# L_2015220EN.01001101.xml

| 21.8.2015 | EN | Official Journal of the European Union | L 220/11 |
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21.8.2015

EN

Official Journal of the European Union

L 220/11

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1416

of 20 August 2015

concerning the authorisation of sodium bisulphate as feed additive for all animal species

(Text with EEA relevance)

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 9(2) thereof,

1

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 such authorisation. |
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(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 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). |
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(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).

2

| (3) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of sodium bisulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of sodium bisulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The application concerns the authorisation of sodium bisulphate as a feed additive for all animal species, to be classified in the additive categories ‘technological additives’. |
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(4)

The application concerns the authorisation of sodium bisulphate as a feed additive for all animal species, to be classified in the additive categories ‘technological additives’.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 October 2011 (3) and of 22 May 2014 (4) that, under the proposed conditions of use, sodium bisulphate does not have an adverse effect on animal health, human health or the environment, and that its use is considered efficacious as preservative and acidity regulator for all animal species. The Authority does not consider that there is a need for specific requirement of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 October 2011 (3) and of 22 May 2014 (4) that, under the proposed conditions of use, sodium bisulphate does not have an adverse effect on animal health, human health or the environment, and that its use is considered efficacious as preservative and acidity regulator for all animal species. The Authority does not consider that there is a need for specific requirement of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

3

4

| (6) | 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. |
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(6)

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.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(7)

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

The substance specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

The substance specified in Annex II, belonging to the additive category ‘technological additives’ and to the functional group ‘acidity regulators’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

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(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  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).

2

(3)  EFSA Journal 2011; 9(11):2415.

3

EFSA Journal 2011

(4)  EFSA Journal 2014; 12(6):3731.

4

EFSA Journal 2014

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of technological additives. Functional group: preservatives |
| 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
   (1)

  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. | All animal species 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. |

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

mg/kg of complete feedingstuff with a moisture content of 12 %

Category of technological additives. Functional group: preservatives

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
   (1)

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.

All animal species 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. |
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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. |
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3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.

10 September 2025

Cats

20 000

Mink

10 000

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(1)  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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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| 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
   (1)

  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. | All animal species other than cats, mink, pet and other non-food producing animals | — | — | 4 000 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

mg/kg of complete feedingstuff with a moisture content of 12 %

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
   (1)

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.

All animal species other than cats, mink, pet and other non-food producing animals

—

—

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. |
| --- | --- |

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. |
| --- | --- |

3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.

10 September 2025

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(1)  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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