vis-à-vis the objectives set out in the EGD and EU Chemicals Strategy for Sustainability.

However, recognising the risk of substitution of products that can no longer be exported from the EU but still sourced from elsewhere in the world, the preferred option also includes a concerted push to reach a global agreement (at international level) on a ban of such products (PO5). A global ban of such products is considered the most effective approach to achieve the maximum reduction of product-related mercury use and emissions. If agreed upon by Parties to the Minamata Convention, it provides for a uniform phase-out of MAPs at global level.

The main overlap between the three problem areas and policy options relates to dental amalgam which is currently manufactured within the EU, and both used in the EU as well as manufactured and exported. The preferred policy option is coherent in that a phase-out of dental amalgam use in the EU would apply from 2025, simultaneously to a ban on the manufacture and export to non-EU countries.

8.1.4 Overall preferred policy package

Overall, the combined preferred options would lead to the following impacts in the EU:

·PO2a resulting in a cumulative reduction in mercury used in dental restorations in the EU of 114 t by 2035 (following a 2025 phase-out) and additional costs of using alternatives of €208 million in 2025 declining over time.

·PO3 (in combination with PO2a) resulting in estimated mercury emissions reductions of 14.5 kg in 2030, delivering human health benefits valued at €280,000 with costs to operators in 2030 estimated as total one-off capital costs of €10.3 million and annual operating costs of €0.32 million.

Alternatively, PO4b (in combination with PO2a) resulting in estimated mercury emissions reductions of 167 kg (i.e., foregone emissions of 54 kg stemming from a 2025 phase-out of dental amalgam and 113 kg from controls on crematoria greater than 4,000 cremations per year) in 2030, delivering human health benefits valued at €2.2 million, and is estimated to result in total one-off capital costs of €15 million and annual operating costs of €0.46 million.

·PO6b resulting in a reduction in demand for mercury for mercury-containing lamps production in the order 0.8-1.5 t (export ban in 2026/2028). This would be associated with potential foregone revenues to businesses €97-190 million (2026-2030; 2026/2028 export ban). In addition, PO6a (2025) resulting in a reduction of mercury use for the production and export of dental amalgam in the order 30-180 t (export ban in 2025). This would be associated with potential foregone revenues to EU businesses €50-300 million (2025-2030).

8.2.1. REFIT

In line with the Commission’s commitment to better regulation, this proposal has been prepared inclusively (3), based on full transparency (3) and continuous engagement with stakeholders (3) with due regard to avoiding unnecessary burdens (2). It is based on the best available evidence (1), referenced in the document, and expert knowledge (1) taking into account the external feedback (1).

The Mercury Regulation does not currently impose reporting (and associated reporting costs) on operators of crematoria, dental practitioners or MAPs producers. Member State Authorities report on the implementation of the Regulation, and the approximate annual administrative burden of this overall reporting is moderate (30 000 – 100 000 EUR/p.a. for the whole EU) and is based on data that should already be available to authorities.

PO2a (phase-out of dental amalgam from 2025) would impact on dentists (all of whom are likely to be SMEs) across the EU as they would no longer be able to offer restorations using dental amalgam. However, impacts are expected to be minimal as there has already been a steady transition towards phase out happening in recent years and any additional costs associated with offering alternatives would be expected to be passed through to the consumer (and/or covered by social security systems and/or private healthcare).

For crematoria, whilst there is uncertainty over how many SMEs are operating in the sector this is expected to be high (aside from those that are publicly run most of the rest are expected to be SMEs.

PO3 would be entirely voluntary and therefore no impacts on SMEs are expected. It would be up to the individual Member States and/or operators to decide whether or not to implement controls.

PO4a (mandatory application of BAT for all crematoria) would cover all crematoria and therefore impacts on SMEs could potentially be significant. However, all additional compliance costs associated with installing mercury controls would be expected to be passed through to the consumer in terms of fees for cremations, as they are already done in many countries where abatement is already required. A mandatory option would also entail some administrative burden for operators (and public authorities) for ensuring and demonstrating compliance e.g. reporting on results of emissions monitoring. However, it is assumed that these would also be passed through to consumers alongside costs for installing and running abatement controls.

PO4b (mandatory application of BAT for large crematoria only) would only cover the largest crematoria (above 4,000 cremations per year) thus excluding the smaller crematoria from any impacts (compared to PO4a this would reduce the number of crematoria potentially impacted from 1,500 to just under 130 crematoria). For those crematoria that are covered by PO4b, impacts could potentially be significant. However, all additional compliance costs associated with installing mercury controls would be expected to be passed through to the consumer in terms of fees for cremations, as they are already done in many countries where abatement is already required. A mandatory option would also entail some administrative burden for operators (and public authorities) for ensuring and demonstrating compliance e.g., reporting on results of emissions monitoring. However, it is assumed that these would also be passed through to consumers alongside costs for installing and running abatement controls.

PO4c (mandatory application of BAT for crematoria operating above ≥ 3000 cremations per year) would cover 170 out of 1200 crematoria, thus excluding the smaller crematoria from any impacts (compared to PO4a). For those crematoria that are covered by PO4c, impacts could potentially be significant. However, all additional compliance costs associated with installing mercury controls would be expected to be passed through to the consumer in terms of fees for cremations, as they are already done in many countries where abatement is already required. Like for PO4b, a mandatory option would also entail some administrative burden for operators (and public authorities) for ensuring and demonstrating compliance e.g., reporting on results of emissions monitoring.

For PO5, a global agreement would have an impact for some SMEs that are manufacturing certain types of MAPs, namely some lamp types other than FLs for general lighting purposes. As only about 8% of current HID exports would be affected by a ban the relative impact would be limited.

For PO6a and PO6b, a unilateral MAP export ban would have similar effects as PO5. In addition, a ban on the export of dental amalgam (only after a phase-out within the EU) would effectively end the production of amalgam by the four remaining EU producers, eliminating a large part of their current business. However, this would lead to a decrease of amalgam use in the EU in the order of 13 to 38 t.

This limits the potential for future streamlining, nevertheless the combination of measures designed to reduce the environmental footprint of European MAPs and aligning EU acquis on the placing on the market, import, export and manufacturing of MAPs will offer more legal certainty on the applicable rules (see Annex 9) for manufacturers and exporters and therefore ensure costs savings (2).

A revision of the Mercury Regulation will allow provisions that have become obsolete to be eliminated which would simplify its implementation (2).

8.1.8.2.2 One-in-one-out

The proposed options will not bring about new administrative burdens to citizens, and the additional burden to businesses will be limited. The administrative impact of the amalgam phase-out (PO2a) and of measures addressing MAPs (PO5 and PO6) will bring limited cost savings – these could not be calculated in an exact manner as the current Mercury Regulation does not impose direct reporting obligations to business operators (dental practitioners, crematoria operators or MAP producers), Member States report on mercury emissions in a highly aggregated way.

PO3 would not introduce any new administrative burdens for businesses, citizens or Member State public authorities as the measure would be voluntary and up to the Member States themselves (and/or operators) to decide whether to implement controls for crematoria using the developed guidance as a framework for any requirements.

Should PO4a,PO4b or PO4c be retained as the preferred policy option, this would introduce new administrative burdens to both crematoria operators and Member State competent authorities, arising from the enforcement of the policy option.

For PO4a, 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 has been 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 83 . Administrative costs are estimated to amount to €400,000 to operators and €500,000 to authorities for PO4a (all crematoria) in 2030.

For PO4b, in addition to the costs of implementing and operating mercury emissions abatement systems at their installations, large 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 84 . Administrative costs are estimated to amount to €23.000 to operators and €28.000 to authorities for PO4b in 2030. For PO4c, administrative costs are estimated to amount to €42,000 to operators and €53,000 to authorities in 2030.

8.2.3. Preferred instrument

Based on the analysis of the problems, the most appropriate instrument to address them is a revision of the current Mercury Regulation.

9.9. How will actual impacts be monitored and evaluated?

9.1.9.1. Identification of monitoring needs

Monitoring the implementation of a phase-out of the use of dental amalgam (PO2) will imply an obligation on Member States to undertake market surveillance and compliance checking in accordance with Regulation (EU) 2019/1020 85 . Under a voluntary application of abatement technology (PO3), no further monitoring obligations will be imposed at EU level, leaving the implementation of mercury emission abatement technology and associated monitoring to Member State competent authorities. However, in case of mandatory application of abatement technology for crematoria (PO4), EU law would have to provide for monitoring, reporting obligations for operators of crematoria and administrative (information processing, inspections etc.) obligations for competent authorities. Similarly, regarding the prohibition to manufacture and export of MAPs (i.e., CFLs and LFLs), the extension of Annex II to the Mercury Regulation will not lead to an ad-hoc EU obligation to monitor implementation (PO5 and PO6). Any relevant information can be provided to the Commission via Member State reports on the implementation of the Mercury Regulation (under Article 18). Jointly with the ongoing decarbonisation efforts, this initiative should translate into a progressively decreased presence of mercury in air, water and soil, to be tracked under the bi-yearly Zero Pollution Monitoring and Outlook Report.

9.2.9.2. Identification of key indicators

The key indicator for dental amalgam could be the amount of dental amalgam used in the EU. The key indicator for crematoria could be the uptake of mercury abatement techniques in crematoria. For MAPs, no indicators are deemed necessary with a ban on their manufacture and export.

Annex 1: Procedural Information

10.1. Lead DG, Decide Planning/CWP references

The preparation of this file was led by DG Environment (ENV) and comprises a review of Regulation (EU) 2017/852 on mercury, in accordance with its Article 19(1).

The Mercury Regulation is the most important legal instrument in regulating the environmental impacts of mercury pollution by addressing the entire life cycle of mercury. Article 19(1) of the Mercury Regulation requires the Commission to review the following aspects:

(a)The need for the Union to regulation emissions of mercury and mercury compounds from crematoria;

(b)The feasibility of a phase out of the se of dental amalgam in the long term, and preferably by 2030, taking into account the national plans referred to in Article 10(3) and whilst fully respecting Member State’ competence for the organisation and delivery of health services and medical care; and

(c)The environmental benefits and the feasibility of a further alignment of Annex II with relevant Union legislation regulating the placing on the market of mercury-added products.

The overall “Mercury Regulation Review” takes into account the feasibility assessment of phasing out dental amalgam (2020)

86 and the study supporting the revision of Regulation (EU) 2017/852 on mercury 87 in order to update the instrument to be able to deliver the aims and targets of the wide-ranging and overarching policy aims as described in Section 2.

The DECIDE/Agenda Planning is the following:

Mercury – Review of EU law: Revision of Regulation (EU) 2017/852 on mercury, and repealing Regulation (EC) No 1102/2008

PLAN/2020/9940

11.Organisation and timing

The Mercury Regulation Review initiative feeds into objectives set out in the European Green Deal 88 , the Zero Pollution Action Plan 89 and the EU Chemicals Strategy for Sustainability 90 . The Inception Impact Assessment Roadmap was published on 5 March 2021 with a feedback period until 2 April 2021.

The Inter Service Steering Group (ISSG) for the Impact Assessment was set up by DG Environment. It included the following DGs and services: ENER (Energy), GROW (Internal Market, Industry, Entrepreneurship and SMEs), JRC (Joint Research Centre), RTD (Research and Innovation), SANTE (Health and Food Safety), SJ (Legal Service) as well as TRADE (Trade). Meetings were organised between January 2021 and October 2022.

The ISSG discussed the Inception Impact Assessment as well as the Terms of Reference (ToR) for the support contract, assisting the Commission with the Impact Assessment. The ISSG meetings have discussed the main milestones in the process, in particular evidence gathering, coherence with other (ongoing draft) legislative initiatives, the consultation strategy and main stakeholder consultation activities. The ISSG has been consulted regarding, and has given input to, key deliverables from the support study and the draft Impact Assessment report prior to its submission to the Regulatory Scrutiny Board (RSB).

12.Consultation of the RSB

An informal upstream meeting with the RSB took place on 11 January 2021.

After final discussion with the ISSG, a draft of the Impact Assessment was submitted to the RSB on 14 November 2022 and discussed at a meeting with the RSB on 14 December 2022.

Following the negative opinion of the RSB, changes were made to the Impact Assessment in order to reflect the recommendations of the Board.

After another consultation of the ISSG, the Impact Assessment was re-submitted to the RSB on 17 February 2023.

Following the positive opinion of the RSB (24 March 2023), additional changes were made to the Impact Assessment in order to reflect the recommendations of the Board.

Table 1 presents an overview of the RSB’s comments and how these have been addressed.

Table 1: How the RSB comments have been addressed

1General RSB comments	2How addressed
3Main findings
41. The report is not sufficiently clear on the scale and the drivers of the problems. It does not sufficiently describe the dynamic baseline.	·Supplementary information on dental amalgam and mercury emissions from crematoria have been added across the whole report. ·Using additional work commissioned to the consultant, the information describes in more granular detail the current baseline situation in the EU and in each Member State (p. 13 and 14), as well as the drivers and scale of issues associated with a phase-out of the use of dental amalgam (p. 15), mercury emissions from crematoria (p. 19) and restriction of mercury-added products (MAPs) (pp. 23 and 24).
52. The report does not present a clear, comprehensive and analytically coherent cost benefit analysis.	·The report provides a clearer and a more comprehensive and analytically coherent picture of the costs and benefits of each Policy Option (Section 7), using additional more granular Member State level information.
63. The report does not provide a clear and comprehensive comparison of options. It is not clear how the choice of the preferred options is supported by the analysis.	·The Policy Options were restructured, separating the options related to crematoria from the options related to dental amalgam. Several options were screened out (Annex 7). ·The link between impacts of a dental amalgam phase-out and costs of crematoria emissions abatement is clearly described in Sections 6.21, 6.2.2 and 7. ·An overview of costs and benefits (qualitative and/or quantitative where it is not feasible to quantify impacts) is presented in a tabular format (Table 12 and 13) describing all available quantitative and qualitative information in Sections 7 (and Annex 3).

