Contents
Article 1Authorisation#
The authorisation of the aqueous solution and the preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ is renewed subject to the conditions laid down in that Annex.
Article 2Repeal of Implementing Regulation (EU) No 795/2013#
Implementing Regulation (EU) No 795/2013 is repealed.
Article 3Transitional measures#
1.The preparations of choline chloride as authorised by Implementing Regulation (EU) No 795/2013 and premixtures containing those preparations, which are produced and labelled before 16 August 2026 in accordance with the rules applicable before 16 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 16 February 2027 in accordance with the rules applicable before 16 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 16 February 2028 in accordance with the rules applicable before 16 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| Identification number of the additive | 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 |
|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||||
| 3a890i | Choline chloride | Additive compositionAqueous solution containing a minimum of 74 % of choline chlorideCharacterisation of the active substanceCholine chlorideC5H14Cl·NOCAS number: 67-48-1Solid form, produced by chemical synthesisPurity criteria: min. 99 % anhydrous basis2-chloroethanol: maximum 40 mg/kg ethylene oxidenote (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide)Analytical methodnoteFor the determination of choline chloride in the feed additive, premixtures, compound feed and water for drinking: ion chromatography with conductivity detection (IC-CD) | All animal species | - | - | - | 1. The additive may be used via water for drinking.2. The directions for use of the additive and premixtures shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.3. Simultaneous use of choline chloride in feed and water for drinking shall not be allowed.4. The labelling of feed for poultry and pigs containing choline chloride shall indicate: Recommended not to exceed supplemental levels of 1000 mg of choline chloride/kg of complete feed for poultry and pigs.5. In the directions for use of feed for poultry or pigs containing choline chloride shall be indicated: Simultaneous use with water for drinking in which choline chloride has been added shall not be allowed.6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. 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. | 16 February 2036 |
| Identification number of the additive | 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 |
|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||||
| 3a890ii | Choline chloride | Additive compositionPreparation with a minimum of 50 % of choline chlorideSolid formCharacterisation of the active substanceCholine chlorideC5H14Cl·NOCAS number: 67-48-1Solid form, produced by chemical synthesisPurity criteria: min. 99 % anhydrous basis2-chloroethanol: maximum 40 mg/kg ethylene oxidenote(sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide)Analytical methodnoteFor the determination of choline chloride in the feed additive, premixtures, compound feed and water for drinking: ion chromatography with conductivity detection (IC-CD) | All animal species | - | - | - | 1. The additive may be used via water for drinking.2. The directions for use of the additive and premixtures shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.3. Simultaneous use of choline chloride in feed and water for drinking shall not be allowed.4. The labelling of feed for poultry and pigs containing choline chloride shall indicate: Recommended not to exceed supplemental levels of 1000 mg of choline chloride/kg of complete feed for poultry and pigs.5. In the directions for use of feed for poultry or pigs containing choline chloride shall be indicated: Simultaneous use with water for drinking in which choline chloride has been added shall not be allowed.6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. 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. | 16 February 2036 |
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