Speaker
Description
The European Commission adopted the new Recommendation 2022/C 229/01 on the definition of ‘nanomaterial’ on 10 June 2022, which updates the definition adopted in a previous Recommendation (2011/696/EU). It is set to apply across several regulations, including REACH for chemicals, as well those on cosmetics, biocides and medical devices. The new definition does not alter the core elements of the 2011 recommendation, which defines nanomaterials as substances with 50% of particles or more between 1nm-100nm. However, a flexibility clause that allowed the threshold to fluctuate between 1-50% of particles under some circumstances was removed, leaving only a default threshold of 50%. This was decided to ensure regulatory consistency and coherence, and to avoid a specific material being considered a nanomaterial under one regulatory framework but not under another. It also adds new concepts such as the solid-state or the identifiable" character of nanomaterials. In this connection, the opinions have been raised by industry groups and NGOs that the changes will exclude many substances from qualifying, for example, nano-plastics, fullerenes, graphene, lipid particles and micelles. Although there is still a controversy over the new definition, the European Commission(EC) is considering changes to REACH requirements on the registration of nanomaterials as part of a forthcoming revision of the law. On May 2023, the European Commission’s Joint Research Centre (JRC) published a guidance document on nanomaterials to support industries and national authorities implement a new definition. Therefore, we will introduce the further significant information in implementing legislation in order to give an advice to industry and academia. In accordance with the new definition and the guidance, the strategies for how to fill up the knowledge gap will be provided.
References
- European Commission. (2022). Commission Recommendation of 10.06.2022 on the definition of nanomaterial
- Joint Research Centre. (2023). Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial
| Keywords | Nanomaterial, EC definition, JRC, REACH, Regulation |
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