EU Regulation No 1935/2004 sets out the harmonised legal framework and general principles and mandatory requirements for ensuring that all FCMs are safe. Similar, harmonised, binding rules exist for other FCMs such as plastics and ceramics.
There are no harmonised EU measures for metals and alloys. However, nationally, some countries, including Belgium, France, Finland, Italy and the Netherlands, do have their own specific legislation.
In an effort to harmonise rules, Council of Europe member states adopted resolutions and Technical Guidelines on FCMs. The Guidelines for metals and alloys used in FCMs provide an important reference for regulators, manufacturers and businesses in the FCM value chain. These recommend specific release limits (SRLs) for metals, specify test conditions and set out a methodology designed to support compliance with the EU framework Regulation on FCM.
The current European Directorate for the Quality of Medicines (EDQM) Guidelines recommend an SRL of 0.14 mg/kg for nickel. This is based on the WHO Tolerable Daily Intake of 0.012 mg/kg body weight/day (0.7 mg/day). The SRL is meant to protect against contact dermatitis in nickel-sensitive individuals.
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