REACH authorisation of Tritons
Posted on 03.12.2015
The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), and the European Diagnostic Manufacturers Association (EDMA) approached high level EU officials with a joint letter in order to raise their awareness with regards to great impact that REACH authorisation of Tritons (4-tert-Octylphenol ethoxylates) would bring to the in vitro diagnostic medical device, pharmaceutical, clinical chemistry and laboratory medicine sectors.
Use of Tritons has been a golden standard in thousands of diagnostic tests for many decades and the prioritisation of Tritons requires their substitution which would trigger a lengthy investigation (validation, verification and stability trials) at the level of each individual test. It might lead to interruption of blood supply screening and clinical chemistry testing availability in Europe. The effects on European investment and jobs are estimated to be substantial impacting diagnostic manufacturers’ businesses, 95% of which are SMEs.