Commission Implementing Regulation (EU) 2015/1114 of 9 July 2015 concerning the authorisation of L-valine produced by Escherichia coli as a feed additive for all animal species and amending Regulation (EC) No 403/2009 and Implementing Regulations (EU) No 848/2014 and (EU) No 1236/2014 (Text with EEA relevance)
Authorisation
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.
Amendments to Regulation (EC) No 403/2009
The Annex to Regulation (EC) No 403/2009 is amended as follows:
(1)
in the first column, the text ‘3c3.7.1’ is replaced by the text ‘3c370’;
(2)
in the ninth column, the second paragraph is deleted.
Amendment to Implementing Regulation (EU) No 848/2014
In the ninth column of the Annex to Implementing Regulation (EU) No 848/2014, the second paragraph is deleted.
Amendments to Implementing Regulation (EU) No 1236/2014
The Annex to Implementing Regulation (EU) No 1236/2014 is amended as follows:
(1)
in the first column, the text ‘3c369’ is replaced by the text ‘3c370’;
(2)
in the ninth column, the third paragraph is deleted.
Transitional measures
1. L-valine authorised in Regulation (EC) No 403/2009 and Implementing Regulations (EU) No 848/2014 and (EU) No 1236/2014 and premixtures containing them, which are produced and labelled before 30 January 2016 in accordance with the rules applicable before 30 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substance specified in paragraph 1 which are produced and labelled before 30 July 2016 in accordance with the rules applicable before 30 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for non-food producing animals, the time period for production and labelling referred to in the first sentence shall end 30 July 2017.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
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
3c370
—
L-valine
Additive composition
L-valine minimum 98 % (on a dry matter basis)
Characterisation of the active substance
L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by fermentation with Escherichia coli NITE SD 00066 or Escherichia coli NITE BP-01755
Chemical formula: C 5 H 11 NO 2
CAS number: 72-18-4
Analytical method
( 1 )
For the determination of L-valine in the feed additive: Food Chemical Codex ‘L-valine monograph’.
For the determination of valine in premixtures, compound feed and feed materials:
Ion exchange chromatography coupled with post-column derivatisation and spectrophotometric detection (HPLC/VIS) — Commission Regulation (EC) No 152/2009 ( 2 ) .
All species
—
1.
The moisture content shall be indicated on the labelling.
2.
For user safety: breathing protection, safety glasses and gloves shall be used during handling.
30 July 2025
( 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 )
OJ L 54, 26.2.2009, p. 1 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.