COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1455 
of 13 July 2023
concer ning the urgent provisional author isation of cobalt(II) acet ate tetrah ydrate, cobalt(II) 
carbonate, cobalt(II) carbonate hydro xide (2:3) monoh ydrate and cobalt(II) sulphate, hept ahy drate as 
feed additiv es for ruminants with a functional rumen, equidae and lagomor phs 
(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 15 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 such author isation. In particular , Article 15 of that Regulation provid es that 
the Commission may provisiona lly author ise the use of additives in specifi c cases where urgent author isation is 
needed to ensure the protection of animal welf are.
(2) Commission Imple menting Regulation (EU) No 601/2013 (2)author ised for a period of 10 years cobalt(II) acetat e 
tetrahydrat e, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrat e, cobalt(II) sulphat e, 
hepta hydrat e and coated granulate d cobalt(II) carbonate as feed additives belonging to the catego ry ‘nutr itional 
additives ’ and to the functional group ‘compounds of trace elements’. Those additives were author ised for use in 
ruminants with a functional rumen, equidae, lagomor phs, rodents, herbivore reptiles and zoo mammals.
(3) No application was submitted within the time limit indicated in Article 14(1) of Regulation (EC) No 1831/2003 for 
the renewal of the author isation of the additives cobalt(II) acetat e tetrahydrat e, cobalt(II) carbonat e, cobalt(II) 
carbonate hydro xide (2:3) monoh ydrate and cobalt(II) sulphate , hept ahydrat e(3), expir ing on 15 July 2023 . For 
those additives, an application for a new author isation was submitted on 20 October 2022 in accordance with 
Article 7 of Regulation (EC) No 1831/2003, for use for the same animal species that the previous author isation 
concer ned and requesting them to be classif ied in the additive categor y ‘nutr itional additives ’ and in the functional 
group ‘com pounds of trace elements’.
(4) Taking into account the time period needed for the processing of the application for author isation submitted for the 
additives cobalt(II) acetat e tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrat e and 
cobalt(II) sulphate , heptahydrat e, no new author isation of those additives can be granted by 15 July 2023 .
(5) As a result, a request was submitted by a compan y to the Commission on 30 May 2023 , to grant, in accordance with 
Article 15 of Regulation (EC) No 1831/2003, a provisional urgent author isation of the use of the additives cobalt(II) 
acetate tetrahydrat e, cobalt(II) carbonate, cobalt(II) carbonate hydro xide (2:3) monoh ydrate and cobalt(II) sulphate, 
hepta hydrat e, intended for ruminants, horses and rabbits.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Implementing Regulation (EU) No 601/2013 of 24 June 2013 concer ning the author isation of cobalt(II) acetate 
tetrahydrat e, cobalt(II) carbonat e, cobalt(II) carbonat e hydro xide (2:3) monohydrat e, cobalt(II) sulphate heptah ydrate and coated 
granulated cobalt(II) carbonate hydro xide (2:3) monohydrat e as feed additives (OJ L 172, 25.6.2013, p. 14).
(3)An application was submitted for the renewal of the author isation of coated granulated cobalt(II) carbonat e as a feed additive in 
accordance with Article 14(1) of Regulation (EC) No 1831/2003. That additive is not covered by this Regulation.EN Offi cial Jour nal of the European Union 14.7.2023 L 179/103  (6) In its opinion of 12 November 2009 (4), the European Food Safety Author ity (‘the Authority’) concluded that due to 
the high ruminal degradation rate of oral vitamin B12, an optimal micronutr ient supply of ruminants should include 
cobalt. The Author ity extende d that conclusion to horses and rabbits, for which it considered that cobalt 
supplementation to their diets should also be maintained. In its opinions of 22 May 2012 (5)and 12 June 2012 (6), 
the Author ity confir med that the additives cobalt(II) acetate tetrahydrat e, cobalt(II) carbonate , cobalt(II) carbonate 
hydroxide (2:3) monoh ydrate and cobalt(II) sulphate , heptahydrat e are efficacious sources of cobalt as an essential 
trace element, whic h is in turn used for the production of vitamin B12 by microbial fermentation in the rumen.
(7) As mentioned in the Authority’s opinion of 12 November 2009 , cobalt deficiency in animals results in general in 
loss of appetite, reduced growth rate, loss of body weight, anaemia, disturbances of lipid metabolism, reduced folate 
level, accumulation of iron and nick el in liver , compr omised neutrophil function and reduced resistance to parasitic 
infections, which is particularly the case as regar ds ruminants.
