Commission Implementing Regulation (EU) 2017/420 of 9 March 2017 concerning the authorisation of a preparation of thyme oil, synthetic star anise oil and quillaja bark powder as feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying (holder of the authorisation Delacon Biotechnik GmbH) (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/420of 9 March 2017concerning the authorisation of a preparation of thyme oil, synthetic star anise oil and quillaja bark powder as feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying (holder of the 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 the preparation of thyme oil, synthetic star anise oil and quillaja bark powder as feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying. 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 the preparation of thyme oil, synthetic star anise oil and quillaja bark powder as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 4 December 2015EFSA Journal 2016;14(7):4351. that, under the proposed conditions of use, the preparation of thyme oil, synthetic star anise oil and quillaja bark powder does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it has the potential to improve the performance of chickens for fattening. According to the Authority, this conclusion can be extended to chickens reared for laying and extrapolated to all minor poultry species for fattening and reared for laying. 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 the preparation of thyme oil, synthetic star anise oil and quillaja bark powder shows that the conditions for authorisation, as 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.(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,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 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, 9 March 2017.For the CommissionThe PresidentJean-Claude JunckerANNEX
As defined by the European Pharmacopoiea of the Council of Europe (PhEur, 2005).A mixture of pure compounds mimicking the profile of natural essential star anise oil (without estragole).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-reportsCategory 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 %
4d15Delacon Biotechnik GmbHThyme oil, synthetic star anise oil and quillaja bark powderAdditive compositionPreparation of essential microencapsulated oils of thyme (Thymus vulgaris L.) and synthetic star anise: ≥ 74 mg/g,Quillaja bark powder (Quillaja saponaria) ≥ 200 mg/gSaponins ≤ 23 mg/gSolid formCharacterisation of the active substancesThyme oil: thymol 2-4 mg/gStar anise oil (produced by chemical synthesis): (trans and cis)-anethole 40-50 mg/gQuillaja bark powder (Quillaja saponaria) ≥ 200 mg/gAnalytical methodsQuantification of thymol in the feed additive, in premixtures and in feedingstuffs: gas chromatography-mass spectrometry (GC/MS)Chickens for fatteningChickens reared for layingMinor avian species for fattening and reared for laying—1501501.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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.30 March 2027