# L_2007256EN.01000801.xml

| 2.10.2007 | EN | Official Journal of the European Union | L 256/8 |
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2.10.2007

EN

Official Journal of the European Union

L 256/8

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COMMISSION REGULATION (EC) No 1138/2007

of 1 October 2007

concerning the authorisation of a new use 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 to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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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 to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a new use the preparation benzoic acid (VevoVitall) as a feed additive for pigs for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of a new use the preparation benzoic acid (VevoVitall) as a feed additive for pigs for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of the preparation of benzoic acid (VevoVitall) was authorised for weaned piglets by Commission Regulation (EC) No 1730/2006 (2). |
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(4)

The use of the preparation of benzoic acid (VevoVitall) was authorised for weaned piglets by Commission Regulation (EC) No 1730/2006 (2).

| (5) | New data were submitted in support of an application for authorisation for pigs for fattening. The European Food Safety Authority (the Authority) concluded in its opinion of 7 March 2007 that benzoic acid (VevoVitall) does not have an adverse effect on animal health, human health or the environment (3). 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 does not have an adverse effect on this additional animal. 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. |
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(5)

New data were submitted in support of an application for authorisation for pigs for fattening. The European Food Safety Authority (the Authority) concluded in its opinion of 7 March 2007 that benzoic acid (VevoVitall) does not have an adverse effect on animal health, human health or the environment (3). 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 does not have an adverse effect on this additional animal. 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.

| (6) | 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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(6)

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.

| (7) | 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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(7)

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, 1 October 2007.

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)  
  OJ L 325, 24.11.2006, p. 9.

2

(3)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product VevoVitall (benzoic acid) as a feed additive for pigs for fattening in accordance with Regulation (EC) No 1831/2003. Adopted on 7 March 2007. The EFSA Journal (2007) 457, p. 1 to 14.

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (trade name) | 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 (urinary pH decrease) |
| 4d210 | 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)

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 (urinary pH decrease)

4d210

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 Diode Array Detection (DAD) detection |
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Analytical method (1):

Reversed Phase HPLC coupled with Diode Array Detection (DAD) detection

Pigs for fattening

—

5 000

10 000

The directions for use shall indicate the following:

| | Complementary feedingstuffs containing benzoic acid shall not be fed to pigs for fattening as such. |
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Complementary feedingstuffs containing benzoic acid shall not be fed to pigs for fattening as such.

| | Complementary feedingstuffs for pigs for fattening should be thoroughly mixed with other feed materials of the daily ration. |
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Complementary feedingstuffs for pigs for fattening should be thoroughly mixed with other feed materials of the daily ration.

| | 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.

22.10.2017

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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/crl-feed-additives

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