Published: 21 January, 2019
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.
As part of the GRACIOUS project, an H2020 EU-funded project investigating approach for the grouping and read-across of nanomaterials, Yordas Group and the European Commission’s Joint Research Centre will be hosting a webinar that will summarise these updates to REACH. The presentation discusses how nanomaterials are covered in the EU with an emphasis on new developments. Nanomaterials are present in almost any industrial sector and are implicitly or explicitly addressed in EU legislation on chemicals and certain consumer products. We will start with an overview of EU Regulations with relevance for nanomaterials and a brief discussion of the EC’s definition of the term ‘nanomaterial’. We will then focus on the provisions for nanomaterials in REACH, the European regulation on chemicals, and discuss its amended annexes with new requirements on how to register and which information to provide on ‘nanoforms’. The presentation finally reviews nanospecific provisions in other sector-specific regulations, e.g. biocides, food, cosmetics and medical devices.
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. It potentially means that different grades of the same substance will require separate hazard, exposure and risk assessments within the same dossier. Nano-specific protocols to meet the endpoint requirements of Annexes VII – X have been formally included and grouping and read-across of nanomaterials, a topic that is still in its infancy, may be relied on heavily to avoid excessive animal testing and costs. These revisions will impact on more than just those who intend to manufacture nanomaterials. Anyone who has registered a powder under REACH may need to revisit their substance characterisation to check whether they have a nanomaterial or not and downstream users could need to investigate whether modification they perform will require adaption of a supplied exposure scenario.
Join Dr Neil Hunt,Yordas Group and Dr Hubert Rauscher, European Commission, DG Joint Reserach Centre (ISPRA) on Thursday 21st February 2019, 2:00PM - 3:00PM GMT for our latest webinar.