OpenLegislation

Annex

United Kingdom

Original text. Later amendments are not shown.

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
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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. 1..

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

  2. 2..

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

  3. 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. 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: C3H3N2-CH2-CH(NH2)-COΟΗ· HCl· H2O

CAS number: 5934-29-2

Einecs number 211-438-9

Analytical method f1

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)

Annotations

Footnotes

f1

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