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Commission Implementing Regulation (EU) 2016/1220 of 26 July 2016 concerning the authorisation of L-threonine produced by Escherichia coli as a feed additive for all animal species (Text with EEA relevance)

Commission Implementing Regulation (EU) 2016/1220 of 26 July 2016 concerning the authorisation of L-threonine produced by Escherichia coli as a feed additive for all animal species (Text with EEA relevance)

Implementing Regulation (EU) 2016/1220 · Regulation · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Authorisation

Article 1

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.

Transitional measures

Article 2

1.   L-threonine authorised by Directive 88/485/EEC and premixtures containing it may be placed on the market until 16 May 2017 in accordance with the rules applicable before 16 August 2016 and used until the existing stocks are exhausted. 2.   Feed materials and compound feed containing the substance referred to in paragraph 1 may be placed on the market until 16 August 2017 in accordance with the rules applicable before 16 August 2016 and used until the existing stocks are exhausted if they are intended for food producing animals. 3.   Feed materials and compound feed containing the substance referred to in paragraph 1 may be placed on the market until 16 August 2018 in accordance with the rules applicable before 16 August 2016 and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Entry into force

Article 3

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. 3c410 — L-threonine Additive composition: Powder with a minimum of 98 % L-threonine (on a dry matter basis). Characterisation of the active substance: L-threonine produced by fermentation with Escherichia coli DSM 25086 or Escherichia coli FERM BP-11383 or Escherichia coli FERM BP-10942 or Escherichia coli NRRL B-30843 or Escherichia coli KCCM 11133P or Escherichia coli DSM 25085 or Escherichia coli CGMCC 3703 or Escherichia coli CGMCC 7.58. Chemical formula: C 4 H 9 NO 3 CAS Number: 72-19-5 Analytical methods  ( 1 ) : For the determination of L-threonine in the feed additive: — Food Chemical Codex ‘L-threonine monograph’ and — Ion exchange chromatography method with post-column derivatisation and photometric detection (IEC-UV/FD) — EN ISO 17180. For the determination of threonine in premixtures: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) — EN ISO 17180 and — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV), Commission Regulation (EC) No 152/2009  ( 2 ) (Annex III, F) For the determination of threonine in premixtures, compound feed, feed materials and water: — Ion exchange chromatography method with post-column derivatisation and photometric detection (IEC-UV): Regulation (EC) No 152/2009 (Annex III, F). All species — — — 1. L- threonine may be placed on the market and used as an additive consisting of a preparation. 2. For users of the additive and premixtures, 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 premixtures shall be used with personal protective equipment, including breathing protection. 3. L-threonine can be also used via water for drinking. 4. Declarations to be made on the labelling of the additive: Moisture content. 5. Declarations to be made on the labelling of the additive and premixtures: ‘If the additive is administered via water for drinking, protein excess should be avoided.’ 16.8.2026 ( 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 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( 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.

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