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Webinar: A change is REACHed for nanomaterials

In December 2018, the long-awaited update to REACH intended to more explicitly account for nanomaterials formally entered the statute book. This update introduces new concepts, could require extensive updates to registration dossiers for some registrants and may impact on actors further down the supply chain.

Nanomaterials are a subgroup of chemicals defined by their size and can display unique physical, chemical and toxicological properties not seen in other forms of the same substance. How well REACH addresses the unique properties of some nanomaterials has been debated since the regulation was introduced. The rash of Board of Appeal decisions in 2015-2016 made it clear that some amendments needed to be made to allow ECHA to have sufficient information to decide whether the risks from these substances are adequately understood and controlled. The update to REACH establishes the concepts of nanoforms and sets of similar nanoforms as part of the regulatory lexicon.

So how will the update impact on existing registrations and downstream users?

  • Manufacturer/importers of powders will need to investigate whether they have a nanomaterial or not.
  • Particle characterization of nanomaterials will be needed.
  • Potentially, different grades of the same substance will require separate hazard, exposure and risk assessments within the same dossier.
  • Nano-specific protocols must be used to meet the endpoint requirements of Annexes VII – X and higher tier tests could be required for low volume nanomaterials.
  • Grouping and read-across of nanomaterials, a topic that is still in its infancy, will be relied on heavily to avoid excessive animal testing and costs.
  • Downstream users could need to investigate whether modifications they perform will require adaption of a supplied exposure scenario.

This webinar will give more detail on the obligations arising from the update to REACH and will also discuss how nanomaterials are treated under other EU regulations.

Who should attend?

  • Regulatory compliance officers for manufacturers and importers of powders
  • Formulators and product manufacturers of nano-enabled products
  • Researchers in nanotechnology
  • National and regional regulators

Presenters

Dr Neil Hunt – Yordas Group

Neil has worked in the regulatory arena for 8 years, having been a Process Development Chemist for Sigma-Aldrich and Millennium Pharmaceuticals. He has been a part of a number of EU-funded projects focusing on the risk assessment of nanomaterials and has been an industry representative of the Partner Expert Group developing the nanospecific guidance documents for REACH.

Dr Hubert Rauscher – European Commission, DG Joint Research Centre (ISPRA)

Hubert has worked on the physicochemical characterisation of nanomaterials for over 20 years, having been a lecturer at the University of Ulm, Germany, and as scientific officer for the European Commission’s Joint Research Centre (JRC). His current focus at the JRC is providing policy support on nanomaterials and nanosafety and regulatory methods.

Date/Time

Thursday 21 February 2019, 13:00-14:00 GMT