Guidance

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These documents provide practical information on REACH, CLP and BPR requirements and best practice on how to fulfil them.

Reference name: ECHA
Description: The aim of this document is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” in a registration dossier. It also outlines what is expected in terms of characterisation of the nanoforms and set of nanoforms in the registration dossier.
Document(s): Download APPENDIX_NANOFORMS_DRAFT_TO_PEG_EN.PDF (9/6/2019 2:03:43 PM)
URL(s): Appendix for nanoforms applicable to the Guidance on Registration and substance identification (9/6/2019 2:04:10 PM)
Reference name: Commission Regulation (EU) 2018/1881 - amending REACH Annexes to address nanoforms of substances
Description: COMMISSION REGULATION (EU) 2018/1881 as of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) as regards Annexes I, III, VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances.
Document(s): Download CELEX_32018R1881_EN_TXT.PDF (9/29/2020 10:45:21 AM)
URL(s): Commission Regulation (EU) 2018/1881 - amending REACH Annexes to address nanoforms of substances (9/29/2020 10:46:46 AM)
Reference name: Nano-specific appendices to the guidance on information requirements and chemicals safety assessment
Description: Four appendices (1 new and 3 updates) for nanomaterials applicable to Chapters R.6, R.7a, R.7b and R.7c of the IR&CSA guidance. The documents include two new pieces of guidance as well as recommendations and updates of the existing guidance on nanomaterials. The new publications are: Nano-specific Appendix to Chapter R.6 of the Guidance on Information Requirements and Chemical Safety Assessment (QSARs and grouping of chemicals): It advises registrants on how to justify the use of hazard data between nanoforms (and the non-nanoforms) and within groups of nanoforms of the same substance. How to prepare registration dossiers that cover nanoforms - best practices: This document gives recommendations for distinguishing between different nanoforms of a substance, and how to report information on nanoforms consistently in the dossiers. This document was originally intended to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing this as an advisory best practice document.
URL(s): Guidance on Information Requirements and Chemical Safety Assessment (9/29/2020 11:04:23 AM)
REACH Guidance for nanomaterials published (9/29/2020 11:03:21 AM)
Reference name: Overview of REACH Annex modifications and available methods
Description: The regulatory testing of nanomaterials for safety relies on the use of standardised test guidelines that aim to ensure tests are done uniformly across different labs, and deliver relevant and reliable data. The EUON tracks the status of test guideline developments for regulatory purposes and here you can find an updated list of test guidelines, or ongoing test guideline developments relevant for the safety testing of nanomaterials under the REACH Regulation. The guidelines are matched to the most relevant REACH information requirements.
URL(s): Overview of REACH information requirements and available methods (9/29/2020 11:15:43 AM)
Reference name: eREACHnano
Description: This e-REACH Guidance is a comprehensive E-learning tool informing on the background and requirements for REACH registration of a nanomaterial at ECHA (The European Chemicals Agency).
URL(s): eREACHnano (2/28/2023 12:00:00 AM)

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caLIBRAte and Gov4Nano have received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement 686239 and 814401, respectively.

Project Office: caLIBRAte
Email: info@calibrate.com


Project Office: Gov4Nano
Email: PO-Gov4Nano@rivm.nl

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