Flukecides

Notice concerning use of flukicidal products in bovine animals intended to produce milk for human consumption

(Extract from The IMB - Irish Medical Board)

The IMB wishes to remind farmers of the ongoing restriction on the use of flukicides which do not have a maximum residue limit (MRLs - control thresholds for residues) for milk. As was the case in 2010, the Department of Agriculture continues to monitor milk for the presence of residues of flukicide drugs without MRL. The veterinary medicines concerned contain clorsulon, closantel, nitroxynil, rafoxanide and triclabendazole. Veterinary medicines containing these substances should not be used in dairy animals intended for milk production, including pregnant heifers intended for milk production for human consumption.

The labels of products containing clorsulon, closantel, nitroxynil, rafoxanide and triclabendazole have been updated during the course of 2010 to reflect the above warning. However, the labels of older stocks of veterinary medicines, which might be still in date and available on farms, might not be sufficiently explicit and apt in respect of the instruction not to use the products concerned in animals intended for milk production for human consumption. Farmers should follow the advice given here even where the label of the product available indicates otherwise. Note that the products concerned continue to be safe for use in animals which are not intended for use for milk production for human consumption, including beef suckler cows.

A list of products containing these substances which are affected by the IMB decision is attached as Appendix 1.

(Flukicide Products for Cattle suitable for Suckler and Beef Herds. As these products have no MRL they are illegal for the dairy herd.)

The IMB advises that flukicidal veterinary medicines containing oxyclosanide or albendazole, which already have a MRL established for milk, can continue to be used to treat adult fluke in animals which are intended for milk production. In these cases, the appropriate withdrawal periods indicated on the product labelling should be strictly followed. A list of products containing these substances is attached as Appendix 2.

(Veterinary Medicines of the authorised for use in milking animals. These products have an MRL.)

Further documentation on the situation of flukicides:

1. The labelling of all fluke products which do NOT have an MRL for milk has been amended in 2010 to advise users that the products are not permitted for use in milk-producing animals, including pregnant animals intended for milk production for human consumption. All such products are expected to be compliant with the Irish Medicines Board (IMB) SPCs as available on its website (www.imb.ie).


2. For those products with an MRL for milk (albendazole and oxyclosanide) a milk withdrawal period is indicated on the product labelling. There has not been any change in the recommendations on these products.


3. The EU Commission has in February 2011 launched a referral procedure under Article 35 of Directive 2001/82/EC, which is expected to harmonise the labelling advice for all flukicide products without MRL for milk. This process is expected to take at least 3 months and probably much longer. It might lead to the labels of the concerned Irish products (i.e. flukicides without MRL for milk) having to be changed yet again in due course, or alternatively, to those for products in other member states harmonising with the current Irish position.


4. The EU Commission has clarified that the MRL applications made by the IMB to the European Medicines Agency (EMA) in June 2010 need to be amended. This is a highly technical point – basically they are not happy that the applications were in accordance with the preferred legal provision of the cited article of EU Regulation 470/2009. This has the effect that the IMB will now have to make new applications for MRLs for the substances concerned under an alternative provision of the same regulation.