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. )

• CELEX: Implementing Regulation (EU) 2017/439
• Articles: 3

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 .

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 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.

Characterisation of the active substance

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

Chemical formula: C 12 H 28 N 4 O 4 · H 2 SO 4 /[NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH] 2 SO 4

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

For the identification of sulphate in the feed additive:

—

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 )

All species

—

—

10 000

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.

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

( 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 ).