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Commission Implementing Regulation (EU) 2021/485 of 22 March 2021 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 (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) 2021/485of 22 March 2021concerning 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(Text with EEA relevance)

Article 1AuthorisationThe substances specified in the Annex, belonging to the additive category "sensory additives" and to the functional group "flavouring compounds", are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2Use in water for drinkingThe authorised substances specified in the Annex shall not be used in water for drinking.

Article 3Transitional measures1.The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 12 October 2021 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted.2.Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2022 in accordance with the rules applicable before 12 April 2021 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 substances as specified in the Annex which are produced and labelled before 12 April 2023 in accordance with the rules applicable before 12 April 2021 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 4Entry 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 additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method.	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg active substance/kg of complete feed with a moisture content of 12 %		Other provisions	End of period of authorisation
Category: Sensory additivesFunctional group: Flavouring compounds
2b489-eo	-	Ginger essential oil	Additive compositionEssential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe.Characterisation of the active substanceEssential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe.α-zingiberene: 29-40 %β-sesquiphellandrene: 8-14 %ar-curcumene: 5-12 %α-farnesene: 4-10 %camphene: 2-10 %β-bisabolene: 2-9 %CAS number: 8007-08-7Einecs number: 283-634-2FEMA number: 2522CoE number: 489Liquid formAnalytical methodFor the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar-curcumene in the feed additive:Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method.	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 %:veal calves (milk replacer): 80 mg;other species or categories of animals: 20 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.The mixture of ginger essential oil with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.6.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.	12.4.2031

Identification number of the additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method.	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg active substance/kg of complete feed with a moisture content of 12 %		Other provisions	End of period of authorisation
Category: Sensory additivesFunctional group: Flavouring compounds
2b489-or	-	Ginger oleoresin	Additive compositionGinger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe.Characterisation of the active substanceGinger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe.Essential oil: 25-30 (w/w)Total gingerols: 0,5-8 % (w/w)6-Gingerol8-Gingerol10-GingerolTotal shogaols: 3-6 % (w/w)6-Shogaol8-ShogaolHumidity and volatiles: 25-30 (w/w)CoE number: 489Liquid formAnalytical methodFor the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin):High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685	Chickens for fatteningLaying hensTurkeys for fatteningPigletsPigs for fatteningSowsDairy cowsVeal calves (milk replacers)Cattle for fatteningSheep and goatsHorsesRabbitsFishPets	-	-	-	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 % and for milk replacers with a moisture content of 5,5 %:chickens for fattening: 5 mg;laying hens and rabbits: 7 mg;turkeys for fattening: 6 mg;piglets: 8 mg;pigs for fattening: 10 mg;sows: 13 mg;dairy cows: 12 mg;veal calves (milk replacers): 21 mg;cattle for fattening: 19 mg;sheep, goats, horses and fish: 20 mg;pets: 1 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.The mixture of ginger oleoresin with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.6.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.	12.4.2031

Identification number of the additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method.	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg active substance/kg of complete feed with a moisture content of 12 %		Other provisions	End of period of authorisation
Category: Sensory additivesFunctional group: Flavouring compounds
2b489-t	-	Ginger tincture	Additive compositionGinger tincture obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture.Characterisation of the active substanceGinger tincture is obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture as defined by the Council of Europe.Solvent (ethanol/water, 90/10): 97-98 % (w/w)Dry matter: 2-3 % (w/w)Total gingerols: 0,14-0,11 % (w/w)6-Gingerol8-Gingerol10-GingerolTotal shogaols: 0,043-0,031 % (w/w)6 Shogaol8-ShogaolAnalytical methodFor the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture):High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685	HorsesDogs	-	-	-	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 %:Horses 1,58 mLDogs 1,81 mL".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.The mixture of ginger tincture with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.6.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.	12.4.2031

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