Scientific opinion on the safety and efficacy of manganese compounds (E5) as feed additives for all species: manganous oxide and manganous sulphate monohydrate, based on a dossier submitted by Eramet & Comilog Chemicals S.A

Abstract

Manganese, an essential trace element, functions as an enzyme activator and is a constituent of several enzymes. Primary signs of manganese deficiency are impaired growth, skeletal abnormalities, depressed reproductive function, ataxia of the newborn and faults in lipid and carbohydrate metabolism. Manganous oxide and manganous sulphate monohydrate are safe sources of manganese for all animal species/categories, provided that the current maximum total contents of manganese authorised in feed are respected. Generally, dietary manganese does not appear to cause any adverse health effects in the population and has not proven to be a risk at the usual intake levels. Manganese intake resulting from the consumption of tissues and products of animal origin is low and not of concern for the safety of consumers, including more sensitive subgroups such as infants and elderly people. It is concluded that the use of manganous oxide and manganous sulphate monohydrate in animal nutrition is of no concern for the safety of consumers, provided that the current maximum total contents of manganese authorised in feed are respected. The handling of manganous oxide and manganous sulphate monohydrate poses a risk to users upon inhalation exposure. The additive manganous oxide should be considered as a potential skin and eye irritant and as a dermal sensitiser. Manganous sulphate monohydrate is not irritating to skin but it is an eye irritant; it is likely not a dermal sensitiser. The use of manganous oxide and manganous sulphate monohydrate in animal nutrition for all animal species is not of concern for the environment, provided that the current maximum total contents of manganese authorised in feed are respected. Manganous oxide and manganous sulphate monohydrate are efficacious sources of manganese in meeting animals’ requirements. 1 On request from the European Commission, Question No EFSA-Q-2012-00438, adopted on 9 October 2013. 2 Panel members: Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino Lopez-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Trace Elements, including Noel Albert Dierick, Jurgen Gropp and Alberto Mantovani, for the preparatory work on this scientific opinion. 4 This scientific opinion has been amended following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections are indicated in the text. 5 An editorial amendment was carried out that does not materially affect the contents or outcome of this Scientific Opinion, under the section on the environmental safety. To avoid confusion, the previous version has been removed from the EFSA Journal, but is available on request, as is a version showing all the changes made. Previous revision: 19 March 2015, publication of full opinion. Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2013. Scientific Opinion on the safety and efficacy of manganese compounds (E5) as feed additives for all species: manganous oxide and manganous sulphate monohydrate, based on a dossier submitted by Eramet & Comilog Chemicals S.A. EFSA Journal 2013;11(10):3435, 28 pp. doi:10.2903/j.efsa.2013.3435 Available online: www.efsa.europa.eu/efsajournal Manganous oxide and manganous sulphate monohydrate for all species EFSA Journal 2013;11(10):3435 2 © European Food Safety Authority, 2013