by Eleanor Grimes, PhD
Nanomaterials have many uses, for example as catalysts, in electronics, and in biomedicine, as their specific form allows them to function in a manner completely different to their parent compounds.
These materials were legislatively defined by the European Commission in 2011 as generally being “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm,” although some exemptions can apply (2011/696/EU).
Nanomaterials & REACH
While nanomaterials were covered under REACH, this new legislative update – which was published on 3rd December 2018 – addresses the specific requirements of the nanoforms, as due to their size they may possess different physical, health and environmental properties to their parent substances that need to be addressed.
For example, when registering a substance in the lowest tonnage bracket (1-10 tonnes), only acute toxicity testing via the oral route is a requirement, however due to their size, it is deemed that the inhalation route is more appropriate for nanoforms. Therefore, companies manufacturing or importing nanomaterials to the EU market will need to address the additional changes outlined in this legislation.
To support this legislative change, ECHA is in the process of updating the relevant guidance documents to reflect these amends in plenty of time to help companies comply by the required implementation deadline of January 1st, 2020.
Never Miss an Update!
UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Our team can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations.
For all of the latest regulatory news and the most important industry updates, sign up to our fortnightly Regulatory Round-Up Newsletter.
EU REACH, Nanomaterials, Nanoforms