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(EU) 2015/1416：批准硫酸氢钠（sodium bisulphate）作为饲料添加剂用于所有动物物种（concerning the authorisation of sodium bisulphate as feed additive for all animal species）

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2015-08-21 04:03:10 来源：欧盟委员会浏览次数：3681

核心提示：2015年8月20日，欧洲委员会发布(EU) 2015/1416号条例，批准硫酸氢钠（sodium bisulphate）作为饲料添加剂用于所有动物物种。列入附录I和II的硫酸氢钠，其添加剂分类均为“技术性添加剂”，在功能分类上分别属于“防腐剂”和“酸度调节剂”，可在规定条件下作为添加剂用于动物营养目的。本法规自发布之日起第20天生效。

发布单位

欧盟委员会

发布文号

(EU) 2015/1416

发布日期

2015-08-20

生效日期

2015-09-09

有效性状态

废止日期

暂无

备注

2015年8月20日，欧洲委员会发布(EU) 2015/1416号条例，批准硫酸氢钠（sodium bisulphate）作为饲料添加剂用于所有动物物种。列入附录I和II的硫酸氢钠，其添加剂分类均为“技术性添加剂”，在功能分类上分别属于“防腐剂”和“酸度调节剂”，可在规定条件下作为添加剂用于动物营养目的。本法规自发布之日起第20天生效。
当硫酸氢钠作为防腐剂使用时，在湿度为12%的饲料全料中的限量如下：

动物	限量mg/kg
猫	20000
貂	10000
除以上两种动物外的所有动物	4000

当硫酸氢钠作为酸度调节剂使用时，在湿度为12%的饲料全料中的限量如下：

动物	限量mg/kg
除猫、貂、宠物以及其他非产肉动物之外的所有动物	4000

　　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.

　　(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 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 (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.

　　(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 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.

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.

10 September 2025

Cats

20 000

Mink

10 000

ANNEX II