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EU Penalties for dentists misusing dental amalgam

For the effective implementation of regulations, it is necessary to establish penalties in case of non-compliance.

Penalties for misuse of mercury in dentistry may be found in various regulations such as Health Care Provider Acts, Public Health Regulations, Chemical Laws, or Environmental Protection Acts.

In the case of EU member states, there may also be specific penalties for violations of the provisions of Regulation (EU) 2017/852 on mercury.

According to Article 16 of the EU Mercury Regulation, Member States shall lay down the rules on penalties applicable to infringements of the Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall, by the respective dates of application of the relevant provisions of this Regulation, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Since the EU Mercury Regulation entered into force 15 Member States notified the EU about their rules on penalties (as of 19 August 2021 *) which include penalties related to the obligations to use (or remove) amalgam only in practices where an amalgam separator is available and the exclusive use of amalgam in children up to 15 years of age, pregnant and lactating women for whom amalgam is absolutely necessary for medical reasons.

*Ask The EU: 👉 https://www.asktheeu.org/en/request/article_16_of_regulation_eu_2017?

Here is an overview:

In Sweden, Finland and Denmark dentist risk a fine or an imprisonment for up to two years.

In Germany and Bulgaria, the fines are up to 50.000 €, in Austria up to 40.000 € (in case of repetition) in the Czech Republic up to 7.800 €, Slovakia up to 3.319 €, Romania up to 1.600 €, Latvia up to 1.400 € and Lithuania up to 600 €.

In Italy, the penalties specifically for the use of dental amalgam were published by the Ministry of Health on 27 October 2021. Italy imposes a fine of 10,000 to 100,000 euros on dentists who use dental amalgam in violation of the regulation.

 

Here is a list with quotes and references:

1. Sweden 🇸🇪

A fine or imprisonment for a term not exceeding two years shall be imposed for an offence against the environment if, intentionally or through negligence

👉Environmental Code (1998 :808), Chapter 29 Article 1 and Article 3 the first paragraph

2. Finland 🇫🇮

A fine or imprisonment for a term not exceeding two years.

👉Chemicals Act, Waste Management Act, Penal Code 1 § (24.8.2018/761) Deterioration of the environment

3. Denmark 🇩🇰

Unless a higher penalty is prescribed by other law, a fine shall be imposed. The penalty may be increased to imprisonment for up to 2 years if the offence is committed intentionally or with gross negligence and if, in committing the offence

1) caused damage to human or domestic animal life or health or created a danger thereof,
2) damage or danger to the environment

👉§59(1)(1) and (2) of the Chemicals Act, as laid down in Legislative Decree No 115 of 26 January 2017

4. Italy 🇮🇹

An administrative fine of 10,000 to 100,000 euros for dentists who use dental amalgam in violation of the regulation and the fine of 4,000 to 20,000 euros for those who do not ensure that the management and collection of their amalgam waste and the same penalty, as well as the temporary closure of the activity, for those who use dental amalgam or remove fillings containing dental amalgam in violation of the rules, until the installation of appropriate amalgam separators.

Atto del Governo 249. Disciplina sanzionatoria per la violazione delle disposizioni divcui al regolamento (UE) 2017/852 sul mercurio

5. Germany 🇩🇪

Any person who intentionally or negligently contravenes a directly applicable provision in legal acts of the European Communities or of the European Union may be punished by a fine of up to 50.000 €.

👉Law on Protection against Hazardous Substances (Chemicals Act – ChemG), 26 Regulations on Fines No. 11. (2)

6. Bulgaria 🇧🇬

Fines from 10 000 to 100 000 BGN; (ca. 5000 to 50000 €)

In case of a repeated violation, the fine, respectively the proprietary sanction shall be imposed in a double amount.

Act on Protection from the harmful impact of chemical substances and mixtures. Chapter eight: Administrative punitive provisions, Section I; Compulsory administrative measures, Article 44-48

7. Austria 🇦🇹

To be fined from a minimum of €500 up to €20180, in case of repetition up to €40375. The attempt is punishable.

👉Art. 71 of the Federal Chemicals Act 1996

8. Czech Republic 🇨🇿

Who uses dental amalgam in the provision of health services in contravention of directly applicable European Union legislation on mercury should be punishable with a fine up to CZK 200 000 (ca. 7.800 €)

👉Health Services Act, Zákon č. 372/2011 Sb

9. Slovakia 🇸🇰

Fines up to EUR 3 319

👉Act No. 578/2014 Coll. on health care providers, healthcare workers, health care organizations and amendments to certain laws (Art.82(10); 79(1)(bd)

10. Romania 🇷🇴

Fines from 3.000 lei to 5.000 lei (ca. 600-1.000 €) for natural persons and a fine from 5.000 lei to 8.000 lei (ca. 1.000-1.600 €) for legal persons.

👉Government Decision No 857/2011 on the establishment and sanctioning of contraventions of public health rules, Art 18. and 53.

