Safety and efficacy of Mintrex®Mn (Manganese 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 manganese chelate of the hydroxy analogue of methionine (Mintrex®Mn) as a feed additive for all species. Mintrex®Mn contains a minimum of 16 % manganese and 76 % 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 manganese. Manganese (in several forms) and HMTBa are already separately authorised as nutritional feed additives in the European Union. In a study on chickens for fattening using a wide dose range, Mintrex®Mn supplementation increased tibia bone deposition, an indicator of manganese bioavailability. The concentration of manganese in tibia bone supplied by Mintrex®Mn did not differ from that supplied by manganese sulphate, a recognised source of available manganese in animal nutrition. Thus Mintrex®Mn can be considered as a bioavailable manganese source, comparable to other authorised sources of manganese. No specific studies on tolerance in target animals to Mintrex®Mn were provided. The efficacy study, which included supplemented doses of up to 800 mg manganese kg-1 diet, provided some evidence of safety but alone was not adequate to draw conclusions on the safety for target animals. However, considering the published data on manganese tolerance in poultry with other manganese sources, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that manganese from Mintrex®Mn is safe for chickens for fattening. There is evidence that chickens for fattening are not the most sensitive animal species/category to manganese toxicity. Therefore, the FEEDAP Panel is unable to extend its conclusion on chickens for fattening to other animal species. Based on the data from acute toxicity and genotoxicity studies, the FEEDAP Panel considers that Mintrex®Mn does not introduce any additional toxicity compared to other sources of dietary manganese. Based on the available data there appears to be no essential differences in bioavailability (assessed from bone manganese concentration) and therefore in edible tissue deposition of manganese from Mintrex®Mn compared to other authorised sources of manganese. However, this conclusion is based on limited evidence and does not include an adequate assessment of manganese concentrations in edible tissues/products. With regards to consumer safety, the FEEDAP Panel retains manganese as the component of potential toxicological significance of Mintrex®Mn. The FEEDAP Panel considers that the data available are limited and do not allow an assessment of consumer exposure to manganese derived from Mintrex®Mn. In the light of the recommendation made by the former Scientific Committee on Food that additional dietary exposure to manganese may carry a health risk, the FEEDAP Panel cannot conclude on the safety for consumers of Mintrex®Mn when used in animal nutrition. The FEEDAP Panel considers that Mintrex®Mn 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 manganese 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.