Information requirements for nanomaterials have applied since 1 January 2020. ECHA and industry associations are taking action to support companies in fulfilling their obligations and to successfully register their nanoforms.
A key element for a successful registration is the guidance and support available for companies. While challenges remain to have all the required guidance and test methods finalised, industry associations are coming up with innovative tools to help.
One such tool, the NanoApp, is under development by the European Centre for Ecotoxicology and Toxicology (ECETOC). Olivier de Matos, ECETOC’s Secretary General gives a sneak preview of the tool and some of its main features.
What does the NanoApp do?
It is web-based and has been designed to help registrants follow ECHA’s guidance on sets of nanoforms. In short, it puts ECHA’s guidance into practice. It covers primarily the ‘Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification’.
The NanoApp has two main Tiers:
- In Tier 1, you are asked to provide basic data required for preparing your registration in IUCLID about the nanoforms you are assessing.
Then, based on transparent similarity algorithms and decision rules, the App establishes whether two or more of those nanoforms can be grouped into a single set based on the intrinsic similarity of their basic properties.
- Tier 2 applies when criteria for Tier 1 grouping are not fulfilled, but the similarity values for the basic properties are still within predefined boundaries.
The App then guides you on what data should be generated to support your justification of that potential set of nanoforms. This could be, for example, data on dissolution, dispersion stability, or in vitro toxicity.
When this data is introduced in the App, it gives the result of the final evaluation and concludes whether the set can or cannot be justified.
What benefits does it have for companies?
It has established criteria and rules that systematically evaluate similarity between nanoforms, and on that basis, conclude whether a set of nanoforms can be justified or not.
Not only does it suggest possible sets of nanoforms that might be applicable for a list of initial nanoforms, but it also gives a report that includes the justification text that can be used in your registration.
Using our App to build and justify sets of nanoforms enhances transparency and trust among stakeholders.
What other sources have you used to build the App?
To develop the decision rules further and to suggest methods for analysis and thresholds for similarity, we have relied on other previous or ongoing grouping frameworks for nanoforms such as DF4nanoGrouping, OECD case studies for nanomaterials, the Nanogravur project, the Horizon 2020 project GRACIOUS as well as NIOSH datasets.
We have also taken the lessons learnt from several other EU nanosafety projects such as Nanodefine, NANoREG and GUIDEnano and relied on publicly available literature.
From these, we have selected only those elements that are required to implement the registration of sets of nanoforms.
Who were involved in developing the app?
It was initiated by ECETOC and developed by a core team of BASF in Germany, Leitat in Spain and ThinkWorks in the Netherlands.
The decision logic, methods and cut-offs used were all discussed with industry, including members of the ECETOC Nano Task Force and the academic and regulatory partners of the EU-funded Horizon 2020 research project GRACIOUS.
We then gave a demo of the app to ECHA in February who also participated in testing the beta-version and reviewing the rationales for the methods and the cut-offs it uses.
We are cooperating with the Nanotechnology Industries Association (NIA) to further involve its members and describe the tool and its use.
We are also engaging with many other stakeholders who have expressed an interest in the project.
How will you update it as information changes?
The NanoApp’s general decision logic is not expected to change.
The methods used to generate data that characterises nanomaterials and their functionalities, as well as the cut-offs to decide on the similarity of nanoforms, will most likely be amended and refined in the future.
These refinements can be easily adapted in the App. While any technical adaptation is comparatively easy, we will be seeking close collaboration with ECHA on exactly what needs to be amended or changed and when.
Can everyone access it for free?
The NanoApp is currently in beta-testing. Anyone interested in testing the App is invited to use it during this test phase and provide feedback to us.
Once the final version is complete, we will also provide training on how to use it. The App is free-of-charge, as are all the tools that ECETOC has developed so far.
We wanted to create this user-friendly App to facilitate REACH registration for producers, users and regulators. It will be further developed as it is used and as the science and methodologies evolve.
Olivier de Matos
Before being appointed Secretary General of ECETOC, I was Managing Director at Burson-Marsteller (now BCW) in Brussels, leading the Environment and Sustainability Team. My work there focused on advising clients on EU environmental and chemicals policies, in particular REACH.
I have also been an industry observer in several UN conventions including the UNEP Stockholm Convention on POPs, the UNEP Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and the UNEP Rotterdam Convention on the Prior Informed Consent.
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