Revision of Council Directive 90/167/EEC - current and future legal situation regarding medicated feed in the European Union as compared to the United States of America and Canada

In animal husbandries with large numbers of animals the use of medicated feed is a common treatment option in many countries.

The European Union (EU) regulates this type of medication in Council Directive 90/167/EEC which had to be implemented into national law in every EU member state. Since the directive was never substantially amended and national implementations were highly divergent, the EU recently decided to revise or replace the directive.

This thesis aims at comparing the regulatory framework in the EU with the one in the United States of America (USA) and Canada.

In general, those regions or countries developed rather different ways to deal with the regulatory topic "medicated feed" which makes a detailed comparison rather complex.

Overall, the EU appears to have the strictest legislation including mandatory approval and regular risk-based inspections of manufacturing sites, compulsory veterinary prescription of medicated feed, and a complete ban of antimicrobial usage for growth promotion. The Canadian legislation, on the other hand, appears to be the most lenient, with neither pre-production approval of medicated feed manufacturers nor regular inspections aside from those carried out within the frame of some national inspection programmes which do not mandatorily include all medicated feed manufacturers. Most medicated feeds are available over-the-counter as long as they comply with some pre-set requirements; the use of medicated feed for growth promotion is common and not planned to be banned in the near future. The USA's current regulation is somewhere in between the Canadian and the EU's approach in so far as they have a rather strict course of action regarding the implementation of Good Manufacturing Practices and the approval and inspection of (certain types of) medicated feed manufacturers, but the veterinary oversight over medicated feed is lacking, which is planned to be changed until 2017.

By repealing Directive 90/167/EEC and passing a new regulation similar to the current proposal the EU will tighten its regulatory framework in most member states (though it will be mitigated in some of them) and retain its position as region with the strictest medicated feed legislation amongst those compared within this thesis, an approach that appears to be highly important regarding the potential threat of antimicrobial resistance which could be fostered by a lax legislation for medicated feed containing antimicrobials.