REACH Annex Revisions

• Nanoform: A form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.
• Particle: A minute piece of matter with defined physical boundaries
• Agglomerate: A collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.
• Aggregate: A particle comprising of strongly bound or fused particles.
• Set of similar nanoforms: A group of nanoforms characterised in accordance with section 2.4 where the clearly defined boundaries in the parameters in the points 2.4.2 to 2.4.5 of the individual nanoforms within the set still allow to conclude that the hazard assessment, exposure assessment and risk assessment of these nanoforms can be performed jointly. A justification shall be provided to demonstrate that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the similar nanoforms in the set. A nanoform can only belong to one set of similar nanoforms.

• Upon registration of nanoforms, names or other identifiers of the nanoforms or sets of similar nanoforms of the substance must be provided.
• Upon registration of nanoforms, specific minimum characterization information shall be provided, including number-based particle number size distribution, surface functionalization or treatment, shape and aspect ratio, specific surface area by volume and/or by mass.
• Upon registration of nanoforms, information on manufacture and use must be provided, such as tonnage used, concentration range used, quantities in articles, human and environmental exposure and waste quantities and composition.
• Registrants of nanoforms that submit joint registration dossiers, must provide adequate justification of why safety information is relevant for all registered nanoforms.
• For nanoforms manufactured or imported in a quantity of 10 tonnes or more per year, a Chemical Safety Report must be provided, which shall specify whether and which different nanoforms have been characterized as part of the registration and whether they are covered by the Chemical Safety Assessment. The Chemical Safety Report shall also contain description of how information is compiled, adequately document control of risks associated with the uses of the nanoforms and ensure that justifications and conclusions are relevant to these nanoforms along their life-cycle.
• For nanoforms manufactured or imported in a quantity of 10 tonnes or more per year, a Chemical Safety Report must be provided, which shall specify whether and which different nanoforms have been characterized as part of the registration and whether they are covered by the Chemical Safety Assessment. The Chemical Safety Report shall also contain description of how information is compiled, adequately document control of risks associated with the uses of the nanoforms and ensure that justifications and conclusions are relevant to these nanoforms along their life-cycle.
• Registrants must fulfil specific ecotoxicity related test requirements for different nanoforms depending on their dissolution and solubility.
• Registrants must fulfil specific toxicity related test requirements for different nanoforms depending on their nature and likely route of exposure.
• For nanoforms that fulfil the criteria for dangerous or hazardous substances, an exposure assessment and risk characterization must be completed. Registrants shall indicate and justify actions or decisions taken if information is inadequate to classify a substance and nanoforms thereof as belonging to a particular hazard class or category.
• When downstream users deem additional information necessary for the completion of the Chemical Safety report, they shall gather the needed information and/or submit a testing strategy proposal.
• In case of waiving of information requirements, justification for this must be provided.
• In specific situations, registrants should propose further testing regarding short-term repeated dose toxicity studies, studies of sub-chronic toxicity and long-term repeated dose toxicity studies and toxicokinetic studies.

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.

• Chemical safety assessment
• Hazard assessment
• Exposure assessment
• Risk assessment
• Qualitative or quantitative structure-activity relationships models ((Q)SARs)

• Manufacturers and importers provide Chemical Safety Report, including where relevant information and documentation that risks are adequately controlled.
• To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms.

• The Member States are required to every five years submit a report on the operation of the regulation in their respective territories, including sections on evaluation and enforcement to the European Commission. The European Chemicals Agency must, submit a report on the operation of the regulation to the Commission every five years.

• Member States are required to maintain a system of official controls and other activities as appropriate to the circumstances. They should furthermore determine the sanctions that follow in case of violation of the regulation.