Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to consider additional data provided by the applicant subsequent to its former opinion on the efficacy and safety of MintrexCu for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the supplementary information supplied by the applicant on the safety for the target animals and consumers. Tolerance studies in piglets, laying hens and calves for rearing were submitted. Notwithstanding uncertainties due to the shortcomings of these studies, there were no indications suggesting that MintrexCu would present additional or different concerns for tolerance of piglets, laying hens or calves as compared to the authorised copper sulfate. Taking also into account the already assessed safety of MintrexCu for chickens for fattening, the FEEDAP Panel concluded that the use of MintrexCu would not pose a greater safety concern for target species studied than the authorised copper sulfate. Thus, the FEEDAP Panel concluded that MintrexCu is safe for all species up to the maximum copper (Cu) content authorised in feed. Tissue/products Cu deposition data were submitted for piglets (muscle, liver, kidney, skin/fat), laying hens (eggs) and dairy cows (milk). The FEEDAP Panel retains the Cu tissue deposition in the piglets study with MintrexCu for consumer exposure calculations. The use of this data is justified by (i) the high Cu content of piglet diet (170 mg/kg), and (ii) the higher supplementation of Cu in pigs over the entire production cycle compared to other animal species. Using this data as well as a model calculation based on SCOOP food consumption data, the FEEDAP Panel concluded that the use of MintrexCu in all animal species would lead to an additional consumer exposure not higher than 0.5 mg/day, compared to the use of copper sulfate. This difference is almost entirely attributable to liver Cu content. The estimated increase would not lead to the UL being exceeded by consumers. Therefore, the FEEDAP Panel concluded that the use of MintrexCu up to the maximum authorised Cu content in feed is safe for consumers.
|Titolo:||Scientific Opinion on the safety of a copper chelate of hydroxy analogue of methionine (Mintrex® Cu) as feed additive for all species|
|Parole Chiave:||Nutritional additive ; trace element ; copper ; chelate ; hydroxy methionine analogue ; tissue deposition ; safety|
|Settore Scientifico Disciplinare:||Settore VET/07 - Farmacologia e Tossicologia Veterinaria|
|Data di pubblicazione:||2009|
|Digital Object Identifier (DOI):||10.2903/j.efsa.2009.1382|
|Appare nelle tipologie:||01 - Articolo su periodico|