Commission Implementing Regulation (EU) 2021/969 of 16 June 2021 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 13325 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/969
• 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/kg of complete feed with a moisture content of 12 %

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

3c411

-

L-threonine

Additive composition:

Powder with a minimum of 98 %

L-threonine and a maximum moisture content of 1 %

All species

-

-

-

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.

3.

The labelling of the additive shall indicate the moisture content.

4.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 2 ) .

5.

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 conditionally essential amino acids in order to avoid imbalances.’

6.

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

7.7.2031

Characterisation of the active substance:

L-threonine produced by fermentation with Escherichia coli CGMCC 13325

Chemical formula: C 4 H 9 NO 3

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.

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

—

ion exchange chromatography coupled with post-column derivatisation and optical 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 optical 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).

( 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 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA ( EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).