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12.2.2014 Official
Journal
of
the
European
Union
L
41/3
COMMISSION IMPLEMENTING REGULATION (EU) No 131/2014
of 11 February 2014
amending Implementing Regulation (EU) No 601/2013 concerning the authorisation of cobalt(II)
acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate,
cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3)
monohydrate as feed additives
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
potential must be placed on the market in a pelleted
form could be expanded to other non-powder forms
without compromising the risk for the users.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
applicant
for
coated
granulated
cobalt(II)
carbonate
hydroxide (2:3) monohydrate submitted data in order to
substantiate that the substance coated is cobalt(II)
Having regard to Regulation (EC) No 1831/2003 of the
carbonate and not cobalt(II) carbonate hydroxide (2:3)
European Parliament and of the Council of 22 September
monohydrate. After verification in the application
2003 on additives for use in animal nutrition ( 1 ), and in
dossier which was the basis for the above mentioned
particular Article 9(2) thereof,
opinion of the Authority ( 6 ), it appears necessary to
change the authorisation terms of this product accord
ingly.
Whereas:
(6) As
a
result
of
the
granting
of
new
authorisations
by
Implementing Regulation (EU) No 601/2013, the
(1) Commission Implementing Regulation (EU) No
provisions of Commission Regulation (EC) No
601/2013 ( 2 ) authorised cobalt(II) acetate tetrahydrate,
1334/2003 ( 7 ) concerning cobaltous acetate tetrahydrate,
cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3)
basic cobaltous carbonate monohydrate and cobaltous
monohydrate, cobalt(II) sulphate heptahydrate and coated
sulphate heptahydrate are obsolete and should be deleted.
granulated cobalt(II) carbonate hydroxide (2:3)
monohydrate as feed additives belonging to the
category ‘nutritional additives’ and to the functional
(7) As
a
consequence
of
these
modifications,
the
transitional
group ‘compounds of trace elements’.
period provided for in Implementing Regulation (EU) No
601/2013 should be extended in order to allow
interested parties to prepare themselves to meet the
(2) In order to clarify the identification of the additive
requirements resulting from the amendments. As
cobalt(II) carbonate, the chemical formula Cobalt
regards feed intended for pet animals, the market
hydroxide should be deleted from the active substances.
consists in a huge number of different products with a
specific labelling system. It is therefore appropriate to
prolong such a transitional period in order to allow a
smooth transition for the feed business operators
(3) For
better
clarity
and
to
avoid
confusion
with
the
identi
concerned.
fication numbers of selenium compounds authorised as
feed additives, it is appropriate to technically modify the
identification numbers for the cobalt compounds.
(8) Implementing
Regulation
(EU)
No
601/2013
should
be
amended accordingly.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinions of 12 June 2012 ( 3 ), ( 4 ) and
(9) In addition, a transitional period for operators who
22 May 2012 ( 5 ) that specific measures for the protection
applied the provisions of Implementing Regulation (EU)
of the users should be foreseen. The respective
No 601/2013 should be established.
requirement that compounds with a high dusting
( 1 ) OJ L 268, 18.10.2003, p. 29.
(10) The
measures
provided
for
in
this
Regulation
are
in
( 2 ) Commission Implementing Regulation (EU) No 601/2013 of
accordance with the opinion of the Standing
24 June 2013 concerning the authorisation of cobalt(II) acetate
Committee on the Food Chain and Animal Health,
tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide
(2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated
granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as
( 6 ) EFSA Journal 2012; 10(7):2782.
feed additives (OJ L 172, 25.6.2013, p. 14).
( 7 ) Commission Regulation (EC) No 1334/2003 of 25 July 2003
( 3 ) EFSA Journal 2012; 10(7):2791.
amending the conditions for authorisation of a number of
( 4 ) EFSA Journal 2012; 10(7):2782.
additives in feedingstuffs belonging to the group of trace elements
( 5 ) EFSA Journal 2012; 10(6):2727.
(OJ L 187, 26.7.2003, p. 11).