7Specific RSB comments	How addressed
Way to improve
81. The report should clarify and further elaborate on the scope and scale of the problems. It should be clear that the term Mercury Added Products also covers dental amalgam. It should specify the amount of mercury addressed by the initiative as compared to the total amount of mercury released from or used in other human activities. It should present the breakdown of amounts between dental amalgam (for use in the EU and for exports), crematoria emissions and the different MAP categories. The report should elaborate on the scale and reasons for the continued use of dental amalgam in certain Member States, in particular considering the availability of safer alternatives and the phase-out in some Member States. It should explain in detail the underlying reasons and whether those are due to technical constraints, cost, or other factors. The report should discuss to what extent, the differing regulations and standards in Member States lead to market fragmentation, affect the functioning of the single market and contribute to the problem.	·Section 2 was amended to improve the description of the scope and size of the problem and includes a breakdown of amounts of mercury addressed by the initiative (p. 11). ·Section 1 provides a clear definition of the term mercury-added products (MAP), describing the type of products addressed, and making clear that dental amalgam is included in the definition of MAPs (p. 5 and 22). ·Section 2.1 describes the reasons for which some Member States continue the use of dental amalgam and presents (in a tabular format Table 1 on pp. 13-14) the current and projected dental amalgam use per Member State. ·Section 6.1.2 presents the price difference between dental amalgam and mercury-free alternatives per Member State (Table 6 on pp. 38 and 39) and Section 2.2 provides an explanation as to why transboundary effects of price differences in cremation costs between Member States are considered negligible.
92. The report should better describe the dynamic baseline. It should further justify the assumptions on the uptake of emissions abatement technologies in view of the recent and parallel initiatives towards zero pollution, as well as in view of potential accelerated deployment of mercury vapour capture in crematoria thanks to more affordable solutions. With regard to MAPs, the report should clarify if the envisaged prohibition of additional MAPs under the Minamata Convention is included in the baseline. It should explain if the baseline considers the accelerated shift towards alternatives to mercury-containing lamps using LED technology. It should also explain why the option related to seeking prohibition under the Minamata Convention is not considered part of the dynamic baseline. It should also consider to what extent non-legislative guidance type options form part of the dynamic baseline.	·Sections 2.2, 6.2.1 and 6.2.2 provide a more detailed description of the current and expected future situation of crematoria emissions in the EU and per Member State, providing a description of the current and expected number of crematoria (Table 2 on pp. 17-18 and Annex 5), size/capacity of crematoria, and mercury emissions from these crematoria. ·Section 5.1.3 presents the baseline for MAPs more clearly and Section 1.2 clarifies the envisaged prohibition of additional MAPs under the Minamata Convention (p. 10 and Annex 8). Section 5.1.3 explains why such a prohibition cannot be considered as forming part of a dynamic baseline but merits from being assessed as a real Policy Option (p. 31). ·Section 5.1.3 also provides a more detailed explanation of the baseline considerations concerning the shift towards using LED technology. ·Section 5 provides justified reasoning for the inclusion of communication campaigns (dental amalgam) and non-legally binding guidance (abatement technologies for crematoria) as real Policy Options rather than as part of a dynamic baseline.
103. The report should present a clear, comprehensive and analytically coherent cost benefit analysis. It should systematically present the available data and estimates for each option and sub-option in a transparent and comparable manner. The environmental impacts should be monetised (to the extent possible) and the results should be brought into the cost benefit analysis. It should provide an overview of the costs and benefits, the net impacts and Benefit Cost Ratio of each option describing all quantitative and qualitative information. It should be clearer on what metrics are used in the analysis and, where metrics differ or where multiple metrics are used, provide information on their comparability.	·Section 7 includes further assessment and an overview of costs and benefits in a tabular format describing all available quantitative and qualitative information, and more specifically for PO3 and PO4 (p. 45-48). ·Sections 6.2.1, 6.2.2 and 7 present and describe in more detail the link between impacts of a dental amalgam phase-out and costs of crematoria emissions abatement. ·Metrics are presented in a more specific and clear manner and, where metrics differ or where multiple metrics are used, information is provided on their (non-) comparability. This is specifically addressed in Section 7 and Annex 3. ·Environmental impacts have been monetised as much as possible and these and been integrated into the cost-benefit analysis (see also response to point 6). ·However, for PO2, indirect emissions to soil and water bodies cannot be accurately nor robustly quantified. Benefits of reduced mercury releases to the environment can only be valued for emissions to air but no other environmental media. Therefore, monetised benefits are significantly underestimated. ·Furthermore, reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions. ·However, benefits of reductions in mercury exposure for dental practitioners and patients cannot be robustly quantified or monetised so health benefits are underestimated. ·Therefore there are limitations to the monetisation of several environmental impacts and as to how far the cost-benefits of the individual options can be compared, as these have been calculated using different methodologies. These uncertainties and limitations are now better described in Annex 3 and 5.
114. The report should be clearer on the likelihood that a ban on EU exports of MAPs will result in competing third-country producers filling the emerging gap (for lamps a substitution rate of 50 to 90% is assumed). It should include a more robust assessment informed by expert views and other available evidence regarding the risk that the substitute third country lamps will contain a higher amount of mercury and thus contribute to higher continued mercury pollution in third countries. The report should further elaborate the analysis on the impact of the stricter options on the EU manufacturers of dental amalgam and MAPs, including on their competitiveness, as well as the possible impact on job losses.	·Additional information included in Section 6.3.2 and Annex 7 on the substitution rate assumed as well as the mercury content in substituted products. ·Additional information on competitiveness and estimated job losses have been included in Section 6.3.2
5. With a view to assessing all relevant policy choices, the report should consider presenting an alternative option regarding the mandatory abatement of mercury emissions by including a variant with a capacity threshold set at 3000 (and above). This seems justified given the expected additional environmental benefits and the fact that the related. Benefit Cost Ratio Is close to the included variant with a threshold of 4000 (and above), in particular, if a dental amalgam phase-out in 2025 is assumed.	·A new Policy (sub) Option has been included in Sections 5.2 and 6.2.2, 7, 8 and Annex 3 and 7 (PO4c) whereby mandatory application of abatement technology would be set for crematoria with a capacity of ≤ 3000 cremations per year.
126. The report should further develop the impact analysis. The environmental and health impacts should be monetised to the extent possible. Where quantitative evidence is lacking, the report should provide the qualitative analysis emphasising uncertainties and limitations. It should assess in greater detail the impact on the EU manufacturers of amalgam and MAPs, in particular on SMEs, including on their international competitiveness. The report should be clearer on the risk of substitution of banned EU exports with third country products and should inform whether the remaining third country producers can be expected to follow similar sustainability standards as EU business. It should clarify the source of amalgam for residual special medical needs in case such exemption is foreseen when phasing-out of the EU production. It should also better explain the impact from the communication campaigns and how the voluntary character of the option on guidance for crematoria on BATs is reflected in the analysis.	·Further assessment provided additional information on environmental impacts for all options, specifically the fate of mercury from dental amalgam (p. 40-43). ·Where quantitative information was lacking, the Impact Assessment filled data gaps with qualitative information. Uncertainties and limitations are better described in Annex 5. ·Tables 12 and 13 on the comparison of options (Section 7) have been re-drafted to include as much quantitative data as possible and are accompanied by a narrative on the comparison of options within problem areas (p. 55-57). ·Whilst the Impact Assessment provides information on EU manufacturers including employment, export volumes and values as well as mercury content of exported MAPs, the assessment of the impacts on the competitiveness of EU manufacturers at global level remains uncertain due to unpredictable global market responses. ·Within the Impact Assessment, an SME test was performed in accordance with the Better Regulation Guidelines. The economic impacts on SMEs of the preferred Policy Options were deemed limited to non-significant. This conclusion results from several factors, which are described in more detail in Sections 6 and 7. ·The Impact Assessment clarifies the potential source of mercury to be used in dental amalgam for the application for specific medical conditions in Section 5.2 (p. 33). ·Sections 6.2.1 and 6.2.2 include a cost/benefit analysis for the Policy Option concerning guidance for crematoria on the use of Best Available Techniques (BAT) including assumptions made on the uptake of such a non-legally binding measure. It also provides a cost/benefit analysis of the option of mandatory abatement/BAT for crematoria divided into different thresholds depending on the size and capacity of crematoria and taking into account a dental amalgam phase-out.
137. The report should further develop an assessment of the effectiveness, efficiency and coherence of each option, as well as provide a detailed and clear comparison of the alternative options using the results of the cost benefit analysis.	·Tables 12 and 13 on the comparison of options (Section 7) were re-drafted to include quantitative data and where not available, qualitative information on effectiveness and efficiency of Policy Options per Problem Area. ·Section 7 also assesses the coherence of Policy Options between Problem Area 1 and 2 (qualitatively and quantitatively). ·Annex 7 includes a list of Policy Options discarded at different stages during the Impact Assessment as well as reasoned justification for doing so. ·Annex 3 includes a comparison for different policy sub options i.e., PO2a will lead to reductions in mercury emissions from crematoria of 54 kg (by 2030), whereas the discarded PO2b would lead to 31 kg (by 2030) and PO2c would lead to 3 kg (by 2030). Annex 3 also contains comparisons between sub-options for PO4, taking into account PO2.
148. The report should further substantiate the choice of the preferred options. It should clearly explain how the analysis feeds into the choice of the preferred options. In particular, the report should better justify why the non-legally binding guidance is preferred over the mandatory application of BAT, based on the comparison of their effectiveness, efficiency and coherence. It should also explain why the majority view of consulted experts was not followed. The report should explain if the effectiveness assessment of the different options for reducing emissions from crematoria reflect the legacy of mercury-containing dental amalgam in the population before phasing out and the related long-term latency effect. The report should also present the total costs and benefits and cost-effectiveness of the preferred option(s).	·The report has assessed in a more detailed and granular way various options related to the mandatory abatement of mercury emissions from crematoria, depending on the size and capacity of crematoria (Section 6.2.1 and 6.2.2), providing additional information as to the cost-benefits of these options (Table 12) and forming the basis for a more substantiated choice of the preferred option. ·In light of further analysis, Sections 6.2.1 and 6.2.2 on the Policy Options concerning mercury emissions from crematoria were amended and include a new sub-option assessing the impact of mandatory abatement technologies for crematoria (using capacity thresholds of > 4000 cremations per year). ·Section 7 clarifies the impact of a dental amalgam phase-out on mercury emissions from crematoria, taking into account the average longevity of a dental amalgam filling (legacy dental amalgam) (p. 34).
159. The report should systematically refer to the views of stakeholders, including diverging views, in particular with regard to the options, impact and comparison sections.	·The Impact Assessment describes in more detail the positions of relevant stakeholders (in Section 6), in particular concerning the preferred Policy Options as well as in Annex 2.

13.Evidence, sources and quality

To support the analysis of the different options, the European Commission awarded a support contract to external experts.

The consortium of consultants comprised:

·BioIS and AQC – Policy impact assessment and links to wider policies

·RPA – Stakeholder engagement

·Ineris – Risk expertise

·BioIS, AQC and GRS – Mercury policy and technical evaluation

Evidence was compiled from previous studies, as well as via specific desk studies and data collection performed as sub-assignments, feeding into the overall Impact Assessment work. Further information is given regarding the evidence bases compiled by the external consultants in the following Annexes:

·Annex 5 – Baselines

·Annex 7 – Impact of shortlisted measures

In addition, extensive consultation of stakeholders was carried out by the external experts, as detailed in:

·Annex 2 – Stakeholder consultation synopsis

The external expert consultants worked in close cooperation with the European Commission throughout the different phases of the study, and particularly in the latter stages of assembling a coherent evidence base and in assessing, screening and adjusting policy measures and options.

Annex 2: Stakeholder Consultation

Introduction

The Impact Assessment accompanying the Mercury Regulation Review was subject to a thorough consultation process. This included a variety of different consultation activities aimed at gathering the views of all relevant stakeholders and ensuring that the views of different organisations and stakeholder types were presented and considered.

This Annex describes the consultation activities that have taken place and presents a summary of views.

Part 1: Description of consultation activities

In order to collect primary data to support the Impact Assessment, a range of different consultation activities were organised to engage with stakeholders. Key stakeholders were consulted through a targeted questionnaire containing specialised questions in the three areas of interest (dental amalgam, mercury emissions from crematoria and mercury-added products), follow-up interviews, two consultation workshops and a focus group. All other relevant stakeholders were consulted through the public consultation questionnaire hosted on the “Have Your Say” portal.

Inception Impact Assessment

The Inception Impact Assessment

91 was published on the Commission’s “Have Your Say” interactive portal (38 responses; consultation period 5 March 2021 to 2 April 2021).

Public consultation

A public consultation 92 was published online via the Commissions’ “Have Your Say” interactive portal (146 valid responses; consultation period 8 February 2022 to 3 May 2022). The survey consisted of two sections: one section aimed at the general public, and the other aimed at those with technical expertise or professional experience within the three areas of interest. The questionnaire contained 66 questions, most of which directly concerned gathering stakeholder opinions on the use of mercury in dental amalgam, the impact of crematoria emissions, and perceptions about the export of mercury-added products. Questions for technical experts aimed at gathering insights into potential policy options. Stakeholders were invited to submit attachments to their response, such as policy briefs or position papers.

Targeted stakeholder survey

A targeted stakeholder survey consisted of an online survey of a more detailed nature (36 valid responses; 15 December 2021 to 15 Aril 2022). The questionnaire was developed in discussion and agreement with the European Commission including the ISSG. The structure and design of the TSS was similar to the public consultation and included a general section, followed by sections for each of the three areas of interest. These latter three sections were more technically detailed than the questions in the public consultation. The TSS was provided by invitation only, to stakeholders with a known stake in the Mercury Regulation. The questionnaire script included a number of multiple-choice questions. Stakeholders were invited to submit policy briefs, position papers, and other articles of interest as part of their response.

In-depth interviews

Interviews (undertaken via telephone or video-conferencing software) were undertaken (13 key stakeholders) and provided in-depth insight into data gaps in all three areas of interest. Stakeholders invited to an interview were selected from responses to the targeted survey, as well as other stakeholders with specific relevant knowledge. Data obtained from interviews was used to validate and clarify concepts and issues identified elsewhere in the consultation.

Because many interviewees had expert roles within highly specialised sectors, a semi-structured interview approach was applied. This approach enabled flexibility in discussing topics relevant to each stakeholder type, whilst also ensuring the structure of the interview was maintained and the desired data collected. Interviews took place between March and July 2022.

Workshops

Two (online) workshops were organised and conducted (December 2021, September 2022) with selected stakeholders to discuss the overall conclusions drawn from the study. The aim of these workshops was to validate the findings of the study, discuss and refine possible policy options available, and discuss the potential impacts of the policy options. Each workshop targeted about 40 participants.

Stakeholders invited to participate in the workshops were carefully selected to ensure that the different sectors within all three areas of interest were adequately represented.

Focus groups

After the completion of the public consultation and targeted stakeholder survey, a focus group was organised, on mercury-added products. This focus group consisted of nine experts. The purpose of the focus group was to provide an expert opinion on the development of the policy options and took place on 14 June 2022.

Stakeholder groups participating in consultations

This section outlines the type of respondents that participated in the survey. As shown below 49% (72/146) were EU Citizens, 19% (28/146) were companies, 14% (21/146) were NGOs. All other stakeholder types provided less than 10% of all responses. In total 87% (127/146) of responses were from an EU Member State, and 13% (19/146) from non-EU countries. Significantly more responses were received from Germany than any other country (34%, 49/146), with Romania being the second highest (19%, 28/146). The six public authority responses were from: the Swedish Chemicals Agency; the City of Gothenburg Environmental Administration; the Estonian Ministry of the Environment; an undeclared French authority; an Italian Joint Research Centre member, and the Norwegian Environment Agency. Tables 1 and 2 below describe the types of stakeholder groups participating in the consultations whilst Table 3 indicated responses per country of origin.

Table 1: Respondent stakeholder types (OPC)

Stakeholder types	Stakeholder types (percentage of total (count/total))
Academic/research institution	1% (2)
Business association	3% (5)
Company/business organisation	19% (28)
Consumer organisation	1% (2)
Environmental organisation	1% (1)
EU citizen	49% (72)
Non-EU citizen	5% (8)
Non-governmental organisation (NGO)	14% (21)
Other	1% (1)
Public authority	4% (6)
Total	100% (146)

Totals may not equal 100% due to rounding

Table 2: Respondent stakeholder types (TSS)

Stakeholder types	Stakeholder types (percentage of total (count/total))
Business association	39% (14/36)
Company/business organisation	14% (5/36)
EU Citizen	3% (1/36)
Public authority	28% (10/36)
Consumer organisation	3% (1/36)
Non-governmental organisation (NGO)	11% (4/36)
Trade union	3% (1/36)
Total	100% (36/36)

Totals may not equal 100% due to rounding

Table 3: Responses by country of origin

Country	Stakeholder types (percentage of total (count/total))	Country	Stakeholder types (percentage of total (count/total))
Austria	1% (2)	Malaysia	1% (1)
Belgium	5% (8)	Malta	1% (1)
Bulgaria	1% (1)	Netherlands	1% (1)
Cameroon	1% (1)	New Zealand	1% (1)
Czechia	1% (1)	Norway	1% (2)
Denmark	1% (2)	Poland	2% (3)
Estonia	1% (1)	Portugal	2% (3)
France	3% (4)	Romania	19% (28)
Germany	34% (49)	Slovakia	1% (2)
Greece	1% (1)	Spain	1% (1)
Hungary	1% (1)	Sweden	3% (5)
Iran	1% (1)	Ukraine	1% (1)
Ireland	1% (2)	United Kingdom	7% (10)
Italy	8% (11)	United States	1% (2)
Total			100% (146)

Figures 1 to 4 below illustrate the overall numbers of respondents with technical expertise or experience for the OPC, as well a breakdown of the proportion of the types of stakeholders for each of the three topics i.e., dental amalgam, crematoria and mercury-added products.

