{"id":"140e1014-8105-56ca-b13a-76fe0d42e8d9","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:efsa-could-not-conclude-on-absorption-of-the-active-enzyme","predicate":"does_not_establish","statement":"EFSA concluded that the information provided on absorption, distribution, metabolism and excretion did not allow conclusions to be drawn on the absorption of active nattokinase or any functional metabolites derived from it.","claim_class":"mechanistic","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"7f42959d-8c70-5624-8172-2687a97cfdbe","mechanism_event_label":"EFSA concluded that the information provided on absorption, distribution, metabolism and excretion did not allow conclusions to be drawn on the absorption of active nattokinase or any functional metab","subject":{"id":"9910223c-2a27-5d75-8003-91d72e71be9a","slug":"nsk-sd","display_name":"NSK-SD fermented soybean extract","entity_type_key":"chemical_species"},"object":{"id":"42b41a0d-c6d1-5147-83d8-b2e56a8bdab3","slug":"oral-active-nattokinase-plasma-exposure","display_name":"Systemic exposure to intact catalytically active nattokinase after oral dosing","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"7f42959d-8c70-5624-8172-2687a97cfdbe","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:efsa-could-not-conclude-on-absorption-of-the-active-enzyme-event","event_type":"observed_intervention","label":"EFSA concluded that the information provided on absorption, distribution, metabolism and excretion did not allow conclusions to be drawn on the absorption of active nattokinase or any functional metab","description":"Whole-body disposition","status":"provisional","compartment":null,"participants":[{"entity":{"id":"9910223c-2a27-5d75-8003-91d72e71be9a","slug":"nsk-sd","display_name":"NSK-SD fermented soybean extract","entity_type_key":"chemical_species"},"role":"acting component","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"42b41a0d-c6d1-5147-83d8-b2e56a8bdab3","slug":"oral-active-nattokinase-plasma-exposure","display_name":"Systemic exposure to intact catalytically active nattokinase after oral dosing","entity_type_key":"cellular_process"},"role":"component the finding is about","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"duration","value_text":"Dossier review","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_access","value_text":"EFSA Journal opinion retrieved and read in full during this curation. Quoted figures are from the opinion text and its specification tables.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Regulatory assessment","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"NSK-SD, up to 100 mg/day","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"The Panel noted in the same passage that nattokinase has in vitro fibrinolytic activity and in vivo thrombolytic activity in animals when administered parenterally, which is the distinction this chapter turns on. An applicant assay of the softgel product at pH 2.0 mimicking gastric fluid was submitted; the opinion records that the results were provided but does not state what they showed.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"organism","value_text":"Regulatory assessment","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"EFSA concluded that the information provided on absorption, distribution, metabolism and excretion did not allow conclusions to be drawn on the absorption of active nattokinase or any functional metabolites derived from it.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Safety of fermented soybean extract NSK-SD as a novel food. (2016) DOI: 10.2903/j.efsa.2016.4541 Not indexed in PubMed.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"route","value_text":"In vivo, oral","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue","value_text":"Whole-body disposition","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"53836924-f2a7-5a20-96f9-1dce50db8d39","evidence_kind":"source_excerpt","locator":"Lines 840-840","start_line":840,"end_line":840,"excerpt":"EFSA concluded that the information provided on absorption, distribution, metabolism and excretion did not allow conclusions to be drawn on the absorption of active nattokinase or any functional metabolites derived from it.","model_system":"Regulatory assessment","directness":"reported_statement","verification_status":"source_derived_draft","notes":"","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"41cb127c-1c23-53aa-b7d0-5ec7f6fa3c99","stable_key":"import-33bef151-bdc7-5892-aff6-0345ab149739","title":"Nattokinase: what the purified enzyme cleaves, what survives being eaten, and the gap between the two (2026-09-23)","document_type":"imported_text","citation_label":"Original AI-assisted curation built from a supplied entity-first document of 105 entities and 129 claims. Every reference in that document was resolved against live PubMed with its abstract read and its DOI cross-checked on 2026-09-23, and the EFSA novel-food opinion was retrieved and read in full. That check corrected two PMIDs that pointed at unrelated papers, two DOIs, and two papers recorded as carrying no erratum that do carry one; it also reversed three findings the supplied document had stated backwards. Two papers carry a published correction, recorded as such and not as a retraction. Three sources are not indexed in PubMed and are cited by what they have. Laboratory lineages are recorded, so the four papers from one group, the three from another and the two readings of a single applicant dossier cannot be counted as separate lines of support. Study-specific doses, units, populations and limitations retained; activity units are never converted between systems. 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