(8) It appears theref ore that such deficiency is likely to cause severe adverse effects on the welf are of animals for whic h 
cobalt is essential to synthesise vitamin B12, including a weakening of the immune system, an increase in the 
frequency of intestinal disorders and ketosis, an imp aired reproductive function, an increased risk for ovines of 
contracting the Ovine White Liver Disease and even possibly an increase in morbidity or mor tality (7).
(9) In order to avoid critical deficiencies, animals grazing on soils low in cobalt, or fed with hay or plants produced in 
those soils, but also certain animal categor ies with specifi c needs, such as animals fed with automatic concentrat e 
dispensers with meter ing pumps or some animals with metabolic disorders, rely on complementary feed in the 
form of bolus or liquid for their supply in essential nutr ients, including cobalt. The altern ative for grassland animals 
to use buck ets or mineral licks to administe r feed is generally not considered as optimal in all circumstances to 
guarant ee a suffi cient, effective and safe supply of cobalt, due to the volun tary and competitive consum ption thereof 
by animals and the derived less controlled and targe ted supplementation, the imp act of climatic conditions on feed’s 
quality and the additional requirements in term s of handling.
(10) The additive coated granulate d cobalt(II) carbonate, for the use of whic h an application for renewal has been 
submitted in accordance with Article 14(1) of Regulation (EC) No 1831/2003 and which is currently author ised as 
a feed additive in accordance with Regulation (EC) No 1831/2003, cannot be used in the formulation of feed 
administe red in liquid compl ementar y feed, nor as bolus. This is because of the technical specifi cations of that 
additive, whic h contains insoluble particles affecting the homogeneity of the liquid feed, has a very low cobalt 
concentration and is not very compr essible, preventing the manufacture of suitable high-density boluses. Liquid 
feed should contain cobalt in soluble form, such as the additives cobalt(II) acetat e tetrahydrat e and cobalt(II) 
sulphate , heptah ydrat e, while the manufactur ing of suitable boluses provid ing the animals with the required safe 
amount of cobalt would include the additives cobalt(II) carbonate and cobalt(II) carbonate hydroxide (2:3) 
monoh ydrate. No other cobalt compound is currently author ised as a feed additive pursuant to Regulation (EC) 
No 1831/2003.
(11) Commission Regulation (EU) 2020/354 (8)establishes as particular nutr itional purpose the long-term supply of 
grazing animals with trace elements and/or vitamins for feed intended for ruminants with a functional rumen, 
which is allowe d to be administered in the form of bolus. A cessation of the use of cobalt compo unds as an additive 
in feed, in particular dietet ic feed in the form of bolus for grazing animals, would prevent operators from meeting 
(4)EFSA Journal 2009;7(12) :1383.
(5)EFSA Journal 2012;10(6):2727.
(6)EFSA Journal 2012;10(7):2791.
(7)A review of the role of cobalt in animal metabolism, in particular of ruminants, and of the effec ts of cobalt deficiency , is avail able in: 
‘Relationship betwe en Vitamin B12 and Cobalt Metabolism in Domestic Ruminant : An Update’, by Jose-Ramiro González-Montaňa et al. 
Animals 2020, 10, 1855; doi:10.3390/ani10101855.
(8)Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed inten ded for particular nutr itional 
purposes and repealing Directive 2008/38/EC (OJ L 67, 5.3.2020, p. 1).EN Offi cial Jour nal of the European Union L 179/104 14.7.2023  that particular nutr itional purpose with regar d to the specifi c nutr itional needs of ruminants whose process of 
assimilation, absor ption or metabolism can be impaired by a lack of cobalt in their diet. Such lack of feed 
appropr iate to the conditions of grazing ruminants would theref ore be detr imental to the welf are of those animals.
(12) The actual impact of the non-a vailability of the additives cobalt(II) acetat e tetrah ydrat e, cobalt(II) carbonate, cobalt(II) 
carbonate hydroxide (2:3) monohydrat e and cobalt(II) sulphate, heptahydrat e can be measured taking into 
consideration the exte nt of use of those additives across the Union, although some Member States are more affected 
by a cobalt deficien cy due to the nature of soils and pastures. For instance, in Ireland, 62 % of all complementary feed 
manufact ured for ruminants and equines contains one of those four additives and more than 11,7 million animals 
could poten tially be negatively affected by a lack of access to those products. In France, 11,5 million ruminants are 
supplemente d with one of those four additives in the form of bolus or liquid feed and would be affected in term s of 
animal welfare in the absence of use of those products. In general, it appears from data received from national 
compet ent author ities and operat ors that the additives concer ned are widely used for ruminants, mostly in feed in 
the form of bolus or liquid, but also for horses and rabbits. It was estimat ed that, at the end of 2021, there were 
76 million head of bovine animals and 71 million head of sheep and goats on Union farms(9). Statistical data on 
rabbit farming (10)from 2016 show that around 180 million farmed rabbits were reared for meat consum ption in 
the Union.
(13) Based on the Authority’s opinions of 12 November 2009 , 22 May 2012 and 12 June 2012 , and data on the actual 
use of the additives cobalt(II) acetate tetrahydrat e, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) 
monoh ydrate and cobalt(II) sulphat e, heptah ydrat e in the Union, it derives that the animal species or catego ries 
whose welfare would be signif icantly impaired by the cessation of the use of cobalt in their nutr ition are ruminants, 
horses and rabbits.
(14) In order to avoid negat ive effects on the welf are of ruminants, horses and rabbits deriving from an interrupti on of 
the author isation of the use of the additives cobalt(II) acetate tetrah ydrate, cobalt(II) carbonate, cobalt(II) carbonate 
hydroxide (2:3) monoh ydrate and cobalt(II) sulphate, hepta hydrat e, as from 15 July 2023 , and in the absence of 
currently available altern ative, their use should be urgently provisionally author ised until a decision on the 
application for their author isation submitted in accordance with Article 7 of Regulation (EC) No 1831/2003 is 
taken. The provi sional author isation should be grant ed for a maximum period of five years, according to Article 15 
of Regulation (EC) No 1831/2003.
(15) In order to ensure that only safe and efficacious additives are used in accordance with the objectives pursued by 
Regulation (EC) No 1831/2003, the term s of the provisional author isation should reflect the terms of author isation 
provid ed for by Implementing Regulation (EU) No 601/2013 for the four additives concer ned as regards the use 
intended for ruminants, equidae and lagomor phs.
(16) The Reference Laborator y set up by Regulation (EC) No 1831/2003 considered that the conclusions and 
recommendations reach ed for those additives in the earlier assessment carried out regarding the method of analysis 
in the cont ext of the author isation granted by Implemen ting Regulation (EU) No 601/2013 are valid and applicable 
to the provi sional author isation.
(17) Due to the expir y of the author isation of use of the additives cobalt(II) acetat e tetrahydrat e, cobalt(II) carbonate, 
cobalt(II) carbonate hydroxide (2:3) monoh ydrate and cobalt(II) sulphat e, hept ahydrat e on 15 July 2023 , and in 
order to ensure a high level of protection of the welfare of the animals concer ned by the provis ional author isation, 
this Regulation should enter into force as a matt er of urgency .
(18) 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,
(9)Key figures on the Euro pean food chain – 2022 edition, Eurostat.
(10)European Commission, Directorat e-General for Health and Food Safet y, Commercial rabbit farming in the European Union – Over view 
report, Publications Offi ce, 2018, https://data.europa.eu/doi/10.2772/62174EN Offi cial Jour nal of the European Union 14.7.2023 L 179/105  HAS ADOPTED THIS REGUL ATION:
Article 1
Provisional author isation
The substances specified in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘compounds of trace elements’, are provisionally author ised as additives in animal nutr ition, subject to the conditions laid 
down in that Annex.
Article 2
Entr y into force
This Regulation shall enter into force on the 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.
Done at Brussels, 13 July 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 179/106 14.7.2023  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation Element (Co) in mg/kg of 
complet e feed with a 
moisture content of 12 %
Categor y of nutr itional additiv es. Functional group: compounds of trace elements
3b301 Cobalt(II) 
acetat e 
tetrahydrat eAdditive composition
Cobalt(II) acetate tetrahydrat e, as 
crystals/granules, with a minimum 
conte nt of 23% cobalt
Particles < 50 μm: below 1 %
Char acter isation of the active substance
Chemical formula:
Co(C H3COO) 2 x 4H 2O
CAS number: 6147-53-1
Analytical methods (1)
For the identificati on of acetate in the 
additiv e:
—European Phar macopoeia mono ­
graph 01/2008:20301.
For the crystallog raphic character isation of 
the additiv e:
— X-Ray diffraction.
For the deter mination of total cobalt in the 
additiv e, premixtures, compound feed and 
feed mater ials:
— EN 15510 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES)
orRuminants with a 
functional rumen, 
equidae, 
lagomor phs- - 1 (total) 1.The additive shall be incor porat ed 
into compo und feed in the form of 
a premixture.
2.Declarations to be made on the la­
belling of the additive and premix ­
ture:
— Cobalt cont ent
— ‘It is recommended to limit the 
supplementation with Cobalt 
to 0,3 mg/kg in compl ete 
feed. In this context, the risk 
for Cobalt deficiency due to 
local conditions and the speci ­
fic compo sition of the diet 
should be taken into account.’
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks resulting 
from their use. Where those risks 
cannot be eliminated by such pro­
cedures and measures, the additive 
and premixtures shall be used with 
personal skin, eye and breathing 
prote ctive equipment.As soon as a decision 
on the author isation 
of the additive has 
been taken under 
Article 9 of 
Regulation (EC) 
No 1831/2003 and 
at the latest on 
14 July 2028 .EN Offi cial Jour nal of the European Union 14.7.2023 L 179/107  — CEN/TS 15621 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES) after pres ­
sure dige stion.
For the deter mination of particle size 
distr ibution:
— ISO 13320 - Particle size analysis - 
Laser diffraction methods.4.Declaration to be made in the in­
structions of use of the compo und 
feed: ‘Prot ective measures to avoid 
exposure with Cobalt by inhalation 
or by dermal route should be ta­
ken.’
3b302 Cobalt(II) 
carbonateAdditive composition
Cobalt(II) carbonate, as powder , with a 
conte nt of 45% - 48% cobalt
Cobalt carbonate: minimum 75%
Cobalt hydroxide: 3% - 15%
Water: maximum 6%
Particles < 11 μm: below 90 %
Char acter isation of the active substance
Chemical formula: CoCO 3
CAS number: 513-79-1
Analytical methods (1)
For the identificati on of carbonate in the 
additiv e:Ruminants with a 
functional rumen, 
equidae, 
lagomor phs- - 1 (total) 1.The additive shall be incor porat ed 
into compo und feed in the form of 
a premixture. This compound feed 
shall be placed on the mark et in a 
non-po wder form.
2.Declarations to be made on the la­
belling of the additive and premix ­
ture:
— Cobalt cont ent
— ‘It is recommended to limit the 
supplementation with Cobalt 
to 0,3 mg/kg in compl ete 
feed. In this context, the risk 
for Cobalt deficiency due to 
local conditions and the speci ­
fic compo sition of the diet 
should be taken into account.’As soon as a decision 
on the author isation 
of the additive has 
been taken under 
Article 9 of 
Regulation (EC) 
No 1831/2003 and 
at the latest on 
14 July 2028 .EN Offi cial Jour nal of the European Union L 179/108 14.7.2023  —European Phar macopoeia mono ­
graph 01/2008:20301.
For the crystallog raphic character isation of 
the additiv e:
— X-Ray diffraction.
For the deter mination of total cobalt in the 
additiv e, premixtures, compound feed and 
feed mater ials:
— EN 15510 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES)
or
— CEN/TS 15621 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES) after pres ­
sure dige stion.
For the deter mination of particle size 
distr ibution:
— ISO 13320 - Particle size analysis - 
Laser diffraction methods.3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks resulting 
from their use. Where those risks 
cannot be eliminated by such pro­
cedures and measures, the additive 
and premixtures shall be used with 
personal skin, eye and breathing 
prote ctive equipment.
4.Declaration to be made in the in­
structions of use of the compo und 
feed: ‘Prot ective measures to avoid 
exposure with Cobalt by inhalation 
or by dermal route should be ta­
ken.’
