Phase down off Amalgam Use
The Regulation on Mercury is the plan adapted by the EU in 2017 for the ratifying of the Minamata Convention, which is a global treaty that aims to protect the environment from mercury pollution and requires that participating countries phase-down their use of dental amalgam. The regulation covers the use, storage and trade in mercury, mercury compounds and mixtures of mercury, the use of and trade in mercury-added products, and the management of mercury waste.
Regulation (EU) 2017/852 contains the following provisions relating to dental amalgam:
- From 1 July 2018, dental amalgam shall not be used for dental treatment of deciduous teeth, of children under 15 years and of pregnant or breastfeeding women, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient.
- A requirement for a national plan, by 1 July 2019, on measures to phase down the use of amalgam.
- From 1 January 2019 a requirement for dental facilities to be equipped with an amalgam separator.
- From 1 January 2019, dental amalgam shall only be used in pre-dosed encapsulated form.
What is the Longer-term Future of Dental 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 dental amalgam.
- The EU Regulation requires Member States to set out a national plan, by 1 July 2019, outlining intended measures to reduce dental 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.
- Despite the UK's intention to leave the EU in 2019, the Regulation has been transposed into UK law and we therefore expect this work to be continuing.
The Practicalities for Dental Practitioners
The restrictions of the future use off mercury for clinicians is now a factor that needs to be considered when discussing choice with patients in order to obtain their valid consent.
The wording of the regulation leaves scope for dental practitioners to exercise clinical judgement and, based on the informed consent of the patient or their parent/guardian, place an amalgam restoration when this the most appropriate course off action.
Can I Still use Dental Amalgam in my Patients?
Yes, with some restrictions. Dental 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 are the Restrictions in Specific Patient Groups, and Why?
The EU Regulation states that, from 1 July 2018, dental 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 dental amalgam in these patient groups, we assume that this is intended to formalise the principle of phasing down dental amalgam use in situations where any intervention should ideally be minimised.
Should Patients Have Existing Amalgams Removed?
There is no justification for removing clinically satisfactory dental amalgam restorations as a precaution, except in those patients properly diagnosed as having allergic reactions to amalgam constituents. This is a rare situation. The process of removing dental amalgam restorations temporarily releases mercury vapour.
What Can I Tell Patients About the Safety of Dental Amalgam?
It should be emphasised to patients that change in approach is part of an environmental agenda, rather than a patient safety issue.
Why is Dental Amalgam an Environmental Problem?
The consumption of fish and other seafood contaminated with methylmercury is the main source of mercury exposure for the majority of the general population. Methylmercury is the most toxic form of mercury, and the most prone to accumulate through the food chain. There is no evidence that the elemental form of mercury present in dental amalgam, which is more stable, poses a health risk to people who have amalgam fillings. However, when dental amalgam is released into the environment, the mercury it contains can be converted into methylmercury by aquatic microbes. This can then accumulate in the food chain and result in an indirect contribution of dental amalgam to human mercury exposure.
SDCEP Advice click here >
BDA Advice click here >