Author:Lin Fang(https://www.linkedin.com/in/fang-lin-fiona/) 

 Regulatory Analyst, Agrochemical Department

Takehome:

The production, importation of chemical growth-promoting antibiotics as veterinary drug shall be halted as of 1 Jan 2020 and the uses as feed additive shall be terminated starting from 1 Jul 2020.

On 9 Jul 2019, the Chinese Ministry of Agricultural and Rural Affairs issued the MoARA Announcement 194 to terminate the feed additive uses of all growth-promoting agents except the traditional Chinese medicines. The move is part of the “National Action Plan against Bacterial Resistance (2016-2020)” and growth-promoting antibiotics that used on both human and animal were foremost obsoleted.

China recognized the feed additive use of veterinary drug by promulgating the “List of Veterinary Feed Additives” in 1994 and the latest comprehensive adjustment was made by MoA announcement 168 in 2001, which collected the name, target animals, dosage and feeding method of all existing pharmaceutical feed additives:

l Pharmaceutical feed additives for disease prevention and growth enhancement purposes and can be used for prolonged periods will be approved in the form of veterinary feed additives. Feed product using these additives shall be labeled with the pharmaceutical ingredient(s), content, applicable scope, safety interval and use precaution and animal farmers should follow the specification accordingly;

l Pharmaceutical feed additives for disease prevention and defined with a treatment course that only administered through feeding will be approved in the form of veterinary drug and can be only purchased and used as feed additive by veterinary prescription;

Most of the growth-promoting additives listed are antibiotics used on both human and livestock, such as Flavomycin, Virginiamycin, Olaquindox, Lincomycin, Ivermectin, Norfloxacin and Ciprofloxacin, etc. As animal-sourced bacterial resistance was highlighted in the Action Plan, 3 categorized measures targeting animal antibiotics will be adopted by 2020:

1. To conduct risk assessment on growth-promoting antibiotics used on both human and animals and obsoleting measures will be carried out accordingly;

2. The animal-use-only antibiotics will be specifically monitored from residue and resistance aspects and opinions on whether to retain will be concluded;

3. Other animal antibiotics with potential risks will be analyzed and risk mitigation measures will be proposed;

The elimination of growth-promoting antibiotic feed additives will be implemented in a phased manner:

• The production, importation of all growth-promoting feed additives shall be halted as of 1 Jan 2020 and the approval number of homemade veterinary drug and registration of imported veterinary drug will be revoked accordingly. The additives previously produced can be circulated until 30 Jun 2020;
• Feed producers will be prohibited from using growth-promoting feed additive excluding traditional Chinese medicines starting from 1 Jul 2019 and feed products previously produced can be circulated until 31 Dec 2020;
• By 1 Jan 2020, MoARA will complete the amendment to the quality specification of the remaining pharmaceutical additive ingredients with dual effects of disease prevention and growth-promoting. Only the disease prevention effect will be recognized;
• MoARA will stop granting the new veterinary feed additive approval to coccidiostatics and traditional Chinese medicines and the existing approval of these additives will be transformed to veterinary drug approval by 1 Jul 2020.
• The Announcement 168 and Announcement 220(supplement to Announcement 168) will be revoked as of 1 Jul 2019

 MoARA’s News Release

http://www.moa.gov.cn/govpublic/xmsyj/201907/t20190710_6320678.htm