The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA). As reported in our April 26, 2018, blog item, the European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. Holmqvist’s article provides answers to what the revised Annexes change, who the changes impact, when the new Annexes come into force, what ECHA is doing to help companies prepare, whether there are test methods already available to comply with the amended requirements, and if the new information requirements imply that nanomaterials on the European Union’s (EU) market are unsafe. Holmqvist recommends that manufacturers and importers familiarize themselves “at the earliest opportunity, with the introduced changes to assess whether they are relevant for your substances.” Industry must comply with the new requirements by January 2020. ECHA is examining which parts of the existing guidance need to be updated or whether new guidance is necessary. Holmqvist states: “We also plan to increase our efforts in reaching out to industry organisations both in bilateral meetings and also through our guidance process. This way, we hope to ensure that there is sufficient support available for companies that are preparing possible updates to their registration dossiers.” Regarding whether the new information requirements imply that nanomaterials currently on the market are unsafe, Holmqvist notes that “without changing the legal information requirements, it would be very difficult for authorities to verify whether companies registering their chemicals have demonstrated the safe use of nanomaterials throughout the supply chain or whether further regulatory actions for managing their risks would be needed,” emphasizing the word verify. Holmqvist states: “I think we all agree that the realisation of the great opportunities that nanotechnology and nanomaterials may offer society should go hand-in-hand with the transparent demonstration by industry of their safety and sustainability.” The article lists the following guidance that is already available to help companies prepare for the revised information requirements:
- How to prepare registration dossiers that cover nanoforms: best practices;
- Guidance on information requirements and chemical safety assessment: Appendix R.6-1 for nanomaterials applicable to the Guidance on QSARs and Grouping of Chemicals; and
- Nano-specific appendices to the guidance on information requirements and chemicals safety assessment.