What is the Regulation and why do we need it?
The Regulation on Mercury
is the EU's plan for ratifying the Minamata Convention
, which is a global treaty that aims to protect the environment from mercury pollution.
Dental amalgam makes a small contribution to this pollution, and measures specified by the Regulation are designed to minimise the release of amalgam into the environment as well as phasing down its use gradually over several years.
Both the Minamata Convention and the EU Regulation recognise that amalgam is a safe, durable and cost-effective material; the measures are purely for environmental protection and do not reflect any evidence-based concerns about adverse effects of amalgam on human health.
The UK dental profession has a longstanding commitment to environmental responsibility and has already implemented many of the measures stipulated by the Regulation.
Why do we use amalgam for filling cavities?
We use dental amalgam because it is a proven, easily manipulated, durable, strong, loadbearing, bacteriostatic and cost-effective material that is straightforward and swift to place in cavities of all sizes.
Can I still use amalgam in my patients?
Yes. Amalgam remains one of the range of restorative materials available to dentists, to enable them to provide the most appropriate treatment for the individual needs of each patient.
What measures do I need to have in place to minimise release of amalgam into the environment?
The measures are, largely, already in place in the UK. From 1 January 2019, dental amalgam must be used only in pre-dosed encapsulated form and amalgam separators will be mandatory.
Service standards are specified for separators, whereby those installed from the time when the Regulation comes into force must retain at least 95 per cent of amalgam particles; all separators must comply with this level of efficiency by 1 January 2021. Dentists must ensure that all amalgam waste is handled and collected by an authorised waste management establishment.
What can I tell patients about the safety of amalgam?
Dental amalgam has been in use and extensively studied for 150 years as a restorative material. Its safety and durability are well established, and it remains the most appropriate material for a range of clinical situations.
Some patients might raise concerns that the restrictions on use in certain patient groups, as specified by the EU Regulation, suggest that the safety of amalgam is in question. However, the Regulation is based entirely on environmental concerns and there is no evidence-based reason to restrict use in these groups on health grounds.
We would expect that if there had been any perceived health risk associated with the use of amalgam in these groups, the restrictions would have been both immediate (rather than coming into force in July 2018) and more stringent.
Should patients have existing amalgams removed?
There is no justification for removing clinically satisfactory amalgam restorations as a precaution, except in those patients diagnosed as having allergic reactions to amalgam constituents. This is a rare situation.
The process of removing amalgam restorations temporarily releases mercury vapour.
What are the restrictions in specific patient groups, and why?
The Regulation states that, from 1 July 2018, amalgam should not be used in the treatment of children under 15 years of age and in pregnant or breastfeeding women,
except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient.
As there is no reliable evidence for restriction based on adverse health effects of amalgam in these patient groups, we assume that this is intended to formalise the principle of phasing down amalgam use in situations where any intervention should ideally be minimised.The EU's expert Scientific Committee SCENIHR stated in its 2015
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.
- Children under 15 years: we surmise that this extension of the recommended restriction on primary (deciduous) teeth is based on the assumption that children tend to have small cavities, for which composite restorations would be appropriate in accordance with a minimally invasive approach. However where there are medical or dental reasons to justify the choice, the practitioner will retain the option to use amalgam.
- Pregnant women: the restriction follows the general precautionary principle of minimising any treatment when possible, as stated by SCENIHR:
As with any other medical or pharmaceutical intervention, caution should be exercised when considering the placement of any restorative material in pregnant women. It is not based on any specific evidence of harm caused by amalgam
- Breastfeeding women: this appears to be an extension of the principle for pregnant women and, again, is not based on any evidence of adverse health effects.Crucially, the wording of the Regulation leaves scope for the dental practitioner to exercise clinical judgement and, based on the informed consent of the patient or their parent/guardian, place an amalgam restoration when this is the most appropriate course of action.
What will happen when Britain leaves the EU?
We don't yet know how Brexit will affect the transposition of the EU Regulation into UK law, or its retention in UK law if transposed this year as expected.
However, we predict that the ban on import of mercury into Europe will lead to reduced availability and increased cost of amalgam, which could have significant implications for its future use.
What is the longer-term future of amalgam?
The Minamata Convention recognises the need for further development and optimisation of alternative restorative materials, in addition to a greater focus on the prevention of dental disease, as essential steps towards an eventual phase out of amalgam.
The EU Regulation requires Member States to set out a national plan, by 1 July 2019, outlining intended measures to reduce amalgam use.
A study will be commissioned to assess the feasibility of phasing out dental amalgam in the EU in the longer term, and preferably by 2030; this will report in 2020. Ensuing plans for a phase out will respect the right of Member States to determine the organisation and delivery of their own health services and medical care.
What is the BDA doing about the future of amalgam?
We have worked intensively with national and international partners over the last ten years to move the debate away from an unworkable and immediate blanket ban towards a gradual reduction in the use of dental amalgam.
We remain in close contact with DEFRA and the Departments of Health in the UK and are continuing to negotiate through the Council of European Dentists (CED) on a European level, where CED will press for representation in the Commission's work towards the phase out feasibility study.
Our domestic work on dental contract reform is ongoing, and we are lobbying hard to ensure that prevention of dental disease is a key focus of NHS dentistry.