The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concluded that the feed additive zinc chelate of amino acids hydrate (3b606) remains safe for target animals and consumers, in a scientific opinion published on 23 July 2026. The opinion, adopted on 30 June 2026, assesses an application from Zinpro Animal Nutrition (Europe), Inc. for renewal of the additive's authorisation for all animal species. The panel found no new evidence to reconsider its previous conclusions, but noted that the additive is an eye irritant and a skin and respiratory sensitiser, and that user exposure by any route should be minimised. The panel was unable to conclude on environmental safety, pending a forthcoming opinion on the environmental risk assessment of trace elements.
The application, submitted to EFSA on 17 July 2025 and validated on 16 September 2025, requested renewal of the authorisation under Regulation (EC) No 1831/2003. The additive is currently authorised as a nutritional additive in the functional group of compounds of trace elements, with maximum total zinc levels in complete feed ranging from 120 mg/kg for most species to 200 mg/kg for dogs and cats. The applicant did not request any change to these conditions of use. The European Union Reference Laboratory confirmed that previous analytical methods remain valid. The panel noted that the applicant proposed extending the source of amino acids to any plant-based proteins, such as hydrolysed corn gluten or potato protein, in addition to the original soy source. Analytical data showed that batches from all three sources complied with specifications. The panel considered microbial contamination and impurity levels of no concern, except for nickel, which was addressed in the user safety section.
The opinion reaffirms the additive's safety for target species and consumers, based on data demonstrating compliance with current authorisation conditions. Efficacy was not reassessed as it is not required for renewal. The panel's inability to conclude on environmental safety means that final authorisation renewal may depend on the upcoming broader environmental risk assessment for trace elements. For users, the additive poses risks as an eye, skin, and respiratory sensitiser, requiring operational procedures and personal protective equipment. The opinion impacts feed additive manufacturers like Zinpro, which may need to manage user safety measures, and livestock producers who rely on the additive as a zinc source. The European Commission will consider the opinion in its decision on renewal of the authorisation.