7 March, Lisbon: REACH CLP and BPR
NIA presented ‘nanomaterials under REACH’ at an excellent conference that grew from the LinkedIn Group REACH, CLP and Biocides Regulations and hosted by the enthusiastic Carlos Miguel Fazendeiro. The meeting was attended by 120 people and you can catch up with the event from its short video.
20 March, Brussels: Parliament meeting ‘Handling innovation in Nanomedicines’
NIA failed to get any croissants in a breakfast meeting at the Parliament hosted by EAACM ‘Handling innovation in nanomedicines: regulatory challenges and opportunities in modern healthcare’. There is no regulatory definition for nanomedicine and NIA wishes luck to anybody that takes on that task, given the immense complexity of materials and applications, with materials being closer to biologics than conventional chemistry. Lessons from biosimilars in ensuring consistency and standardisation are probably more relevant, while the level of existing requirements to ensure safety in medicines, both in the US and EU, means that nano could well need no further regulatory detail.
27 March, Brussels: NIA’s 8th Annual Symposium
We were delighted to be joined by 50 participants from industry, policy, regulation and research for an intense day of presentation, discussion and networking. The discussed nanomaterials at the interface between all these worlds, and takes a scientific, business, policy and regulatory perspective. 2019 brought a focus on nano in advanced applications, future societal positions, how nano is evolving at EU level, the business bottlenecks, regulatory and standards pathways and finally, the topic for the afternoon – Nano in Waste. This was a really good open discussion about whether nanomaterials needed additional regulatory structures based on current knowledge and practicability and you needed to be there or be a Member to find out the answer! Catch up with the agenda and speakers HERE.
1-2 April, Parma: EFSA Stakeholder workshop on nanoscience and nanotechnology
NIA was one of participants, mainly from industry, hosted by the European Food Safety Authority to gather first views and inputs on the EFSA 2018 ‘Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health’. NIA presented ‘Bottlenecks faced in the industry and multi-disciplinary approach in risk assessment of nanomaterials: A Regulatory perspective’. The inputs from the event will feed into the EFSA working group to revise and update the guidance document for publication late 2019, or early 2020 as a final EFSA Guidance. Catch up with all the presentations HERE.
9 April, Helsinki ECHA PEG Meeting Nanoform Guidance
As part of the Partner Expert Group (PEG), NIA travelled up to Helsinki to join 25 participants from Members States, NGOs, ECHA and industry in discussing ECHA’s draft Appendix for nanoforms applicable to the Guidance on registration and substance identification. ECHA received 780 comments to the February draft and the meeting anticipated to be ‘lively’, was actually perceived to be constructive and conclusions were agreed. NIA looks forward to the next version by June and hopefully a published document by December.