5 Amendments of Ulrike MÜLLER related to 2016/0023(COD)
Amendment 119 #
Proposal for a regulation
Recital 11
Recital 11
(11) The export, import and manufacturing of a range of mercury-added products accounting for a significant share of the use of mercury and mercury compounds within the Union and globally should be prohibited; continued use should be strictly monitored and meet the conditions set out in Articles 3 and 4 of this Regulation.
Amendment 146 #
Proposal for a regulation
Recital 17
Recital 17
(17) The use of dental amalgam in an encapsulated form and the implementation of amalgam separators should be made mandatory to protect dental practitioners and patients from mercury exposure and to ensure that resulting mercury waste are not released into the environment, but are collected and subjected to sound waste management. Given the size of the undertakings from the dentristry sector concerned by this change, it is appropriate to provide sufficient time to adapt to the new provision and to encourage the dentistry sector to gradually and permanently reduce the use of dental amalgam.
Amendment 169 #
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 2 a (new)
Article 3 – paragraph 1 – subparagraph 2 a (new)
The first subparagraph shall not apply to the export of mercury and of mercury compounds and mixtures listed in Annex I used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities involving mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.
Amendment 173 #
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
The import of mercury and of mercury compounds and mixtures listed in Annex I shall be permitted if used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities with mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.
Amendment 216 #
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
1a. From one year after the entry into force of this Regulation, dental amalgam shall not be used for the treatment of pregnant or breastfeeding women or children who undergo treatment on their deciduous teeth.