Abstract
BackgroundFor nanomaterials, not only their chemical composition but also their morphological properties and surface properties determine their characteristics. These properties do not only differ in comparison to the corresponding bulk material but also between different nanoforms of the same substance. Changes in these physico-chemical characteristics can cause changes in chemical properties, reactivity, (photo-) catalytic activities and energetic properties and in turn alter their (eco-) toxicity, fate and behaviour in environmental media and toxico-kinetics. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) deals with chemical substances in general and although there are no special provisions that explicitly refer to nanomaterials, they are principally covered by REACH. In October 2012, the European Commission published the Second Regulatory Review on Nanomaterials. In February 2013, the REACH Review from the European Commission was published. Both papers address questions about the regulation of nanomaterials in REACH. The Commission proposes to improve the future situation by adaptation of the REACH Regulation. However, the European Commission plans to revise the annexes only and not the main text of the regulation.Results and conclusionsIn this publication, the authors present their considerations and recommendations on how REACH can adequately be adapted to nanomaterials. In the author's view, the bulk form and nanoforms of the same chemical composition should be treated as the same substance in the context of REACH. However, the regulation of nanomaterials under REACH has to meet specific requirements. Taking into account the plurality of physico-chemical characteristics and resulting changes in the hazard profile, an approach must be found to adequately cover nanomaterials under REACH. Accordingly, the REACH information requirements have to be adapted. This includes lower tonnage thresholds for different REACH obligations (e.g. registration, chemical safety report) which are justified by highly dispersed use together with low mass application, linked with the uncertainties regarding (eco-) toxicity, environmental fate and exposure. If the physico-chemical characteristics of different nanoforms of the same substance differ in a relevant manner they have to be considered separately for further test performance and REACH requirements.
Highlights
Their chemical composition and their morphological properties and surface properties determine their characteristics
Speciality of nanomaterials and the challenges regarding their assessment According to the European Commission (EU COM), the global quantity of nanomaterials is around 11.5 million tonnes with a market value of roughly 20 bn € per year [1]
The adaptation of existing test methods and, in particular, the creation of nanospecific information requirements for the REACH registration are two possible options. It is described how nanomaterials are currently regulated under REACH. The authors present their considerations and recommendations on how REACH can adequately be adapted to nanomaterials
Summary
Their chemical composition and their morphological properties and surface properties determine their characteristics These properties do differ in comparison to the corresponding bulk material and between different nanoforms of the same substance. In February 2013, the REACH Review from the European Commission was published Both papers address questions about the regulation of nanomaterials in REACH. Their chemical composition and their morphological properties like size, shape and surface properties determine their characteristics. These parameters can affect the chemical properties, reactivity, (photo-) catalytic activities of a substance as well as energetic properties and their confinement. The question arises how these specific properties influence behaviour and effects in the environment and whether existing risk assessment and mitigation methods can be applied to nanomaterials without further a do
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