5 key facts about the EU’s ZnO ban

Here are 5 key facts to help pig producers make sense of the ZnO ban.

Zinc oxide can still be used as a feed additive at low dosages

Pigs require zinc for various metabolic functions. The European Food Safety Authority (EFSA) holds that a total level of 150ppm meets the animals’ physiological needs for zinc. The European Commission has turned this recommendation into law: 150ppm is the legal limit for zinc supplementation for piglets. ZnO can be used as a source for this supplementation; it is included in the EU’s official register of feed additives.

The EU sets common rules for veterinary medicinal products

ZnO-based products to treat post-weaning diarrhoea in piglets, on the other hand, are classified as veterinary medicinal products (VMPs). A commonly administered dosage is 100mg per kg body weight per day for 14 consecutive days, i.e. 2500ppm zinc in feed. The EU’s rules for the production, distribution, and authorisations of VMPs are laid down in Directive 2001/82/EC and in Regulation (EC) No 726/2004. Just as the EFSA advises the European Commission on feed additives, they turn to the European Medicines Agency (EMA) regarding VMPs (Table 1).

Table 1- Zinc oxide: 2 different uses – 2 different situations.

ZnO as a feed additive ZnO as a veterinary medicinal product (VMP)
EU agency European Food Safety Authority (EFSA) European Medicines Agency (EMA)
Legislation Regulation (EC) No 1831/2003 on additives for use in animal nutrition Directive 2001/82/EC on veterinary medicinal products + Regulation (EC) No 726/2004
Levels Max. total 150ppm of zinc (from ZnO and other sources) Normal dosage ca. 2500ppm
Ban? No! There is no indication that ZnO will be banned as a feed additive. Yes! Marketing authorisations for ZnO-based VMPs will be withdrawn the across EU by June 2022.

Zinc oxide VMPs need marketing authorisations

VMPs can only be sold and traded in the EU if they have received a marketing authorisation. Depending on the VMP and its release date, the marketing authorisation is either issued by the EMA or by national authorities. Veterinary medicines containing zinc oxide fall under the remit of national authorities. However, national authorities are supposed to turn to the EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) if they have any issues with an application they receive. This is what happened in the case of zinc oxide.

France and the Netherlands initiated the review of zinc oxide

A company applied for a marketing authorisation for its ZnO-based medicated feeding stuff for piglets in the United Kingdom, hoping for a so-called decentralised authorisation procedure. This procedure would mean that the marketing authorisation issued in the UK would also be valid in other EU countries. However, France and the Netherlands objected to this, citing environmental concerns, doubts about the efficacy of risk mitigation measures and the issue of antimicrobial resistance. After some back and forth, they were successful.

Bottom line: ZnO-based VMPs will be banned

In March 2017, the CVMP concluded that zinc oxide’s benefits of preventing diarrhoea do not outweigh the risks to the environment. Therefore the panel recommended that national authorities withdraw existing marketing authorisations for zinc oxide-based VMPs and that they no longer grant new authorisations. On 26 June 2017, the European Commission adopted the CVMP’s recommendation, which means that all EU countries have to implement it. Countries may defer the implementation, but only until 26 June 2022.

Hence the search is on for effective strategies to control post-weaning diarrhoea without zinc: through better management and feed practices, as well as the support of targeted, functional feed additives.

Article from PIG PROGRESS