The European Chemicals Agency (ECHA) is in the process of updating its guidance on the information requirements and chemical safety assessment (IR&CSA) for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA has developed three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R.7a, R.7b, and R.7c) to provide advice to registrants for use when preparing REACH registration dossiers that cover nanoforms. ECHA is updating two of the appendices, Appendix R7-1 to Chapter R.7a and Appendix R7-2 to Chapter R.7c. The draft update states that the advice provided focuses on specific recommendations for testing materials that are nanoforms of substances. Annex VI defines the terms “nanoform” and “set of similar nanoforms” and establishes the requirements for characterization of the identified nanoforms/sets of similar nanoforms of the substance. According to the draft update, part of the advice provided is not strictly nanoform specific and may also be applicable to other particulate forms of substances (e.g., relevance of dissolution rate). The draft update notes that when such advice has been included, “it is because it is considered especially relevant for nanoforms and should be part of the nanoform specific guidance.” In the absence of any suitable specific provision (either because the endpoint is not relevant for nanoforms, because the guidance already provided is considered to be equally applicable to nanoforms as to non-nanoforms, or because more research or adaptation is needed before developing advice), no additional guidance for the information requirement has been included.
The appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in Chapter R.7a (i.e., the parent guidance). When no advice has been given for a specific endpoint, the advice provided in the parent guidance should be followed. ECHA notes that the appendix and its parent guidance provide specific guidance on meeting the information requirements set out in REACH Annexes VI to XI. General information for meeting the information requirements, such as collection and evaluation of available information and adaptation of information requirements, is available in Chapters R.2 to R.5 of the Guidance on IR&CSA.
ECHA states that when considering the use of data already available, the Guidance on information requirements and chemical safety assessment — Appendix R.6-1 for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals “may be useful as it provides an approach on how to read-across the hazard data between nanoforms (and the non-nanoform) of the same substance.”