Commission Implementing Regulation (EU) No 849/2012 of 19 September 2012 concerning the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for chickens for fattening, chickens reared for laying, all minor avian species for fattening and reared for laying and weaned Suidae other than Sus scrofa domesticus (holder of the authorisation Vetagro SpA) Text with EEA relevance
Commission Implementing Regulation (EU) No 849/2012of 19 September 2012concerning the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for chickens for fattening, chickens reared for laying, all minor avian species for fattening and reared for laying and weaned Suidae other than Sus scrofa domesticus (holder of the authorisation Vetagro SpA)(Text with EEA relevance) 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 nutritionOJ L 268, 18.10.2003, p. 29., 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 a preparation of citric acid, sorbic acid, thymol and vanillin. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns the authorisation of a preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for chickens for fattening, chickens reared for laying, all minor avian species for fattening and reared for laying and all minor porcine species (weaned), to be classified in the additive category "zootechnical additives".(4)The use of a preparation of citric acid, sorbic acid, thymol and vanillin was authorised for 10 years as a feed additive for use in weaned piglets by Commission Regulation (EU) No 1117/2010OJ L 317, 3.12.2010, p. 3..(5)The European Food Safety Authority ("the Authority") concluded in its opinion of 25 May 2012EFSA Journal (2012); 10(5):2670. that under the proposed conditions of use, the preparation of citric acid, sorbic acid, thymol and vanillin set out in the Annex does not have an adverse effect on animal health, human health or the environment, and that this additive has the potential to improve performance of the target 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.(6)The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this 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 "zootechnical additives" and to the functional group "other zootechnical additives", is authorised as an additive in animal nutrition as specified in that Annex.
Article 2This 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, 19 September 2012.For the CommissionThe PresidentJosé Manuel BarrosoANNEX
Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical parameters)
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 %
4d 3Vetagro SpAPreparation of citric acid, sorbic acid, thymol and vanillinAdditive compositionPreparation of protected microbeads containing citric acid, sorbic acid, thymol and vanillin with a minimum of:Citric acid: 25 g/100 gSorbic acid: 16,7 g/100 gThymol: 1,7 g/100 gVanillin: 1 g/100 gCharacterisation of active substancesCitric acid C6H8O7 (purity ≥ 99,5 %)2-hydroxy-1,2,3-propanetricarboxylic acid, CAS number 77-92-9 anhydrousSorbic acid C6H8O2 (purity ≥ 99,5 %)2,4-hexadienoic acid, CAS number 110-44-1Thymol (purity ≥ 98 %)5-methyl-2-(1-methylethyl)phenol, CAS number 89-83-8)Vanillin (purity ≥ 99,5 %)4-hydroxy-3-methoxybenzaldehyde, CAS number 121-33-5)Analytical methodsDetermination of sorbic acid and thymol in feed: reverse phase high performance liquid chromatography method equippedwith ultraviolet/diode array detection (RP-HPLC-UV/DAD). Determination of citric acid in the additive and premixtures: (RP-HPLC-UV/DAD). Determination of citric acid in feedingstuff: enzymatic determination of citric content-NADH (reduced form of nicotinamide adenine dinucleotide) spectrometric method.Chickens for fattening and reared for layingMinor avian species for fattening and reared for laying—200—For safety: breathing protection, glasses and gloves shall be used during handling.10 October 2022
Weaned Suidaeother than Sus scrofa domesticus1000