SAFEGUARDS | Food NO. 102/16

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On April 14, 2016, the European Union published Regulation (EC) 2016/576 in the Official Journal of the European Union, extending the provisional MRL for Rafoxanide in bovine and ovine milk. This provisional MRL will be extended until December 31, 2017.

Rafoxanide, N-[3-chloro-4-(4-chloro-phenoxy)phenyl]-2-hydroxy-3,5-diiodobenzamide, is a broad-spectrum antiparasitic agent belonging to salicylanilide antibiotics. It is commonly used to treat and control fascioliasis in sheep, cattle, goat, and horses. An oral route of administration for animals is generally set at a dose of 11.25 mg/kg body weight. Due to its property to bond strongly with plasma protein, Rafoxanide is therefore effective and remains in animals up to 28 days.

To ensure the food safety for consumer, the maximum residue limit (MRL) of Rafoxanide in foodstuffs of animal origin has been set out in the Annex to Commission Regulation (EU) No 37/2010. It is allowed to be used in bovine and ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption. In 2011, the Irish Medicines Board submitted a request for the extrapolation of MRL in bovine and ovine milk to the European Medicines Agency (EMA). Based on the available data at that time, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended a provisional MRL of Rafoxanide in these products and then amended the Annex to Regulation EU No 37/2010 with Regulation (EU) No 681/2014 [1]. Nevertheless, this provisional MRL was valid to be used until December 31, 2015. In order to continue protecting the legitimate expectation of food producers, the application and scientific progressive data for extension of the existing provisional MRL of Rafoxanide was requested and submitted to EMA for consideration. Eventually, the provisional MRL was approved with an extension until December 31, 2017. With the opinion of the Standing Committee on Veterinary Medicinal Products, the Annex to Regulation (EU) No 37/2010 was amended and changed to a new one in Regulation (EU) No 2016/576 [2], as shown in Table 1.

Table 1:  MRLs of Rafoxanide in foodstuffs of animal origin

Active substance Marker residue Animal species Target Tissues MRL (μg/kg)
Rafoxanide Rafoxanide Bovine Muscle 30
-- -- -- Fat 30
-- -- -- Liver 10
-- -- -- Kidney 40
-- -- Ovine Muscle 100
-- -- -- Fat 250
-- -- -- Liver 150
-- -- -- Kidney 150
-- -- Bovine, ovine Milk 10

What do the changes mean?

This EU MRL has the potential to affect agricultural producers and food manufacturers in all Member States and third countries. The residue of Rafoxanide in or on food products destined for EU must not exceed the MRLs. For support in complying with the food safety regulation, the producers should seek professional advice.

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 further information, please visit our website:

For enquiries, please contact:

Amornpun Dajsiripun
Global Competence Support Centre Food Specialist
t: +66 2683 0541 ext 2423

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