Commission Implementing Regulation (EU) 2021/709 of 29 April 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/709
• Articles: 3

Article 1

L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 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 a feed additive 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

Maxi-mum 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.

3c352i

-

L-histidine monohydrochloride monohydrate

Additive composition:

Powder with a minimum content of

98 % L-histidine monohydrochloride monohydrate and

72 % histidine and

a maximum content of 100 ppm histamine

All animal species

-

-

-

1.

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

2.

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

3.

Declaration to be made on the label of the additive and premixture:

—

‘The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depend on the species, the physiological state of the animal, the performance level, the environmental conditions, the level of other amino acids in the diet and the level essential trace elements such as copper and zinc.’

—

Histidine 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.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation 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 protection, safety glasses and gloves.

20.5.2031

Characterisation of the active substance:

L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80212

Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 )-COΟΗ·ΗCl·Η 2 O

CAS number: 5934-29-2

Einecs number 211-438-9

Analytical method

( 1 ) :

For the quantification of histidine in the feed additive:

—

high performance liquid chromatography coupled with photometric detection (HPLC-UV)

—

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

For the quantification of histidine in premixtures, feed materials and compound feed:

—

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

For the quantification of histamine in the feed additive:

—

high performance liquid chromatography coupled to a spectrophotometric detection (HPLC-UV)

( 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).