# L_2012046EN.01003301.xml

| 17.2.2012 | EN | Official Journal of the European Union | L 46/33 |
| --- | --- | --- | --- |

17.2.2012

EN

Official Journal of the European Union

L 46/33

---

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

(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,

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. |
| --- | --- |

(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) | 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. |
| --- | --- |

(2)

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.

| (3) | The application concerns the authorisation of sodium bisulphate as a feed additive for pets and other non-food producing animals, to be classified in the additive categories ‘technological additives’ and ‘sensory additives’. |
| --- | --- |

(3)

The application concerns the authorisation of sodium bisulphate as a feed additive for pets and other non-food producing animals, to be classified in the additive categories ‘technological additives’ and ‘sensory additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 October 2011 (2) 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 acidity regulator in feed for pets and other non food-producing animals, and as flavouring substance in feed for pets. The Authority does not consider that there is a need for specific requirements 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. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 October 2011 (2) 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 acidity regulator in feed for pets and other non food-producing animals, and as flavouring substance in feed for pets. The Authority does not consider that there is a need for specific requirements 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.

| (5) | 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. |
| --- | --- |

(5)

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.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

The preparation specified in Annex II, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, 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 20th day following 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, 16 February 2012.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  
  EFSA Journal 2011; 9(11):2415.

2

EFSA Journal

---

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: acidity regulators |
| 1j514ii | — | Sodium bisulphate | | Additive composition

  Sodium bisulphate: ≥ 95,2 % |

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 |
| --- | --- | --- |

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

| | Na 19,15 % |
| --- | --- |

Na 19,15 %

| | SO4 80,01 % |
| --- | --- |

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. |
| --- | --- |

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.

Pets and other non-food producing animals

—

—

5 000

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
| --- | --- |

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 mixture of different sources of sodium bisulphate must not exceed the maximum permitted level in complete feedingstuff of 5 000  mg/kg complete feedingstuff. |
| --- | --- |

3.

The mixture of different sources of sodium bisulphate must not exceed the maximum permitted level in complete feedingstuff of 5 000  mg/kg complete feedingstuff.

8 March 2022

---

(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

---

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 sensory additives. Functional group: flavouring compounds |
| 1j514ii | — | Sodium bisulphate | | Additive composition

  Sodium bisulphate: ≥ 95,2 % |

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 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 |
| --- | --- | --- |

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

| | Na 19,15 % |
| --- | --- |

Na 19,15 %

| | SO4 80,01 % |
| --- | --- |

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. |
| --- | --- |

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.

Pets

—

—

5 000

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
| --- | --- |

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 mixture of different sources of sodium bisulphate must not exceed the maximum permitted level in complete feedingstuff of 5 000  mg/kg complete feedingstuff. |
| --- | --- |

3.

The mixture of different sources of sodium bisulphate must not exceed the maximum permitted level in complete feedingstuff of 5 000  mg/kg complete feedingstuff.

8 March 2022

---

(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

---