Second commenting round on the draft guidance document on in vitro testing for intestinal fate of orally ingested nanomaterials

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. 

The draft Guidance Document on in vitro testing for intestinal fate of orally ingested nanomaterials and its six annexes are currently under a commenting round by the Working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 06 March 2026. 

• Draft Guidance Document on in vitro testing for intestinal fate of orally ingested nanomaterials
• Draft Annex 6.1: SOP for Sterile Cascade Digestion Assay
• Draft Annex 6.2: SOP for Tri-culture barrier model
• Draft Annex 6.3: SOP 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 Form_NMs in vitro Uptake Translocation