Japan has Revised MRLs for Enramycin in Meat Products

Japan’s Ministry of Health, Labor and Welfare (MHLW) announced Notification no. 80 revising MRLs for Enramycin in meat products. It came into force on March 23, 2023.

Enramycin (also called Enduracidin) consists of two components, namely enramycin A and enramycin B. This compound belongs to a class of polypeptide antibiotics produced by Streptomyces fungicidicus which is widely used in food-producing animals to improve growth efficiency and for disease prevention. Due to the overuse of antibiotics and ignorance of the withdrawal time in feed, concerns have been raised about multi-drug resistance microbes transferring from animals to human via foods or other media. This is a particular concern for chemical substances used in growth promotants in modern animal husbandry.

In 2014, the Food Safety Commission of Japan (FSCJ) conducted a human health risk assessment of antimicrobial-resistant bacteria following the use of enramycin as a feed additive in livestock animals. They found there is no bacterial cross-resistance between enramycin and other antimicrobials with enramycin-like chemical structures and the mode of action.  Thus, the risk to humans regarding this issue is negligible [1]. Recently, the maximum residue limits (MRLs) for enramycin in specific meat products were revised by the MHLW [2], [3] see Table 1.

For the analytical process, liquid chromatography with mass spectrometry (LC-MS/MS) is a recommended technique for quantitative results and the results needs to be expressed as the sum of both forms.

Table 1:  Japanese MRLs for enramycin (CAS # 11115-82-5) in meat products

What do the changes mean?

This update has the potential to affect farms and food manufacturers. Food products destined for Japan, if listed in Table 1, must not have enramycin residues exceeding the MRLs. Complying with food safety regulations can be a complex, time-consuming and expensive process. Food producers should seek professional advice.

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Next step
The regulation was effective on September 24, 2021. Objections and requests for hearing be received on or before November 23, 2021.

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