11. Latvia 🇱🇻

A fine shall be imposed on natural persons from 30 to 430 €, and on legal persons – from 350 to 1.400 €.

👉Law of the Republic of Latvia “Latvian Administrative Violations Code” Article 88, 88.4, 166.9, 166,10

12. Lithuania 🇱🇹

Fines of between 400 and 600 €

👉Article 3. Addition of Article 1091 to the Law, Add Article 1091 to the Act: “Article 1091. Liability of legal persons for non-compliance with the requirements laid down in Regulation (EU) 2017/852” Law on Environmental Protection No XIII-1109

13. Spain 🇪🇸

Laws on Contraband, penalties provided for REACH, Prevention and Control of Pollution, Waste and Contaminated Soils, Air Quality and Atmospheric Protection, General Health, Consumer and User Protection Regulations and other complementary laws.

👉https://environmentalmedicine.eu/wp-content/uploads/Penalties-SPAIN.pdf

14. Belgium 🇧🇪

Law on product standards aimed at promoting sustainable production and consumption and protecting the environment, health and workers and Royal Decree on medical devices

👉https://environmentalmedicine.eu/wp-content/uploads/Penalties-BELGIUM.pdf

15. Luxembourg 🇱🇺

Act of February 23, 2010 concerning certain implementing rules and the sanctioning of Regulation (EC) No 1102/2008 of the European Parliament and of the Council of October 22, 2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of and the safe storage of metallic mercury.

👉https://environmentalmedicine.eu/wp-content/uploads/LU-penalties-Art-16-Hg-Reg.pdf

16. France 🇫🇷

Code de l’environnement for installations classified for the environment and Code de l’environnement regarding waste management

👉https://environmentalmedicine.eu/wp-content/uploads/Penalties-FRANCE.pdf

 

European Union:

  • Dental amalgam is being replaced in the public health care system by Glass Ionomers and Alkasite, with fees having been increased by 64%.
  • The Austrian Dental Association still rejects the proposal to fully reimburse Alkasite in the Public Program.
  • The charge of a composite filling in private dentistry continues to be about three times higher.

  • Dental amalgam is being replaced in the public health care by adhesive Materials, with fees having been increased by 10% to 27% depending on the number of dental checkups and access to social care.
  • The charge of a composite filling in private dentistry continues to be about three times higher.

  • Dental amalgam is replaced in the public health care services by Composites with fees increasing by 15%. Children up to 18 years are fully covered, adults pay a low co-payment.
  • The charge of a Composite filling in private dentistry is up to three times higher, depending on the dentist and the size and complexity of the filling.

  • Dental amalgam is replaced in the public health care services by Glass Ionomer Cements with an indication for permanent fillings (glass-hybrid) and Composites for children up to the age of 18.
  • The Dental Association rejects the planned introduction of full reimbursement for composite fillings and only accepts glass ionomer cements for the entire population.
  • The charge of a Composite filling in private dentistry is up to four times higher than currently reimbursed for composites in the public health care services.

  • Non-layered Composite fillings  are replacing dental amalgam with reimbursement fees only being 20% higher. 
  • The charge of a composite filling in private dentistry is about two times higher for Patients up to 18 years and up to five times higher for adults.

  • The General Health System in Cyprus currently only covers preventive services (like check-ups and cleanings), while restorative treatments such as fillings are generally not included.
  • The Health Sector Strategic Plan 2024-2026 is foreseeing to increase the oral health coverage and develop an Oral Health Plan in line with WHA 74.5 Resolution on Oral Health.
  • Dental amalgam is replaced in the public health care services by Single-Layer Composite and Compomere with fees only 12 % higher than for amalgam.
  • The charge of a Multilayer Composite filling in private dentistry is up to four times higher.

  • Dental amalgam is being replaced in the public health care by Mercury-free Alternatives, without specifying the Material, while fees having been increased by 70 %.
  • The charge of a composite filling in private dentistry is only about 40% higher.

  • Dental amalgam is being replaced in the public health care depending on municipality’s pricing structure with Composite Materials or even Laboratory-made Inlays/Onlays. The fees were increased by 72% to 123% depending on the municipality.
  • The charge of a composite filling in private dentistry is about twice as high.

  • Dental amalgam is being replaced in the public health care without specifying the alternative Material. The fees were increased by 52 % while the share of reimbursement to the patient was reduced from 70% to 60%.
  • The charge of a composite filling in private dentistry is now about three times higher.

  • Dental amalgam is being replaced in the public health care by Self-Adhesive Materials and Bulk-fill Composites (in exceptional cases), with fees having been increased by 8 %.
  • The charge of a composite filling in private dentistry continues to be about four times higher.

