eREACHNano tool, Image: eREACHNano project
Chemicals in volumes above 1 tonne which are either manufactured or imported are covered by the EU chemicals regulation, REACH. Until recently, REACH has addressed all chemicals, including bulk chemicals and nanoforms of substances, without making a distriction between the two in terms of information requirements to ensure safe use.
Following the increasing awareness of the different properties of nanoforms compared to bulk chemicals, manufacturers and importers have, since 1 January 2020, been met with specific information requirements for registering their nanoforms. Guidance documents on how to handle nanoforms in the registration process are developed and available on the European Chemicals Agency’s (ECHA) website.
Even so, it still requires expertise on the regulation of nanoforms to fulfil the obligations and successfully register a nanoform.
eREACHNano was developed to explain REACH requirements for nanoforms. It guides companies through the registration process for nanoforms and its requirements through e-learning modules developed through the eREACHNano project by DHI A/S in cooperation with the N-Nano project group - a working group of the Nordic Council of Ministers. This includes giving an introduction to nanoforms, describing the main elements of REACH, its actors, and their roles and responsibilities. Extra emphasis has been placed on describing the documentation on safe use – and to explain where the distinction between bulk chemicals and nanoforms should be made.
The tool focuses on – but is not limited to – helping small and medium-sized companies who may not have sufficient in-house expertise on regulations that cover nanomaterials.
eREACHNano: what’s inside?
eREACHNano’s e-learning modules help you identify if you are working with a bulk substance or a nanoform and what obligations you have under REACH.
The sessions give you a better understanding of the more extensive guidelines from helpdesks, associations and other public bodies, and how you can apply these in your specific case.
Through a series of narrated video animations, the data requirements for nanoforms according to REACH guidance are explained.
They cover the following:
- Introduction to nanomaterials
- REACH definition of nanoforms
- Comparison of the physical and chemical properties of conventional chemicals and nanoforms
- Overview of nanoform-specific annexes to existing REACH guidance
- How to identify nanoforms of a substance and how to prepare for registration, including how to prepare a set of nanoforms
- Nanoform-specific test requirements according to tonnage-level
- How to handle testing when not having in-house laboratories
- Exposure and risk assessment of nanoforms
- Description of and links to tools for risk assessment of nanomaterials
- Links to relevant guidance
Under REACH, data on chemicals is submitted to ECHA in IUCLID format. The IUCLID software used for this is freely accessible on the ECHA website.
Examples of how to enter data on nanoforms in IUCLID are given in eREACHNano.
A case study for the nanoform of zinc oxide is included as an example of how to register a nanoform. This includes guidance on which data to select for the registration and how to enter the information into IUCLID.
eREACHNano also includes two general modules: one that gives an overview of how to carry out a risk assessment of chemicals and another introducing REACH and its processes.
Safety assessment of nanoforms and outsourcing testing
If your tonnage is above 10 tonnes per year, you need to prepare a safety assessment of you nanoform. This includes a hazard assessment, where you Derive No Effect Levels (DNELs) for human health and the corresponding Predicted No Effect Concentrations (PNECs) for the environment.
For hazardous substances the safety assessment must also include an exposure assessment, where you determine the expected human exposure levels from the uses of your nanoform and the expected concentrations in the environment.
Finally, a safety assessment needs to be prepared where you compare your DNELs and PNECs with the expected exposure levels to assess if your nanoform exhibits a risk to humans or the environment. eREACHNano has sessions and examples of how to carry out the hazard, exposure and risk assessment.
Human safety assessment, Image: eREACHNano project
You may need to generate test data on your nanoform, for example for the physicochemical characterisation of your nanoform or if test data usable for your nanoform does not exist. If you cannot perform the test in your own laboratory, eREACHNano gives you guidance on your options and how to make the most suitable choice in your situation.
eREACHNano also provides links on guidance documents and links, where you can obtain more information and help via the the national helpdesks.
The webtool is published in English.
The webtool can be freely accessed on http://ereachnano.dk/ or http://ereachnano.com/.
Who are we?
A working group of the Nordic Council of Ministers, N-Nano project group, established eREACHNano with the aim of developing a simple and easily usable online tool to explain EU chemical legislation requirements for nanoforms.
The project was coordinated by Norway, Sweden, Finland and Denmark through the N-Nano project group of the Nordic Working Group for Chemicals, Environment, and Health (NKE) together with an informal advisory group with representatives from ECHA and industry (European Chemical Industry Council (Cefic), Nanotechnology Industries Association (NIA)).
DHI A/S developed eREACHNano in close cooperation with the N-Nano project group.
A later update and a case study was prepared by a working group of the Swedish Chemicals Agency (KEMI) and DHI A/S.
Dr Dorte Rasmussen
I have been working on the exposure and risk assessment of chemicals at DHI A/S for almost 25 years.I am a chemical engineer by education and hold a PhD in applied thermodynamics from the Danish Technical University.