(2) Commission Regulation (EU) No 350/2010 of 23 April 2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species (

OJ L 104, 24.4.2010, p. 34

(3)

EFSA Journal

2020;18(11):6281

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Content of element (Mn) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b510

Manganese chelate of hydroxy analogue of methionine

Characterisation of the additive:

Manganese chelate of hydroxy analogue of methionine containing 14 % manganese and 76 % (2-hydroxy-4-methylthio) butanoic acid.

Maximum content of nickel: 170 ppm.

Solid form.

Analytical method (1):

For the quantification of the hydroxy analogue of methionine content in the feed additive:

—	Titrimetry, potentiometric titration after oxidation reduction reaction;

For the quantification of total manganese in the feed additive and premixtures:

—	Atomic Absorption Spectrometry,AAS (EN ISO 6869); or

—	Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or

—	Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621);

For the quantification of total manganese in feed materials and compound feed:

—	Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or

—	Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

—	Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or

—	Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621).

All species

Fish: 100 (total)

Other species: 150 (total)

1.	The additive shall be incorporated into feed in the form of a premixture.

2.	Manganese chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation.

For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact, in particular due to the content of heavy metals including nickel. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

7 July 2031