Commission Implementing Regulation (EU) 2024/1070

Contents

Article 1Renewal of the authorisation#

The authorisation of 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 for chickens for fattening, turkeys for fattening, other poultry and pigs, subject to the conditions laid down in that Annex.

Article 2Authorisation#

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 authorised as an additive in animal nutrition for ruminants, subject to the conditions laid down in that Annex.

Article 3Repeal#

Regulation (EC) No 887/2009 is repealed.

Article 3aTransitional measures#

1.The feed additive 25-hydroxycholecalciferol, as authorised by Regulation (EC) No 887/2009, and premixtures containing that additive, which are produced and labelled before 5 November 2024 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.

2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 May 2025 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.

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 feed additive	Additive	Composition, chemical formula, description, analytical method.	Species or category of animal	Maximum content	Other provisions	End of period of authorisation
mg active substance/kg of complete feed with a moisture content of 12 %
Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect
Sub classification: vitamin D
3a670a	25-Hydroxy cholecalciferol	Additive compositionPreparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol.Solid formCharacterisation of the active substance25-Hydroxycholecalciferol. Its precursor compound, 5,7,24-cholestatrienol, is produced with Saccharomyces cerevisiae CBS 146008. After extraction, the precursor is converted chemically to 25-hydroxy-pro-vitamin D₃, which is further transformed photochemically to 25-hydroxycholecalfciferol.C₂₇H₄₄O₂.H₂OCAS number: 63283-36-3Purity criteria25-hydroxycholecalciferol > 94 %other sterol derivatives ≤ 1 % eacherythrosine < 5 mg/kgAnalytical method^noteFor the determination of 25-hydroxycholecalciferol in the feed additive: Ultra Performance Liquid Chromatography coupled to spectrophotometric detection (UPLC-UV)For the determination of 25-hydroxycholecalciferol in premixtures: High Performance Liquid Chromatography coupled to spectrophotometric detection (HPLC-UV)For the determination of 25-hydroxycholecalciferol in compound feed and in low concentrated premixtures: High Performance Liquid Chromatography coupled to tandem mass spectrometry (HPLC-MS/MS)	Chickens for fattening	0,100	1. The additive shall be incorporated in feedingstuffs via the use of a premixture.2. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.3. Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol (vitamin D3) per kg of complete feedingstuff: ≤ 0,125 mg (equivalent to 5000 IU of cholecalciferol) for chickens for fattening and turkeys for fattening,≤ 0,080 mg (equivalent to 3200 IU of cholecalciferol) for other poultry,≤ 0,050 mg (equivalent to 2000 IU of cholecalciferol) for pigs,≤ 0,100 mg (equivalent to 4000 IU of cholecalciferol) for milk replacers for calves,≤ 0,100 mg (equivalent to 4000 IU of cholecalciferol) for bovines and ovines,≤ 0,050 mg (equivalent to 2000 IU of cholecalciferol) for ruminants other than bovines and ovines.4. The simultaneous use of the additive with glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophylum extract shall not be permitted.5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 breathing and skin protective equipment.	5 May 2034
Turkeys for fattening			0,100
Other poultry			0,080
Pigs			0,050
Bovines and ovines			0,100
Ruminants other than bovines and ovines			0,050