This European Food Safety Authority opinion assesses manganese hydroxychloride (tribasic manganese chloride, at least 45% manganese) as a nutritional feed additive for all animal species. The Panel concludes that it is safe for target animals and for consumers of animal products when total manganese in complete feed stays within the EU maximum contents, and that it is not expected to harm the environment. It could not conclude on safety for workers handling the powder, because inhalation data were lacking.
Key numbers
- EU maximum total manganese in complete feed: fish 100 mg/kg; other species 150 mg/kg feedingstuffs (Abstract; Section 3.1.4).
- Chicken breast muscle manganese ranged 0.9 to 2.3 mg/kg dry matter across eight feeding groups (60, 120, 960 and 1920 mg/kg feed from the additive or manganese sulphate), with no significant differences by source or dose (Section 3.2.2.1).
- Impurities reported for the additive (first set of five production lots): cadmium 0.69 to 0.82 mg/kg, lead 26 to 29 mg/kg, arsenic 28 to 30 mg/kg; all within Directive 2002/32/EC limits according to the Panel (Section 3.1.2).
- Dusting potential averaged 95 mg/m3 (range 75 to 110) (Section 3.1.2).
Methods (brief)
Regulatory review by the FEEDAP Panel of a technical dossier from the applicant, including composition data, a tolerance study and two efficacy studies in chickens for fattening, together with earlier EFSA assessments of manganese compounds and the published literature.
Evidence fitness
The opinion supports citing the EU maximum manganese contents for complete feed and the Panel’s conclusion that feed use within those limits does not raise consumer exposure through meat, milk or eggs. It does not estimate human dietary manganese intake and does not set food limits.
Limitations
Most data were supplied by the applicant. No data on transfer to milk or eggs from this additive were provided; the Panel relied on literature for those products. User safety for inhalation could not be assessed.
Related evidence
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