Figure 1: Number of respondents with technical expertise or experience (OPC)

Figure 2: Sub-sectors of operation: Dental Amalgam

Figure 3: Sub-sectors of operation: Crematoria

Figure 4: Sub-sectors of operation: Mercury-added Products

Figures 5 to 8 below illustrate the overall numbers of respondents with technical expertise or experience for the TSS, as well a breakdown of the proportion of the types of stakeholders for each of the three topics i.e., dental amalgam, crematoria and mercury-added products.

Figure 5: Number of respondents with technical expertise or experience (TSS)

Figure 6: Sub-sectors of operation: Dental Amalgam

Figure 7: Sub-sectors of operation: Crematoria

Figure 8: Sub-sectors of operation: Mercury-added Products

Part 2: Summary of stakeholder views on the problems and options

This section summarises the view of different types of stakeholders with regard to the two problem areas as well as view on possible policy options.

2.1. Summary of OPC results

Dental amalgam: A total of 95% (129/136) of the general public would choose a mercury free material, of which 88% (114/129) stated this was because of the associated lower potential health risk, and 60% (78/129) stated this was to reduce environmental impact. Another 74% (102/137) stated they would pay more for non-mercury materials to be used, 44% (44/100) suggested they would pay more than 50% increase in price. Finally, 91% (125/137) believed amalgam be banned for use in dental fillings (except for a limited number of cases where other materials cannot be applied due to specific health conditions of the patient).

Crematoria: A total of 61% (80/131) stated they were aware that mercury is emitted through crematoria emissions, 77% (101/131) were concerned about these emissions, and 86% (115/113) believed there should be an EU wide policy limit to these emissions. Of experts, 71% (5/7) believed emission limits should apply to all crematoria facilities. In addition, 88% (7/8) of experts believed state-of-the-art emission control technologies should be made obligatory across the EU.

MAPs: A total of 56% (9/16) of experts believed there is no future for EU exports of MAPs, whereas 31% (5/16) believed there may be a future for a narrow range of specialist products. Of experts, 56% (9/16) believed demand for MAPs (that are banned in the EU but still being exported) will further decrease in importing countries; only 19% (3/16) believed it will increase. Finally, 47% (7/15) of experts believed an EU export ban would be effective in reducing the sale of MAPs in importing countries, whereas 33% (5/15) believed the exports need to be accompanied by global trade restrictions.

Position papers: In total 21 respondents uploaded a total of 33 additional documents, two were removed due to being corrupt & irrelevant, leaving a total of 31 valid documents (submitted by 19 respondents) suitable for analysis: 20 regarding dental amalgam, one regarding the environmental effects of mercury emissions, two regarding MAPs, and eight papers on general issues unspecific to the three interest areas. Of the 19 respondents, five were from Belgium, seven from Germany, one from Greece, three from Sweden, one from Cameroon, and two from the United Kingdom. Not all documents were position papers, however information from non-position papers has been used elsewhere in the study.

2.2. Summary of TSS results

Dental amalgam: A total of 75% (3/4) of experts estimated the average decayed missing and filled teeth (DMFT) score for those under 18 years of age to be 0-1.1, 75% (3/4) believed those between 18-60 years of age to have a score of greater than 6.5, and 100% (3/3) believed those over 60 years of age to have a score greater than 6.5. Experts showed no consensus as to whether filling therapy would change in cost if alternatives to dental amalgam were used, although 67% (2/3) believed there would be an increase in cost. In total 60% (3/5) of experts believed that less than 5% of all ages would require exemptions from the phase-out, 20% (1/5) believed it would be 11%-25% of the population, and 20% (1/5) believed it would be 5-10%. A total of 75% (6/8) of experts did not believe alternatives to amalgam are impractical to implement, and 88% (7/8) stated their patients ask for alternatives, and generally oppose the continued use of amalgam.

Crematoria: A total of 75% (12/16) of experts believed it is important to restrict mercury emissions from crematoria, and 53% (9/17) stated that these emissions are already regulated in their Member State (41% (7/17) stated regulations were not in place in their country). Again, 75% (12/16) believed EU legislation is the right method to control mercury emissions. A total of 75% (12/16) believed crematoria should be treated similarly to other point emission sources in Europe (31% (5/16) suggesting through application of minimum emission limit values, and 44% (7/16) stating through applied Best Available Techniques to reduce emission levels). Furthermore, 65% (11/17) believed emission limits should apply to facilities of all sizes (35% (6/17) were in favour of lower limits for crematoria with lower numbers of annual cremations. A total of 88% of all experts (15/17) believed cremations are increasing in their Member State, and 82% (14/17) believed emission abatement technologies will be more common in the future.

MAPs: Experts provided little to no data regarding TSS questions on MAPs.

Position papers

In total, 13 respondents provided 22 additional documents. Of these, only eight were classified as position papers (submitted by six respondents). The remaining 14 documents provided additional sources of information could not be classified as position papers. Therefore, a total of eight valid position papers have been included in the analysis. In total, one paper covered MAPs, and the remaining seven papers (submitted by five respondents) covered dental amalgam. In total, 67% (4/6) of those who submitted a position paper were business associations (the remainder were NGOs). A total of 33% (2/6) of respondents that submitted a paper were from Belgium, 33% (2/6) were from Germany, and 17% (1/6) were from Ireland, and the United Kingdom.

Annex 3: Who is affected and how?

Introduction

This Annex sets out the practical implications of the preferred policy package for the various types of stakeholders concerned. It describes the actions that the enterprises or public authority might need to take in order to comply with the obligations under the revised legislation and indicated the likely costs to be incurred in meeting those obligations, or where quantitative information is not available the nature and magnitude of such costs. It also presents the implications for the public.

14.1. Practical implications of the initiative

Dentists

For dentists, the economic impact of a phase-out can be positive or negative depending on their skills in handling various filling materials. In the beginning, it may be negative but may become positive because of increased revenues (the handling and application of alternatives usually is more expensive). A phase-out of dental amalgam is also expected to affect costs that are borne by dentists for the collection and treatment of waste from amalgam separators. This cost will vary across Member States and within countries. However, these costs won’t disappear until the last amalgam filling has been removed. Maintenance cycles of separators do not depend on the amount of waste collected and would remain constant as well.

Dental amalgam manufacturers

The phase-out of amalgam use will impact on dental fillings manufacturers with a high share of dental amalgam in their overall production. On the other hand, companies with a high share of mercury-free materials in their production will gain an even more significant competitive advantage. The supporting study to the impact assessment identified only four main EU companies producing encapsuled dental amalgam, therefore overall, the economic impact on the dental industry is expected to remain limited.

Crematoria operators

For crematoria, the preferred policy package could include the development of guidance for controlling mercury emissions (PO3), or the mandatory abatement of mercury emissions abatement at all crematoria (PO4a), or at large crematoria (PO4b; defined as those operating at annual capacity of 4,000 cremations per year and higher). Where crematoria are required (under PO4a and PO4b) or choose (under PO3) to install abatement equipment for reducing mercury emissions then the operators will incur additional capital and operational costs although these would be expected to be passed on to the consumer in higher prices. Measures mandating emissions abatement systems at crematoria would present additional administrative costs to crematoria operators, arising from the need to submit information on their abatement systems and any periodic emissions monitoring and reporting to Member State competent authorities. Measure PO3 would present an additional, albeit limited, administrative burden on European institutions in the development of guidance for the cremation sector, although this is not anticipated to be significant.

Mercury abatement technology manufacturers

Where crematoria operators are required to install abatement equipment for reducing mercury emissions (PO4a and PO4b), or choose to do so (PO3), then there would be benefits for manufacturers of such equipment as demand would increase.

Businesses that are currently engaged in manufacturing and/or exporting mercury-added products that are no longer allowed to be placed on the EU market

By the date specified for each product group, businesses would have to stop manufacturing and export of MAPs. In case of an export ban in 2026 (halophosphate FLs)/ 2028 (all other relevant MAPs), an export value in the order of €97 - €190 million would be lost. This is connected to several hundred jobs at two manufacturing sites in Poland and Germany.

Depending on the time gap between an EU export ban and the entering into force of a global manufacture and trade ban, a considerable part of this loss will likely be compensated by increased manufacture and sale of LED products and by the general increase of the global lighting market. Export losses for other MAPs than lamps could not be quantified but are considered low.

Products that have been legally imported into the EU for the purpose of distribution to non-EU countries would have to be shipped to distribution centres outside the EU before the specified phase-out date to be available for future trade with non-EU countries. With a sufficient time between adoption of the instruments and entering into force such secondary shipments could be largely avoided by directly shipping products made outside the EU to distribution centres in third countries.

Competent authorities

The preferred policy package is not expected to have any significant impacts on public authorities. The phase-out of dental amalgam would apply uniformly across the EU. Member States may choose to undertake some level of surveillance to ensure that the phase-out is being implemented across their territory but this would not be mandated by the preferred policy package. Overall, a phase-out should have a positive economic impact on municipalities (and taxpayers), as it will reduce the environmental costs associated with managing mercury pollution from dental amalgam.

For crematoria, PO4a and PO4b mandating application of abatement emissions systems would result in additional administrative burden on Member State competent authorities arising from the need to process information submitted by crematoria operators on their abatement systems and any periodic emissions reporting. The development of guidance to the sector (PO3) would present no such burden.

Concerning MAPs, the policy package does not have an impact on public authorities.

The public

The phase-out of dental amalgam use would have two main impacts on the general public:

1.It has implications on the dental health treatment options available in that amalgam would no longer be available (except for certain medical exemptions). This may have cost implications in that, at least in the short term, there is an additional cost for consumers of amalgam alternatives.

2.Human health and environmental benefits from the phase-out of the use of dental amalgam. This includes a reduction in associated emissions from crematoria.

Where crematoria are required to install abatement equipment for reducing mercury emissions (PO4a and PO4b), or choose to do so (PO3), then the overall costs to consumers of cremations may rise slightly. However, there would also be human health and environmental benefits from a reduction in emissions and exposure.

Concerning MAPs, the policy package does not have an impact on the European public.

Other

There is an impact for the public in importing non-EU countries. Banning the export of EU products will lead to decreased supply of MAPs to national markets which may cause higher product prices in the short-term. Also, substituting imports from third countries are expected to have higher mercury contents per unit, so that the total net mercury content of imported products may increase in the short-term. Such a potentially negative effect is likely to be compensated due to a globally observed decreasing demand for MAPs, notably lamps and would be eliminated once a global ban under the Minamata Convention enters into force.

15.2. Summary of costs and benefits

15.1.Policy Option 2a – Dental amalgam phase-out in 2025

I. Overview of Benefits (total for all provisions) – PO2a
Description	Amount	Comments
Direct benefits
Establish a 2025 legally binding end-date for the use of dental amalgam in the EU	Estimated cumulative reductions in direct mercury releases by 2030 of 3.1 t to air, 3.4 t to soil, 0.6 t to waterbodies, 2.6 t to wastewater, and 42.1 t sequestered or recycled.	Indirect emissions to soil and water bodies not feasible to quantify. Benefits of reduced mercury releases to the environment can only be valued for emissions to air but no other environmental media. Therefore, monetised benefits are significantly underestimated.
Reduced mercury exposure to dental practitioners and patients	In the absence of PO2a, the expected amount of mercury put into teeth will be about 9.3 t in 2025.	Significant reductions in mercury vapour exposure for dental practitioners.
Reduction in hazardous waste generation	In the absence of PO2a, the expected amount of mercury wasted and collected in amalgam separators will be about 11 t in 2025.	Significant reductions in hazardous waste generation.
Indirect benefits
Compliance cost reductions	Reduced costs associated with dental amalgam waste (collected by authorised waste management establishments or undertakings) borne by dentists.	Not possible to robustly quantify. These benefits would be realised once all legacy amalgam restorations have been disposed of. The majority of amalgam in the population would be replaced / disposed of within around 15 years.
Reduced mercury emissions from crematoria	PO2a will lead to reductions in mercury emissions from crematoria of 54 kg (by 2030) Note: Discarded PO2b would lead to 31 kg (by 2030) and PO2c would lead to 3 kg (by 2030).
Public health & safety and health systems	For PO2a, human health benefits valued at €900,000 as a result of reduced mercury emissions from crematoria in 2030.	Reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions. Benefits of reductions in mercury exposure for dental practitioners and patients cannot be robustly quantified or monetised so health benefits are underestimated.

II. Overview of costs – PO2a
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
Compliance costs	Direct costs	0	The recurrent costs will depend on the reimbursement of dental treatment by state social security and private medical insurance.	Not possible to accurately quantify the cost impacts resulting from pressure on manufacturers of amalgam fillings and dentists using amalgam products.		0	0
	Indirect costs	Increased costs of dental treatment estimated at €208 million in the first year of phase-out (in 2025).	0	0	Short-term and/or limited increase in dentist fees, most likely to be passed on to state or private health insurance.	0	Not possible to accurately quantify the cost impacts resulting from increased pressure on the state health insurance systems across the EU.
Admin costs	Direct costs	0	0	0	0	0	0
	Indirect costs	0	0	0	0	0	0

15.2.Policy Option 3 – EU guidance on emissions abatement in crematoria

The following tables provide a summary of the costs and benefits of Policy Option 3.

I. Overview of Benefits (total for all provisions) – PO3
Description	Amount	Comments
Direct benefits
EU guidance on emissions abatement in crematoria	N/A	A consequence of PO3 is a possible reduction in mercury emissions to air. This has indirect benefits in terms of environmental quality and human health.
Indirect benefits
Quality of natural resources	Mercury emissions reductions of 17kg (6-29kg). Mercury emissions reductions of 14kg (3-27kg) when combined with a 2025 phase-out (PO2a)	Any reduction in mercury emissions will result in reduced deposition of atmospheric mercury to soil and waterbodies. It is not possible to robustly quantify the reduced deposition or to put an economic value on it.
Public health & safety and health systems	Human health benefits valued at €300,000 (€100,000-€600,000) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans. Human health benefits valued at €300,000 (€100,000-€500,000) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans, when combined with a 2025 phase-out (PO2a).	Reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions.

II. Overview of costs – PO3
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
Compliance costs	Direct costs	0	0	€10.3 million	€320,000 per year	0	0
	Indirect costs	Costs to operators are passed on to consumers. Not quantified.	0	0	0	0	0
Admin costs	Direct costs	0	0	0	0	Limited cost to institutions to develop guidance	0
	Indirect costs	0	0	0	0	0	0

15.3.Policy Option 4a – Mandatory abatement of mercury emissions at all crematoria

The following tables provide a summary of costs and benefits of Policy Option 4a.