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L 41/4
EN
Official Journal of the European Union
12.2.2014
HAS ADOPTED THIS REGULATION:
are produced and labelled before 4 September 2014 in
accordance with the rules applicable before 15 July 2013
Article 1
may continue to be placed on the market and used until
the existing stocks are exhausted. As regards feed intended
Amendment to Implementing Regulation (EU)
for pet animals, the time period for production and labelling
No 601/2013
referred to in the first sentence shall end on 4 March 2016.’
Implementing Regulation (EU) No 601/2013 shall be amended
as follows:
3. The Annex is replaced by the text set out in the Annex to
1. The following Article 1a is added:
this Regulation.
‘Article 1a
Article 2
Amendment to Commission Regulation (EC)
No 1334/2003 (*)
Transitional measures
In the Annex to Regulation (EC) No 1334/2003, the entries
The substances specified in the Annex which were authorised by
“cobaltous acetate tetrahydrate”, “basic cobaltous carbonate
Implementing Regulation (EU) No 601/2013 and feed
monohydrate” and “cobaltous sulphate heptahydrate”, related
containing them, which are produced and labelled before
to the element E3 Cobalt-Co, are deleted.
4 September 2014 in accordance with the rules applicable
before 4 March 2014 may continue to be placed on the
market and used until the existing stocks are exhausted. As
___________
regards feed intended for pet animals, the time period for
(*) OJ L 187, 26.7.2003, p. 11.’
production and labelling referred to in the first sentence shall
end on 4 March 2016.
2. Article 2 is replaced by the following:
Article 3
‘Article 2
Entry into force
Transitional measures
This Regulation shall enter into force on the twentieth day
The substances specified in the Annex which were authorised
following that of its publication in the Official Journal of the
by Directive 70/524/EEC and feed containing them, which
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 February 2014.
For the Commission
The President
José Manuel BARROSO

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12.2.2014 Off
ANNEX
‘ANNEX
Minimum
Maximum
Identifi
content
content
EN
cation
Name of the

number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b301
— Cobalt(II) Additive composition
ruminants with a
—
— 1
(total) 1.
The
additive
shall
be
incorporated
into 15 July 2023
acetate
functional rumen,
compound feed in the form of a
tetrahydrate
Cobalt(II) acetate tetrahydrate, as
equidae,
premixture.
crystals/granules, with a minimum
lagomorphs,
content of 23 % cobalt
rodents, herbivore
2. Protective measures shall be taken
reptiles and zoo
according to national regulations
icial
Particles < 50 μm: below 1 %
mammals
implementing EU legislation on health
Jour
and safety at work including Council
Characterisation of the active substance
Directives 89/391/EEC (2 ),
nal
89/656/EEC (3 ), 92/85/EEC (4 ) and
Chemical formula:
98/24/EC (5 ). Appropriate protective
of
Co(CH
the
3COO) 2 × 4H 2O
gloves, respiratory and eye protection
according to Council Directive
European
CAS number: 6147-53-1
89/686/EEC (6 ) shall be worn during
handling.
Analytical methods (1 )
3. Declarations to be made on the labelling
Union
For the identification of acetate in the
of the additive and premixture:
additive:
— Cobalt content
— European Pharmacopoeia
monograph 01/2008:20301.
— “It is recommended to limit the
supplementation with Cobalt to
For the crystallographic characterisation
0,3 mg/kg in complete feed. In this
of additive:
context, the risk for Cobalt deficiency
due to local conditions and the
— X-Ray diffraction.
specific composition of the diet
should be taken into account.”
For the determination of total cobalt in
the additive, premixtures, compound feed
4. Declarations to be made on the
and feed materials:
instructions of use of the compound feed:
— EN 15510 — inductively coupled
‘Protective measures to avoid exposure
plasma optical (atomic) emission
with Cobalt by inhalation or by dermal
spectrometry (ICP-AES)
route should be taken.’
L
41/5
or

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L 41/6
Minimum
Maximum
Identifi
content
content
cation
Name of the
number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
EN
—
CEN/TS 15621 — inductively

coupled plasma optical (atomic)
emission spectrometry (ICP-AES) after
pressure digestion.
For determination of particle size
distribution:
— ISO 13320:2009 — Particle size
analysis — Laser diffraction methods.
Off
3b302
— Cobalt(II) Additive composition
ruminants with a
—
— 1
(total) 1.
The
additive
shall
be
incorporated
into 15 July 2023
icial
carbonate
functional rumen,
compound feed in the form of a
Cobalt(II) carbonate, as powder, with a
equidae,
premixture. This compound feed shall be
Jour
minimum content of 46 % cobalt
lagomorphs,
placed on the market in a non-powder
nal
Cobalt carbonate: minimum 75 %
rodents, herbivore
form.
reptiles and zoo
of
Cobalt hydroxide: 3 % - 15 %
mammals
the
Water: maximum 6 %
2. Appropriate measures shall be taken to
avoid the cobalt emission in the air and
European
Particles < 11 μm: below 90 %
prevent the exposure by inhalation or by
dermal route. If such measures are
Characterisation of the active substances
technically not feasible or not sufficient,
protective measures shall be taken
Union
Chemical formula: CoCO
according to national regulations

3
implementing EU legislation on health
and safety at work including Directives
CAS number: 513-79-1
89/391/EEC, 89/656/EEC, 92/85/EEC,
98/24/EC and 2004/37/EC of the
Analytical methods (1 )
European Parliament and of the
Council (7 ). Appropriate protective gloves,
For the identification of carbonate in the
respiratory and eye protection according
additive:
to Directive 89/686/EEC shall be worn
during handling.
— European Pharmacopoeia monograph
01/2008:20301.
3. Declarations to be made on the labelling
of the additive and premixture:
For the crystallographic characterisation
of additive:
— Cobalt content
12.2.2014
— X-Ray diffraction.

