On June 27, 2018, Japan’s Ministry of Health, Labor and Welfare (MHLW) announced the intention to implement MRLs for Betamethasone in food producing animals. After the due date of July 11, 2018 for embassy comments, the proposal will be submitted to the World Trade Organization (WTO).

SAFEGUARDS | Food NO. 104/18

SafeGuardS chicken

Betamethasone (9a-fluoro-16b-methylprednisolone) CAS # 378-44-9 belongs in a group of glucocorticoids used in human and veterinary medicine for anti-inflammatory, anti-allergic, and antipyretic properties. It is frequently used to promote growth and increase weight grain in cattle when it is combined with b-agonist and other anabolic steroids. Due to its adverse effects on human health, the European Union and China have established maximum residue limits (MRLs) of Betamethasone – 2 µg/kg (0.002 ppm) in liver, 0.75 µg/kg (0.00075 ppm) in muscle and kidney, and 0.3 µg/kg (0.0003 ppm) in milk for consumption [1], [2]. However, Codex Alimentarius has not set international MRLs for this compound.  Recently, the MHLW has amended its stance from no permitted use to being able to use Betamethasone in food producing animals as long as the MRLs [3] shown in Table 1 are met.

Many methods for analysis of Betamethasone residues, including enzyme-immunoassay, gas and liquid chromatography coupled with mass spectrometry (GC/MS, LC/MS), have been developed in various food matrices and published in scientific journals.  The highest levels of sensitivity and specificity are acquired by GC/MS but require derivatization to enhance the volatility of analytes.

What do the changes mean?

This update has the potential to affect farms and food producers. Any meat tissue, honey, and dairy products designated for Japan, must not be found to have Betamethasone residues higher than the MRLs listed in Table1. To ensure compliance with food safety regulation, food producers should seek professional advice.

Table 1. Japanese maximum residue limits (MRLs) for Betamethasone

Food commodity Target tissue MRLs
Cattle, pigs Muscle, kidney 0.0008
Fat, liver, edible offal 0.002
Other terrestrial mammals Muscle, fat, liver, kidney, edible offal 0.0003
Chicken, other poultry Muscle, fat, liver, kidney, edible offal 0.0003
Eggs 0.0003
Milk - 0.0003
Seafood products - 0.0003
Honey and royal honey - 0.0003

1ppm = part per million

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