Commission Implementing Regulation (EU) 2019/8 of 3 January 2019 concerning the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for all animal species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/8
• Articles: 3

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘ nutritional additives ’ and to the functional group ‘ amino acids, their salts and analogues ’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2 Entry into force

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

mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: amino acids, their salts and analogues

3c310

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Hydroxy analogue of methionine and its calcium salt

Additive composition:

Preparation of hydroxy analogue of methionine and calcium salt of hydroxy analogue of methionine, having a minimum content of hydroxy analogue of methionine of 88 % and a minimum content of calcium of 8 %.

Characterisation of the active substances:

Hydroxy analogue of methionine:

IUPAC name: 2-hydroxy-4-(methylthio)butanoic acid

CAS number 583-91-5

Chemical formula: C 5 H 10 O 3 S

calcium salt of hydroxy analogue of methionine:

IUPAC name 2-hydroxy-4-(methylthio)butanoic acid, calcium salt

CAS number 4857-44-7

Chemical formula: (C 5 H 9 O 3 S) 2 Ca

Analytical method

( 1 ) :

For the determination of hydroxy analogue of methionine in the additive:

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Titrimetry, potentiometric titration after oxidation reduction reaction.

For the determination of hydroxy analogue of methionine in premixtures, compound feed and feed materials:

—

High-Performance Liquid Chromatography and photometric detection (HPLC-UV).

For the determination of total calcium in the additive:

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

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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 animal species

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—

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1.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use, in particular considering that it is corrosive to skin and eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

2.

In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

3.

Declaration to be made on the label of the additive and premixture: content of hydroxy analogue of methionine.

4.

The labelling of feed materials and compound feed, into which the additive has been incorporated, shall contain in the listing of additives information as regards:

—

Name of the additive,

—

Amount of the hydroxy analogue of methionine added.

24 January 2029

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