The category of product referred to by the Deputy falls to be regulated in terms of Irish legislation under either the Animal Remedies Act, 1993, or the European Communities (Additives in Feedingstuffs) Regulations, 1989. Decisions are made on a case by case basis depending on a range of factors, including nature and level of active ingredient, labelling, medicinal claims, method of administration etc. Accordingly, details of individual products of this nature should, in the first instance, be submitted to the tillage and plant health division of my Department for a decision as to the appropriate regulatory route.