I. Overview of Benefits (total for all provisions) – PO4a
Description	Amount	Comments
Direct benefits
Mandatory abatement of mercury emissions at all crematoria	N/A	A consequence of PO4a is a reduction in mercury emissions to air. This has indirect benefits in terms of environmental quality and human health.
Indirect benefits
Quality of natural resources	Mercury emissions reductions of 314kg (105-542kg). Mercury emissions reductions of 269kg (50-496kg) when combined with a 2025 phase-out (PO2a)	Any reduction in mercury emissions will result in reduced deposition of atmospheric mercury to soil and waterbodies. It is not possible to robustly quantify the reduced deposition or to put an economic value on it.
Public health & safety and health systems	Human health benefits valued at €6.1 million (€2.2 million-€10.4 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans. Human health benefits valued at €5.4 million (€1.3 million-€9.6 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans, when combined with a 2025 phase-out (PO2a).	Reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions.

II. Overview of costs – PO4a
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
Compliance costs	Direct costs	0	0	€182 million	€5.7 million per year	0	0
	Indirect costs	Costs to operators are passed on to consumers. Not quantified.	0	0	0	0	0
Admin costs	Direct costs	0	0	0	€400,000	0	€500,000
	Indirect costs	0	0	0	0	0	0

15.4.Policy Option 4b – Mandatory abatement of mercury emissions at large crematoria (operating at an annual capacity of ≥4,000 cremations per year)

The following tables provide a summary of costs and benefits for Policy Option 4b.

I. Overview of Benefits (total for all provisions) – PO4b
Description	Amount	Comments
Direct benefits
Mandatory abatement of mercury emissions at large crematoria (operating at an annual capacity of ≥4,000 cremations per year)	N/A	A consequence of PO4b is a reduction in mercury emissions to air. This has indirect benefits in terms of environmental quality and human health.
Indirect benefits
Quality of natural resources	Mercury emissions reductions of 141kg (70-210kg). Mercury emissions reductions of 113kg (33-182kg) when combined with a 2025 phase-out (PO2a)	Any reduction in mercury emissions will result in reduced deposition of atmospheric mercury to soil and waterbodies. It is not possible to robustly quantify the reduced deposition or to put an economic value on it.
Public health & safety and health systems	Human health benefits valued at €2.7 million (€1.3 million-€3.9 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans. Human health benefits valued at €2.2 million (€0.7 million-€3.5 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans, when combined with a 2025 phase-out (PO2a).	Reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions.

II. Overview of costs – PO4b
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
Compliance costs	Direct costs	0	0	€14.9 million	€460,000 per year	0	0
	Indirect costs	Costs to operators are passed on to consumers. Not quantified.	0	0	0	0	0
Admin costs	Direct costs	0	0	0	€23,000	0	€28,000
	Indirect costs	0	0	0	0	0	0

15.5.Policy Option 4c – Mandatory abatement of mercury emissions at large crematoria (operating at an annual capacity of ≥3,000 cremations per year)

The following tables provide a summary of costs and benefits for Policy Option 4c.

I. Overview of Benefits (total for all provisions) – PO4c
Description	Amount	Comments
Direct benefits
Mandatory abatement of mercury emissions at large crematoria (operating at an annual capacity of ≥3,000 cremations per year)	N/A	A consequence of PO4c is a reduction in mercury emissions to air. This has indirect benefits in terms of environmental quality and human health.
Indirect benefits
Quality of natural resources	Mercury emissions reductions of 191kg (82-302kg). Mercury emissions reductions of 156kg (39-268kg) when combined with a 2025 phase-out (PO2a)	Any reduction in mercury emissions will result in reduced deposition of atmospheric mercury to soil and waterbodies. It is not possible to robustly quantify the reduced deposition or to put an economic value on it.
Public health & safety and health systems	Human health benefits valued at €3.6 million (€1.6 million-€5.7 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans. Human health benefits valued at €3.0 million (€0.9 million-€5.1 million) as a result of reductions in emissions of mercury, PM2.5, lead, cadmium, arsenic, chromium, nickel and dioxins and furans, when combined with a 2025 phase-out (PO2a).	Reductions in mercury emissions to air will result in reduced human exposure to atmospheric mercury. This will deliver human health benefits. These have been valued by applying EEA damage costs to predicted mercury emission reductions.

II. Overview of costs – PO4c
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
Compliance costs	Direct costs	0	0	€24.9 million	€780,000 per year	0	0
	Indirect costs	Costs to operators are passed on to consumers. Not quantified.	0	0	0	0	0
Admin costs	Direct costs	0	0	0	€42,000	0	€53,000
	Indirect costs	0	0	0	0	0	0

15.6.Policy Options 6a and 6b – EU ban on the manufacture and export of dental amalgam by 2025 and MAPs by 2026/2028

The following tables provide a summary of costs and benefits for Problem 3 for the options included in the preferred policy package.

I. Overview of Benefits (total for all provisions) – PO6a and PO6b
Description	Amount	Comments
Direct benefits
EU ban on the manufacture and export of dental amalgam by 2025 (PO6a) and MAPs by 2026/2028 (PO6b)	PO6a will lead to a decrease of demand for mercury for dental amalgam in the order of 30 to 180 t between 2025 and 2030 PO6b will lead to decreased demand for mercury for MAP production of 0.8 to 1.5 t between 2026 and 2030	A direct consequence of decreased demand for MAP production is a significant decrease of mercury in exported products.
Indirect benefits
Quality of natural resources	PO6a will lead to a reduction of mercury in exported dental amalgam in the order of 30 to 180 t between 2025 and 2030. PO6b will lead to a reduction of mercury in exported MAPs of 0.8 to 1.5 t and consequently a reduction of mercury into general waste streams of 0.7 to 1.3 t. In importing third countries, the net reduction may be smaller or even negative (increase of total mercury content) due to possible substitution by MAP imports from non-EU countries: -0.3 to +1.1 t (PO6b).	In importing third countries: PO6a would lead to positive net impact depending on the level of substituting imports from non-EU countries PO6b would lead to a positive net impact if an EU ban is closely followed by a global ban.
Public health & safety and health systems	Lower risk of exposure to mercury due to contact with waste or contaminated land, if non-EU MAP substitution is minimal.	Reduced input into the general waste stream will lessen the risk of exposure to mercury for the population living close to waste disposal sites or directly involved in waste management (in importing third countries).
Conduct of business	PO6a will lead to a higher demand for mercury-free filling materials PO6b will lead to a significant increase in sales of LED lamps, luminaires and lighting systems (but lower increase than in policy option PO5)	Dental amalgam no longer provided by EU manufacturers may partially be substituted by products (incl. amalgam) from non-EU manufacturers Possible risk of short-term negative impact due to non-EU substituting MAP imports, limiting demand for mercury-free alternatives.

II. Overview of costs –PO6a and PO6b
		Citizens/Consumers		Businesses		Administrations
		One-off	Recurrent	One-off	Recurrent	One-off	Recurrent
PO6a Export ban 2025 (Dental amalgam)	Direct costs	0	0	Loss of revenues: €50 to €300 million (retail value, revenue considerably smaller) (2025 – 2030)	0	0	0
	Indirect costs	0	Dental amalgam: possible short-term increased costs for dental restorations in third countries due to decreased supply.	0	0	0	0
PO6b Export ban 2026/ 2028 (MAPs)	Direct costs	0	0	Loss of revenues: €97 to €190 million (2026-2030)	0	0	0
	Indirect costs	0	Dental amalgam: possible short-term increased costs for dental restorations in third countries due to decreased supply.	0	0	0	0

Annex 4: Analytical methods

Introduction

Due to the two distinct issues covered, the Impact Assessment is not based on a single methodology, but rather on a variety of qualitative and quantitative approaches that have been synthesised. Most Policy Options will likely induce various magnitudes of effects on operators, associated manufacturers, Member States’ Authorities, National Health Care Systems and the general public, which is very difficult to quantify at high accuracy levels at an overall EU level. The assumptions and methods used for the assessment of these impacts are described in the respective sections in Annex 7.

The following summary provides information on the analytical methods used.

1.Overview of tasks and methods

The methods employed were developed according to the European Commission’s Better Regulation Guidelines and Toolbox, adapted based on the time available to complete the Impact Assessment support work and the report team’s wealth of practical experience in delivering Impact Assessments.

The Impact Assessment support work was structured around seven tasks, represented in Figure 1.

Figure 1: Overview of the tasks of the Impact Assessment support work

Each task was based on and/or followed the EC’s Better Regulation Guidelines and Toolbox.

These tasks are described below:

·Task 1: Define and clarify the problem to be addressed

This tasked aimed at setting the scene by developing an overall problem definition as well as specific definitions for each of the three focus areas of this study (dental amalgam, mercury emissions from crematoria and mercury-added products).

·Task 2: Construct the baseline scenario against which impacts of options will be assessed

The study considered how the status quo would likely evolve and based on that developed baseline scenarios, which form the basis for comparing the impacts of different policy options (developed, assessed and compared under tasks 3, 4 and 5).

·Task 3: Develop policy options

Whilst the baseline was being defined, the study team engaged with the European Commission and stakeholders to develop a longlist of policy options that could address the problems identified, taking into account the problem drivers. As not all policy measures or actions were viable, the external expert team defined the screening criteria to shortlist the most relevant options.

·Task 4: Assessment of impacts of identified options

A longlist of possible impacts was developed and screened. From these, impact categories were identified as likely to be significant for a more in-depth assessment. Across these impact categories, different types of costs and benefits were considered.

·Task 5: Comparison of the options and concluding results

The evidence on impacts, costs and benefits was employed to compare policy measures and options and develop conclusions as to whether a given option would contribute to achieving set objectives and generate benefits that would likely outweigh costs.

·Task 6: Stakeholder consultations (public and targeted)

Stakeholder engagement was a horizontal task and key to this support study, feeding into all of the aforementioned tasks. The consultation activities and data analysis carried out in this study included an open consultation, a targeted survey, workshops, focus groups and interviews.

·Task 7: Additional targeted assessment

This task aimed at allowing the external expert team to provide ad-hoc additional targeted assessments addressing the feedback received from the Regulatory Scrutiny Board. This task addressed the need for additional information, complementing the information on dental amalgam and mercury emissions from crematoria, to enable a more detailed assessment of the types and magnitude of the impacts with respect to a phase-out of the use of dental amalgam (in terms of costs borne by stakeholders) and mercury emissions from crematoria (in terms of geographical distribution).

Multiple methods were employed across these tasks, which are presented in Table 1.

Table 1: Overview of the approach for the synthesis of evidence

Element	Approach
Desk research	•Clearly set out what sources were used giving an indication of the reliability of the data sources and possible bias (for example, date of the report, geographical coverage, which stakeholder group commissioned/produced it, whether it was peer reviewed or not.) •Indicate what specific data gaps were there (e.g., lack of studies at the national level, or a lack of recent studies etc.) and the approach taken to fill them.
Field research (survey, interviews and public consultation submissions)	•Indicate which stakeholders were asked about each topic and what research tools were used (interviews/surveys). •Report on the responses provided where relevant or cross-reference to the stakeholder consultation report. •Indicate which groups the responses came from and how representative the responses were (for surveys). •Reflect as to whether the input refers to facts, estimates or opinions and their relevance for the specific questions. •Indicate limitations such as low number of responses, low quality of responses, or views of some stakeholder groups not being well-represented.
Case studies	•Use a similar approach as for desk research presenting the relevant findings to the illustrate impacts in a specific context (e.g., country, product, issue) •Identify the limitations (in terms of scope, ability to extract more general conclusions).
Technical Workshops / Focus groups	•Indicate which types of stakeholders participated •Report on the responses provided by stakeholder type •Indicate which groups the responses came from and how representative the responses were. •Reflect the level of agreement among different categories of stakeholders
Overall conclusions for impact assessment
Synthesis of evidence	•Set out clear conclusions for the specific impacts drawing together the evidence presented from the different assessment methods •Compare to what was anticipated in the baseline Reflect and comment on the balance and strength of evidence and conclusions (triangulation or cross-checking of conclusions from alternative sources)
Comment on level of certainty and robustness of conclusions	•Summarise the level of certainty of the conclusions based on the robustness of available evidence and taking into account the nature of the sources used. •Be clear on where conclusions are stemming from the stakeholder input and where they are stemming from the literature review. For example, conclusions based predominantly on the online stakeholder consultation that were not possible to triangulate (or at least cross-check) with other sources will need to be considered as less robust than those based on analysis of data collected from validated datasets or peer reviewed studies.

The analysis of problems followed the major steps advised in BR Guidelines Tool #14. For the Intervention logic, links between problem drivers and policy options were established.

The development of the baseline and analysis of options, including the development of baseline, was based on the principles set out in BR Guidelines Tool # 17. In particular, an initial set of (sub)policy options were screened by using a set of criteria for determining which options to include or not as advised in BR Guidelines Tool # 17.

A description and, where possible, quantification of the economic, social and environmental impacts of the short-listed options was performed, following BR Guidelines Tool # 19. The main direct impacts were quantified and monetised (for both the baseline and the policy options under consideration). Furthermore, indirect impacts were quantified, where possible, and if not then they were assessed qualitatively with a clear indication of their nature and likely magnitude. Costs and benefits identified according to the standard typology of costs (e.g., administrative, enforcement) and benefits (BR Guidelines Tool #58 and #59). The assessment was undertaken in line with the Better Regulation Guidelines and, in particular, Chapter 8 of the Toolbox (“Methods, models and costs and benefits”).

Stakeholder consultation followed the advice outlined in BR Guidelines Tools # 53 – # 56. In line with BR Guidelines Tool #54, questionnaire surveys were used to allow the stakeholders and the public to voice their opinions on the review of the Mercury Regulation. To avoid limitations of a questionnaire survey in terms of the focus on pre-defined answer options, open questions and follow-up interviews were designed. Descriptive statistics and MS Excel were used for the analysis of quantitative data. Visual aids were used for the presentation of quantitative data. For interpreting qualitative data thematic analysis was applied and supported by NVivo content analysis software.

16.2. Data resources and analytical support

Evidence utilised has been collected from literature (studies, reports, articles) to support the analyses in most of the tasks, especially in Tasks 1-5.

·Review of the core sources for this report, such as the recent Commission Review Report 93 , the Assessment of the feasibility to phase-out dental amalgam 94 as well as the Commission’s Inception Impact Assessment and associated feedback.

·Carry out evidence mapping exercise to identify key needs and/or data gaps.

·Undertake a literature review through systematic web searches, coverage of a wide range of stakeholders’ sources and considering a diverse set of document types.

·Screening of literature to determine the types of information contained and the extent that the data is reliable and sound.

The output of this process is the evidence base that underpins the impact assessment.

17.3. Consultations and field research

a. Open public consultation (OPC)

The online OPC offered the opportunity for interested individuals from any type of stakeholder groups to give their opinion on the review of the Mercury Regulation. The OPC was launched on the Commission’s website 95 .

b. Targeted stakeholder engagement: online survey

To gather more in-depth information from those stakeholders already possessing a good understanding of mercury and the associated problem areas addressed, a combination of targeted stakeholder consultation methods was used. A targeted online survey was utilised to gather the views of key groups of stakeholders, including Member States’ authorities, industry sector (individual companies or trade associations) or other types of organisations (e.g., environmental or civil society NGOs, research bodies, etc).

c. Interviews

Targeted telephone interviews to complement the online survey took place with representatives of regional and national competent authorities, industry associations, civil society, and other key stakeholders.

d. Focus group

A focus group discussion was held on mercury-added products to complement the online survey and interviews. Representatives of industry associations and the NGO community took part in the discussion. Attendance at the focus group was by invitation only.

e. Stakeholder workshops

Two workshops were held online.

