The European Chemicals Agency, ECHA, is forced to “run before they can walk.” There is an urgent need to define the methods and technical guidance for identifying, characterizing and assessing the risks of nanomaterials. This was the conclusion that came out of the recent ECHA Topical Scientific Workshop on Regulatory Challenges in Risk Assessment of Nanomaterials held in Helsinki on 23th and 24th October, 2014. Senior researcher Keld Alstrup Jensen (NRCWE) and Associate professor Steffen Foss Hansen (DTU Environment) were invited to participate.
It is expected that many nanomaterials will be subject to REACH registration by 2018. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals and is the chemical legislation of the European Union. The European Chemical Agency is preparing for the next and final wave of industrial chemical registrations required for chemicals produced or imported in volumes exceeding 1 metric ton. It is expected that many nanomaterials (e.g. particles, flakes, fibers, nanotubes) will be registered in this round of small- to medium volume productions.
Therefore ECHA is working and discussing with scientists, standardization bodies and stakeholders to clarify:
- how they can ensure that nanomaterials are identified and registered specifically as planned
- what specific evidence ECHA may ask for when it comes to nanoparticle properties
- which (new) methods are to be used when it comes to characterization
- potentially new methods, that ECHA should ask the producers to apply to any risk assessment.
These themes were the main elements of the presentations and discussions which took place between, inter alia, employees of regulatory bodies in Europe, Canada and the United States, stakeholders from industry, researchers and employees in the standardization organizations at the meeting in Helsinki. Senior researcher Keld Alstrup Jensen (NRCWE) and Associate professor Steffen Foss Hansen (DTU Environment) both partners in the Danish NanoSafety Centre attended the meeting giving an oral presentation and several posters providing input on solutions and new methods that can bring us towards a safer implementation of industrial nanotechnology.
ECHA has a tremendous task ahead of them getting their technical guidance documents in place and being ready for start in 2016 in order to enable the industry to categorize and report nanomaterials and perform adequate naomaterial risk assessments. Fulfilling the regulatory needs for new methods and revision of risk assessment approaches has only reached focused attention within the last few years. Although several projects now focus on this problem, the action is late. It appears to be more than a challenge to consider even all main aspects and to establish validated procedures and methods for the start of the next registration period. Consequently, ECHA is forced to learn “how to run before they can walk”.
Presentations from Denmark
Steffen Foss Hansen is a member of ECHA’s Expert NanoMaterial Working Group (NMWG) and was invited to attend the meeting because of his general expertise in regulation and his previous involvement in the REACH Implementation Project 1, 2 and 3, which were part of ECHA’s first work on identification of the weaknesses in existing chemical detection and risk assessment methods. Steffen Foss Hansen presented a poster on the Danish database of consumer products based on nanomaterials in the EU and NANORISKCAT, which is a screening and risk assessment tool developed in collaboration between DTU and NRCWE in the Danish NanoSafety Centre.
Keld Alstrup Jensen was invited because of his expertise in nanomaterials characterization and risk assessment. He was invited to give a presentation on the EU FP7 NANoREG project in general as well as
- the first results from his work-package in the project where methods for identification and categorization of nanomaterials are developed to comply with the EU-proposal for a regulatory definition of manufactured nanomaterials and
- standardized dispersing protocols and minimum characterization requirements with the aim to harmonize the exposure and exposure characterization in the toxicological studies of the project.
In addition to the lecture, he contributed with two posters from the work completed in the Danish NanoSafety Centre. A poster on NanoSafer – a tool for identifying of handle possible risks associated with the production and use of nanomaterials and one poster on two methods that NRCWE has developed for measuring nanoparticle solubility and their pH – and oxidative reactivity of synthetic biological fluids and cell media . Finally, he presented a poster from the work in NANoREG, on a proposal for revision of material categorization procedure in REACH to enable better identification of chemically modified nanomaterials for risk assessment.
The entire program and all presentations from the meeting can be viewed via this link: ECHA website.
See the poster presentations presented by the participants from The Danish Nanosafety Centre: