In 2017, the European Medicines Agency (EMA) concluded that the benefit-risk balance of veterinary medicines containing zinc oxide that are administered orally to pigs is negative. The assessment, which was conducted by the EMA expert group, the Committee for Medicinal Products for Veterinary Use (CVMP).
The CVMP recommended to the EU Commission that all existing marketing authorisations for products concerned by this procedure be withdrawn in a phased basis, to allow farmers and other stakeholders to adapt to the new situation. The EU Commission took such a decision on 26 June 2017, meaning that the products concerned must be withdrawn from the European Union, within 5 years, i.e. before 26 June 2022. The decision is binding on all Member States.
Marketing authorisation holders as well as veterinary practitioners and farmers were informed of the decision at the time.
Serial Or Batch Number And Expiry Date:
In Ireland, the following products containing zinc oxide have been authorised by the HPRA for use in pigs:
- Gutal premix, VPA 10782/16/1 (Huvepharma Ltd)
- Pigzin premix, VPA 10443/1/1 (DSM Nutritional Products Ltd)
- Zincotec premix, VPA 10446/1/1 (Provimi Ltd)
Problem Or Issue:
Although authorised for the control of diarrhoea in piglets by the HPRA only since 2013, zinc oxide has traditionally been favoured by veterinary practitioners as an alternative to antibiotics.
The premix is normally incorporated into finished piglet feed to give a dosage of 2300 to 2500 mg elemental zinc /kg bodyweight and fed for up to 14 days during the high risk weaning period.
The products concerned are extensively used, with most animals receiving the product during the period post-weaning.
With one year remaining until the medicines cease to be authorised, veterinary practitioners and farmers are urged to review disease control options for post-weaning pigs and plan accordingly.
Actions To Be Taken:
Pending the withdrawal of the marketing authorisations for the products concerned, in accordance with the decision of the EU, medicines containing zinc oxide remain authorised and veterinary practitioners can continue to prescribe these products until June 2022. However, it is expected that the medicines concerned will be withdrawn before this deadline, and therefore veterinarians and farmers should review their use of the medicines concerned and make alternative plans.
For the control of diarrhoea in piglets there are a range of potential therapeutics and vaccines authorised for use. Users should discuss their needs with their veterinary practitioners, who will also advise on other disease control measures including biosecurity measures, hygiene, husbandry and nutrition.
The HPRA wishes to stress that the issue does NOT raise any issues of consumer safety or animal safety. Zinc is an essential trace element for humans. Zinc use in animals contributes negligibly to concentrations in edible tissues and is therefore biologically insignificant for the consumer. Zinc oxide has a ‘no MRL required’ status in food-producing animals in the EU.