Commission Implementing Regulation (EU) 2020/2116 of 16 December 2020 concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/2116
• Articles: 5

Article 1

The authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed subject to the conditions laid down in the Annex.

Article 2

1.   L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 and premixtures containing it, which are produced and labelled before 6 July 2021 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 6 January 2022 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for salmonids.

Article 3

Regulation (EC) No 244/2007 is repealed.

Article 4

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.

3c351

-

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

Finfish

-

-

-

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.

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

6 January 2031

Characterisation of the active substance:

L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268

Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 )-COΟΗ· HCl· H 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