Safety and efficacy of iron chelates of lysine and glutamic acid as feed additive for all animal species

nutritional additives, compounds of trace elements, iron chelates of lysine and glutamic acid, ProPath Fe, safety, efficacy
First published in the EFSA Journal
25 luglio 2019
Adopted
4 luglio 2019
Type
Scientific Opinion

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of iron chelates of lysine and glutamic acid (Iron‐LG) as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concludes that, owing to safety considerations, Iron‐LG should not be used in water for drinking. Iron‐LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species/categories provided that the maximum authorised levels in the EU for total iron in feed are not exceeded. No increases in the iron content of animal tissues and products are expected from the use of Iron‐LG in animal nutrition. There is no indication that the toxicity of Iron‐LG is essentially different from that described for inorganic divalent iron. The use of Iron‐LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total iron levels in feed are respected. Owing to the iron and nickel content of Iron‐LG, the handling of the additive, poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitizer; it is irritant to eye and non‐irritant to skin. Iron‐LG is intended to be a substitute for other authorised iron additives and will not further increase the environmental burden of iron; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Owing to the limitations in the study provided, the FEEDAP Panel cannot conclude on the efficacy of the additive for chickens for fattening, and thus, on the efficacy of Iron‐LG to all animal species and categories. The FEEDAP Panel posed a recommendation concerning the description of the additive.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5792
EFSA Journal 2019;17(7):5792
Question Number
On request from
European Commission
Disclaimer
Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.