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COMMISSION REGULATION (EC) No 1730/2006
of 23 November 2006
concerning the authorisation of benzoic acid (VevoVitall) as a feed additive
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
(3)
The application concerns authorisation of the preparation benzoic acid (VevoVitall) as a feed additive for weaned piglets, to be classified in the additive category zootechnical additives.
(4)
The European Food Safety Authority (the Authority) concluded in its opinion of 9 December 2005 that benzoic acid (VevoVitall) does not have an adverse effect on animal health, human health or the environment ( 2 ). It further concluded that benzoic acid (VevoVitall) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation improves the performance parameters, such as weight gain or feed gain ratio, in piglets. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post-market monitoring. This opinion also verifies the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of that preparation shows that the conditions for authorisation, 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.
(5)
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
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 20th 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.
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Identification number of the additive
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Name of the holder of authorisation
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Additive
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Composition, chemical formula, description, analytical method
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Species or category of animal
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Maximum age
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Minimum content
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Maximum content
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Other provisions
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End of period of authorisation
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mg/kg of complete feedingstuff with a moisture content of 12 %
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Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters: weight gain or feed gain ratio)
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4d210
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Emerald Kalama Chemical BV
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Benzoic acid
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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
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Piglets
(weaned)
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5 000
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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.
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14.12.2016
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(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
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