COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1070 
of 12 Apr il 2024
concer ning the renewal of the author isation of a preparation of 25-h ydro xycholecalciferol produced 
by Sacc haromy ces cerevisiae CBS 146008 for chickens for fattening, turk eys for fattening, other 
poultr y and pigs and the author isation of that preparation for ruminants and repealing Commission 
Regulation (EC) No 887/2009 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting and renewing such an author isation.
(2) A preparation of 25-h ydro xycholecalcif erol produced by Saccharomy ces cerevisiae CBS 146008 was author ised for a 
period of 10 years as a feed additive by Commission Regulation (EC) No 887/2009 (2)for chic kens for fattening, 
turke ys for fattening, other poultr y, and pigs.
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of the preparation of 25-hydr oxycholecalcifer ol produced by Sacchar omyces cerevisiae CBS 146008 
for chick ens for fattening, turk eys for fattening, other poultr y and pigs. In accordance with Article 7 of Regulation 
(EC) No 1831/2003, another application was submitted for a new use of that preparation for ruminants. Those 
applications request ed that additive to be classif ied in the catego ry ‘nutr itional additives’ and in the functional group 
‘vitamins, pro-vitamins and chemically well-def ined substances having similar effect’ and were accompanied by the 
particulars and documents required respectively under Article 14(2) and Article 7(3) of that Regulation.
(4) The European Food Safet y Auth ority (‘the Auth ority’) concluded in its opinions of 5 July 2023 (3)that under the 
conditions of use currently author ised the preparation of 25-h ydro xycholecalcifer ol produced by Saccharomy ces 
cerevisiae CBS 146008 remains safe for chickens for fattening , turke ys for fattening, other poultr y and pigs, and that 
it is safe for all ruminants. It concluded also that the preparation of 25-h ydro xycholecalcif erol produced by 
Saccharomy ces cerevisiae CBS 146008 is safe for the consumers and the environment. It concluded that the 
preparation of 25- hydro xycholecalcifer ol produced by Sacchar omyces cerevisiae CBS 146008 is an efficient source of 
vitamin D3 for all ruminants and that, since the application for renewal of the author isation does not include a 
proposal for amending or supplementing the conditions of the original author isation that would have an impact on 
the efficacy of the additive, there is no need for assessing the efficacy of the additive in the cont ext of the renewal of 
the author isation. The Author ity also concluded that 25-hydr oxycholecalcifer ol produced by Sacchar omyces cerevisiae 
CBS 146008 is not irritant to the skin or eyes but no conclusion on its pote ntial to be a skin sensitiser or on its 
effects on the respirato ry system can be reac hed due to absence of data. The Authority does not consider that there 
is a need for specific requirements of post-market monitori ng.
Offi cial Jour nal 
of the European Union EN 
L series 
2024/1070 15.4.2024
ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj 1/6(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Regulation (EC) No 887/2009 of 25 Sept ember 2009 concer ning the author isation of a stabilised form of 
25-hyd roxycholecal ciferol as a feed additive for chick ens for fattening, turke ys for fattening, other poultr y and pigs (OJ L 254, 
26.9.2009, p. 68, ELI: http://data.europa.eu/eli/reg/2009/887/oj).
(3) EFSA Journal 2023;21(8):8168 and EFSA Journal 2023;21(8):8169.(5) The Author ity also verified the repor t on the methods of analysis of the feed additive in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003 for the application for renewal of the author isation 
for chick ens for fattening , turk eys for fattening, other poultr y and pigs. In accordance with Article 5(4), point (a), of 
Commission Regulation (EC) No 378/2005 (4), the Reference Laboratory set up by Regulation (EC) No 1831/2003 
considered that the conclusions and recommendations reac hed in the previous assessment concer ning the same 
additive are valid and applicable for the current application for ruminants.
(6) In view of the above, the Commission considers that the preparation of 25-hydr oxycholecalciferol produced by 
Saccharomy ces cerevisiae CBS 146008 (5)satisfi es the conditions provided for in Article 5 of Regulation (EC) 
No 1831/2003. According ly, the author isation of that additive should be renewed for chick ens for fattening, 
turke ys for fattening, other poultr y and pigs and should be author ised for ruminants. As 25-hydro xycholecalciferol 
depresses the activity of 1α-hydro xylase in the kidne y, the Commission considers that the simultaneous use of 
1,25-dihydr oxycholecalcifer ol from Solanum glaucophy llum extract with that additive should not be allowe d. The 
Commission further considers that the combination of the preparation of 25-h ydro xycholecalcif erol with 
cholecalciferol should be limited in order not to exceed the maximum daily intake level for vitamin D3. The 
Commission considers that the restr iction to use the additive via premixtures should be maintained. In addition, the 
Commission considers that appropr iate protective measures should be taken to prevent adverse effects on the health 
of the users of the additive.
(7) As a consequence of the renewal of the author isation of the preparation of 25-hydr oxycholecalciferol, Regulation 
(EC) No 887/2009 should be repealed.
(8) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Renewal of the author isation
The author isation of the preparation specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives’ and to 
the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed for 
chick ens for fattening, turk eys for fattening, other poultr y and pigs, subject to the conditions laid down in that Annex.
