New Requirements for Nanomaterials under EU REACH
With the rapid development of nanotechnology, nanomaterials are now widely used across many fields. At present, the most commonly used nano-materials for industrial purposes in Europe are silicon dioxide, titanium dioxide, carbon nanotubes, carbon black, and etc. According to scientific studies, the toxicity of nano-form substances and their impact on the human environment may differ from traditional substances. Therefore, since 2012, ECHA has established a Nano Expert Panel (ECHA-NMEG) to study and formulate the registration requirements and scientific as well as technical guidelines for nanomaterials under EU REACH regulations. In December 2018, the European Commission issued a REACH Regulation Amendment (Commission Regulation (EU)2018/1881), which proposed new regulatory requirements for nanomaterials to ensure that enterprises can provide enough information for the safe use of nanomaterials.
The amendment will officially be implemented on January 1, 2020. This means enterprises that have completed registration of nanomaterials will have to update their dossiers according to the new registration requirements before the above date, and newly registered companies will need to submit their registration information according to the new registration requirements.
ECHA additionally launched a series of substantive measures for the registration of nanomaterials:
-October 30, IUCLID 6.4 was published;
-November 7th, reminder emails regarding the update of dossiers was sent to enterprises that may register
nanomaterials;
-November 12th, a webinar was held on nanomaterials identification and registration
All of the above measures taken by ECHA reflect the agency’s current emphasis and attention on the registration of nanomaterials. Therefore, companies involved in nanomaterials should stay vigilant. Based on the information and experience gained from communicating with ECHA and leading registrants, REACH24H would like to propose the following:
| Suggestions for Enterprises that Have Completed the Nano Material Registration | For Enterprises to Register Nano Materials |
| Registration dossiers originally submitted by some lead registrants have met the latest registration requirements and will not need to update their dossiers for the time being. Nevertheless, most of the lead registrants are currently in the process of collecting information and updating their dossiers. Registered companies as joint members should take the following steps:
1)Stay up to date on the movement of the lead registrant, and provide timely feedback on the nano-group information survey sent by the lead registrant, in order for them to complete the identification and characterization of the sets of nanoforms, cover the substances of the joint members, and complete the update of the lead file; 2)Characterize their own nano products, including particle size, shape, surface treatment, crystal form and specific surface area, etc., for material identity (SIP) verification; 3)Upload all relevant materials for nanomaterial classification to the IUCLID software, and complete the registration dossier update based on the latest requirements provided by REACH regulations. |
New enterprises to register nano materials need to submit registration data in accordance with the latest requirements. We suggest enterprises take the following under advisements:
1) When requesting a LOA quote from LR, also request SIP to verify substance sameness; 2) Characterize their own nano products, including particle size, shape, surface treatment, crystal form and specific surface area, etc., for material identity (SIP) verification; 3) Submit relevant materials for nanomaterial characterization though IUCLID software and complete the registration dossier in accordance with the latest REACH requirements. |
