Commission Implementing Regulation (EU) 2021/421 of 9 March 2021 concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2022/385of 7 March 2022correcting Implementing Regulation (EU) 2021/421 concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species, Implementing Regulation (EU) 2021/485 concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs and Implementing Regulation (EU) 2021/551 concerning the authorisation of turmeric extract, turmeric oil, turmeric oleoresin from Curcuma longa L. rhizome as feed additives for all animal species and turmeric tincture from Curcuma longa L. rhizome as a feed additive for horses and dogs(Text with EEA relevance), 32022R0385, March 8, 2022
Commission Implementing Regulation (EU) 2021/421of 9 March 2021concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species(Text with EEA relevance)
Article 1The tincture derived from Artemisia vulgaris L. (mugwort tincture) specified in the Annex, belonging to the additive category "sensory additives" and to the functional group "flavouring compounds", is authorised as a feed 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.ANNEX
Natural sources of flavourings – Report No 2 (2007).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-reports
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additivesFunctional group: Flavouring compounds
2b72-t-Mugwort tinctureAdditive compositionTincture produced from the fragmented aerial parts of Artemisia vulgaris L.Characterisation of the active substanceTincture produced from the fragmented aerial parts of Artemisia vulgaris L by extended extraction with a water/ethanol mixture as defined by the Council of Europe.The specifications of the active substance are:Dry matter: 1,4-1,9 %Ash: 0,2-0,5 %Organic fraction: 1,13-1,65 %, of whichTotal polyphenols:0,05-0,2 %Phenolic acids 0,02-0,11 %Chlorogenic acid: 0,0028-0,0136 %α- and β-thujone: < 0,005 %1,8-cineole: 0,005 %Solvent (ethanol): 98,1-98,6 %CoE number: 72Liquid formAnalytical methodFor the characterisation of the feed additive (Mugwort tincture):gravimetric method for the determination of loss on drying and the ash contentspectrophotometric method for the determination of total polyphenols contenthigh performance thin layer chromatography (HPTLC) method for the determination of total phenolic acids, chlorogenic acid, alpha- and beta- thujones and eucalyptol.All animal species---1.The additive shall be incorporated into the feed in the form of a premixture.2.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.3.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 400 mg/kg".4.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. 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, safety glasses and gloves.30.3.2031
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