# L_2020048EN.01000301.xml

| 21.2.2020 | EN | Official Journal of the European Union | L 48/3 |
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21.2.2020

EN

Official Journal of the European Union

L 48/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/238

of 20 February 2020

concerning the authorisation of L-threonine as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of L-threonine produced by Corynebacterium glutamicum KCCM 80117 or by Corynebacterium glutamicum KCCM 80118 as a feed additive for use in feed for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of L-threonine produced by Corynebacterium glutamicum KCCM 80117 or by Corynebacterium glutamicum KCCM 80118 as a feed additive for use in feed for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | Those applications concern the authorisation of L-threonine produced by Corynebacterium glutamicum KCCM 80117 or by Corynebacterium glutamicum KCCM 80118 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’. |
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(3)

Those applications concern the authorisation of L-threonine produced by Corynebacterium glutamicum KCCM 80117 or by Corynebacterium glutamicum KCCM 80118 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 January 2019 (2) (3) that, under the proposed conditions of use, L-threonine produced by Corynebacterium glutamicum KCCM 80117 or Corynebacterium glutamicum KCCM 80118 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the additive is an efficacious source of the amino-acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 January 2019 (2) (3) that, under the proposed conditions of use, L-threonine produced by Corynebacterium glutamicum KCCM 80117 or Corynebacterium glutamicum KCCM 80118 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the additive is an efficacious source of the amino-acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of L-threonine produced by Corynebacterium glutamicum KCCM 80117 and by Corynebacterium glutamicum KCCM 80118 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of L-threonine produced by Corynebacterium glutamicum KCCM 80117 and by Corynebacterium glutamicum KCCM 80118 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

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 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 February 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2019;17(2):5602.

2

EFSA Journal

(3)  
  EFSA Journal 2019;17(3):5603.

3

EFSA Journal

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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. |
| 3c410 | — | L-threonine | Additive composition

  Powder with a minimum of 98 %
  L-threonine (on a dry matter basis).

  Characterisation of the active substance

  L-threonine produced by fermentation with Corynebacterium glutamicum KCCM 80117 or

  Corynebacterium glutamicum KCCM 80118
  Chemical formula: C4H9NO3

  CAS Number: 72-19-5.

  Analytical methods
   (1)

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






  — | Food Chemical Codex ‘L-threonine monograph’, and |

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.

3c410

—

L-threonine

Additive composition

Powder with a minimum of 98 %

L-threonine (on a dry matter basis).

Characterisation of the active substance

L-threonine produced by fermentation with Corynebacterium glutamicum KCCM 80117 or

Corynebacterium glutamicum KCCM 80118

Chemical formula: C4H9NO3

CAS Number: 72-19-5.

Analytical methods
   (1)

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

—

Food Chemical Codex ‘L-threonine monograph’, and

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

For the determination of threonine in premixtures:

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

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 (Annex III, F). |
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—

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

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

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

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

For the determination of threonine in water:

| — | ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD). |
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—

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD).

All species

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—

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| 1. | L-threonine may be placed on the market and used as an additive consisting of a preparation. |
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1.

L-threonine may be placed on the market and used as an additive consisting of a preparation.

| 2. | L-threonine may be used via water for drinking. |
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2.

L-threonine may be used via water for drinking.

| 3. | The labelling of the additive shall indicate the moisture content. |
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3.

The labelling of the additive shall indicate the moisture content.

| 4. | The labelling of the additive and premixtures shall indicate the following:
  ‘The supplementation with L-threonine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ |
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4.

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

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

12.3.2030

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(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

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