The project to develop a new Guidance Document on in vitro testing for intestinal fate of orally ingested nanomaterials was launched in 2019 at the 19th meeting of WPMN. The regulatory needs for determining dissolution rate of nanomaterials in condition representative of human gastrointestinal tract (GIT) was emphasized by regulatory agencies such as EFSA, as it was identified as a critical parameter for some nanomaterials in determining fate within the body after oral ingestion and may be considered a useful predictor to their (bio)availability in vivo.
First commenting round on the draft guidance document on in vitro testing for intestinal fate of orally ingested nanomaterials
- Submission period
- 29 September - 10 November 2025
Background public consultation
Project description
The new Guidance Document would establish a conceptual framework and procedures for determining intestinal fate of orally ingested nanomaterials using an integrated in vitro approach simulating the human GIT environment. Primary objective of the document is to provide drivers to identify the most appropriate two-step approach to investigate fate and internalization of different nanomaterials after ingestion. In particular, the two steps of digestion process, i.e., behaviour of nanomaterials once exposed to different digestive compartments and their interactions with the intestinal mucosa, was considered.
How to contribute
The draft Guidance Document on in vitro testing for intestinal fate of orally ingested nanomaterials and its six annexes are currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes and open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 10 November 2025.
Related documents
- Draft Guidance Document on in vitro testing for intestinal fate of orally ingested nanomaterials
- Draft Annex 6.1: Standard Operating Procedure for Sterile Cascade Digestion Assay
- Draft Annex 6.2: Standard Operating Procedure for Tri-culture barrier model
- Draft Annex 6.3: Standard Operating Procedure for Nanomaterials Uptake Translocation Tri-Culture Model
- Draft Annex 6.4: Case Study
- Draft Annex 6.5a: Test Data Recording Form_Dissolution
- Draft Annex 6.5b: Test Data Recording FormNMs in vitro Uptake Translocation
