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Commission Implementing Regulation (EU) No 101/2014 of 4 February 2014 concerning the authorisation of L-tyrosine as a feed additive for all animal species (Text with EEA relevance)

In forceVersion 2014-02-04from 2013-02-25
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Contents
  1. Preamble
    1. Article 1
    2. Article 2
  3. ANNEX
  4. ANNEX

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-tyrosine as a feed additive in the functional group amino acids, their salts and analogues. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) That application concerns the authorisation of L-tyrosine as a feed additive for all animal species, to be classified in the additive category nutritional additives.

(4) The European Food Safety Authority (the Authority) concluded in its opinion of 20 June 2013 that, under the proposed conditions of use, L-tyrosine does not have an adverse effect on animal health, human health or the environment and that it may be considered efficacious to contribute to the requirements for sulphur-containing amino acids in all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) The assessment of that substance shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised, as specified in the Annex to this Regulation.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

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.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 February 2014. For the Commission The President José Manuel Barroso

ANNEX

(1) Additive composition Powder produced by hydrolysis of keratin from poultry feathers with a minimum L-tyrosine content of 95 % (2) Characterisation of the active substance IUPAC name: (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid CAS number: 60-18-4 Chemical formula: C9H11NO3 (3) Analytical methods For the determination of L-tyrosine in the feed additive: Titrimetry, European Pharmacopoeia (Ph. Eur. 6.0, method 01/2008-1161). For the determination of L-tyrosine in premixtures, compound feed and feed materials: Ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009 (Annex III, F). Pt_1_. 2. For user safety: breathing protection, safety glasses and gloves should be worn during handling. Pt_2_. 2. The instructions of use shall include a recommendation that the content of L-tyrosine does not exceed 5 g/kg complete feed with a moisture content of 12 % for food-producing animals and 15 g/kg complete feed with a moisture content of 12 % for non-food-producing animals. Anx. 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 complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues 3c401 — L-tyrosine All species — — — 25 February 2024

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 complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues 3c401 — L-tyrosine All species — — — 25 February 2024 (1) Additive composition Powder produced by hydrolysis of keratin from poultry feathers with a minimum L-tyrosine content of 95 % (2) Characterisation of the active substance IUPAC name: (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid CAS number: 60-18-4 Chemical formula: C9H11NO3 (3) Analytical methods For the determination of L-tyrosine in the feed additive: Titrimetry, European Pharmacopoeia (Ph. Eur. 6.0, method 01/2008-1161). For the determination of L-tyrosine in premixtures, compound feed and feed materials: Ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009 (Annex III, F). Pt_1_. 2. For user safety: breathing protection, safety glasses and gloves should be worn during handling. Pt_2_. 2. The instructions of use shall include a recommendation that the content of L-tyrosine does not exceed 5 g/kg complete feed with a moisture content of 12 % for food-producing animals and 15 g/kg complete feed with a moisture content of 12 % for non-food-producing animals.

Additive composition Powder produced by hydrolysis of keratin from poultry feathers with a minimum L-tyrosine content of 95 %

Characterisation of the active substance IUPAC name: (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid CAS number: 60-18-4 Chemical formula: C9H11NO3

Analytical methods For the determination of L-tyrosine in the feed additive: Titrimetry, European Pharmacopoeia (Ph. Eur. 6.0, method 01/2008-1161). For the determination of L-tyrosine in premixtures, compound feed and feed materials: Ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009 (Annex III, F).

1. For user safety: breathing protection, safety glasses and gloves should be worn during handling.

2. The instructions of use shall include a recommendation that the content of L-tyrosine does not exceed 5 g/kg complete feed with a moisture content of 12 % for food-producing animals and 15 g/kg complete feed with a moisture content of 12 % for non-food-producing animals.

Versions

  1. 2014-02-04

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