Commission Implementing Regulation (EU) No 131/2012 of 15 February 2012 concerning the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices as a feed additive for weaned piglets (holder of authorisation Delacon Biotechnik GmbH) Text with EEA relevance
Commission Implementing Regulation (EU) No 131/2012of 15 February 2012concerning the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices as a feed additive for weaned piglets (holder of authorisation Delacon Biotechnik GmbH)(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 caraway oil, lemon oil with certain dried herbs and spices. That 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 the preparation of caraway oil, lemon oil with certain dried herbs with spices, as specified in the Annex, as a feed additive for weaned piglets, to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 7 April 2011EFSA Journal 2011; 9(4):2139. that, under the proposed conditions of use, the preparation of caraway oil, lemon oil with certain dried herbs and spices, as specified in the Annex, does not have an adverse effect on animal health, human health or the environment, and that its use can improve the growth rate of weaned piglets. 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)In order to ensure efficacy and safety and accordance with the characterisation provided by the applicant for the active substances, the maximum levels of natural substances laid down in Annex III, Part B to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/ECOJ L 354, 31.12.2008, p. 34. should be respected as regards dried herbs and spices used in the preparation, as specified in the Annex, and the product characterisations laid down in the European Pharmacopoeia should apply to caraway oil and lemon oil, respectively.(6)The assessment of the preparation of caraway oil, lemon oil and dried herbs with spices, as specified in the Annex, 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, 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, 15 February 2012.For the CommissionThe PresidentJosé Manuel BarrosoANNEX
European Pharmacopoeia of the Council of Europe.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 performance 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 of the additive/kg of complete feedingstuff with a moisture content of 12 %
4d6Delacon Biotechnik GmbHPreparation of caraway oil, lemon oil with dried herbs and spicesAdditive compositionPreparation of essential oil > 1,5 % (caraway oil ≥ 0,75 % and lemon oil ≥ 0,75 %)Dried herbs and spices: 50 %Carriers substances: q.s. 100 %Characterisation of the active substances and other ingredientscaraway oil: d-carvone 3,5-6,0 mg/g, as defined by the European Pharmacopoeialemon oil: limonene 2,3-9,0 mg/g, as defined by the European PharmacopoeiaDried herbs and spices:Clove powder 1,5 %, cinnamon powder 10 %, nutmeg powder 1,5 %, onion powder 5 %, pimento powder 2 %, orange peel powder 5 %, peppermint power 12,5 % and chamomile powder 12,5 %.The maximum levels laid down in Part B of Annex III to Regulation (EC) No 1334/2008 shall be respected as regards dried herbs and spices used in the preparation.The product characterisations laid down in the European Pharmacopoeia shall apply to caraway oil and lemon oil used in the preparation.Method of analysisDetermination of carvone: gas-chromatographic/mass-spectrometry (GC/MS) in single ion monitoring (SIM).Piglets (weaned)—2504001.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.For use in weaned piglets up to approximately 35 kg.3.For safety: breathing protection and gloves shall be used during handling.4.The additive shall be incorporated in compound feedingstuff in form of a premixture.7 March 2022