On July 31, 2019, Japan’s MHLW proposed a draft revision of the country’s MRLs for Amoxicillin by referring Codex Alimentarius Commission. The closing date to submit comments is September 29, 2019.

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On July 31, 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) proposed a draft revision of the country’s MRLs for Amoxicillin by referring Codex Alimentarius Commission. The closing date to submit the comments is 29 September 2019.

Amoxicillin is a broad spectrum β-lactam antibiotic that is widely used in veterinary medicine for treatment of bacterial infection caused by Gram-negative and Gram-positive organisms in food-producing animals. This use can lead to health problems because of allergenic reaction and increasing incidence of microbial resistance.

To ensure human food safety, many countries and regions including Canada, the European Union (EU), Japan, and the USA established their own maximum residue limits (MRLs). Different MRLs, may cause trade barriers for food exporters from developing countries. Therefore, harmonization of MRLs for veterinary drugs by referring to the Codex Alimentarius standards have been used by the World Trade Organization as reference points. Recently, Japan’s MHLW adopted the Codex MRLs for Amoxicillin in meat, fat, edible offal, and milk [1]. The previously published MRLs will be amended and proposed per the draft MRLs [2] as shown in Table 1. As the results of amphoteric and high polarity characteristics of this compound, liquid chromatography-tandem mass spectrometry (LC-MS/MS) is suitable for unambiguous identification/confirmation and quantification of the residues in complex food matrix.

What Do the Changes Mean?

This update has the potential to affect farms and food producers. Any imported foods designated for Japan must not be found to contain Amoxicillin in excess of the MRLs. To ensure compliance with food safety regulations, food producers should seek professional advice.

Table 1. Japanese provisional MRLs for Amoxicillin in food producing animals

Substance Animal species Target Tissue MRL (ppm)
Amoxicillin (CAS# 26787-78-0) Cattle, pig, chicken, other poultry, other terrestrial mammals, and other poultry Muscle
Edible offal

Cattle Milk 0.004
Perciformes Muscle 0.05

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