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Commission Implementing Regulation (EU) 2015/1414 of 20 August 2015 amending Implementing Regulation (EU) No 136/2012 concerning the authorisation of sodium bisulphate as feed additive for pets and for non-food producing animals (Text with EEA relevance)

Type Implementing Regulation

Publication 2015-08-21

State In force

Text As published

Department European Commission

Source EUR-Lex

articles 4

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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21.8.2015	EN	Official Journal of the European Union	L 220/3

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ¹, and in particular Article 13(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or modifying such authorisation.

(2) The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 ².

(3) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted requesting a modification on the conditions of use. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The application concerns a modification of the conditions of use for pets and other non-food producing animals requesting to modify the content of the additive in the complete feedingstuff.

(5) The European Food Safety Authority concluded in its opinion of 22 May 2014 ³ that, under the proposed conditions of use, the previous content of sodium bisulphate as acidity regulator and as flavouring compound should be modified by new data received.

(6) In order to allow for the use of sodium bisulphate under the new proposed conditions, it is appropriate to amend Implementing Regulation (EU) No 136/2012.

(7) The assessment of sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes to this Regulation.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Implementing Regulation (EU) No 136/2012 shall be replaced by the Annex I to this Regulation.

Article 2

Annex II to Implementing Regulation (EU) No 136/2012 shall be replaced by the Annex II to this Regulation.

Article 3

The substance specified in the Annex, and feed containing it, which are produced and labelled before 10 September 2017 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

This Regulation shall enter into force on the twentieth 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, 20 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

OJ L 268, 18.10.2003, p. 29.

Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food producing animals (OJ L 46, 17.2.2012, p. 33).

EFSA Journal 2014; 12(6):3731.

ANNEX I

‘ANNEX I

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

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 mg/kg of complete feedingstuff with a moisture content of 12 % mg/kg of complete feedingstuff with a moisture content of 12 % Other provisions End of period of authorisation

Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators Category of technological additives. Functional group: acidity regulators

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Pets and other non-food producing animals other than cats and mink — — 4 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species 8 March 2022

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Cats — — 20 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species 8 March 2022

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Mink — — 10 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species 8 March 2022

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
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	mg/kg of complete feedingstuff with a moisture content of 12 %	mg/kg of complete feedingstuff with a moisture content of 12 %	Other provisions	End of period of authorisation
Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators	Category of technological additives. Functional group: acidity regulators
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Pets and other non-food producing animals other than cats and mink	—	—	4 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species	8 March 2022
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Cats	—	—	20 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species	8 March 2022
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000502-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Mink	—	—	10 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species	8 March 2022

[^ntr1-L_2015220EN.01000502-E0001]: Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports’

ANNEX II

‘ANNEX II

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

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 mg/kg of complete feedingstuff with a moisture content of 12 % mg/kg of complete feedingstuff with a moisture content of 12 % Other provisions End of period of authorisation

Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds Category of sensory additives. Functional group: flavouring compounds

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Pets and other non-food producing animals other than cats and mink — — 4 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 8 March 2022

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Cats — — 20 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 8 March 2022

1j514ii — Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. Mink — — 10 000 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 8 March 2022

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
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	mg/kg of complete feedingstuff with a moisture content of 12 %	mg/kg of complete feedingstuff with a moisture content of 12 %	Other provisions	End of period of authorisation
Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds	Category of sensory additives. Functional group: flavouring compounds
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Pets and other non-food producing animals other than cats and mink	—	—	4 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.	8 March 2022
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Cats	—	—	20 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.	8 March 2022
1j514ii	—	Sodium bisulphate	Additive composition Sodium bisulphate: ≥ 95,2 % Characterisation of the active substance Sodium bisulphate CAS No 7681-38-1 NaHSO4 Na 19,15 % SO4 80,01 % Produced by chemical synthesis Method of Analysis [^ntr1-L_2015220EN.01000602-E0001] Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.	Mink	—	—	10 000	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. For safety: breathing protection, eye protection and gloves shall be used during handling. 3. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.	8 March 2022

[^ntr1-L_2015220EN.01000602-E0001]: Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports’

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