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Commission Implementing Regulation (EU) 2015/1426 of 25 August 2015 concerning the authorisation of the preparation of benzoic acid, thymol, eugenol and piperine as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying (holder of the authorisation DSM Nutritional Product) (Text with EEA relevance)

In forceVersion 2015-08-25from 2015-09-15
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Contents
  1. Preamble
    1. Article 1
    2. Article 2
  3. ANNEX
  4. ANNEX 1.2.3.4.
  5. ANNEX Additive composition

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 the preparation of benzoic acid, thymol, eugenol and piperine. 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 preparation of benzoic acid, thymol, eugenol and piperine as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, to be classified in the additive category zootechnical additives.

(4) The European Food Safety Authority (the Authority) concluded in its opinions of 7 March 2012 and 28 October 2014 that, under the proposed conditions of use, the preparation of benzoic acid, thymol, eugenol and piperine does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve feed to gain ratio in chickens for fattening. It also considered that this conclusion could be extended to chickens reared for laying. Since the mode of action can be assumed to be the same in all poultry species, this conclusion can be extrapolated to include the minor poultry species for fattening and reared for laying. 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 the preparation of benzoic acid, thymol, eugenol and piperine 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.

(6) 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 preparation 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, 25 August 2015. For the Commission The President Jean-Claude Juncker

ANNEX

ANNEX 1.2.3.4.

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 (improvement of zootechnical parameters). 4d10 DSM Nutritional Products AG represented in the EU by DSM Nutritional Products Sp. z o.o. Poland Preparation of benzoic acid, thymol, eugenol, piperine Chickens for fattening Chickens reared for laying Minor poultry species for fattening and reared for laying — — 300 In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. The additive shall not be used with other sources of benzoic acid or benzoates. For safety: breathing protection, glasses and gloves shall be used during handling. Minimum recommended dose: 300 mg/kg of complete feedingstuff 15.9.2025

ANNEX Additive composition

Preparation of benzoic acid, thymol, eugenol, piperine having a content of:

benzoic acid 80 %-83 %

thymol 1 %-1,9 %

eugenol 0,5 %-1 %

piperine 0,05 %-0,1 %

benzyl salicylate, iso-amyl salicylate and trans-anethole ≤ 0,6 %

Characterisation of the active substances

benzoic acid (≥ 95,5 % purity): C7H6O2 CAS number: 65-85-0 thymol: C10H14O CAS number 89-83-8 eugenol: C10H12O2 CAS number 97-53-0 piperine: C17H19O3N CAS number 94-62-2 Isoamyl salicylate CAS number 87-20-7 Benzyl salicylate CAS number 118-58-1 Trans-anethole CAS number 4180-23-8

Analytical method

For the determination of benzoic acid in the feed additive and premixtures: For the determination of benzoic acid in compound feed: For the determination of thymol, eugenol and piperine in the feed additive:

Reverse Phase High-Performance Liquid Chromatography coupled to an Ultraviolet detector (RP-HPLC-UV)

Gas Chromatography Isotope Dilution Mass Spectrometry (GC-IDMS)

Gas Chromatography coupled to a Flame Ionisation Detector (GC-FID)

Versions

  1. 2015-08-25

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