Availability of mercury for homeopathic and anthroposophic medicinal products
30 Mar 2017
A new EU regulation on the import and export of mercury may have an impact on the availability of mercury, mercury compounds and certain mixtures of mercury for use in homeopathic and anthroposophic medicinal products.
Mercury (mercurius) is an important starting material for some homeopathic and anthroposophic medicinal products, used in highly diluted form and commonly prescribed by homeopathic and anthroposophic doctors and practitioners.
Current EU policy bans exports of mercury, provides for the storage of mercury waste, restricts the use of mercury in various products and seeks to address the pollution it causes. In 2013, the EU signed the United Nations’ Minamata Convention on mercury, a global treaty to protect human health and the environment from the adverse effects of mercury. Although mercury use has declined significantly in recent decades, mercury released into the air, water and land remains a serious threat to human health and the environment. Once emitted into the air or water, mercury can travel over long distances, which makes it a global problem. One important element of the Minamata Convention is a ban on new mercury mines, and the phasing out of existing ones.
The report on the proposal for a regulation of the European Parliament and of the Council on mercury, and repealing Regulation (EC) No 1102/2008 was adopted by the European Parliament on 14 March, as part of the Minamata ratification package, the aim of which is to update EU law where needed to fully conform with the Minamata Convention.
During the course of the legislative process, ECHAMP worked with other associations to secure the future import and export of mercury and its compounds used as starting material for homeopathic and anthroposophic medicinal products. The resulting legislation will permit the import into the EU of mercury compounds. It will also permit the import into the EU of mercury and of certain mixtures of mercury for the production of homeopathic or anthroposophic medicinal products, so long as their use is allowed in the Member State and with the exception of mercury from primary mining. However, the export outside the EU of mercury and of certain named mercury compounds and mixtures of mercury is prohibited. There is no exception for starting material for homeopathic medicinal products, although the export of certain named mercury compounds for the purposes of laboratory-scale research or laboratory analysis will be allowed. The import and export of certain mercury compounds and certain mixtures of mercury only for the purpose of reclaiming the mercury are also prohibited.
Finished medicinal products including finished homeopathic and anthroposophic medicinal products will not be affected by this export prohibition nor by the new import provision. It will also remain possible, under certain conditions, to export semi-finished homeopathic or anthroposophic medicinal products containing mercury, mercury compounds or mixtures.
Under the Minamata Convention, primary mining of mercury will be phased out within the next 15 years, meaning a future scarcity or lack of availability of the ‘natural’ primary source of this important starting material for these medicinal products. Recycled mercury will still be available.
Subject to approval by the Council, the Regulation should be implemented from 1 January 2018. Although directly applicable in all Member States, Member States may apply stricter requirements than those laid down in the Regulation.