Commission Regulation (EC) No 1139/2007 of 1 October 2007 concerning the authorisation of L-arginine as a feed additive (Text with EEA relevance)
Commission Regulation (EC) No 1139/2007of 1 October 2007concerning the authorisation of L-arginine as a feed additive(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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 nutritionOJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8)., 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)An application for authorisation has been submitted for L-arginine as an aminoacid.(3)As the application for authorisation was submitted before the date of application of Regulation (EC) No 1831/2003, it was submitted under Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutritionOJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).. As from 18 October 2004, aminoacids, their salts and analogues fall under the scope of Regulation (EC) No 1831/2003. The application is therefore to be considered as an application under Article 7 of Regulation (EC) No 1831/2003.(4)In order to comply with the requirements laid down in Article 7 of Regulation (EC) No 1831/2003, additional information was submitted in support of the application.(5)The application concerns authorisation of L-arginine as a feed additive for all animal species, to be classified in the additive category "nutritional additives" and the functional group "aminoacids, their salts and analogues".(6)The European Food Safety Authority (the Authority) concluded in its opinions of 17 April 2007Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product L-arginine produced by fermentation from Corynebacterium glutamicum (ATCC-13870) for all animal species. Adopted on 17 April 2007. The EFSA Journal (2007) 473, p. 1-19. that L-arginine does not have an adverse effect on animal health, human health or the environment. It further concluded that L-arginine does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. It does not consider that there is a need for specific requirements of post market monitoring. The report on the method of analysis of the feed additive in feed was submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003 to the Authority. The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.(7)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 1The preparation specified in the Annex, belonging to the additive category "nutritional additives" and to the functional group "aminoacids, their salts and analogues", is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2This Regulation shall enter into force on the 20th day following 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, 1 October 2007.For the CommissionMarkos KyprianouMember of the CommissionANNEX
OJ L 257, 19.9.1998, p. 14.Category of nutritional additives. Functional group: amino acids, their salts and analogues
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg/kg of complete feedingstuff with a moisture content of 12 %
3c3.6.1—L-arginineCharacterisation of the additive:L-arginine 98 %produced by Corynebacterium glutamicum (ATCC 13870)C6H14N4O2Analytical method:Community method for the determination of amino acids (Commission Directive 98/64/EC amending Directive 71/393/EEC)All species————22.10.2017