Article 2
Author isation
The preparation specifi ed in the Annex, belonging to the additive catego ry ‘nutr itional additives’ and to the functional 
group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar effect,’ is author ised as an additive in 
animal nutr ition for ruminants, subject to the conditions laid down in that Annex.
Article 3
Repeal
Regulation (EC) No 887/2009 is repealed.EN OJ L, 15.4.2024 
2/6 ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the impl ementation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference 
Laboratory concer ning applications for author isations of feed additive (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 
2005/378/oj).
(5) EFSA Journal 2023;21(8):8168.Article 4
Entr y into force
This Regulation shall enter into force on the twentieth day followi ng 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.
Done at Brussels, 12 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 15.4.2024 EN 
ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj 3/6ANNEX 
Identification 
number of the 
feed additiveAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or 
categor y of 
animalMaxi -
mum 
ageMini -
mum 
conten tMaximum 
content
Other provisionsEnd of period of 
author isation mg active substance/kg 
of complet e feed with a 
moisture content of 
12 %
Categor y: Nutr itional additiv es. Functional group: Vitamins, provitamins and chemically well-def ined subst ances having similar effect
Sub classif ication: vita min D
3a670a 25-Hydro xy cho­
lecalciferolAdditive composition
Preparation with a maximum conte nt of 
1,25 % of 25-h ydro xycholecalcif erol.
Solid form
Char acter isation of the activ e substance
25-Hydro xycholecalciferol. Its precursor 
compo und, 5,7,24-cholestatr ienol, is 
produced with Saccharom yces cerevisiae 
CBS 146008. After extraction, the pre­
cursor is conver ted chemically to 
25-h ydro xy-pro-vitamin D3, which is 
further transf ormed photoc hemically to 
25-h ydro xycholecalfcif erol.
C27H44O2.H2O
CAS number: 63283-36-3
Purity criteria
— 25-h ydro xycholecalcifer ol > 94 %
— other sterol derivatives ≤ 1 % each
— erythrosine < 5 mg/kgChic kens for 
fatteni ng0,100 1. The additive shall be incor po­
rated in feedingstuffs via the 
use of a premixture.
2. In the directions for use of the 
additive and premixtures, the 
storag e conditions and the 
stability to heat treatment 
shall be indicated .
3. Maximum cont ent of the 
combination of 25-hydro xy­
cholecalciferol with chole ­
calciferol (vitamin D3) per kg 
of compl ete feedingstuff:
— ≤ 0,125 mg (2)(equiva ­
lent to 5 000 IU of cho­
lecalcifer ol) for chick ens 
for fattening and turke ys 
for fattening,
— ≤ 0,080 mg (equivalent 
to 3 200 IU of cholecal ­
cifer ol) for other poultr y,5 May 2034
Turke ys for fat­
tening0,100
Other poultr y 0,080
Pigs 0,050
Bovines and 
ovines0,100
Ruminants 
other than 
bovines and 
ovines0,050EN OJ L, 15.4.2024 
4/6 ELI: http://data.europa.eu/eli/reg_impl/2024/1070/ojAnalytical method (1)
For the deter mination of 25-h ydro xy­
cholecalcifer ol in the feed additive: Ultra 
Performance Liquid Chromatograp hy 
coupled to spectrophotomet ric detection 
(UPLC -UV)
For the deter mination of 25-h ydro xy­
cholecalcifer ol in premixtures: High Per­
formance Liquid Chromatograph y 
coupled to spectrophotomet ric detection 
(HPL C-UV)
For the deter mination of 25-h ydro xy­
cholecalcifer ol in compo und feed and in 
low concentrat ed premixtures: High Per­
formance Liquid Chromatograph y 
coupled to tandem mass spectrometr y 
(HPL C-MS/MS)— ≤ 0,050 mg (equivalent 
to 2 000 IU of cholecal ­
cifer ol) for pigs,
— ≤ 0,100 mg (equivalent 
to 4 000 IU of cholecal ­
cifer ol) for milk repla ­
cers for calves,
— ≤ 0,100 mg (equivalent 
to 4 000 IU of cholecal ­
cifer ol) for bovines and 
ovines,
— ≤ 0,050 mg (equivalent 
to 2 000 IU of cholecal ­
cifer ol) for ruminants 
other than bovines and 
ovines.
4. The simultaneous use of the 
additive with glycosylated 
1,25-dihydr oxycholecalci ­
ferol from Solanum glauco ­
phylu m extract shall not be 
permitted .
5. For users of the additive and 
premixtures, feed business 
operat ors shall establish op­
erational procedures and or­
ganis ational measures to ad­
dress the potential risks 
resulting from their use. OJ L, 15.4.2024 EN 
ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj 5/6Where those risks cannot be 
eliminated by such proce ­
dures and measures, the ad­
ditive and premixtures shall 
be used with personal 
breathing and skin prot ective 
equipment.
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts.
(2)40 IU cholecal ciferol (vitamin D3) = 0,001 mg cholecalcif erol (vitamin D3).EN OJ L, 15.4.2024 
6/6 ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj