Commission Implementing Regulation (EU) 2022/652 of 20 April 2022 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2023/54of 4 January 2023correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species(Text with EEA relevance), 32023R0054, January 5, 2023
  • Commission Implementing Regulation (EU) 2024/239of 15 January 2024correcting and amending Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320(Text with EEA relevance), 32024R0239, January 16, 2024
Commission Implementing Regulation (EU) 2022/652of 20 April 2022concerning the authorisation of bitter orange extract as a feed additive for certain animal species(Text with EEA relevance)
Article 1AuthorisationThe substance specified in the Annex, belonging to the additive category "sensory additives" and to the functional group "flavouring compounds", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Transitional measures1.The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 February 2024, may continue to be placed on the market and used until the existing stocks are exhausted.2.Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 5 February 2025 in accordance with the rules applicable before 5 February 2024, may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.3.Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 5 February 2026 in accordance with the rules applicable before 5 February 2024, may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3Entry into forceThis 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 additives. Functional group: Flavouring compounds
2b136-ex—Bitter orange extractAdditive compositionBitter orange extract from the fruit of Citrus x aurantium L.Solid formCharacterisation of the active substanceBitter orange extract from the fruit of Citrus x aurantium L. as defined by the Council of Europe.Flavonoids: 45-55 % of whichNaringin: 20-30 %Neohesperidin: 10-20 %5-methoxypsoralen (also known as bergapten): ≤ 0,03 %(-)-Synephrine: ≤ 1 %CoE number: 136Analytical methodFor the quantification of naringin (phytochemical marker) in the feed additive:High performance liquid chromatography (HPLC) with spectrophotometric (UV) detectionAll animal species except dogs, cats, ornamental fish and ornamental birds——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 %:Chickens for fattening and minor poultry species for fattening: 102 mg;Laying hens and minor poultry species for laying or breeding: 151 mg;Turkeys for fattening: 136 mg;Piglets of all Suidae species: 182 mg;All Suidae for fattening: 217 mg;Sows of all Suidae species: 268 mg;Dairy ruminants other than dairy sheep and dairy goats: 259 mg;Calves (milk replacer), sheep, goats, other ruminants for fattening, horses, salmonids and all other fin fish: 400 mg;Rabbits: 161 mg;Other animal species and categories except dogs, cats, ornamental fish and ornamental birds: 102 mg".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.Mixture of bitter orange extract with other botanical additives is permitted provided that the amounts of 5-methoxypsoralen and (-)-synephrine in feed materials and compound feed are lower than the ones resulting from the use of a single additive at the maximum or recommended level for the species or animal category.6.The mixture of bitter orange extract from the fruit of Citrus x aurantium L. with other authorised additives obtained from Citrus aurantium L. shall not be allowed in feedingstuffs.7.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 eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.11 May 2032
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