Registration duties for nanoforms
- The regulation makes it clear that different nanoforms of substances have to be registered individually or as groups
The purpose of the regulation is to clarify registration duties for nanomaterials under REACH. The purpose of REACH is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks.
Manufacturers and importers of substances on nanoforms in 1 tonne or more per year must register their substances at the European Chemicals Agency (ECHA). ECHA evaluates the registrations for their compliance. The EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed. Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.
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Manufacturers and importers must register nanoforms, if produced in quantities of 1 tonne or more per year. If the nanoforms to be registered are manufactured or imported in quantities of 10 tonnes or more per year, a Chemical Safety Report must follow the registration. In the Chemical Safety Report, information must be gathered to document that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. It should be described whether and which different nanoforms are covered by the assessment and how the information has been compiled in the report. If the manufacturer or importer considers that the Chemical Safety Assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or “category” of substances are adequately controlled then he can use that Chemical Safety Assessment for the other substance or group or “category” of substances. The manufacturer or importer shall provide a justification for this.
A use may modify the nanoforms of the substance, potentially changing one nanoform into another form or generating a new nanoform. Downstream users shall provide this information up the supply chain to ensure that the use is adequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report.Regulation
ECHA, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this regulation for the purposes of Regulation (EC) No 1907/2006.
European Member states approve the European Commission’s draft regulation.
European Commission adopts the regulation.
The regulation enters into force.
Blog post. See attachment.