New OECD guidance documents for the risk assessment of nanomaterials
The Organisation for Economic Co-operation and Development (OECD) has published two guidance documents for the testing of manufactured nanomaterials. They cover dissolution and dispersion stability and aquatic and sediment toxicity. Both are applicable for testing under the REACH Regulation.
Helsinki, 27 July 2020 – The two guidance documents as described by the OECD:
- Guidance 318: covers testing of dissolution and dispersion stability of nanomaterials, and the use of the data for further environmental testing and assessment. It gives guidance for test methods used to address dissolution rate and dispersion stability for nanomaterials with a focus on environmental aqueous media. The guidance is relevant for solids in the nanoscale as well as their aggregates and agglomerates and it focuses on their fate and behaviour in aqueous media. It presents the influence of various experimental conditions on the performance and outcomes of the discussed methods. This guidance also addresses modifications or additions to the methods and aims to give support for the interpretation of test results.
- Guidance 317: covers aquatic, including sediment, ecotoxicity testing of manufactured nanomaterials for determining their hazard. It focuses on freshwater aquatic and sediment toxicity test methods described by OECD test guidelines and gives practical considerations for carrying out valid tests with manufactured nanomaterials including interpreting and reporting results. It addresses modifications or additions to OECD test guideline procedures intended to incrementally improve the accuracy, intra-laboratory repeatability and intra-laboratory reproducibility of results.
Both guidance documents can be used to cover specific information requirements for nanomaterials under the REACH Regulation that entered into force on 1 January 2020. A full list of test methods relevant to address REACH information requirements for nanoforms is available on the EU nanomaterials observatory.
OECD test guidelines and guidance
According to the OECD, their currently available test guidelines address the safety testing of chemicals in its broadest sense with respect to physical-chemical properties, effects on biotic systems (ecotoxicity), environmental fate (e.g., degradation and bioaccumulation), health effects (toxicity), and other areas such as pesticide residue chemistry and the efficacy testing of biocides.
The test guidelines are internationally accepted as standard methods for safety testing and provide the common basis for the mutual acceptance of test data.
They provide guidance for professionals working in industry, academia and government on the testing and assessment of chemical substances.
REACH information requirements for nanomaterials
Updated REACH information requirements for nanoforms of substances have applied since 1 January 2020. Beyond this date, companies must have a REACH registration compliant with these requirements to manufacture or import nanoforms of substances that need to be registered under REACH. The purpose of the new requirements is to make sure companies provide adequate data to show the safe use of their nanoforms for human health and the environment.
- Guidance document 318: Testing of dissolution and dispersion stability of nanomaterials and the use of the data for further environmental testing and assessment strategies [PDF] [EN] [Excel]
- Guidance document 317: Aquatic and sediment toxicological testing of nanomaterials [PDF] [EN]
- EUON: Overview of REACH information requirements and available methods
- European Chemicals Agency: nanomaterials under the REACH Regulation
- OECD: Testing programme of manufactured nanomaterials