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)
Date: 2015-08-25
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry




L_2015223EN.01000601.xml










26.8.2015   


EN


Official Journal of the European Union


L 223/6








            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)


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)


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 (2) and 28 October 2014 (3) 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
            





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

(2)  
            EFSA Journal 2012;10(3):2620.

(3)  
            EFSA Journal 2014;12(11):3896.




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 (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



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 (1): C10H14O CAS number 89-83-8
eugenol (1): C10H12O2 CAS number 97-53-0
piperine (1): C17H19O3N CAS number 94-62-2
Isoamyl salicylate (1) CAS number 87-20-7
Benzyl salicylate (1) CAS number 118-58-1
Trans-anethole (1) CAS number 4180-23-8

Analytical method
 (2)

For the determination of benzoic acid in the feed additive and premixtures:






—


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




For the determination of benzoic acid in compound feed:






—


Gas Chromatography Isotope Dilution Mass Spectrometry (GC-IDMS)




For the determination of thymol, eugenol and piperine in the feed additive:






—


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






Chickens for fattening
Chickens reared for laying
Minor poultry species for fattening and reared for laying


—


—


300








1.


In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.










2.


The additive shall not be used with other sources of benzoic acid or benzoates.










3.


For safety: breathing protection, glasses and gloves shall be used during handling.










4.


Minimum recommended dose: 300 mg/kg of complete feedingstuff






15.9.2025






(1)  JECFA, Online Edition: ‘Specifications for Flavourings’: http://www.fao.org/ag/agn/jecfa-flav/index.html#T

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports