Amendment to Implementing Regulation (EU) No 601/2013
Implementing Regulation (EU) No 601/2013 shall be amended as follows:
1.
The following Article 1a is added:
‘Article 1a
Amendment to Commission Regulation (EC) No 1334/2003 ( *1 )
In the Annex to Regulation (EC) No 1334/2003, the entries “cobaltous acetate tetrahydrate”, “basic cobaltous carbonate monohydrate” and “cobaltous sulphate heptahydrate”, related to the element E3 Cobalt-Co, are deleted.
( *1 )
OJ L 187, 26.7.2003, p. 11 .’
"
2.
Article 2 is replaced by the following:
‘Article 2
Transitional measures
The substances specified in the Annex which were authorised by Directive 70/524/EEC and feed containing them, which are produced and labelled before 4 September 2014 in accordance with the rules applicable before 15 July 2013 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 production and labelling referred to in the first sentence shall end on 4 March 2016.’
3.
The Annex is replaced by the text set out in the Annex to this Regulation.
Transitional measures
The substances specified in the Annex which were authorised by Implementing Regulation (EU) No 601/2013 and feed containing them, which are produced and labelled before 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 production and labelling referred to in the first sentence shall end on 4 March 2016.
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.
ANNEXSupplementary provisions
ANNEX
‘ANNEX
Identification number of the additive
Name of the holder of authorisation
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
Element (Co) in mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b301
—
Cobalt(II) acetate tetrahydrate
Additive composition
Cobalt(II) acetate tetrahydrate, as crystals/granules, with a minimum content of 23 % cobalt
Particles < 50 μm: below 1 %
Characterisation of the active substance
Chemical formula: Co(CH 3 COO) 2 × 4H 2 O
CAS number: 6147-53-1
Analytical methods
( 1 )
For the identification of acetate in the additive:
—
European Pharmacopoeia monograph 01/2008:20301.
For the crystallographic characterisation of additive:
—
X-Ray diffraction.
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
—
EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
—
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.
ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
—
—
1 (total)
1.
The additive shall be incorporated into compound feed in the form of a premixture.
2.
Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Council Directives 89/391/EEC ( 2 ) , 89/656/EEC ( 3 ) , 92/85/EEC ( 4 ) and 98/24/EC ( 5 ) . Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC ( 6 ) shall be worn during handling.
3.
Declarations to be made on the labelling of the additive and premixture:
—
Cobalt content
—
“It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.”
4.
Declarations to be made on the instructions of use of the compound feed:
‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’
15 July 2023
3b302
—
Cobalt(II) carbonate
Additive composition
Cobalt(II) carbonate, as powder, with a minimum content of 46 % cobalt
Cobalt carbonate: minimum 75 %
Cobalt hydroxide: 3 % - 15 %
Water: maximum 6 %
Particles < 11 μm: below 90 %
Characterisation of the active substances
Chemical formula: CoCO 3
CAS number: 513-79-1
Analytical methods
( 1 )
For the identification of carbonate in the additive:
—
European Pharmacopoeia monograph 01/2008:20301.
For the crystallographic characterisation of additive:
—
X-Ray diffraction.
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
—
EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
—
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.
ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
—
—
1 (total)
1.
The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.
2.
Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC of the European Parliament and of the Council ( 7 ) . Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.
Declarations to be made on the labelling of the additive and premixture:
—
Cobalt content
—
‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’
4.
Declarations to be made on the instructions of use of the compound feed:
‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’
15 July 2023
3b303
—
Cobalt(II) carbonate hydroxide (2:3) monohydrate
Additive composition
Cobalt (II) carbonate hydroxide (2:3) monohydrate, as powder, with a minimum content of 50 % cobalt
Particles < 50 μm: below 98 %
Characterisation of the active substance
Chemical formula: 2CoCO 3 × 3Co(OH) 2 × H 2 O
CAS number: 51839-24-8
Analytical methods
( 1 )
For the identification of carbonate in the additive:
—
European Pharmacopoeia monograph 01/2008:20301.
For the crystallographic characterisation of additive:
—
X-Ray diffraction.
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
—
EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
—
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.
ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
—
—
1 (total)
1.
The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.
2.
Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.
Declarations to be made on the labelling of the additive and premixture:
—
Cobalt content
—
‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’
4.
Declarations to be made on the instructions of use of the compound feed:
‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’
15 July 2023
3b304
—
Coated granulated cobalt(II) carbonate
Additive composition
Coated granulated preparation of cobalt(II) carbonate with a cobalt content of 1 % - 5 %
Coating agents (2,3 % - 3,0 %) and dispersants (choice of poly-oxy-ethylene, sorbitan monolaurate, glycerol polyethyleneglycol ricinoleate, polyethyleneglycol 300, sorbitol, and maltodextrin)
Particles < 50 μm: below 1 %
Characterisation of the active substance
Chemical formula: CoCO 3
CAS number: 513-79-1
Analytical methods
( 1 )
For the identification of carbonate in the additive:
—
European Pharmacopoeia monograph 01/2008:20301.
For the crystallographic characterisation of additive:
—
X-Ray diffraction.
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
—
EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
—
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.
ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
—
—
1 (total)
1.
The additive shall be incorporated into feed in the form of a premixture.
2.
Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.
Declarations to be made on the labelling of the additive and premixture, if applicable:
—
Cobalt content
—
‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’
15 July 2023
3b305
—
Cobalt(II) sulphate heptahydrate
Additive composition
Cobalt(II) sulphate heptahydrate, as powder, with a minimum content of 20 % cobalt
Particles < 50 μm: below 95 %
Characterisation of the active substance
Chemical formula: CoSO 4 × 7H 2 O
CAS number: 10026-24-1
Analytical methods
( 1 )
For the identification of sulphate in the additive:
—
European Pharmacopoeia monograph 01/2008:20301.
For the crystallographic characterisation of additive:
—
X-Ray diffraction.
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
—
EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
—
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.
ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
—
—
1 (total)
1.
The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.
2.
Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.
Declarations to be made on the labelling of the additive and premixture:
—
Cobalt content
—
‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’
4.
Declarations to be made on the instructions of use of the compound feed:
‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’
15 July 2023
( 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 .’
