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Reduction of limits for prohibited substances chloramphenicol and nitrofurans (additionally newly demanded: Nifursol)

Jan 10, 2023

The “minimum performance limits” (MRPL) for the prohibited antibiotic substances chloramphenicol (MRPL = 0.3 ppb) and nitrofuran metabolites (MRPL = 1.0 ppb) in animal foods such as honey, which have been in force in the EU for many years, have been replaced by “reference points for action” (RPA) and tightened significantly.

The new RPA are valid since 28.11.2022 (COMMISSION REGULATION (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC):

•  New RPA Chloramphenicol = 0.15 µg/kg (ppb)
•  New RPA Nitrofurans and their metabolites = 0.5 µg/kg (ppb)
•  Newly included is the nitrofuran Nifursol and its metabolite DNSH (3,5-dinitrosalicylic acid hydrazide)

Art. 5 of Regulation (EU) 2019/1871 is especially relevant for the enforcement:
Food of animal origin, containing residues of a pharmacologically active substance in a concentration at or above the reference point for action, shall be considered not to comply with Union legislation and shall not enter the food chain. Food of animal origin containing residues of a pharmacologically active substance in a concentration at a level below the reference point for action shall not be prohibited from entering the food chain.

QSI has expanded the nitrofuran method scope (previously SEM, AOZ, AMOZ and AHD) to include the metabolite DNSH in accordance with the new regulatory requirements.
QSI already offers the analysis of chloramphenicol and the nitrofuran metabolites with sufficiently sensitive limits of quantitation (LOQ) below the new reference points for action (RPA).
Choices for chloramphenicol include two LC-MS/MS confirmatory methods with 0.1 ppb LOQ and 0.05 ppb LOQ, and a screening ELISA assay with 0.1 ppb LOQ.
Together with the other amphenicols thiamphenicol and florfenicol (no prohibited substances, LOQ remains at 0.3ppb), chloramphenicol is now only available with the two low LOQ´s 0.1 ppb and 0.05 ppb, respectively.
Two LC-MS/MS confirmatory methods with 0.5 ppb LOQ and 0.2 ppb LOQ are available for the five nitrofuran metabolites.
Additional Information (pdf-file) is automatically issued for confirmed positive LC-MS/MS results of prohibited substances from ½ LOQ, so that you as a customer are also reliably informed about results below the LOQ (optionally de-selectable).
The codes with limits of quantitation (reporting limits) on the obsolete MRPL have been decommissioned, as they are no longer sufficiently sensitive for legal evaluation in the EU.

Please do not hesitate to contact us with any questions or for a quote – we look forward to actively supporting your company!

+49 (0) 421-596607-0

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