Renewal of authorisation
The authorisation of the substance specified in the Annex belonging to the additive category ‘technological additives’ and the functional group ‘preservatives’ for use in feed for all animal species other than aquatic animals, and to the additive category ‘technological additives’ and the functional group ‘acidity regulators’ for use in feed for terrestrial animal species other than pets and other non-food-producing animals, is renewed subject to the conditions laid down in that Annex.
Authorisation
The substance specified in the Annex, belonging to the additive category ‘technological additives’ and the functional group ‘acidity regulators’ and to the additive category ‘sensory additives’ and the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition for pets and other non-food-producing animals other than aquatic animals, subject to the conditions laid down in that Annex.
Repeal
Implementing Regulation (EU) 2015/1416 is repealed.
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
Identification number of the feed additive
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
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Category: technological additives. Functional group: preservatives
1j514ii
Sodium bisulphate
Additive composition
Sodium bisulphate: ≥ 95,2 %
Nickel: maximum 1 mg/kg
Characterisation of active substance
Sodium bisulphate
Produced by chemical synthesis
Na: 19,15 %
SO 4: 80,01 %
Chemical formula: NaHSO 4
CAS number: 7681-38-1
Analytical method
( 1 )
For the determination of sodium bisulphate in the feed additive:
Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’.
All animal species other than aquatic animals, cats and mink
-
-
4 000
1.
In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.
2.
The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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 skin, eye and breathing protective equipment.
30 September 2034
Cats
20 000
Mink
10 000
Identification number of the feed additive
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
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Category: technological additives. Functional group: acidity regulators
1j514ii
Sodium bisulphate
Additive composition
Sodium bisulphate: ≥ 95,2 %
Nickel: maximum 1 mg/kg
Characterisation of active substance
Sodium bisulphate
Produced by chemical synthesis
Na: 19,15 %
SO 4: 80,01 %
Chemical formula: NaHSO 4
CAS number: 7681-38-1
Analytical method
( 2 )
For the determination of sodium bisulphate in the feed additive:
Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’.
All animal species other than aquatic animals, cats and mink
-
-
4 000
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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 skin, eye and breathing protective equipment.
30 September 2034
Cats
20 000
Mink
10 000
Identification number of the feed additive
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
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Category: Sensory additives. Functional group: flavouring compounds
1j514ii
Sodium bisulphate
Additive composition
Sodium bisulphate: ≥ 95,2 %
Nickel: maximum 1 mg/kg
Characterisation of active substance
Sodium bisulphate
Produced by chemical synthesis
Na: 19,15 %
SO 4: 80,01 %
Chemical formula: NaHSO 4
CAS number: 7681-38-1
Analytical method
( 3 )
For the determination of sodium bisulphate in the feed additive:
Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’.
Pets and other non-food-producing animals other than aquatic animals, cats and mink
-
-
4 000
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
3.
The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.
4.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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 skin, eye and breathing protective equipment.
30 September 2034
Cats
20 000
Mink
10 000
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .
( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .
( 3 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .
