As is the case with all veterinary medicines, treatments for fluke in cattle are subject to licensing in accordance with relevant EU and national legislation. The Irish Medicines Board is the national licensing authority for Ireland and sponsoring companies wishing to place medicines on the market here are required to satisfy the Board that their products meet the required scientific standards in terms of quality, safety and efficacy and that post treatment withdrawal periods or other restrictions, to appear on product labelling, have an adequate scientific basis.
Recent advances in analytical technologies being used under the national residue plan implemented by my Department have demonstrated that the product labelling for a number of flukicidal medicines needed to be updated. Arising from this, the Irish Medicines Board has engaged with the sponsoring companies concerned with a view to amending the relevant product labelling so as to avoid their use in cows whose milk is intended for human consumption and, in the interim, medicine distributors and farmers are being advised of the prospective changes.
While individual residue detections at very low levels resulting from improvements in analytical technologies must, in the absence of a maximum residue limit, be regarded as technically positive under EU rules, they do not in the specific cases in question represent any risk to consumer health, a fact endorsed by the Food Safety Authority of Ireland. Nonetheless, it is appropriate that follow-up action is taken to provide better information to farmers on the use of these products and also to enhance consumer protection in the broader sense, as has happened in this case by amending product labelling in line with current analytical findings.
My Department understands that a number of fluke treatments will continue to be available on the Irish market for cows whose milk is intended for human consumption, subject to compliance with the withdrawal periods specified on the product labelling. Information on the treatments concerned is available on the IMB's website: (www.IMB.ie).
