Danish environmental impact study behind EMA decision on zinc oxide

By Jane Byrne

- Last updated on GMT

© istock/Petmal
© istock/Petmal

Related tags Zinc oxide European union

New research prompted the European Medicines Agency (EMA) to revise its previous assessments on zinc oxide risk.

The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded at a meeting earlier this month​ that the benefits of zinc oxide for the prevention of diarrhea in pigs do not outweigh the risks for the environment. 

The UK’s national pig association (NPA) decried the lack of clear explanation from CVMP on what it termed a “U-turn”​ decision.    

It was a finding contrary to the CVMP’s conclusions in relation to the authorization of a Belgian company’s ZnO product in October 2015​and its previous assessments on those products. 

Danish findings 

However, this morning, a spokesperson for the EMA briefed FeedNavigator on the reasons behind the CVMP’s new recommendation: 

pig farm istock
Danish research on risk of ZnO run-off triggered EMA proposal on marketing authorizations for ZnO medical products © istock

She said, in 2015, the referral procedure under Article 33(4) of Directive 2001/82/EC was only for one veterinary medicinal product containing ZnO - Gutal 1000 g/kg premix for medicated feeding stuff for piglets. “This referral related to a specific generic product, and pertained to the environmental risk relating to Gutal only,”​ said the spokesperson.  

During this procedure, she said a risk to the environment was identified due to accumulation of zinc in the terrestrial and aquatic compartment, including sediment, with acidic, sandy, well-drained soils being most vulnerable. However, at that stage, supporting field studies on zinc accumulation in soils were not available, noted the EMA representative. 

“In the meantime, new data was published which was taken into account by the CVMP for the referral procedure (EMEA/V/A/118) under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing zinc oxide to be administered orally to food producing species.

“A study in Denmark​ showed that the use of pig slurry on soils has led to a significant increase in soil concentrations of zinc, especially in the latest period monitored (1998 to 2014).

“The authors concluded that the current use of zinc in pig production in Denmark may lead to leaching of zinc from fields fertilized with pig slurry into the water compartments, in concentrations that may pose a risk to aquatic species,” ​she explained.

Right to appeal  

In terms of next steps, the EMA spokesperson said the marketing authorization holders for these medicines have the right to launch an appeal on the outcome of the review. 

“Should an appeal be launched, a re-examination of the outcome will be started, which is likely to take up to four months. In line with the usual procedure, the final opinion of the CVMP will be sent to the European Commission who will adopt a decision following a vote in the Standing Committee on Veterinary Medicinal Products; the Decision will be applicable in all EU member states,” ​she added.  

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