Commission Implementing Regulation (EU) 2022/1493 of 8 September 2022 concerning the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1493
• Articles: 3

Article 1

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 feed additives 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

Mini-mum content

Maxi-mum 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

3c305

-

L-methionine

Additive composition

L-methionine with a minimum content of 98,5 % and a maximum moisture content of 0,5 %

Powder form

All species

-

-

-

1.

L-methionine may be used via water for drinking.

2.

The labelling of the additive and premixtures shall indicate the following:

‘The supplementation with L-methionine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

3.

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

4.

The endotoxin content of the additive and its dusting potential shall ensure that the maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 3 ) is not exceeded.

5.

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. 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 breathing protection.

29 September 2032

Characterisation of the active substance

L-methionine produced by fermentation with Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246

Chemical formula: C 5 H 11 NO 2 S

CAS Number: 63-68-3.

Analytical methods

( 1 )

For the determination of L-methionine in the feed additive:

—

Food Chemical Codex ‘L-methionine monograph’ and

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the determination of methionine in premixtures

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180 and

—

Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009  ( 2 ) (Annex III, F)

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

—

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

For the determination of methionine in water:

—

Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

3c305ii

-

L-methionine

Additive composition

Preparation of L-methionine with a minimum content of 90 % and a maximum moisture content of 0,5 %

—

other amino acids ≤ 0,63 %;

Powder form

All species

-

-

-

1.

L-methionine may be used via water for drinking.

2.

The labelling of the additive and premixtures shall indicate the following:

‘The supplementation with L-methionine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

3.

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

4.

The endotoxin content of the additive and its dusting potential shall ensure that the maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 3 ) is not exceeded.

5.

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. 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 breathing protection.

29 September 2032

Characterisation of the active substance

L-methionine produced by fermentation with Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246

Chemical formula: C 5 H 11 NO 2 S

CAS Number: 63-68-3.

Analytical methods

( 1 )

For the determination of L-methionine in the feed additive:

—

Food Chemical Codex ‘L-methionine monograph’ and

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the determination of methionine in premixtures

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180 and

—

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

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

—

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

For the determination of methionine in water:

—

Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 2 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).

( 3 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).