Nanomaterials are not intrinsically hazardous per se but there is a need to take into account specific considerations in their risk assessment, requiring additional characterization of the material or application of specific or adjusted methods. In some legislation, specific labelling provisions for nanomaterials also apply.
In order to trigger nanomaterial-specific provisions in any legislation, a definition of a nanomaterial is required that can be applied to a substance/material addressed by the legislation. While it is difficult to consider common specific provisions across the different sectors due to the multiple objectives and scope, a single horizontal definition, used by different pieces of legislation, is the preferred solution to facilitate coherence and overall efficiency of implementation.
The European Commission first adopted such definition in 2011 (Recommendation on the definition of a nanomaterial 2011/696/EU). In the definition, the sole determinant on whether material is also a nanomaterial is based on the distribution of the size of particles of which the material consist: if the proportion of particles with size between 1nm-100nm exceeds a threshold, material is a nanomaterial (simplified; for detail see full text of the definition in the link above).
The definition from the Recommendation 2011/696/EU has been copied into different EU directives and regulations, including as the definition of nanoform of a substance under REACH, introduced in 2018. Further uses of the Recommendation 2011/696/EU include national registries on nanomaterials and sectoral guidance on Ecolabel. Not all EU legislation including nanomaterial-specific provisions has been updated: regulation on novel food and regulation on cosmetics products have until now retained their initial definitions that differ to the one in the Recommendation 2011/696/EU.
The definition in the Recommendation 2011/696/EU has been supported by implementation guidance, starting with the "questions and answers" and later complemented by comprehensive work by the European Commission’s Joint Research Centre (JRC) and a dedicated research project NanoDefine (see links below).
A review of the Recommendation 2011/696/EU concluded with the adoption of the revised Recommendation (reference and link to be included) on 10th June 2022. The definition in the new Recommendation has been modified in several ways to facilitate implementation and the uptake of the horizontal definition in the legislation. It has however retained the principal features of the old definition and it will not significantly alter determinations already made. The Recommendation is complemented by a comprehensive Staff Working Document (reference and link to be included). The document outlines the review process and provides the rationale behind the changes and the individual choices made regarding the thresholds in the definition. The document also includes an analysis of, and feedback to, the review’s 2021 targeted stakeholder consultation. The consultation included series of questions on individual changes being considered. All 136 non-duplicated replies are compiled in the XLS spreadsheet. Additional contribution by the French authorities is available here, together with the supplemental information provided by the Industrial Minerals Association IMA and the Germany Federal Institute for Risk Assessment BfR.).
Uptake and implementation
Following the adoption of the new Recommendation, it is expected the different individual sectors will update their internal definition, replacing the old definition with the new one by copying the text of the definition or by referring directly to the Recommendation. That will also make the new definition legally binding within the scope of the particular legislation.
Each sector will proceed in accordance with its own timetable.
Relevant uptake information available (last updated 10 June 2020):
To facilitate implementation, a dedicated guidance to the horizontal definition is developed by JRC; its publication is scheduled for 2022. Due to limited changes in the definition, almost all of the existing guidance continues to be applicable to the new definition. On the impact of specific changes to the implementation, please see the Staff Working Document (reference to be included).
The present guidance supporting implementation continues to be fully applicable serving the ‘old’ horizontal definition of 2011/696/EU while it is still being used in the legislation.
Main documents and links:
Selected documents supporting implementation of the definition: