Ivermectin residues in milk of lactating donkey (Equus asinus): current regulation and challenges for the future

Abstract

Ivermectin (IVM) is a macrocyclic disaccharide anthelmintic agent with broad-spectrum antiparasitic action.\ud It is used for controlling internal and external parasites in food-producing animals (bovine, swine and equine\ud species), including donkey. This drug is included in Council Regulation (EEC) 2377/9, annex I, with\ud Maximum Residue Limit (MRL) ranging from 15 to 100 μg kg−1 depending on the species. The\ud pharmacokinetic characteristics of IVM mainly depend on the animal species, formulation and route of\ud administration. Due to its high lipophilicity it accumulates in milk of food producing animals. Detailed IVM\ud pharmacokinetic studies were carried out for horse, pig, cattle, sheep, and goat, but there is lack of information\ud for asinine species. Consequently, the absence of “label milk withdrawal time” and MRLs in donkey’s milk\ud indicates that IVM should not be used in lactating animals. On the contrary, information about IVM residues\ud in milk would be of paramount importance in view of the fact that donkey’s milk is a suggested substitute\ud for infants suffering from hypersensitivity to cow’s, sheep’s and goat’s milk protein or from multiple\ud hypersensitivity. European legislation does not explicitly state that an MRL should be determined for every\ud target species; however it’s interpretation led to MRLs being adopted for each species and each foodstuff.\ud Although IVM is approved for use in all lactating animal species the possibility of an illegal use should be\ud considered. In this paper, the problems arising from IVM administration in lactating donkey are analysed. A\ud particular attention is paid for the existing legislation and some proposals are suggested for regulatory\ud framework formulation

Assessment of donkey milk chemical, microbiological and sensory attributes in Greece and Cyprus

“…Passantino et al . () have reported, however, the challenges of ivermectin residues in DM. With reference to aflatoxin M1, Caloni and Cortinovis () reported the occurrence of aflatoxins in feeds for equines, while there is no report on aflatoxin M1 occurrence in DM.…”

Potential Hazards Associated with Raw Donkey Milk Consumption: A Review

“…Paksoy et al [63] evaluated the concentrations of essential elements and heavy metals in milk of dairy donkeys, goats, and sheep in Turkey. Regarding heavy metals, the authors stated that Ni, Cd V and barium (Ba) concentrations (expressed in μ g/L) in donkey milk were lower than the detection limit (1 mg/L).…”

“…Ivermectin (IVM), a macrocyclic disaccharide anthelmintic agent, with broad-spectrum antiparasitic action, is used to control internal and external parasites in bovine, swine, and equides, including donkey [63]. Commission Implementing Regulation 418/2014/EU [75] set out the Maximum Residue Limits (MRLs) for IVM for all mammalian food producing species, applicable to muscle, fat, liver, and kidney.…”

“…IVM is not licensed for use in lactating species in the EU, due to its persistent excretion in milk and its lipid-soluble character, which facilitates the absorption in humans after oral administration [63, 76].…”

“…The presence of unknown or uncontrolled IVM residues in milk may cause potential risk to consumers' health. Producers must be informed about possible risks related to the use of this drug in lactating animals, and advice concerning this matter should be given to the veterinarians [63, 76].…”