Commission Implementing Regulation (EU) No 469/2013 of 22 May 2013 concerning the authorisation of DL-methionine, DL-methionine sodium salt, hydroxy analogue of methionine, calcium salt of hydroxy analogue of methionine, isopropyl ester of hydroxy analogue of methionine, DL-methionine protected with copolymer vinylpyridine/styrene and DL-methionine protected with ethylcellulose as feed additives Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 469/2013
• Articles: 4

Article 1 Authorisation

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

Article 2 Transitional measures

The substances specified in the Annex that are authorised pursuant to Directive 82/471/EEC and feed containing these substances, which are produced and labelled before 12 December 2013 in accordance with the rules applicable before 12 June 2013 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 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 feedingstuff with a moisture content of 12 %

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

3c301

DL-methionine, technically pure

Additive composition

Methionine content: minimum 99 %

Characterisation of the active substance

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

CAS number: 59-51-8

Chemical formula: C 5 H 11 NO 2 S

Analytical methods

( 1 )

For the determination of methionine in the additives:

—

Ion exchange chromatography coupled with post-column derivatisation and photometric or fluorescence detection (HPLC-UV/FD) - ISO/DIS 17180.

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

—

Ion exchange chromatography coupled with post-column derivatisation and photometric detection (HPLC-UV) - Commission Regulation (EC) No 152/2009 (Annex III, F).

all animal species

1.

DL-methionine, technically pure can be also used via water for drinking.

2.

Declarations to be made on the labelling of the additive and premixtures:

‘If the additive is administered via water for drinking protein excess should be avoided.’

12 June 2023

3c302

Sodium DL-methionine, liquid

Additive composition

DL-Methionine content: minimum 40 %

Sodium: minimum 6,2 %

Water: maximum 53,8 %

Characterisation of the active substance

IUPAC name: 2-amino-4-(methylthio)butanoic acid sodium salt

CAS number: 41863-30-3

Chemical formula: (C 5 H 11 NO 2 S)Na

Analytical methods

For the determination of methionine in the additives:

—

Ion exchange chromatography coupled with post-column derivatisation and photometric or fluorescence detection (HPLC-UV/FD) - ISO/DIS 17180.

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

—

Ion exchange chromatography coupled with post-column derivatisation and photometric detection (HPLC-UV) - Commission Regulation (EC) No 152/2009 (Annex III, F).

all animal species

1.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

2.

Sodium DL-methionine, liquid can be also used via water for drinking.

3.

Declarations to be made on the labelling of the additive and premixtures:

—

DL-Methionine content,

—

‘If the additive is administered via water for drinking protein excess should be avoided.’

12 June 2023

3c303

DL-methionine protected with copolymer vinylpyridine/styrene

Additive composition

Preparation with

DL-Methionine: minimum 74 %

Stearic acid: maximum of 19 %

Copolymer poly(2-vinylpyridine) co-styrene: maximum 3 %

Ethylcellulose and sodium stearate: maximum 0,5 %

Characterisation of the active substance

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

CAS number: 59-51-8

Chemical formula: C 5 H 11 NO 2 S

Analytical methods

( 1 )

For the determination of methionine in the additives:

—

Ion exchange chromatography coupled with post-column derivatisation and photometric or fluorescence detection (HPLC-UV/FD) - ISO/DIS 17180.

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

—

Ion exchange chromatography coupled with post-column derivatisation and photometric detection (HPLC-UV) - Commission Regulation (EC) No 152/2009 (Annex III, F).

Ruminants

12 June 2023

3c304

DL-methionine protected with ethylcellulose

Additive composition

Preparation with

DL-Methionine: minimum 85 %

Ethylcellulose: maximum 4 %

Starch: maximum 8 %

Sodium aluminium silicate: maximum 1,5 %

Sodium stearate: maximum 1 %

Water: maximum 2 %

Characterisation of the active substance

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

CAS number: 59-51-8

Chemical formula: C 5 H 11 NO 2 S

Analytical methods

( 1 )

For the determination of methionine in the additives:

—

Ion exchange chromatography coupled with post-column derivatisation and photometric or fluorescence detection (HPLC-UV/FD) - ISO/DIS 17180.

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

—

Ion exchange chromatography coupled with post-column derivatisation and photometric detection (HPLC-UV) - Commission Regulation (EC) No 152/2009 (Annex III, F).

Ruminants

12 June 2023

3c307

—

Hydroxy analogue of methionine

Additive composition

Hydroxy analogue of methionine: minimum 88 %

Water: maximum 12 %

Characterisation of the active substance

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

CAS number 583-91-5

Chemical formula: C 5 H 10 O 3 S

Analytical methods

( 1 )

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

—

Titrimetry, potentiometric titration followed by oxidation reduction reaction.

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

—

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

All animal species

—

—

—

1.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

2.

Hydroxy analogue of methionine can be also used via water for drinking.

3.

Declarations to be made on the labelling of the additive and premixtures:

—

‘If the additive is administered via water for drinking protein excess should be avoided.’

4.

Declarations to be made on the labelling of feed materials and compound feed in the listing of additives, if appropriate:

—

Name of the additive,

—

Amount of the hydroxy analogue of methionine added.

12 June 2023

3c3108

—

Calcium salt of hydroxy analogue of methionine

Additive composition

Hydroxy analogue of methionine: minimum 84 %

Calcium: minimum 11,7 %

Water: maximum 1 %

Characterisation of the active substance

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 methods

( 1 )

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

—

Titrimetry, potentiometric titration followed by 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).

All animal species

—

—

—

1.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

2.

Declarations to be made on the labelling of the additive and premixtures:

—

Hydroxy analogue of methionine content.

3.

Declarations to be made on the labelling of feed materials and compound feed in the listing of additives, if appropriate:

—

Name of the additive,

—

Amount of the hydroxy analogue of methionine added.

12 June 2023

3c309

—

Isopropyl ester of hydroxy analogue of methionine

Additive composition

Preparation of isopropyl ester of hydroxy analogue of methionine: minimum 95 %

Water: maximum 0,5 %

Characterisation of the active substance

IUPAC name isopropyl ester of 2-hydroxy-4-(methylthio)butanoic acid

CAS number 57296-04-5

Chemical formula: C 8 H 16 O 3 S

Analytical method

For the determination of isopropyl ester of the hydroxy analogue of methionine in the feed:

—

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

Ruminants

—

—

—

1.

Declarations to be made on the labelling of the additive and premixtures:

—

Content of hydroxy analogue of methionine

2.

Declarations to be made on the labelling of feed materials and compound feed in the listing of additives, if appropriate:

—

Name of the additive,

—

Amount of the hydroxy analogue of methionine added.

12 June 2023

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx