Safety and efficacy of Mintrex®Cu (Copper chelate of hydroxy analogue of methionine) as feed additive for all species

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety and efficacy of a copper chelate of the hydroxy analogue of methionine (Mintrex®Cu) as a feed additive for all species. Mintrex®Cu contains a minimum of 17 % copper and 78 % hydroxy methionine analogue ((2-hydroxy-4-methylthio)butanoic acid, HMTBa), as shown from analyses of the product. It is intended to be used as a source of the essential trace element copper. Copper (in several forms) and HMTBa are already separately authorised as nutritional feed additives in the European Union. Mintrex®Cu shows the same pattern as copper sulphate in increasing liver copper content in chickens for fattening when added to a basal diet in supplementations between 10 and 500 mg kg-1 diet. These findings are taken as a demonstration of bioavailability. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers Mintrex®Cu as a source of available copper for all animal species. No specific studies on tolerance in target animals to Mintrex®Cu have been provided. The safety for chickens for fattening could be assessed from one of the efficacy studies. The FEEDAP Panel concludes that Mintrex®Cu is safe for chickens for fattening. However, considering the marked differences in copper sensitivity existing among species and even breeds and the fact that avian species are amongst the most tolerant, the FEEDAP Panel is unable to extend its conclusion from chickens for fattening to other animal species. The FEEDAP Panel considers it unlikely that the use of Mintrex®Cu would significantly alter tissue deposition compared to inorganic copper. However, this conclusion is based on limited evidence and does not include a direct assessment of copper concentration in edible tissues. Based on the data from acute toxicity and genotoxicity studies, the FEEDAP Panel considers that Mintrex®Cu does not introduce any additional toxicity compared to other sources of dietary copper. With regards to consumer safety, the FEEDAP Panel retains copper as the component of potential toxicological significance of Mintrex®Cu. A model calculation was made based on recent data on copper intake, and a higher copper deposition in tissues compared to authorised copper sources, taken as a worst case scenario. This showed that under these conditions, consumer exposure would not exceed the upper intake level for copper (5 mg day-1). Therefore, the FEEDAP Panel concludes that no concerns for consumer safety would result from the use of Mintrex®Cu in feed at the maximum authorised copper levels. The FEEDAP Panel considers that Mintrex®Cu is safe for the user provided that protective measures are taken and that it does not represent additional risks to the environment compared to other sources of copper for which it will substitute. The FEEDAP Panel made some recommendations with regards to the Register entry and highlighted the need for analytical methods specific to the determination of the chelates rather than the trace element.