LegalizeCommission Implementing Regulation (EU) 2026/164 of 26 January 2026 concerning the renewal of the authorisation of an aqueous solution of choline chloride and a preparation of choline chloride as feed additives for all animal species and repealing Implementing Regulation (EU) No 795/2013
Article 1
Authorisation
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 2
Repeal of Implementing Regulation (EU) No 795/2013
Implementing Regulation (EU) No 795/2013 is repealed.
Article 3
Transitional measures
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.
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.
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 4
Entry 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||
| 3a890i | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Choline chloride | Additive composition Aqueous solution containing a minimum of 74 % of choline chloride Characterisation of the active substance Choline chloride C5H14Cl·NO CAS number: 67-48-1 Solid form, produced by chemical synthesis Purity criteria: min. 99 % anhydrous basis 2-chloroethanol: maximum 40 mg/kg ethylene oxide [^E0001] (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide) Analytical method [^E0002] For the determination of choline chloride in the feed additive, premixtures, compound feed and water for drinking: ion chromatography with conductivity detection (IC-CD) | Other provisions | End of period of authorisation | 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 1 000 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 |
Although the level of 40 mg is expressed as ethylene oxide it refers to the presence of the impurity 2-chloroethanol. The method of analysis requires 2-chloroethanol to be expressed in this manner.
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||
| 3a890ii | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Choline chloride | Additive composition Preparation with a minimum of 50 % of choline chloride Solid form Characterisation of the active substance Choline chloride C5H14Cl·NO CAS number: 67-48-1 Solid form, produced by chemical synthesis Purity criteria: min. 99 % anhydrous basis 2-chloroethanol: maximum 40 mg/kg ethylene oxide ^E0003 Analytical method [^E0004] For the determination of choline chloride in the feed additive, premixtures, compound feed and water for drinking: ion chromatography with conductivity detection (IC-CD) | Other provisions | End of period of authorisation | 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 1 000 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 |
Although the level of 40 mg is expressed as ethylene oxide it refers to the presence of the impurity 2-chloroethanol. The method of analysis requires 2-chloroethanol to be expressed in this manner.
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
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