Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/378
• Articles: 3

Article 1

L-leucine produced by Escherichia coli NITE BP-02351, specified in the Annex, is authorised as a feed additive in animal nutrition in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’, 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.

3c382

-

L-leucine

Additive composition:

Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

All animal species

1.

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

2.

The additive can be also used via water for drinking.

3.

In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

4.

For users of the additive and premixture, 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 by such procedures and measures, the additive and premixture shall be used with personal protective equipment, including breathing protection.

5.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m 3 air  ( 2 ) .

6.

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

26.3.2030

Characterisation of the active substance:

L-leucine produced by fermentation with Escherichia coli NITE BP-02351.

Chemical formula: C6H13NO2

CAS number: 61-90-5

Analytical method

( 1 ) :

For the identification of L-leucine in the feed additive:

—

Food Chemical Codex ‘L-leucine monohydrochloride monograph’

For the quantification of leucine in the feed additive:

—

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

For the quantification of leucine in premixtures:

—

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

—

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

For the quantification of leucine 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

For the quantification of leucine in water:

—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

Category: Sensory additives. Functional group: Flavouring compounds

3c382

-

L-leucine

Additive composition:

Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

All animal species

-

-

-

1.

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

2.

The additive shall be incorporated into the feed in the form of a premixture.

3.

In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

6.

For users of the additive and premixture, 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 by such procedures and measures, the additive and premixture shall be used with personal protective equipment, including breathing protection.

7.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m 3 air  ( 2 ) .

26.3.2030

Characterisation of the active substance:

L-leucine produced by fermentation with Escherichia coli NITE BP-02351

Chemical formula: C6H13NO2

CAS number: 61-90-5

FLAVIS No 17.012

Method of analysis

( 1 ) :

For the identification of L-leucine in the feed additive:

—

Food Chemical Codex ‘L-leucine monohydrochloride monograph’

For the quantification of leucine in the feed additive:

—

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

For the quantification of leucine in premixtures:

—

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

—

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

( 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 2019;17(5):5689); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).