In our many previous blog entries, we have talked about nanomaterial regulation within the EU. In general, nanomaterials and nanoforms are covered within the same meticulous regulatory framework, i.e. the REACH and CLP regulations. After decades of discussions between the EU member states, the European Commission, scientists and other stakeholders, new revisions to the existing REACH framework was proposed in April 2018 and were enforced from 1st January 2020. These are specifically aimed to provide structure and clarity to the use, manufacture and import of nanomaterials within and into the EU.
At present, nanomaterial specific revisions are incorporated in 9 Annexes within the REACH framework. These Annexes stipulate several technical and scientific details of nanomaterial legislation, in addition to proposing newer and validated criteria for when, how and what actions are required from various stakeholders with respect to nanomaterial safety evaluation.
We receive many enquiries from our clients regarding these new regulations. I’ve tried to summarize most of them and attempted to answer some of these questions.
1. What is a “nanomaterial” according to REACH and EC?
“Nanomaterials” are defined in multiple ways according to the sector of their application. A summary of definitions can be found here.
2. When should nanoforms be registered?
As with the existing REACH regulation, manufacturers and importers have to register their nanoforms if produced or imported in quantities of 1 tonne or more per year. In general, information on manufacture and use presented in the registration requirements for regular substances also apply to nanoforms.
3. What are the differences that are to be noted when registering a nanomaterial?
Identification: Names or other identifiers of the nanoforms or sets of similar nanoforms of the substance as part of the substance identification.
Characteristics: Number-based particle size distribution, morphology and aspect ratio (if applicable) of the particles, surface functionalization or treatment, crystallinity and information on assembly structure, specific surface area by volume and/or by mass and solubility (in water or octanol-water partition coefficient) or dustiness, whichever is applicable.
It has to be noted here that, while REACH allows grouping of nanoforms for registration, grouping cannot be solely based on similar molecular structures. Additional justifications need to be provided as to why different nanoforms have been grouped into one common set (boundary conditions), and how the prescribed set is appropriate in conjunction with the aforementioned characteristics. Justifications are also required to ascertain that within the set, individual nanoforms do not exhibit varying hazard, exposure and/or risk.
Safety: According to the new Annexes, first and foremost, a Chemical Safety Report shall specify whether nanoforms have been adequately characterized and assessed as part of the registration. This report should adequately address characteristics of nanoforms that may cause safety concerns, their likely route of exposure to environment and/or humans, ecotoxicity and human health hazard assessment (and conditions of testing) and last but not least, safety (or hazards) evaluation or demonstration throughout the life-cycle of the substance.
4. What aspects of safety should be regarded while registering nanoforms?
In general, safety requirements are to be decided based on the nanoform itself (identification and characteristics), in conjunction with other Annexes that define tonnage, concentration range in articles, human or environmental exposure and nature and quantity of wastes generated as a result.
Specifically, registrants can pick and choose which tests are right for their nanoform, provided, they can justify why these tests are optimal. A cassette of tests may be required to satisfactorily determine possible exposure routes, ecotoxicity and human health hazards. A set of OECD guidelines are available or under preparation to provide validated test guidelines. Hence, for nanomaterial registration, there is still a lot of emphasis on a “case-by-case” manner of assessment. However, more structure in terms of what aspects are required to understand safety, and a set of validated test guidelines to standardize test conditions, are now available.
Once possible exposure routes are understood (based on characteristics of the nanoforms and life cycle assessments), specific tests pertaining to ecotoxicity and/or toxicity to humans are to be conducted. For instance, if a nanomaterial is partially soluble in water, it can cause exposure hazards mostly via aquatic systems, where they may undergo dissolution and/or dispersion. These processes now needs to be separately assessed and documented, according to the new regulationsThe effect of the dissolved component and dispersed component on aquatic life needs to be addressed separately and concomitantly while registration.
This does not mean that the registrant should conduct a wide array of tests, which may be monetarily taxing. It is reiterated that nanoforms can be grouped (within justifiable boundaries of characteristics), and that registrants can pick and choose tests that are appropriate to completely determine exposure effects through the life cycle of the nanoform. Registrants also have the option of waive off information requirements. For instance, if a nanoform exhibits a high or nearly 100% dissolution rate in water, then this can be used to argue why bioaccumulation in aquatic species and adsorption-desorption screening was not conducted. However, at the same time, a high insolubility cannot be used as a reason for not conducting acute toxicity studies in aquatic animals or growth inhibition in aquatic plants. Therefore, justifications provided for waiving off tests should be based on irrefutable scientific observations.
Below, you will find a checklist of what is required and what sort of new information should be provided for registration of nanomaterials.
- Information on the identification of the nanoform.
- Information on the characteristics of nanoforms.
- Life cycle assessments to demonstrate possible sources and routes of exposure.
- Justification and details for which, how and why the safety assessments were conducted, according to prescribed OECD guidelines.
- Data showing fulfilment of specific ecotoxicity and human toxicity related test requirements for different nanoforms depending on their dissolution and solubility.
- Justification for waiving information requirements.
- Propose further testing and/or comply with ECHA testing requirements.
We at nEcoTox are experts at nanomaterial characterization and fate analyses. We can help you with identifying the most suitable characterization and analytics techniques for your nanomaterials.
Contact me by phone: 06346/9661490 or via email: menon@necotox.de