18.4. Robustness of the Evidence

a. Consultations

The level of credibility varies with regard to each source of information that has been used for the assessment. In principle, sources of information that are based on measured or reported information are believed to be quite certain. However, even in these cases the robustness depends on the correct measuring and/or reporting of the parameter concerned. It is assumed that even if there are errors, these are not systematic.

In other cases, literature may draw itself on a lot of stakeholders opinion, or be based on a small sample or have other features that weaken its robustness.

Literature which originates from stakeholders with a particular vested interest are treated with greater caution. Such literature may selectively present information or present it in a certain manner to support an argument that the interested party may wish to pursue.

Stakeholder opinion presents similar risks to stakeholder-sourced literature. In their opinions, stakeholders may be seeking to manipulate the results to support their preferred outcome.

In the case of this assessment, one dentist association holds opposite views to researchers and NGOs, specifically on problem 1a (phase-out of the use of dental amalgam). In general, it opposes a short-term phase-out of the use of dental amalgam, pointing to the potential for problems in access to dental health care. Conversely, researchers and NGOs would like to see a complete phase-out of the use of dental amalgam in 2025.

b. Analytical methods

Dental amalgam

Uncertainties of the estimate

The quantification estimate bears some uncertainties, which are discussed below:

The use of the DMFT index to quantify the amount of caries in the European Union’s population: Indeed, this index is the Decayed, Missing, and filled Teeth index, meaning that not only filled teeth and teeth to treat are considered but also the missing teeth. This index is well correlated with the amount of treated caries for the population up until 40 to 50 years, when teeth removal starts to increase and outweigh cavity treatment. So, the model is expected to overestimate the total use of mercury per year.

Inconsistencies in historical data: The historical datasets used for extrapolation of the estimates are poorly collected. Most importantly, the time of recording age and the DMFT index is inconsistent. This reduces the power of forecasting. Moreover, we have extant data on DMFT per median age for every member state. Using the same to estimate a distribution across age intervals can lead to overestimation and/or high variance.

The model does not consider the replacement of failing filling material: Materials used for teeth filling when treating cavities does is not everlasting, so it needs sometimes to be replaced. The replacement was not considered due to too much uncertainty on the failure rate of the different materials as well as on the share of dental amalgam used to replace the failed materials. So, a small underestimation of the quantity of mercury used per year is expected.

The share of the dental amalgam used in tooth filling: These estimates for all Member States come from the 2012 BioIS report, and no better values could be found. Unfortunately, it cannot be said what type of deviation can be expected from this source of uncertainty.

The assumption under which the improvement of dental health in the EU follows the same trend in all Member States: Indeed, our assumption is that the evolution of dental health in different MS can be compared to Germany (for which a lot of data was available). It cannot be said what type of deviation from reality this model can cause, however, we expect it to be small.

It is believed that the overestimation due to the use of the DMFT index will compensate the underestimation due to the unconsidered replacement of failed filling material.

Emissions from crematoria

Data gaps and uncertainties

The assessment of impacts associated with measures addressing emissions from crematoria follows the same quantitative framework as used to establish baseline emissions. The uncertainties in quantification are set out in Annex 5. These include uncertainties and assumptions made in aspects including uptake of abatement technology across the EU in the baseline scenario, cremation rates across different Member States, and the use of dental amalgam across Europe. In quantifying emissions in the future baseline and measure scenarios, projections of key parameters have been made based on historical data and there are uncertainties associated with such forecasting.

Limited information could be obtained through the literature review and stakeholder consultation on the role of SMEs in the sector across Europe. It is assumed that SMEs will form at least part of the sector, especially in countries with a high number of small-capacity crematoria, but specific information upon which to base an assessment of the impacts on SMEs was not available. Further engagement with the industry through Member State surveys could provide further details which could inform a judgement on the impacts to SMEs.

Mercury-added products

Data gaps and uncertainties

For the estimation of impacts of policy measures, models were developed that allow quantitative statements on future export volumes, export values and mercury contents, at least for fluorescent lamps for general lighting purposes. The models and the associated assumptions and model parameters are described in the Annex 5. For most of the factors used, bandwidths describing the known or assumed uncertainties were used. Many of these factors and ranges were discussed with stakeholders or derived based on information from stakeholders. Some factors are based on assumptions in the absence of concrete data. These factors are discussed in detail and the range used is explained. Nevertheless, it cannot be ruled out that individual factors will turn out differently in the actual future development. For example, unforeseen political decisions in important importing countries can cause a significant drop in demand that exceeds the forecast range. Special effects, such as strong price increases for components, could make certain lamp types considerably more expensive and less attractive.

A quantitative assessment was only possible for fluorescent lamps and, with restrictions, for dental amalgam. For other lamp types as well as for other MAPs, the data material was missing. Based on the available information, however, it is assumed that fluorescent lamps have the highest export volume and dental amalgam the highest mercury content. These two products are thus the most important from an economic and environmental point of view. When a quantitative assessment of measures appeared too uncertain, either a qualitative assessment was made, or the magnitude of an effect was estimated.

Annex 5: Detailed Baseline

The baseline option represents a ‘no policy change’ scenario. That is, the baseline assumes that the current EU-level and national policies and measures continue to be in force and that the sectors are affected by baseline expectations.

1.Baseline for dental amalgam

To develop a baseline for the mercury used in the EU due to the use of dental amalgam as a tooth filling material, an epidemiologic approach was used. A German study 96 used data from national dental health studies, which showed good correlation and predictive capacity for DMFT in the country using the DMFT for different age groups 97 and specific years (2000, 2005, 2015, and 2030). A similar approach has been applied in this assessment using the German data to create a model approximating the DMFT for Germans at different ages and dates of birth to a good degree.

The approach uses non-linear estimation methods to calculate a close estimate of total mercury in dental patients on an average across EU Member. There are primarily three reasons for the application of this method:

1.The DMFT index and age groups in the baseline data show a clear non-linear trend. The share of people that require dental care (sorted by mean age) spikes during adolescence and puberty. There is a relative fall and stabilisation of this share during working age while spiking again during retirement years. A 3rd-degree polynomial fit for the data is hypothesised.

2.The baseline raw data has been poorly maintained, with inconsistency in DMFT recorded for each age and the time of recording. German data was found to be the most consistent among the EU Member States.

3.For the German dataset, age has not been recorded as a discrete variable but as a categorical interval (“6-9 years old”, “10-19 years old”, etc.). Therefore, standard Ordinary Least Squares (OLS) methods may be inconsistent 98 . Even if the age intervals may record frequencies to be later used as weights, the inconsistency of data recording makes robust estimation a big challenge.

Since the German data was used as a baseline for estimation across the other EU Member States, consideration needs to be given to the interval nature of age groups. Using midpoints for each interval for OLS estimation does not take into account the distribution of frequencies assigned to each interval. Hence, we cannot substitute the midpoint as a proxy for mean age in each interval. Moreover, there are some statistical concerns with this form of estimation – the errors of predictions (and standard deviation) for each age interval can be non-constant. Since OLS assumes constant variance of error terms, a significant scatter in standard deviation values (or heteroscedasticity) can have the following issues:

·The point estimates are unbiased, meaning they converge to the true estimate over large samples. However, they are inconsistent i.e., they do not have a minimised variance out of all other unbiased point estimates.

·Statistical tests to prove the significance of the point estimates are invalidated as they assume a constant variance of error terms across all observations.

Since the German data for the baseline includes a categorical variable, an approach to the estimation is made via choice models. As the categories, i.e., age intervals, are ordered, an ordered logistic regression was used to build the model.

Considering the following estimation:

Where β is the point estimate for the regression coefficient, and ε is the error residual in time,

t {2000, 2005, 2015, 2030}, and observation (i). We assume a symmetric and cumulative probability density function for the error term, F(.). The error terms are normalised with their standard deviation, . Age* is a latent variable as we cannot observe the exact age given some DMFT. Hence, we introduce cut off points to observe this variable. This is done to accommodate the categorical nature of the dependent variable.

Observing category j for Age,

For cut off points A at each category j. For estimation purposes, we find the probability of observing a certain age category as a proxy for the share of people that require dental care given a non-zero DMFT.

Where F[.] is the cumulative density function of the error terms.

To find the optimum point estimates, we use maximum likelihood estimation. The log-likelihood function of the exercise above is given by finding the joint density of the observed data and taking the natural log for computational simplicity.

Over 10 observations, i, and 10 age intervals, j. 1{i=j} is an indicator function that returns a value of 1 when observation i belongs to category j.

For identification of the point estimates, we introduce 9 cut off points A. Hence, we obtain estimates with reference to one age category. We also assume a parallel regression assumption, i.e., the point estimates are constant along all thresholds. Also, we take the logistic function as the cumulative density for the error terms.

The ordered logistic regression is used to calculate expected probabilities for each age interval at the mean level of DMFT. Using collected data on each Member State’s average DMFT at median age, we find the expected probability of being in the corresponding age group. This extrapolation is supplemented through a linear trend of expected probabilities where the year 2000 is taken as the base (t=00). The probabilities extrapolated thus far are used to estimate the share of the population sorted by age that requires dental care, the total amount of dental operations, and the absolute share of amalgam in said operations. Finally, we estimated the average mercury content in patients and wasted away from the calculations above.

Ordinal logistic regressions for the German data over four years (2000, 2005, 2015, 2030) are summarised in the following table.

Table 1: Ordinal regressions for the German Data

Odds Ratio for Age Categories

Year 2000

Year 2005

Year 2015

Year 2030

Point Estimate of DMFT

1.43438

(0.1493)

t = 2.417*

1.5184

(0.1655)

t = 2.524*

1.6968

(0.1975)

t = 2.678**

1.9457

(0.239)

t = 2.785**

Note: Cut off points for age categories omitted for brevity

Brackets denote standard errors

*Significant at 95% Confidence

**Significant at 99% Confidence

The point estimate reports the odds of a dental patient moving from a younger age group to a higher one. The regression model predicts that as the DMFT score rises by one unit, the patient is 43% more likely to be older than 10-19 years old (the reference category) in 2000. The odds over the years have risen to the point that the 2030 projection predicts that the patient’s chance of being older nearly doubles. A case in point to explain this trend can be a rise in dental health and demographic change wherein the median age of dental patients is moving away from younger populations.

Figure 1: Predicted Probabilities for each Age Interval, Germany 2000

Figure 2: Predicted Probabilities for each Age Interval, Germany 2005

Figure 3: Predicted Probabilities for each Age Interval, Germany 2015

Figure 4: Predicted Probabilities for each Age Interval, Germany 2030

The predicted probabilities above are used to forecast expected population shares for all other Member States. We assume a third-degree polynomial forecast. Having well characterised the German case, other Member States can be compared to it and will either experience a “delay” when compared to it or a “head start”. To perform this comparison, the DMFT index for all Member States at different ages for a given year was compared to that of Germany. The aim was to determine in which year in Germany could the same DMFT and age combination be observed. Once this was determined, the delay or head start was determined e.g., for Austria, the DMFT of 40-year-olds in 2000 was 14.7 meaning that in Germany, this set of conditions was met in 1996. Thus, Austria has a 4-year delay when comparing its population’s dental health with that of Germany. This same calculation was done for all Member States, and the corresponding data is available in Table 2 below.

Table 2: DMFT at specific ages and year for all Member States and year at which the same conditions were met in Germany for 2019

	DMFT	Age	Year in Member State	Corresponding year with German model	Year equivalent to 2019 for model (corresponding year + 2019 – year)	Dental health “delay” or “head start”
Austria	14.7	40	2000	1996	2015	-4
Belgium	10.3	40	2008	2011	2022	3
Bulgaria	12.1	35	2006	1998	2011	-8
Croatia	3.5	12	1999	1981	2001	-18
Cyprus	2	15	2010	2013	2022	3
Czech Republic	17.1	40	2006	1990	2003	-16
Denmark	13.5	40	2008	2000	2011	-8
Estonia	6.75	17	1993	1984	2010	-9
Finland	0.9	12	2010	2016	2025	6
France	14.6	40	1994	1997	2022	3
Germany			2022	2022	2019	0
Greece	1.95	12	2011	1999	2007	-12
Hungary	15.4	40	2003	1995	2011	-8
Ireland	15.4	40	1990	1995	2024	5
Italy	26.3	70	1993	1987	2013	-6
Latvia	18.5	40	1993	1987	2013	-6
Lithuania	17.3	40	1997	1990	2012	-7
Luxemburg	3	12	1990	1986	2015	-4
Malta	1.4	12	2003	2007	2023	4
Netherlands	17.4	40	1986	1989	2022	3
Poland	19.2	40	1997	1985	2007	-12
Portugal	10.4	40	2013	2010	2016	-3
Romania	6.9	18	1995	1987	2011	-8
Slovakia	4.1	12	2005	1996	2010	-9
Slovenia	19	40	1993	1986	2012	-7
Spain	7.4	40	2020	2024	2023	4
Sweden	0.7	12	2017	2021	2023	4

Thanks to this model, the baseline for the state of dental health in the EU in 2019 was calculated and expected population given a DMFT for all ages for all Member States was determined. These values were then used together with the share that dental amalgam represents in the fillings used for restorations in all Member States, the mercury content of dental amalgam capsules and the share of said capsules fitted in the tooth to calculate the amount of mercury used in the EU every year.

To estimate the quantity of mercury used for the treatment of dental cavities, three datasets are crucial:

1.The mercury content of the dental amalgam capsules used by dentists,

2.The share of dental amalgam used in the treatment of caries in the different MS, and

3.The share of the dental amalgam capsule put in the tooth.

Mercury content of dental amalgam capsules

It was identified for different types of capsules namely

·Pre-dosed amalgam capsules permite, logic+ and gs-80 99

·MegalloyⓇ EZ 100

·Septalloy NG 70, Securalloy 101

·DispersalloyⓇ 102

Using the mercury content of the medium size capsules, the mercury content of dental amalgam capsules was approximated to range between 480 mg and 700 mg (data was available for capsules ranging from small to large sizes, the choice was made to use the data for the medium-sized capsules to have a narrower range of mercury content since medium-sized capsules are expected to be the most used).

Share of dental amalgam use

Share of dental amalgam use was approximated using data from the different sources. Where more recent data was available it was used, else the data from previous sources were used such as BioIS (2012), Deloitte (2020) or the final Staff Working Document 2016/017 (which also relied on BioIS (2012) 103 .

The share of dental amalgam use (minimum and maximum) per country is presented in Table 3 below, along with the data source and whether the data is estimated or reported. It also indicates which Member States have (known) phase-out plans, by when and the phase-out objective.

