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 MintrexZn 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. Piglets showed the same degree of intolerance to MintrexZn when supplied at the same overdose level as the authorised zinc sulfate. In laying hens, there is sufficient evidence to conclude that zootechnical parameters were unaffected by the zinc (Zn) supplementation and source at three times the maximum level authorised in the EU; the small differences observed in haematology and blood biochemistry between Zn levels and source were considered being of limited relevance. In calves for rearing there was no reason to consider MintrexZn unsafe compared to zinc sulfate. The FEEDAP Panel concluded that the use of MintrexZn up to the maximum authorised Zn content in feed would not pose a greater safety concern for the target species studied than the authorised inorganic Zn sources. Taking also into account the already assessed safety of MintrexZn for chickens for fattening, the FEEDAP Panel concludes that MintrexZn is safe for all species up to the maximum authorised Zn content in feed. Tissue/products Zn deposition data were submitted for piglets (muscle, liver, kidney, skin/fat), laying hens (eggs) and dairy cows (milk). There was no indication that MintrexZn would lead to any higher Zn concentration in tissues/products compared to inorganic Zn. Consequently, differences in Zn exposure of the consumer due to the use of MintrexZn are not expected. The FEEDAP Panel concluded that no specific concerns for consumer safety would arise from the use of MintrexZn in feed for all species.

Scientific Opinion on the safety of a zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) as feed additive for all species / E. Panel on Additives, P. or Substances used in Animal Feed, G. Aquilina, G. Bories, P. Brantom, F. Caloni, A. Chesson, P.S. Cocconcelli, J. de Knecht, N.A. Dierick, M.A. Gralak, J. Gropp, I. Halle, N.G. Ilbäck, R. Kroker, L. Leng, S. Lindgren, A.K. Lundebye Haldorsen, A. Mantovani, M. Mézes, D. Renshaw, M. Saarela. - In: EFSA JOURNAL. - ISSN 1831-4732. - 7:11, art. 1381(2009), pp. 1-13. [10.2903/j.efsa.2009.1381]

Scientific Opinion on the safety of a zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) as feed additive for all species

F. Caloni;
2009

Abstract

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 MintrexZn 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. Piglets showed the same degree of intolerance to MintrexZn when supplied at the same overdose level as the authorised zinc sulfate. In laying hens, there is sufficient evidence to conclude that zootechnical parameters were unaffected by the zinc (Zn) supplementation and source at three times the maximum level authorised in the EU; the small differences observed in haematology and blood biochemistry between Zn levels and source were considered being of limited relevance. In calves for rearing there was no reason to consider MintrexZn unsafe compared to zinc sulfate. The FEEDAP Panel concluded that the use of MintrexZn up to the maximum authorised Zn content in feed would not pose a greater safety concern for the target species studied than the authorised inorganic Zn sources. Taking also into account the already assessed safety of MintrexZn for chickens for fattening, the FEEDAP Panel concludes that MintrexZn is safe for all species up to the maximum authorised Zn content in feed. Tissue/products Zn deposition data were submitted for piglets (muscle, liver, kidney, skin/fat), laying hens (eggs) and dairy cows (milk). There was no indication that MintrexZn would lead to any higher Zn concentration in tissues/products compared to inorganic Zn. Consequently, differences in Zn exposure of the consumer due to the use of MintrexZn are not expected. The FEEDAP Panel concluded that no specific concerns for consumer safety would arise from the use of MintrexZn in feed for all species.
Nutritional additive ; trace element, zinc, chelate, hydroxy methionine analogue, tissue deposition, safety
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
2009
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/149997
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