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Description of the draft amendment: Expanding scope of exemptions from manufacturing and import business licenses, clarifying scope of medical device advertisements, overhauling recall procedures for medical devices, establishing the management standards for integrated information of medical devices and Integrated Medical Device Information System (IMDIS) including UDI (Unique Device Identification), rationalizing GSP (Good Supply Practice).
The Court of Justice of the EU (CJEU) ruled on Thursday (21 June) that Germany had breached EU law by allowing an excessive use of manure as a fertiliser, thus violating the limits set out in the EU’s nitrates directive which aims to reduce water pollution caused by nitrates from agricultural sources.“Manure doesn’t appear ou...
Humans and wildlife are exposed to an infinite number of different combinations of chemicals, via food, consumer products and the environment. Combined exposure to multiple chemicals can lead to unacceptable effects, even if single substances in the mixtures are below their individual safety thresholds. The assessment and management of chemical mix...
In February 2018, the European Commission announced that it had commissioned Oeko Institut to conduct another substance review project under the RoHS Directive.Seven shortlisted substances have been identified, including Beryllium and its compounds, to be assessed in the frame of a future review and amendment of the RoHS Directive.BeST objects...
On June 13, 2018, President Temer enacted Decree No. 9,406/18, which modernizes certain aspects of the Brazilian Mining Code Regulations. It is important to clarify that the Mining Code itself has not been modified and the new rules shall only become effective upon the enactment of a further Decree installing the National Mining Agency (ANM). We ha...
The Strategic Approach to International Chemicals Management (SAICM) is a policy framework for promoting chemical safety around the world. SAICM sets itself apart through its comprehensive scope: ambitious “2020 goal” for sound chemicals management; multi-stakeholder and multisectoral character; endorsement at the highest political leve...
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