---

12.2.2014 Off
Minimum
Maximum
Identifi
content
content
cation
Name of the
number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
For the determination of total cobalt in
— ‘It is recommended to limit the
the additive, premixtures, compound feed
supplementation with Cobalt to
EN
and feed materials:
0,3 mg/kg in complete feed. In this

context, the risk for Cobalt deficiency
— EN 15510 — inductively coupled
due to local conditions and the
plasma optical (atomic) emission
specific composition of the diet
spectrometry (ICP-AES)
should be taken into account.’
or
4. Declarations to be made on the
instructions of use of the compound feed:
— CEN/TS 15621 — inductively coupled
plasma optical (atomic) emission
‘Protective measures to avoid exposure
spectrometry (ICP-AES) after pressure
with Cobalt by inhalation or by dermal
digestion.
route should be taken.’
icial
For determination of particle size
Jour
distribution:
nal
— ISO 13320:2009 — Particle size
of
analysis — Laser diffraction methods.
the
3b303
— Cobalt(II) Additive composition
ruminants with a
—
— 1
(total) 1.
The
additive
shall
be
incorporated
into 15 July 2023
European
carbonate
functional rumen,
compound feed in the form of a
hydroxide
Cobalt (II) carbonate hydroxide (2:3)
equidae,
premixture. This compound feed shall be
(2:3)
monohydrate, as powder, with a
lagomorphs,
placed on the market in a non-powder
Union
monohy
minimum content of 50 % cobalt
rodents, herbivore
form.
drate
reptiles and zoo
Particles < 50 μm: below 98 %
mammals
2. Appropriate measures shall be taken to
avoid the cobalt emission in the air and
Characterisation of the active substance
prevent the exposure by inhalation or by
dermal route. If such measures are
Chemical formula:
technically not feasible or not sufficient,
2CoCO 3 × 3Co(OH) 2 × H 2O
protective measures shall be taken
according to national regulations
CAS number: 51839-24-8
implementing EU legislation on health
Analytical methods (1 )
and safety at work including Directives
89/391/EEC, 89/656/EEC, 92/85/EEC,
For the identification of carbonate in the
98/24/EC and 2004/37/EC. Appropriate
additive:
protective gloves, respiratory and eye
protection according to Directive
— European Pharmacopoeia monograph
89/686/EEC shall be worn during
01/2008:20301.
handling.
3. Declarations to be made on the labelling
L
of the additive and premixture:
41/7
— Cobalt content

---

L 41/8
Minimum
Maximum
Identifi
content
content
cation
Name of the
number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
For the crystallographic characterisation
— ‘It is recommended to limit the
EN
of additive:
supplementation with Cobalt to

0,3 mg/kg in complete feed. In this
— X-Ray diffraction.
context, the risk for Cobalt deficiency
due to local conditions and the
For the determination of total cobalt in
specific composition of the diet
the additive, premixtures, compound feed
should be taken into account.’
and feed materials:
4. Declarations to be made on the
— EN 15510 — inductively coupled
instructions of use of the compound feed:
plasma optical (atomic) emission
spectrometry (ICP-AES)
‘Protective measures to avoid exposure
Off
with Cobalt by inhalation or by dermal
or
route should be taken.’
icial
— CEN/TS 15621 — inductively coupled
Jour
plasma optical (atomic) emission
nal
spectrometry (ICP-AES) after pressure
digestion.
of
the
For determination of particle size
European
distribution:
— ISO 13320:2009 — Particle size
analysis — Laser diffraction methods.
Union
3b304
— Coated Additive composition
ruminants with a
—
— 1
(total) 1.
The
additive
shall
be
incorporated
into 15 July 2023
granulated
functional rumen,
feed in the form of a premixture.
cobalt(II)
Coated granulated preparation of
equidae,
carbonate
cobalt(II) carbonate with a cobalt content lagomorphs,
2. Protective measures shall be taken
of 1 % - 5 %
rodents, herbivore
according to national regulations
reptiles and zoo
implementing EU legislation on health
Coating agents (2,3 % - 3,0 %) and
mammals
and safety at work including Directives
dispersants (choice of poly-oxy-ethylene,
89/391/EEC, 89/656/EEC, 92/85/EEC
sorbitan monolaurate, glycerol poly
and 98/24/EC. Appropriate protective
ethyleneglycol ricinoleate, polyethyle
gloves, respiratory and eye protection
neglycol 300, sorbitol, and maltodextrin)
according to Directive 89/686/EEC shall
be worn during handling.
Particles < 50 μm: below 1 %
3. Declarations to be made on the labelling
Characterisation of the active substance
of the additive and premixture, if
applicable:
Chemical formula: CoCO 3
12.2.2014
— Cobalt content
CAS number: 513-79-1

