Harmonization of the EU nanomaterial definitions:a much-needed initiative

摘要

In European Union legislation, the regulatory status of nano-materials in sectoral regulations is established by their definition, indicating what is considered a nanomaterial, and thus subject to the application of specific nano provisions in each product category. Therefore, there is more than one regulatory definition of nanomaterial. The first definitions were those of cosmetics [1] followed by the food labelling regulation [2]. The European Commission then released a Recommendation for nanomaterial definition [3]. It must be kept in mind that a Recommendation is not binding unless included in a Regulation. The Recommendation is based on particle number size distribution as the primary parameter and specific surface area as the secondary parameter. In addition, it was stated that >50% particles by number must be in the size range 1-100 nm for a substance to be considered a nanomaterial, which made the parameters measurable and thus the EC Recommendation applicable. The recommendation was takenup by more recent legislation, such as the Biocide Product Regulation [4] and the Medical Device Regulation (approved on 5 May 2017). Since 2011, the use of the EC Recommendation has resulted in issues and the need for clarification, which in turn led tothe ongoing revision that should be released soon by the Environment Directorate-General. The expected revision will not include major modifications but will only add some text clarifications. Also, guidelines for implementation of the Recommendation will be issued, setting out the best testing strategy to date to identify a substance as a nanomaterial. After the revision is published, it is expected the Commission will harmonize the definition of nanomaterial across sectoral regulations.