Date: May 31, 2024
FDA determined under the Laboratory Accreditation for Analyses of Foods program (21 CFR Part 1, Subpart R) that there is sufficient laboratory capacity for mycotoxin analyses of covered imported foods. From December 1, 2024, owners and consignees of that food must use a LAAF-accredited laboratory for mycotoxin testing. FDA said that future analyte groups will carry a compliance date six months after they are posted to the LAAF dashboard, and that no capacity determination had yet been made for the other covered testing circumstances.
What it means for calibration
LAAF accreditation rests on ISO/IEC 17025 accreditation by an FDA-recognized body, and FDA can request the full analytical package behind a result. Mycotoxin methods are judged at the action level, so the calibration has to be demonstrably accurate at the low end, with the model and any excluded standards documented. Labs that expect further analyte groups to be added should treat every LC-MS/MS calibration as a record FDA may read.
Source: fda.gov, FDA announces sufficient capacity to test for mycotoxins under the LAAF program
Part of the WLTR Standards Hub. This is a plain-language summary, not regulatory advice. Confirm requirements with your accrediting body or regulator. Questions or a different read on this change? Leave a comment below.