Commission Implementing Regulation (EU) 2019/1125 of 5 June 2019 concerning the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/1125
• Articles: 3

Article 1

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

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 (Zn) in mg/kg of complete feed with a moisture content of 12 %

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

3b614

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Zinc chelate of methionine sulfate

Additive composition:

Zinc chelate of methionine sulfate as a powder with a zinc content between 2 % and 15 %.

Characterisation of the active substance:

Zinc, 2-amino-4 methylsulfanylbutanoic acid, sulfate; zinc chelated with methionine in a molar ratio 1:1.

Chemical formula: C 5 H 11 NO 6 S 2 Zn

CAS Number: 56329-42-1

Analytical methods

( 1 ) :

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

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

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

For the quantification of methionine content in the feed additive:

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ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) – EN ISO 17180 or VDLUFA 4.11.6 and EN ISO 13903

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

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Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); or

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

—

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

All animal species

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Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total)

Piglets, sows, rabbits and all fish other than salmonids: 150 (total)

Other species and categories: 120 (total)

1.

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

2.

Zinc chelate of methionine sulfate may be placed on the market and used as an additive consisting of a preparation.

3.

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. Where risks cannot be reduced to an acceptable level by those procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

22 July 2029

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/eurl/feed-additives/evaluation-reports