Reminder – phasing out of veterinary medicines containing zinc oxide

Notice type: Advisory

Date: 21/05/2021

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recommended to the EU Commission that all existing marketing authorisations for products concerned by this procedure be withdrawn in a phased basis, to allow farmers and other stakeholders to adapt to the new situation. The EU Commission took such a decision on 26 June 2017, meaning that the products concerned must be withdrawn from the European Union, within 5 years, i.e. before 26 June 2022.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.


Product name or type:
Zinc oxide containing veterinary medicines that are administered orally to pigs


Active Substance:
Zinc Oxide


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)


Authorisation Holder:
Authorisation Holder:
- Huvepharma Ltd, Gutal premix, VPA 10782/16/1
- DSM Nutritional Products Ltd, Pigzin premix, VPA 10443/1/1
- Provimi Ltd, Zincotec premix, VPA 10446/1/1 


Prescription Required:
Yes


Target Audience:
Veterinary practitioners


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.



Background Information Or Related Documents:

The opinion of the CVMP is contained in the CVMP press release March 2017 . The original referral procedure was initiated by France and the Netherlands in February 2016, due to concerns relating to the potential risk to the environment and increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide in food-producing animals. More information of the scientific background to the decision of the CVMP is available here.

Pigzin and ZInctotec were first authorised in Ireland in 2013, while Gutal was authorised in December 2015. Before this time zinc oxide was imported into Ireland under a special Department of Agriculture licence.



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.


Further Information:

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.



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