# L_2017067EN.01007001.xml

| 14.3.2017 | EN | Official Journal of the European Union | L 67/70 |
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14.3.2017

EN

Official Journal of the European Union

L 67/70

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/439

of 13 March 2017

concerning the authorisation of L-lysine sulphate produced by Escherichia coli 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 an application was submitted for the authorisation of L-lysine sulphate as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-lysine sulphate as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’. |
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(3)

That application concerns the authorisation of L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 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 16 June 2015 (2) and 26 January 2017 (3) that, under the proposed conditions of use, L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 does not have an adverse effect on animal health, human health or the environment and that it is an effective source of the amino acid lysine for all animal species. It also concluded that for the supplemental L-lysine sulphate to be fully efficacious in ruminants, it 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 16 June 2015 (2) and 26 January 2017 (3) that, under the proposed conditions of use, L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 does not have an adverse effect on animal health, human health or the environment and that it is an effective source of the amino acid lysine for all animal species. It also concluded that for the supplemental L-lysine sulphate to be fully efficacious in ruminants, it 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 that substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of that substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance 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, 13 March 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  EFSA Journal 2015; 13(7):4155.

2

EFSA Journal

(3)  
  EFSA Journal 2017; 15(2):4714.

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 additive/kg of complete feed with a moisture content of 12 % |
| Category of nutritional additives. Functional group: amino acids, their salts and analogues |
| 3c323 | | L-lysine sulphate | Additive composition

  Granulate with a minimum L-lysine content of 55 % and a maximum content of






  — | 4 % moisture 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 additive/kg of complete feed with a moisture content of 12 %

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

3c323

L-lysine sulphate

Additive composition

Granulate with a minimum L-lysine content of 55 % and a maximum content of

—

4 % moisture and

| — | 22 % sulphate. |
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—

22 % sulphate.

Characterisation of the active substance

L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705

Chemical formula: C12H28N4O4 · H2SO4/[NH2-(CH2)4-CH(NH2)-COOH]2SO4

CAS number: 60343-69-3

Analytical methods
   (1)

For the quantification of L-lysine in the feed additive:

| — | ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) — EN ISO 17180 |
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ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) — EN ISO 17180

For the identification of sulphate in the feed additive:

| — | European Pharmacopoeia Monograph 20301 |
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—

European Pharmacopoeia Monograph 20301

For the quantification of L-lysine in compound feed and feed materials:

| — | ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV) — Commission Regulation (EC) No 152/2009 (2) |
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—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV) — Commission Regulation (EC) No 152/2009 (2)

All species

—

—

10 000

| 1. | The L-lysine content shall be indicated on the labelling of the additive. |
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1.

The L-lysine content shall be indicated on the labelling of the additive.

| 2. | L-lysine sulphate may be placed on the market and used as an additive consisting of a preparation. |
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2.

L-lysine sulphate 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 organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

2 April 2027

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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

(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).

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