Proposed mercury regulation – will the EU Council grasp the nettle?

Reading an article on the BBC website by Dr Daniel Sokol (medical ethicist at St George's, University of London), I chuckled at his anecdote about his medical students. He was recounting that when asked to name famous doctors his students first came up with Harold Shipman, the GP who murdered hundreds of patients. This was not quite the person Dr Sokol had in mind. Their next candidate was ... Dr House, from the eponymous US TV series. Eventually they named Hippocrates.

According to the Dental Ethics Manual of the World Dental Federation (FDI), the Hippocratic oath applies to dentists. The most well-known part of the oath is undoubtedly that doctors should not harm their patients: "And I will use treatments for the benefit of the ill in accordance with my ability and my judgment, but from what is to their harm and injustice I will keep them."1 Note that the oath is silent on causing pain.

I do not want to come across as being flippant, but it worth stopping and pausing for a moment about the following fact.  Today in the EU, some dentists still use a chemical ranked by the World Health Organisation (WHO) as one of the “ten chemicals of major public health concern”.2 They do not use it to disinfect their equipment or to wash their floor.  They put it in your mouth. About 44% of all the fillings used in the EU are dental amalgams.3 A dental amalgam is a tooth filling. It is made up of about 50% mercury in the elemental form. The other metals used are silver (35%), tin, copper and, other trace metals. I read recently that manufacturers of encapsulated dental amalgam typically ship their products in packaging with a “skull and crossbones” symbol affixed next to the words: “Poison, contains metallic mercury.”4 Sadly, however, these warnings are generally not passed along to the public.

I hear you thinking. Something should be done about this. And maybe something will be done. The idiomatic window of opportunity is wide open. In February 2016 the European Commission proposed a Regulation to deal with mercury. That Regulation is the EU’s response to the commitment it took in 2013 when signing the Minamata Convention, named after a Japanese town where the release of methylmercury in the industrial wastewater (from 1932 to 1968) caused severe mercury poisoning. It also gave its name to a disease. The list of symptoms induced by this disease is not pleasant, look it up. The objective of the Convention is to phase down mercury. That means to reduce the presence of mercury in the EU.

As a signatory, the EU should therefore come up with a plan. Especially now that dental amalgam will become the largest source of mercury in the EU, with current usage estimated at 75 tonnes per year.5 You would think that reducing the use of mercury in dentistry would be the next logical step, right?

That is not what the European Commission proposed. In their original proposal, the Commission selected 2 out of the nine measures listed in the Minamata Convention to phase down the use of dental amalgam. Article 10 of the European Commission Proposal, states that: (1) As of 1st January 2019, dental amalgam shall only be used in encapsulated form and, (2) dental facilities shall be equipped with amalgam separators to retain and collect amalgam residues. Given that most of the EU Member States have already made amalgam separators mandatory and that the use of dental amalgam in encapsulated form is widespread, the Proposal is little more than a cosmetic regulatory catch-up exercise maintaining the status quo.

Fortunately, the ENVI Committee of the European Parliament adopted a robust report on 13th October 2016. Stefan Eck, the rapporteur, proposed a phase out of dental amalgam for the treatment of pregnant or breastfeeding women or individuals who undergo treatment on their deciduous teeth. The phase out should come into effect one year after the date of entry into force of the Regulation. With a view to allowing the dental profession to adapt to the new rules, the use of dental amalgam in any form will only be prohibited by 31st December 2022.

This looks like the right approach to me. But to be honest, I am somewhat apprehensive about the discussions that have now started in the Council, which represents the views of the government of the 28 EU Member States. For some countries, such as Sweden, Denmark, Finland, and the Netherlands, the proposed phase out will not change much as they have already virtually banned the use of dental amalgam. This shows that mercury-free fillings are viable.

Yet for others, the phase out might not come at the right time. I fear that some Member States might not conduct these discussions on their own merit, and instead might be influenced by other considerations. For example, they could be influenced by the impact of a phase out of dental amalgam on their national (compulsory) health care insurance schemes. Also, what will be the cost of mercury-free fillings and what will the reimbursements for mercury-free fillings be? Will the use of mercury-free fillings even be reimbursed? If not, how will dentists absorb these changes? If the mercury-free fillings are more costly, will that impact the health of those economically less well-off? 

These are all valid points. But we have empirical evidence, from countries where a ban on dental amalgam exists, that shows that “the cost of mercury-free restoration has continued to decline with new technologies, and with further training and experience of dental practitioners”.6 Moreover, there are lessons to be learned from member states whose national insurance schemes are already paying for mercury-free fillings.7 The glass is clearly half full and the EU should therefore not miss the boat. It should show leadership and embrace this opportunity to get rid of what is to become the largest source of mercury in the EU. 

The ENVI Committee of the European Parliament has shown political courage and it is in effect truly representing the views of consulted EU citizens. If you consider the results of the online public consultation conducted by the European Commission on the Minamata Convention, you will see that 88% of the participating European public supported the “phase out of amalgam” over a “phase down of amalgam”.8 I hope the Council will rise to the occasion and grasp the nettle.

Philippe Vandendaele, Chemicals Policy Advisor


3 SWD/2016/017 final - 2016/023 (COD) Commission Staff Working Document Ratification and Implementation by the EU of the Minamata Convention, page 36

5 SWD/2016/017 final - 2016/023 (COD) Commission Staff Working Document Ratification and Implementation by the EU of the Minamata Convention, page 143

6 UNEP (2016)  Lesson from countries phasing down dental amalgam use, page 11