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 diarrhoea in pigs do not outweigh the risks for the environment.
“The Committee adopted by consensus an opinion concluding that overall the benefit-risk balance for the products concerned by this referral is negative,” it said.
The matter was referred to the Committee by the Netherlands and France under Article 35 of Directive 2001/82/EC.
The French food safety agency, ANSES, initiated a class referral opposing the authorization of all ZnO veterinary premixes for piglets in the EU citing environmental impact grounds, and alleging that ZnO can increase antibiotic resistance in microbes.
The CVMP acknowledged that there is a risk of co-selection for resistance associated with the use of ZnO, but, added that, at the present time, that risk is "not quantifiable".
However, the committee’s conclusion is not in line with its October 2015 ruling.
We reported earlier this year on the EU registration for Huvepharma’s ZnO feed targeted product, Gutal, which had come about through that Belgian company submitting an authorization application via the decentralized procedure (DCP), with the UK acting as the reference member state.
Arbitration procedure
In May 2015, the EMA completed a long arbitration procedure following disagreement during the DCP among EU member states regarding approval for Gutal, with its CVMP finding then there were insufficient grounds to support concerns expressed by some countries over the use of ZnO products.
The CVMP concluded then that by applying a few risk mitigation measures, the risk for the environment was acceptable. And it, therefore, determined the marketing authorization for Gutal could be granted provided the recommended controls were added to the product information.
The final decision on registration then lay with the Commission and the Standing Committee on Plants, Animals, Food and Feed (SCOPAFF) which implemented the CVMP opinion and agreed with the approval for Gutal.
The EMA was not able to respond to our request for clarification on this month's ruling prior to publication.
A spokesperson for ANSES only said that the CVMP's opinion was "in line with the French position." She said the next move was up to the EU Commission, and that the decision on marketing authorizations will be made in Brussels at a later stage.
Opposition to move
The UK’s national pig association (NPA) has written to the Veterinary Medicines Directorate (VMD) to outline its significant concerns about the CVMP ruling and a potential ban on medicinal products containing zinc oxide (ZnO).
The association has requested a meeting early in the New Year with the VMD and other UK industry bodies concerned at the prospect of a ban on such products.
NPA senior policy advisor, Georgina Crayford, said the association accepted the CVMP opinion was based on the scientific evidence available.
“However, clearly, and as stated by CVMP, there is insufficient evidence regarding the risk of development of resistance. Indeed, the strength of some of the existing science around this subject has been called into question
“Of course, the environmental risk of zinc oxide use is an important factor to consider, but in all previous assessments the CVMP has found the benefits of its use to outweigh the environmental risk, so you can understand our surprise at this apparent U-turn without clear explanation.
“There also appears to be a stark omission from the CVMP’s assessment – that of the risk of development of resistance due to the increased use of antimicrobials that will likely occur should the ban on therapeutic use of zinc oxide proceed,” she wrote.
The NPA policy expert stressed that a ban on the use of zinc oxide for oral treatment of pigs would result in increased incidence of post-weaning diarrhoea, which would negatively affect piglet welfare.
It would also seriously hamper the ability of the pig sector to reduce its use of antibiotics, she added.
Tim Goossens, business development manager at feed additive supplier, Nutriad, sees a market opportunity. He said the ZnO decision 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. He added functional feed additives that can be shown to improve intestinal health are likely to receive more attention as a result.
The CVMP recommendation comes on top of the proposal from the European Food Safety Authority (EFSA) earlier this year to lower the maximum copper content allowed in piglet feed.