  • Oral healthcare in Greece is almost entirely provided by private practitioners, with patients paying the entire cost of the care themselves. The participation of private dentists in the public health system (EOPYY) is minimal.
  • Within NHS hospitals dentists provide simple and complex dental fillings for children up to the age of 14 and simple dental fillings for adolescents and adults that are covered by the EOPYY.
  • Aesthetic fillings were added to the reimbursement system in 2011 with fees only 14 % higher than for dental amalgam. Dental fillings are free for citizens up to the age of 18, students, people aged 62 years or older, and pregnant women.
  • The charge of a Multilayer Composite filling in private dentistry is probably up to two times higher.

  • Dental amalgam is being replaced in the public health care by Composite with adhesive, while fees having been increased by 60 %.
  • The charge of a composite filling in private dentistry is about twice as high.

  • Dental care is mostly private in Italy (only 4% of dental care is provided within the National health system) so most of the population (more than 95%) pays for dental care out of pocket.
  • The Servizio Sanitario Nazionale (SSN) guarantees dental restorations to individuals of developmental age and to vulnerable people, but does not specify the material used. There were no significant changes with the ban on dental amalgam.
  • The charge of a Composite filling in private dentistry is up to five times higher than a filling in the SSN.
  • Dental amalgam is replaced in the public health care services by Composite, Compomere and Glass Ionomer Cement with fees only 53 % higher for Composites, but only children up to 18 years and other stipulated groups are covered.  
  • The charge of a Multilayer Composite filling in private dentistry is about five times higher.

  • The Public Health Services only cover dental fillings for children. Medical Centers serving Ministry staff (police, border guards, firefighters, etc.) fully reimburse Composite and Glass Ionomer fillings.
  • The estimated cost for a Composite filling in private dentistry may range between 70 € and 150 €, depending on the dentist and the size and complexity of the filling.

  • Dental Fillings continue to be reimbursed in the public health care system without specifying the material. Children up to 18 years get fully reimbursements, adults 88%. The fees were increased in April 2025 by 12,5%.
  • The charge of a Composite filling in private dentistry is up to three times higher.

  • Malta’s NHS fully covers Dental Fillings in public hospitals or Maltese health centers (public service clinics) for diabetics and people on social security (means tested based on income, assets, or overall financial situation)
  • However, most dentists have their own private practices. For private practice, the patient has to pay directly for the dental treatment received. All restorations done privately are paid for by the patient out of pocket and there is no coverage.
  • Dental amalgam is replaced in the public health care services by Glass Ionomer, Glass Carbomer or Compomere and Composite with fees about 21% to 42 % higher than for dental amalgam, but only children up to 18 years are fully covered.
  • The charge of a Composite filling in private dentistry is usually not higher than in public dentistry as the fee-recommendations by the dental association also apply to adults. Dentists are never the less free to charge more.

  • Dental amalgam is being replaced in the public health care by Glass Ionomer Cements, High Density Glass Ionomer Cements and Resin-reinforced Glass Ionomer Cements, with fees having been increased by 17 %.
  • The charge of a composite filling in private dentistry continues to be about four to five times higher.

  • In Portugal, the public healthcare system covers dental fillings, without specifying the material, only for children and adolescents up to the age of 18, pregnant women and elderly individuals receiving the solidarity supplement. Annual vouchers for dental treatments could last for simple and complex fillings, but also need to be used for preventive measures.
  • The charge of a Composite filling in private dentistry is comparable to the reimbursements received under the public program.

  • Dental Fillings continue to be reimbursed in the public health care system without specifying the material. Children up to 18 years and other stipulated groups get fully reimbursements, adults 60%. The fees increased in October 2024 by 12%.
  • The charge of a Multilayer Composite filling in private dentistry is up to three times higher.

  • Dental amalgam is replaced in the public health care services by Glass-Ionomer Cements or Single Layer Composites with fees about 28% to 48 % higher than for dental amalgam, but only children up to 18 years are fully covered, adults receive subsidies. 
  • The charge of a Multilayer Composite filling in private dentistry is not significantly higher.

  • Dental amalgam is replaced in the public health care by Composite and Compomere while fees are increasing by 96 % for adults older than 26 Years.
  • The charge of a composite filling in private dentistry is about twice as high.

  • The Spanish National Health System (SNS) does not comprehensively cover dental care including dental fillings; much of dental care is paid out-of-pocket or via private insurance.
  • A recent announcement by the Spanish government indicates that an “oral health plan” will benefit about 13 million people by extending public coverage of certain dental services.
  • Dental amalgam is being replaced in the public health care by Composites with adhesive. Subsidies for dental amalgam were already removed in 1999.
  • The charge of a composite filling in private dentistry is less than two times higher than referenced in the public health care system.

Europe:

  • Norway introduced a general ban on dental amalgam in 2008, with three years exemptions for special cases.
  • The Public health services cover Composite and Glass Ionomer fillings for children up to 18 years, mentally and physically disabled people and groups of seniors.
  • The Charge of a Composite filling for adults in private dentistry is up to 25 % higher than in public dentistry, depending on the dentist and the size and complexity of the filling. (approx. 1.000-2.500 kr vs. approx. 1.000-2.000 kr