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)

In forceVersion 2015-08-20from 2015-09-10

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Contents

Preamble
ANNEX
ANNEX I 1.2.3.
ANNEX II 1.2.3.

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, 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.

(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.

(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.

(5) The European Food Safety Authority (the Authority) concluded in its opinions of 11 October 2011 and of 22 May 2014 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.

(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,

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.

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

ANNEX

ANNEX I 1.2.3.

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 All animal species other than cats and mink — — 4000 In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. For safety: breathing protection, eye protection and gloves shall be used during handling. 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 20000 Mink 10000

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

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.

ANNEX II 1.2.3.

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 All animal species other than cats, mink, pet and other non-food producing animals — — 4000 In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. For safety: breathing protection, eye protection and gloves shall be used during handling. The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 10 September 2025