JAPAN – Japan has established maximum residue limits (MRLs) for Zeranol, a synthetic nonsteroidal estrogen used as a growth promoter in animals.

Ministry of Health, Labor, and Welfare informed that the regulation is already in force for those products placed on the Japanese market.

Zeranol also known as α-Zearalanol, is derived from Zearalenone, a mycotoxin produced by Fusarium (a fungi species) on many grain crops including corn, wheat, sorghum, and barley.

Currently, it is produced commercially and widely used to improve feed conversion efficiency and promote growth rates in livestock production.

However, the application of Zeranol to food producing animals has raised public health concerns due to its potentially endocrine disrupting properties.

Japan’s Ministry of Health, Labor, and Welfare recently approved Zeranol for use in animal products and seafood and most of the MRLs set at 0.002 parts per million (ppm).

Food products destined for Japan must not have residues of Zeranol exceeding the MRLs.

With the aid of enzyme-linked immunosorbent assay (ELISA),  traces of Zeranol can easily be detected in food products. Results are rapid and cost effective.

Nevertheless, due to unreliable results, ELISA is not recommended for complex foods. For result validation, a technique like liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) should be considered because of its high selectivity, specificity and sensitivity.

Merck Animal Health markets Zeranol under the brand name Ralgro in the United States while in Spain it is marketed as Ralone.

If administered by injection in livestock, Zeranol has long-term consequences on beef consumers, including breast cancer, prostate cancer, hormonal imbalances and infertility.

So as to protect consumers from the risk of residues, the main beef exporting countries, such as the USA, Canada, Australia, and New Zealand have established MRLs for Zeranol, whereas EU has banned it.

The European Union banned all the synthetic estrogens for use in food-producing animals on the basis of their carcinogenity. Moreover, no residues of any anabolic agent should be present in animal products imported or produced within the European Union.

Although Zeranol may increase cancer cell proliferation in already existing breast cancer, dietary exposure from the use of Zeranol-containing implants in cattle is insignificant. It is 3 to 4 times more potent as an estrogen than the related compound zearalenone.

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