Table 3: Dental amalgam data for all Member States

	Amalgam use %			Method	Ref. year	Phase-out plan	Goal	Comment
	Min.	Mean	Max.
Austria	35%	43%	50%	estimated	2010
Belgium	7%	7%	7%	reported	2018
Bulgaria	6%	21%	35%	estimated	2010
Croatia	35%	43%	50%	estimated	2010	2025		IGU(1)
Cyprus	6%	21%	35%	estimated	2010	2025?		under consideration
Czechia	35%	43%	50%	estimated	2016	2030	1%
Denmark	1.7%	1.7%	1.7%	reported	2017
Estonia	1%	2.5%	5%	estimated	2010
Finland	1%	1%	1%	reported	2019	2030
France	20%	25%	30%	reported	2021			Reimbursement scheme 2021 100% Alternative, assumption: 50% reduction
Germany	5%	6%	7%	reported	2018
Greece	35%	43%	50%	estimated	2010
Hungary	5%	7%	9%	reported	2018	2030	1%	IGU <1%
Ireland	20%	20%	20%	reported	2018	2030
Italy	1%	2.5%	5%	estimated	2010	2025		IT NAP: end of 2014(2)
Latvia	6%	21%	35%	estimated	2010
Lithuania	4.6%	4.6%	4.6%	reported	2019
Luxembourg	6%	21%	35%	estimated	2010
Malta	35%	43%	50%	estimated	2010
Netherlands	0.5%	0.5%	0.5%	reported	2018
Poland	35%	43%	50%	estimated	2010	2022		0% in public, but private?
Portugal	5%	10%	15%	reported	2025
Romania	7.5%	7.5%	7.5%	reported	2018
Slovakia	40%	50%	60%	reported	2010	2031
Slovenia	70%	70%	70%	reported	2019	2030		IGU
Spain	1%	1%	1%	reported	2019	2030
Sweden	0%	0%	0%	reported	2009	2020

(1)IGU https://www.ig-umwelt-zahnmedizin.de/aktuelles/update-nationale-aktionsplaene-zum-ausstieg-aus-der-verwendung-von-amalgam-in-der-eu/

(2)IT NAP Trova Norme & Concorsi - Normativa Sanitaria (salute.gov.it)

Share of the dental amalgam capsule actually put in the tooth

Only one number could be found regarding the share of dental amalgam capsule content put in patients’ teeth. It was estimated to range from 26% up to 66%

104 , which would represent a range of 125 mg, up to 462 mg of mercury put in patients’ teeth per capsule used.

Quantification of Mercury in the EU due to dental amalgam use

Using the above information in combination with the population data from Eurostat for 2019 with projections to 2030 and the DMFT estimates for all MS 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 using the following formula:

Where:

a)n is the age of the population group

b)DMFTn is the DMFT index at age n

c)Popn is the population number at age n

d)DA% is the share of dental amalgam use

e)Hg is the mercury content of dental amalgam capsules

f)DAtooth Is the share of the dental amalgam capsule actually put in the tooth.

The mean total mercury used in dental amalgam in the EU and its fate is displayed in the Figure 5 below.

Figure 5: Baseline mercury consumption in the EU Member States in the form of dental amalgam in 2019, 2025 and 2030 (tonnes)

The mean total mercury used in the EU for dental amalgam use is estimated to be 40.4 tonnes (18.6 tonnes in teeth and 21.8 tonnes wasted) in 2019 (with the lower estimate being 31.6 tonnes and the upper estimate 50.3 tonnes). In 2030, mercury use is expected to decrease to 11.2 tonnes (with the lower estimate being 7.2 tonnes and the upper estimate being 16.8 tonnes). The lower and upper estimates were calculated using the extreme values for the three parameters discussed earlier. The values used for the different estimates are listed in Table 4 (except the share of dental amalgam use per Member State displayed in Table 3).

The previous study estimated the total dental amalgam use in the EU in 2018 between 26.9 tonnes and 58.3 tonnes. Our estimate range is slightly different; several factors may explain this:

·This study’s estimate is for the EU27, whereas the previous one considered the EU28.

·This study uses a total mercury content of amalgam capsules of ~590 ± 110 mg, whereas the previous study used a mercury content per capsule of 850 mg.

·This study based the calculation of dental amalgam use on the DMFT index and an extrapolation model based on an epidemiologic approach, whereas the previous study used population data to fill in data gaps related to the number of treatments (assuming the same number of procedures per person but using a different population total for different countries which does not consider the varying status of dental health in different Member States).

Table 4: Values of the parameters used for the lower, mean and upper values of the estimate of dental amalgam use in 2019

Parameter	Lower estimate	Mean estimate	Upper estimate
Mercury content in dental amalgam capsule (mg)	474	587	701
Share of dental amalgam capsule put in the tooth (%)	26	46	66

Figure 6 demonstrates the number of dentists per 100,000 inhabitants for each Member State as per the latest date of data collection. It illustrates that Greece has the highest density of dentists, with around 126 dentists per 100,000 inhabitants. Furthermore, it illustrates that Poland has the lowest density of dentists, with around 35 dentists per 100,000 inhabitants.

Figure 6: Number of dentists per 100,000 inhabitants in Member States

Table 5: Number of dentists and access to dentists across Member States

Member State	Number of dentists for latest year of data	Latest year of data	Number of dentists per 100,000 population
			2012	2013	2014	2015	2016	2017	2018	2019	2020	2021
AT	5,206	2020	56.9	57	57.25	57	56.7	57	56.86	58	58.38	ND
BE	8,871	2020	70.85	71.37	72.33	73.54	74.82	74.86	75.38	75.7	76.84	ND
BG	7,373	2020	94.92	97.23	99.56	100.26	104	106.06	103.66	106.64	106.33	ND
CY	1,001	2019	94.45	96.18	98.42	103.34	103.57	109.25	112.18	113.5	ND	ND
CZ	7,914	2020	70.98	70.63	75.11	ND	75.29	74.77	73.79	73.32	73.98	ND
DE	71,108	2020	84.42	84.84	85.57	85.75	85.58	85.65	85.78	85.5	85.51	ND
DK	4,190	2019	79.67	78.27	77.01	76.06	74.18	71.83	71.84	72.06	ND	ND
EE	1,336	2020	90.42	90.29	92.98	94.19	95.53	96.02	96.6	98.2	100.49	ND
EL	13,464	2019	131.8	129.5	128.5	124.8	124.5	125.5	125.4	ND	ND	ND
ES	1,303	2019	90.4	90.2	92.9	94.2	95.5	95.9	96.5	ND	ND	ND
FI	3,954	2018	73.64	71.98	72.87	73.05	72.68	71.77	71.69	ND	ND	ND
FR	42,844	2020	61.8	62.06	61.69	61.97	62.44	62.37	63.36	63.29	63.59	ND
HR	3,526	2020	75.5	75.8	78.54	79.54	80.07	83.13	84.82	87.01	87.12	ND
HU	6,578	2020	56.54	60.27	62.87	60.31	61.98	67.32	70.28	73.12	67.47	ND
IE	1,303	2020	57.7	57.4	59.6	60.8	62.8	65.5	66.8	68.5	ND	ND
IT	50,993	2021	ND	78.09	78.32	78.39	80.09	81.85	83.63	86.98	86.93	86.05
LT	3,100	2020	89/87	90.54	91.02	91.02	97.17	100.37	103.23	105.44	110.92	ND
LV	1,362	2020	71.03	72.49	70.22	71.76	72.01	71.05	70.62	71.27	71.67	ND
LU	581	2017	83.06	84.66	85.56	88.83	94.27	97.43	ND	ND	ND	ND
MT	269	2020	45.24	46.25	46.25	46.29	47	47.65	47.87	50.19	52.2	ND
NL	9,879	2020	49.48	49.48	48.87	51.54	51.11	55.07	55.58	56.51	56.64	ND
PL	13,331	2017	32.82	32.39	34.43	33.18	35.05	35.1	ND	ND	ND	ND
PT	10,896	2018	80.4	84.7	87.6	91.3	95.6	101.2	ND	ND	ND	ND
RO	18,298	2020	68.1	71.3	74.57	77.66	82.66	79.11	83.51	86.8	95.02	ND
SE	8,003	2019	82.06	81.72	81.52	81.69	81.5	81.36	80.76	77.86	ND	ND
SI	1,570	2019	63	64.9	66.2	67.46	68,81	70.41	71.94	72.5	74.68	ND
SK	2,852	2019	49.2	47.7	48.7	48.7	49.6	50	51	ND	ND	ND

ND = No data

Data expressed as total number of dentists and number of dentists per 100,000 inhabitants obtained from Eurostat available here . With the exception of Greece, Estonia, Ireland, Portugal and Slovakia where data was obtained from the World Health Organisation available here and here .

Uncertainties of the estimate

The quantification estimate bears some uncertainties, which are discussed below:

·The use of the DMFT index to quantify the amount of caries in the European Union’s population: The DMFT does not only consider filled teeth and teeth to be treated but also missing teeth. This index is well correlated with the amount of treated caries for the population up until 40 to 50 years, at which point when teeth removal starts to increase and outweigh cavity treatment. So, the model is expected to overestimate the total use of mercury per year.

·Inconsistencies in historical data: The historical datasets used for extrapolation of the estimates are poorly collected. Most importantly, the time of recording age and the DMFT index is inconsistent. This reduces the power of forecasting. Moreover, we have extant data on DMFT per median age for every Member State. Using the same to estimate a distribution across age intervals can lead to overestimation and/or high variance.

·The model does not consider the replacement of failing filling material: Materials used for teeth filling when treating cavities is not everlasting, so it needs to be replaced sometimes. The replacement was not considered due to too much uncertainty on the failure rate of the different materials as well as on the share of dental amalgam used to replace the failed materials. So, a small underestimation of the quantity of mercury used per year is expected.

·The share of the dental amalgam used in tooth filling: These estimates for all Member States come from the 2012 BioIS report, and no better values could be found. Unfortunately, it cannot be said what type of deviation can be expected from this source of uncertainty.

·The assumption under which the improvement of dental health in the EU follows the same trend in all Member States: The assumption is that the evolution of dental health in different Member States can be compared to Germany (for which a lot of data was available). It cannot be said what type of deviation from reality this model can cause, however, we expect it to be small.

It is believed that the overestimation due to the use of the DMFT index will compensate the underestimation due to the unconsidered replacement of failed filling material.

2.Baseline for emissions from crematoria

At present, there is no EU-level legislation requiring Member States to install mercury abatement systems in crematoria. The OSPAR Commission adopted its non-binding Recommendation 2003/4, which states that “Contracting Parties should ensure that the operators of crematoria apply BAT at their crematoria to prevent the dispersal into the environment of mercury from human remains, especially from dental amalgam”. The Recommendation also identifies a number of abatement options including co-flow filtration, solid-bed filtration, and gas scrubbing.

Similarly, the Baltic Marine Environment Protection Commission (Helsinki Commission – HELCOM) adopted Recommendation 29/1 in 2008, which recommends that governments of the Contracting Parties implement measures to ensure that crematoria operators with a capacity exceeding 500 cremations/year implement BAT to comply with an emissions limit value of 0.1 mg/Nm3. Recommendation 29/1 also identifies the same techniques set out in OSPAR Recommendation 2003/4 as potential BAT. Parties to OSPAR and/or HELCOM within the EU are highlighted in Figure 6.

Figure 7: Members of OSPAR and/or HELCOM

National-level legislation addressing mercury emissions from crematoria is varied. Information on national regulatory approaches gained through the stakeholder survey and literature review is set out in Table 6 below.

Table 6: National-level regulation of crematoria mercury emissions (based on information fathered to date)

Member State

Regulation of crematoria mercury emissions

AT	No regulation identified, although some sources indicate an emissions limit value (ELV) of 0.1 mg/Nm3 applies 105 .
BE	ELVs of 0.2 mg/Nm3 and 0.1 mg/Nm3 in effect in Flanders and Brussels, respectively 106 .
BG	No regulation identified.
CY	No regulation identified.
CZ	No regulation identified.
DE	No legislation, but Germany has adopted guidance on BAT in human cremation installations, which indicates that when dust filters and/or sorbents are utilised, typical mercury emissions range between 0.0001 and 0.05 mg/m3 (fixed bed or sorbent injection).
DK	Legislation BEK nr 2079 af 15/11/2021 107 sets a mercury ELV of 0.1 mg/Nm3 (dry gas) for crematoria with an annual capacity of over 400 cremations. Flue gas must be tested once yearly for mercury.
EE	No regulation identified.
EL	No regulation identified.
ES	No regulation identified.
FI	No regulation identified.
FR	The Arrêté du 28 janvier 2010 relatif à la hauteur de la cheminée des crématoriums et aux quantités maximales de polluants contenus dans les gaz rejetés à l'atmosphère 108 sets an ELV of 0.2 mg/Nm3.
HR	Regulation NN 87/2017 109 establishes an ELV of 0.05 mg/Nm3.
HU	No regulation identified.
IE	No national-level regulation in place. Crematoria emissions are regulated locally through the permitting system, where ELVs are specified on an installation-by-installation basis.
IT	No national regulation in effect. Regional rules generally establish an hourly average emission limit value of 0.05 mg/Nm3.
LT	Order No. D1-357 110 sets an ELV of 0.1 mg/Nm3.
LU	No regulation identified.
LV	No regulation identified.
MT	No regulation identified.
NL	Article 4.119 of the Environmental Management Activities Decree 111 sets an ELV of 0.05 mg/Nm3.
PL	No regulation identified.
PT	No regulation identified.
RO	No regulation identified.
SE	All crematoria require environmental permits, either from national or local authorities depending on operating capacity. Permits specify best practices and BAT.
SI	No regulation identified.
SK	No regulation identified.

The Commission’s Article 19(1) review report estimated that mercury emissions from crematoria totalled 1.6 tonnes in 2018 in the EU; the basis for this estimate is not clear. Data officially submitted by EU27 Member States as part of their reporting requirements under the CLRTAP indicate that emissions totalled 0.9 tonnes in 2019 112 . These figures have been derived following methodologies specific to crematoria emissions set out in the EMEP/EEA air pollutant emission inventory guidebook 113 . The guidebook sets out a ‘Tier 1’ methodology as the default approach to quantifying crematoria emissions; this involves applying emission factors to activity data (number of bodies cremated). The recommended emission factor for mercury emissions, 1.49 grams per cremated body (95% CI 0.149 – 14.9 g/body), is based on sources from 1992, and is an average factor covering different abatement technologies. While the guidebook highlights that more detailed information should be used where available, it does not specifically set out any more detailed ‘Tier 2’ and ‘Tier 3’ methodologies for quantifying emissions from human cremation. It is therefore likely that the emissions inventory data reported under the CLRTAP are largely derived using a top-down approach based on the broadly averaged EMEP/EEA emission factors, and there is significant uncertainty in the estimated total emissions across the EU27.

As part of the Impact Assessment, information was gathered for each EU Member State on the number of cremations (derived using mortality statistics and reported cremation rates), as well as the number of crematoria operating in the country. Additionally, information on the split of crematoria by capacity band was collated from publicly available data sources and through stakeholder consultation for Denmark, Finland, and France.

Informed by the data available for a small subset of countries, as well as the average crematorium annual capacity calculated for each Member State, the total number of crematoria in each Member State was manually allocated to the annual capacity bands; these allocations are displayed in Table 3-5. As outlined, these figures have been obtained based on a number of assumptions in the absence of any specific national data and are therefore subject to high uncertainty.

The table also presents data for 2030; the number of crematoria by capacity band in each Member State in 2019 were adjusted to 2030 based on the anticipated change in cremation numbers between those two years. Where the change in cremations between 2019-2030 is forecast to be less than ±10%, it was judged that the change in cremation numbers could be absorbed by existing crematoria numbers, and no adjustment was applied.

The data indicate that Spain has the largest number of crematoria (434) in 2019 and 2030, followed by France and Germany. Looking at the EU27 as a whole, over half of crematoria in 2019 and 2030 are in the smallest capacity band (<1,000 cremations per year). Most countries are expected to see an increase in the number of crematoria from 2019 to 2030.

