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


— 4 % moisture and
— 22 % sulphate.

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

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
 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

