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Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for sows (holder of authorisation DSM Nutritional Product Sp. z o. o.) (Text with EEA relevance)

In forceVersion 2016-06-08from 2016-06-29
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Contents
  1. Preamble
    1. Article 1
    2. Article 2
  3. ANNEX
  4. ANNEX

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

(3) That application concerns the authorisation of the benzoic acid as a feed additive for sows, to be classified in the additive category zootechnical additives.

(4) That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 and in pigs for fattening by Commission Regulation (EC) No 1138/2007.

(5) The European Food Safety Authority (the Authority) concluded in its opinions of 14 June 2012 and 16 June 2015 that, under the proposed conditions of use, the benzoic acid does not have an adverse effect on animal health, human health or the environment, and that it has a potential to introduce a small reduction in urine pH in sows. 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.

(6) The assessment of the benzoic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex 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 additive specified in the Annex, belonging to the additive category zootechnical additives and to the functional group other zootechnical additives, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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, 8 June 2016. For the Commission The President Jean-Claude Juncker

ANNEX

ANNEX

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 zootechnical additives. Functional group: other zootechnical additives (urinary pH decrease) 4d210 DSM Nutritional Products Sp. z o. o. Benzoic acid Sows — 5000 10000 29 June 2026

Additive composition

Benzoic acid (≥ 99,9 %)

Characterisation of the active substance

Benzenecarboxylic acid, phenylcarboxylic acid, C7H6O2 CAS number 65-85-0 Maximum level of the impurities:

Phthalic acid: ≤ 100 mg/kg

Biphenyl: ≤ 100 mg/kg

Analytical method

For the quantification of benzoic acid in the feed additive: For the quantification of the benzoic acid in the premixtures and feedingstuffs:

titration with sodium hydroxide (European Pharmacopoeia monograph 0066).

reversed phase liquid chromatography with UV detection (RP-HPLC/UV) — method based on ISO9231:2008.

1. The directions of use shall be indicated the following in complementary feed: Complementary feedingstuffs containing benzoic acid shall not be fed to sows as such. Complementary feedingstuffs for sows shall be thoroughly mixed with other feed materials of the daily ration.

2. For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

Versions

  1. 2016-06-08

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