The consensus report based on the outcomes obtained during the Edinburgh meeting (April 1 and 2) has been shared with all experts, observers and sponsors. Experts have been giving input over the past 2 weeks and Kevin Driscoll and myself look forward to submit a final report before end of October. The [...]
On August 27 and 28th 2019 the MDOT consortium met in San Sebastian at CIDETEC for its first interim meeting. We discussed the business plans towards a platform organizing and sharing relevant data on clinical evaluation as well as biocompatibility to comply with the new MDR. As we speak the time for [...]
In a recent meeting of World Trade Organization Technical Barriers to Trade (TBT) committee, during which delegations of the USA, New-Zealand, Australia, Canada and Mexico expressed their concerns about several aspects of the intended classification of TiO2 as a class 2 carcinogen by the European committee. Although the EU commission claims [...]
On March 6 and 7th 2019 we had the official kick-off of our Horizon 2020 project MDOT (grant 814656, www.mdot.eu) at the Fraunhofer Institute ITEM in Hannover. The project focusses on new methods to test and certify medical devices to meet the upcoming medical device regulation (MDR) in Europe. The Medical [...]
We spent 2 full days with 15 invited experts and 15 observers to discuss the state of the art science on PSLT. In breakout sessions we discussed the definition of PSLT, the definition of overload, the releavnce of the rat as a model for PSLT inhalation toxicology and finally the human [...]
Last night most experts and observers joined us at the reception at St Leonards Hall, where they were welcomed by Paul Borm, Kevin Driscoll and Lang Tran from the IOM as one of our hosts. First bridges are being build.
Charges have been set, Experts have been briefed, observers have signed in, dinner speeches prepared!. We are ready to take off to Edinburgh to discuss the state-of-the art on Poorly Soluble Low Toxicity Particles (PSLT) hosted at the University of Edinburgh Medical Campus. We look forward to meet and great all stakeholders [...]
Our commentary on expert opinion on PSLT is now online in Particle & Fibre Toxicology. To (open) access click here.
EU Commission has started a public consultation on the 14. ATP of the CLP Regulation, deadline for input is 8 February 2019. One PSLT is involved, i.e. TiO2 and for this substance the following classification is suggested: Carc. 2, H351 (inhalation), GHS08, Wng, H351 (inhalation), Notes: V and 10 If you want [...]
The classification of TiO2 by the European Chemical Agency in 2017 has initiated a series of events and discussions that forward a workshop on particle overload and the consequences drawn from rodent inhalation studies. After the EU classification of titanium dioxide, the suggestion has been raised that Poorly Soluble particles of [...]