---

12.2.2014 Off
Minimum
Maximum
Identifi
content
content
cation
Name of the
number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
Analytical methods (1 )
— ‘It is recommended to limit the
EN
supplementation with Cobalt to
For the identification of carbonate in the

0,3 mg/kg in complete feed. In this
additive:
context, the risk for Cobalt deficiency
— European Pharmacopoeia monograph
due to local conditions and the
01/2008:20301.
specific composition of the diet
should be taken into account.’
For the crystallographic characterisation
of additive:
— X-Ray diffraction.
For the determination of total cobalt in
the additive, premixtures, compound feed
and feed materials:
icial
— EN 15510 — inductively coupled
Jour
plasma optical (atomic) emission
spectrometry (ICP-AES)
nal
of
or
the
— CEN/TS 15621 — inductively coupled
European
plasma optical (atomic) emission
spectrometry (ICP-AES) after pressure
digestion.
For determination of particle size
Union
distribution:
— ISO 13320:2009 — Particle size
analysis — Laser diffraction methods.
3b305
— Cobalt(II) Additive composition
ruminants with a
—
— 1
(total) 1.
The
additive
shall
be
incorporated
into 15 July 2023
sulphate
functional rumen,
compound feed in the form of a
heptahydrate Cobalt(II) sulphate heptahydrate, as
equidae,
premixture. This compound feed shall be
powder, with a minimum content of
lagomorphs,
placed on the market in a non-powder
20 % cobalt
rodents, herbivore
form.
Particles < 50 μm: below 95 %
reptiles and zoo
mammals
2. Appropriate measures shall be taken to
Characterisation of the active substance
avoid the cobalt emission in the air and
prevent the exposure by inhalation or by
Chemical formula: CoSO 4 × 7H 2O
dermal route. If such measures are
CAS number: 10026-24-1
technically not feasible or not sufficient,
protective measures shall be taken
according to national regulations
L
implementing EU legislation on health
41/9
and safety at work including Directives

---

L 41/10
Minimum
Maximum
Identifi
content
content
cation
Name of the
number
holder of
Additive
Composition, chemical formula, description,
Species or category of Maximum
Other provisions
End of period of
of the
authorisation
analytical method
animal
age
Element (Co) in mg/kg of
authorisation
additive
complete feed with a
moisture content of 12 %
Analytical methods (1 )
89/391/EEC, 89/656/EEC, 92/85/EEC,
98/24/EC and 2004/37/EC. Appropriate
EN
For the identification of sulphate in the
protective gloves, respiratory and eye

additive:
protection according to Directive
89/686/EEC shall be worn during
— European Pharmacopoeia monograph
handling.
01/2008:20301.
3. Declarations to be made on the labelling
For the crystallographic characterisation
of the additive and premixture:
of additive:
— Cobalt content
— X-Ray diffraction.
— ‘It is recommended to limit the
For the determination of total cobalt in
Off
supplementation with Cobalt to
the additive, premixtures, compound feed
icial
0,3 mg/kg in complete feed. In this
and feed materials:
context, the risk for Cobalt deficiency
Jour
— EN 15510 — inductively coupled
due to local conditions and the
plasma optical (atomic) emission
specific composition of the diet
nal
spectrometry (ICP-AES)
should be taken into account.’
of
the
or
4. Declarations to be made on the
instructions of use of the compound feed:
European
— CEN/TS 15621 — inductively coupled
plasma optical (atomic) emission
‘Protective measures to avoid exposure
spectrometry (ICP-AES) after pressure
with Cobalt by inhalation or by dermal
digestion.
route should be taken.’
Union
For determination of particle size
distribution:
— ISO 13320:2009 — Particle size
analysis — Laser diffraction methods.
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(2 ) OJ L 183, 29.6.1989, p. 1.
(3 ) OJ L 393, 30.12.1989, p. 18.
(4 ) OJ L 348, 28.11.1992, p. 1.
(5 ) OJ L 131, 5.5.1998, p. 11.
(6 ) OJ L 399, 30.12.1989, p. 18.
(7 ) OJ L 158, 30.4.2004, p. 50.’
12.2.2014

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Document Outline

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