6 Nov 2019
EU Calls on Companies to Prepare for New Information Requirements Regarding Nanomaterials
The European Chemicals Agency (“ECHA”) has published a news item calling on companies to prepare for the new requirements under the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (“REACH”) coming into force on 1 January 2020. Hong Kong manufacturers and exporters should know that the REACH Regulation will impose additional information requirements for nanoforms of substances that are subject to registration under REACH. This will include providing such information for future registrations as well as updating existing dossiers.
By 1 January 2020, companies must provide more information on nanomaterials on the EU market under REACH. This is a result of the European Commission adopting a regulation in early December 2018 modifying certain provisions of the REACH Annexes relating to nanomaterials. ECHA encourages potential registrants to familiarise themselves with the new legal requirements. Hong Kong manufacturers and exporters may wish to note that the new requirements will oblige manufacturers and importers into the EU market to provide more information on their products which contain nanoforms of substances subject to the notification requirements under REACH.
Roughly speaking nanoparticles are natural, incidental or manufactured materials containing particles (in an unbound state or as an aggregate or agglomerate) where 50% or more of the particles have one or more external dimensions in the size range between 1 and 100 nm. Nanomaterials are used in an increasingly wide range of products and concerns have been raised as to their toxicological impact. Given their small size but large surface area, nanoforms of materials can have unique chemical and physical properties which the substance does not otherwise demonstrate. As a result, the European Union has adopted legislation requiring specific characterisation and risk assessment for nanoparticles introduced onto the EU market.
The following annexes of the REACH were revised to include updated provisions on nanomaterials: (1) Annex VI on the characterisation of nanoforms or sets of nanoforms covered by the registration, (2) Annex I on the chemical safety assessment, (3) Annexes III and VII-XI on the registration information requirements and (4) Annex XII on the downstream user obligations.
In particular, Hong Kong manufacturers and exporters may want to note that the amendments apply to all new as well as existing registrations covering nanoforms. This means that ECHA expects producers and exporters to update existing dossiers with specific information relating to nanoforms by 1 January 2020.
The changes made by the updated provisions can be divided into 5 categories as follows:
1) Introduction of the requirement to specifically identify and characterise nanoforms of substances covered by the registration requirement. This includes clear identification of size, shape, and surface chemistry of particles of the nanoforms.
2) A compilation of basic information on volumes and uses of nanoforms.
3) Clarifications on how the obligations regarding the substance apply to all nanoforms covered by the registration: the requirement of a chemical safety assessment, documentation of information requirements on hazard assessment and application of adaptation possibilities, etc.
4) Introduction of requirements for sample preparation, route of exposure and characterisation of test material when it is in nanoform, consideration of appropriate metrics when reporting the results and specific principal physico-chemical properties that can support the safety assessment of nanomaterials.
5) Qualification of existing adaptation possibilities to ensure their responsible application to nanoforms and modification to the information requirement where the test method is not applicable/informative for nanoforms.
In order to facilitate companies’ compliance with their obligations, ECHA is expected to publish guidance on certain issues by the end of 2019 and has already made drafts available. Guidelines on the testing standards for nanomaterials are also available.
On 30 October, the ECHA software to capture, store, maintain and exchange data on intrinsic and hazardous properties of chemical substances (“IUCLID”) was scheduled to be updated to include new fields to report the additional characteristics of nanoforms and sets of nanoforms. New registrations will automatically require characterisation information on the nanoforms or sets of nanoforms. Nanomaterials can be registered individually or as a set where they share similar characteristics. They can, as before, be linked with relevant data provided elsewhere in the dossier regarding the relevant properties and hazards. The fields will be accompanied by some advice on how to enter the data. In addition, ECHA will publish updated policies on the dissemination of information and confidentiality under REACH which will assist companies in completing the dossiers. ECHA encourages companies to also use the “Validation assistant tool” to verify that all required elements for the nanoforms are included before the submission of the dossier. All submissions of information on nanoforms will need to be based on the new version of IUCLID.
Hong Kong producers and exporters may like to participate in an ECHA webinar on 12 November 2019 during which the guidance on identifying and reporting nanoforms and sets of nanoforms will be explained. The webinar will also allow participants to ask questions to the ECHA experts and could be a valuable opportunity to request clarifications.