The European Commission has awarded Risk & Policy Analysts (RPA) with support from BiPRO the contract to assist with the preparation of an impact assessment on possible measures relating to nanomaterials. The aim of the study is to determine whether, in addition to existing/planned information requirements under the REACH regulatory framework, there should be new measures introduced to increase transparency and ensure regulatory oversight for nanomaterials.
The terms of reference and the associated reports are available (in pdf) below. Further reports will be published on this website as they become available.
- Terms of Reference
- Evaluation Report (Final), November 2014
- Building Blocks Report (Final), October 2014
- Options Assessment Report (Second Draft), August 2014
Definition of Nanomaterials used for this study
The term “nanomaterials” refers to nanomaterials as defined in Commission Recommendation 2011/696/EU on the Definition of Nanomaterial (read/download in pdf). For the purpose of this study and the public consultation, only manufactured nanomaterials were considered. Natural and incidental (e.g. resulting from combustion processes) nanomaterials were not covered. Several legal instruments refer to “intentionally manufactured”, or “engineered” nanomaterials. Due to the difficulty to clearly define intention, this study and the public consultation referred to manufactured nanomaterials in general (in a wide interpretation, probably most manufactured nanomaterials will be intentionally manufactured). It should also be noted that the definition of nanomaterials only covers solid nanoparticles and excludes liquid nanoparticles such as micelles (e.g. in milk, chocolate, mayonnaise etc.), unless otherwise stated.
Belgium, Denmark and France have introduced national nanomaterials registers. Relevant links and documents include:
- Belgian decree and associated impact assessment
- an overview of the Danish approach is accompanied by detailed guidance and an associated impact assessment
- French legislation and documents at: https://www.r-nano.fr/
An impact assessment for a European registry, prepared on the initiative of the German Environment Protection Agency, is available here (in pdf).
Glossary of Terms
- CASG: Competent Authorities Sub-Group on Nanomaterials
- DNEL: Derived No Effect Levels, exposure levels below which hazardous substances are expected to have no effect on human health
- OEL: Occupational exposure limits
- PNEC: Predicted No Effect Concentrations, exposure levels below which hazardous substances are expected to have no effect on the environment