# L_2006325EN.01000901.xml

| 24.11.2006 | EN | Official Journal of the European Union | L 325/9 |
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24.11.2006

EN

Official Journal of the European Union

L 325/9

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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. |
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(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. |
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(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’. |
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(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. |
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(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, |
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(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.

Done at Brussels, 23 November 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product VevoVitall® as a feed additive for weaned piglets in accordance with Regulation (EC) No 1831/2003. Adopted on 30 November 2005. The EFSA Journal (2005) 290, pp. 1 to 13.

2

The EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (Trade name) | Maximum content of element (Se) in mg/kg of complete feedingstuff with a moisture content of 12 % | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
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| mg of active substance/kg of complete feedingstuff |
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters: weight gain or feed gain ratio) |
| 4 d 210 | DSM Special Products | Benzoic acid
  (VevoVitall) | | Additive composition:

  Benzoic acid (≥ 99,9 %) |

Identification number of the additive

Name of the holder of authorisation

Additive

(Trade name)

Maximum content of element (Se) in mg/kg of complete feedingstuff with a moisture content of 12 %

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters: weight gain or feed gain ratio)

4 d 210

DSM Special Products

Benzoic acid

(VevoVitall)

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
  Heavy metals: ≤ 10 mg/kg
  Arsenic: ≤ 2 mg/kg |
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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

Heavy metals: ≤ 10 mg/kg

Arsenic: ≤ 2 mg/kg

| | Analytical method
   (1)

  Reversed Phase HPLC coupled with UV detection |
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Analytical method
   (1)

Reversed Phase HPLC coupled with UV detection

Piglets

(weaned)

—

5 000

5 000

Complementary feedingstuffs for piglets may not contain more than 10 000 mg/kg of benzoic acid.

The directions for use shall indicate the following:

| | ‘To be used for animals up to 25 kg’ |
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‘To be used for animals up to 25 kg’

| | ‘Complementary feed containing benzoic acid may not be fed to piglets as such’ |
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‘Complementary feed containing benzoic acid may not be fed to piglets as such’

| | The additive shall be incorporated in compound feedingstuffs in form of a premixture. |
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The additive shall be incorporated in compound feedingstuffs in form of a premixture.

| | ‘For user safety: measures should be taken to minimize the production of breathable dust from this additive. Material safety data sheets (MSDS) available.’ |
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‘For user safety: measures should be taken to minimize the production of breathable dust from this additive. Material safety data sheets (MSDS) available.’

14.12.2016

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

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