Published: 1 August, 2019
With the formal adoption of the REACH revision by the European Commission in December 2018, all companies that manufacture or import nanomaterials have to fulfill new and increased/extended regulatory data requirements until the early date of 1 January 2020. The nanospecific amendment 2018/1881 which affects Annexes I and III, as well as Annexes VI-XII replaces the term “nanomaterial” by “nanoform” based on a recommendation of the European Commission.
Despite this definition, assessing whether their substance(s) will fall into the updated regulation and to what extent they consequently have to update their registration dossier(s), will be a challenging task for a lot of companies and requires a well-conducted particle characterisation as a first step.
The generation of a set of similar nanoforms shall help for reducing animal tests and costs but has to be scientifically justified for being accepted and the broad variety in which form one and the same substance can be placed on the market (different size, shape or surface functionalisation) makes a challenging task out of it.
It is recommended that even companies that do not manufacture nanomaterials, but for example, solid materials have to clarify/consider if they thereby have to meet the updated requirements.
If you are a manufacturer or importer of nanomaterials you should have in mind that you have to submit one registration dossier for all similar nanoforms and the bulk substance together to be compliant with the updated REACH regulation. If you need help regarding your REACH compliance, for starting to define if you have a nanoform or not as well as for meeting all the needed regulatory requirements, Yordas Group can support you with the help of a broad range of experts in this field. Please take a look at our regulatory services that will help you to be prepared for the upcoming changes.
You can find further information which changes you have to expect under the new REACH regulation with the help of our nano-specific Whitepapers.