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Japan has Revised MRLs for Enramycin in Meat Products

May 19 2023

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.

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

Animal Species
Taget tissue MRLs (ppm)
Chickens, pigs Muscle, liver, kidney, fat, and edible offal 0.03

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.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical tests, audits, certifications, inspections and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, improve food safety and quality. For furthermore information, please visit our website: www.sgs.com/foodsafety  

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

For Inquiries, please contact

Amornpun Dejsiripun
Global Food Technical Support Center
T: +66 2683 0541 ext. 2423

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Tags: food safety, articles, safeguards


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