Japan Proposes MRLs for Betamethasone for Food Producing Animal Products
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

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 (ppm)1 |
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
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.foodsafety.sgs.com
For enquiries, please contact:
Amornpun Dajsiripun
Global Competence Support Centre Food Specialist
t: +66 2683 0541 ext 2423
Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!
Read more articles on Hot Source!
© SGS Group Management SA - 2018 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.