3b303 Cobalt(II) 
carbonate 
hydroxide (2:3) 
monohydrat eAdditive composition
Cobalt(II) carbonate hydro xide (2:3) 
monoh ydrate, as powder , with a 
minimum content of 50% cobalt
Particles < 50 μm: below 98 %Ruminants with a 
functional rumen, 
equidae, 
lagomor phs- - 1 (total) 1.The additive shall be incor porat ed 
into compo und feed in the form of 
a premixture. This compound feed 
shall be placed on the mark et in a 
non-po wder form.As soon as a decision 
on the author isation 
of the additive has 
been taken under 
Article 9 of 
Regulation (EC) 
No 1831/2003 and 
at the latest on 
14 July 2028 .EN Offi cial Jour nal of the European Union 14.7.2023 L 179/109  Char acter isation of the active substance
Chemical formula:
2CoC O3 x 3Co(OH) 2 x H2O
CAS number: 51839-24-8
Analytical methods (1)
For the identificati on of carbonate in the 
additiv e:
—European Phar macopoeia mono ­
graph 01/2008:20301.
For the crystallog raphic character isation of 
the additiv e:
— X-Ray diffraction.
For the deter mination of total cobalt in the 
additiv e, premixtures, compound feed and 
feed mater ials:
— EN 15510 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES)
or
— CEN/TS 15621 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES) after pres ­
sure dige stion.
For the deter mination of particle size 
distr ibution:
— ISO 13320 - Particle size analysis - 
Laser diffraction methods.2.Declarations to be made on the la­
belling of the additive and premix ­
ture:
— Cobalt cont ent
— ‘It is recommended to limit the 
supplementation with Cobalt 
to 0,3 mg/kg in compl ete 
feed. In this context, the risk 
for Cobalt deficiency due to 
local conditions and the speci ­
fic compo sition of the diet 
should be taken into account.’
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks resulting 
from their use. Where those risks 
cannot be eliminated by such pro­
cedures and measures, the additive 
and premixtures shall be used with 
personal skin, eye and breathing 
prote ctive equipment.
4.Declaration to be made in the in­
structions of use of the compo und 
feed: ‘Prot ective measures to avoid 
exposure with Cobalt by inhalation 
or by dermal route should be ta­
ken.’EN Offi cial Jour nal of the European Union L 179/110 14.7.2023  3b305 Cobalt(II) 
sulphate, 
heptah ydrat eAdditive composition
Cobalt(II) sulphate, hept ahydrat e, as 
powder , with a minimum conte nt of 20% 
cobalt
Particles < 50 μm: below 95 %
Char acter isation of the active substance
Chemical formula: CoSO 4 x 7H 2O
CAS number: 10026-24-1
Analytical methods (1)
For the identificati on of sulphate in the 
additiv e:
—European Phar macopoeia mono ­
graph 01/2008:20301.
For the crystallog raphic character isation of 
the additiv e:
— X-Ray diffraction.
For the deter mination of total cobalt in the 
additiv e, premixtures, compound feed and 
feed mater ials:
— EN 15510 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES)
or
— CEN/TS 15621 - inductively coupled 
plasma optical (atomic) emission 
spectrometr y (ICP -AES) after pres ­
sure dige stion.Ruminants with a 
functional rumen, 
equidae, 
lagomor phs- - 1 (total) 1.The additive shall be incor porat ed 
into compo und feed in the form of 
a premixture. This compound feed 
shall be placed on the mark et in a 
non-po wder form.
2.Declarations to be made on the la­
belling of the additive and premix ­
ture:
— Cobalt cont ent
— ‘It is recommended to limit the 
supplementation with Cobalt 
to 0,3 mg/kg in compl ete 
feed. In this context, the risk 
for Cobalt deficiency due to 
local conditions and the speci ­
fic compo sition of the diet 
should be taken into account.’
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks resulting 
from their use. Where those risks 
cannot be eliminated by such pro­
cedures and measures, the additive 
and premixtures shall be used with 
personal skin, eye and breathing 
prote ctive equipment.As soon as a decision 
on the author isation 
of the additive has 
been taken under 
Article 9 of 
Regulation (EC) 
No 1831/2003 and 
at the latest on 
14 July 2028 .EN Offi cial Jour nal of the European Union 14.7.2023 L 179/111  For the deter mination of particle size 
distr ibution:
— ISO 13320 - Particle size analysis - 
Laser diffraction methods.4.Declaration to be made in the in­
structions of use of the compo und 
feed: ‘Prot ective measures to avoid 
exposure with Cobalt by inhalation 
or by dermal route should be ta­
ken.’
(1)Details of the analytical methods are available at the follo wing address of the Reference Laboratory : https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union L 179/112 14.7.2023