Table 7: Number of crematoria by capacity band by Member State (2019 and 2030)

Member State	Number of crematoria, 2019 (by capacity band)							Number of crematoria, 2030 (by capacity band)
	<1k	1k – k	2k – 3k	3k – 4k	4k – 5k	>5k	Total	<1k	1k – 2k	2k – 3k	3k – 4k	4k – 5k	>5k	Total
AT	1	2	4	2	3	1	13	1	3	6	3	4	1	18
BE	1	3	6	4	4	1	19	1	4	7	5	5	1	24
BG	1	0	0	0	0	0	1	1	0	0	0	0	0	1
CY	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CZ	2	5	10	4	4	2	27	2	5	10	4	4	2	27
DE	8	22	50	30	38	11	159	11	29	67	40	51	15	213
DK	1	10	6	0	0	2	19	1	12	7	0	0	2	22
EE	2	0	0	0	0	0	2	4	0	0	0	0	0	4
EL	1	0	0	0	0	0	1	1	0	0	0	0	0	1
ES	434	0	0	0	0	0	434	434	0	0	0	0	0	434
FI	3	12	4	0	1	0	20	4	16	5	0	1	0	27
FR	88	71	21	3	1	1	185	110	89	26	4	1	1	231
HR	0	0	0	0	0	1	1	0	0	0	0	0	1	1
HU	1	1	2	5	5	3	17	1	1	2	5	5	3	17
IE	5	1	1	0	0	0	7	9	2	2	0	0	0	13
IT	29	19	26	8	2	1	85	46	30	41	13	3	2	135
LT	0	0	0	0	1	0	1	0	0	0	0	2	0	2
LU	0	0	1	0	0	0	1	0	0	1	0	0	0	1
LV	0	0	0	1	0	0	1	0	0	0	2	0	0	2
MT	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NL	66	24	6	1	1	1	99	80	29	7	1	1	1	120
PL	12	13	17	7	2	1	52	21	23	30	12	4	2	92
PT	1	4	6	3	4	2	20	1	4	6	3	4	2	20
RO	4	0	0	0	0	0	4	5	0	0	0	0	0	5
SE	25	24	5	2	0	2	58	28	27	6	2	0	2	65
SI	0	0	0	0	0	2	2	0	0	0	0	0	2	2
SK	0	0	0	0	1	2	3	0	0	0	0	2	4	6
EU-27	685	211	165	70	67	33	1,231	762	274	224	94	87	42	1,482

Table 8: Number of crematoria by capacity band by Member State (2019 and 2030)

Member State	Number of crematoria, 2019 (by capacity band)							Number of crematoria, 2030 (by capacity band)
	<1k	1k – 2k	2k – 3k	3k – 4k	4k – 5k	>5k	Total	<1k	1k – 2k	2k – 3k	3k – 4k	4k – 5k	>5k	Total
AT	1	2	4	2	3	1	13	1	3	6	3	4	1	18
BE	1	3	6	4	4	1	19	1	4	7	5	5	1	24
BG	1	0	0	0	0	0	1	1	0	0	0	0	0	1
CY	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CZ	2	5	10	4	4	2	27	2	5	10	4	4	2	27
DE	8	22	50	30	38	11	159	11	29	67	40	51	15	213
DK	1	10	6	0	0	2	19	1	12	7	0	0	2	22
EE	2	0	0	0	0	0	2	4	0	0	0	0	0	4
EL	1	0	0	0	0	0	1	1	0	0	0	0	0	1
ES	434	0	0	0	0	0	434	434	0	0	0	0	0	434
FI	3	12	4	0	1	0	20	4	16	5	0	1	0	27
FR	88	71	21	3	1	1	185	110	89	26	4	1	1	231
HR	0	0	0	0	0	1	1	0	0	0	0	0	1	1
HU	1	1	2	5	5	3	17	1	1	2	5	5	3	17
IE	5	1	1	0	0	0	7	9	2	2	0	0	0	13
IT	29	19	26	8	2	1	85	46	30	41	13	3	2	135
LT	0	0	0	0	1	0	1	0	0	0	0	2	0	2
LU	0	0	1	0	0	0	1	0	0	1	0	0	0	1
LV	0	0	0	1	0	0	1	0	0	0	2	0	0	2
MT	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NL	66	24	6	1	1	1	99	80	29	7	1	1	1	120
PL	12	13	17	7	2	1	52	21	23	30	12	4	2	92
PT	1	4	6	3	4	2	20	1	4	6	3	4	2	20
RO	4	0	0	0	0	0	4	5	0	0	0	0	0	5
SE	25	24	5	2	0	2	58	28	27	6	2	0	2	65
SI	0	0	0	0	0	2	2	0	0	0	0	0	2	2
SK	0	0	0	0	1	2	3	0	0	0	0	2	4	6
EU-27	685	211	165	70	67	33	1,231	762	274	224	94	87	42	1,482

In defining an assessment baseline, the study has adopted a bottom-up approach to quantifying emissions. This involved exploring trends and activity levels in the underlying drivers in order to build up to an estimate of crematoria emissions. This method is detailed in the following section.

Approach

Mercury emissions from crematoria are influenced by a number of underlying drivers including the following:

·Mercury content of corpses, which is determined predominantly by the presence of dental amalgam restorations

·The prevalence of cremation relative to other funeral options. This can be expressed as a cremation rate, and varies significantly across the EU27

·The level of uptake of emissions abatement technologies, which have varying mercury removal efficiencies

In constructing an assessment baseline, these underlying drivers have been 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 Figure 7, and includes the following steps:

·The annual cremation rate is defined

·Total mercury content among corpses is estimated based on (i) the estimated body mercury content for different age groups, and (ii) the number of deaths per age group

·The proportion of crematoria fitted with emissions abatement systems is defined and, where data are available, a distinction can be drawn between crematoria at different annual operating capacities

·The mercury removal efficiencies of emissions abatement systems are accounted for

The framework is applied to each Member State separately to account for variation in the drivers across the EU, and emissions for the EU as a whole can be aggregated from the granular data.

Figure 8: Framework for quantifying baseline mercury emissions from crematoria

The following sections detail the methodologies applied in quantifying the underlying drivers, and how they have been forecast into the future to provide a future baseline with no further EU intervention.

Cremation rates

Data on national annual cremation rates are collated by the Cremation Society; these are displayed in Figure 8. Data for each Member State were obtained for the period 2010 to 2019 where available and used to extrapolate historical trends to future baseline years of 2025 and 2030 using a linear regression. For Spain and Portugal, there is no discernible trend in the historical data upon which to base future projections, therefore the cremation rates for 2019 were adopted for future years. There are challenges in projecting future cremation rates for countries with no, or very low, cremations in 2019. Data indicates that neither Malta nor Cyprus operated any crematoria in 2019, while Greece saw its first crematorium commence operation that year. With no reliable indication from past trends as to how future cremation rates may evolve in these countries, it has been assumed that rates will remain at their current low levels.

Figure 9: National annual cremation rates (2019, 2025 and 2030 114 )

Complete data are available only up to the year 2019 and therefore do not reflect changes brought about by the COVID-19 pandemic. Limited data on 2020 cremation rates in some Member States were accessed during targeted stakeholder consultation 115 . 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 (the Netherlands and Sweden). The largest increases were seen in countries with very low cremation rates in 2019, for example Greece which saw a 435% increase from 2019-2020 but only observed a 0.4% cremation rate in 2019. Most other Member States for which data is available saw an increase closer to 5-7% from 2019 rates. Therefore, it is likely that the COVID-19 pandemic caused an increase in cremation rates in some Member States. However, data is too limited at this point to make an informed assessment of how the pandemic affected rates above the increase already expected by changing funerary trends in the EU. It is also expected that as the pandemic diminishes, cremation rates will return to pre-pandemic trends. Consequently, future projections are based solely on pre-pandemic trends. There is, however, uncertainty concerning nearer-term trends in cremation rates.

In the absence of any more granular data, it was assumed that cremation rates are uniform across deaths in different age groups within a country (i.e., a 50% cremation rate in Austria in 2019 means that 50% of individuals that die at age 50 are cremated, 50% that die at age 51 are cremated, etc.).

Mercury content of corpses

The mercury content for corpses has been calculated for each Member State. This was based on (i) the mean number of decayed, missing and filled teeth (DMFT) for each Member State; (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 the Section above, which discusses the baseline for the dental amalgam problem area. For each Member State and for each year group, a lower, mean and upper value was produced for the mercury content per corpse to account for the uncertainty in the share of amalgam use. Additionally, the future share of amalgam use in different Member States has been estimated based on the available data.

Dental amalgam restorations in bodies arriving at crematoria will have been fitted in varying years, which will have had varying rates of dental amalgam use. Consequently, it is necessary to account for the lag in a dental amalgam restoration being made, and its arrival at a crematorium. A study concluded that the average age of replaced amalgam fillings is 15.3 ± 6.6 years 116 . Therefore, for any given assessment year, the rate of dental amalgam use in restorations was based on the average dental amalgam share over the lifetime of the restoration; this accounts for the fact that a restoration could be any age up to 15.3 ± 6.6 years. For example, the dental amalgam share used in estimating emissions from crematoria for the year 2019 was based on the average dental amalgam share over the years 2004 to 2019. As a sensitivity test, longer (21.9 years) and shorter (8.7 years) amalgam lifespans were used in calculating a higher and lower estimate, respectively.

Data on historical deaths by age group are available from Eurostat; figures for 2019 were obtained from the demo_magec dataset 117 . The dataset also includes figures for 2020 at 5.2 million deaths in the EU27, compared with 4.7 million deaths in 2019, 2018 and 2017. This increase in deaths is attributable to the COVID-19 pandemic and, as discussed in the context of cremation rates above, increased deaths are anticipated to return to pre-pandemic trends as the pandemic abates. As such, 2019 has been selected as the baseline year that would be most consistent with long-term projections for future year scenarios. Eurostat also includes future population projections by year group (dataset proj_19np) and forecasts for probability of dying by age in future years (proj_19naasmr). These datasets were combined to provide projections for the number of deaths by age group in 2030.

The mass of mercury in all corpses was then quantified by combining the figures on mercury content per body with the number of deaths per corresponding age group. By applying the cremation rates determined above, the mass of mercury in corpses reaching crematoria was calculated. Masses for each Member State are displayed in Figures 9, 10 and 11. The figures indicate that the mass of mercury reaching crematoria is decreasing from 2019 to 2030 in most Member States with a few exceptions, most notably Poland. The increase in these countries appears to be driven by increasing rates of cremation as well as increased mortality resulting from aging populations.

Figure 10: Masses of mercury in corpses reaching crematoria (low estimates) for 2019, 2025 and 2030

Figure 11: Masses of mercury in corpses reaching crematoria (central estimates) for 2019, 2025 and 2030

Figure 12: Masses of mercury in corpses reaching crematoria (high estimates) for 2019, 2025 and 2030

Uptake of emissions abatement technologies

Data on uptake of emissions abatement technologies at crematoria for some OSPAR members have been collated via the following phased approach:

·Where up-to-date information was provided through the stakeholder survey and consultations, this was adopted as the default assumption

·Where no stakeholder response was provided, but data were available from other sources, assumptions were made based on these sources

·For Member States where there was neither a stakeholder response, nor any data in the literature, it was conservatively assumed that emissions abatement uptake was 0% where there was no evidence of regulation addressing crematoria emissions

Assumed abatement uptake rates are displayed in Table 9 below.

Table 9: Percentage of crematoria with/without abatement technologies

Member State	Crematoria with abatement (%)	Source / notes
AT	30	30% uptake in 2005. No requirements for crematoria emissions identified; uptake rate conservatively assumed to remain at 2005 levels.
BE	100	Targeted stakeholder survey response.
BG	0	No survey response; assumed to be 0%.
CY	0	No crematoria in Cyprus.
CZ	0	0% uptake in 2018; assumed to be at same level2.
DE	100	Targeted stakeholder survey response.
DK	95	Targeted stakeholder survey response.
EE	0	No survey response; assumed to be 0%.
EL	0	No survey response; assumed to be 0%.
ES	4	Assumed consistent with 2014 data in OSPAR 2016 report 118 .
FI	0	OSPAR member, but no survey response provided and no information found indicating any regulation in place. Previous assessment work does not identify any regulation addressing mercury emissions from crematoria. Assumed to be 0%.
FR	100	100% uptake in 2018; assumed to be at same level2.
HR	0	0% uptake in 20181; assumed to be at same level2.
HU	70	Targeted stakeholder survey response.
IE	71	Targeted stakeholder survey response.
IT	90	Targeted stakeholder survey response.
LT	100	Targeted stakeholder survey response.
LU	100	Assumed consistent with 2014 data in OSPAR 2016 report14.
LV	0	No survey response; assumed to be 0%.
MT	0	No crematoria in Malta.
NL	100	Assumed consistent with 2014 data in OSPAR 2016 report14.
PL	0	No survey response; assumed to be 0%.
PT	0	Targeted stakeholder survey response.
RO	0	No survey response; assumed to be 0%.
SE	83	Targeted stakeholder survey response.
SI	0	No survey response; assumed to be 0%.
SK	0	No survey response; assumed to be 0%.

Historical data on the uptake of emissions abatement systems at crematoria are lacking, nor was any information obtained through the stakeholder survey. It was therefore not possible to project uptake trends into the future and it was therefore assumed that, under a business-as-usual baseline scenario, future uptake of abatement systems would remain at the same level as the historical data.

Data on the percentage of cremations carried out by crematoria falling into different annual operating classes was also requested through the survey (e.g., fewer than 1,000 cremations a year, over 5,000 cremations a year, etc.). Information was received for a number of Member States (Germany, Ireland and Sweden), and publicly available data were used for several other Member States (Finland, France and Denmark). For other Member States, the distribution of cremations into different capacities was estimated based on the average cremation capacity in the country. The total number of crematoria in each Member State, obtained from the Cremation Society, was then manually apportioned into each operating capacity. Total emissions can therefore be disaggregated by crematoria size to identify whether larger or smaller installations are currently the greatest sources of emissions.

In the absence of capacity-specific abatement uptake rates, it was assumed that abatement rates are constant across all capacity bands.

Mercury removal efficiency of abatement systems

For the assessment, it has been assumed that 100% of mercury reaching crematoria in corpses is emitted to air during cremation; while in reality a small proportion of mercury released from a cremation will adhere to the surfaces of the crematorium or remain in the ash. This assumption is considered a generally accurate approximation of operating conditions 119 . Data collated from the literature on mercury removal efficiencies for the most widely used abatement technologies are displayed in Table 4.

Table 10: Mercury removal efficiency of different abatement technologies

Technology	Lower value (%)	Upper value (%)	Source / notes
Unabated emissions	0.0	0.0	Assumed 100% of mercury mass reaching crematoria are emitted to air
Injection of adsorbent (AC)	90.0	98.0	Lower value: Umwelt Bundesamt (2021) 120 Upper value: OSPAR Commission (2003) 121
Solid bed filtration using adsorbent (AC)	90.0	99.9	OSPAR Commission (2003)

Data on the relative uptake of specific abatement technologies in Member States was not available, and therefore it was not possible to apply technology-specific removal efficiencies in calculating emissions. Information on typical removal efficiencies was sought from Member States through the consultation activities; data received are displayed in Table 5.

Table 11: Typical mercury removal efficiency reported by Member States

Member State	Typical mercury removal efficiency (%)	Notes
DE	90 – 98	Response states that carbon injection is the BAT, with a removal efficiency of 90-98% (see Table)
DK	98	-
IT	90 – 95	-
SE	97	-

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 estimate of 95%. This was based on reported removal efficiencies for carbon injection and solid bed filtration (see Table 5), the most widely used abatement technologies.

