Use of dental amalgam in the UK: what do I need to know?
The European Parliament agreed on 14 March 2017 to the final version of its Regulation on Mercury. The Regulation is the EU's instrument to ratify the
Minamata Treaty of 2013.
The Minamata Treaty is a global environmental treaty aimed at reducing the release of mercury into the environment. The EU's Mercury Regulation has the same aim for the territory of the European Union.
Both documents prescribe a phase-down of the use of dental amalgam for environmental reasons.
The Minamata Treaty advocates a phase-down of the use of dental amalgam, in line with the domestic circumstances of each country and in tandem with recommendations for prevention programmes and increased research into alternative materials.
The EU has formalised some of these recommendations by including them in a piece of legislation and adding some specific requirements aimed at reducing the use of amalgam.
The Regulation does not ban the use of amalgam.
The detail of the amalgam regulation
The main body of the regulation deals with a ban of mercury exports and regulation of waste mercury disposal, as well as prohibiting within the EU any future new uses of mercury in products and industry, unless significant environmental and health benefits are demonstrated and there are no mercury-free alternatives.
In relation to dental amalgam, it stipulates the following:
No use of amalgam in: the treatment of deciduous teeth; in children under 15 years; or pregnant or breastfeeding women, except when strictly deemed necessary by the practitioner on the ground of specific medical needs of the patient (from 1 July 2018)
- Dental amalgam only to be used in pre-dosed encapsulated form; use of bulk mercury by the practitioner prohibited (from 1 January 2019)
- Mandatory use of amalgam separators (from 1 January 2019)
- Service standards from Jan 2019: mandatory retention of at least 95% of amalgam particles for separators installed from Jan 2018, and for all separators by 1 January 2021
- Dentists to ensure that their amalgam waste is handled and collected by an authorised waste management establishment
- Member States to set out a national plan (by 1 July 2019) on the measures they intend to implement to phase down the use of dental amalgam
- The Commission to report (by 30 June 2020), on the outcome of its assessment regarding:
- the need for the Union to regulate mercury emissions from crematoria;
- the feasibility of a phase out of dental amalgam use in the long term, and preferably by 2030, taking into account national plans for measures to phase down amalgam use, and respecting Member States' competence for the organisation and delivery of health services and medical care.
What is the BDA's position?
We have worked alongside the Council of European Dentists (CED) to avoid a full ban of dental amalgam, which was included in earlier proposals of this Regulation and intended to be implemented by the early 2020s.
There is still an intention to phase out amalgam on environmental grounds, possibly by 2030, but only following a full feasibility study to which we and the CED will contribute.
With the provisions of this Regulation, amalgam remains one of a range of safe and effective filling materials that are available to dentists to provide the most appropriate treatment for the needs of each individual patient.
Both the Minamata Treaty and the EU Regulation recognise the need for further development and optimisation of alternative materials, in addition to a greater focus on the prevention of dental disease, as necessary steps towards an eventual phase out of amalgam.
New restrictions of use
The Regulation does introduce a restriction, from 1 July 2018, on the use of amalgam in children under 15 years of age, and in pregnant and breastfeeding women, unless deemed strictly necessary by the practitioner on the grounds of medical needs of the patient.
The issue of pregnant women (and by extension, breastfeeding women), is best explained by the general approach that all dental interventions regardless of materials used should be kept to a minimum during pregnancy; it is not a reflection on any specific safety concerns about amalgam.
The restriction on use in children under 15 is not based on any robust evidence. We can only assume that permanent teeth in young children might be deemed to have smaller cavities, which are best treated with alternative materials in accordance with a minimally invasive approach, but an explanation for this point has not been given.
EU's Scientific Committee has recommended that:
"To reduce the use of mercury-added products in line with the intentions of the Minamata Convention (reduction of mercury in the environment) and under the above mentioned precautions, it can be recommended that for the first treatment for primary teeth in children and in pregnant patients, alternative materials to amalgam should be the first choice."
What is the BDA doing about the impact on dentists?
We know that many practitioners are concerned about the increased time required and extra costs of using other restorative materials, particularly those who are working under a NHS or Health Service contracts.
We are pressing the devolved Government departments to address these concerns, and we are arguing for a workable solution to ensure dental practitioners are not left out of pocket.
In England, we have asked for a meeting with NHS England and are awaiting a response, and we are doing similiar lobbying work in Wales.
In Northern Ireland four new fees for the provision of non-amalgam fillings for under 15-year- olds and pregnant/breastfeeding women have been agreed. GDS activity in relation to these new fees will be monitored and BDA Northern Ireland will continue to engage with the Department of Health as these are reviewed.
The Scottish Government has introduced relevant fees for children under 15-years old with a review of the fees in 12 months-time, and BDA Scotland will continue to monitor the situation.
It is important to note that the EU Regulation on Mercury is an environmental regulation, not a health regulation. The EU cannot make laws that directly change the way health systems in member states are arranged.
EU's Scientific Committee is clear that:
"Current evidence does not preclude the use of amalgam in dental restorative treatment in the general population. Dental restorative therapy during pregnancy, as for any other therapeutic treatment, should be limited as much as possible in order to reduce the exposure of the foetus. The choice of material should be based on patient characteristics such as primary or permanent teeth, pregnancy, the already existent number of dental amalgam fillings, presence of allergies to mercury or other components of the restorative materials, and presence of decreased renal clearance."
Nevertheless, the aim of the Regulation is to reduce the use of dental amalgam in the medium- to long-term, and to phase it out eventually.
This can only be achieved with a focus on long-term prevention of dental disease as well as research into the appropriateness and environmental risks of alternative materials and related teaching of the use of such materials to dentists and their teams.
We will be working with the UK Departments of Health to develop advice for dental practitioners.