Commission Implementing Regulation (EU) No 226/2012 of 15 March 2012 amending Regulation (EC) No 1730/2006 as regards the conditions of use of benzoic acid (holder of authorisation Emerald Kalama Chemical BV)  Text with EEA relevance
Date: 2012-03-15
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, market approval, swine




L_2012077EN.01000601.xml










16.3.2012   


EN


Official Journal of the European Union


L 77/6








            COMMISSION IMPLEMENTING REGULATION (EU) No 226/2012
of 15 March 2012
         
amending Regulation (EC) No 1730/2006 as regards the conditions of use of benzoic acid (holder of authorisation Emerald Kalama Chemical BV)
(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 13(3) thereof,

Whereas:







(1)


The preparation benzoic acid, belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 (2) and for use in pigs for fattening by Commission Regulation (EC) No 1138/2007 (3).












(2)


In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of the preparation benzoic acid as feed additive for weaned piglets to delete the condition regarding inclusion of that preparation in compound feed via premixture and to modify the conditions regarding complementary feedingstuffs. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’).












(3)


The Authority concluded in its opinion of 6 September 2011 (4) that there is no reason to continue to restrict the inclusion of the preparation benzoic acid to compound feed via premixtures. It considered the restrictions on the use of the additive in complementary feed established by Regulation (EC) No 1138/2007 as being sufficient and applicable to weaned piglets.












(4)


The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.












(5)


Regulation (EC) No 1730/2006 should therefore be amended accordingly.












(6)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,





HAS ADOPTED THIS REGULATION:



Article 1
Annex to Regulation (EC) No 1730/2006 is replaced by the text of the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the 20th day following 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, 15 March 2012.


For the Commission


The President

José Manuel BARROSO
            





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

(2)  
            OJ L 325, 24.11.2006, p. 9.

(3)  
            OJ L 256, 2.10.2007, p. 8.

(4)  
            EFSA Journal 2011; 9(9):2358.




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 (improvement of performance parameters: weight gain or feed gain ratio)






4d210


Emerald Kalama Chemical BV


Benzoic acid








 



Additive composition

Benzoic acid (≥ 99,9 %)










 



Characterisation of the active substance

Benzenecarboxylic acid, phenylcarboxylic acid, C7H6O2

CAS number 65-85-0
Maximum level in:






 


Phthalic acid: ≤ 100 mg/kg










 


Biphenyl: ≤ 100 mg/kg














 



Analytical method
 (1)

Quantification of benzoic acid in the feed additive: titration with sodium hydroxide (European Pharmacopeia monograph 0066)
Quantification of benzoic acid in the premixture and feedingstuff: Reversed Phase Liquid chromatography with UV detection (RP-HPLC/UV) — method based on ISO9231:2008






Piglets
(weaned)


—


—


5 000 








1.


The mixture of different sources of benzoic acid must not exceed the permitted maximum level in complete feedingstuff of 5 000  mg/kg of complete feed.










2.


Recommended minimum dose: 5 000  mg/kg of complete feed.










3.


Complementary feed containing benzoic acid must not be fed directly to weaned piglets, unless thoroughly mixed with other feed materials of the daily ration.










4.


For weaned piglets up to 25 kg.










5.


For safety: it is recommended to use breathing protection and gloves during handling.






14.12.2016









(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx’