Outcome of EMA referral procedure: Veterinary medicines containing zinc oxide

Notice type: Advisory

Date: 03/04/2017

On 16 March 2017, the European Medicines Agency EMA) concluded its assessment of the benefit-risk balance of veterinary medicines  containing zinc oxide that are administered orally to pigs. The assessment, which was conducted by the EMA expert group, the Committee for Medicinal Products for Veterinary Use (CVMP), concluded that overall the benefit-risk balance for the products concerned is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment. The CVMP acknowledged that there is also a risk of co-selection for antimicrobial resistance associated with the use of zinc oxide. However, at the present time, that  risk is not quantifiable. 
The CVMP has recommended to the EU Commission that all existing marketing authorisations for products concerned by this procedure be withdrawn in a phased basis, to allow farmers and other stakeholders to adapt to the new situation. A final decision from the Commission in respect of the CVMP recommendation is not expected before June 2017. It is anticipated that any decision to withdraw the products,concerned will be the subject of discussion between the Commission, Member State governments and the companies concerned, and will take a number of years to come into effect.


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


Active Substance:
Zinc Oxide


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:
Zinc is relatively poorly absorbed and is eliminated in the faeces. When excreted by pigs, it is presented to the environment in pig slurry. Zinc is very toxic to aquatic organisms and can cause toxic effects in both aquatic and terrestrial animals. Zinc is persistent in soils and may accumulate in sediments. Toxicity will depend on environmental conditions, soil types and amount added to the environment through use in pigs. 

Although only authorised for the control of diarrhoea in piglets by the HPRA 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.
 


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. 


Actions To Be Taken:
Pending the decision of the EU Commission, medicines containing zinc oxide remain authorised and veterinary practitioners can continue to prescribe these products. 

As use of the products continues, Veterinary practitioners and farmers are advised to closely follow the existing recommendations regarding the environment and medicines containing zinc oxide. 

In particular, it is currently recommended that manure from treated pigs should not be spread on vulnerable soils, identified as free draining, acidic (pH < 6), sandy soils. Manure from treated pigs should be diluted with those of untreated animals or sows, so that the amount of treated piglet manure is as low as possible and never exceeding 40% when manure from weaned piglets and sows is stored together. Manure containing zinc should not be spread on the same area of land in successive years to avoid accumulation of zinc which may cause adverse effects in the environment. When spreading manure from treated animals, the minimum buffer distance from water courses is at least 3 metres.  
 


Further Information:

Following the communication of the March 2017 CVMP opinion to the EU Commission, the Commission will now consider the opinion in consultation with the Member State governments before making a final decision on the matter. This is not expected before June 2017.

 

Following the publication of the final decision, and details of the expected transition period, the HPRA will provide a further update on the situation.

 

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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