There is limited information in the literature to indicate that mercury removal efficiencies have changed historically as a result of improvements to existing systems, or introduction of new technologies. Emissions estimates are therefore based on the assumption that removal efficiencies will remain constant into the future.

Summary

Crematoria mercury emissions have been calculated by combining the data on the underlying drivers, discussed above. Estimated emissions for individual Member States in 2019, 2025 and 2030 are presented in Figure 12, and for the EU27 as a whole in Figure 13 (below).

Total mercury emissions for the EU27 are estimated at 689 kg in 2019. This is slightly lower than the figure reported to the CLRTAP (0.9 tonnes). Figures reported to the CLRTAP are largely based on Tier 1 emission factors dating from 1992, which represent an average of crematoria both with and without abatement systems. As uptake of emissions abatement technologies has likely increased since these emissions factors were produced, it is likely that they overestimate emissions in 2019.

Emissions are forecast to gradually decline to 519 kg in 2025, and 355 kg in 2030. All Member States are predicted to see a decline in emissions over this period.

Figure 13: Estimated mercury emissions from crematoria (2019, 2025 and 2030)

Figure 14: Estimated mercury emissions per Member State from crematoria (2019, 2025 and 2030 122 )

3.Baseline for MAPs

Approach

The purpose of the baseline scenario is to predict manufacture and export of MAPs, the associated mercury use and the probable impacts in the near future. While the relevant legal framework in the EU is considered as constant (taking into account restriction that will enter into force the coming years), the legal situation in importing countries and on the global level is currently changing or may change soon. The legal situation as well as national programmes/ initiatives that will lead to a change of demand products exported from the EU was analysed and considered. Moreover, rising environmental awareness, as well as technical progress and increasing price competitiveness, may also lead to a decline in end-user demand. Such developments are indicated by past and current trends in export volume or sale patterns in importing countries. Such data are available for lamps, but time series may not be readily at hand for other relevant products. In that case, opinions from industry experts were invited to allow at least rough estimates about future trends.

On the background of these considerations, a baseline scenario was calculated covering central boundary conditions of future developments:

·No further legal actions in the EU beyond those already agreed or planned to take place in the near future, but consideration of existing legal measures in importing countries that become effective in the near future

·The impact of potential national measures in importing countries that follow or lead to similar results as the EU restrictions laid down in the RoHS directive and the subsequent Commission regulations.

The baseline scenario considers that several countries have implemented legislation or are considering adopting legislation that mirrors, at least in part, European product-related law, especially the REACH regulation, the RoHS Directive, and the Ecodesign Directive and any associated delegated acts. Furthermore, the legal situation in some selected countries or regions were looked at in more detail.

For these scenarios, future exports of relevant MAPs in terms of number, value, and mercury content were estimated based on identified current and past trends. Trend data were available only for compact fluorescent lamps (CFL) and double-capped fluorescent lamps (linear and non-linear FL). Almost all lamps of these types are addressed by the recent Delegated Acts under the RoHS directive so that data on past trends will allow the prediction of impacts of future measures.

The situation is different for high-intensity discharge lamps (HID, HPS, HPMV, MH). Although export data are available for this group, only a part of export is related to lamp types banned within the EU.

Limited information from other sources could be gathered to allow an overview of the situation and trends for other relevant products within the scope of the present study. For them, no quantitative recent export data were available and there is currently no basis to predict future trade volumes.

The export value and the amount of mercury in CFLs and double-capped FLs was estimated for the years 2025 to 2030. For importing countries, it was calculated how much mercury will likely end up in the environment due to inappropriate waste management practices. Minamata Initial Assessments (MIAs) as well as reports on mercury waste management provided an indication which percentage of mercury in products is likely to be released during disposal.

Based on the problem description, three groups of MAPs were selected for which quantitative or at least semi quantitative data on export volumes were available:

·CFL lamps for general lighting purposes

·LFL lamps for general lighting purposes except those addressed by RoHS Annex III 2(b)4

·Dental amalgam

These three product groups most likely constitute the vast majority of MAPs both in number as well as in value currently exported from the EU.

Expected global market development: fluorescent lamps

According to a study by the IEA (2021) 123 , fluorescent lamps for general lighting purposes continue to lose significant market share. Their share (CFL+LFL) of the global market fell from 43% to 33% between 2013 and 2020. In turn, the share of LED lamps rose from 3% to 51%. While market penetration in industrialised countries is already well advanced, the situation in less developed countries is still somewhat different. A higher share of non-LED lamps is also observed in existing light sources. The authors of the IEA study expected that the LED share of the total market will increase to close to 100% by 2025. In the authors’ view, there are several reasons for this:

·The price of LED lamps and light sources continues to fall relative to other lamp types, making them even more competitive.

·The energy efficiency of LEDs has continued to increase and has doubled in five years. It is now on average well above that of CFLs and slightly above that of LFLs. A further increase (doubling again) is technically possible but is expected to be slower. In contrast, no further increase in efficiency can be expected for fluorescent lamps.

·The use of energy-saving LEDs are a low-hanging fruit to decrease energy consumption and to contribute achieving climate goals. Many, especially less developed countries (e.g., India) have started programmes to make LEDs accessible to broad sections of the population.

In an earlier publication, the IEA predicted a less optimistic expectation of future developments. It is no longer available online but cited in a recent JRC report 124 . According to this prediction, LED would dominate the market in 2025 with a 75.8% market share and would further rise to 87% in 2030. In this scenario, the share of fluorescent lamps would decrease to a market share of 23.5% in 2025 and to 12.5% in 2030. This prediction may be more realistic as for example in the EU many exemptions for lamps extend to 2025 or beyond. A global ban for all remaining fluorescent lamps for general lighting purposes cannot be agreed before COP5 of the Minamata Convention (2023) and would enter into force not earlier than two years after (rather considerably later, considering the extended time needed for national ratification and preparation).

In the area of street lighting, the share of LED lamps in new installations is expected to rise to 80% already in 2020, reaching 89% globally in 2017. Replacing existing sodium lamps with LEDs usually requires higher investments and pays off only over a longer period (4-12 years), so it will progress more slowly. The focus of investment will be in Europe, North America, and South Asia, while countries in the Arab region and Southeast Asia will continue to prefer traditional solutions.

A summary study of CLASP concluded that 48% of European exports go to countries that have RoHS-like regulations, which will also phase out CFL and LFL by 2024/2025 125 . In addition, it must be taken into account that 61% of current production is shipped to other EU countries, a market that will disappear in 2023. Thus, about 80% of the current CFL and LFL production would no longer find a market by the end of 2025 and may pose a serious challenge for the few remaining EU manufacturers to maintain their manufacturing lines.

Another major incentive to accelerate the shift to LEDs are the strongly increasing energy-prices observed since 2021 due to the combined effect of higher demand in the course of economic recovery after the COVID-19 pandemic and the aftermath of the Russian invasion of Ukraine. Higher energy prices will likely strengthen the demand for more cost-effective LEDs. However, it is too early to quantify the effect.

Business-as-usual scenario

In the baseline scenario, it was assumed that the EU does not take any further measures to restrict MAP exports. Global restrictions agreed at COP4.2 of the Minamata Convention were taken into account. The decrease in exports was extrapolated into the future according to the observed continuous development from 2008 to 2020. This represents an average global trend that already includes more or less ambitious measures taken by non-EU countries in the past.

In addition to that, based on historical experience and observed legal practice, it is considered that the EU is a forerunner in product-related policy and that countries outside the EU may decide to translate restrictions imposed in the EU into their national legislation (especially the most recently adopted restrictions on CFL and LFL). Depending on national circumstances and ambition, this will probably take place with some delay and possibly only in part (see RoHS, Ecodesign). Moreover, third country manufacturers that export products to the EU need to comply with EU rules. Establishing a RoHS-compliant product line while maintaining a non-compliant line causes extra costs in research and production so that even without domestic legislation EU law could have an effect.

An overview was prepared to gain an impression of how many years later the main recipient countries may follow the EU example or implement policies with a comparable effect (Table 9). According to the analysis, the ten countries with the highest share in EU exports could be categorized in five groups:

·Identical rules with no delay: Switzerland, Norway

·Similar rules in 2028: United Kingdom

·Similar rules in 2030: Russian Federation, United Arab Emirates

·Partially similar rules in some states: United States

·No additional national measures before 2031: China, Egypt, Republic of Korea, Saudi Arabia, Turkey

Table 12: RoHS-like legislation/programmes/standards in main recipient countries

Country	RoHS 1 (2003)	RoHS 2(2011)	Years between EU RoHS and national RoHS-like legislation
China		2018	7
Egypt			Not applicable
Norway		2013	2 (but exemptions and entry into effect identical)
Republic of Korea	2008 (lamps are not included)		Not applicable
Russia/ Eurasian Union		2016 (adopted by Member States in 2018)	7
Saudi Arabia		2021	10
Switzerland	2005		2 (but exemptions and entry into effect identical)
Turkey	2012		9
United Arab Emirates		201731	6
United Kingdom			So far consistent (including ban on CFL.i and c, but UK may decide differently/ later on new product bans
USA		Different approach (incentives)	Not applicable
Turkey	2012		9
United Arab Emirates		2017 126	6
United Kingdom			So far consistent (including ban on CFL.i and c, but UK may decide differently/ later on new product bans
USA		Different approach (incentives)	Not applicable

For each country, the percentage of lamps that are likely not affected by national measures was derived for the years 2025, 2028 and 2030 (100% or 0%, for USA: 85% and 70%, Table 10). These values were multiplied with predicted EU exports to the individual countries. This resulted in a reduced number of total exports.

Table 13: Impact of national policy measures on export of FLs from the EU (100% = no specific national impact)

Country	2025-2027	2028-2029	2030
China	100%	100%	100%
Egypt	100%	100%	100%
Norway	0%	0%	0%
Rep. of Korea	100%	100%	100%
Russian Federation	100%	100%	0%
Saudi Arabia	100%	100%	100%
Switzerland	0%	0%	0%
Turkey	100%	100%	100%
United Arab Emirates	100%	100%	0%
United Kingdom	100%	0%	0%
United States	85%	85%	70%

Predicted export volumes in 2025 to 2030 (lamps)

Export data for discharge lamps was obtained from the EU-PRODCOMM and UN-COMTRADE databases.

Based on the data from 2008 to 2020, trends were developed from which the future development was predicted. The year 2008 was chosen as starting point because a historic peak in the export volume of discharge lamps was achieved in this year. In the following years, exports declined continuously. The development of exports in this period can be represented by different function types. From a statistical point of view, the decrease in exports would be best described linearly. However, this would inevitably lead to a complete disappearance of exports in a few years. As long as there are still existing installations that can be fitted with fluorescent lamps at low or no cost, demand will continue to exist, even if the use of LEDs would be more economical in the long-term. It therefore seems more obvious to describe the decrease in exports by an exponential function. It also leads to a continuous decrease, but it slows down more and more. To derive a bandwidth, standard deviations were calculated from the deviations between the smoothing curve and the reported export volumes. The upper and lower limits of the range were derived from the predicted curve by adding or subtracting twice the standard deviation. This was done on the basis of the logarithmic export figures due to high relative differences in size between the older and more recent export figures. The range, therefore, becomes narrower in absolute terms, but it is constant on a relative scale. The following figures show that all export data lie within or at least just outside this range (Figure 20).

Figure 15: Reported and predicted amount and value of exported CFLs and double-capped FLs (incl. LFLs) between 2008 and 2030

Future development of exports can also take a different course. Decisions by individual manufacturers to rearrange production capacity among production sites worldwide or changed international flows of goods (which affect lamps that are only distributed via the EU to countries outside the EU) can influence exports beyond the calculated ranges. It was observed, for example, that the value of exports decreases faster than the number of exported lamps – the average price achieved thus decreases so that in individual cases the limit of profitability could be reached. This may lead to an abrupt end of individual production lines. In addition, production exceeding annual demand has been observed in recent years. Thus, stocks may have been built up in view of expected restrictions on placing on the market. Reducing these stocks by relocating them abroad would lead to exports that exceed expectations.

Also, the legal framework in the current export markets is not predictable. Increased efforts to meet climate targets are already leading to increased scrutiny of the lighting sector. A forced phase-out of less efficient fluorescent lamps could be one of the rather easy ways for more countries to save energy. The forecast presented here therefore only sketches one of several possible development paths.

The projected exports for the BAU scenario are summarised in Table 11. According to these and under BAU, 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%.

Acronym	Meaning or definition
AEL	Associated Emission Level
ASGM	Artisanal and Small-Scare Gold Mining
BAT	Best Available Techniques
BAU	Business As Usual
BREF	Best Available Techniques Reference Document
BRG	Better Regulation Guidelines
CAMEO	Crematoria Abatement of Mercury Emissions Organisation
CFL.i	Compact Fluorescent Lamp with integrated ballast
CFL.ni	Compact Fluorescent Lamp with non-integrated ballast
CJEU	Court of Justice of the EU
CLRTAP	Convention on Long-Range Transboundary of Air Pollution
COP	Convention of the Parties
DEFRA	Department of Environment, Food and Rural Affairs
DMFT	Decayed, Missing and Filled Teeth
EAC	Equivalent Annual Cost
EC	European Commission
EEA	European Environment Agency
EGD	European Green Deal
ELV	Emission Limit Value
EMEP	European Monitoring and Evaluation Programme
EPA	Environmental Protection Agency
EU / Union	European Union
HELCOM	Helsinki Baltic Marine Environment Protection Commission
Hg	Mercury
HID	High Intensity Discharge Lamps
IA	Impact Assessment
IED	Industrial Emissions Directive
HPS	High Pressure Sodium lamps
IQ	Intelligence Quotient
LED	Light-Emitting Diode
LFL	Linear Fluorescent Lamp
MAP	Mercury-Added Product
MCP	Medium Combustion Plant
Member States	Member States of the European Union (EU 27)
MIA	Minamata Initial Assessment
NEC	National Emissions Reduction Commitments
OSPAR	Convention for the Protection of the Marine Environment of the North-East Atlantic
OPC	Online Public Consultation
R&D	Research and Development
REACH	Registration, Evaluation, Authorisation and Restriction of Chemicals
RoHS	Restriction of Hazardous Substances
SCENIHR	Scientific Committee on Emerging and Newly Identified Health Risks
SCHER	Scientific Committee on Health and Environmental Risks
SDG	Sustainable Development Goal
SMEs	Small and Medium Size Enterprises
Third countries	Non-EU countries
TFEU	Treaty on the Functioning of the European Union
TSS	Targeted Stakeholder Consultation
UNEP	United Nations Environment Programme
UWWTP	Urban Wastewater Treatment Plants
WHO	World Health Organisation
ZPAP	Zero Pollution Action Plan

Parameter	Export from EU (2020)	BAU 2025	BAU 2028	BAU 2030
CFL (million units)	35,5	15 – 32	11 – 24	8 – 17
Double-capped FL (million units)	121,6	69 – 108	54 – 85	41 – 65
Total export (million units)	157,1	83 – 141	65 – 109	49 – 83
CFL (million EUR)	33,6	16 – 24	10 – 16	7 – 11
Double-capped FL (million EUR)	58,6	26 – 52	19 – 37	14 – 27
Total export value (million EUR)	92,2	42 – 76	29 – 53	21 – 38
Mercury content CFL (kg)	62-64	26 – 58	19 – 43	14 – 31
Mercury content in, double-capped FL (kg)	388-438	219 – 356	172 – 280	132 – 214
Total mercury content (kg)	450-501	245 – 414	192 – 323	146 – 246