The European Medicines Agency (EMA) has recommended that all veterinary medicines containing zinc oxide should be withdrawn. This decision follows an EMA conclusion that the benefit-to-risk balance for veterinary medicines containing zinc oxide is negative. The Digestive Performance team of feed additives producer Nutriad examines the impact of such a possible ban.
More risks than benefits
The EMA investigation was instigated by the Netherlands and France, following concerns about the potential risk non-degradable zinc oxide presents to the environment, and the risk for co-selection of antimicrobial resistance.
To evaluate the overall benefit-to-risk balance for the products, consideration was also given to the authorized treatment benefits.
The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP), which is represented by all EU member states, has now concluded the treatment benefits of zinc oxide for the prevention of diarrhoea in pigs did not outweigh the environmental risk associated with their use. Effective measures to manage and reduce the accumulation of zinc in the environment could not be identified.
Furthermore, the CVMP acknowledged a risk existed of co-selection for antimicrobial resistance associated with the use of zinc oxide, but, at the present time, the risk was not quantifiable.
Based on its scientific conclusions, the committee recommended withdrawal of the marketing authorizations for the products.
Impact on pig industry
The full grounds for the CVMP conclusion will be set out in their Opinion, which is expected to be released within the next few months. Following adoption, the CVMP’s opinion will be forwarded to marketing authorization holders who may, within 15 days of receipt, make a request for re-examination.
Prior to adopting a final decision, the European Commission, in consultation with member states, will consider the impact on the EU pig farming industry (changes in pig farming practices to avoid increases in the occurrence of diarrhoea at weaning, to ensure animal welfare and prevent increases in the use of antibiotics) at a meeting of the Standing Committee on Medicinal Products for Veterinary Use.
A number of associations related to pig production have already said they will fight a future ban on the use of zinc oxide in animal feed, as it would remove a key tool in controlling post-weaning diarrhoea.
Feed additives with antimicrobial function
“Just as with the current focus on how to decrease the overuse of antibiotics, this is an example of how consumer concerns and regulatory controls continue to make the traditional tools to combat bacterial diseases in animal production less available”, says Tim Goossens, business development manager at Nutriad.“ As the industry is seeking effective alternatives that can help overcome these challenges, functional feed additives that improve intestinal health receive more attention”. His colleague Daniel Ramírez adds: “Especially a product like SANACORE®EN, which is designed to exert a broad antibacterial effect and to strengthen the intestinal barrier, can be of critical importance when considering strategies to reduce veterinary medicines. The fact that we have excellent data from several trials where SANACORE®EN is successfully being used in piglet production programs with a decreased inclusion level of zinc oxide, confirms the potential of this product.”
NUTRIAD delivers products and services to over 80 countries through a network of sales offices and distributors. These are supported by 4 application laboratories and 5 manufacturing facilities on 3 continents. Find out more at http://nutriad.com/